chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dyspnoea, Fatigue, Joint swelling
Clinical narrative: Took Covid shot March 6 (J&J). Since then has felt fatigued and achy. No fever but has had joint pains. Feels SOB with walking. Feels it is worse since the shot. Having pain in the back of the neck, and her hands and knees are swollen (but not red or hot). Feels this is worse than it was before. Taking furosemide but swelling not going away. Taking spironolactone and potassium. Takes furosemide 4 days a week. No N, V, but has had diarrhea since taking vaccine.  She says her husband has had very similar symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Peripheral swelling
Clinical narrative: Took Covid shot March 6 (J&J). Since then has felt fatigued and achy. No fever but has had joint pains. Feels SOB with walking. Feels it is worse since the shot. Having pain in the back of the neck, and her hands and knees are swollen (but not red or hot). Feels this is worse than it was before. Taking furosemide but swelling not going away. Taking spironolactone and potassium. Takes furosemide 4 days a week. No N, V, but has had diarrhea since taking vaccine.  She says her husband has had very similar symptoms.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle soreness (back and breast), fatigue
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Contusion, Reaction to previous exposure to any vaccine, Vein disorder
Clinical narrative: vein engorgement - arms, hands, legs, feet, chest; nose bleeds, calf pain; elevated blood pressure; bruising
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Starting 2 hours after the injection- Moderate injection site pain and tenderness for 1 day.  Starting 18 hours after injection-  Severe Joint pain and moderate muscle pain for 3 days - unable to do normal tasks, slept extra, acetaminophen and ibuprofen only resolved the pain 20%. Pain Symptoms resolved upon waking on the fourth morning.  Starting 18 hours after injection-  Extreme tiredness for 3 days with moderate tiredness for additional 1.5 days.  It felt worse than when I had Flu B last year, but resolved  quicker.   Note: second shot given  4/16/2021 and outcome was much much less. Just moderate joint pain and tiredness and only for 2 days and ibuprofen resolved the pain 80%.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Vision blurred
Clinical narrative: Pt. develop a reaction to 1st dose of covid-19 vaccine.  Symptoms described as having elevated heartrate and headache and blurred vision.  Pt. current medications cytomel and levothyroxine, also pt. in remission for cancer with a thyroid of 4/14/21 removal.  V/S: 123/71, 73 P.  Pt. verbalizes feeling better and recovered .   No hospital provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pain
Clinical narrative: Dizziness, vertigo, nausea- onset 30 minutes after recdiving shot, on day 5 and still feeling it  Chills, sweats, aches- days 2-3
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Dizziness, vertigo, nausea- onset 30 minutes after recdiving shot, on day 5 and still feeling it  Chills, sweats, aches- days 2-3
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Depression, Menstruation delayed
Clinical narrative: Significant increase in depressive and anxiety symptoms. Menstrual cycle is also a week and counting late
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive on 4/16. has been greater than 14 days from second vaccine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Right arm and hand severe pain and tingling
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardiac death, Death, Respiration abnormal, Respiratory arrest
Clinical narrative: respiratory and cardiac arrest Narrative:  Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: respiratory and cardiac arrest Narrative:  Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: she had a reaction to an unknown vaccine in the past / it may have made the patient's unknown skin condition worse; she had a reaction to an unknown vaccine in the past / it may have made the patient's unknown skin condition worse; This spontaneous report as received from a female patient of unknown age who reported on herself. There was no information about the patient's concomitant therapies or medical history provided. Her concurrent conditions included unspecified skin condition.     On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (it was also reported as unknown vaccine, conflicting information).  On an unknown date, the patient had a reaction to the vaccine and it may have made her unknown skin condition worse. The outcome of the events was unknown. It was unknown, if the patient received any treatment for the event or sought any medical attention. It was also reported she was concerned because she wanted the shingles vaccine that is a two part series, because the single dose may not be effective enough and she was concerned that she would develop shingles.  The causality assessment between the events and the suspect vaccine was unknown (since it was reported that she had a reaction to an unknown vaccine in the past and it may have made the patient's unknown skin condition worse, however it was also reported that "she did not state if the shingles vaccine caused an issue" (conflicting information)).
Sex: F
Vaccine: HPV9
Symptoms: Electric shock sensation, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Trouble sleeping; Pain in hands, legs, and feet; numbness in hands, legs, and feet; tingling / electric shock sensation in hands, legs, and feet; This spontaneous report was received from a female patient of unknown age referring to herself.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 04-MAR-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly (dose, lot #, and expiration date not reported) for prevention of disease.   On 17-MAR-2021, The patient experienced numbness, tingling, and pain in hands legs and feet. She also stated feeling electrical shocks in those areas, and troubling sleep. Consumer stated that she had made contact with planned parenthood who gave her the vaccine, and they had instructed her to get additional bloodwork completed. Consumer stated that she had not taken the those steps as of yet. The patient did not receive treatment for the events. At the reporting time, the patient had not recovered from the events.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired PROQUAD to patient; vaccine experienced previous temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (route of administration and anatomical location were not reported) lot # S031881, expiration date: 07-APR-2021, 0.5 ml for prophylaxis.  Administered dose of vaccine underwent previous temperature excursion of 4.7 degrees Celsius for 36 hours on 14-FEB-2021. Digital data logger was involved. No additional adverse events were reported.
Sex: U
Vaccine: RV5, UNK
Symptoms: Foetal exposure during pregnancy, Rotavirus infection
Clinical narrative: at 3 months old developed rotavirus and was subsequently hospitalized; Indication: Prevention of Rotavirus; the patient should not of received the ROT ATEQ vaccine because the mother of the patient was on Humira while pregnant; because the mother of the patient was on Humira while pregnant; This spontaneous report refers to a 2-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, 2 ml once (formulation, strength,lot # and expiration date were not reported) for prevention of rotavirus. On an unknown date (but about 1 month later as the patient was 3-months-old), the patient developed rotavirus and was subsequently hospitalized. The patient should not received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) because the mother of the patient was on adalimumab (HUMIRA) while pregnant (foetal exposure during pregnancy, product use issue). On an unknown date, the unspecified treatment was given to the patient. The outcome of the events was not reported. The causality between the event of drug ineffective and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was assessed to be related. The causality assessment between the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event of rotavirus infection was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; The customer said that the patient missed the 3rd dose of GARDASIL 9 on 3/23/2021; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patient was vaccinated with first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact doses, injection sited, routes of administration, lot # and expiration dates were not provided) for prophylaxis.  On 23-MAR-2021, the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), because the patient received the first dose of the Pfizer COVID 19 vaccine. The patient was scheduled to receive the second dose of the Pfizer COVID 19 vaccine on 18-APR-2021. No other adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: was scheduled to receive their second dose of GARDASIL 9, however just before the vaccine was going to be administered, the patients guardians refused the vaccine, resulting in a missed dose; No additional adverse events reported.; This spontaneous report was received from a nurse and refers to an unknown patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 13-APR-2021, the patient was scheduled to receive their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. However, just before the vaccine was going to be administered, the patients guardians refused the vaccine, resulting in a missed dose. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Two patients that received Shingrix first dose almost a year ago; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost a year ago on 17th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up by email. This case has been linked with US2021084266, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021084266:Same reporter. Pt 1.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Migraine
Clinical narrative: reports a migraine; left arm injection site pain; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 13th September 2020) and Engerix B (2nd dose received on 10th February 2021).   On 4th April 2021, the patient received the 1st dose of Shingrix. On 4th April 2021, 1 hr after receiving Shingrix, the patient experienced migraine and injection site pain. On 5th April 2021, the outcome of the migraine and injection site pain were recovered/resolved.   It was unknown if the reporter considered the migraine and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 56 or 57 years. The patient received 1st dose of Shingrix in left arm. The patient experienced migraine and left arm injection site pain which started an hour after the vaccination. The patient wished to remain anonymous.  The reporter did not share lot number or expiration date of Shingles vaccine and did not share where she received vaccines or who was her health care professional.  The reporter did not consent for follow up with her health care professional and did not provide email to offer Shingrix PI to be emailed to her. The reporter accepted MI telephone number to share with her health care professional. This case had been linked with US2021085458, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085458:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose planning to be given today (Feb 22nd 2021) / 29 days apart /first dose (Dic 26th 2020).; circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, 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.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of shingrix on 26th December 2020.  The reporter was looking for guidance on administration of Shingrix second dose and was planning to give on the day of reporting, which was only 29 days apart from 1st dose and led to shortening of vaccination schedule. No further information available. The reporter consented to follow up.   Follow up information was received from pharmacist on 16th April 2021: Since in the initial reporting, it is stated that the reporter reconstituted the vaccine and was in hurry but was not clearly stated if dose was given or not. Therefore event circumstance or information leading to medication error was added. The reporter said that there were no further details to share and requested no further contact.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: Suspect Vaccine Start Date:24Jul2019 / given a split adult Havrix dose of 0.5 ml on 07Apr2021; pediatric female patient was given a split adult Havrix dose of 0.5 ml; Adult product administered to child; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 13-year-old female patient who received HAV (Havrix adult) (batch number X9A9B, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Havrix (1st dose received on 24th July 2019).   On 7th April 2021, the patient received the 2nd dose of Havrix adult. On 7th April 2021, unknown after receiving Havrix adult, the patient experienced drug dose administration interval too long, wrong technique in product usage process and adult product administered to child. On an unknown date, the outcome of the drug dose administration interval too long, wrong technique in product usage process and adult product administered to child were unknown.  Additional details were provided as follows: The reporter stated that, the patient received split adult Havrix dose of 0.5 ml, which led to wrong technique in product usage process and adult product administered to child. The patient received 2nd dose of Havrix late than the recommended interval, which led to lengthening of vaccination schedule. No symptoms were reported. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late second dose / First dose was given on Jan2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by pharmacist on behalf of a physician. The age at vaccination was not applicable for this report. The age group of the patient was not reported. but selected as an adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter called for information regarding the administration of a late 2nd dose of Shingrix. The reporter consented to follow up but mentioned that it would be best to contact the physician, but pharmacist could not provide consent on their behalf.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 1 engerix-9/27/19 dose 2 engeix-12/01/19 (late); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old female patient who received HBV (Engerix B) (batch number MN7XR, expiry date 18th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 27th September 2019).   On 1st December 2019, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 1st December 2019, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, 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.   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 2nd dose of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule. On 27th January 2020, he patient received 3rd dose of Heplisav instead of Engerix B. No reactions were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: LOW GRADE FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned female of unspecified age.. The patient's height, and weight were not reported. The patient's past medical history included fibromyalgia, heart disease, heart attack, hip surgery, gall bladder removed, and angioplasty, and concurrent conditions included cigarette smoker, sulfa allergy, penicillin allergy, and abstains from alcohol, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: not reported) .5 ml, administered on 10-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, body aches, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: DIZZY; LITE HEADACHE; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 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 09-MAR-2021, the subject experienced dizzy. On 09-MAR-2021, the subject experienced lite headache. On 09-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lite headache and fatigued was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: FEVER WITHIN 24 HOURS OF RECEIVING THE VACCINE; CHILLS WITHIN 24 HOURS OF RECEIVING THE VACCINE; FATIGUE THAT WORSENED WITHIN 48 HOURS AND THEN GOT BETTER IN 72 HOURS; BODY ACHES FOR TWO DAYS; This spontaneous report received from a consumer concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced fever within 24 hours of receiving the vaccine. On MAR-2021, the subject experienced chills within 24 hours of receiving the vaccine. On MAR-2021, the subject experienced fatigue that worsened within 48 hours and then got better in 72 hours. On MAR-2021, the subject experienced body aches for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever within 24 hours of receiving the vaccine, chills within 24 hours of receiving the vaccine, fatigue that worsened within 48 hours and then got better in 72 hours, and body aches for two days on MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20200840971.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: HEADACHE; ACHINESS; SORE ARM; FEVER; INCREASING TIREDNESS; 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 frequent headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced increasing tiredness. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced achiness. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, achiness, increasing tiredness, sore arm, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea, Neck pain
Clinical narrative: SHAKING; PAIN ACROSS UPPER BACK WHOLE BACK; PAIN BEHIND THE NECK; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 10:00 AM for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 15:00 pm, the patient experienced shaking. On 08-MAR-2021 15:00 pm, the patient experienced pain across upper back whole back. On 08-MAR-2021 15:00 pm, the subject experienced pain behind the neck. On 08-MAR-2021 15:00 pm, the patient experienced chills. On 08-MAR-2021 15:00 pm, the patient experienced nausea. On 08-MAR-2021 15:00 pm, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, pain across upper back whole back, pain behind the neck, nausea and shaking was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING; PAIN ACROSS UPPER BACK WHOLE BACK; PAIN BEHIND THE NECK; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 10:00 AM for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 15:00 pm, the patient experienced shaking. On 08-MAR-2021 15:00 pm, the patient experienced pain across upper back whole back. On 08-MAR-2021 15:00 pm, the subject experienced pain behind the neck. On 08-MAR-2021 15:00 pm, the patient experienced chills. On 08-MAR-2021 15:00 pm, the patient experienced nausea. On 08-MAR-2021 15:00 pm, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, pain across upper back whole back, pain behind the neck, nausea and shaking was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: TIRED; ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, and batch number: 1808025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced achy. On 10-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, and tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: MUSCLE SORENESS AT 4 AM, POSSIBLY A LITTLE EARLIER; SLIGHT QUEASINESS  AT 4 AM, POSSIBLY A LITTLE EARLIER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5ml, administered on 09-MAR-2021 06:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported .On 10-MAR-2021, the subject experienced muscle soreness at 4 am, possibly a little earlier. On 10-MAR-2021, the subject experienced slight queasiness at 4 am, possibly a little earlier. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle soreness at 4 am, possibly a little earlier and slight queasiness at 4 am, possibly a little earlier was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased
Clinical narrative: TEMPERATURE OF 99 F; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 03-SEP-2021) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced temperature of 99 f. Laboratory data included: Body temperature (NR: not provided) 99 F. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 114/75, and Body temperature (NR: not provided) 97.7-98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temperature of 99 f was not reported. This report was non-serious.  .
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: HEADACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021 10:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and chills, and low grade fever on MAR-2021. 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 weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: FEVER 101-104; CHILLS; WEAKNESS; SWEATS; DIZZINESS; HEADACHES; CONGESTION; INTERMITTENT SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fever 101-104. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced sweats. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced headaches. On MAR-2021, the subject experienced congestion. On MAR-2021, the subject experienced intermittent soreness. Laboratory data included: Body temperature (NR: not provided) 101-104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent soreness, and the outcome of fever 101-104, chills, weakness, sweats, dizziness, headaches and congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasal congestion, Pain, Pyrexia
Clinical narrative: FEVER 101-104; CHILLS; WEAKNESS; SWEATS; DIZZINESS; HEADACHES; CONGESTION; INTERMITTENT SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fever 101-104. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced sweats. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced headaches. On MAR-2021, the subject experienced congestion. On MAR-2021, the subject experienced intermittent soreness. Laboratory data included: Body temperature (NR: not provided) 101-104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent soreness, and the outcome of fever 101-104, chills, weakness, sweats, dizziness, headaches and congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle tightness, Oropharyngeal pain, Pain
Clinical narrative: TIGHTNESS IN BODY; BODY SORES; BODY CHILLS; BODY ACHES; TIREDNESS; COLD HANDS; SORE THROAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced tightness in body. On 09-MAR-2021, the subject experienced body sores. On 09-MAR-2021, the subject experienced body chills. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced tiredness. On 09-MAR-2021, the subject experienced cold hands. On 09-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in body, body sores, body chills, body aches, tiredness, cold hands, and sore throat. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: TIGHTNESS IN BODY; BODY SORES; BODY CHILLS; BODY ACHES; TIREDNESS; COLD HANDS; SORE THROAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced tightness in body. On 09-MAR-2021, the subject experienced body sores. On 09-MAR-2021, the subject experienced body chills. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced tiredness. On 09-MAR-2021, the subject experienced cold hands. On 09-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in body, body sores, body chills, body aches, tiredness, cold hands, and sore throat. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Pain
Clinical narrative: INJECTION SITE PAIN; BODY ACHES; HEADACHE; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 14:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and dizziness on 10-MAR-2021, and had not recovered from body aches, headache, and injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: AFTER 12 HOURS OF INJECTION FELT HAZY; 20 HOURS AFTER THE INJECTION HAD  103 FEVER; This spontaneous report received from a patient via a company representative concerned a 39 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced after 12 hours of injection felt hazy. On MAR-2021, the subject experienced 20 hours after the injection had 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from 20 hours after the injection had 103 fever, and the outcome of after 12 hours of injection felt hazy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Dizziness, Dyspepsia, Headache
Clinical narrative: INSOMNIA X 1 NIGHT; LOSS OF TASTE X1 HOUR DURING BREAKFAST; STRANGE TASTE; DIZZINESS X8HOURS; SEVERE HEADACHE; NAUSEA; "DEEP STRETCH" SENSATION; LOSS OF APPETITE; VOMITING; DIAPHORETIC; SOUR FEELING IN THE STOMACH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sour feeling in the stomach. On 07-MAR-2021, the subject experienced diaphoretic. On 07-MAR-2021, the subject experienced "deep stretch" sensation. On 07-MAR-2021, the subject experienced loss of appetite. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021 17:00, the subject experienced severe headache. On 09-MAR-2021, the subject experienced dizziness x8hours. On 09-MAR-2021, the subject experienced insomnia x 1 night. On 09-MAR-2021, the subject experienced loss of taste x1 hour during breakfast. On 09-MAR-2021, the subject experienced strange taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diaphoretic, "deep stretch" sensation, and vomiting on 08-MAR-2021, dizziness x8hours, insomnia x 1 night, and loss of taste x1 hour during breakfast on 09-MAR-2021, and severe headache on 08-MAR-2021 18:00, had not recovered from nausea, strange taste, and loss of appetite, and the outcome of sour feeling in the stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Nausea, Sensory disturbance, Taste disorder
Clinical narrative: INSOMNIA X 1 NIGHT; LOSS OF TASTE X1 HOUR DURING BREAKFAST; STRANGE TASTE; DIZZINESS X8HOURS; SEVERE HEADACHE; NAUSEA; "DEEP STRETCH" SENSATION; LOSS OF APPETITE; VOMITING; DIAPHORETIC; SOUR FEELING IN THE STOMACH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sour feeling in the stomach. On 07-MAR-2021, the subject experienced diaphoretic. On 07-MAR-2021, the subject experienced "deep stretch" sensation. On 07-MAR-2021, the subject experienced loss of appetite. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021 17:00, the subject experienced severe headache. On 09-MAR-2021, the subject experienced dizziness x8hours. On 09-MAR-2021, the subject experienced insomnia x 1 night. On 09-MAR-2021, the subject experienced loss of taste x1 hour during breakfast. On 09-MAR-2021, the subject experienced strange taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diaphoretic, "deep stretch" sensation, and vomiting on 08-MAR-2021, dizziness x8hours, insomnia x 1 night, and loss of taste x1 hour during breakfast on 09-MAR-2021, and severe headache on 08-MAR-2021 18:00, had not recovered from nausea, strange taste, and loss of appetite, and the outcome of sour feeling in the stomach was not reported. This report was non-serious.