chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from a medical assistant and refers to a 21-year-old female patient. Her medical history, concurrent conditions and concomitant drugs were not reported. On 24-DEC-2018, the patient came to the office for wellness checkup and was vaccinated with GARDASIL 9, intramuscularly, lot# R026380, expiration date 23-JUN-2021 (exact dose and site of administration were not reported) for prophylaxis (reported as for vaccination). On the same day, after the vaccination, an unspecified pregnancy test results came back positive. The date of last menstrual period (LMP) was 03-DEC-2018 (as the patient reported) and estimated delivery date (EDD) was 09-SEP-2019. It was reported that at the time of the report, the patient was still pregnant and she did not experienced any adverse reactions. The pregnancy outcome was pending.
After receiving the Anthrax vaccination on the 18th of Aug, my arm began to swell and the swelling gradually spread down to my elbow. I went to see my primary care (form is torn here) on the 20th of August and he gave me Ibuprofen (form torn here)..(arm) is still sore and the swelling is going down.
Within 2 hours of being vaccinated, the patient had a warm raised, red area, about 3-4 mm at site of injection. The next day, 10/30 the area remained red and induration was 9 mm. On 11/1 injection site was 11 mm and patient was advised to contact primary doctor for oral antibiotics.
Approximately 2 weeks after the vaccination, patient developed a second mastocytoma, confirmed by dermatology
have not received the second dose of the Moderna vaccine yet, and is now day 42; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (have not received the second dose of the Moderna vaccine yet, and is now day 42) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received the second dose of the Moderna vaccine yet, and is now day 42). At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received the second dose of the Moderna vaccine yet, and is now day 42) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
person describes extreme pain & heat @ inject site off & on since 7APR92; noted pain AM of 7APR92; no loss of motion; (appt made to be eval 6JUL92);
Soreness in left arm; it has continued for three weeks with it getting worse in middle of the night.
Rash on hands; This is a spontaneous report received from a contactable nurse. A 38-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Right on 27Dec2020 06:30 (at the age of 38-year-old) as single dose for covid-19 immunisation. Medical history included asthma and sulfa meds allergy. The patient's concomitant medications were not reported. Patient did not receive other vaccine within four weeks of suspect vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID since vaccination. On 28Dec2020, the patient experienced rash on hands. Patient received steroid cream as a therapeutic measure to treat rash. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was recovered/resolved.   Follow-up attempts completed. No further information expected.
Delayed Onset Pruritis and hives, full body. Started with intensely pruritic palms and soles which woke me during the night, then extended to full body, lingering now for more than 5 wks. The pruritis occurs where something rubs, like bra or tight clothing or wool clothing. When I give in to the urge to rub and scratch, hives erupt.
No adverse effects reported; One dose of an improperly stored vaccine, VAQTA, to one patient; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-SEP-2019, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) injection, for prophylaxis, lot number S005723 with expiration date in 10-JUL-2020 (strength and anatomical location  were not reported).  The hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature of 0.24 Celsius (°C) (reported as multiple) for the time frame of 5 hours and 30 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported.
Initial and follow-up information has been received from a registered nurse and a medical assistant concerning about 20 female patients who "within the last month," in approximately August 2007, were vaccinated with Gardasil. Immediately after receiving the Gardasil vaccinations the patients experienced pain at the injection site. These were not all first dose cases as the patients were all at different staging doses in the series. The medical assistant reported that when they first started giving the vaccine, they received no complaints. But as the girls were coming back for their second and third doses as well as the patients when received the first dose of Gardasil, they were complaining of pain. Subsequently the patients recovered. On 23-AUG-2007 the medical assistant reported that she could not provided any additional patient details or lot number of the Gardasil. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
swelling, erythema, warmth @ site, generalized achiness over entire arm rt minimal tenderness @ inj site;also c/o generalized joint pain;
SORE ARM, PAIN ON LEFT SIDE OF BODY INCLUDING KNEE AND LOWER LEG; HAND AND FINGERS NOT WORKING CORRECTLY; 2ND 3RD AND 4TH FINGERS CLUNK AND MAKE NOISE; PAIN IN UPPER LEFT ARM
Flu shot given on Friday 9/14/12. Patient called Tuesday 9/18/12 saying she has severe pain in arm, trouble breathing, nerve damage, neck pain, cannot pick up anything with left hand, severe pain can't sleep and no strength in left arm.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL injection, by intramuscular route, lot number M014929, expiration date: 27-MAY-2017 (strength and dose were not reported) for prophylaxis. The Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine was stored appropriately. No adverse effects were reported and not product quality complaint (PQC) was involved. Additional information has been requested.
Experienced left side facial paralysis (Bell's Palsy) beginning approximately 2 hours after receipt of influenza vaccine at a community pharmacy near his home. Seen for urgent care visit at PCP's offic on 10/15/15 and treated with steroid taper beginning 10/15/15 x 10 days. As of 10/27/15 symptoms remain with little improvement.
1cm lymphadenopathy in the right groin and left supraclavicular area; This is a spontaneous report from a contactable physician (patient) reported for herself that a 32-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELIZ84) via Intramuscular at left arm, on 06Jan2021 at single dose for COVID-19 immunisation. Medical history was none. Patient has no known allergies. Concomitant medications included oral contraceptive (OCP) and cetirizine hydrochloride (ZYRTEC). Patient previously received first dose of BNT162B2 (Pfizer, Lot number: EH9S99) via intramuscular at left arm on 16Dec2020 for COVID-19 immunisation at the age of 32 years old. Patient received her Pfizer vaccines at hospital on 16Dec2020 and 06Jan2021. After her second vaccination, she had noticeable 1cm lymphadenopathy in the right groin and left supraclavicular area on 07Jan2021. No treatment received for events. Patient did not receive other vaccine in four weeks. Patient did not test COVID post vaccination. Outcome of the event was recovering.
The pt experienced 25 varicella lesions at approximately 16 days post vax.
extra dose of PENTACEL was administered to a patient instead of Prevnar with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 months old female patient to whom extra dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered instead of prevnar with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.  On 21-Jul-2023, the patient received an extra 0.5 mL dose 2 of suspect diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (batch number: UJ859AA; expiry date: 02-Apr-2024) via intramuscular route in the left thigh for immunization instead of prevnar with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event extra dose of pentacel was administered to a patient instead of prevnar with no reported adverse event.  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 guidelines. 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.
Headaches with exertion.  Patient reports extreme L sided head pain when doing any exertion after receiving the vaccine.  Denies vision changes, nausea, vomiting, fevers, chills, malaise or any other symptom. Denies hx of migraines or headaches.
Presented with cough/congestion x 10 days; + Covid in ED; admitted to hospital with Covid PNA; tx with zithromax, rocephin, steroids, remdesivir, Vit C, Vit D3, zinc, 2-4 LPM O2; back to baseline O2 at time of dc
arm is tender; delayed reaction of redness in the arms; redness in the arms; arm is itching; arm hurt; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness in the arms), PRURITUS (arm is itching), PAIN IN EXTREMITY (arm hurt), TENDERNESS (arm is tender) and SKIN REACTION (delayed reaction of redness in the arms) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ERYTHEMA (redness in the arms), PRURITUS (arm is itching), PAIN IN EXTREMITY (arm hurt), TENDERNESS (arm is tender) and SKIN REACTION (delayed reaction of redness in the arms). At the time of the report, ERYTHEMA (redness in the arms), PRURITUS (arm is itching), PAIN IN EXTREMITY (arm hurt), TENDERNESS (arm is tender) and SKIN REACTION (delayed reaction of redness in the arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt recv vax 14MAY97 & & approx 30min post vax pt exp wheezing;15MAY97 pt exp a hot feeling, nausea & a sl h/a @ temples;w/in 90minof onset pt recovered;
Patient had vaccination administered at 1615 on Feb. 19 after being educated about the Moderna Vaccination and recieving the Moderna EUA and V-Safe Flyer. With her history of having an allergic reaction to citrus and having emesis after the shingles vaccination, it was decided that the patient would be monitored for 30 min after vaccination. at 1636 patient stated she didn't feel good and a rash started to break out on the outside of her throat. She went pale and stated her throat was starting to swell up. Patient was then laid down flat with feet elevated and was given an epi pen to her right thigh. Ice packs were applied to her upper chest and to the back of her neck. After 5 minutes, patient's throat cleared up and there was no rash. Breathing returned to normal. a FNP listened to her lungs and heart and stated she was getting good air flow. Continued to monitor patient. Offered to transport her to hospital for continued monitoring and the patient declined stating she has had this happen before with citrus and knows what to expect and look out for. Patient was monitored for an additional 30 minutes before being driven home by friend.
Substantial muscle issues/tightness in neck, chest, feet with major muscle and weight loss (at 15 lbs to date). We cannot determine the cause of this or the source so far.   I am still eating food but do not seem to get the nutritional benefit of such foods.   I continue to try and determine the cause of this with no results yet.
Nerve pain shooting from knee down lower legs; Causing knees to buckle; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the left arm on 04Nov2021 at 10:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 14Jan2021 (at the age of 73-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 05:00, the patient experienced nerve pain shooting from knee down lower legs causing the knees to buckle. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerve pain shooting from knee down lower legs causing knees to buckle was unknown at the time of this report.
Child presented in clinic after visit to ER for c/o hot rash to R thigh. Reported syringe blew off during administration. Child's leg was red blotchy in appearance, redness was not bold but covered 60-70% of R thigh anterior and medial.
After each vaccine, I got very sick. I got a horrible headache, muscle aches, tired and weak. I would have a headache for at least two days after each vaccine. I received a smart watch as a gift in in the middle of October 2022. On 10/15/2022, I noticed my watch showed I was in AFib. It must have monitored overnight because I saw it on 10/15/2022. I had absolutely no symptoms. It took some time to get into see my doctor, but I did see a provider at 11/04/2022. The provider recommended that I see a cardiologist. I finally got to see the cardiologist on 01/05/2023.
After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified.; After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified.; had mainly digestive issues; brain fog; anxiety; depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she had Covid virus", start date: Apr2020 (unspecified if ongoing), notes: Mentioned she had Covid virus in Apr2020; "she is a Type 1 diabetic" (unspecified if ongoing), notes: she is a Type 1 diabetic. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization completed), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster)), for COVID-19 Immunization; Bnt162b2 (Dose 4 (Booster)), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "After Bivalent vaccine: she is really sick; clarifies as a combination of all her symptoms of Covid long haul; but amplified."; DYSPEPSIA (non-serious), outcome "unknown", described as "had mainly digestive issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ANXIETY (non-serious), outcome "unknown"; DEPRESSION (non-serious), outcome "unknown".  Additional information: Patient had some of these side effects after the second Pfizer Covid booster, but not to this extent, it was very mild. She thought really long and hard before getting the new bivalent Pfizer vaccine. After having the bivalent booster, the first two days she was aboslutely fine, it was the third day after getting the vaccine that the brain fog, depression and anxiety started. Its been really bad, they are not different symptoms, they are just worse. She's really been stuck in bed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201218322 same patient, different dose/event;
The patient developed a very short episode of flushing a few minutes after administration of the vaccine. About 30 mins after the vaccine she developed significant nausea without vomiting. She was administered Zofran with no relief. She was monitored for an additional 90 mins with no resolution of symptoms and could not function and was sent to emergency room and given Phenergan with eventual resolution of symptoms.
I started becoming really tired which was abnormal for me because I have high energy. I lost my appetite and had a pounding headache with a runny nose, but put it off thinking it was my sinuses due to weather change. The entire weekend, I stayed in bed resting and forced myself to eat something. By 12/19/2022, my body started aching terribly as if I was just beat with a baseball bat. That's when I knew something was terribly wrong; I woke up in the middle of that evening and took an at-home COVID-19 test which came back positive so fast. So the next morning, I called my doctor to see what I should do. My physician prescribed me PAXLOVID which I started taking the same day. Since taking the treatment, my body aches have gone; but I still have slight headaches, slight fatigue, and slowly regaining my appetite back.
Patient had typical local injection site pain for first days. Then several days after she experienced shooting pain from the shoulder down to fingers with tingling in fingers in same arm as injection. She is not sure the symptoms are related, but as a pharmacist and administrator, I did refer her to see her physician since the pain is high level and persisting 12 days after the injection.
10 minutes after the injection, my left arm became itchy for approx. 4 hrs and had a lump approx. the size of a plumb. The next day (Tues) slightly sore and a small reddened area. Wed my lt upper arm is red posterior ( 3/4 of my arm) and warm to the touch. I will be going to Employee Health in the morning.
rubella virus granulomatosis disease; rubella virus granulomatosis disease;   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included asthma and seasonal allergies.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as two years after vaccination), the patient experienced a solitary papule that increased to several papules coalescing into a plaque localized to the left arm which was diagnosed initially as granulomatous dermatitis which was treated with methotrexate, bexarotene, hydrozychloroquine, topical clobetasol, and topical imiquimod, without benefit. After four years from the onset of the event, an skin biopsy was collected and histophatology results showed atypical CD8 lymphocytic infiltrate with associated granulomatosis inflammation, which due to similar rubella virus associated cutaneous granulomatosis dermatitis, plasma tests for rubella virus were performed with the following results: Blood immunoglobulin G: 688 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 851 mm3, CD3 CD4 T cells count: 470 mm3, CD3 CD8 T cells count: 345 mm3, CD19 B cells count: 345 mm3, CD56 CD16 NK cells count: 107 mm3, T-Cell mitogen proliferation: 7% (low), Rubella IgG titer: 580 IU/ml, Rubella neutralization titer: 1280 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA009517: US-009507513-2212USA009518:
Information has been received from a registered nurse (RN) concerning a 4-month-old patient who was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  It was unknown if medical attention was sought and no symptoms were involved.  Additional information has been requested.