chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Lymphadenopathy, Somnolence
Clinical narrative: lymph node swelling in the armpit of the arm that got the shot; exhausted all day; slept all day; heart rate has been elevated all day; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingles vaccine. On 7th July 2021, less than a day after receiving Shingles vaccine, the patient experienced heart rate increased, exhaustion and sleepiness. On 8th July 2021, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the heart rate increased, axillary lymph nodes enlarged, exhaustion and sleepiness were unknown.   It was unknown if the reporter considered the heart rate increased, axillary lymph nodes enlarged, exhaustion and sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. This case was reported by patient herself/himself. The patient had received first Shingles shot a day before reporting date and his/her heart rate had been elevated all day and now lymph node swelling in the armpit of the arm that got the shot and also exhausted, slept all day.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: First Shingrix shot 12/2/2020 / Is it too late to get 2nd shot?; First Shingrix shot / (arm sore to two weeks); This case was reported by a consumer via Shingrix GSK  and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included illness (Family History) (family illness).   On 2nd December 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The patient had received 1st dose of Shingrix and experienced side effects of arm soreness for two weeks. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient enquired that was it too late to get 2nd shot, as it had been 7 months. The patient reported that he/she had family illness to deal with, did not like the side effects and the cost was really high, therefore kept putting it off. The follow-up would not possible as no contact details were available.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose / after the maximum recommended time of 6 months / first dose was administered / during Nov 23rd 2019; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 7f94c, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd November 2019).   On 2nd July 2021, the patient received the 2nd dose of Shingrix. On 2nd July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix after the maximum recommended time of 6 months, which led to lengthening of vaccination schedule. The reporter consented to follow up. The case is linked with the case- US2021143505, reported by the same reporter.   Follow- up information was received on 9th July 2021: Upon follow up case classification was changed to "FU NO - Permission Denied" as unable to contact reporter due to incorrect phone number/ no longer in service.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021143505:Same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: stomach/cramping/stomach pain; sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th July 2021, the patient experienced stomach cramps. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the stomach cramps was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and stomach cramps to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient reported that, she received Shingrix vaccine yesterday and experienced sore arm and in morning experienced stomach pain and cramping. The pain in arm was resolved and stomach pain and cramping were not resolved till the time of reporting. The patient does not know the lot number or expiration date. The reporter consented to follow up. This case was linked with case US2021148602, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021148602:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingrix vaccine a day before reporting date and experienced sore arm. The lot number, expiry date and birth date was not reported. The reporter did not consent to follow up. This case was linked with case US2021148603, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021148603:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: inadvertently administrated frozen / vaccines; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients 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, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In June 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Menveo and Havrix. In January 2021, the patient started Havrix Pre-Filled Syringe Device. In June 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Havrix, Havrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 applicable for this report. The doctor reported that, there was a glitch in the thermometer and believed that a temperature excursion did not happen. In June 2021, the frozen vaccines of Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix and Infanrix was administered to several patients, which led to incorrect storage of drug.  The vaccines were exposed to below temperature 11.7 Fahrenheit. No details of patients were available. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 1 years old received / adult dose; 1 years old received / adult dose; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) (batch number y29kl, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 8th July 2021, unknown after receiving Havrix adult 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 provided are as follows: Nurse reported that 1 year old patient received a Havrix adult dose during this Thursday, which led to adult product administered to child and overdose. The reporter consented to follow-up.
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration on 6/30/2021of Infanrix/ pregnant patient; administration on 6/30/2021of Infanrix/17 year old; Infanrix instead of Boostrix.; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 11th August 2021. The patient received Infanrix at an unknown time during the pregnancy. On 30th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the patient experienced drug exposure during pregnancy. On an unknown date, the outcome of the wrong vaccine administered, drug exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.   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 the vaccination was not reported. The patient had taken Infanrix instead if Boostrix, which led to wrong vaccine administered. The patient had taken Infanrix at inappropriate age during pregnancy, which led to Inappropriate age at vaccine administration. The patient was 32 weeks pregnant at the time of call. No further events were reported. The reporter agreed on follow up. This case is linked to the case US2021149596 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149596:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water instead of with the adjuvant AS01B; reconstituted with sterile water instead of with the adjuvant AS01B; This case was reported by a pharmacist and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had taken Shingrix but the vaccine was reconstituted with sterile water instead of with the adjuvant AS01B which led to wrong solution used during drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have any information regarding patient's demographics or vaccine information (lot number and expiration date) on call and was not on the same facility were the event happened. Pharmacist did consent to follow up by email.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first does of Shingrix on last year on  9/18/2020 /  came in today (7/9/2021) with interest in getting the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th September 2020).   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: Pharmacist reported that the patient received the first does of Shingrix on last year but came in today (day of reporting) with interest in getting the second dose, which led to lengthning of vaccination schdeule. Pharmacist asked was it okay to give the second dose of Shingrix. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MINIMAL SIDE EFFECTS; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 29-JUN-2021 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 subject experienced minimal side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Neuropathy peripheral
Clinical narrative: NEUROPATHY IN FEET WAS WORSED; ARTHRITIS HE HED GOT WORSED; FELT WEAKNESS; This spontaneous report received from a patient concerned a 60 year old white and not Hispanic Latino male. The patient's height, and weight were not reported.  The patient's concurrent conditions included arthritis, and neuropathy in feet, and other pre-existing medical conditions included patient had no other underlying conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, frequency one total, administered at left arm on 13-MAY-2021 for prophylactic vaccination.No concomitant medications were reported. After the vaccination, patient felt weakness on 14-May-2021 and on 15-May-2021 his arthritis had got worse and the neuropathy in his feet was worse. But the weakness he had noticed was more than anything. His weakness was steady throughout since he had received the shot  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt weakness, arthritis he hed got worsed, and neuropathy in feet was worsed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210713986 - covid-19 vaccine ad26.cov2.s - Neuropathy in feet was worsed- 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: Blood pressure measurement, Erythema, Feeling abnormal, Hypertension, Muscle spasms
Clinical narrative: BLOOD PRESSURE WENT UP 165 OVER 80 VERY HIGH; RED BLOOD SPOTS; BLURRING VISON; FEELS HAZY; CRAMPS IN BACK OF LEGS; PAIN ON THE CALFS OF LEGS; SKIN BLOTCHY; 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, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced blood pressure went up 165 over 80 very high, red blood spots, blurring vison, feels hazy, cramps in back of legs, pain on the calfs of legs, and skin blotchy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 165 over 80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red blood spots, and the outcome of pain on the calfs of legs, blurring vison, feels hazy, blood pressure went up 165 over 80 very high, skin blotchy and cramps in back of legs was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular, Vision blurred
Clinical narrative: BLOOD PRESSURE WENT UP 165 OVER 80 VERY HIGH; RED BLOOD SPOTS; BLURRING VISON; FEELS HAZY; CRAMPS IN BACK OF LEGS; PAIN ON THE CALFS OF LEGS; SKIN BLOTCHY; 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, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced blood pressure went up 165 over 80 very high, red blood spots, blurring vison, feels hazy, cramps in back of legs, pain on the calfs of legs, and skin blotchy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 165 over 80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red blood spots, and the outcome of pain on the calfs of legs, blurring vison, feels hazy, blood pressure went up 165 over 80 very high, skin blotchy and cramps in back of legs was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fall, Head injury, Headache, Hyperventilation
Clinical narrative: SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino 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 admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Joint injury, Laboratory test, Limb injury, Nodule
Clinical narrative: SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino 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 admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Syncope, Tremor
Clinical narrative: SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino 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 admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 62 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 (suspension for injection, route of admin not reported, batch number: 205A21A, and  expiry: unknown) dose was not reported, 1 total administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the patient had confirmed covid-19 infection. On an unspecified date, the patient had confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: PCR (Polymerase Chain Reaction) (Result: Covid 19 positive). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210718595-covid-19 vaccine ad26.cov2.s-Confirmed Clinical Vaccination Failure. This event(s) is considered not related. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 42 year old male of unspecified 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, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the patient became aware of loss of smell and tested positive on 03-JUL-2021 (confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: COVID-19 (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210720833.; Sender's Comments: V0: 20210718648-COVID-19 VACCINE Ad26.COV2.S-  confirmed clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinus headache, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE HEADACHE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included none reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown  expiry UNKNOWN) frequency 1 total dose was not reported, administered at right arm on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-JUL-2021, at night the patient started experiencing symptoms until next morning on 06-Jul-2021 the patient had sinus pressure headache, mild sore throat, some body aches, cough, chills, fever. On 07-JUL-2021, the patient experienced more severe sore throat, increased body aches, loss of taste. It was reported that he did not actually take his temperature but felt that he had fever. On 08-JUL-2021, Laboratory data included: COVID-19 PCR test and patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 09-JUL-2021 he received his positive results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure headache, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210722832-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. 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
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Feeling abnormal, Pain
Clinical narrative: FEEL LIKE GOT RAN OVER BY A CAR/DAY BEING ROUGH; SORENESS EVERYWHERE; LIGHTHEADED; SHORTNESS OF BREATH; REALLY BAD CHILLS; 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 was not reported, administered on 07-JUL-2021 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 08-JUL-2021, the subject experienced feel like got ran over by a car/day being rough. On 08-JUL-2021, the subject experienced soreness everywhere. On 08-JUL-2021, the subject experienced lightheaded. On 08-JUL-2021, the subject experienced shortness of breath. On 08-JUL-2021, the subject experienced really bad chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like got ran over by a car/day being rough, soreness everywhere, lightheaded, shortness of breath, and really bad chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a male 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: 043821A expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Mobility decreased, Nausea, Pneumonia
Clinical narrative: could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved.      It was reported that the blood pressure intervals were high mainly during the day time.  The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out.  Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-023313 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved.      It was reported that the blood pressure intervals were high mainly during the day time.  The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out.  Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-023313 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness
Clinical narrative: DIZZINESS, BLOOD SUGAR DROPPING
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hot flush, Nausea
Clinical narrative: Intractable headache, 3 1/2 days (unsuccessfully treated with acetaminophen, ibuprofen; dark & quiet room, heating pad); hot & cold flashes, 2 days; nausea, 3 days ( successfully treated with zofran); body aches, 3 days; moderate - severe fatigue, 3 days
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Intractable headache, 3 1/2 days (unsuccessfully treated with acetaminophen, ibuprofen; dark & quiet room, heating pad); hot & cold flashes, 2 days; nausea, 3 days ( successfully treated with zofran); body aches, 3 days; moderate - severe fatigue, 3 days
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blindness, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: 6/1 visual disturbance  6/4 ED visit for vision loss, dizziness  6/11 ED visit for dizziness, confusion, hazed vision, generalized weakness ? CT SCAN - unremarkable 6/18 opthamologoist appt to check ? all normal  6/21 dizziness still present, tingling in left fingers and toes 6/23 mri scan  6/25 PT visit for ?vertigo? 6/29 neurologist visit
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Vertigo, Vision blurred, Visual impairment
Clinical narrative: 6/1 visual disturbance  6/4 ED visit for vision loss, dizziness  6/11 ED visit for dizziness, confusion, hazed vision, generalized weakness ? CT SCAN - unremarkable 6/18 opthamologoist appt to check ? all normal  6/21 dizziness still present, tingling in left fingers and toes 6/23 mri scan  6/25 PT visit for ?vertigo? 6/29 neurologist visit
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram, Headache, Magnetic resonance imaging
Clinical narrative: 6/1 visual disturbance  6/4 ED visit for vision loss, dizziness  6/11 ED visit for dizziness, confusion, hazed vision, generalized weakness ? CT SCAN - unremarkable 6/18 opthamologoist appt to check ? all normal  6/21 dizziness still present, tingling in left fingers and toes 6/23 mri scan  6/25 PT visit for ?vertigo? 6/29 neurologist visit
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual field defect
Clinical narrative: 6/1 visual disturbance  6/4 ED visit for vision loss, dizziness  6/11 ED visit for dizziness, confusion, hazed vision, generalized weakness ? CT SCAN - unremarkable 6/18 opthamologoist appt to check ? all normal  6/21 dizziness still present, tingling in left fingers and toes 6/23 mri scan  6/25 PT visit for ?vertigo? 6/29 neurologist visit
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Sudden death
Clinical narrative: Patient receive vaccine, was very sick the first 3 days after getting it started to feel better for two more days and then died suddenly around 3 p.m.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Atrial septal defect, Blood test, Computerised tomogram, Disturbance in attention
Clinical narrative: migraines, vision issues within 12 hrs.  On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min).  I went to hospital and had CT, ekg, blood work, all were ok.   Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure.  Surgeon also said to get the procedure but as of now my insurance has not approved payment.  I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue.  I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay.   I have gone from a healthy person who is very active to  someone who is always tired and is constantly worried about having another TIA.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: migraines, vision issues within 12 hrs.  On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min).  I went to hospital and had CT, ekg, blood work, all were ok.   Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure.  Surgeon also said to get the procedure but as of now my insurance has not approved payment.  I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue.  I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay.   I have gone from a healthy person who is very active to  someone who is always tired and is constantly worried about having another TIA.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Transient ischaemic attack, Visual impairment
Clinical narrative: migraines, vision issues within 12 hrs.  On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min).  I went to hospital and had CT, ekg, blood work, all were ok.   Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure.  Surgeon also said to get the procedure but as of now my insurance has not approved payment.  I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue.  I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay.   I have gone from a healthy person who is very active to  someone who is always tired and is constantly worried about having another TIA.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood test normal, Cough, Dyspnoea, Exophthalmos
Clinical narrative: See description previously mentioned Saw practitioner May 24, treated for sinusitis w prednisone and antibiotic for 5 days. Cough returned on June 1.  Saw practitioner again on June 7, treated with zpack and a prednisone for 5 days. Cough returned June 15 and I have not been back to the dr; waiting to be seen by PCP
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lacrimation increased, Pain, Secretion discharge, Sinusitis
Clinical narrative: See description previously mentioned Saw practitioner May 24, treated for sinusitis w prednisone and antibiotic for 5 days. Cough returned on June 1.  Saw practitioner again on June 7, treated with zpack and a prednisone for 5 days. Cough returned June 15 and I have not been back to the dr; waiting to be seen by PCP
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: See description previously mentioned Saw practitioner May 24, treated for sinusitis w prednisone and antibiotic for 5 days. Cough returned on June 1.  Saw practitioner again on June 7, treated with zpack and a prednisone for 5 days. Cough returned June 15 and I have not been back to the dr; waiting to be seen by PCP
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Severe culls and body aches
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Uterine dilation and curettage
Clinical narrative: I hemorrhaged for a month and had to ultimately get a D&C to stop the bleeding, despite also taking progesterone and ibuprofen to stem the flow. Nothing worked except the operation
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Substantial numbness in feet below ankles and hands below wrist.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Periodic bouts of extreme fatigue typically mid day needing to sleep for an additional  4 hours after a good nights sleep.   Episodes occur every week or 2.  Never experienced this before Covid Vaccine.  Events have not diminished 5 months later.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Ear discomfort, Tinnitus
Clinical narrative: Tinnitus & pressure in both ears, mostly left ear. Possible hearing loss.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Muscle Weakness