chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shivers in a 64-year-old male patient who received SHINGRIX (batch number DA34Z, expiry date 30th April 2019). On an unknown date, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced shivers, injection site pain, lightheadedness, upset stomach and headache. The patient was treated with Aspirin. On an unknown date, the outcome of the shivers, lightheadedness, upset stomach and headache were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. The reporter considered the shivers, lightheadedness, upset stomach and headache to be related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient received first dose of SHINGRIX last night of the date of reporting. The patient was experiencing shivers, upset stomach, headache and lightheadedness. He has taken 2 aspirin to treat his events. The reporter could not provide full demographics for the pharmacy that administered the vaccine. The patient denied permission to contact their physician.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/30/21 (EN6205 Pfizer Dose 2 4/20/21 (EM9809) COVID Positive 11/22/21  11/22/21: Patient is a 91 year male from home and recently discharged. He presents to the ER today with complaints of shortness of breath and generalized weakness. Patient's past medical history significant with CKD 3, diastolic CHF, anemia of CKD hyperlipidemia, hypertension and Hashimoto thyroiditis. Patient is fully vaccinated for COVID-19.  He had stable vital signs upon arrival to the ER. Chest x-ray showed cardiomegaly with mild pulmonary venous congestion and early pulmonary edema.  Blood work in ER showed proBNP 4305, creatinine 1.5, troponin positive x1 and hemoglobin 8.2. Patient was treated with 40 mg IV 1 time, aspirin and Nitro-Bid. Patient was transfer to the medical unit.   I met with the patient and the he was resting in bed and denies any discomfort at this time. Patient is currently 2 L oxygen nasal cannula with sats around 92%. Patient denies fever chills, abdominal pain, constipation, chest pain, palpitation, dizziness, headaches. Patient will be admitted and treated for CHF at exacerbation. And discussed the plan of care with the patient and she is agreeable to stay for further management. Patient reports having a caregiver twice a week  11/29/21: Patient is a 91 year male from home who presents to the ER today with complaints of shortness of breath and generalized weakness. Patient's past medical history significant with CKD 3, diastolic CHF, anemia of CKD hyperlipidemia, hypertension and Hashimoto thyroiditis. Patient is fully vaccinated for COVID-19.  He had stable vital signs upon arrival to the ER. Chest x-ray showed cardiomegaly with mild pulmonary venous congestion and early pulmonary edema. Blood work in ER showed proBNP 4305, creatinine 1.5, troponin positive x1 and hemoglobin 8.2. Patient was treated with 40 mg IV 1 time, aspirin and Nitro-Bid. Patient was transfer to the medical unit and treated for CHF exacerbation, Covid 19  pneumonia, acute kidney injury and hyperkalemia. He was treated with Remdesivir, dexamethasone and IV antibiotics. Nephrology was consulted for AKI and hyperkalemia. The patient's symptoms improved and he was able to transfer to Allure in Moline for skills nursing. Today patient denies fever chills, abdominal pain, constipation, chest pain, palpitation, dizziness, and headaches. he has stable vitals and will be transferred by EMS services.
Fever; Joint pain; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 16Mar2021 at 10:30 hours (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The medical history included high BP and cholesterol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 15:15 hours, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced fever, joint pain and weakness. The patient did not receive treatment for the reported events. The clinical outcome of fever, joint pain and weakness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
pain in my (left) arm; fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my (left) arm), PYREXIA (fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my (left) arm), PYREXIA (fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in my (left) arm) and CHILLS (Chills) outcome was unknown and PYREXIA (fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient was treated with Tylenol (paracetamol).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 15:30 as dose 1, single (Lot number: EN6201), in right arm, on 10Mar2021 at 15:30 as dose 2, single (Lot number: EN6199), in right arm, on 07Oct2021 at 17:30 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 15Apr2022 at 17:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension (under successful treatment)" (unspecified if ongoing), notes: Other medical history: Hypertension (under successful treatment). Concomitant medication(s) included: ATORVASTATIN, start date: 01Oct2015, stop date: 20Oct2022; TRIAMTERENE/HCTZ, start date: 01Oct2015, stop date: 20Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid as Covid-19 treatment from 20Oct2022 to 25Oct2022. Patient has no known allergies.
Information has been received from a physician referring to a 6 week old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 31-JUL-2017, the patient was vaccinated with a dose of pediatric VAQTA (lot # M039202, expiration date 11-MAR-2018, intramuscular; dose was unknown) for prophylaxis (incorrect dose administered and drug administered to patient of inappropriate age). No adverse effects were reported.
Sore arm and swelling at injection site, headache, fatigue,  diarrhea
I experienced heart fluttering. I have an app that can check for A-fib. It registered for A-fib. The number one thing that was related to this was low heart rate. Since I've been taken off nabibolol 2.5mg, I haven't had this experience in three days. While I was taking nabibolol 2.5mg, I was having this experience regularly. When I was 45, I learned that I had coronary artery disease and I had 2 stints put in. I have not experienced any other heart issues since then, until now.
Patient's arm has been hurting since 6/10/23 beyond the usual soreness.  He says it's difficult for him to lift his arm since getting vaccinated.
Patient received a Hepatitis A vaccine #2 at 1630 on 12/8/15. Mom reports a high fever and headaches 2 hours later. Mom states her muscles were tight and rigid. Physician on call recommended ibuprofen 800 mg which helped. Remains tired.
Day 8 post vaccine. Large Severe redness, swelling, hotness left arm. Day 8 post Moderna vaccine. Also had armpit pain on L. Severe itching L arm.  Circular redness about 3 inches in diameter. Diagnosed with cellulitis. Put on Keflex.
Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, on 08-JAN-2008 was vaccinated with a first 0.5 ml dose of Gardasil (lot#655327/1287U).  There was no concomitant medication.  On 08-JAN-2008 the patient experienced fainted, fell off the exam table and bumped her head.  Unspecified medical attention was sought.  No laboratory diagnostic tests were performed.  On 09-JAN-2008, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
First shot rash appeared on day 7 lasted around 9 days was itchy but finally went away in left arm.  Second shot more severe!! Headache started almost an hour after shot followed by fever, chills,  muscle aches, and swollen lymph nodes that lasted 2 days  The Day after I had the  2nd shot my right arm started swelling, turned red was painful to the touch had fever and rash appeared both swelling and rash is from top of arm to elbow. Headache comes and goes now. It has also caused a fever Blister on my bottom lip. It is now the day 5 and is still there If not Better by end of week will go to my doctor
(+) Pain in while area, arm swelling "fist size" at injection site, hot to touch, redness, itching symptoms started 09/07/03.
I received the first dose the the pizer vaccine on december 18th and did not know I was pregnant at the time. A couple weeks later I found out I was pregnant and due date was September 7th. Hence, my conception was likely within a week of receiving my first dose. We later found out our baby had turners syndrome and have since lost the baby. Obviously it is unclear the cause but I wanted to report it .
Information has been received from a nurse practitioner concerning a female with multiple drug allergies who on 07-FEB-2008 in the morning, was vaccinated intramuscularly with 0.5 ml of her first dose of Gardasil (lot# 659962/1740U).  Concomitant therapy included LOESTRIN 24 FE).  In the afternoon on 08-FEB-2008, the patient developed hives.  She was seen by her primary care Doctor and she was placed on a high dose of BENADRYL (dose not specified) on 11-Feb-2008.  At the time of this report, the hives were "getting better" but not resolved.  Additional information has been requested.
dizziness while lying down and moving to fast; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness while lying down and moving to fast) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1CC021-427 (?)) for COVID-19 immunisation.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced DIZZINESS (dizziness while lying down and moving to fast). At the time of the report, DIZZINESS (dizziness while lying down and moving to fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug information provided. No concomitant drug information provided.
Patient felt air bubble up her throat, she could not swallow or breathe. Patient was able to speak, lasted about a couple minutes. Medic was called and they transported to hospital for further evaluation. Patient was breathing and was feeling ok when she left with medic.
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 - A0756556A, A0756558A - 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.
itching at the injection site; rash around the injection site; headache; hurting all over; shivering; swelling at injection site about the size of a baseball; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included multiple myeloma.   On 29th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 4 hrs after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, shivering and general body pain. On 30th October 2020, the patient experienced headache. On 1st November 2020, the patient experienced injection site itching and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash, shivering, headache and general body pain were recovered/resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site rash, shivering, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was in his 50's, experienced hurting all over, shivering, swelling at injection site about the size of a baseball, rash around the injection site, itching at the injection site, and headache.  Events were resolved.  The reporter did not consent to follow up.
3 minutes after janssen covid vaccine, person was feeling nauseated and shaking a bit. later she was feeling like passing out and seeing blackout. she didn't pass out and didn't go to hospital. later she had a headache and took acetaminophen, which helped her a lot.
symptoms on second day was tiredness, feeling unwell, chills, fever, muscle pain and diarea.
A report has been received from a Pharmacist concerning a 39 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 11-Nov-2013. The reporter stated that the patient had administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one is unknown. The report was considered to be non-serious.
At 3 am, I woke up with sever vomiting and diarrhea. I laid on the bathroom floor for three hours until I had enough energy to get back in the bed. I had water next to me to drink and I took 2 tylenol. I finally was able to get up at 8 pm. Could not eat until the following morning.
First started noticing vestibular equilibrium issues that would manifest, after working on a computer all day long, it didn?t cause any harm, so no larger events were caused by that. Since then, I?ve gone to see a physical therapist specialist and an ENT to work on that. Around the same time, I was also diagnosed with GAD and started having panic attacks in October, first time in my life.  Initially my PCP put me on anxiety medicine and after being on it for a month, we chose to not move forward with it because of being able to manage without medication.
right big toe red on bottom and left side  have used hydocortizone  with some relief. Will contact Dr in the morning
With the first dose the pt experienced joint pain 24 hours post vax, with the 2nd dose, the pt experienced swelling face, neck. With the 3rd dose, the pt developed reddish, purple rash in lower legs 32 days later. 37 days post vax, the pt developed pain in legs was unable to walk, 41 days post vax, the pt developed edema in ankles and lower legs. Left eye had redness, pain, soreness and photophobia.
Soreness in arms after each dose; This case was reported by a consumer and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2020 1st dose received. refer case US2022AMR156681).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR156681   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: In 2020 (summer), the patient received Shingrix. The patient experienced soreness in her arm after injection in 2020.; Sender's Comments:  US-GSK-US2022AMR156681:Same reporter
21JAN numbness in legs; dad thought it was related to cross country skiing; 24JAN numbness in arms & legs; called MD, went to ER;
Patient reported 9/10 that Right Arm was warm at injection site. starting to swell by the 13th was still swollen and red warm to the touch redness and swelling gone by 9/15/2019
No additional information; a dose of VARIVAX was administered after being improperly stored; This spontaneous report was received from an other refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 07-FEB-2022 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot numbers T031388, U007471 and T041685, expiration dates 15-SEP-2022, 08-MAR-2023 and 10-DEC-2022 respectively for prophylaxis (dose and route of administration not reported) (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of -14 degrees Celsius for 672 hours. No previous temperature excursion were reported.
OBSTRUCTIVE SLEEP APNEA 6/9/2022 &  8/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I woke up the morning of 10/12/22 with a cough and congestion.  Tested 10/13 with a Rapid COVID-19 test, positive.  Tested also with a PCR COVID-19 test, also positive.  Fatigue in addition to the cough and congestion on 10/13.   Televisit with Doctor who prescribed Paxlovid, Promethazine cough syrup, and Mucinex.  Paxlovid not taken, other 2 medications were.  The symptoms tapered off over the course of 7 days, The Fatigue was most memorable.  Cramping calves is pronounced and continues to time of reporting.
Acute ST elevation myocardial infarction - Status post insertion of drug-eluting stent into right coronary artery for coronary artery disease. Recovered in hospital and discharge home. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a licensed practical nurse concerning a 6 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-APR-2017, the patient was vaccinated "too early" with his first dose of PROQUAD, lot # reported as M041083, expiration date 04-APR-2018, for prophylaxis (route and anatomical location of administration were unknown). No adverse effects were reported. Additional information has been requested.
Severe cramps and diarrhea 2 days after 2nd shot.  Sweaty, lightheaded and achy with shaking chills, but no fever.
Information was received on 30-JUN-2017 from a registered nurse who was reporting on multiple unspecified patients. No medical history or concomitant medications were provided. The nurse reported that the multiple patients were vaccinated with improperly stored GARDASIL 9 (Lot L037554, expires 25-DEC-2017) (dose and site not reported) on unknown dates. No adverse effects reported. The temperature was 9 degrees C to 25 degrees C for 31 minutes. There was a previous excursion that was 9 degrees C to 25 degrees C for 19 minutes, recorded on data logger. No further information was provided. As of 21-NOV-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This case was previously considered valid, but per current process it was determined to be non-valid as there are no patient identifiers, therefore it is being sent to Distribution for the last time to notify all recipients.
Child got shots on 2/18/05, during early morning of 2/19/05 child was noticed by mother jerking uncontrollably. Pediatrician notified by mother and child taken to hospital were child went through a series of test and then was released. Parents instructed to follow up with Pediatrician of choice.
This 72 year old   white male hospice patient received the Covid shot on  2/20/21   and went to the ED on  3/27/21   and was admitted  on  3/27/21    with shortness of breath, pneumonia, hyponatremia, anemia, bilateral pleural effusion, metastatic cancer and died on 4/17/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
This report describes the occurrence of maculopapular rash in a 21 year old female who received her 1st dose of Havrix on 5/24/00 and 24 hours later, she experienced an erythematous maculopapular rash and lymphadenopathy (occipital and left clavicular). She had mildly swollen lymph nodes prior to the vaccination. She was without headache, photophobia, chills, myalgia, nausea, vomiting or itching. She was treated with Benadryl po on 5/25/00, after which her rash worsened. The most recent information, received on 5/26/00, reports the outcome of the event is ongoing.
pt recv flu vax & was given APAP because said arms hurt;then had a fever ranging from 100.2 to 102.3;APAP only tx;