chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my head felt on fire and I felt I was going to faint; felt I was going to faint/dizziness; developed irregular menses; vertigo; chest tightness; elevated blood pressure; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 11:30 as dose 2, single (Lot number: EW0153) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Vaccination history included: BNT162b2 (dose lot number=EN6198, dose administration time=11:00 AM, dose number=1, dose vaccine location=Arm Left), administration date: 30Mar2021, when the patient was 43-year-old, for COVID-19 immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "chest tightness"; MENSTRUATION IRREGULAR (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "developed irregular menses"; BLOOD PRESSURE INCREASED (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "elevated blood pressure"; DIZZINESS (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "felt I was going to faint/dizziness"; FEELING HOT (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "my head felt on fire and I felt I was going to faint"; PALPITATIONS (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown"; VERTIGO (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling hot, dizziness, menstruation irregular, vertigo, chest discomfort, blood pressure increased, palpitations.  Additional information: Prior to vaccination the patient was not diagnosed with COVID- 19, Since the vaccination, patient has been tested for COVID-19. The patient received Tylenol within 2 weeks of vaccination. Within 20 minutes her head felt on fire and she felt she was going to faint. Since then, she developed irregular menses, vertigo, dizziness, chest tightness. Four days after she had elevated blood pressure, palpitations. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Serious: No. Hospitalization Prolonged: No.
Light sensitivity which turned into serious adverse reaction to being in sunlight. Caused severe shakiness, sweating, diarrhea, vomiting, nausea, severe ongoing headache that wouldn?t respond to medications. Sunlight caused majority of symptoms. Face numbness and inability to function as normal in sun. Vision changes. Loss of appetite. Swelling of right side of lips.
PAIN, SWELLING, REDNESS, THE FEELING THAT THE ARM IS ON FIRE, BRUISING
Information has been received from an RN concerning a female patient who in June 2007, was vaccinated with her first dose of GARDASIL. On 24-SEP-2007 the patient was vaccinated with her second dose of GARDASIL. The nurse stated that 2 days later after getting her first and second doses, the patient experienced weakness and sick. Medical attention was sought. The patient was diagnosed with mononucleosis. Her outcome was This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from an registered nurse (RN) concerning a 15 year old female patient with a hypersensitivity reaction to penicillin, AMOXIL and erythromycin, who on 30-JUL-2007 (previously reported as in June 2007), was vaccinated in the left deltoid with her first dose of GARDASIL vaccine (lot #658560/1062U). There was no illness at the time of vaccination. There was no concomitant medication. The nurse stated that 2 to 3 days after getting her first vaccination, the patient developed a sore throat, fever, weakness, malaise and generally not feeling good. She also experienced a localized reaction on 08-AUG-2007, she visited the physician's office and was diagnosed with strep throat when a rapid strep test was postive for group A stretococcus, and possible mononucleosis. Treatment included clindamycin. After an unknown duration the patient recovered from the symptoms. On 24-SEP-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (lot # not provided). Two to three days after the vaccinaton, similar symtoms recurred and included headache, sore throat, fever (valve not specified), and localized reaction though they were not as severe as those following the first dose. Follow up information in the form of medical records, revealed that the patient visited her primary care physician for a well check up on 25-OCT-2007, and at that time there were no complaints of headache, sore throat no swollen glands, no inflammation, no abnormalities on tonsils, no fever, no skin lesions, and no mention of cough (no anomilies in lungs). The duration of the symptoms was not specified. Additional information is not expected.
After receiving the vaccine on the first evening I got very tired and felt like I needed to lay down. I was dizzy, nauseas, and had a headache. That lasted for 7 days.  I also had received the first dose of the Shingrix vaccine on July 6, 2021. After receiving that vaccine I had a fever, headache, body aches, itching in both of my forearms, swelling under my right arm, and my lypmh nodes were swelling under my right arm as well. I had received the Shingrix shot in my right arm.
Tingling sensation to entire body, hands and feet. BP 187/96 HR 136. hreart palpitationsw, tinling in legs;
Info has been received from a licensed practical nurse concerning a 53 year old female with fibromyalgia, gastroesophageal reflux disease, irritable bowel syndrome and an allergy to propoxyphene HCl (DARVON) who was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent in approximately 1995 and on 10/28/2002 in the right arm (lot 642720/0172M), respectively. On an unspecified date, the pt was vaccinated with a dose of influenza virus vaccine. Concomitant therapy included citalopram hydrobromide (CELEXA), medroxyprogresterone acetate (PROVERA), estrogens, conjugated (PREMARIN), esomeprazole magnesium (NEXIUM), amitriptyline hydrochloride (ELAVIL), fexofenadine (ALLEGRA), hydroxyzine and "bellaspas". On 10/29/2002, the pt developed a fever of 101 which resolved on 10/30/2002. On 10/30/2002, the pt presented with a rash. The welts were the size of a quarter, very warm to the touch and painful. There were 3 welts just below the injection site and 3 were under the arm. Her arm was sore, and she had difficulty moving her arm. Overall, her joints ached, and she had nausea but no vomiting. The pt sought unspecified medical attention and was treated with promethazine HCl (PHENERGAN) for the nausea. Additional info has been requested.
migraine; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 at 07:45 as dose 4 (booster), single (Lot number: GL0446) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 07Jan2023 at 07:30, outcome "unknown", described as "headaches"; MIGRAINE (non-serious) with onset 07Jan2023 at 07:30, outcome "unknown". Therapeutic measures were not taken as a result of migraine, headache. Additional information: The patient has no covid prior vaccination, no covid tested post vaccination, no known allergies, and no other medical history.  No follow-up attempts are possible. No further information is expected.
pt recv vax 18JUN97 & 20JUN97 pt exp a low grade fever all over body which looked like little blisters;the rash was non-localized & almost looked like poison ivy;
Patient is 50 yo female employee of Medical Center who received dose of 2019-2020 Afluria influenza vaccine on Monday 21 Oct. That day she had significant discomfort, with fairly severe itchiness all over her body. She treated that with bendryl which provided some relief. That issue evolved to generalized achiness, which has persisted to today. She also developed mild redness and swelling at the vaccine site (L deltoid), which also evolved and worsened until it reached it's peak in redness and itchiness last night (20 Oct). At that time it was ~4 inches in diameter. This morning the localized swelling and redness were improved. She does have a mottled, diffuse rash at the vaccine site. Generalized symptoms were mild to resolved at time of exam, however, she believes this may be due to her use of Benadryl and ibuprofen.
The above patient was brought to the clinic with his siblings by the grandmother. She had a signed permission from the mother giving permission to vaccinate all the children. When asked about the age of the child the grandmother said he was 12. The date on the original form she filled out was incorrect. Unfortunately, he was given a vaccination. He is a large for his age child, at over 100 pds and over 5' tall.  Later when trying to enter his vaccines into database, it was discovered he was not of age. The mother was contacted, she said he had no side effects and no adverse reactions at all. She brought the boy back in three weeks later and INSISTED that we complete his vaccination series.
Lightheadedness, Dizziness, Low Hemoglobin, Low Red Blood Cells, labored breathing upon physical exertion, diarrhea, nosebleeds
Pt test positive for H-flu B meningitis, also devel endopthalmitis; Previously exhibited 4-5 days of flu-like sx; transferred from another hosp;
Others tell me second (expletive) they got had more side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The patients experienced side effects after 1st dose. Nurse stated others told second (expletive) they got had more side effects.  Consented to follow up via mail. No further details provided at the time of this chat interaction. This case is linked to the case US2020056774, reported for the 2nd dose. This case is linked to the case US2020056770, reported by the same reporter.
Swelling, discoloration, hot to the touch next day.  Treated with cold compress and children's tylenol
This spontaneous report as received from a Healthcare Worker (also was an Office manager) refers to an unknown number of patients of unknown age who may have received doses of RECOMBIVAX HB (start date, dose, route and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same source. It was linked to MARRS# 1308USA007105. Additional information has been requested.
Arm hurts; Feels numb/sleepy; Feels numb/sleepy; Sharp pain in her chest (That increases with arm movement); Hardness at injection site (for 2 days); Fever (for a day); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), HYPOAESTHESIA (Feels numb/sleepy), SOMNOLENCE (Feels numb/sleepy), CHEST PAIN (Sharp pain in her chest (That increases with arm movement)) and INJECTION SITE INDURATION (Hardness at injection site (for 2 days)) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR) and LISINOPRIL for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), HYPOAESTHESIA (Feels numb/sleepy), SOMNOLENCE (Feels numb/sleepy) and CHEST PAIN (Sharp pain in her chest (That increases with arm movement)). On an unknown date, the patient experienced INJECTION SITE INDURATION (Hardness at injection site (for 2 days)) and PYREXIA (Fever (for a day)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts), HYPOAESTHESIA (Feels numb/sleepy), SOMNOLENCE (Feels numb/sleepy) and CHEST PAIN (Sharp pain in her chest (That increases with arm movement)) outcome was unknown and INJECTION SITE INDURATION (Hardness at injection site (for 2 days)) and PYREXIA (Fever (for a day)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Numbness and tingling throughout right arm and fingers by 15 minutes post vaccination. By 45 min - 1 hour post vaccination there is numbness and tingling and sensation of limited blood flow down continuing in right arm, and right side of face, and neck and into right leg.  Right extremities are cooler to touch and there is diminished sensation with some right side weakness.  Slight head-ache observed. Capillary refill within 2 seconds, but noted to be sower than usual.  All symptoms continue to be observed up to current time of filing report and continuing to be monitored at home.
25 yrs ago an expired Hep A was given to a child and this was reported back then with no AE; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a child patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  On an unknown date in 1995 (reported as 25 years ago), the patient received a unspecified dose of suspect HIB (PRP/T) VACCINE (lot and expiry date unknown via an unknown route in the left deltoid for prophylactic vaccination. A product complaint with HIB (PRP/T) VACCINE. When the nurse attempted to extract the medicine from the vial, the medicine was not extracted. It had only occurred with one vial of HIB (PRP/T) VACCINE (lot no UJ359AA and expiry 21-Jul-2021). It was reported that 2 different nurses tried 2 different syringes and were still was not able to extract all the liquid from the HIB (PRP/T) VACCINE vial. There was still quite a bit liquid in this vial and it would not come out. It was reported that all the medication would not draw up and the nurses tried different needles and syringes. Some liquid came out but not enough to give dose. The nurses noted that the diluent vial was checked twice to make sure it was empty and all diluent was drawn out.  This happened last Friday (11-Dec-2020).   It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was 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
Began feeling bad on 11/11/2022. Began having fever up to 103 degrees for 4 days.Tested positive for COVID-19 on 11/14/2022. Had cough, congestion, runny nose, sore throat, and fatigue. Symptoms lasted 3 weeks with dry cough persisting 4 weeks. Took advil for fever,  vitamin C, and airborne supplement. Tested negative on 11/21/2022
New onset of dizziness lasting 1 day (approx.). Temp 101 - 102 degrees F. Dizziness reported significant could not walk comfortably. TYLENOL/Ibu to bring temp. down.
5 month old patient got tdap instead of dtap vaccine with no reported adverse event; Initial information received on 06-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 5 months old female patient who had 5 month old patient got tdap instead of dtap vaccine with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine (pneumococcal vaccine) for prophylactic vaccination; polio vaccine inact 3v (vero) (ipol [polio vaccine inact 3v (vero)]) for prophylactic vaccination; hib vaccine conj (tet tox) (acthib) for prophylactic vaccination; and rotavirus vaccine (rotavirus vaccine) for Prophylactic vaccination.  On 06-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6767AA via intramuscular route.  On 06-JAN-2022 the patient developed a non-serious 5 month old patient got tdap instead of dtap vaccine with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (5 month old patient got tdap instead of dtap vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 5 month old patient got tdap instead of dtap vaccine 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 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.
ith cold symptoms: cough, congestion, loss of taste. starting 12/31/21
pt stated that her face started swelling a couple of days after receiving the vax.  She also had redness in her face and chest when she got hot.  Pt states the swelling is going down but her face is still tight. Pt saw her PCP on 2/11 for normal annual check up and he advised her not to take the 2nd dose.
1 day post vax, pt woke up with swollen, painful knees.  Right knee was worse, stayed painful for 2 weeks and caused difficulty sleeping.  Slight pain is still present today.
Morning after 2d dose adverse effects - back pain; could not sit at work; severe back pain. Second morning extreme back pain - far worse than Friday- can barely move, cannot stand up straight, cannot walk and carry a cup of water at same time, extreme pain just sitting.
Immediately began bleeding, which ran down arm from injection site. Approximately 4 minutes later, back of entire arm that received injection was numb from underarm to pinky and ring finger; warm hives on front of both arms down to wrists; warm, rosy cheeks and cold hands/fingers; tickle in back of throat.  Benadryl given at clinic.   2.5 hours later, numbness in arm reduced to upper arm only; hives on arms have reduced; tickle in throat gone. Continues to have pain at site of injection.
Febrile Seizures on the evening following the vaccine. Taken to emergency room and stabilized. The patient has since recovered from the event.
Pt states he has pressure behind the tear by temple, has been feeling nauseas, and has tinging in arm.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. In October 2012, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml. The pharmacist reported that he might had given a patient a ZOSTAVAX shot that had some bubbles in it. No adverse experienced were reported. The outcome of the event was unknown. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
10/21: flu shot given. 10/22: localized mild soreness with mild inflammation and 3 hives near site. 10/23: seen in clinic for the above and it was noted as a localized reaction. 10/24: pt reports waking with itching to face and extremities with NO rash/SOB noted. Resolved.
BODY ACHE; SWEATING; SHIVERING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced body ache. On 23-MAR-2021, the subject experienced sweating. On 23-MAR-2021, the subject experienced shivering. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering, sweating, headache and body ache was not reported. This report was non-serious.
Pt was called on 3/31/21 She stated that she could not remember where her car was parked at the clinic when she got into car didn't remember where live  had to have her son come pick her up  next day sick flu like feeling with a swollen red /hives , had tongue swelling, she is normally a nice care giver, she feels the shot has done something that changed her from nice to mad really quickly Today she stated that her face swelled up and arm now has a blistered spot
Left arm deltoid area red and swollen, painful upon raising arm, 6mm circle around injection site (reaction began night after receiving vaccine). Ice pack applied. T98 DF, center MD prescribed Keflex 250 mg 2tab TID x 5 days and Benadryl 25 mg PO now then 50 MG 9 hs.