chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling tired; Had a "foggy like" sensation; "I" started running a low grade fever; Chills; Runny nose; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Sep2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Sep2021 at 09:30, shortly after getting the vaccine, the patient started feeling tired and had a foggy like sensation. Towards the later part of the evening, the patient started running a low grade fever followed by chills and a runny nose which lasted about 48 hours and then fully subsided. The patient woke up 48 hours after and all symptoms resolved. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL). The clinical outcome of the events started feeling tired, foggy like sensation, started running a low grade fever followed by chills and a runny nose was resolved on 30Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Had a positive covid test; Sounds like pseudo-lymphoma; had hives in some exposed areas. Much of it on her lower extremities; Red maccular papular rash; Red maccular papular rash; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Had a positive covid test), PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities), RASH MACULO-PAPULAR (Red maccular papular rash) and RASH ERYTHEMATOUS (Red maccular papular rash) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included Overweight.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had a positive covid test), PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities), RASH MACULO-PAPULAR (Red maccular papular rash) and RASH ERYTHEMATOUS (Red maccular papular rash). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Had a positive covid test) and RASH ERYTHEMATOUS (Red maccular papular rash) outcome was unknown and PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities) and RASH MACULO-PAPULAR (Red maccular papular rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient was very overweight, and at higher risk.  Patient received bivalent booster in early fall 2022. She had also had boosters before that. Had a positive covid test, no medical treatment. Patient developed hives in some exposed areas. Much of it on her lower extremities. Red maccular papular rash. Sounds like pseudo-lymphoma. Patient was told to take a Medrol dose pack.
Within 2 hours of getting the shot my heart rate shot up when I was in resting position. It would go back and forth between normal heart rate and the highest it got was 175bpm. After a week of this going on I followed up with my PCP had an EKG done and saw I had sinus Tachycardia. They put me on a Beta blocker from now until 2 weeks after my second dose to see if that slows my heart rate down.
Patient hospitalized on 5/25/2022 with a 2 day history of cough and dyspnea. Upon admission, he required supplemental oxygen.
R arm with 2 cm vesicular lesion surrounding erythema and induration- ? cellulitis, started Benadryl and Bactrim and Motrin, seen on 10-30-09 and rechecked on 10-31 and was improving.
4/28/06 had been recovering from cold symptoms that began 2 wks prior. Had nasal congestion day of vaccine. Went to school after vaccine became hot, dizzy, sl. nauseated, left school, temp 100.2. Symptoms lasted several hrs then gone. 4/29 and 4/30 nasal congestion only. 5/1 and 5/2 sore throat increased nasal congestion.
This is a 50 year old female, who was identified by me due to anaphylaxis following her 2nd dose Moderna on 5/25/21.  Upon further review of her chart, additional administration errors were identified.  On 4/9/21, the patient received a J&J vaccine dose (lot#1805018, IM, left arm).  A few weeks later, the patients contacted her primary care physician with a concern that she took an ibuprofen prior to the J&J vaccine dose and was concerned about that ibuprofen dose impacted her immune response.  She had spoken to a retail pharmacist who recommended an antibody test to check for immunity.  Her primary care provider agreed that the antibody test 'would be reasonable to do.'  The patient took a SARS -COV2 Antibody IGG test on 4/27/21.  The result was negative, and the covering provider communicated to the patient 'covid testing is negative.'  No additional chart documentation regarding any communication/interpretation of this lab result as it pertains to her post-vaccination immune status.  The patient reported to the vaccine clinic on 4/30/21 and received her 1st dose of Moderna (lot# 021C21A, IM, left arm).  She reported this was 'OK with her PCP,' however no chart documentation to confirm that.  No adverse events reported following either the J&J dose on 4/9, or the Moderna dose on 4/30.  She returned to our vaccine clinic on 5/25/21 and received the 2nd dose of Moderna.  Immediately following that dose, she developed swollen eyelids, itching in her throat, and nausea.  The onsite provider administered diphenhydramine 50mg IM with some improvement.  The symptoms returned within 10 minutes, and the patient was treated with famotidine 10mg orally.  EMS was called and evaluated patient.  The patient refused EMS/transport to an emergency room. The patient then drove herself to a nearby emergency room where she was observed further.  The following day, the primary care clinic contacted patient and she reported resolution of her symptoms.    Overall, likely anaphylaxis following her 2nd dose Moderna vaccine AND duplicate therapy (received both J&J and Moderna vaccines).
I received my first shot on Friday morning 3/19 at 11:30. Over the weekend, I suffered rigors and a max temp of 101.7. I then had 4 days (Monday-Thursday) of extreme weakness, cough, nausea, vomiting and diarrhea. I felt like I had Covid all over again. I did not feel back to almost normal until Friday evening 3/26. I just thought this might be something you are monitoring.
the flu shot caused me to be very sick with the flu for two weeks; nowsick for the fourth day after taking the latest Covid booster; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional via Social Media.  This case involves an unknown age and unknown gender patient who received the flu shot that caused to be very sick with the flu for two weeks and now sick for the fourth day after taking the latest covid booster after receiving vaccines COVID-19 vaccine and influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation- not reported) via unknown route in unknown administration site for prophylactic vaccination and also received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number, expiry date, strength, formulation- not reported) via unknown route in unknown administration site for covid-19 immunization.  On an unknown date the patient developed a non-serious event, the flu shot caused me to be very sick with the flu for two weeks (influenza) and nowsick for the fourth day after taking the latest covid booster (malaise) (unknown latency) following the administration of influenza vaccine and COVID-19 vaccine.  It is unknown if there were lab data/results available  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-NOV-2013, the patient was inoculated (by an unspecified health care professional) at a clinic with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 29-APR-2016, the female patient was treated at the same clinic (by an unspecified health care professional), and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Erythema and swelling of right arm injection site; pruritis and right axilla node tenderness.
right arm, redness, swollen, itchy, redness spreading from outside arm to inside of arm (7"w x 5.5"L)
Death Narrative:  Patient tested positive for COVID-19 on 1/25/21 after receiving her first vaccine on 1/8/21. He was discharged from hospital on 1/26/21 with admitting diagnosis of COVID pneumonia. He did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had made it through the COVID infection period but suffered complications including pneumonitis, lung, heart, and kidney failure requiring high flow oxygen. He required readmission to hospital for the complications in 3/2021 but ultimately passed away on 3/24/21 likely due to the multi organ failure complication of COVID
This spontaneous report as received from the director of quality at a facility via a company representative refers to a 18 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot number and expiration date were not provided) intramuscularly for prophylaxis. Concomitant medication was nor reported. Additional information has been requested.
Severe migraine type headache after receiving 3rd GARDASIL 24 hours after.
Headache, sl. vertigo, nausea rested and improved. Went to class but nausea worsened so he was sent home.
On 2/9/21, The associate had a tingling sensation in her throat and forehand and it felt like her throat was closing up. The associate stated to the nurse that she had the same issue with the first dose and she did not notify anyone of the that reaction. She just went home and took benadryl and it resolved. The associate received diphenhydramine (50 mg per ml IM once ) on 2/9/21 .
Swelling of arm, redness, severe pain & inability to use arm for 3 days due to pain & swelling
Narrative: pt contacted clinic states he had his 2nd shingles vaccine on 3/5 and that afternoon started feeling awful, pain, and slept most of the next day. Had a rash to left arm where injection was given with white spot in center.
initial symptom: pressure on the heart on and off for five weeks after the first shot. more severe symptom: heart vibrating at night 2 weeks after first shot 3am most severe symptom: heart vibrating at night. woke me up. could feel a sensation in hands and feet. the night of the second shot 2am.
Upper Left Quadrant Pain; Initial Report Received on 22-SEP-2022  This is a spontaneous report, received from a pharmacist regarding a male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # not reported), route and site not specified, was administered for hepatitis B immunisation.    On an unknown date, after having been vaccinated with HEPLISAV B, the patient experienced upper left quadrant pain.  The patient did not reportedly finish the vaccine series.    No further information was available at the time of the report.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Tightness of chest; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (Batch/Lot Number: EL9269) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Uterine Cancer (treated with surgery followed by chemotherapy). The patient's concomitant medications were not reported. On 02Mar2021 13:45, the patient experienced tightness of chest. The patient did not receive treatment for the event. The outcome of the event was recovered. The patient did not have COVID prior vaccination. The patient was not covid test post vaccination.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unkonwn date, the patients were administered with PROQUAD (Merck) (dose, Lot number, expiration date and route were not provided), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. On 09-FEB-2015 or after the date, an unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot # L007559 with expiration date of 01-JUN-2017, dose and route unknown). The excursion was reported as temperature at 47 for 23 hours and no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
always cold; no energy, just wants to sleep; does not feel like herself; sore arm; pressure in her head and shooting pain; pink circle at injection site; vertigo; She will loose her balance; pressure in her head and shooting pain; feeling exhausted all the time; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm) and HEAD DISCOMFORT (pressure in her head and shooting pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (pressure in her head and shooting pain), VACCINATION SITE DISCOLOURATION (pink circle at injection site), VERTIGO (vertigo), BALANCE DISORDER (She will loose her balance), HEADACHE (pressure in her head and shooting pain) and FATIGUE (feeling exhausted all the time). At the time of the report, FEELING COLD (always cold), SOMNOLENCE (no energy, just wants to sleep), FEELING ABNORMAL (does not feel like herself), PAIN IN EXTREMITY (sore arm), HEAD DISCOMFORT (pressure in her head and shooting pain), VACCINATION SITE DISCOLOURATION (pink circle at injection site), VERTIGO (vertigo), BALANCE DISORDER (She will loose her balance), HEADACHE (pressure in her head and shooting pain) and FATIGUE (feeling exhausted all the time) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-051775 (Patient Link).
7 days after vaccines -> urticarial rash. 8 days after vaccines -> rash worsened to resemble serum sickness-like reaction and fever (antihistamines & steroid given).
myalgia-local w/high fever, severe rt shoulder pain (deltodi) rt axillary adenopathy-no systems sx-resolving over several days
Flu shot admininstered 8/26 and today patient has a red, swollen area the size of about 3 inches in diameter. Today is day 3. Mother states has been getting progressively worse. She is not startled based on patient's reaction 2 years ago.
Received call form PCP on 08/10/2021 stating that this person is complaining of left arm pain and she feels that it is a side effect of the vaccine or from the injection.  PCP states that she is diagnosing client with Left Brachial Neuritis.
At about 9AM I was feeling achy in my joints and in my shoulders, nausea, chills and a headache. The headache concentrated above my forehead. I did run a small fever of 101 in the afternoon. I took Zofran for the nausea and tylenol for my headache. On the 12/26/2021 most of my symptoms had subsided but I was lethargic and had fatigue for about 3 days.
Approximately 35.5 hours post vaccine administration, nursing was called to Resident's room due to "jerking movements" observed by staff.  At that time, VS were taken.  T 101.2, 88% O2 on RA, 74/45, 54 bpm, and 24 RR.  Resident did not recover, and was pronounced deceased at 0730 am.  Resident had previously received Pfizer on 1/12/21, 2/05/21, and 1/04/22.  This was her fist Moderna manufactured COVID vaccine.  She received this 2023-2024 updated Spikevax vaccination on the evening of 11/07/23.
Woke with very significant arm pain at the injection site, two days later it had spread to neck, upper back pinched nerve and all the way down right arm.  Went to urgent care.  Dr prescribed MethyIprednisolone tablets, 4 mg.  21 tablets, and Cyclobenzaprine 10 mg.  Neither had any effect at all.  Pain is significantly increased overnight.  Daytime is uncomfortable.  Nightime is terrible.  Do not sleep for more than twenty minutes at a time.
Hospitalized with hypoxia (sats in the 60s), weakness  and diarrhea.
pt recvd vax 3nov94;45min to 1 hr later pt became irritable;tired & "not myself" "wiped out & tired"; legs & arms no strenght; pale; no energy;
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756488A, A0756490A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013A21A and 030M20A) for COVID-19 vaccination. Concurrent medical conditions included HIV infection since 1996. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 27, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. No concomitant drug details or treatment information reported. This case linked to MOD-2021-073142, MOD-2021-073169 (patient link).
THIS REPORT IS DUE TO INCORRECT ADMINISTRATION.  THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OTHER THAN SORENESS AT THE INJECTION SITE. THE INJECTION WAS NOT GIVEN IN THE PROPER SITE; IT  WAS GIVEN BELOW THE DELTOID REGION.
Client experienced less than 5 second syncopal episode within 5 minutes of vaccination. Client reported lightheadedness, nausea, and was visibly diaphoretic. Staff helped client down to a crash mat and elevated legs. Client remained conscious and responsive, but continued feeling dizzy, nausea, and persistent shivering. Paramedics contacted, evaluated and client moved to ambulance for remainder of monitoring period. Client recovered.