chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 24 hours after the vaccine I started to get real achy. My knees especially were sore. Later in the day I started getting a very severe headache. It felt as bad as a migraine. I also felt hot. After work, I took my temperature at it was consistently 101°. I was fevering the whole night with a severe headache until about midnight. Once the fever broke, my headache was also gone. The next day I was not fevering but my injection site was still tender and my armpit on the side where the injection was was sore. The next day, which is the day I am writing this, my injection site is still very sore and my armpit of that arm is extremely sore. I am assuming the armpit soreness is from swollen lymph nodes.
Information has been received from a physician concerning a "4 month old" male who was vaccinated with a 2 ml second dose of ROTATEQ (lot # was not provided).  Subsequently the patient developed hives. Unspecified medical attention was sought.  At the time of this report, 20-FEB-2009, the outcome was unknown.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/13/2009. Follow up information was received from the physician who reported that the 18 weeks old patient with a history of eczema on 03-NOV-2008 was vaccinated with a second dose of ROTATEQ vaccine (lot# 661031/0467X). On 04-NOV-2008, within 24 hours of administration the patient developed generalized urticaria. On 05-NOV-2008 the patient recovered. Additonal information is not expected.
No additional AE was reported; Temperature Excursion vaccine administered; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 25-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency, strength and route were not reported, and lot number was one of the two reported number: lot #T022315 has been verified as valid, expiration date 30-JUN-2022; lot #T021822 has been verified as valid, expiration date 25-JUN-2022) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (dose, frequency, strength and route were not reported, and lot number was one of the two reported number: lot #T023920 has been verified as valid, expiration date 09-JAN-2022; lot # T027114 has been verified as valid, expiration date 07-FEB-2022) for prophylaxis.  The vaccines administered experienced a temperature excursion of 31.3 degrees Fahrenheit, for a time frame of 6 hours. There were no previous temperature excursions. Digital data logger was involved. The patient had not reported side effects.; Sender's Comments:  US-009507513-2102USA008302:
Patient received dose 3 of HPV series early. First dose administered 2/7/23. Second dose administered 4/19/23. Third dose administered 5/22/23. Patient has been rescheduled to repeat third dose in series in August. No adverse effects noted.
Patient reports today, 2 days after she got the vaccine here, she developed muscle pain on the back and on left side of the abdomen which is persisting - went to Dr on 4/30. Was given Tramadol 50 mg Rx - dispensed today.
Patient experienced a rash on her arm about a day after vaccination and has spread to small patches on other areas of the body. No other issues.
Consistent chest pains all day long, including some sharp chest pains, with shortness of breath.
Pt given IPV rather than PCV, along with his PEDIARIX, so received double dose of IPV.
METALLIC TASTE IN MOUTH; VERY MILD NAUSEA; LITTLE TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, asthma, and unspecified allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced metallic taste in mouth. On APR-2021, the subject experienced very mild nausea. On APR-2021, the subject experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little tired, metallic taste in mouth, and very mild nausea. This report was non-serious.
Patient got what appeared to be a bullseye cruise with a bump. Complained of pain and bruising, bruise was lower on arm than deltoid. I gave vaccine to best ability. Patient had disformity of the arm.
At onset extreme fatigue, terrible migraines and constant nausea. As of today, fatigue has finally subsided.  However, extreme migraines and constant nausea are not going away!!
PATIENT HAS A RASH ALL OVER BACK AND SIDES ON MONDAY FOLLOWING VACCINE ADMINISTRATION THE PRIOR TUESDAY. HE WAS SEEN IN THE LOCAL ER AND PRESCRIBED DIPHENHYDRAMINE, LORATADINE, AND TRIAMCINOLONE CREAM
This is a spontaneous report from a contactable pharmacist received via a sales representative. This pharmacist reported same events for two patients. This is the second of 2 reports. An elderly female patient received PREVNAR 13 (lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red arms for 3 days on an unspecified date. The patient used cold compresses, but did not require medical treatment. Outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018500257 same reporter, same suspect drug, same event; different patients.
Rash; raised, blotchy, itchy. Still has temperature at or below 100.7, one time a week. Sensitive to light once a week. Muscle soreness in arms and legs 3 days a week.
A report has been received from a Health Professional concerning a, Male subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. The FLUMIST Quadrivalent was administered to patient outside of indicated age which started on 28-Mar-2016. The outcome of the event of FLUMIST administered to patient outside of indicated age is unknown. The reporter's description of the event(s) was as follows: unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between FLUMIST administered to patient outside of indicated age and FLUMIST Quadrivalent.
Information received from an Investigator in a vaccine pregnancy registry. A 35 year old female (gravida 1 para 0) received dose 4 of BioThrax vaccine in JAN2015 (at 4 weeks 0 days estimated gestational age (EGA)). The female was determined to be pregnant in JAN2015, 10 days after vaccination. She sent a study referral (generated from active case finding efforts) in FEB2016 which indicated that she had a miscarriage in MAR2015 (5 weeks + 3 days EGA). Treatments included: oxycodone hcl / acetaminophen, promethazine and acetaminophen. No further information is expected. The subject was not eligible for entry in the registry; the Investigator forwarded the information to the vaccine manufacturer.
Pfizer-BioNTech Covid-19 vaccine EUA HA and migraine
A quality assurance analysis has revealed that the patient likely received an additional Shingrix vaccination above the recommended 2 (two) doses of the complete Zoster (Shingles) vaccination series, with the additional dose being given at doctor's office.  In a good faith effort for full disclosure, it appears that due a problem in the connection between our computer system and the state?s vaccination registry,  our office would not have been aware that she had already finished her Shingrix vaccination series at her Primary Care Physician?s office.
8 days after administering vaccine, pt. has red welt and warmth in vicinity of injection sight. Tenderness, no other symptom.
This is a spontaneous report from a Pfizer-sponsored program, received from a contactable Nurse. A 33-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient also started to receive amoxicillin (manufacturer unknown), buprenorphine (manufacturer unknown), ibuprofen (manufacturer unknown) and hydrocodone (manufacturer unknown), all via an unspecified routes of administration from unspecified dates of therapy at unspecified doses for unspecified indications. Medical history included allergies: sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced allergies: pneumococcal, hydrocodone, ibuprofen, amoxicillin, buprenorphine on an unspecified date. The action taken in response to the event for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was not applicable while unknown for amoxicillin, buprenorphine, ibuprofen and hydrocodone. The outcome of the event was unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), ibuprofen, buprenorphine and amoxicillin in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), ibuprofen, buprenorphine and amoxicillin has submitted the same report to the regulatory authorities. The information on the lot number and expiration date has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 11:30 as dose 1, single (Lot number: EM3809), in left arm and on 28Feb2021 at 12:30 as dose 2, single (Lot number: ENG200) at the age of 68 years, in left arm for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 at 16:15 as dose 3 (booster), single (Lot number: OHD21A), in left arm and on 01Jul2022 at 15:00 as dose 4 (booster), single (Lot number: 014B22A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "b/k amputee" (unspecified if ongoing); "high bp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE, start date: May2022; ATORVASTATIN, start date: Sep2003; BENAZEPRIL, start date: Sep2004. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: on day 6; (Jul2022) Positive, notes: very faint antigen positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19.  Clinical course: The initial COVID infection (very faint antigen positive) included shallow cough and sore throat. This initial infection resolved in a few days (antigen negative on day 6). Anti-viral details: COVID-19 Treatment (Paxlovid) started from 26Jul2022 and stopped on 30Jul2022.
Initial report received from a healthcare professional on 23 July 2013. A 02-month-old patient, whose date of birth, gender, medical history and concomitant medications were not reported, had received a dose of PENTACEL (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination the patient had started to cry for 6 hours. It was reported that reporter had believed it was due to pertussis allergy. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender: none.
No adverse event; He reconstituted VARIVAX with expired STERILE DILUENT but did not administer the dose to the patient; caller states that he reconstituted VARIVAX with expired STERILE DILUENT; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age or gender.  The patient's medical history, conditions and concomitant therapies were not reported.  On 05-DEC-2022, a varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U022320, expiration date: 15-JUL-2023 was reconstituted with an expired sterile diluent 0.5 milliliter, lot #T015779, expiration date: 02-DEC-2022 (Inappropriate preparation of medication). It was stated that after reconstituting the varicella virus vaccine live (oka/merck) (VARIVAX) the pharmacist realized that the sterile diluent  was expired and did not administer the dose to the patient (Intercepted medication error). No additional  adverse event was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 12:00 as dose 1, single (Lot number: ER8735), in left arm, on 04May2021 at 12:00 as dose 2, single (Lot number: ER8735), in left arm and on 22Nov2021 at 13:00 as dose 3 (booster), single (Lot number: EW0173) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden" (unspecified if ongoing), notes: other medical history: Factor V Leiden; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "migraines" (unspecified if ongoing), notes: other medical history: migraines; "seasonal allergies" (unspecified if ongoing), notes: other medical history: seasonal allergies; "known allergies: Sulfa based" (unspecified if ongoing), notes: known allergies: Sulfa based. Concomitant medication(s) included: METOPROLOL, start date: 01Jan2005; LOSARTAN, start date: 01Jan2005; WARFARIN, start date: 15Jun2009; ALLEGRA, start date: 01Jan2005. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was reported about covid treatment. Yes, other medication was taken in 2 weeks. Paxlovid was taken as COVID-19 treatment from 23Jun2022 till 25Jun2022 (Lot# 1917995A). Patient received BNT162b2 (BNT162B2), on 25Jul2022 at 02:30 PM as dose 4 (Lot# FN2908) in right arm.
Chills, aching in elbow on shot side, tiredness, stiff neck for about 24 hours
04/05/23 presents to ED for "fatigue" "shortness of breath". PMHx of "COPD, CHF, hypertension"
Fever and body aches for 12 hours, worse than when I had covid in November. A week-long migraine with nausea and sensitivity to light.
Dizziness, Headache, Myalgia, HYPERtension, Fatigue, Narrative:
Arm pain; Fatigue; Swelling - Near Injection Site; Chills; Fever - Temperature of 99.0F; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 99.0F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 99.0F). At the time of the report, PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 99.0F) 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.   No concomitant medications were provided treatment medication include Aleve" - Self medicating to try to alleviate symptoms, "Tylenol" - Self medicating to try to alleviate the symptoms.
Child immunized on 3/4/03 in office. Seen 3/5/03 for immunization reaction; borders drawn and Benadryl ordered (return visit scheduled for next morning). Child seen in ER on 3/5/03 (placed on Keflex). Child rechecked after ER visit. Seen in office 3/6/03; site spreading. Admitted to hospital for IV ABX; in-patient for 2 days.
I got a positive COVID-19 test at a drive thru testing site. I had symptoms of nausea, tiredness, headache, body aches. cough, and low grade fever. These symptoms lasted for 9 days. I had a telehealth visit and was prescribed Prednisone which did help. I had a bloody nasal discharge for 5 weeks which I have never had before. I lost my sense of taste and smell which I did regain but my sense of taste is not normal like it was before. I still fell tiredness.
Several weeks after the second shot I experienced severe, radiating pain in my legs at night. The location of the pain varied. It moved from my knee to thigh to calf, and affected both legs at different times.   The pain has continued, but gotten less severe and less often. It seems to be exacerbated by exercise. It's both joint pain and muscle/soft tissue pain.
swollen firm, red area around inject site rt deltoid extending approx 8-10cm down rt arm; area warm to touch, painful; had fever noc  p/vax;
Few Seconds of High Pitch Tinnitus night of vaccine - awoke with ongoing low level tinnitus that is not resolved
Narrative: Patient reported abdominal pain and a softball sized lump on her right arm after receiving the first dose of the Moderna Covid-19 vaccine. The patient reports going to an outside ED in which the ED provider told her the reaction was related to the vaccine, The patient was instructed to take famotidine or loratadine to help decrease the local reaction.
Injection site pain, low-grade fever, bodyaches, sore throat, headache, tiredness - lasted from around 10 am to 9 pm, when I went to bed. I had a confirmed negative antibody test 11/24/20
bad breathing problems; heart palpitations; loss of balance; stuffy nose; dizziness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose) and DIZZINESS (dizziness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-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 DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Patient reported that chills and stuffy nose started first, followed by heart palpitations within 4 hours of the start of symptoms. She had no previous diagnoses of COVID-19, myocarditis or pericarditis.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-415851, MOD-2021-415850 (Patient Link).
nausea, fever, chills, sore throat, throat sore to touch-top of mouth sore, head cold
Information has been received from a pharmacist concerning a 68 year old male who has had a liver transplant and has an allergy to penicillin who on Oct 23 2004 was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included tacrolimus (prograf), levofloxacin (Levaquin), prednisone, panthoprazole sodium (Protonix), citalopram hydro bromide (Celexa) and insulin. The patient has had no reaction to the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Received Flu vaccine 11/3/06. Pt states on 11/6/06 around 4:30pm started having left arm pain at chest pain. States she called RN yesterday et was instructed to apply ice to shot site and take Tylenol. States she applied ice et took Aleve. Also took Lusonex for allergies left upper arm, red, swollen and area size of quarter having bruise. Red and swollen left upper approx 4-6" long et 2" wide. Warm to touch.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Apr2023 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received COVID 19 treatment with Paxlovid form 21Jul2023 to 26Jul2023 and patient did not receive other medication in 2weeks. No Known allergies.   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.