chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 brief spells of rapid heart beat; Sore Arm; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 (Batch/Lot Number: EL8982), age at vaccination of 75-years-old, as single dose, for covid-19 immunisation.  Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination.  The patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jan2021 08:30 (Batch/Lot Number: EL3249), age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. The patient's concomitant medications were not reported.  The patient experienced 2 brief spells of rapid heart beat on 05Feb2021 (30 min of dose 2) and sore arm on 05Feb2021. No visit to emergency room nor physician office required. No treatment was given for the event heart rate increased. Vaccine facility type: health dept. The outcome of the event sore arm was unknown while the patient was recovered from the event heart rate increased on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Arm was sore. Went to sleep about 11pm woke up at 2 AM could not go back to sleep. Mind racing .  Body aches. Heart racing. Got up temp about 100.7 all day. Heart rate elevated. All lasted about 1 day. Except arm sore for about 5 days.
BURNING SENSATION IN ONE SPECIFIC SPOT IN LEFT ELBOW- ALSO HAD A SENSATION ON THE TOP OF LEFT FOR ARM INTO FINGERS ( NUMING SENSATION) BEGIN ABOUT 15-20 MINUTES AFTER FIRST SHOOT CONTINUED INTERMITTENTLY FOR THE NEXT FEW WEEKS. AFTER RECEIVING SECOND SHOT SAME EXACT SENSATION HAPPENED AND I CONTINUE TO HAVING BURING SENSATION IS SAME EXACT SPOT INTERMITTENTLY TODAY- MENTIONED THIS TO MY CHIROPRACTOR AND HE SAID TO REPORT THIS TO YOU AS HE FELT IT WAS A REACTION TO SHOT.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 injection via unknown route. Concomitant medications were not reported. On an unknown date, 7 days after onset of therapy, the patient experienced shingles without rash. The patient also had lot of pain. On an unknown date the patient died. The outcome of shingles without rash and lot of pain was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
I had high temperature from 101- 103 Thursday night and Friday and Saturday  for the duration of 3 days and on Sunday the temperature was  100 . I had chills, high heart rhythm and overall body pain, I had a SOB and had to go to the emergency room to get checked. I had Covid in March of 2020 and it was all the symptoms back.  I had to miss 2 days of work.
Next day when patient woke up there was a rash that went from scalp, neck, back and down right arm. Mother applied Benadryl cream and seen by Dr in clinic.
Diarrhea; a lot of pain in her arm; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (a lot of pain in her arm), NAUSEA (Nausea) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (a lot of pain in her arm), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (a lot of pain in her arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
child recv vax, father exp rt side face paralyzed;ER Dx Bells Palsy or poss Ramsay Hunt Synd;tx:steroids & Famvir;had rxn Famvir;lost hearing, ear pain;couldn't blink;speech affected;blisters of mouth allowed neuro MD  Dx Ramsay Hunt Synd. As of 5/10/00 Pt has contracted pneumonia, and gout and has experienced high blood pressure. He is presently under care of physician and has frequent use of artificial tears.
face drooping; Joint swelling; face swelling; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "face drooping"; JOINT SWELLING (non-serious), outcome "unknown", described as "Joint swelling"; SWELLING FACE (non-serious), outcome "unknown", described as "face swelling".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Facial paralysis,Joint Swelling, face oedema and the suspect drug BNT162B2   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot# K020675; expiration date 31-OCT-2016) (dose and route of administration were not reported). No adverse effects reported. There was not a product quality complaint involved. The lot# K020675 is not valid for VARIVAX. Additional information has been requested.
Pt rec'd her DTaP, MMR and VZV vaccines on 7/27/2008. She complained of pain the next day and her mother noted redness and swelling on the right thigh. Because of increasing size and because site was painful and warm, she was brought in 7/24/08.
Fever, chills, fatigue, nausea, near fainting, feeling of low blood pressure, all night of vaccination. Sept 20, 2013 at 3 pm 3 days of fatigue and nausea.
Tingling sensation to lips and sense of throat closure started approx 50 minutes after vaccine administration.  Returned to clinic area and received Benadryl 25 mg PO.  Vital signs: HR 66, BP 123/75, RR 14, 02 SAT 100%.  No visible signs of redness or swelling.
hair was coming out, lost all of her hair, bald; sore arm; passed out; tingling in face and hands; head was burning; A spontaneous report was received from a consumer concerning a 72-year-old ,female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events passed out(loss of consciousness), tingling in face and hands (paraesthesia), head was burning (burning sensation), hair was coming out, lost all of her hair(alopecia), and sore arm(pain in extremity).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021,immediately after the vaccination, the patient passed out, and when she woke up she had tingling on her face and hands, a sore arm, and head was burning. On 13 Feb 2021, the patient's hair was coming out and by 19 Feb 2021, she had  lost all of her hair. She was bald by the end of the week.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, loss of consciousness, paraesthesia, burning sensation, alopecia and pain in extremity were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
welts; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (welts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (itching). On 23-Jan-2021, the patient experienced URTICARIA (welts). At the time of the report, PRURITUS (itching) and URTICARIA (welts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I contracted COVID-19 with symptoms of mild congestion. I was prescribed Paxlovid on the evening of 06/13/2022. I began having diarrhea after I began taking the Paxlovid. I was told by pharmacy I could take Imodium for my Paxlovid side effects, but my doctor instructed me not discontinue taking Imodium due to the risk of heart failure when paired with Paxlovid. My congestion resolved after 5 days. Once I finished Paxlovid on 06/18/2022, but on 06/19/2022 my symptoms returned and I developed new symptoms. I had symptoms of congestion, cough, and  low grade temp. I had to use my Ventolin Inhaler regularly due to this, Tylenol, and take Benzonatate for cough. I was ill for an additional 5 days before the symptoms began to resolve. The congestion returned again on 07/03/2022 and it resolved in 4 days.
This spontaneous report was received from a health care worker refers to a male patient of unknown age. The patient was vaccinated with the first dose of VAQTA 50/1.0 U/ML (dose, route and lot not reported) on 02-OCT-2009 and the second dose of VAQTA on 24-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. The outcome of the event reported is unknown. The event reported was not related to VAQTA. Additional information is not expected.
Burning sensation; Hives appeared on back of legs, on back or torso, on hands and feet; Itchiness and itching sensation; This is a spontaneous report from a contactable consumer, the patient. A 24-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER-8733) via an unspecified route of administration in the left arm on 03Apr2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included low blood pressure, polycystic ovarian syndrome and graves disease. The patient had known allergies to cefzil (MANUFACTURER UNKNOWN). Concomitant medications included pindolol (MANUFACTURER UNKNOWN) and thiamazole (METHIMAZOLE) from unknown dates, for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, 5 hours post vaccine i.e., at 20:45 the patient experienced first itchiness at scalp, then on 03Apr2021, at 21:30 the patient experienced hives appeared on back of legs, on back or torso and on hands, feet and were creating a mixed burning and itching sensation. Events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included benadryl as a treatment for the events. The clinical outcome of the events itchiness, hives and burning sensation was not recovered.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVENAR 13 on an unknown date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced back pain. Clinical outcome of the adverse event was unknown at time of this report. The information on the lot number has been requested.
This child had an 8 cm firm, red, hot area at the site of injection. The thigh was very swollen and tight, with red streaks extending toward the knee. Recommended MD visit. No fever, no pain or soreness.
he noticed that the infection came/tooth infection; This is a spontaneous report from a non-contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included tooth infection from an unknown date to an unknown date (prescribed with antibiotics for it). The patient's concomitant medications were not reported. The patient noticed that the tooth infection came back on an unspecified date after 1st dose of BNT162B2 . Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 8MAY94 & devel fever 104 evening of 8MAY97;pt was seen 9MAY97 by MD;UA & CBC obtained & were both nl;clinical exam ok;
Arm pain (moderate, resolved within 24 hours.) Dizziness (mild, resolved within 24 hours.) Fatigue (severe, resolved within 48 hours.) Exacerbation of GERD and nausea (mild, began 72 hours post vaccination, resolved within 5 days of vaccination.) Low grade fever (mild, 2 degrees F above normal basal body temperature for patient, or less - began within 12 hours of vaccination, resolved within 72 hours.) Somnolence (moderate, excessive sleepiness e.g. 3 or 4 hours beyond normal 8 hour sleep requirement daily - began 4 days post-vaccination and resolved within 1 week of vaccination.) Both myself and the older relative who was vaccinated with me (report submitted for them as well, same email address) We still plan to receive our second dose on June 11th and are not concerned by these effects. We will report any additional effects with the second dose as well, in hopes that they are useful data.
COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
fever; Chills; arm sore at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (arm sore at the shot site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (arm sore at the shot site). At the time of the report, PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (arm sore at the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a patient who on approximately 28-APR-2006 was vaccinated with a dose of Varivax. On approximately 29-APR-2006, 24 hours after vaccination, the patient developed chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (fever and lethargy after receiving 1st dose in March 2018, refer case US2018175513). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, lethargy and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, lethargy and pain were not recovered/not resolved. It was unknown if the reporter considered the chills, lethargy and pain to be related to SHINGRIX. Additional details were provided as follows: Approximately 3 to 4 weeks before the reporting date at around 1:00 pm, the patient received the 2nd dose. The patient again experienced the same symptoms as experienced after 1st dose.
Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Pt recvd vax 10NOV92 & devel a three inch swelling @ the inject site around upper rt arm; no further details were provided;
Tired and sore muscles in general; Tired and sore muscles in general; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 11:00 (Lot number: EL3247) at the age of 53 years as dose 1, single and administered in arm right, administration date 31Mar2021 10:30 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "History of babesiosis" (unspecified if ongoing); "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis, start date: 1995 (ongoing). The following information was reported: FATIGUE (non-serious), MYALGIA (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "Tired and sore muscles in general". Therapeutic measures were not taken as a result of fatigue, myalgia. Additional information: The patient became first became aware of feeling tired and having sore muscles on days 11Mar2021 (first dose was on 10Mar2021) and again on 01Apr2021 (second dose on 31Mar2021). The patient was tired and had sore muscles in general, these were also experienced after the 1st and 2nd doses in March but not as severe as after the booster in November. The events happened the next day, day after each dose - mild. Vaccine facility type was Pharmacy or Drug store. The patient did not have any prior vaccinations (within 4 weeks). The patient did not have any relevant test or specific relevant test for thromboembolic events with Thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
15May91 Fever 103.7 (A) irritable-however, pt also noted to have otitis media-child treated /w antibiotic Ceclor-followed by ofc visit 16May91-T.99.8 (A) condition improved.
Received DTAP, MMR and IPV on 3/5/02; pt tolerated well initially. Mom was sleeping with child. She awoke at 06:00 on 3/7/02 and child was convulsing. Eyes rolled back and was foaming at the mouth. Called 911. Convulsions lasted about 1 1/2 minutes. Child was unresponsive about 40-45 minutes. She was taken by EMS to the hospital and gradually awakened. Mom reports she is fine today.
Tenivac that expired yesterday, was given today with no reported adverse event; Initial information received on 23-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that expired yesterday, was given today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) for Immunisation.  On 23-Jan-2023, the patient received ).5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation was unknown, lot U6922AA and expiry date: 22-Jan-2023) via intramuscular route in the right arm for Immunization.  On 23-Jan-2023 the patient developed a non-serious event of tenivac that expired yesterday, was given today with no reported adverse event (expired product administered) (Latency: same day) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  It was not reported if the patient received a corrective treatment for the event .  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient administered incorrect vaccine. Patient given Pfizer bivalent versus Moderna bivalent booster. No adverse effects or response noted. Patient remained alert and responsive after administration.
pt recv vax; lab test showed hep B surface antibody 41.7;pt had dog bite in aug92 & devel severe cellulitis,hep B test showed hep B surface antibody 24,12,6 on 4jun93,12jul94 and 10jul95 successively;