chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 3/1/21 (EL9266) Pfizer Dose 2 3/24/21 (EN6204) Pfizer Dose 3 12/26/21 (33130BA) COVID Positive 1/1/22  1/1/22: Patient is  74 year old female with known history of hypertension, hypothyroidism, chronic pain, history of stroke, and other medical problems.  She presents with generalized weakness, SOB, subjective fever, cough, vomiting, and diarrhea since 12/27/2021. Pt denies any chest pain or abdominal pain. Pt states she received her COVID-19 booster shot on 12/26/21 and her symptoms started to next day.  She reported worsening dyspnea on exertion.  Chest x-ray showed pneumonia on right side.  She tested positive for  SARS-CoV-2.  1/5/22: discharge home with Home Health
Stinging in legs began three days after starting Paxlovid 300/100 mg BID on August 5, 2022. Last Moderna vaccination was administered 11/04/2021. Positive COVID-19 test 8/5/2022. Symptoms improved drinking water and applying an topical creams.
Arthralgia: neck, collar bone, left shoulder, knees, fingers.  Fatigue, no rash, no dyspnea.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
administrator had an eye exposure; administrator had an eye exposure; This case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in an administrator who was administering Men ACWY-CRM NVS (Menveo) to a patient for prophylaxis.  On 22nd June 2022, the patient received Menveo. On 22nd June 2022, unknown after receiving Menveo, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: Nurse reported that an administrator had an eye exposure to the Menveo liquid component. The reporter consented to follow-up. Additional supportive information: The administrator had an eye exposure to the Menveo liquid component, which led to accidental occupational exposure to product and exposure via eye contact.
Information has been received from an other health professional concerning 2 adults who were accidentally vaccinated with Zostavax (Oka/Merck) instead of Varivax (MSD).  The physician reported that the vaccines looked alike and were labeled almost identically.  No adverse events were reported.  Additional information is not expected.
Covid 19 positive antigen test on Jan 1,2023.   This was 86 days after vaccination.
pt recv vax 10AM 19APR96 & pt called back @ about 1250PM that day c/o of swelling of back @ tongue & flushed face;nurse advised pt to go to ER:22APR96 pt stated OK & ER MD gave DPH;
injection site pain; tiredness; headache; muscle pain; chills; fever; joint pain; throat hurts; tongue sensitive (burn sensation); tongue sensitive (burn sensation); start spotting brown blood; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 12:00 (at the age of 44-years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. The patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, joint paint, throat hurts, tongue sensitive (burn sensation), start spotting brown blood on 20Apr2021 13:00. The latency between suspect and event was of 1 hour. The patient received no treatments in response to events. The clinical outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Last night around 6pm I couldn?t walk. My husband has to carry me to and from the bathroom, my arms and legs were going numb and pale, I was so light headed I couldn?t function and I have had a fever of 102. I had a lower blood pressure 90/47 and my pulse was 137. I was able to get in bed and use a tens unit on the area that I was able too. I haven?t slept, no appetite and barely drinking. None of this is me. I felt 100% when I walked in for my vaccine and by the time me of the night I wasn?t walking at all. Since that episode Iv had a headache on a level 10, my entire body feels like it?s being ripped apart and light headed.
Pt felt dizzy after the 1st dose of Pfizer vaccination. As I was walking out to check on her, she fainted. She regained conscious immediately. I gave a small soda to drink and she threw up after but she didn't faint again. She felt better right after she threw up and stated that this never happened before. After about 45 minutes, pt stated that she felt much better and wanted to leave with her dad.
CDC reports: 5 yo child developed local rxn at inject site day following DTP/OPV immunization, lasted 5 days.
66yo male present to clinic to follow up on an ER visit from 07-20-19. Pt went to the ER for a rash in the arms, back and  flank. Pt states that had the rash for about two weeks before he went to the ER. He states that he thinks this rash was due to the shingles  or pneumonia vaccine that he got on 06-24-19.  Today he states that the rash is better after using Hydroxyzine and Triamcinolone that was given at the ER. He still experiencing some itching. Pt states he never had a rash like this before, no one at home with similar rash, no change in body wash or detergent.
neuropathic; shooting pain down arms; myalgia in both arms; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA, PAIN IN EXTREMITY, and MYALGIA in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA, PAIN IN EXTREMITY, and MYALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, NEURALGIA, PAIN IN EXTREMITY and MYALGIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC-MOD-2021-073650, MOD-2021-073913. Sender's Comments:  US-MODERNATX, INC-MOD-2021-073650: MOD-2021-073913.
Rash, high temperature, pain in joints, exhaustion, lymph node swelling under arm and side of neck, pain in left arm, swelling over complete upper left arm injection site, headache, weakness, dizziness, chest pain, nausea, hallucinations, memory loss.
Don't know time or date of onset.  Patient was prescribed Cephalexin for infection at injection site on 4/7/17.
Heart Palpitations, High Blood pressure, Extreme High Pulse rate, cold compresses, water, lie down, more than three hours. Sent home with high blood pressure and palpitations
12/23/21 presents to ED for "for evaluation of MVC by EMS". PMHx of "HIV, sensorineural hearing loss (deaf), ESRD on PD, type I DM"
hurt her hip; hives from head to toe; always get sick; went without a shot; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number- 00440564) was received from a consumer/ non-health care professional and transmitted to Sanofi on 21-Jan-2021.  This case involved a female patient of unknown age who hurt her hip (joint injury), hives from head to toe (urticaria), always get sick (illness) and went without a shot (product dose omission issue), while patient received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Alpha-gal allergy and Hives.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA QUADRIVAL A-B VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who hurt her hip (joint injury), hives from head to toe (urticaria), always get sick (illness) and went without a shot (product dose omission issue) (latency: unknown) following the administration of suspect vaccine.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown and not applicable for the event missed dose.  Disclaimer: 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 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.  There will be no information available regarding batch number in this case.
Left arm is red, swollen, hot and hard. Pt was told by another health care worker to report it to the place where she had it done. Provider talked to pt, pt was advised to put warm, moist compresses, pt went and saw her local md and was told to take Motrin and continue with the compresses. Allergy listed in pt's medical chart.
Sciatica; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SCIATICA (Sciatica). At the time of the report, SCIATICA (Sciatica) had not resolved.            No concomitant medication was reported. On an unknown date, the patient experienced Sciatica. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.    Causality for HUMIRA(ADALIMUMAB):The reporter's causality for the event(s) of SCIATICA with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Significant follow-up received: Event back pain was updated to Sciatica. Humira indication and ongoing status were updated. Reporter causality was updated.
Pt recv vax on 10/23/97; on same day pt exp itching, swelling, redness & warmth of vax site; hives over body; tx=Benadryl.  Pt imp 11/5/97.
Pt recvd 2 doses of vax 5MAR92 & 3APR92 & pt exp pain @ inject site & a sore arm; that evening exp rt shoulder & neck pain, sore rt ankle, area of tenderness about 3 cm localized to one spot;
Information has been received from a RN concerning a 6 yr old male who on 28Aug99 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The RN reported that on 17Jun05, the pt presented to the physician's office with 20-30 varicella lesions. The pt was treated with acyclovir (Zovirax). At the time of this report, the pt was recovering from the varicella lesions. Additional information has been requested.
Initial information received on 09-Oct-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 10 years old female patient who experienced arthus reaction, while she received vaccine FLUZONE QUADRIVALENT. The patients past vaccination(s) included INFLUENZA VACCINE. The patients past medical history, medical treatment(s) and family history were not provided. On 05-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UI982AB and Exp. Date 30-JUN-2019) via intramuscular route in the left arm. On an unknown date, the patient developed a serious arthus reaction (type iii immune complex mediated reaction) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. No information about relevant tests reported. Final diagnosis was arthus reaction. No information about corrective treatment was reported. The event outcome was unknown. List of documents held by sender: none.; Sender's Comments: This case concerns a young patient who presented with Arthus reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is not known. There is, moreover, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
I experienced two nosebleeds per day for the three days after receiving the second vaccine. I also experienced the more traditional side effects - chills, fatigue
Information has been received from a certified medical assistnat (C.M.A.) concerning a patient of unknown age and gender. The patient's emdical history, concurrent condition and concomitant hterapy were not reported. On 18-MAR-2015, the patient was vaccinated wiht a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional informaiton is not expected because the physician did not wish to be contacted.
This spontaneous report as received from a certified medical assistant (CMA) refers to a male patient of unknown age. Concurrent conditions and medical history were not reported. On an unknown date, the patient was inadvertently administered a dose of VAQTA (lot# H012642; expiration date: 16-APR-2015), 0.5 ml, intramuscular. Concomitant therapies were not reported. The C.M.A stated that this VAQTA had been improperly stored. No adverse effects were reported and product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt said she felt heart palpitation from 4-9 pm. she drank water and stretched and felt better. she reported feeling heart palpitation next day . recommended calling dr and seek medical help if needs to.
severe chest pain; leg cramps; lightheadedness; swollen lymph nodes; headache; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: SH7485, Expiry Date: Unknown) via an unspecified route of administration, administered in arm right on 01Aug2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications reported. No investigation assessment was provided. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: SW0167) via an unspecified route of administration, administered in arm right on 02Jul2021 (at the age of 57-years-old) as dose 1, single for COVID-19 vaccination. The patient wanted to report her side effects. Stated with the first shot that she had fever, chills, sleepiness and pain in her right arm, headache where she got the shot on 02Jul2021. On unknown date in Aug2021, the patient stated that within three days of second shot, she had severe chest pain, leg cramps, lightheadedness and swollen lymph nodes. Stated that she does not think that she should get the third shot because of the chest pain. The patient stated that she was having chest pain 2-3 times a week but now she was having it once a week. Mentioned that she had a headache with the second shot in 2021. No treatment was reported for the reported events. The outcome of the events of severe chest pain was recovering; event of lightheadedness was recovered on an unknown date in 2021; and other events was not recovered at the time of reporting.
I had mild gout in the past. Shortly after getting the vax, my foot swelled up and looked like a water balloon. It was very tender and I could not walk. The pain was unbearable. I could hardly walk to the bathroom. The pain was from my knee, down to my foot, although the bad swelling was only from my ankle, throughout my foot.  I had to go out on  short term disability and I was back and forth to my PCP, Urgent Care and the emergency room. One doctor at the E.R was concerned about blood clots and they gave me an ultra sound (?) to test for them.  I also got. A referral to a Rhumatologist and he prescribed steroids, but was never able to come up with a diagnosis.  I have had several instances of swelling in different joints, including both feet, ankles, and knees.
Case number PHEH2016US028667, is an initial spontaneous report received from a nurse on 31 Oct 2016. This report refers to a 34 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: 185888, expiry date: May 2017) at a dose of 0.5 ml intramuscularly on 31 Oct 2016. On the same day after about 30 mins of vaccination, the patient experienced light headedness. The outcome of the event was unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Terrible taste in my mouth that does not go away; Upset stomach; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Terrible taste in my mouth that does not go away), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 042B21A and 021B21A-1) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Penicillin allergy and RA. Concomitant products included ADALIMUMAB from 20-May-2022 to an unknown date, METHOTREXATE from 19-May-2022 to an unknown date, GUAIFENESIN from 24-May-2022 to an unknown date, TRAZODONE from 23-May-2022 to an unknown date, FOLIC ACID from 22-May-2022 to an unknown date, CALCIUM CITRATE from 22-May-2022 to an unknown date and MULTIVITAMIN [VITAMINS NOS] from 18-May-2022 to an unknown date for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022, the patient experienced TASTE DISORDER (Terrible taste in my mouth that does not go away), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). At the time of the report, TASTE DISORDER (Terrible taste in my mouth that does not go away), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment details were reported.
Information has been received from a registered pharmacist concerning a 69 year old female patient with cancer (diagnosed on an unspecified date) in chemotherapy treatment and drug reactions allergies to allopurinol and cilastatin sodium (+) imipenem (MSD, WAES 1203USA01127) who on 22-MAR-2011 was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (Lot # reported as 1480Z, Exp. 14-AUG-2012) (route not reported). It was unknown if the patient received other doses of PNEUMOVAX 23 in the past. The registered pharmacist reported that he received a phone call from a doctor stating that the patient now had strep pneumonia. The patient had blood transfusion in the past 6 months. The patient was recently in the hospital, for possible sepsis and after a few days was discharged on 21-FEB-2012. On an unspecified date blood cultures and possibly sputum test were performed (results not provided). At the time of the report, the patient had not recovered from possible sepsis and strep pneumonia. At the time of the report, the patient's outcome for had a blood transfusion was unknown. Additional information has been requested.
Severe swelling/inflammation at Shingrix vaccine site; flu-like joint aches and pains throughout the body; extreme fatigue. Symptoms lasted 4-5 days.