chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a one year old female. On 26-NOV-2018, she was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N025933, expiration date 19-SEP-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012374: US-009507513-1908USA012377:
(10:10am)  Waiting at the 10-minute mark, I realized my throat was closing quickly, hard to swallow, short breaths,  and my lower lip was swelling quickly. Knowing I was at the  pharmacy and would have to be routed to a Hospital.  I alerted the nurse about the symptoms, who then administered an  Epi-pen. (10:30am)  By the time the EMTs arrived the Epi-pen had done a lot of the work. Confirming my Lungs were clear,  my oxygen saturation was stable with facial swelling presenting.(11:05am) Findings at The ED found my uvula, my throat, and my lips had swollen.  With IV Steroids, Benadryl,  facial swelling  was minimal at discharge.  However extreme dizziness, and weakness presented in ED
This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M032635 with expiration date 05-MAY-2018, dosage and route of administration were not reported), which was exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
headache; light pain on my right shoulder; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 04Apr2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 17:00, the patient experienced headache and light pain on right shoulder. It was reported that the patient still had headache and shoulder pain on 05Apr2021, the second day of vaccination. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event headache and shoulder pain was not resolved.   No follow-up attempts are possible. No further information is expected.
3 days after the second shot, 2 seizures within 1 hour, hospital for help for 3 days; This is a spontaneous report from a contactable consumer(patient).   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, on an unknown date, as SINGLE DOSE for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient previously received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunisation. After 1 week of first dose of vaccination patient had experienced two strokes on both sides of the brain. On an unknown date, after 3days of second dose of vaccination, patient had two seizures within 1hour and was hospitalized for help for 3 days. The patient truly believed it was not a good thing, and patient suffered a lot. The outcome of the event was unknown.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  The date of positive pregnancy test was 29-Oct-2020   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details.
1st dose - local soreness at injection site several days, very mild brain fog afternoon after morning injection 2/27/21 10AM 2nd dose (this report, received 10AM 4/6/21) - local soreness at  injection site several days, morning after 2nd injection woke with severe headache and muscle/join aches (particularly hips) , moderate fever (100 Fahrenheit), moderate brain fog. Symptoms moderated with aspirin (I prefer no to use acetaminophen) , symptoms persisted throughout the day, retired that evening early with symptoms.  2nd morning after 2nd injection awoke with mild body/join aches, no headache or brain fog, mild fever (99 Fahrenheit, my normal temperature is 97.9 Fahrenheit). Again moderated with aspirin.  3rd day after 2nd injection - normal temp, very mild almost unnoticeable muscle/joint aches, no headache or brain fog.
Pt reports abdominal pain, nausea, diarrhea, loss of appetite. St's she feels like she has the flu.
Significant arm pain upon first dose; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in right arm. The patient experienced significant arm pain upon 1st dose. The reporter did believe pain was related Shingrix administration. For tolerance to 2nd dose, refer linked case US2020AMR226401, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR226401:Same reporter
Pt acquired covid-19 several months after administration of vaccine that requires hospitalization.  Symptoms include sever, cough, decreased O2 saturation requiring supplemental oxygen administration.
Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: EXTEMITIES
Right upper arm pain after HPV injection. Swelling at injection site on same day. Swelling has decreased, but pain when moving arm. Lump in muscle.
feels malaise/has not felt well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels malaise/has not felt well) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feels malaise/has not felt well). At the time of the report, MALAISE (feels malaise/has not felt well) outcome was unknown.            No concomitant medications was included. No treatment drug was mentioned.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:04, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237:  US-009507513-1704USA000485:  US-009507513-1704USA000486:  US-009507513-1704USA000487:  US-009507513-1704USA000488:  US-009507513-1704USA000489:  US-009507513-1704USA000490:  US-009507513-1704USA000491:  US-009507513-1704USA000492:  US-009507513-1704USA000493:  US-009507513-1704USA000494:  US-009507513-1704USA000495:  US-009507513-1704USA000496:  US-009507513-1704USA000497:  US-009507513-1704USA000498:  US-009507513-1704USA000499:  US-009507513-1704USA000500:  US-009507513-1704USA000501:  US-009507513-1704USA000502:  US-009507513-1704USA000504:  US-009507513-1704USA000505:
Miscarriage 1 week post getting dose 1 of vaccine.  Estimated due date was 08/18/2021.  Previous pregnancy history is 3 pregnancies, with 3 full term live births, no complications.
Pfizer 1/5/21, 1/26/21, 10/13/21. Positive on 2/5/22
About 5 minutes after vaccine shot my heart started racing very rapidly and I had an immediate onset of a moderate headache with feelings of dread and slight difficulty breathing. The person who administered the vaccine gave me some water which helped a bit. I had a moderate to severe headache for going on 27 or so hours with throbbing and pulsing in teeth and roof of mouth. I also had pungent and odorous urine, extreme fatigue, and feelings of heaviness in my head and hands.
fainted for 5-10 minutes; he felt pain when it was administered; his whole body began to hurt.; he felt nauseous; He then slept for 12 hours that night; would be slumped/slouching throughout the day; he was very hungry when he had the shot administered.; This spontaneous report was received from the patient's mother and refers to a 14-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-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) injected into left arm (exact dose, route of administration, lot # and expiration date were not provided), as routine vaccination.  On the day of the vaccination, the patient experienced pain when the vaccine was administered and his whole body began to hurt. After a while, he felt nauseous and fainted for 5-10 minutes. He then slept for 12 hours that night and would be slumped/slouching throughout the day. Reported mentioned that the patient was very hungry during the vaccine administration. On an unknown dates in 2021, he recovered from all events.  The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
Mother of child called Health Dept 5/1/09 with complaints of redness and swelling in child's arm - child had Tdap inject. L delt. 4/30/09. Mother was referred to Urgent Care - Child was seen that afternoon in UC and advised to keep arm elevated, apply ice pack and take BENADRYL.
pt recvd vax & devel itchy skin, like something is crawling under skin; pt was seen by family MD who suspected scabies; pt was treated w/Lindane & epsom salt bath for itchiness;
pt gets twitching with Hib vaccine every time  pt was seen on 5/29 had Hib vaccine, pt went to grand mother's house , immediately after falling sleep , he starts twiching ,grand mother will hold him for 15 minutes, it lasts for 15 minutes, it is persistent, but slowly going away,   pmh similar episodes with prior Hib vaccine as per grandmother. it lasted for couple of weeks, no other problems,   mother reports her previous Pediatrician did one shot at a time, at that time it also happened with Hib, not with Dtap ( he was fine with it)  reviewed video, small twiches on his hand and distal leg, every few seconds , no other problem,  no problems while he is awake,   he has been having "ear tugging"  pmh hx of tongue and lip tie done last week  family denies seizure disorder  Plan  discussed in detail with mohter and grandmother  watched video of twiching,  reassure since patient is not getting any more Hib , and it is getting better, with hx of improving over time, wll not further investigate  hold off on vaccines until 18 months,to observe affter twiching is resolved
Feeling sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL and TREPROSTINIL DIOLAMIN (ORENITRAM) for Secondary pulmonary arterial hypertension, TADALAFIL and MACITENTAN (OPSUMIT).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MALAISE (Feeling sick) and PYREXIA (Fever). At the time of the report, MALAISE (Feeling sick) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
FLANK PAIN, CHILLS, INTERMITTENT CHEST PAIN AND INCREASED WORK OF BREATHING, FEVER
No adverse effects; improperly stored doses of PEDVAX HIB and ROTATEQ were administered to the patient; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Informaion regarding patient's medical history, concurrent conditions and concomitant medications was not provided.  On 19-JUN-2019 the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot # R033485, expiration date 24-JUN-2020, and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R027328, expiration date 12-JUL-2021 and lot number reported as R019391 and expiration date 23-OCT-2020 (strength and dose were not reported for any of the vaccines), both for prophylaxis. No Adverse effects reported.   Regarding the temperature, the total time and highest temperature wa above 47 °F/9° C  for 1 hour and 30 minutes. There was no previous temperature excursion. The call  was done because a data logger.  This case is one of several cases received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA008683: US-009507513-1906USA009093:
¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.). At the time of the report, FATIGUE (¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications  were not reported  Treatment was not specified
Patient seen in the ED on 12/12/22 with fatigue, mild shortness of breath, and cough. He reported testing positive for COVID at home earlier that morning. At that time, he was discharged back home with a prescription for Paxlovid. Patient returned to the ED on 12/13/22 with increased weakness, difficulties ambulating, and diarrhea. Repeat COVID PCR test done in the ED also resulted positive. He was admitted 12/13/22 - 12/14/22 with discharge diagnosis of acute hypoxic respiratory failure due to COVID-19 pneumonia. He initially required 2 L of supplemental oxygen, however was able to be weaned off. Patient has been vaccinated for COVID-19.
Patient complained of fast heart rate, dizziness, numbness and tingling in hands and feet. 10/12/09 Medical records received from dates of service 10/2/09 to 10/8/09 10/2/09 OV for c/o ball in throat feeling, acne, hair loss and to begin gardasil vaccination series. DX: questionable reflux, acne, hair loss. 10/8/09 OV c/o HA, dizziness, moody, heart racing, jerking arms, tingle in fingers occurring after getting gardasil vaccination. DX: HA, dizziness, tachycardia.
Child had vaccination of TDAP on Tuesday December 6, 2005. Started PM of 12/7 with temperature of 103, headache, and sleepiness.
pt is hospitalized; dx GBS 19OCT93 pt had funny feeling, salty taste in mouth, tingling weakness in legs; adm to hosp 22OCT93 ascending paralysis;, difficulty swallowing & breathing; intubated 27OCT93;
Vaccine administered came from vial that was kept in fridge for longer than manufacturer recommended storage date.  Patient did not return our multiple calls to inform them of the expire vaccine that they received.  The patient did not call back in any capacity to complain about any adverse events. The manufacture informed us via written statement that patients "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination was not advised.
A 24-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2022 at 14:55 as dose 1, 30 ug single (Lot number: FM7553, Expiration Date: Oct2022) at the age of 24 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing). There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 14Oct2022 at 14:55, outcome "unknown" and all described as "The product stored when excursion occurred: Fridge (2 to 8 degree centigrade) Outside of fridge. Duration of Excursion: Days: 1, Hours: 1".    Follow-up attempts are completed. No further information is expected.  Follow-up (20Oct2022): This is a spontaneous follow-up report from the same contactable Pharmacist. This Pharmacist reported for a patient that: Updated information included: Reporter details added, Expiration date of suspect drug added, Vaccination facility name added, and events added.  Follow-up attempts are completed. No further information is expected.  Follow-Up (27Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (01Nov2022): This is a spontaneous follow-up report received from a contactable Pharmacist in response to HCP letter sent. Updated information included: Reporter slider #02 added. Other medical history ongoing ticked. Vaccination time added. Anatomical location added. Vaccination facility details added. Onset time of previous events added.  No follow-up attempts possible. No further information expected.
Patient  Signed up for second dose of Moderna and after receiving vaccine came to realize he got Johnson and Johnson
Narrative:  77 yo male patient did not receive care or meds from medical facility, but did receive immunizations of covid 19 vaccines on 1/29/21 & 2/26/21. Pt died of unknown causes on 8/17/2021. Active problem list: Allergic rhinitis (SCT 61582004) (ICD-10-CM 07/30/2019 J30.9) Hypothyroidism (SCT 40930008) (ICD-10-CM E03.9) 07/30/2019 Cerebrovascular accident (SCT 230690007) 08/03/2018 (ICD-10-CM G46.4) Dizziness (SCT 404640003) (ICD-10-CM R42.) 11/28/2017 Inflammatory dermatosis (SCT 703938007) 03/10/2017 (ICD-10-CM L20.89) Eruption (SCT 271807003) (ICD-10-CM R21.) 03/10/2017 Benign essential hypertension (SCT 1201005) 02/18/2016 (ICD-10-CM I10.) Overweight (SCT 238131007) (ICD-10-CM E66.3) 02/18/2016 Hearing loss (SCT 15188001) (ICD-10-CM H90.0) 02/18/2016 Diabetes mellitus (SCT 73211009) (ICD-10-CM 02/18/2016 E11.21) This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
This spontaneous report was received from a 77 years old female patient who was allergic to sulfur drugs and cholesterol medications. The patient's medical history included hypothyroid. The patient was vaccinated SQ with a dose of ZOSTAVAX (dose, lot # unknown) on 14-AUG-2012. Concomitant medications included thyroid medications. On 14-AUG-2012 the patient had itching and a red circular ash at the site of injection. The patient stated it was oval and 3 inches long. It was reported on 19-AUG-2012 the patient had a breaking out of blistered rash, similar to what she called chickenpox, on her upper right leg. The patient was not sure if she had chickenpox before. No treatment was given for the AE. There was no lab diagnostics studies performed. The outcome of the patient was unknown. The patient did not seek medical attention. Additional information has been requested.