chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose on 6/3/21 and third on 7/8/21; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 10-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap IPV HepB with an associated reaction of no adverse event (first dose received on unknown date unknown batch number). Concomitant products included PEDIARIX.   On 8th July 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 8th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: Registered Nurse reported that, a patient received 1st dose of series as non-pediarix (Dtap-IPV-HepB). Then the patient got second dose with Pediarix and the third dose was given too early, which led to shortening of vaccination schedule. The reporter inquired about Pediarix as how to proceed with series, could pediarix, be a booster every 4 weeks as a catch up or would they do third dose over.  The reporter did not consent to follow up.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Immediate post-injection reaction, Incorrect dose administered, Vomiting projectile
Clinical narrative: Projectile vomiting; Vomited prior to swallowing the complete dose; This case was reported by a nurse via call center representative and described the occurrence of vomiting projectile in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number KN3J4, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th February 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 9th February 2022, immediately after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced vomiting projectile and incomplete dose administered. On 9th February 2022, the outcome of the vomiting projectile was recovered/resolved. On an unknown date, the outcome of the incomplete dose administered was unknown.   It was unknown if the reporter considered the vomiting projectile to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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 was given the dose of Rotarix vaccine by Medication Technician, and he projectile vomited prior to swallowing the complete dose, which led to incomplete dose administered. The reporter stated that, they believed the patiet might have been overfed and the patient did not appear to be ill. Till the time of reporting, the patient had not been re-dosed. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysarthria, Fatigue, Headache, Insomnia
Clinical narrative: Experienced shivering; Experienced headache; Experienced fever; Experienced myalgia; Experienced insomnia or restlessness; Experienced insomnia or restlessness; Experienced fatigue; Experienced slurred speech; Developed arm pain which has not resolved; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Shingrix. On 8th February 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 9th February 2022, the patient experienced shivering, headache, fever, myalgia, insomnia, restlessness, fatigue and slurred speech. On an unknown date, the outcome of the pain in arm, shivering, headache, fever, insomnia, restlessness, fatigue and slurred speech were not recovered/not resolved and the outcome of the myalgia was recovering/resolving.   It was unknown if the reporter considered the pain in arm, shivering, headache, fever, myalgia, insomnia, restlessness, fatigue and slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. One day after receiving Shingrix, the patient experienced shivering, headache, fever, myalgia, insomnia or restlessness, fatigue and slurred speech. She explained that myalgia had mostly resolved but none of the other symptoms had resolved. The reporter refused to provide healthcare professional information. She would be seeing them in March and will call them on the day of reporting. The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Restlessness
Clinical narrative: Experienced shivering; Experienced headache; Experienced fever; Experienced myalgia; Experienced insomnia or restlessness; Experienced insomnia or restlessness; Experienced fatigue; Experienced slurred speech; Developed arm pain which has not resolved; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Shingrix. On 8th February 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 9th February 2022, the patient experienced shivering, headache, fever, myalgia, insomnia, restlessness, fatigue and slurred speech. On an unknown date, the outcome of the pain in arm, shivering, headache, fever, insomnia, restlessness, fatigue and slurred speech were not recovered/not resolved and the outcome of the myalgia was recovering/resolving.   It was unknown if the reporter considered the pain in arm, shivering, headache, fever, myalgia, insomnia, restlessness, fatigue and slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. One day after receiving Shingrix, the patient experienced shivering, headache, fever, myalgia, insomnia or restlessness, fatigue and slurred speech. She explained that myalgia had mostly resolved but none of the other symptoms had resolved. The reporter refused to provide healthcare professional information. She would be seeing them in March and will call them on the day of reporting. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Cap removed without stopper being punctured; This case was reported by a nurse via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported a product storage error as the cap of Shingrix was removed without stopper being punctured. There was no temperature excursion. The cap was removed from the vials without the stopper being punctured with a needle, which led to wrong technique in product usage process. The vaccine was not administered. The reporter stated that, he/she was not allowed to share the patient's information and thought the report was a simple question but it had evolved to something more. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product quality issue
Clinical narrative: less than 0.4 ml of shingrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2022, the patient received Shingrix. On 9th February 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that less than 0.4 ml of Shingrix was administered to a patient and was not due to product quality issue, which led to incomplete dose administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: given a Bexsero injection that expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) 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.   Previously administered products included Bexsero (received 1st dose on an unknown date).   On 9th February 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Bexsero and Bexsero 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 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. The patient was given a Bexsero injection, that expired on 31st January 2022, which led to expired vaccine used.   This would have been her 2nd dose.  The reporter asked, what should the patient be made aware of.  The reporter also asked, if the patient needed another one still. The reporter consented to follow up. Healthcare professional declined to provide patient's demographics and said she would prefer not to and she could give the patient the information if she would like to give her information. Obtained permission for follow up via email.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Infanrix; Kinrix given to pt; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: The patient received Kinrix instead of Infanrix at the age of 18 months, which led to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. This case had been linked with case US2022025617, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022025617:Same reporter.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Infanrix; Kinrix given to patient ; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: The patient received Kinrix instead of Infanrix at the age of 15 months, which led to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. This case had been linked with case US2022025615, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022025615:Same reporter.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to pediatric patient; Adult dose given to pediatric patient; 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 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Engerix B. On 25th October 2021, unknown after receiving Engerix B, 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.  Additional details were provided as follows: The patient received 1st dose of adult Engerix B at the age of 19 years which led to adult product administered to child and overdose. The 2nd dose of Engerix B was administered on 26th November 2021, batch number 722KC and expiry date 06th April 2022 but it was a pediatric one. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient got Menveo instead of an MMR dose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, in another facility, the patient received Menveo by mistake dose instead of an MMR dose, which led to wrong vaccine administered.  Then, the patient went to the pharmacy, where this case had been reported to get Boostrix and MMR vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Cold; Fever; Headache; soreness/ everything hurts; This case was reported by a consumer via call center representative and described the occurrence of cold in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2022AMR026451).   On 10th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th February 2022, 1 days after receiving Shingrix, the patient experienced cold, fever, headache and pain. On an unknown date, the outcome of the cold, fever, headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the cold, fever, headache and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR026451  Additional details were reported as follows: The patient self-reported this case. The patient received a dose of Shingrix and experienced cold, fever, headache and soreness and stated that everything hurts. The symptoms were not resolved. The reporter gave permission to contact healthcare professional. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR026451:Same patient, different dose
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On 10th February 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 10th February 2022, unknown after receiving Twinrix and Twinrix 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. The patient received an expired dose of Twinrix, which led to expired vaccine used.  Healthcare professional did not provide demographics from the patient because did not know if that was possible. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number A54M3, expiry date 11th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th June 2021) and Shingrix (received 2nd dose on 16th September 2021).   On 10th February 2022, the patient received the 3rd dose of Shingrix. On 10th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Skin papilloma
Clinical narrative: BOOTY WARTS; 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 not reported, batch number: Unknown) 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 26-OCT-2021, the patient experienced booty warts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of booty warts was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included: explosive gallbladder, and atrial fibrillation. 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 and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. On an unspecified date, following primary vaccination with covid-19 vaccine ad26.cov2.s, she experienced chills and a little bit of headache (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: unknown) dose was not reported, 1 total, administered on 29-OCT-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, after receiving the vaccine, the patient experienced chills, and little bit of headache. She put on a heating pad and went to bed and the next day she felt fine. She did not have any ache or soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and little bit of headache on 30-OCT-2021. This report was non-serious. This case, involving the same patient is linked to 20220217857 (dose number in series 1 case).
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media through company representative concerned a female of unspecified age, race and ethnicity. 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose not reported, start therapy date were not reported for prophylactic vaccination. It was unknown if the patient experienced any adverse events following vaccination with covid-19 vaccine (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, and batch number: unknown, expiry: unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-FEB-2022, the patient stated she got new form of covid and was sick (suspected covid-19 infection, and suspected clinical vaccination failure) (all events with dose number in series 2). It was reported that "well I had all three. Yes, I felt sick after the 3rd one but it went away after 3 days, that was last year. The new form of covid got me 4 days ago. I am sick but not dying". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000216413.; Sender's Comments: V0: 20220217928-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Ear discomfort, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; CONGESTION IN EAR CLOGGED; This spontaneous report received from a patient concerned a 45 year old 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 (dose number in series:1) (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 on left arm for prophylactic vaccination. No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 1)  Non-company suspect vaccine included: mrna 1273 ( Moderna) (dose number in series:2) ( batch number: 033F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-JAN-2022, the patient experienced covid-19 infection, using the binax home rapid antigen test and congestion in ear clogged (dose number in series:2). Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 infection, and the outcome of congestion in ear clogged was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Asthma, Bronchitis, Pain, Therapeutic response unexpected
Clinical narrative: BRONCHITIS; ASTHMA; BODY ACHES; WITHIN HOURS ALL THE SYMPTOMS GONE; NO ENERGY; This spontaneous report received from a patient via other company (Pfizer, Inc) concerned a female patient of unspecified age, race, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that patient currently had a pink looking tongue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered 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 bronchitis, asthma, body aches and no energy (dose number in series 1). The patient had a rough health year. The patient recovered from bronchitis, asthma, body aches, and no energy on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received Pfizer vaccine (dose number in series 2), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported on an unspecified date in 2022 for prophylactic vaccination and within hours all her symptoms gone (Unexpected therapeutic benefit) (dose number in series 2). The patient reported that he was feeling so great and was not sick anymore.  The action taken with Pfizer vaccine was not applicable. The outcome of within hours all the symptoms gone was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: BRONCHITIS; ASTHMA; BODY ACHES; WITHIN HOURS ALL THE SYMPTOMS GONE; NO ENERGY; This spontaneous report received from a patient via other company (Pfizer, Inc) concerned a female patient of unspecified age, race, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that patient currently had a pink looking tongue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered 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 bronchitis, asthma, body aches and no energy (dose number in series 1). The patient had a rough health year. The patient recovered from bronchitis, asthma, body aches, and no energy on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received Pfizer vaccine (dose number in series 2), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported on an unspecified date in 2022 for prophylactic vaccination and within hours all her symptoms gone (Unexpected therapeutic benefit) (dose number in series 2). The patient reported that he was feeling so great and was not sick anymore.  The action taken with Pfizer vaccine was not applicable. The outcome of within hours all the symptoms gone was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a pharmacist concerned a 45 year old male. The patient's weight was 100 kilograms, and height was 71 inches. The patient's concurrent conditions included: fatty liver, dyslipidemia, diabetes, and hypertension. Patient reported no allergy to medication, food and other products. It was unknown if patient had any acute illness at the time of vaccination and up to one month before vaccination. Patient did not experience any similar event in the past. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) 0.5 ml, 1 in total administered to arm on 09-APR-2021 for prophylactic vaccination. On 22-DEC-2021, the patient tested positive for covid, the type of test was unknown. (dose number in series: 1). Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On 24-JAN-2022, at 08:50 AM the patient received Non-company suspect vaccine included: mrna 1273 (dose number in series: 2) (intramuscular, batch number: 070H21A expiry: UNKNOWN, form of admin was not reported) 0.25 ml, vaccinated to arm for prophylactic vaccination.  No adverse events were reported following mrna 1273 (dose number in series: 2). Concomitant medications included insulin aspart for diabetes, insulin glargine for diabetes, metformin for diabetes, atorvastatin for dyslipidemia, and candesartan for hypertension.  The patient recovered from expired vaccine administered on 24-JAN-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Headache, Neck pain, Paranasal sinus discomfort
Clinical narrative: SINUS PRESSURE; HEADACHE; NECK PAIN; BACK PAIN; JOINT PAIN/STABBING FEELING WITH JOINTS; LOW GRADE FEVER; This spontaneous report received from a patient via other company (AbbVie) concerned a 59 year old female of unspecified race and ethnicity. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included: tobacco user, smoker (cigarettes a pack every three days (started 1978)), and abstains from alcohol. The patient had no known drug allergy. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, (dose number in series was 1), administered 1 in total on MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, (Dose number in series was 2) administered 1 in total on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 12-JAN-2022, the patient experienced low grade fever. On 25-JAN-2022, the patient experienced neck pain, back pain, and joint pain/stabbing feeling with joints. On an unspecified date, the patient experienced sinus pressure, and headache (Dose number in series was 2). Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and loratadine/pseudoephedrine sulfate. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose was not reported, 1 time every 2 weeks, from MAR-2021 for rheumatoid arthritis Concomitant medications included docusate sodium for bowel movement, influenza vaccine for flu vaccination, tizanidine for muscle relaxer, and hydrocodone bitartrate/paracetamol for pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from low grade fever on 14-JAN-2022, was recovering from sinus pressure, and headache, and had not recovered from joint pain/stabbing feeling with joints, neck pain, and back pain. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: SINUS PRESSURE; HEADACHE; NECK PAIN; BACK PAIN; JOINT PAIN/STABBING FEELING WITH JOINTS; LOW GRADE FEVER; This spontaneous report received from a patient via other company (AbbVie) concerned a 59 year old female of unspecified race and ethnicity. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included: tobacco user, smoker (cigarettes a pack every three days (started 1978)), and abstains from alcohol. The patient had no known drug allergy. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, (dose number in series was 1), administered 1 in total on MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, (Dose number in series was 2) administered 1 in total on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 12-JAN-2022, the patient experienced low grade fever. On 25-JAN-2022, the patient experienced neck pain, back pain, and joint pain/stabbing feeling with joints. On an unspecified date, the patient experienced sinus pressure, and headache (Dose number in series was 2). Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and loratadine/pseudoephedrine sulfate. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose was not reported, 1 time every 2 weeks, from MAR-2021 for rheumatoid arthritis Concomitant medications included docusate sodium for bowel movement, influenza vaccine for flu vaccination, tizanidine for muscle relaxer, and hydrocodone bitartrate/paracetamol for pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from low grade fever on 14-JAN-2022, was recovering from sinus pressure, and headache, and had not recovered from joint pain/stabbing feeling with joints, neck pain, and back pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: COULD NOT WALK; LEGS HURT SO BAD FOR 3 DAYS; This spontaneous report received from a patient via a company representative from social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal arteriovenous malformation. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (dose number in series: 1). The patient recovered from legs hurt so bad for 3 days and outcome of couldn't walk was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs hurt so bad for 3 days, and the outcome of could not walk was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 3) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (dose number in series: 3). This report was non-serious.  This case, involving the same patient is linked to 20220220578 (dose number in series: 1) and 20220222831 (dose number in series: 3).
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test, Suspected COVID-19, Wrong technique in product usage process
Clinical narrative: SUSPECTED COVID-19 INFECTION; OFF LABEL USE; WRONG TECHNIQUE IN DRUG USAGE PROCESS; 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 concurrent conditions included: bronchitis, chronic sinus infection, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-DEC-2021, the patient experienced off label use, and wrong technique in drug usage process. On 01-JAN-2022, the patient experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of off label use and wrong technique in drug usage process was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE DISEASE; This spontaneous report received from a consumer from social media via company representative concerned a 34 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced guillain-barre disease, and paralyzed from the waist down for a year. It was reported as, "I have a 34 yr healthy old friend. He got J & J shot. Within 2 days got Guillain-Barre disease and paralyzed from waste down for a year. Finally now walking again. These shots are experimental". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from guillain-barre disease. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220224976- covid-19 vaccine ad26.cov2.s-guillain-barre disease.This event(s) is labeled per regulatory authority and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: DEVELOPED A HUGE FLUID FILLED GROWTH ON RIGHT LUNG; This spontaneous report received from a consumer via a company representative via social media. on 09-FEB-2022 and concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. 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: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included chemotherapy. On an unspecified date, it was reported that the doctors treating the patient's cancer forced him to get the jab twice during his chemo at which point he developed a huge fluid filled growth on his right lung (dose number in series 2). He had to have emergency surgery nearly killing him. Then months of recovery and he was still not back to health. In his words "cancer wasn't any fun but easily manageable compared to what I experienced after getting vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from developed a huge fluid filled growth on right lung. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220225763-COVID-19 VACCINE AD26.COV2.S-developed a huge fluid filled growth on his right lung . 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; DEATH; This spontaneous report was received from literature. This report concerned multiple patients of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: inflammatory bowel disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date 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.  The patients with inflammatory bowel disease who received at least one vaccine dose prior to diagnosis of COVID-19 were included, among which 12 were hospitalized and 1 died. On an unspecified date, the patients experienced suspected covid-19 infection, (suspected clinical vaccination failure) and was hospitalized on an unspecified date for unspecified number of days. On an unspecified date, one 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. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with product quality complaint.; Sender's Comments: V0-20220225916-covid-19 vaccine ad26.cov2.s-Death, Suspected covid-19 infection. 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). Therefore, this event(s) is considered unassessable. 20220225916-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Thrombosis
Clinical narrative: BLOOD CLOT; STROKE ISSUES; HEART ISSUES; This spontaneous report received from a consumer via a company representative via social media on 09-FEB-2022 and concerned multiple patients of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, it was reported that "More and more people I know have heart issues, blood clot and stroke issues after getting the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart issues, blood clot and stroke issues was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220224963.; Sender's Comments: V0:20220227232-COVID-19 VACCINE AD26.COV2.S-Blood clot, stroke issues. 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). Therefore, this event(s) is considered unassessable.