chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an unknown reporter regarding a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient developed a red raised rash, at the injection site (reported as "insertion site"). The outcome of the events (injection site erythema/Injection site rash) was unknown at the reporting time. The reporter did not provide a causality assessment between the suspect vaccine and the events. Additional information is not expected as the reporter refused additional contact.
Feverish, muscle aches , weakness,  severe anxiety  by  Saturday morning.  Repetitive  feeling of anxiety  throughout night and upon waking with a ringing to ears.  Unbearable of feeling of inescapable dread fixed on a specific experience . This was something that I have never experienced  in such a manner before.  Very concerning.  Diminishing effect over the  next two days as it subsided.  I have not had a flu shot before and would not attempt to be vaccinated for this again.
3days after first vaccination  my husband developed a rash on his back,chest and behind both knees. He has a weakened immune system due to a lot of medical problems in 2020.
LIGHTHEADEDNESS, AND NAUSEA FOR APPROX 10 MIN THEN C/O SUBSIDED. NO TREATMENT INITIATED R/T SYMPTOM SUBSIDED. VR 02/11/14.
Woke up with a slight fever the morning after getting second dose. Fever got worse as day went on. About 24 hours after getting vaccinated, developed high fever, nausea, vomiting and a cough. All symptoms except for the cough were gone the next day. The cough and a feeling of shortness of breath and wheezing developed and has lasted for two weeks. Seems to be getting better, but still feeling the respiratory side effects  currently
Information has been received from a registered nurse concerning a year old virus vaccine live subcutaneously. On 04/22/01, the pt started to develop a few spots and pruritus. it was noted that the pt was treated with diphenhydramine hydrochloride )Benadryl) and calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) oatmeal bath. It was unknown if the pt was seen in the physician's office. subsequently in 2001, the pt recovered from her symptoms. Additional information is not expected.
Redness and swelling at injection site. Some pain and discomfort. Pain subsided but redness is moving to the right side of left arm to muscle area and swelling is still present.
1st vaccine triggered anterior uveitis in both of my eyes, 3 days after 1st shot. 3 days after the second shot, it got significantly worse and I knew what it was. I went to the ophthalmologist on the 4th day. After the 2nd shot.  I?ve had it once before in 2014. I was sent for autoimmune panels for both instances, and did not have any  abnormal results in my blood work.
Chills; Swelling of the injection site; Redness of the injection site; Itchiness on the injection arm.; Welts on the injection arm.; Knots on the injection arm.; A spontaneous report was received from a consumer concerning herself, who is a 70-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, swelling of the injection site, redness of the injection site, itchiness on the injection arm, welts on the injection arm, knots on the injection arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the events chills, swelling and redness of the injection site, itchiness, welts and a knot on the injection arm. Side effects have begun to subsided but are still present at this time.  Treatment for the event included ice/heat.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events chills, swelling, redness, itchiness, welts, knots at site was recovery at the time of reporting.
Pt recvd Engerix-B vax 30AUG90 & 1OCT90 & 5 months later was hesitant about receiving 3rd inject because exp migraine h/a p/1st 2 doses; MD decided to stop the Engerix-B & titer was checked; HBSAB titer was 2.6; pt exp seroconversion;
Moderna COVID-19 Vaccine EUA Soreness in shoulder, swelling and redness on inside of arm from shoulder to middle of arm, swelling of elbow.
Patient remained for required 15 minute wait.  When she got up to leave, said she was a little dizzy but was okay.  Her husband with her said she was fine also.  Patient stated she has history of fainting from some vaccinations in past.  They insisted they were okay and left.  Husband came back down the aisle and said she had fainted in his arms when they were about to walk out the door.  I gave her a bottle of cold water to sip on and asked her how things happened and if she was okay and she states that she did not fall to the ground, she did not hit her head, she did not hit anything or report any bodily harm in any way.  The fact that he caught her as she was experiencing syncope assured that she did not experience an injury.  After several minutes with them at their car, they were fine to leave and did so.
55 year old patient received gardasil 9; No additional adverse effects reported; This spontaneous report was received from an office manager via company representative refers to a 55-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), first dose (strength, dose, route, anatomical location, lot/batch # and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse effects were reported (no adverse event). No product quality complaint (PQC) was involved.
The afternoon after receiving the vaccine I had a job interview at 1:00PM EST and I wasn't certain I could make it because I felt a little off. I drank a bottle of water that was offered and I started feeling lightheaded and worse. As soon as I stood up, I thought I was going to fall so I sat back down. I waited around for about an hour before leaving. I stood up and felt a little better, but still a little off. I felt okay enough to drive and went to my interview. Once I got to the building, I had no clue how I got there. I completed my interview and remember leaving the building and sat in my car for a long time. I don't remember how I got home. I walked into my apartment and I lay on my bed and didn't wake up until the next morning. In the morning I went to my kitchen and grabbed more water. My ears started hurting, my head starting hurting and I felt off. I called and made an appointment with Dr. and informed her that I did not feel right. She wasn't sure if my feeling was from the vaccine or if it was a sinus infection. She gave me vancomycin 160mg capsule and tobramycin 20mg capsule. I feel that the shot is what messed me up. I felt like someone stuck a pencil in my ears. I felt like I wanted to sleep all the time. I also had chills in 65 degree weather. I had to have the heat on in my house. I'm still feeling a bit of pain around the injection site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 16:33, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.1 and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Facility is unsure if the proper dose was given to the pt.  Contacted health dept who confirmed to revaccinate after 8 wks.
Headache, Myalgia, Fever, ARE SORENESS, SWELLING Narrative:  Other Relevant History:
Moderate soreness on the arm that received the vaccine shot; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 08Mar2021(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, the patient experienced moderate soreness on the arm that received the vaccine shot. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate soreness on the arm that received the vaccine shot was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Very sore left arm/shoulder, unable to lift up over head for a week after. Now, over a month later it is still sore and stiff especially moving a certain way, sleeping on it, and in the morning.
patient came down with a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (patient came down with a cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot in October 2021. Past adverse reactions to the above products included No adverse event with flu shot.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (patient came down with a cold). At the time of the report, NASOPHARYNGITIS (patient came down with a cold) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  The patient had waited till Nov2021 to get booster shot.
Administered with expired vaccines; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021.     Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccines). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccines) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  No treatment medications were reported.
patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient received  IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Aug-2022, the patient received 0.5 ml dose of suspect IPV (VERO), suspension for injection from a punctured vial (lot V1B901M; Expiration Date :22-Jun-2024)  via unknown route in unknown administration site for immunization after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency; same day). This situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  Action taken: not applicable.  Outcome: Unknown.   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.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: diaphoretic, low BP 90/50s-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
The mother states the child lips were swelling and started at 8:00PM after the shots were given at 2:30PM. Mother gave the child Benadryl and the swelling decreased. No other problems noted. Mother denies the child was eating anything unusual.
really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days; It's a linear rash, a raised red linear rash, Today she had it all over her back in lines; sore arm after 3 doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days), RASH ERYTHEMATOUS (It's a linear rash, a raised red linear rash, Today she had it all over her back in lines) and PAIN IN EXTREMITY (sore arm after 3 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced PRURITUS (really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days) and RASH ERYTHEMATOUS (It's a linear rash, a raised red linear rash, Today she had it all over her back in lines). In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm after 3 doses). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. In December 2021, PAIN IN EXTREMITY (sore arm after 3 doses) had resolved. At the time of the report, PRURITUS (really intense itching all over 13 days after booster, itching chest, itching legs, itching bottom of the feet, itching pretty much the whole body, itching even the scalp, Still having itching after 6 days) and RASH ERYTHEMATOUS (It's a linear rash, a raised red linear rash, Today she had it all over her back in lines) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-420889, MOD-2021-420890 (Patient Link).
This spontaneous report was received from a healthcare worker refers to 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 6 unspecified patients were vaccinated with improperly stored VARIVAX lot # L015046 (expiry date: 29-APR-2017) (dosage not reported). The VARIVAX doses were at a temperature of 8F. The time frame was 29 days. No adverse effects reported. No additional information provided. Additional information has been requested.
Vaccine was invalid due to prolonged shipping time; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a unknown.  This case is linked to case 2019SA317566.  This case involves a 11 years old male patient for whom it was reported vaccine was invalid due to prolonged shipping time (Product storage error), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE suspension for injection (batch number UJ3058a; expiration date 12-JUN-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that the vaccine was invalid due to prolonged shipping time (product storage error) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was Not Applicable vaccine was invalid due to prolonged shipping time.  Event outcome was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.    No other information was reported.
Swollen, red, and painful. On 10/26 still a little red and swollen but much better. Took 1 BENADRYL at onset.
w/in min of vax pt exp SOB, chest tightening, extreme flushing of face, chest, upper extremities 02 administered by 1PM feeling better, face flushed-next day still some redness on chest
Received shot on 1/5/2021 at 9:30 am, at around 9:30 pm same day I started to get a headache.  At 10:00 pm my headache was the worse headache I've had so I took 1 Ultracet and after 30 minutes of no relief I took a gabapentine.  Still no relief and at 1:00 am I started vomiting uncontrollably and that last until around 4:00 am.  I ran a low grade fever for the next 24 hours, highest fever was 100.1 but that was with taking Tylenol.  I slept all day on the 1/6 and left every worn out and drained.  1/7 i stopped running a fever at 5:00 am started to feel better just tired.  1/8 I woke up feeling completely normal and fine.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative who reported for himself. This elderly male patient received on an unknown date a single dose of PREVNAR 13 and influenza vaccine (manufacturer unknown), both for immunization. Concomitant medications and medical history were not reported. On an unspecified date the patient felt sick and arm was sore. Outcome of the event arm was sore was recovered on an unspecified date after 12 hours. Outcome of the event felt sick was unknown.
Severe flu like symptoms,   High Temperature, chills, body aches,  slight nausea, groggy.   Symptoms improved at 24 hours, and ended in 30 hours.
Significant swelling in thigh, extending upwards towards hip & also extending below the knee. Accompanied by redness & what almost looks like bruising. No pain present from what I can tell.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date, unspecified numbers of patients were with RECOMBIVAX HB (dose, frequency, route of administration and indication were not provided). RECOMBIVAX HB was exposed to 8.8C for 10 days, and then administered to unspecified number of patients on unspecified dates. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. This report is linked to 1405USA013338 and 1405USA013915 by the same reporter link. Additional information has been requested.
4 inch rash at site of injection. Rash is raised. Itches and skin pain down right arm and hands.