chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have the Pfizer vaccine just tested positive for COVID-19 last night.; Have the Pfizer vaccine just tested positive for COVID-19 last night.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 1, single (Lot number: FK5127), in arm, on 01Dec2021 as dose 2, single (Lot number: FL0007), in arm and on 09Jun2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 8 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2022, outcome "unknown" and all described as "Have the Pfizer vaccine just tested positive for COVID-19 last night.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The report was not related to a study or program. NDC number, expiry date of COVID-19 vaccine: Unknown. Caller reported that her two kids who have the Pfizer vaccine and just tested positive for covid-19 last night. Her children received two doses plus a booster. The patient received all 3 vaccines in morning. No additional vaccines administered on same date of the Pfizer suspect, no vaccines administered on same date with the Pfizer vaccine considered as suspect.
Now developing small rashes on that arm in different locations, also raised itchy, hot; Little dizzy; Developed huge rash on arm where injection site was its hot, its raised, it itches; Developed huge rash on arm where injection site was its hot, its raised, it itches; Developed huge rash on arm where injection site was its hot, its raised, it itches; Developed huge rash on arm where injection site was its hot, its raised, it itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Now developing small rashes on that arm in different locations, also raised itchy, hot), DIZZINESS (Little dizzy), VACCINATION SITE RASH (Developed huge rash on arm where injection site was its hot, its raised, it itches), VACCINATION SITE WARMTH (Developed huge rash on arm where injection site was its hot, its raised, it itches) and VACCINATION SITE PRURITUS (Developed huge rash on arm where injection site was its hot, its raised, it itches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Undifferentiated connective tissue disease (Autoimmune disease -UCTD). Concomitant products included HYDROXYCHLOROQUINE and VITAMINS NOS for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (Developed huge rash on arm where injection site was its hot, its raised, it itches), VACCINATION SITE WARMTH (Developed huge rash on arm where injection site was its hot, its raised, it itches), VACCINATION SITE PRURITUS (Developed huge rash on arm where injection site was its hot, its raised, it itches) and VACCINATION SITE SWELLING (Developed huge rash on arm where injection site was its hot, its raised, it itches). On an unknown date, the patient experienced RASH PRURITIC (Now developing small rashes on that arm in different locations, also raised itchy, hot) and DIZZINESS (Little dizzy). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Now developing small rashes on that arm in different locations, also raised itchy, hot), DIZZINESS (Little dizzy), VACCINATION SITE RASH (Developed huge rash on arm where injection site was its hot, its raised, it itches), VACCINATION SITE WARMTH (Developed huge rash on arm where injection site was its hot, its raised, it itches), VACCINATION SITE PRURITUS (Developed huge rash on arm where injection site was its hot, its raised, it itches) and VACCINATION SITE SWELLING (Developed huge rash on arm where injection site was its hot, its raised, it itches) outcome was unknown.            Reporter did not allow further contact
FLUVIRIN W/ THIMERASOL GIVEN TO OB PT. PT NOTIFIED ON 11/5/2009. DENIES ANY ADVERSE EFFECTS.  11/10/2009 Medical records received. OB/GYN office note. DOS 11/3/09.  Uterine cramping x4 days. Prodromal labor. Neg bloody/mucous d/c. Comfort measures.
5 day old was given a flu shot, Fluzone instead of a Hepatitis B shot/no AE; 5 day old was given a flu shot, Fluzone instead of a Hepatitis B shot/no AE; Based on information previously received on 15-Oct-2019, the following information [classification "non-valid case" removed"] have been amended.  Initial information received on 15-Oct-2019 regarding an unsolicited non-valid non-serious case received from a physician.  This case involves a 5 days old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of HEPATITIS B VACCINE   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was of potential medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.  Addendum:  Based on information previously received on 15-Oct-2019, the following information [classification "non-valid case" removed"] have been amended.
Fever 101.6, myalgias, fatigue later same day. Swelling 2hr post injection.
pt recv vax in approx 1997 & on 5/1/98 pt devel chickenpox with well over 100 pox over body. pt was well covered & did get pox marks from some.
The 3rd shot was given in the same arm as the other two, and much higher, not in my deltoid muscle, but higher in my shoulder.  I immediately felt a sharp pain in my shoulder during the injection, as well as a muscle spasm.  When I arrived home immediately after the vaccination I began to feel a dull pain in my shoulder and upper arm, eventually seeking a medical evaluation on 12/23/2021.  I was  prescribed a pain medication, and told to return in 3 weeks.  I returned on 1/19/2022 and was sent for an MRI which took place on 1/21/2022.  I have been prescribed pain killers and muscle relaxers since my 1/19/2022 appointment, and have a referral for an orthopedic surgeon and pain management physician.
Rash, itching and swelling to injection site (3 days after administration). Treatment: diphenhydramine HCL at home for 3 days.
pt recvd vax & 2hrs post vax was flushed,hot,sweaty,nauseous,& dizzy;sx resolved overnoc while asleep w/o treatment;
About 6 hours after getting my second vaccine, I began feeling itchy (around 5:30 PM CST). I began breaking out in hives everywhere on the body (started in arms, then legs, stomach, chest, backside, EVERYWHERE except the face). At first I wondered if it could be from the outside like allergies but I have never experienced anything like this. I became itchy everywhere and had red little bumps all over and would get bigger if I scratched it. This continued from Friday evening, ALL DAY Saturday and Sunday. I made a telehealth appointment with a doctor regarding this because nothing I did would alleviate the itchiness. I was prescribed two antihistamines: cetirizine and prednisone. I only took the cetirizine Monday night and while it did relieve the itchiness, the effect wore off and to this day (Tuesday evening) I am STILL breaking out in hives.
I woke up in the middle of the night with a very high fever/ temperature of 101.5; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206 and expiration date not provided) via an unspecified route of administration on 20Mar2021 14:45 as a single dose for COVID-19 immunisation. Medical history included asthma and fibromyalgia. Concomitant medications included albuterol (SALBUTAMOL), oxcarbazepine (TRILEPTAL), sertraline hydrochloride (ZOLOFT), clonidine (CATAPRES) and artemether, lumefantrine (LUFART). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient received her second dose of the vaccine on 20Mar2021 and she woke up in the middle of the night (on 21Mar2021) with a very high fever. The temperature was perfectly fine before the vaccine and she wake up at around 4 oclock this morning (21Mar2021) with a temperature of 101.5 and it still hasn't gone down. She thought she should call and report it. No treatment was given in response to the event. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Patient was sitting in post-vaccination waiting area in front of the pharmacy and fell off his chair.  He regained consciousness right away and didn't remember passing out.  I asked him to recline and elevate his legs and he held that position for several minutes and then seemed fine after that.  He said he has an extreme fear of needles and felt he passed out from the anxiety he was feeling prior to getting the shot.  He remained in the post-vaccine waiting area for an additional 15-20 minutes and did not have another episode of syncope.
Mother noted right sided face/jaw swelling hrs AM (4/28/06) no fevers, eating well, active. Afebrile, 4AM right pre-auricular and sucinandibular swelling near angle of jaw on right. No erythema, no warmth. Rx given for Augmentin but is suspected more likely to be parotitis 2 hrs vaccination.
Following day lg local reaction with mild pruritus, warmth and soreness. No systemic sx. 2 days post vac he was noted to have circular welts in axilla. Over the next 5-7 day hives migrated from axilla to lower extremities. Hives would clear for a day but would return. Has had 5-6 episodes in the same pattern over from Aug through Oct. Currently hives controlled with antihistamines and recur when antihistamines are stopped. Symptoms: Hive, erythema.
Mild injection site pain & slight swelling for two days. Low grade fever (~99.5) that lasted for a few hours in the ealry morning of 17 Mar 2021.
PT father states that two days after her second dose Pfizer vaccine his daughter developed allergies in her whole body. Her skin became dry with little bumps all over her body, face, arm, hands and feet. He also states his daughter?s lips, hands and feet swelled up. Also that on her inner thighs and vaginal region her skin was also dry with cuts of dry skin. PT father states his daughter went to the doctor where they prescribed Cephalxin, Triamcinolone and Acetonide as medication.  As of today, PT father states she continues with the dry skin and little bumps on her whole body, face and arms.   PT father states that for her first dose vaccine, his daughter only had soreness to her left arm.
Shortly after vaccination #1 within a week or so, I began experiencing pain; numbness/tingling in my legs, feet, arms and hands. It was excruciating and would wake me up during the night. I got neuropathy with each shot, and every time it hit worse (including back). I was beginning to get arthritis in my back and knee. Also after booster shot, within 2 days couldn't move my right thumb. I saw a doctor and told this was the beginning of trigger finger, which I find funny because I never had any health issues at all before. Now I have neuropathy; back pain etc. My experience with these vaccines has been awful. It has caused me a lot of health issues.
Pain/ Soreness; Fatigue; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   The patient's past medical history included shoulder operation.   On 13th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th March 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, fatigue and influenza-like symptoms. On 14th March 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting the patient had Shingrix in the same arm that he previously he had shoulder surgery and had quite a bit of pain in the area, more so than most people reported. The patient also had flu like symptoms, stating he was down and out, with fatigue and soreness. The symptoms started later that evening of the vaccine and lasted for about 24 hours. The patient received the second dose in the opposite arm, caller has not heard anything from the patient regarding any side effects at the time of reporting. No further information was provided. Separate adverse event reported for the most patients.
No medical history provided by the reporter.  Concomitant products included METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and INSULIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergies acting bad), MYALGIA (Body aches / muscle aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F). On 22-Jan-2021, PYREXIA (Fever 101F) had resolved. At the time of the report, HYPERSENSITIVITY (Allergies acting bad) and MYALGIA (Body aches / muscle aches) had resolved and CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101.0 (High) °F. On 22-Jan-2021, Body temperature: 98.0 (normal) °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took ibuprofen for the treatment of the events.
I woke up the morning after receiving my 2nd dose with a severe headache and bad congestion.  I fought the congestion with Afrin, but it only offered temporarily relief.  I contacted my PCP when the symptoms persisted.  I tried an antibiotic to fight the symptoms, but it was to no avail.  At the advice of a nutritionist, I began to drink pine needle tea for the congestion.  This did provide relief from the congestion, and I was able to stop constantly using tbe Afrin.  The headaches remained.  My pcp, then prescribed a steroid treatment (prednisone) fir the headaches.  This worked!  Following tge prednisone, my headaches subsided and have stayed away.
Received 2nd dose of vaccine on 2/1/21.  On 2/2/21 and 2/3/21 felt chills, headache, fatigue.
rash all over( macular- papular small lesions; Chills; sweating; shaking; HA; Fatigue; small lesions not resolved; This case was reported by a nurse via call center representative and described the occurrence of maculopapular rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 1st dose of Shingrix. In August 2020, couple of hours after receiving Shingrix, the patient experienced maculopapular rash, chills, sweating, tremor, headache, fatigue and skin lesion. On an unknown date, the outcome of the maculopapular rash, sweating, tremor and skin lesion were not recovered/not resolved and the outcome of the chills, headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the maculopapular rash, chills, sweating, tremor, headache, fatigue and skin lesion to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and couple hours after developed shaking, chills, sweating, rash all over macular popular small lesions not resolved at time of report, fatigue, headache and chills. The reporter consented to follow up.  The HCP gave permission to contact and she did not have full information that was located at the pharmacy at the time of the call.
When the vaccinator pushed down on syringe to administer vaccination, all of the liquid in syringe came out at the connection between syringe and needle, soaking my left arm down to my hand. This would indicate the vaccine was not administered properly.  I reported this event to the supervisor present, who stated that if some of vaccine went into the arm, the vaccination is considered successful. There is no means of knowing if any of the vaccine was actually injected.  I do not know if this event was recorded or reported by the health department; it appeared to me that the site facilitators were not concerned. I was told I can contact my primary care doctor  when I asked for information re: titer screen to assess for immunity.
sore throat, difficulty breathing, hives & blotches, edema in hands & feet. Sores on lip 2 hr after vax.  Lasted 6 days so far prednisone rx. taking benadryl, still have sx. MD visit confirmed allergic rxn.
Caller was reporting an expired PNEUMOV AX 23 that was administered to a 95 year old female.; This spontaneous report was received from a pharmacist referring to a 95-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 22-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter (concentration, vaccination scheme frequency, route of administration and anatomical location were not reported; lot # S002640, expiration date reported 29-SEP-2020) (expired product administered).
Achy, high fever (103), hallucinating, with scattered edematous papules 5 days after receiving vac. Has been fatigued, unable to concentrate.
Patient states felt as skin was burning, face became flushed. Had very bad headache the next morning. Injection site lightly red and swollen, painful to touch.
Left upper arm developed swelling; warmth, erythema extending from shoulder to elbow (lateral/outer arm only). Child c/o burning and itching and pain. Received Benadryl, Ibuprofen and cool compress as treatment.
Hand going numb, fingers twitching, dizzy, -pt states had gone for a long walk prior to receiving vaccine - after resting and eating something symptoms resolved.
The morning after the 2nd shot, I woke up with a rash that looks like a bruise on my chin.; The morning after the 2nd shot, I woke up with a rash that looks like a bruise on my chin.; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration in Arm Left on 17May2021 13:45 (at the age of 33-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included norethindrone taken. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccination. On 18 May 2021 in morning after the 2nd shot, he woke up with a rash that looks like a bruise on his chin. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Muscle pain in arm; Received vaccine while pregnant; This is a spontaneous report from a contactable consumer(Patient). A 41-years-old pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 16Mar2021 14:00 (Age at vaccination: 40-years-old) as single dose and second dose via an unspecified route of administration, administered in Arm Left on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) taken for an unspecified indication, start and stop date were not reported. last menstrual date was 25Sep2020. Gestational period was 25 weeks. expected  delivery date was 06Jul2021. Patient was not diagnosed with covid-19 prior to vaccination. Patient did not receive any other vaccine in four weeks. It was reported that on 16Mar2021 14:00 received vaccine while pregnant. Upon date 07Apr2021 it was reported that on 06Apr2021 received second dose while pregnant. Muscle pain in arm. Patient did not receive treatment for the events. Patient did not tested for covid post vaccination. The outcome for the event muscle pain in arm was reported as resolving at the time of this report.   Follow up information has been requested.