chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/ shingrix vaccination in 2020, yet I recently developed shingles; shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax (had both the zostravax vacination in 2015 and amp (unspecified)).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received both doses of Shingrix in 2020 and recently developed shingles. The patient asked that need to do another shingles vaccination. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Got second shot and got them a second time/Suspected vaccination failure; Got second shot and got them a second time; Got the 1st shot and got it; It was awful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient's friend.  The age at vaccination was not reported. The patient got the Shingle shot and got shingles. Then physician recommended a second Shingles shot and she got shingle again second time and it was awful for the patient. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Vaccine positive rechallenge
Clinical narrative: Minor fatigue side effect; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of fatigue (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR017687  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced minor fatigue side effect. The follow-up would not possible, as no contact details were available. This case had been linked with case US2022AMR017687, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR017687:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had it terrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's spouse. The age at vaccination was not reported. The reporter stated they (reporter and patient) were vaccinated years ago so the reporter had to get it soon. The reporter stated that his/her husband just had terrible shingles. The reporter urged not to wait. This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were not available. The follow-up would not be possible as no contact details were available.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 18 months old pt received an adult dose of Havrix; 18 months old pt received an adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-month-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2022, the patient received Havrix 1 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received an adult dose of Havrix at the age of 18 months by mistake which led to adult product administered to child and overdose. The reporter consented to follow up was granted.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 5397f, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting an expired dose of Engerix-B was inadvertently administrated to a patient, which led to expired vaccine used. At the moment of the call the reporter had no information regarding the patient but agreed to be contacted follow-up and give further detail.  No further events were reported. The reporter agreed to follow-up.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number FS734, expiry date 21st January 2022) for prophylaxis.   On 26th January 2022, the patient received the 2nd dose of Boostrix. On 26th January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter reported a patient was administered an expired dose of the Boostrix vaccine inadvertently in left deltoid, which led to expired vaccine used. The reporter consented to follow up. The case has been linked to US2022014885,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022014885:Same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva380a, expiry date 31st August 2021) for prophylaxis.   On 26th January 2022, the patient received the 1st dose of Menveo. On 26th January 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was inadvertently administrated an expired dose of Menveo, which was already expired in 31st August 2021, which led to expired vaccine used. No further events were reported. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 15 years old administrated with adult dose; Adult product administered to child; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old male patient who received HAV (Havrix adult) (batch number km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 25th January 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Vaccine coordinator reported that a 15 years old patient was administrated with adult dose of Havrix which led to overdose and adult product administered to child.  No adverse event was reported. The reporter did not consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Off label use
Clinical narrative: senior citizen has prescription for BEXSERO; This case was reported by a consumer via call center representative and described the occurrence of off label use in a elderly female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not applicable. The patient had a prescription for Bexsero from her infectious disease doctor and had not yet received the vaccination. She stated that she had a splenectomy and described herself as a senior citizen, which led to off label use.  The patient did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: third dose on JAN2022; first dose on SEP2020, second on NOV202; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th September 2020).   On 14th January 2022, the patient received the 3rd dose of Shingrix. On 14th November 2021, the patient received the 2nd dose of Shingrix. On 14th November 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 14th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were provided as follows: The reporter stated that a patient received first dose of Shingrix series and then did not return within recommended timeframe for second dose, so the next dose was not administered until 14th November 2021, which led to lengthening of vaccination schedule. The patient's physician ordered a third dose to be administered, which was given on 14th January 2022, which led to extra dose administered. The reporter did not have the lot number and expiration date information for the doses. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022015427:Case duplicate -Deleted
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose / already expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old male patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Engerix B pediatric that was already expired on 24th January 2022, which led to expired vaccine used. The vaccine administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrated only the diluent portion of the vaccine; administrated only the diluent portion of the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number hm24h, expiry date 25th March 2023) for prophylaxis.   On 10th November 2021, the patient received Shingrix. On 10th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was inadvertently administrated only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No further events were reported. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case has been linked to the case US2022016943 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016943:same reporter
Sex: M
Vaccine: COVID19, UNK
Symptoms: Full blood count, Full blood count decreased
Clinical narrative: This spontaneous report received from a patient concerned a 6 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced full blood count decreased. Laboratory data (dates unspecified) included: Full blood count (NR: not provided) Decreased. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full blood count decreased was not reported. This report was non-serious. This case, involving the same patient is linked to 20220209734.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced weird taste in mouth on tongue and lips. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth on tongue and lips. This report was non-serious. This case, involving the same patient is linked to 20220145141.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned three patients. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced death. Reporter stated that "I know of three that died after taking it." On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220200402-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, 01 in total, administered on 26-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient had blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220200866- COVID-19 VACCINE AD26.COV2.S- Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced going downhill fast within a day or two of getting it. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse event. This report was non-serious. This case, from the same reporter is linked to 20220200358.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Illness
Clinical narrative: SEVERE REACTIONS; SICK; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reactions, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reactions and sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220200753.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 19-SEP-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JAN-2022, the patient experienced Covid-19 test positive. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 test positive was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000215029. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events). This report indicates medical adverse events for the patient, there was no product quality issue described. Based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220202166.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinus operation
Clinical narrative: DRAINS IN SINUS; STUFFY NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced drains in sinus, and stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stuffy nose, and the outcome of drains in sinus was not reported. This report was non-serious. This case, from the same reporter is linked to 20220201810.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: ALWAYS SICK; This spontaneous report received from a parent via a company representative concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced always sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from always sick. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN THE EARS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 01-OCT-2021) dose was not reported, 1 total, administered on 07-AUG-2021 at left deltoid for prophylactic vaccination. It was reported that patient was fine following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 08-NOV-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in DEC-2021, (a little bit after thanksgiving) she began to experience ringing in both ears, but left one was louder. She stated that the ringing was all the time, the ringing did not sound like a bell but more like crickets or peepers. She stated that the symptom was not going away or subsiding. She noticed the ringing at night first when it was quiet, and since then it had progressed and she was experiencing at the time of reporting while she was on the call. She also mentioned that she had not brought that issue up with her physician yet, but planned to bring that up in the future if she still had it in 6 months (event with dose number series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ears. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000215590. This case is a duplicate of 20220202442. This case, from the same reporter is linked to 20220202505.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 56 year adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, route of admin was not reported, and batch number: Z07AUA, expiry: unknown) dose was not reported, 1 total, administered in left arm on 03-JUN-2021 for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination covid-19 vaccine ad26.cov2.s. (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number series was 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: unknown) dose was not reported, 1 total administered in left arm on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2022, the patient tested positive for COVID-19 with home antigen test. The patient had not tested with a PCR (polymerase chain reaction) test. (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fluid retention, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOTS; WATER RETAINAGE; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unknown date the patient reported that "Thanks for almost killing me. Blood clots, water retainage, ultrasound, prescription drugs for all the side effects from your vaccine. But I still think vaccines are good". Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and water retainage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220203871-covid-19 vaccine ad26.cov2.s-Blood clots.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was other healthcare professional. The patient was experiencing symptoms, did not as sick as husband and never developed a cough. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2022, the patient experienced suspected covid-19. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative, and COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a 49 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total,  dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient developed a blood clot. Patient was seeing doctor for follow up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220204276-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Gait disturbance, Gait inability, Paraesthesia
Clinical narrative: BARELY WALKED AND WALKED IN AN ODD AND STRANGE WAY; TINGLING WENT UP TO ARMS AND LEGS; LOST THE ABILITY TO WALK; FINGERS TINGLING; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cancer of the kidney, and 2 strokes, and concurrent conditions included: non-alcohol user, and smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced fingers tingling. On NOV-2021, the patient experienced lost the ability to walk. On an unspecified date, the patient experienced barely walked and walked in an odd and strange way, and tingling went up to arms and legs. Laboratory data (dates unspecified) included: EKG (NR: not provided) ECG was okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fingers tingling, tingling went up to arms and legs, lost the ability to walk, and barely walked and walked in an odd and strange way. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE WAS GIVEN TO 4 PATIENTS AFTER IT WAS REFROZEN AND RETHAWED; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, administered on 28-JAN-2022, and dose was not reported, administered on 31-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 28-JAN-2022, the patient experienced vaccine was given to 4 patients after it was refrozen and rethawed. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given to 4 patients after it was refrozen and rethawed and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SICK; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220203920.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood iron decreased, Contusion, Haemoglobin decreased, Laboratory test
Clinical narrative: LOW ENERGY LEVELS; LOW PLATELETS; LOW HEMOGLOBIN; LOW IRON; BRUISES ON THUMB SPREAD TO ARMS AND LEGS AS WELL; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have any known allergies. Patient did not have any relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the patient experienced bruises on thumb spread to arms and legs as well. On AUG-2021, the patient experienced low platelets, low hemoglobin, and low iron. Laboratory data included: Lab test (NR: not provided) low platelets, low heamoglobin, low iron. On an unspecified date, the patient experienced low energy levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelets, low hemoglobin, bruises on thumb spread to arms and legs as well, and low energy levels, and the outcome of low iron was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: LOW ENERGY LEVELS; LOW PLATELETS; LOW HEMOGLOBIN; LOW IRON; BRUISES ON THUMB SPREAD TO ARMS AND LEGS AS WELL; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have any known allergies. Patient did not have any relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the patient experienced bruises on thumb spread to arms and legs as well. On AUG-2021, the patient experienced low platelets, low hemoglobin, and low iron. Laboratory data included: Lab test (NR: not provided) low platelets, low heamoglobin, low iron. On an unspecified date, the patient experienced low energy levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelets, low hemoglobin, bruises on thumb spread to arms and legs as well, and low energy levels, and the outcome of low iron was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid after receiving the janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 after 1st dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced COVID-19 (COVID-19 after 1st dose). At the time of the report, COVID-19 (COVID-19 after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Patient called and asked about interval after 2nd dose. The reporter stated that the patient had a deficiency and asked if 2nd dose would make platelets drop. The reporter stated that the patient was due for 2nd dose on 02-Feb-2022.  Company Comment: This is a spontaneous case concerning a 26-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 (COVID-19 after 1st dose) which occurred 12 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 26-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 (COVID-19 after 1st dose) which occurred 12 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had high fever 24 hours after the booster.  No concomitant medication was provided.  No treatment medication was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: sweated a lot; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweated a lot), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL, SIMVASTATIN, VITAMINS NOS, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), ASPIRIN [ACETYLSALICYLIC ACID], PROBIOTICS NOS and CELECOXIB (CELEBREX) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (sweated a lot), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). At the time of the report, HYPERHIDROSIS (sweated a lot), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment details were not given. After the first dose, the patient experienced a sore arm, tiredness. and sweated a lot.   This case was linked to MOD-2022-466462, MOD-2022-466488 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.  No Medical History information was reported.On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.It was reported that that some patients who received the expired vaccine had reported flu-like symptoms after receiving the vaccination.It was reported that some individuals received a primary dose of the Pfizer vaccine and then received a second primary dose of the Moderna vaccine but for whom it was reported, was not provided by the reporter. Vial was initially stored in the refrigerator on 01-Dec-2021. Vial did not undergo any temperature excursions.This case was linked to MOD-2022-449812 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 31-Jan-2022: Reporter information, suspect product information (batch number, expiration dates and route of administration) and event description was updated.