chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My wife and I got shots in February and both have Covid; My wife and I got shots in February and both have Covid; This is a spontaneous report from a contactable consumer (patient) reported same events for two patients. This is the first of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported, expiration date not provided) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said, his wife and he got shots in February and both have COVID on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021902573 Same reporter/drug/AE, different patient
Covid arm rash. Large area of red and itchy skin on arm of vaccine site. Also itchy red area on chin and around mouth. Started one week after receiving the vaccine. Also had swollen lymph glands in several places. Some joint pain for a few days
pt received covid19 vaccine on 1/21/21 (not sure if it was moderna or pfizer) and later that day started to feel lightheaded/head heaviness. two days later back/joints were hurting , feeling hot /chills. those symptoms improved but had ongoing lightheadedness and head heaviness.
I was driving and my eyes began to get very puffy and itchy. I pulled over at the gas station and took 2 BENADRYL and after seeing my face the employee suggested that I go to the hospital about 5 miles away. At that point my tongue was swelling quickly and was starting to notice trouble breathing. The amount of itchiness that onset was complete insanity. By the time I arrived at the hospital I was having an extremely hard time breathing and could not talk due to the swelling. I was given an IV of BENADRYL. 3 shots of Epinephrine over 30 minute intervals and I believe one other antihistamine. The symptoms subsided over about 2 hours.
Chills, fever up to 104.5, body aches, headache, disorientation, no appetite. Treatment was lots of fluids and waiting it out with medication.
No additional AE reported; Pharmacist reports an expired dose of sterile diluent [U035268 11/9/2022] was used to reconstitute VARIVAX [U030161 9/28/2023] and it was administered to a patient on 13DEC2022. Caller confirmed sterile diluent was not involved in a temperature excur; Pharmacist reports an expired dose of sterile diluent [U035268 11/9/2022] was used to reconstitute VARIVAX [U030161 9/28/2023]; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-DEC-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot# U030161 confirmed to be valid with expiration date 28-SEP-2023 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with an expired dose of sterile diluent, lot # U035268 confirmed to be valid with expiration date 09-NOV-2022 (exact dose was not reported) (expired product administered, product preparation error). The reporter confirmed that sterile diluent was not involved in a temperature excursion and was stored according to the recommended storage range until administration. There was no additional adverse event reported.
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
Last shot was on 3/17/21. Developed first symptom of shingles on 8/31/21. Diagnosed on 9/6/22
Sweating, chills, body aches, headache, muscle soreness of the right arm and my entire body, swollen neck, fatigue, chest pain due to very painful indigestion(was not moving around much after eating peanut butter) pain so severe it followed with vomiting. Unkown if related. It?s very rare for me to vomit.  Unable to get around well. Right knee pain which caused limping and not being about to walk at times. (Previous history of knee pain, but not for years). As of now I still have these symptoms besides chest pain and vomiting.
3/8/2021 - 9 hours after vaccine had severe chills for 4 hours, headache, nausea - stayed in bed for 1 day and then seemed fine. 3/16/2021 - late afternoon - developed swelling in left foot along with rash on both legs from the knee down to toes.  on 3/17, swelling on both feet with rash and swelling of left hand.
Patient noticed Red knot around injection site. Lasted for about 2 weeks, took Tylenol, had chills. Gradually, began to go away, left armpit was swollen, Hives up and down legs. On the way to appointment for AEs.
Anorexia; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Anorexia), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DECREASED APPETITE (Anorexia), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DECREASED APPETITE (Anorexia), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Varicella lesions began clustered around vaccination site and then became widespread.  Disseminated varicella several days following immunization.
Lightheaded and dizziness; Increased heart rate; Difficulty Breathing; . This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced dizziness, heart rate increased and difficulty breathing. On an unknown date, the outcome of the dizziness, heart rate increased and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, heart rate increased and difficulty breathing to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was reported. The patient reported that he received 1st dose of Shingrix on the other day. The patient reported difficulty breathing, increased heart rate, lightheaded and dizziness after receiving 1st dose of Shingrix. The reporter did not consented to follow up. No additional information provided.
Dizziness/vertigo - re-current to present. Has been treated w/ Prednisone. Headaches: start 4/2007, re-current, because intractable Oct 2007, daily. No analgesics work anymore. ELAVIL tried - no effect. Ataxia/paresthesia, Jan 2008, partial recovery.
Extreme fatigue that comes in waves, was having really stiff knees and my eye was twitching but after a few weeks that has stopped, periods have become almost non existent for the last 4 cycles
Sore arm and body aches after 1st dose.  ALL problems started shortly after 2nd dose: Cervical cord lesion C2 Hemangioma T6 vertebrae body Neurocardiogenic syncope worsened Decreased sensation of lower extremity Pain and numbness of left upper extremity Ataxia Difficulty in walking Thoracic spine pain Muscle spasm of back Syringomyelia in thoracic spinal cord T3-T9 Brain single focus of signal abnormality in the right occipital periventricular region Early demyelination plaque possible
no adverse events; VARIVAX was administered after improperly stored; This spontaneous report as received from a medical assistant refers to a 15 months old patient of unknown gender. On 23-SEP-2021, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T027303 exp date 12-AUG-2022) (route not reported) after improperly stored. The temperature of excursion was 6°F to 14°F (8.5F) for 0 hours 18 minutes and 0 seconds, 6°F to 14°F (11.9F) for 1 hour 0 minutes and 0 seconds. Cumulative timeframe 1 hour and 18 minutes. There was no previous temperature excursion.
This spontaneous report was received from a Nurse Practitioner via a company representative and refers to an adolescent female patient who was 15 or 16 years old. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was intramuscularly vaccinated with GARDASIL (dose, lot # and expiration date were not reported). On an unknown date, the patient developed orthostatic hypertension. There was no treatment given for the event. The outcome of orthostatic hypertension and the relatedness between the event and quadrivalent GARDASIL were not reported. Additional information has been requested.
Chills; tired; light headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (tired) and HEADACHE (light headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included lung. Concurrent medical conditions included Drug allergy (Nitrofurantonin), Drug allergy (Macbid), Drug allergy (Metronidazole), Drug allergy (Liptor), Drug allergy (Niacin) and Asthma. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), CETIRIZINE and MONTELUKAST for Allergy, FLUTICASONE PROPIONATE (FLOVENT) for Asthma, PRAVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021 at 11:31 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (light headache). 27-Feb-2021, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, CHILLS (Chills), FATIGUE (tired) and HEADACHE (light headache) had resolved.            This case was linked to MOD-2021-098562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up document attached on 3-JUN-2021 :  Race ,Allergies, medical history updated.
Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep for about an hour - we were not able to complete simple tasks and went to bed early.  My husband was up every half hour urinating from 6pm  until about 3am.  We both felt fine this morning but about 11am I got super dizzy and had to sit down, the dizziness caused vomiting and a sever headache.  I laid down for about an hour and feel a bit better but the headache has remained!!   Hopefully this too will pass in a few more hours!  Just thought you might want to know.  If it gets worse I will contact my doctor.   My husband has not had any other adverse reactions.
Broke out with varicella rash on trunk, arms, legs and face, 1 day ago.
Woke with arm pain, hot to touch, swollen, red and painful. Child exam by provider - put on antibiotic Augmentin 250/62.5mg 1 BID x 7 days
fever & rash reported 25NOV96 in MD file temp 100R;spoke w/parent 20FEB98 pt states went to MD next day 1NOV96;pt was covered w/but red rash-screaming-fever 102;
14 weeks pregnant. Patient fainted after vaccination. Person nearby stated also pt was convulsing before going unconscious. She was conscious after about a minute and was sweaty/nauseous. 911 was called and she was taken to the hospital .
Dizzy; runny nose; sore throat; headache; tired; weak; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included back pain and migraine. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and ascorbic acid (VITAMIN C), all taken for unspecified indications from unknown dates. The patient previously took codone and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. 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 11Apr2021 at 14:00, the patient experienced dizzy, runny nose, sore throat, headache, tired and felt weak. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizzy, runny nose, sore throat, headache, tired and felt weak were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received Janssen covid vaccine in April 2021. She presented to the ED with the one-day onset of fever, malaise, cough, and body ache on 12/26/21, and she was admitted to the hospital. She also found out her partner was tested positive for COVID. She was given IV steroids while hospitalized. She was hemodynamically stable, did not require supplemental oxygen, and was discharged home on 12/27/21.
This is in f/u to initial report sent on 8MAR95 MD reported administered 5 doses of vax & failed to seroconvert;f/u pt recv 2 doses of vax;given 3rd dose 11MAY94 & 14JUL94 anti-Hbs positive;WAES93041051 deleted from files
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 044A21A), on 15Apr2021 as dose 2, single (Lot number: 041B21A) and on 19Nov2021 as dose 3 (booster), single (Lot number: 020F21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TAMSULOSIN; FINASTERIDE; OMEPRAZOLE. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: strongly positive test. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.  Clinical information: Rebound of symptoms, congestion/throat/sick feeling/weakness/fatigue and a strongly positive test.
Patient came in for Shingles shot and reported it had been "years" since he had one but in reality he had received one on 11/12/2019 and again on 1/14/2020.
Information has been received from a physician assistant concerning a 61 year old female patient with codeine allergy, post menopausal, lipid and anxiety disorder who on 20-APR-2009 was vaccinated with PNEUMOVAX (Lot Number 662664/0981X) 0.5 mL IM on the right deltoid. Concomitant therapy included simvastatin, BUSPAR and ESTRATEST H.S. On 21-APR-2009, the patient had a very impressive local reaction that was the size of a baseball. The patient had a fever and myalgia. The patient had arm pain that was so severe, the patient could not lift the right arm. The patient was treated with prednisone. The patient improved within 24 to 48 hours after being on prednisone. The patient sought medical attention at office visit. The reporter felt the patient's pain in extremity, local reaction, myalgia, fever, and injected limb mobility decreased were disabling and other important medical events. This is a one of several reports received from the same source. The reporter requested that a lot check be performed on reported lot number. Additional information has been requested.
Persistent tinnitus symptoms started 4 days later in the morning of Monday, Sep 12, 2022 and have continued through the present date.
Developed sore throat, headache and vomiting. Tested COVID-19 positive on rapid antigen test 9/7/2022.
Half left arm was very red. (all around) after 3 days of vaccine redness-showed to my pharmacy on 3/11/16 she called doctor same day. Went to see my provider (given cephalexin 500 mg).
5:00 am following day awoke with bad headache. 8:00 am felt faint, sore muscles in arms and legs, (ADVIL) hurt to open eyes. Shot site slightly red. 10:30 am felt somewhat better, shot site swollen to (ice and heat to site) 3 inches, red and hot to touch. (We believe this was meningitis site, GARDASIL on other arm.)
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medication. On 23-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU, (incorrect product storage). Temperature was 6.7 F (Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer's mother concerning her 6 year old male patient with no pertinent medical history or drug reactions/allergies, who on 28-SEP-2010 was vaccinated with a dose of GARDASIL (Lot # not provided), instead of "flu shot". There was no concomitant medication. No adverse effect seen. The patient sought unspecified medical attention. Follow up information was received from physician indicated that the patient was given a dose of GARDASIL (Lot # not provided), instead of "flu shot" in error. No adverse effect was reported by parents. Follow up information has been received from a Registered Nurse concerning the student male patient with no illness at time of vaccination who on 28-SEP-2010 at 18:00 was vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL (Lot# 666163/0664Z). The nurse reported that the patient presented to office with family of four to receive influenza vaccine. 2 patient's sisters would be going to receive GARDASIL. GARDASIL was given to patient intramuscularly by mistake. No further information is available.
12/15/2020 I felt terrible with muscle aches, shivering, chills, fever was 102.8,I took tylenol and ibuprofen (alternated) 24 hours after initial fever I ceased meds and fever was still 101.5, this morning I was 98.6. The course of the fever was 36 hours total
Epistaxis; This is a spontaneous report from a contactable physician. This physician (Patients parent) reported for a 14-year-old male patient that:  A 14-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration on 22May2021 10:00Am (At the age of 14 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. On an unspecified date May2021 01:00 PM, the patient had experienced epistaxis. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in May2021, the event was recovered.  Follow-up attempts are completed. No further information is expected.
Felt like something was coming over me abd breathing got faster.  Got to car to wait  15 minutes and calmed down.  6 hours later right arm(got) shot started getting abd achy, felt worse  and very fatigued and low grade fever then just wanted to sleep, kept getting sorer and tiredness up to 3/18/2021 and just went to bed early hoping to feel better.  3/19/21 woke up soreness better and felt like myself with energy instead of like I had the flu.  When first got shot I noticed a discomfort to my right back side middle way and thought I might had turned wrong.  Everything was better on 3/19/21.
Initial case was received from a health care professional on 16 April 2012. This case contains information to describe the fetal death; information for the mother was captured in case number 2011-12525. A male fetus was exposed while in utero to ADACEL, lot number C3984AA. His mother was vaccinated on 22 December 2011 (weeks gestation was not reported). The mother's last menstrual period was on 04 November 2011. On 08 April 2012, the mother had a miscarriage which resulted in an early fetal death between 20-27 weeks gestation (exact weeks gestation not reported). The outcome was fatal. Documents held by sender: None.
10JUL92 c/o swelling red hardness to lt leg very fussy; afebrile; 14JUL92 leg still hard but much better-rx APAP;
Moderna COVID-19 01/22/2021: I noticed my arm was itching while at work on the afternoon of 01/22/21 (one week after receiving the injection). That evening, upon inspecting the area, I noticed a 4cmx7cm rash around the vaccine injection site. The rash was raised, red, and mildly pruritic. The erythema subsided a bit that evening, leaving a faint, flat rash that did not itch. 01/23/21-01/25/21: I experienced increased fatigue and a general feeling of malaise, but did not note any changes to the rash or injection site.  01/26/21: I woke to find the rash had increased in size (approx. 7cmx15cm) and had a distinct, darker red border. The border progressively became more pronounced and darker. The rash remained that way through the day.  01/27/2021: I woke to find the rash had resolved entirely and have not had any symptoms since.