chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 4 year old male with an IgA deficiency, selective IgG subclass deficiency, decreased complement C3 factor, a possible allergy to eggs, allergies to foods and animals and a history of eczema who on 7/20/04 was vaccinated with MMR (lot # 646343/0960N). Concomitant therapy included poliovirus vaccine inactivated (IPOL) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, budesonide, carbinoxamine maleate, and montelukast sodium. That same day approximately 30 minutes post vaccination the patient developed a dry cough, rubbing throat, rubbing chest, generalized hives and both of his eyes swelled shut. He did not experience wheezing, shortness of breath, or difficulty swallowing. The patient was taken to the emergency room and treated with diphenhydramine hydrochloride, 12.5mg, PO, and subsequently recovered within 30 minutes. The physician stated that she did not see the patient for this event, therefore, could not determine if the events would have progressed to a life-threatening situation if the patient had not received the diphenhydramine hydrochloride. The reporter indicated that the chest discomfort, cough, eye edema, throat irritation, and generalized urticaria were determined to be other important medical events (OMIC). Additional information has been requested.
not feeling well at all; This is a spontaneous report from a contactable consumer (patient's wife) reported for her husband. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, Reporter stated that her husband had very bad side effects after the first dose and was hospitalized and her husband was not feeling well at all. Outcome of the event was unknown.  Information related to lot/batch number has been requested.
Patient passed suddenly at home on 03/28/2021 8 days after his first vaccine.
Immediate pain around injection site, has persisted until now 9:30pm began feeling nauseous/ experiencing stomach pain all night: muscle soreness, joint soreness, body aches, clamminess/feverishness Next day 4/11: weakness, fatigue, body aches, muscle and joint soreness, diarrhea, nausea (no vomiting), clamminess/feverishness intermittent-- confined to bed for 24 hours after side effects began
nausea, lightheadedness, body aches.  I was sick for about 2 days after the onset of symptoms
Fatigue and body aches beginning about 18 hours after dose 1 and lasting 24 hours; exactly 7 days after injection, body rash lasting 72 hours. Fatigue, body aches, fever, and brain fog that included forgetting common everyday words after dose 2 and lasting about 24 hours. Pain at injection site beginning about 6 hours after each injection and lasting about 48 hours.
pt was itching on bilat arms & devel welts around waistline area & upper lip swollen then next AM rx DPH
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/14/2021, 02/10/2021, and 11/17/2021. It was not noted if the individual had a specific onset date for COVID-19 symptoms, as the individual had several underlying medical conditions which also cause cough and/or shortness of breath. The individual tested positive for COVID-19 on 01/20/2022 at a hospital; the main complaint seems to have been assessment for stroke. The individual died on 01/22/2022.
Fever; Pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing); "RRMS" (ongoing), notes: Patient's concurrent condition included: RRMS. Concomitant medication(s) included: OCREVUS; TESTOSTERONE; VITAMIN D [COLECALCIFEROL]; BACLOFEN. Past drug history included: Benzoyl peroxide, reaction(s): "Allergies: Drug allergy". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Leg cramp; A lot of fatigue; a lot of pain after vaccine/Body pain; with fever; diarrhea for mre than 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg cramps in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: diarrhea for mre than 2 days). On 29-JUN-2023, the patient experienced fever (Verbatim: with fever) and pain (Verbatim: a lot of pain after vaccine/Body pain). On an unknown date, the patient experienced leg cramps (Verbatim: Leg cramp) and fatigue (Verbatim: A lot of fatigue). The outcome of the leg cramps and fatigue were not reported and the outcome of the fever, diarrhea and pain were not resolved.   It was unknown if the reporter considered the leg cramps, fever, diarrhea, pain and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the leg cramps, fever, diarrhea, pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-JUL-2023 This case was reported by a consumer via interactive digital media. The reporter reported that vaccine was given on Tuesday (day before reporting) 3 days with fever and body pain and diarrhea for more than 2 days now. Leg pain and lot of pain after the vaccine and lot of fatigue.
Have you heard of numbness on the arm after the shot; Have you heard of cold on the arm after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Have you heard of numbness on the arm after the shot) and PERIPHERAL COLDNESS (Have you heard of cold on the arm after the shot) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Have you heard of numbness on the arm after the shot) and PERIPHERAL COLDNESS (Have you heard of cold on the arm after the shot). At the time of the report, HYPOAESTHESIA (Have you heard of numbness on the arm after the shot) and PERIPHERAL COLDNESS (Have you heard of cold on the arm after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Information has been received from a physician concerning a 19 year old female who on 03-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 657622/0388U) IM in the right arm. Concomitant therapy was not reported. On approximately 04-MAY-2007 or 05-MAY-2007 about 24 to 48 hours after the shot he patient developed an orange sized knot at the injection site. Medical attention was sought. At the time of reporting the patient recovered from the orange sized knot at the injection site and no further adverse event information was available. Follow-up information was received on 27-JUN-2007 via telephone. The physician reported that on 03-MAY-2007 the patient developed a softball-size swelling and a knot at the injection site. The physician advised the patient to use cold compresses and to take ibuprofen (MOTRIN). On approximately 05-MAY-2007 the patient recovered from the softball size swelling and a knot at the injection site but the physician is not sure whether or not to continue with the Gardasil dosing schedule due to the patient's experience. The patient has been previously sensitive to other vaccines. No further information was available.
eyes became swollen-taken to hosp ER also states got hives that evening & broke out in hives several times in the week after;
Nerve pain in both upper arms,  heavy pressure in both upper arms, nerve pain in neck and noticable weakness in both arms.
This spontaneous report as received from an office manager refers to an adolescent male patient of unknown age. On an unknown date in 2015 (reported as within the last couple weeks) the patient was vaccinated with a dose of GARDASIL 9 (lot #, strength and dose were not reported), intramuscularly. Other suspect therapies included MENVEO which the patient received on the same day. On an unknown date in 2015, the patient experienced a loss of blood pressure with reported result: 60/30 (units not specified) and almost fainted after receiving GARDASIL 9. He could barely speak and came close to needing an ambulance. He recovered after lying down for an unspecified period of time at the physician's office. The outcome of the patient's events was reported as recovered (date unspecified, 2015). The relatedness between vaccination with GARDASIL 9 and MENVEO and the patient's events was not reported. Additional information has been requested.
Cold sweats, stomach ache, flu-like symptoms 30 min after pt rcv'd inject of Anthrax.
patient received an expired dose of vaccine/no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a nurse via Medical Information (Reference number- 00655131).  This case is linked with case 2021SA213671 (same reporter).  This case involves a patient of unknown age and gender who was vaccinated with 0.5 mL [once; standard] expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number R2A301M and expiry date 31-May-2021) via an intramuscular route at the left deltoid on 23-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  It was reported that "Wanted to know what to do and what recommendations were".  At the time of report, no adverse event reported.  Result of assessment was not reported.  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.
Case number PHHY2011US55140 is an initial spontaneous report received from a health care professional on 21 Jun 2011. This report refers to an adolescent female patient. She was vaccinated with the MenA lyophilized component of MENVEO (batch number: 029011) which was inadvertently reconstituted with MENACTRA (batch number: U3466AA and expiry date: 17 Sep 2011) intramuscularly on 20 Jun 2011. No other adverse reaction was reported.
Didn't expect the "usual reported" AEs to develop with FIRST injection.  4/14/21: Experienced sore arm w/i 10 hrs, excessive thirst, fatigue. Took tylenol about q4hrs throughout day. 4/15/21: Sore arm, fatigue, excessive thirst, otherwise fine. Took a couple doses of Tylenol/ibuprofen throughout the day. 2:00am 4/16/21: chills, fever 101.1, fatigue x 6 hours. Took Tylenol, fever broke. Fatigued throughout day.
Headache pressure get worse; Headache; Pressure in my head; Ear congestion; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included heart arteries, lactose intolerance from an unknown date and unknown if ongoing (Known allergy- Lactose intolerance). Concomitant medication(s) included ramipril (ALTACE, oral capsule, 1.25 mg), metoprolol tartrate (25 mg), amlodipine besilate (NORVASC, 2.5 MG), ranolazine (RANEXA, 500 mg), lactobacillus acidophilus (ACIDOPHILUS), colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium , clopidogrel bisulfate (PLAVIX, 75 mg), acetylsalicylic acid (ASPIRIN EC, 325 mg), isosorbide mononitrate (ISOSORBIDE MN, 30 mg), famotidine (tablet, 40 mg) and Multi Vitamin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient was not pregnant at the time of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, on unspecified date as single for covid-19 immunisation. On 15Jan2021 the patient after second shot about a week and a half after she developed a headache that would not go away. Pressure in head and ear congestion. Headache pressures get worse when she bends down or look up. Also had been to ENT and she does not know what is going on and scheduled to see a neurologist in September. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. On unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test found to be negative. Patient had been being treated with 5 doses of steroids and nothing seems to help. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected
Information has been received from a Physician's Assistant concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown) 0.5mL injection.  On an unspecified date, within a minute after receiving the first dose of Gardasil fainted.  Medical attention was sought.  Subsequently, on an unspecified date the patient recovered from fainting.  No further information was provided.  Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, lot # reported as K026384, expiration date reported as 15-MAY-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
A week and a day later, my arm began to itch a lot at the injection site. It was hard under the skin and hot to the touch.
PFIZER COVID VACCINE #3 GIVEN 8/30/21, LOT # FC3182; pt had a positive COVID test on 2/10/22, ordering physician was at Medical Center; PCP unknown; pt passed away at home
Developed a Heart Flutter roughly 40 hours after second dose of Pfizer.  Unclear whether the vaccine caused the event, but patient has never had this condition in the past. Treatment put on metoprolol and eliquis.  Conditions have subsided but still a mild heart flutter two days post incident
joint pain,fevers,nausea,left axillary adenopathy and left breast swelling,redness and pain
Rec'd flu vaccine 11/16/06 that evening developed sore arm with increased redness, increase swelling. Seen in our office 11/17/06. Diagnosed with cellulitis and prescribed Omnicef.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing), notes: Other medical history: Prediabetes; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile the event Drug ineffective and Covid-19  is assessed as related to the suspect drug BNT162b2.
Information has been received from a physician concerning a 6 year old female patient who on an unknown date was vaccinated with a dose of MMR II (it was reported that the number of doses patient received was zero). On 29-NOV-2009 the patient experienced mumps. (The date of diagnosis was reported as 30-NOV-2009). The patient was afebrile and had right sided parotitis. She presented with a cough for 7 days. On 30-NOV-2009 the patient had the following laboratory results: serum IgM 0.7, serum IgG 4.15 and serum amylase 98. The outcome for mumps was not reported. No further information is available.
Patient experienced mild reddness and itching at injection site only.  Cool compress applied to site.  patient waited 30 min after incident & symptoms improved prior to discharge.
This is a spontaneous report from a contactable consumer (mother) via a Pfizer sales representative. A 20-month-old, female patient received a dose of PREVNAR 13 given in the right thigh along with a dose of HAEMOPHILUS INFLUENZAE B given in the left thigh, both on 15Oct2011 for immunization. Relevant medical history and concomitant medications were unknown. In October of 2011, the patient experienced a hard lump on her right thigh, a low appetite, and felt fussy. Therapeutic measures taken as a result of the events were unknown. The patient has not yet recovered from the vaccination site induration. The outcomes for the other events were unknown.
Soreness, redness at injection site, fever, abdominal discomfort, mild nausea, loose BM. Diphenhydramine 25 mg TID.
SIDE EFFECT FROM BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SIDE EFFECT FROM BOOSTER SHOT) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (SIDE EFFECT FROM BOOSTER SHOT). At the time of the report, IMMUNISATION REACTION (SIDE EFFECT FROM BOOSTER SHOT) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SIDE EFFECT FROM BOOSTER SHOT with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
The patient received the vaccine around 1430 on Thursday. He felt lethargic that evening. On Friday, he experienced chills, followed by mild fever about a hour later. Later in the day, a coworker noticed that the patient's face was red and "spotty". The patient took Benadryl and Tylenol. The fever was gone by 2100. He was still lethargic on Saturday. He was fine by Sunday
I was 30 + 2 weeks at the time of my second Moderna vaccine. My due date is 4/22/2021. Pregnancy has been uneventful until the second Moderna vaccine. At 3:00 am (14 hours post vaccine), I woke up with the urge to go to the bathroom. I went, urinated, and had a small amount of diarrhea. I laid back down and within 30 second had urge to go again. I repeated this six times back to back. I began to have severe lower abdominal cramping and could not sleep again. I didn't know if I had to urinate or defecate but the urge was extremely severe and constant. My temperature began to rise, and I was shaking/aching severely. I took 500 mg tylenol at 5:45 am and that kept my temperature around 99.5 (normal 97.5).  Around 7:30 am I called my OB and they told me to go to emergency/labor and delivery ward of the hospital. At this time, my diarrhea and urge to defecate to stop and it turned to a constant urge to urinate with near constant, severe, lower abdominal cramping. At the labor and delivery ward, they monitored the baby (stable and moving the whole time), did a fetal fibronectin (normal), did a CBC (normal except preexisting mild anemia), and a urinalysis (normal). Hospital determined I was not in labor and did not have UTI so they sent me home. I continued to have temperature raises (up to 100.4 but always took tylenol at this point), severe lethargy, no appetite, severe abdominal cramping, constant urge to urinate, severe shaking, etc. until approximately 8 or 9 pm that evening (32 hours post vaccine). Everything except the constant urge to urinate resolved. Three days post vaccine (evening of 2/15/2021), I began to urinate large blood clots. I scheduled an appointment with my OB for a repeat urinalysis and urine culture. I had the appointment on 2/16/2021 and the only abnormality was hematuria. Urine culture was negative. Doctor prescribed 7 days of antibiotics just in case (while waiting for urine culture). My symptoms finally resolved on 2/19/2021 (7 days after vaccination), with slow improvement after urinating the large blood clots. I have not had any symptoms since then and my baby appears healthy still in utero. I have no history of UTIs.
Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain headache nausea
Full dose Moderna covid vaccine given in error. Shingrix was supposed to be administered instead. Shingrix was still administered and the patient did not react adversely after both vaccines administered. Shingrix and Moderna vaccines do not have any drug-drug interactions. Both Shingrix and Covid vaccines have high reactogenicity and this was communicated with the patient that the following day they could experience symptoms of this.
This spontaneous reported as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose/frequency, lot # unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.