chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 14 month old patient who on 14-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot # 671427/1217AA). The nurse mentioned that on 31-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. A lot check has been initiated. Follow-up information has been received from a registered nurse concerning a 14 month old female patient with seborhaeic dermatitis and no illness at time of vaccination who on 14-MAR-2012 at 15:30, was vaccinated with the first dose of VARIVAX (Merck), SC, right leg. The nurse reported that the patient came to clinic on 31-MAY-2012, with a rash described as "1-2 mm area of erythema, some areas have vesicles developing. Most lesions are on the lower legs and upper thighs and buttocks with few lesions on upper extremities". The patient was diagnosed with varicella. There was no laboratory testing done. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. This is one of the several reports from the same source. Additional information is not expected.
After about 5 hours my arm was hurting, I had a headache, chills, nausea. I was very very tired. I had rough night sleeping.
This spontaneous report was received from a physician assistant refers to herself, a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. Approximately on an unknown date in July-2006 (reported as 12 years ago), the patient was vaccinated with GARDASIL for prophylaxis (lot#, expiry date, route and dosage details were not reported). Approximately on an unknown date in July-2016 (reported as 2 years ago), the physician assistant was potentially exposed to an unknown type of human papillomavirus (HPV) during a procedure to burn off anal warts in a patient. It was known that the anal warts were HPV positive, but the physician assistant did not know exactly what HPV type. The physician assistant also had not been tested for HPV since this procedure and did not know if she was HPV positive. The outcome of the events was unknown. The reporter did not provide any causality assessment. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA009641.
patient was given 0.3 mL instead of 0.25 mL for booster shot, no adverse effects
HEARTBURN IMMEDIATELY AFTER EACH MEAL; COLD SWEATS; FATIGUE; SEVERE HEADACHE/BILATERAL PARIETAL LOBE PAIN; FEVER; NAUSEA; PAIN TO RIGHT UPPER THIGH; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 66 kilograms, and height was 65 inches. The patient's concurrent conditions included heartburn, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient has no known allergies and history of drug abuse or illicit drug usage. the patient never received any flu vaccine in 13 years. the patient never had the flu and covid-19 at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain to right upper thigh. Treatment medications included: acetylsalicylic acid. On 08-APR-2021, the subject experienced severe headache/bilateral parietal lobe pain. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced cold sweats. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced heartburn immediately after each meal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, fever, and nausea on 11-APR-2021, and pain to right upper thigh on APR-2021, was recovering from heartburn immediately after each meal, and had not recovered from severe headache/bilateral parietal lobe pain, and fatigue. This report was non-serious.
BRUXISM; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bruxism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruxism was not reported. This report was non-serious. This case, from the same reporter is linked to 20221211969.
feverish symptoms with no fever (chills, flushing), body aches, fatigue for 48 hours
Fever (highest was 102.5) - 24 hours Fatigue - 48 hours Chills - off and on for 24 hours Nausea - 48 hours Body Aches - 48 hours
tested positive for covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient wanted to confirm if it is recommended to take the second dose of vaccine or not.
Fever (99.2 fahrenheit); missed his second dose on 01Mar2021 due to fever; This is a spontaneous report from a contactable consumer (patient)  A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  .  Medical history:none  There were no concomitant medications.  The patient missed his second dose on 01mar2021 due to fever .The patient underwent lab tests and procedures which included body temperature: 99.2 fahrenheit on 01Mar2021 .    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderate left arm pain, radiating into upper back; Moderate left arm pain; This is a spontaneous report from a non-contactable nurse (patient). A 36-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration at left arm on 21Dec2020 10:45 at single dose for covid-19 immunization at hospital. Medical history included allergy to penicillin (PCN). Concomitant medication included fish oil, cetirizine hydrochloride (ZYRTEC), fluticasone propionate within 2 weeks of vaccination.  The patient experienced moderate left arm pain, radiating into upper back on day 2 (22Dec2020), the adverse event start time was 21Dec2020 08:00 PM. No treatment received for the adverse event. No COVID prior vaccination, no COVID tested post vaccination. The event outcome was not recovered. The was not reported as a serious report.  No follow-up attempts are possible. No further information is expected.
VARIVAX vaccine given 2/26/10 at 0930 swelling observed next day, went to urgent care admitted to hospital - 4 hr stay and discharged.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of varicella virus vaccine live.  Sometime later, he developed 12 varicella lesions.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Fever, congested, fatigued. Went to urgent care and tested negative for covid/flu/strep. Continued taking OTC medications for symptoms and rested
anxiety/ I started feeling, little shaky, little nervous, like anxious; bottom lip broke out; the vaccine affected her immune system; I have a slight headache; It's breaking out, and it's breaking out like Herpes simplex; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Jul2021, (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included psychogenic seizures from an unknown date and unknown if ongoing.The patient concomitant medications were not reported. Caller stated she was doing really well until yesterday specifically last night (01Aug2021) she felt anxiety and her bottom lip broke out (patient started feeling, little shaky, little nervous, like anxious). Caller stated it was almost as if she chewed on it and she may have but she did not know if she did. Caller stated she generally did not have the same kind of anxiety she was experiencing but she could feel anxiety and she was diagnosed with psychogenic seizure disorder because she was abused as a child. Caller stated when she was younger she had a lot of anxiety and she worked through it with therapy and it seemed to subside. Caller stated maybe it was just the way the vaccine affected her immune system as to why she felt anxiety. Caller stated she knows people who have had COVID-19 and they felt like they were not functioning correctly but there was nothing in the brain wrong but she thinks they call them long haulers or something like that. On an unspecified date in 2021, the patient experienced bottom lip broke out, the vaccine affected her immune system, have a slight headache, it was breaking out and breaking out like herpes simplex but it was not that bad. Consumer meant it was just slightly swollen. The clinical outcome of the events were unknown.  Information on the lot/batch number has been requested.
Inflammation, pain an swelling in my feet, toes, bottom of my feet, knees , Hands, thumb finger etc. and joints.  In the fleshy part of my body.  Mostly on the Right side.   I did not have this before and I. work out and do yoga often.   I AM STILL HAVING PAIN.  Have been seeing my GP  Dr.  and my orthopedic Dr..  tomorrow I will be seeing and rheumatoid doctor subject by orthopedic PCP.
soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on arm). At the time of the report, PAIN IN EXTREMITY (soreness on arm) outcome was unknown.            This case was linked to MOD-2021-036287 (E2B Linked Report).; Sender's Comments:  MOD-2021-036287:dose 2
Cold sore breakout, rash on arm, migraine headaches, bone aches, fever, blood changes. Thickening of blood noticed when spit blood out of mouth the weeks after. it was just sticking to teeth and not absorbing or joining saliva.
big lump that was hard, round the size of orange; Redness; Red and rash around it; Painful itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (big lump that was hard, round the size of orange), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Red and rash around it) and VACCINATION SITE PRURITUS (Painful itching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ENALAPRIL, METOPROLOL, DILTIAZEM HYDROCHLORIDE (CARTIA XT) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE MASS (big lump that was hard, round the size of orange), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Red and rash around it) and VACCINATION SITE PRURITUS (Painful itching). On 18-Jan-2021, VACCINATION SITE MASS (big lump that was hard, round the size of orange), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Red and rash around it) and VACCINATION SITE PRURITUS (Painful itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl and Tylenol
My period was irregular; It lasted for 10-14 days since first day of period; delayed for  more than 7 days, about 10 days; my period completely stooped; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 18:00 (Lot number: EN8727) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Postpatum Depression, depression" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 18:00), administration date: 01Mar2021, when the patient was 45-years-old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (disability) with onset 31Mar2021, outcome "not recovered", described as "My period was irregular"; HEAVY MENSTRUAL BLEEDING (disability) with onset 31Mar2021, outcome "not recovered", described as "It lasted for 10-14 days since first day of period"; MENSTRUATION DELAYED (disability) with onset 31Mar2021, outcome "not recovered", described as "delayed for  more than 7 days, about 10 days"; AMENORRHOEA (disability) with onset 31Mar2021, outcome "not recovered", described as "my period completely stooped". The patient reported her period was irregular since Mar2021, the month she had her COVID-19 vaccine. It lasted for 10-14 days since first day of period; sometimes lasted for 5 days. It was delayed for more than 7 days, about 10 days. Six months after injection, her period completely stopped. Her mom had menopause at 52-years-old. The patient didn't have other menopause symptoms besides stopped period. The events "my period was irregular", "it lasted for 10-14 days since first day of period", "delayed for  more than 7 days, about 10 days" and "my period completely stooped" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, menstruation delayed, amenorrhoea. Since the vaccine, the patient was not tested for COVID-19.
Arm pain x3 day; low grade fever x3 day; generalized muscle pain x2 day; nausea x2 day; fatigue x3 day; shivering x2 day.
Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced flu like symptoms and nausea.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 21 year old female student with an allergy to sulfa, who on 03-Aug-2007 was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (Lot # 0469U). On 06-Aug-2007 the patient experienced flu like symptoms, nausea, a severe headach, malaise, swollen glands, and a fever. The patient sought unspecified medical attention. A strip screen was performed (results unknown). On 10-Aug-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Child had 15 second febrile seizure on 10-14-16 - was transported to emergency department.
Patient found unresponsive at home 04/04/21 at 11pm per child. Sent to hospital via 911. Deceased 4/6/2021.
two shots were one year apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose about 1 year ago from 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 self-reported this case. The age at vaccination was not reported. The patient received two shots of Shingles vaccine exactly about one year apart, which led to lengthening of vaccination schedule. The patient stated that the store did not tell him/her there was a second shot nor did they reach out to got him/her to came in. The patient asked whether it still work. He/she did not want to get shingles. The patient also asked should he/she get a third shot in two months. Note: From the narrative it was not clear if the patient received shingrix vaccine hence shingles vaccine was coded as suspect  conservatively.
This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered PNEUMOVAX 23 (lot: M026317; expiry:11-JAN-2018 and lot: M029680; 17-JAN-2018) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010325: same reporter.
pt recvd vax & p/24 hrs started w/fever & urticarial type rash over trunk; rash turned generalized & itching plus palpable edema adm on9NOV92; hematomas, petechial lesions; mac pap erythematous, poss (allergy) reaction;
76 yo AAM PMH including incomplete quadriplegia and long-term abx suppressive therapy for osteomyelitis received Shingrix vaccine dose #2 in R deltoid on 4/24/19. A rash on R hip developed approximately 5 days later. Rash is described as "discrete clusters of purulent appearing blisters on erythematous base" in 7/29 note. Patient's wife also reported he fall on R side prior to rash appearing. Rash now resolved but remains cool to the touch.
Got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away; Got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset Mar2022, outcome "not recovered" and all described as "Got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away". The event "got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away" and "got the booster shot 6 days ago; started having headache for 3 days non stop and sometime its throbbing; the headache is not going away" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, pain.  Additional information: The patient go got first dose and second dose and got the booster shot 6 days ago and she men-tioned that her son was started having headache for 3 days nonstop and sometime its throbbing. She just wants to confirm if it was normal, or he need to get medical attention. On paraphrasing the concern: Reporter stated that he was experiencing. He has the Pfizer booster shot, last Wednesday so, 6 days ago. So, he was having normal side effect before (further not clarified) but, last 3 days he has nonstop headache and even reporter gave him 3 Advil the pain does not go away (further clarifications unknown). Sometimes it's always there but then throbbing happen. The pa-tient took him to the urgent care. They checked provision all that stuff he said, he was ok, but the headache was not going away. It's been 3 days. Reporter wanted to  know if that was normal, or anybody reported that to you guys.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seen 3/27/09 for "diffuse maculo - papular rash "from abdomen down -slight "scaly" feel to it - macular rash on bottom of feet.
but my arm was excruciating, the pain was unbearable; nausea; vision was getting blurry; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "but my arm was excruciating, the pain was unbearable"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VISION BLURRED (non-serious), outcome "unknown", described as "vision was getting blurry".  Additional information: Caller states "I gotta talk to you, what happened was 07Jul2021 I got first dose, people I know got the first shot before me and said expect soreness in the arm. Alright that doesn't sound bad but my arm was excruciating, the pain was unbearable". Caller states "because shortly after they gave me the vaccine, my vision was getting blurry, but I do have cataracts in both eyes. Could it make it blurry because I have cataracts"?. Caller states "here's my crucial question. I had the first shot and I'm going back for the second shot any time after 28Jul. Is it true my pharmacist told me this is it true that after the second dose your side effects are worse"?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.