chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/04/2022  Started getting very nauseous, this was very severe. I was very weak. I called home health service for help. They went over my symptoms, my hands felt numb, felt like I was going to pass out. I laid on the couch. When the girl came over to talk to me, from home health, I was talking to her .  I was so weak, I was chilled and could not open my eyes. All of a sudden, she was standing by my door and I did not remember how she got there. Very nauseous and weak, felt terrible. I talked to my primary doctor and he had me take Zofran and started me on Zoloft for anxiety. Got off Zoloft after 10 days, made me more nauseous.  I was on Zofran off and on. Several doctors put me on different medications. After several weeks, I was off all medications because the nausea was gone.  I would have colon pain , both quadrants, fatigued, loss of weight because I had no appetite.  I had this before with my previous vaccines, it had gotten better, but it worsened after the booster.  I also had chest pains that felt like I had been beat up and bruised, but it is better.  Sometimes I have pain in my ears.  Sometimes I would have a sensation of my rectum burning, it was terrible.
Patient experienced severe pain and loss of use of arm injected starting on day of injection and continuing. I talked to her the next day (10/7/17) and advised her to use ice packs 15 minutes every hour. Also advised use of ALEVE at appropriate intervals.
Client vaccinated in February 2021 with 2 doses of Pfizer vaccine for Covid.  Developed symptoms on 9/14/2021 - extreme fatigue and cough.  Has tested negative on 9/26 but as of 10/28 still has fatigue and occ cough.
Headache, Fever, Fatigue, chills Narrative:  Other Relevant History:
felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 10th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. For tolerance of 2nd dose of Shingrix, refer case US2019AMR234116. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.
Information has been received from an emergency medical technician concerning a 22 year old female student with no pertinent medical history , who on 14-AUG-2007 at 11:15 am was vaccinated IM in the left deltoid with a first dose of Gardasil (lot # 658556/1060U).  On 14-AUG-2007 at 11:30 am, the patient experienced a syncopal episode and hypotension that lasted 5-10 seconds.  The patient had not had a recollection of the event.  On 14-AUG-2007, the patient recovered from syncopal episode and hypotension.  Additional information is not expected.
Itchy arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy arm), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, the patient experienced PRURITUS (Itchy arm) and FATIGUE (Fatigue). On 28-Feb-2021, NAUSEA (Nausea) had resolved. At the time of the report, PRURITUS (Itchy arm) and FATIGUE (Fatigue) outcome was unknown.            The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.  No treatment medication was reported.
Vaccines were given on 3/8/12. On the morning of 3/9/12 mom noticed redness around injection site (left). Patient has brought to office & prescribed AUGMENTIN (600/5) 5 ml PO BID x 10 days.
Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.
Feeling of itchiness over medial right elbow area and extending down medial side of arm to end of right 5th finger. There were 5-7 small reddened spots near elbow area initially but these have disappeared. Also an episode of twitching or spasm as of today of right 4th and 5th finger which resolved spontaneously. Ibuprofen nor cetirizine really did not help. Severity described as annoying but not extremely painful. Ice pack has been most helpful.
Initial report received from a health care professional on 25Aug05. A 19 yr old female pt with a medical history of Turner's syndrome, had received an injection of Menactra, lot number not reported, on 14Jul05. 14 days later, on 28Jul05, the pt experienced complete paralysis from T-6 down. She also developed complete bowel and bladder dysfunction. She was hospitalized for six days. An MRI revealed abnormalities from C-3 down, however, no specifics were provided by the reporter. The pt was discharged from the hospital and sent to a rehabilitation facility. She has since recovered from the events.
pt recv vax 24OCT95 & exp inj site pain, especially when lifting;also has the flu for 2 days;
A little swelling; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EW0173) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. She had her covid vaccine about 30 minutes ago she had  a question because her pharmacist gave her soluble thereafter because she was experiencing little swelling on an unspecified date. The outcome of event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was admitted to Hospital on 11/8/2021 for COVID related symptoms. This is considered a breakthrough case.
Patient called and spoke to vaccine administrator and said she had received a different manufacturer of the Covid-19 vaccine from her first dose. The first dose was Pfizer and the second dose received was Moderna. Patient called to let the pharmacy know this occurred between March 12th and March 16th.
It was reported that a 42-year-old male patient received a TD Adult vaccination on 1/15/01. Reportedly 3-4 days after vaccination the patient developed "flu-like" symptoms. Patient saw his primary care physician and was placed on antibiotics. About 3 weeks later patient became light-headed, legs were weak, vision focused "in and out". These symptoms are unresolved.
Fever(105F). Report received from physician on 03-Oct-2008. A 60 year-old patient received AFLURIA (batch number unknown) on 01-Oct-2008. The patient called the physician's office on 03-Oct-2008 to report a fever of 103 F. the patient consulted with the physician. Awaiting further information.
Headaches  with eye twitching started on day three.  Persisting  Headaches got worst with stabbing shooting pain  Above right eye . Tingling and numbness On both side of face  follow by pressure on right eye swelling off eyelid  redness/rash and swelling face
vaccine makes you sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 04-OCT-2022 Reporter's comment:  This case was reported by patient via interactive digital media. The patient had vaccine 2 years ago from reporting and stated he/she knew how sick it makes you. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sweating in night; Having painful arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating in night), PAIN IN EXTREMITY (Having painful arm) and FATIGUE (Fatigue) in a 73-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating in night), PAIN IN EXTREMITY (Having painful arm) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweating in night), PAIN IN EXTREMITY (Having painful arm) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that all symptoms went away in couple of days.  Concomitant medications were not reported.  No treatment details were provided   This case was linked to MOD-2021-074734 (Patient Link).
I know this is NOT a "live vaccine" but i did turn up positive  for covid on 1/4/2021. my menstrual was delayed after shot by 2 days which is usual for me.
afib; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (afib) and COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (afib) had not resolved and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient also received the Moderna COVID-19 Vaccine. It was reported that patient had been to the hospital 4 times with COVID-19 and afib in the past 8 weeks. No diagnosis of myocarditis or pericarditis. Hospital kept changing medications. No information on treatment. Company comment: This spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced Serious, unexpected (due to Hospitalization, Medically Significant criteria) AESI of atrial fibrillation and serious (hospitalization criteria) unexpected event of COVID-19. A dose of mRNA-1273 Vaccine was administered as fifth dose in COVID 19 vaccination series. Previous vaccinations were not reported. The patient assisted to the hospital 4 times in 8 weeks due to the events. Medication was indicated (details not provided). At the time of the latest report, atrial fibrillation had not resolved; and the outcome of COVID-19 was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA157122, 2023SA157746, 2023SA157755, 2023SA157204, 2023SA156938, 2023SA157726 and 2023SA157752.  This case involves a 12 years old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-May-2023, the patient received a dose of 0.5 ml (dose 1) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for Immunization.  On 17-May-2023, the patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  It was reported, "Nurse says that the vaccine was administered to 8 people after the excursion. She says that the excursion was caused by additional gel packs being placed in the refrigerator. She asked for appropriate follow-up. The vaccines had been transported due to power outage and then cold packs were put into refrigerator and apparently made the refrigerator temperature drop."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DIZZY; RUN DOWN; TIRED; WEAK; FEVERISH; HEADACHE; TIRED; WEAK; SORE ARM; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included leg amputation, and other pre-existing medical conditions included past medication include glybizide. The patient was previously treated with metformin for drug used for unknown indication, simvastatin for drug used for unknown indication, gabapentin for drug used for unknown indication, and insulin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced weak. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced weak. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 09-APR-2021, and tired, and weak on APR-2021, and had not recovered from feverish, headache, dizzy, run down, tired, and weak. This report was non-serious. This case, from the same reporter is linked.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group.  A male patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 10Mar2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID". While reporting for herself, patient indicated that she wanted to have her husband call in and complete report for himself. He also has never been sick and only once in the entire time in 12 years she has known him, has he ever called out from work. He got COVID too and got his shots on the same dates. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested positive for COVID.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036150 same reporter/drug/event, different patient
Rashes all over body that began at 7:30am today. Changed clothes but rashes come back with a prickling feeling
I started with an earache and headache, presence of lesions such as blisters on the right side of the head, swollen tongue, the corner of the mouth radiating to the left, eye and right eyelid drooping, ringing in the ear. For fear that it was a stroke, I went to the emergency room at the Medical Center. Where, after conducting studies, I was discharged two days after my admission, I still continue with the symptoms of my mouth radiating to the left and the drooping eye.
Hot, swollen lump below shot site in left arm. Lasted about a week.  Dizziness, sweating, hot "flushing", anxiety
Injection arm has severe  pain (nerve) that is constantly present and strength, movement significantly reduced, above elbow only.
I have had 8 pregnancies. 4 miscarriages, then a live birth. Then 2 miscarriages and another live birth. And I am currently in early pregnancy, I don?t know how far along I am. On the day I got the 2nd dose I experienced chills that night. The next day I had a bad headache, chills, and body aches. The morning after that I was having stomach cramps and I developed a rash on my arm that is getting bigger.
ten hours after injection, chills, 103.5 temp, pounding headache, serve muscle aches.  I could not get vertical for about 36 hours.  I took tylenol every 4 or 5 hours and my fever did not go below 101 until  48 hours after it started..  I had COVID in June of 2020 and there was not one 36 hour period of my 7 days of up and down fever that I felt as bad as I did after the vaccine. I am going to count myself lucky that fever and fatigue were what I had with COVID, but I could at least move around.
Headache 8:00 AM ongoing. Two episode of diarrhea 8:30 AM, 9:15 AM. Nausea 8:30 AM ongoing. Inability to concentrate 8:00 AM ongoing.
Headache every day since the 1st vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL 3249) via an unspecified route of administration in the left arm on 19Jan2021 (at the age of 52-year-old) and second dose of as a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL 9269) via an unspecified route of administration in the left arm on 09Feb2021 for COVID-19 immunisation. Medical history. The patient was not allergic to food, medications and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), propananol (MANUFACTURER UNKNOWN) and estrogen patch (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN) on unspecified date for unknown indication. On an unknown date in 2021 the patient had experienced patient had a headache every day since the first vaccine. The patient did not receive treatment for the reported events. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event headache was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected
Patient hospitalized on 10/23/21 with COVID infection, and previously received Pfizer COVID vaccine ( doses reported on 2/24/2021 and 2/3/2021, but no lot number or other information available). Patient came to the emergency department complaining of shortness of breath.  He had previously been diagnosed with Covid-19.  He was treated with remdesivir, dexamethasone.  He was admitted to the progressive care unit.  He was started on BiPAP.  He has not shown significant improvement.  He had worsening oxygen requirement.  Critical care was consulted.  Patient was made DNR.  Patient decided on comfort care.  BiPAP was discontinued.  Patient expired at 1622 on 11/17/2021.
Case number PHEH2013US021116 is an initial spontaneous report received from a medical assistant on 08 OCT 2013: This report refers to a 16-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006021A) intramuscularly on 07 OCT 2013. No adverse event was reported following this administration error.
Arm is red, swollen. around 9:30 that night the arm began to itch. Fri Oct 11 arm is still red and swollen at injection site.
This case was reported by a pharmacist and described the occurrence of threw up in a child  subject of unspecified gender who was vaccinated with ROTARIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of ROTARIX (unknown).  At an unspecified time after vaccination with ROTARIX, the subject experienced threw up. The reporter's child threw up after receiving ROTARIX. She was questioning if he should receive another does. No other information was provided. At the time of reporting the outcome of the event was unspecified.
COVID vaccine breakthrough case.  Moderna 1/27/21 031L20A, 2/24/21 023M20A, 11/3/21 032F21A and 7/21/22 037A22B
1135: Pt complained of dizzines and weakness. Patient was immediataly assesed by onsite NP and EMT. Vitals were taken BP 160/100, P 85, O2 99%, and blood glucose 112. Patient stated he was at work all night until the morning, and did not eat anything prior to getting his vaccination. Patient was given a breakfast bar and water, and started to feel better.  1145: Second set of vitals were taken. 149/98, P 81, 02 99%. Patient stated he was comfortable going home. He did not want further medical intervention