chrisvoncsefalvay/vaers-outcomes huggingface dataset:
does not feel good; sick to stomach; feels very cold; cannot eat; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AB21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, LOSARTAN, APIXABAN (ELIQUIS) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 99 to 101 (Inconclusive) temperature 99F to 101F..     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.
This case was reported by a physician via a sales representative and described the occurrence of itching in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMR vaccine (non-gsk) and VARIVAX (non-gsk). Concurrent medical conditions included asthma. On 19 February 2009 the subject received unspecified dose of KINRIX (unknown), unspecified dose of MMR vaccine (Non-GSK) and unspecified dose of VARIVAX. On 19 February 2009, approximately 5 minutes after vaccination with KINRIX, MMR vaccine (Non-GSK) and VARIVAX, the subject experienced itching, congestion (unknown) and wheezing). The subject was treated with BENADRYL, SOLUMEDROL and EPINEPHRINE. The subject was admitted to the hospital overnight for observation. At the time of reporting the outcome of the events was unspecified.
This spontaneous report as received fro a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reaction were reported. On 20-OCT-2015 04:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.3 and -2.1 (14hours and 47 mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
slight skin sensitivity; Injection arm became very sore; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EL3247) via unspecified route of administration, in left arm on 19Feb2021 14:45 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization in other facility. The patient medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via unspecified route of administration, in left arm on 29Jan2021 02:45 PM (at the age of 23-years-old) as a dose 1, single for covid-19 immunization in other facility. Patient did not have any known allergies. Patient did not have any other vaccine in four weeks and no other medications in two weeks. Patient not had COVID prior to vaccination and was not tested for COVID post vaccination. On 19Feb2021 22:00 the patient experienced injection arm became very sore. On 20Feb2021 the patient experienced slight skin sensitivity. The patient did not receive any treatment for the reported events. Outcome of all the reported events was recovering.  No follow up attempts are possible. No further information is expected.
Raised red rash  with itching on waist line, torso and arms. Mother states talked with PMD and was told reaction to vaccine. Was advised to give Benadryl by PMD.
her arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the left arm on an unspecified date (at the age of 63-years-old) as first dose, single dose for COVID-19 immunization. Medical history included pain in the arm (from the Allergy shots) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously took allergy shot and experienced pain in the arm. It was reported that the patient gets them every 5 weeks and she has been getting them for 30 years. She has had no problems and she has no idea what they gave her. On an unspecified date, after the 1st vaccine, the patient experienced arm hurt at the injection site. It was reported that the reporter knew your arm hurts for 2-3 days after shot because of the allergy shots she got. The outcome of the event was recovered on an unspecified date (reported to be done in the first 24 hours or believes so). The patient was vaccinated with the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Feb2021.  Information on the lot/batch number has been requested.
Patient received first dose of Moderna vaccine, complained of light headedness, fast heart rate, chills and sweating  and ended up passing out and falling. 911 was called. This lasted about 20 minutes after which the patient felt better and was discharged.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 13Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 301258A) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE; SYNTHROID, start date: Feb2022; EMERGEN C, start date: 03Apr2022, stop date: 11Apr2022; TYLENOL, start date: 04Apr2022, stop date: 11Apr2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 06Apr2022 at 10:00, outcome "recovered" (11Apr2022) and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Received other medications in 2 weeks. There were known allergies.  No follow-up attempts are possible. No further information is expected.
fainted as I was walking to my daughters room; I cannot move around quickly without getting dizzy.; I cannot move around quickly without getting dizzy.; woke up in the middle of the night in a terrible sweat; headache; Felt a massive migraine; I later felt numbness in both of my calves down to my toes; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Jul2021 (Batch/Lot number was not reported) (at the age of 31 years old) as single dose for Covid-19 immunisation. No other medical history reported. Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medications were reported as none. The patient received the first dose on 29Jul2021. She felt a massive migraine on 30Jul2021. She later felt numbness in both of her calves down to her toes. On 31Jul2021, she still had a migraine and then she woke up in the middle of the night in a terrible sweat worst she'd ever experienced. The patient then woke up on 01Aug2021 and fainted as she was walking to her daughter's room. On 01Aug2021, she cannot move around quickly without getting dizzy. She still has calf numbness and a headache which started on 30Jul2021. The patient did not receive any treatment for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent Covid-19 test nasal swab: negative on 02Aug2021. Outcome of the events was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Injection site was sensitive to touch; Light to moderate light-headednessafter the vaccine; Arrived home, laid down semi upright, and slept for 5 hour and sleeping for extended long periods of time; Ongoing fatigue; Small rash at the vaccine site; This is a spontaneous report received from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in right arm on 12Mar2021 at 09:00 (at the age of 56 years), as a single dose for COVID-19 immunisation. The patient medical history included type1 diabetes, rheumatoid arthritis and psoriatic arthritis since unknown dates. The patient was allergic to penicillin. The patient received secukinumab (COSENTYX) for an unknown indication and from unknown start date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 09:30 after the vaccine, the patient experienced light to moderate light-headedness. He arrived home, laid down semi-upright, and slept for 5 hours. On days 2 (13Mar2021), the injection site was sensitive to touch. The patient developed a small rash at the vaccine site, had fatigue and was sleeping for extended long periods of time on unknown dates in Mar2021. Patient did not received any treatment for the events. The clinical outcome of events injection site was sensitive to touch, light to moderate light-headedness, small rash at the vaccine site, fatigue and sleeping for extended long periods of time were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
The pt experienced a rash that started the morning of the visit. The pt had approximately 30 chicken pox lesions. No fever was noted.
running a 103 fever all over; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves an unknown demographic patient who had running 103 fever and all over  (pyrexia)/ it was a reaction of the INFLUENZA VACCINE which the patient received.  Medical history, concomitant conditions, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had running 103 fever and all over  (pyrexia)few hours following the administration of INFLUENZA VACCINE.went to the doctor the next day was told it was a reaction of the shot.  Reporter reported that not had one since, nor the flu.   Other relevant laboratories details not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Large area of swelling (approx 2in x 2in) and pain, redness.
LEFT SHOULDER BLADE PAIN, WEAKNESS IN THE LEGS SO PATIENT SOUGHT ER TX.
Information has been received from a registered nurse concerning a female pt between the age of 25 and 32 years old who on 8/5/99 was vaccinated with the second dose of Hep B. On 8/11/99, the pt experienced headache with nausea and low grade fever. Subsequently, the pt recovered from the episodes. It was indicated that the pt did not develop any adverse event following vaccination with the first dose of the vaccine. Two additional pt's were reported with similar symptoms following vaccination with second dose of Hep B.  No further information is available.
pt c/o sore throat, ear ache, cough, chills & weakness; there was no local soreness @ site; 24OCT91 pt seen in hosp ER Dr dx URI, pharyngitis & sore throat;
I received the Moderna Bivalent booster for COVID-19 on 9/12/2022. On 11/26/2022, I woke up coughing and had nasal congestion, and I had trouble breathing. The symptoms got progressively worse throughout the day. At one point, I had a fever of 100.9. I had difficulty breathing while I slept on account of the congestion and cough, and I had to sit up rather than lie down to get some sleep. I took an ALEVE for my temperature and BENADRYL for the other symptoms; they helped a little. The ALEVE was especially helpful since it got rid of my headache. On 11/27/2022, my fever was a little higher, plus my cough was worse and I had chills. I took some ALEVE and BENADRYL, which helped just a little. On the morning of 11/28/2022, I went to an urgent care clinic and underwent a rapid test for COVID-19, which yielded a positive result. I was prescribed molnupiravir, plus cefdinir, which I was to take in case I developed pneumonia. I started taking the molnupiravir that day. On 11/29/2022, I felt a little bit better. My temperature was down a little, my voice was less hoarse, and the coughing was less frequent and less intense. Ever since then, I have progressively gotten better, though at the time of this writing, I still have an annoying cough. On a happier note, though, my temperature is now in the normal range.
Having periods of memory loss at school today. Informed dad to take her to ER or doctor.
pain in the right shoulder, which gravitated to the elbow, forearm and hand, the opposite side of the vaccine site; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 87 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2021 (Lot number: EN6201) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "known allergies: food - uncooked fish roe" (unspecified if ongoing), notes: known allergies: food - uncooked fish roe. Concomitant medication(s) included: AMIODARONE; BYSTOLIC; EDARBI. The following information was reported: PAIN (non-serious) with onset 07Mar2021, outcome "recovering", described as "pain in the right shoulder, which gravitated to the elbow, forearm and hand, the opposite side of the vaccine site". Therapeutic measures were taken as a result of pain.  Additional information: The patient did not receive any other vaccine in four weeks. Covid prior vaccination and covid tested post vaccination was reported as no. Happened during the third week after the first Pfizer shot was administered on 10Feb. It started as a pain in the right shoulder, which gravitated to the elbow, forearm and hand, the opposite side of the vaccine site. The pain got worse after the second vaccine shot on 10Mar. Covid vaccine details: [{Product= COVID 19, Brand= Pfizer, Lot number=EN6206, Lot unknown= False, Administration date= 10Mar2021, Administration time= 10:30 AM, Vaccine location= Left arm}]. Ae treatment: tylenol and ibuprofen.   No follow-up attempts are possible. No further information is expected.
LOW PLATELET COUNT; STOMACH ACHE; STARTED FEELING BAD; POSSIBLE COVID-19 VACCINE REACTION; THIS REACTION ATTACKED HER LIVER; FELT WEIRD; This spontaneous report received from a patient concerned a 47 year old female race and unknown ethnicity.. The patient's height, and weight were not reported. The patient's past condition included: hepatitis c. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: Unknown) dose was not reported, 1 total, administered in right arm on 14-OCT-2021 for prophylactic vaccination. Concomitant medications included lactulose, lorazepam, omeprazole, sucralfate and folic acid.  On 14-OCT-2021, the same day of vaccination patient felt weird. The next day on 15-OCT-2021 patient started feeling bad and experienced stomach pain. On 15-OCT-2021, patient was admitted to hospital and was hospitalized for 6 days. Laboratory data included: Platelet count (NR: not provided) 75. Patient was discharged on 20-OCT-2021 with a diagnosis of low platelet count and this reaction attacked her liver. Patient's discharge summary states that this could be a possible Covid-19 vaccine reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and the outcome of stomach ache, felt weird, started feeling bad, possible covid-19 vaccine reaction and this reaction attacked her liver was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211107885-JANSSEN COVID-19 VACCINE Ad26.COV2.S.- low platelet count, stomach ache, started feeling bad, possible covid-19 vaccine reaction ,this reaction attacked her liver -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Then a week after my second shot, I had severe nausea.; This is a spontaneous report received from a contactable consumer (patient) via medical information team.   A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization and the patient had had no side effects after first dose. On an unknown date, the patient experienced severe nausea. The patient reported that He got the 1st dose of the Pfizer COVID vaccine, and had no side effects. Then a week after my second shot, patient had severe nausea. The patient asked how long will this last. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of limbs stiffness in a 60-year-old female patient who received SHINGRIX (batch number M224F, expiry date 8th February 2021) for prophylaxis. On 1st August 2018, the patient received SHINGRIX. On 1st August 2018, immediately after receiving SHINGRIX, the patient experienced limbs stiffness, shoulder pain, injected limb mobility decreased and wrong route of administration. The patient was treated with ibuprofen and medication unknown (Ice Pack (Nos)). On 15th August 2018, the outcome of the limbs stiffness was recovered/resolved. On 16th August 2018, the outcome of the shoulder pain was recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased and wrong route of administration were unknown. It was unknown if the reporter considered the limbs stiffness, shoulder pain and injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The patient experienced significant pain after injection, and difficulty in moving her arm. This required evaluation in urgent care. The patient received SHINGRIX approximately 2 inches above the recommended site in the deltoid, which led to wrong route of administration. The healthcare professional uncertain where the vaccine was actually administered. If it reached the muscle, in the joint, tendon.
Anxiety Narrative: 22/28/21 at 1045 BP 143/83 P. 80 C/O dizziness, Dry throat, anxiety 2/28/21 at 1100 BP 138/80, PL 62 2/28/21 at 1120 BP 135/78 P. 62 patient given water. Reported he felt better once he was outside in fresh air.
Pfizer-BioNTech COVID-19 Vaccine EUA.    Swollen lymph gland at base of neck, left side.   Day after 2nd shot, collar bone was sore and a lump had developed where collar bone meets neck.  Quite swollen lymph node.  It has been two weeks since 2nd shot and swollen gland has not changed.  Still swollen.
symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart palpitation; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, allergies, early bone loss, allergy to penicillin, latex, lactose and sugar; all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and unspecified allergy medications. The patient previously took codeine and experienced allergies. The patient had no other vaccine in four weeks prior to vaccination. It was unknown if the patient had COVID prior to vaccination. On 23Mar2021, the patient experienced heart pain, severe fatigue, pain in head, heart palpitation and brain fog. The patient described the events as having "long hauler" symptoms since 23Oct2020. The symptoms were intensified by first COVID vaccine. Four days after the first shot, the patient had severe fatigue, heart palpitation, heart pain, pain in head through out day which comes and goes and brain fog. The symptoms intensified and remained for 18 days after first shot. The patient had the second shot on 09Apr2021 on the left arm (lot number was unknown) and had no head pain for the first time since last Oct2020. The patient was not COVID tested post vaccination. The patient had a visit to a doctor or other healthcare professional office/clinic. There were no treatment given. The patient recovered with lasting effects on an unspecified date.   Information on the lot/batch number has been requested.
Pentacel vaccine was given she woke up the next day with a hot and raised knot in her arm the redness covered her entire shoulder.