chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 minutes after the shot, my chest and head felt as though a wave had hit me. A few seconds later, my throat began to feel like it was constricted. My heart beat rapidly. My head felt fuzzy (similar to when I have accidentally ingested pistachio), but even more intense. It began to subside but came back like a smaller wave approximately 10 minutes later. This continued for approximately 90 minutes. I was seen at urgent care (before symptoms went away), and was told I had an allergic reaction. I was told to take 50mg of Benadryl every 6 hours. I took it twice that day. Symptoms resolved by late afternoon.
Patient received bivalent booster from local Healthcare on 11/30/22. Pharmacy was unaware of this and administered a bivalent booster on 12/13/22.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Patient fainted right after receiving the shot. He became conscious about 1 minute later and stated he feels dizzy. He was then checked by healthcare team and came back to normal.
Developed fever 99.9F and left upper arm pain for 1st 3 days after getting the vaccines; resolved. Developed rash to right upper arm; resolved. Developed body-aches and moderate-severe muscle and joint pain that has lasted for ~3 weeks and still persists, which caused patient to make an appointment today. Affected joints: bilateral knees and hips. Affected muscles: bilateral biceps and quadriceps. Tried aleve, ibuprofen, and tylenol with mild improvement. Prescribed short-course of prednisone. Outcome pending.
Chills, Shakiness, Neck/Jaws/Legs Tightness Racing Heart, Nausea
I received my 4th dose of Pfizer on 04/07/2022 and tested positive for COVID on 05/14/2022.
because he got 2 Pfizer COVID-19 vaccines and a booster;where he got a SOFIA FIA nasal test because he had chills and body aches, and that's when he was prescribed with Paxlovid; because he got 2 Pfizer COVID-19 vaccines and a booster;where he got a SOFIA FIA nasal test because he had chills and body aches, and that's when he was prescribed with Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "because he got 2 Pfizer COVID-19 vaccines and a booster;where he got a SOFIA FIA nasal test because he had chills and body aches, and that's when he was prescribed with Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: could test positive after a certain time. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information:  He then added that before starting Paxlovid, he went to a walk-in clinic, where he got a SOFIA FIA nasal test because he had chills and body aches, and that is when he was prescribed with Paxlovid.He also wanted to know if he was still contagious because he no longer had COVID-19 symptoms, he stated so far, so good and added that he no longer had body aches nor coughing. He also showed interested in knowing Paxlovid develops antibodies, because he got 2 Pfizer COVID-19 vaccines and a booster, possibly monovalent as he received it on late 2021, but he feels scared of getting the new booster because of the stories in the news of people getting sick from vaccine, mentioning the cases of blood clots and heart problems. He then showed interest in learning information about the Pfizer COVID-19 Booster, including if he could receive it while having a recent COVID-19 infection and the possible side effects for people 65 years of age and older, which he then confirmed was his age group, mentioning he was in his 70s. He finally added that he had some side effects when he took the vaccines, but they did not last long and did not had a reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069211 same reporter/patient/product, different dose/event.;US-PFIZER INC-2021015210 same reporter/patient/product, different dose/event.;
No additional adverse events.; a pediatric VAQTA administered to an adult patient; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 20-JUL-2020, the patient was vaccinated with a pediatric hepatitis a vaccine, inactivated (VAQTA) lot # S020241, expiration date 23-AUG-2020, (exact dose, injection site and route of administration were not reported) for prophylaxis. There was no adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. On 14th August 2018, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient received SHINGRIX at a pharmacy 2 weeks before the date of reporting and on the day of reporting the patient was diagnosed with shingles. The reporter agreed to be contacted for follow up.
stomach cramping and diarrhea, took Immodium AD and still had diarrhea symptoms and stomach cramping 4 hours later
Warm, erythema, and induration over site of injection. Advised warm compress. Per mom, it didn't seem to bother the patient.
I felt chest pression that went to my ears; I got scared and thought it was a heart attack; I felt tired like when I had COVID before the first dose of the Moderna vaccine; strong pain in left lower leg / the pain came back a week after and then pain got better; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in left lower leg / the pain came back a week after and then pain got better), CHEST DISCOMFORT (I felt chest pression that went to my ears), FEAR (I got scared and thought it was a heart attack) and FATIGUE (I felt tired like when I had COVID before the first dose of the Moderna vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (strong pain in left lower leg / the pain came back a week after and then pain got better). On an unknown date, the patient experienced CHEST DISCOMFORT (I felt chest pression that went to my ears), FEAR (I got scared and thought it was a heart attack) and FATIGUE (I felt tired like when I had COVID before the first dose of the Moderna vaccine). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 85 mg; IBUPROFEN at a dose of 200 mg once a day and AMLODIPINE at a dose of 5 mg. At the time of the report, CHEST DISCOMFORT (I felt chest pression that went to my ears), FEAR (I got scared and thought it was a heart attack) and FATIGUE (I felt tired like when I had COVID before the first dose of the Moderna vaccine) 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.
pt recv vax 3APR97 & mom reports 2wk p/vax pt devel resp congestion & low grade fever;congestion cont to worsen;pt saw MD;rx ATB & steroid prescribed;mom reports no other side effects noted;pt had bronchopulmonary dysplasia since birth;
Information has been received from a nurse referring to a patient of unknown age and gender. On 15-JUN-2015, the patient was administered with improperly stored dose of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The evening following flu vaccine in December 2017, my lower left leg became numb and swollen, with a red/black and blue band around entire calf.   This was a Friday.  By Sunday evening I was not able to weight bare on the left leg.  I returned to employee health Monday morning with the leg able to bare weight.  Dr., my primary care physician and employee health physician did not feel that it was caused by the flu vaccine.  I continued to have itching, swelling and discomfort.  Had a Doppler ultrasound which was negative.  Saw two separate dermatologist, primary care physicians who all stated that "this was not from the flu vaccine, but they could not tell me what it was".  I learned to live with the discomfort and the sore started to fade. In December of 2018, following my flu vaccine, the same sore became angry, swollen and much worse, with another sore now forming just above the first sore.   Following my own research, ( I am a registered nurse), I found that it seems to resemble "granuloma annulare".  There were several cases which this happened following the flu vaccine, but not a lot of research out there on this.  Once again several doctors looked at the sore, but no one can give answers.  In July of 2019 I saw Dr., Infectious Disease, who advised me never to take the flu vaccine again, as it seems to be an immunoreaction to the flu vaccine.  I still have yet to find a doctor or anyone who can tell me what to do for this.   It seems to be getting worse and more irritated.  I feel that this should be reported to the CDC so that maybe further research can be done or if I can be directed to someone who can help me.  I am convinced it is from the flu vaccine as it flared up following the second one last December.
Patient experienced sudden nausea and vomited once, he was also light headed and dizzy for 20 minutes after vaccination.  After waiting approximately 30 minutes, the individual stated that he felt better and returned to work.   While recovering, the patient stated that he had no oral intake other than an energy drink, since waking up at 5am this morning.
5 days after vaccine onset of fever to 101, Exfoliative rash on hand 1 week after vaccine. Strep screen 07/18 neg. Once fever subsided generalized rash noted on 07/25/2005. No complications and resolved in 48 hrs. Given Orapred.
swollen lymph node under arm; Severe abdominal pain; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 08:45 as dose 2, single for covid-19 immunisation.  The patient's medical history included systemic lupus erythematosus from Jan2011 and ongoing Verbatim: lupus, hashimotos from Mar2011 and ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9267, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 11Feb2021 as dose 1, single for COVID-19 immunization. The patient had a couple of uncommon reactions, and she wants to make sure there's nothing she can do. The second vaccination hit her pretty hard.  On Friday the caller had the second vaccine and on 08Mar2021, she noticed a large lump under her arm were she got shot in, she thinks her lymph node was swollen and that was really sore. The patient also had abdominal pain which started on 08Mar2021 Friday at 10 in the morning and her shot was given at 8:45 that day. If the lymph node swelling was from the vaccine, the caller figured that it would have shown up rather quickly and not a delayed reaction.The outcome of events were not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 30-SEP-2009, the patient was vaccinated VARIVAX dose 1, lot # 664468/0684Y, expiry date 15-MAY-2011 (dose, route, vaccination site unknown). On 01-FEB-2010, the patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y, expiry date 07-AUG-2011 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistences in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sluggish; No strength; Feeling tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish), ASTHENIA (No strength), FATIGUE (Feeling tired) and HEADACHE (Slight headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, the patient experienced SLUGGISHNESS (Sluggish), ASTHENIA (No strength), FATIGUE (Feeling tired) and HEADACHE (Slight headache). At the time of the report, SLUGGISHNESS (Sluggish), ASTHENIA (No strength), FATIGUE (Feeling tired) and HEADACHE (Slight headache) had not resolved.            No concomitant medication information was provided. Patient stated that adverse events were not that serious, just uncomfortable feeling. No treatment medications were provided.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 384 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Red rash, skin reaction, itchy, warm to touch. Was given Loratadine 10 mg tab 1 tab daily for 7 days (Both injection sites).
Dizziness for 30 minutes; This is a spontaneous report from a non-contactable pharmacist. An 18-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an intramuscular route of administration in the left arm on 30Mar2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient reported dizziness for 30 minutes, symptoms resolved and patient was able to leave. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, it was unknown whether the patient had not been tested for COVID-19. The clinical outcome of the event dizziness for 30 minutes was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Chills for 5 hours Night Sweats for 8 hrs Sore Body for 5 hrs
Bruise at injection site, with redness and warm to touch. Very sore. On March 9 a red rash by injection site. On March 12 a red circle around injection site. No itching or soreness
COVID positive after fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID positive after fully vaccinated) in a patient of an unknown age and gender 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 SARS-COV-2 TEST POSITIVE (COVID positive after fully vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive after fully vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 15-NOV-2017, 16-JAN-2018 and 29-MAR-2018, the patient was vaccinated with ROTATEQ (strength were unknown) (lot# M042169 and expiration date 22-JUN-2018; lot# N003984 and expiration date 19-NOV-2018; lot# M022173 and expiration date 15-MAR-2019) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
I got really hot and started sweating a few minutes after my injection and I have been getting hot and sweaty for no reason since.  I want to know if it's safe to get the second injection.  And if this will go away.
01/09/21  woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flush feeling, night sweats,  body aches, tired, fatigue, lymph node tenderness under both arms and arm at injection site was red and swollen about the size of a baseball.  Slept most of the day and still did not feel well when woke up later in the day and called into work evening of 01/09/21.  Reports when she woke up the morning of 01/10/21 felt great.
Fever reached 101F; flu like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (Fever reached 101F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product AZTREONAM LYSINE inhalation vapour, liquid for Cystic fibrosis.    Concurrent medical conditions included Cystic fibrosis. Concomitant products included DORNASE ALFA (PULMOZYME) and ELEXACAFTOR, IVACAFTOR, TEZACAFTOR (TRIKAFTA) for an unknown indication.   In 2018, the patient started AZTREONAM LYSINE (unknown route) 75 milligram. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PYREXIA (Fever reached 101F). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and PYREXIA (Fever reached 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 (High) 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided