chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/20/21-This patient has tested Covid positive but has had illness w/in 90 days: Current positive Covid testing date:10/19/21 Previous positive Covid testing w/ illness date: 2 weeks ago at a fast track.  Testing today to "see if it had gone away".  COVID Follow-up 10/25/21- Started on 10/7/2021 Fever, sinus congestion, cough, loss of taste and smell, headache, body aches, diarrhea, fatigue  She is fully vaccinated She was seen on 10/9/2021 and was tested positive for COVID Patient received Regeneron infusion on 10/11/2021 She is feeling a little better Cough has improved Fever, headache, diarrhea have resolved  Still very fatigue, loss of taste and smell Joint pain, mostly isolated to her hips, knees, and low back History of bilateral hip replacement  Walking/movement/stagnent positions make it worse  She has tried Mobic, Tylenol, and warm showers for her pain without significant improvement Denies any chest pain, shortness of breath
NOT ABLE TO SLEEP ALL NIGHT; FELT LIKE RUN OVER BY A TRUCK; TEMPERATURE, BURNING UP; BAD HEADACHE; This spontaneous report received from a parent concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, ulcer, non smoker, and non alcohol, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug use and have no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced felt like run over by a truck. On AUG-2021, the patient experienced temperature, burning up. On AUG-2021, the patient experienced bad headache. On 25-AUG-2021, the patient experienced not able to sleep all night. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine was not applicable. The outcome of the not able to sleep all night, temperature, burning up, bad headache and felt like run over by a truck was not reported. This report was non-serious.
Aches and chills for 3 days, intense rash at injection site and arm, and thorax, neck.
nausea, h/a, sore itchy arm since recv vax APAP & ice to arm w/full recovery aside from arm soreness on 27OCT96;
Hot/cold; Body aches; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Apr2021 at 09:00, the patient experienced headache, body aches, hot/cold, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, hot/cold, fatigue was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 hours after vaccination sore upper arm at injection site,   13-18 hours after vaccination, chills
No other adverse events reported; Expired PROQUAD was administered to patient today; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 10-MAR-2022 (also reported as today), the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, lot # T030760, expiration date on 08-MAR-2022, for prophylaxis (strength, route of administration and anatomical location were not reported) (expired product administered). No other adverse events were reported (no adverse event). Additionally, it was reported that dose was properly stored up through time of administration.        This was one of several reports received from the same reporter.
I received the injection at approximately 3:20pm.  Sometime during the night I experienced urticaria and  hives/welts on my throat-neck.   They were only mildly annoying and except for scratching during the night I didn't do anything.  The bumps and intermittent itching continued and as of 4 days later, the symptoms have slowly decreased.  I did take Benadryl 50 I currently mg during the second night. The bumps and itching went from the my throat to my chin and upper lip at times.  I currently have mild symptoms.  I have asked two physicians regarding what I should do concerning the second dose and both said they were uncertain, but I should get the second dose, take a antihistamine, and alert the provider.
Information has been received from a medical assistant concerning a 2 month old female with relevant medical history or past drug history reported as none who on 16-MAR-2009 was vaccinated with a single dose of ROTATEQ (lot # 662825/1168X) orally.  There was no concomitant medication.  On 16-MAR-2009 the patient was in for a well baby appointment.  That night after getting the ROTATEQ she had diarrhea.  It was unknown if there was any relevant laboratory data.  As of 11-SEP-2009 she had not had any more doses of the ROTATEQ due to her mother's refusal, and she recovered from the diarrhea on an unknown date.  Additional information has been requested.
8 hour later sudden onset fever 103, vomiting, diarrhea, myalgia, lasting 4 days.
Patient returned to receive her second injection for COVID vaccine. as stated in first report Dad identified patient as his daughter with interpreter inadvertently was give the Moderna vaccine requested by the dad. According to the dad with interpreter assistance she had no adverse reaction. Dad stated with the assistance of (interpreter)  the only thing she complained of was a sore arm.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAR-2013 the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 18.50 (also reported a 11 hours -1 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Patient cried continuously, then stopped crying, stopped breathing and stiffened up entire body and seemed to be having a seizure for approximately 30 seconds to 1 minute. Patient then went completely limp. Patient's father then called 911 and the EMT airlifted patient to ER. He was sent to the PICU for 4 days and had various tests done. He had a CT scan & MRI that showed he had brain swelling and a bleed. A retinal test came back negative for retina hemorrhage. A spinal tap test initially came back positive for enterovirus, but a day and a half later the Dr.'s came back to tell us that the lab test was cross contaminated and he did not have the virus. Patient also had a skeletal survey that came back fine, no broken bones, fractures or anything. He was also given an EEG. Patient has been put on phenobarbital and he now has follow up appointments with a hematologist, a neurosurgeon and a neurologist. He seems currently to have recovered completely.
Seen by MD dx w/chickenpox;w/macular, papular rash (scattered lesions), fever & h/a;lesions total 1-2 dozen on scalp, arms, legs, back, forehead; on call MD saw 10/26/99 w/dx shingles-burning, pins & needles;pain rt chest;itching;T99.7
Very itchy red skin rash all over back, abdomen, arms, upper legs, for two weeks.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; vials that were put in the fridge and after that refrozen and thawed again; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given day before the day of report from vials that were put in the fridge and after that refrozen and thawed again, lot number unknown to the HCP.  No treatment medication was provided by reporter.  This case contains information for the 14th of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
Vaccines 3/5/12. Diarrhea began that pm with loose, mucus, bloody stools. Today 3/9/12 green, mucus, stools, Heme (+).
Possible vaccine failure. Child expired with Flu A cultured. 5/20/09-autopsy report received-COD-cardiopulmonary arrest. Due to: systemic infection with influenza type A/H1. Sudden onset of muscle and leg cramps on 2/14/09, URI symptoms last day or so including sore throat. Suddenly developed tachypnea fever and diaphoresis within 20n minutes of onset of leg cramps. In ED fever of 107, tachycardia and dyspnea, developed flutter then bradycardia. Intubated, v-tach, coded and expired.
Patient complained of dizziness and headache after second Pfizer dose. Patient was monitored and discharged to home.
Initial report received from a healthcare professional on 4 October 2013. A 70 year old female received FLUZONE HD (Lot # U4781AA, expiration date unknown) intramuscularly at left deltoid on 02-Oct-2013. After vaccination, on 04-Oct-2013 (onset of reaction not reported) he experienced severe flu like symptoms and a nodule formed at the injection site and it was red and swollen. The patient did not recover from the events. Documents held by sender: none.
persistent left arm pain Tdap administration into deltoid muscle. had difficulty lifting arm and rest pain for about a month. now has persistent pain with movement. no neurologic deficits. no previous adverse reaction to vaccine. no allergies. vaccine administered at pharmacy by pharmacist.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. No vaccines data and no patient data were provided. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and developed shingles. The reporter consented to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
5 mins p/inject pt had syncopal episode; had 5-10 sec period of not responding to verbal stimuli; revived w/Amonia salts; P92, BP 102/64; no further syncopal episodes juice given;
pt called the office on 6/12/19 to say the day after receiving the MMR vaccine she woke up with  totally blurred vision in her left eye.  Pt was seen by the eye doctor the following week and found to have decreased visual acuity even with glasses and vein occlusion in the retina.  She was given a growth hormone injection in the eye to stop any further oozing and sent for bloodwork (completed ion 6/4/19)by her PCP.  She was noted to have an elevation in her autoimmune antibodies.  She has followup in one week with her eye doctor to see if another injection in the eye is needed and will f/u with her PCP for the elevated autoimmune antibodies.
heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); more and more palpitations; it was getting progressively worse after every vaccine; My blood pressure is all over the place; Fluctuating heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe immune deficiency" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: patient already had heart issues before vaccinations; "Palpitations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations; it was getting progressively worse after every vaccine"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "Before I had any of the vaccine I already had heart issues. After I had the vaccine and the boosters I have had more and more palpitations. I have been having a lot of PVC's. My blood pressure is all over the place. I have Fluctuating heart rate. All of that is because of all the vaccines. I noticed it was getting progressively worse after every vaccine. It has gotten better the longer I haven't taken a vaccine. My last vaccine was in September 2022 and it has improved while not having any more vaccines". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose (dose 4);
COVID vaccine breakthrough event  Dose 1 was on  2/1/21 EL9265 Dose 2 was on 2/22/21 EL9267
This spontaneous report as received from a nurse via vender refers to 2 patients of unknown age and gender. On 04-DEC-2014 the patients were vaccinated with improperly stored PNEUMOVAX23 (dose, route of administration and lot # were not provided). PNEUMOVAX23 was found to be supported with in-house stability data. No adverse symptoms reported.   Follow up information was received from a nurse and refers to 67 year old male patient. On 04 DEC 2014 the patient was vaccinated with improperly stored PNEUMOVAX23 dose and route of administration were not provided (lot # K008410, expiration date: 26-FEB-2016). The nurse reported that no adverse event have been reported since the time of the vaccination and there was no need for revaccination. No additional information was available at the time of the call. This is one of several reports from the same source. Additional information has been requested.
The pt experienced rapid swelling and erythema over most of the upper arm. This occurred 16 to 18 hours post vax and persisted 72 hours.
Rash on body not near vaccination site. Bad on back, light on stomach.  Headache  Injection arm soreness
Fever inc 105; "Drowsy but could be aroused". Fever subsided 48 hrs p/vax; Child then ill w/URI; Not seen by hlth provider; Tel consults w/PHN
Patient called 10-21-10 stating that about 4 hours after vaccination she developed a bad headache, achiness in her back and chills. Was instructed to use TYLENOL for symptoms & return if not improving. Developed a rash on 10/21/2010. Saw doctor on 11/3/2010. Diagnosed with vesicular rash of unknown etiology. Prednisone 20mg prescribed & OTC BENADRYL 50mg at hs.
administration of expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Oct-2021 and was forwarded to Moderna on 07-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345445, MOD-2021-345460, MOD-2021-345565, MOD-2021-345619, MOD-2021-345620, MOD-2021-345666, MOD-2021-345456, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received contains significant Information as batch and expiration date of the suspect product.
15 minutes after vaccine, c/o scratchy throat. RN on site gave benadryl 25mg. BP 134/84, o2sat 98, pulse 90. Lungs clear, no wheezing. No hives. Monitored an hour and 15 minutes. No change in throat, no difficulty swallowing. Released to home, instructed if change in symptoms or develops hives or respiratory symptoms to call 911.
Very loud pulsating tinnitus in my right ear which started 5 days after vaccine; Feeling dizzy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in left arm on 05Apr2021 at 14:30 (at the age of 48 years-old) as single dose for COVID-19 immunisation. Medical history included diabetes type 2. The patient reported that she was not aware of any known allergies to medications food or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN) and doxylamine succinate (UNISOM). Prior to vaccination, it was unknown if the patient was 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 4 weeks prior to the COVID-19 vaccine. On 09Apr2021 at 14:00, the patient reported that she had started to feel dizzy. On 10Apr2021, the patient experienced a very loud pulsating tinnitus in right ear which started 5 days after the vaccine. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event pulsating tinnitus in right ear which started 5 days after the vaccine and felt dizzy were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Tachycardia persisting now for 18 hours. Pulse has been no lower than 110 and as high as 152 checked on auto blood pressure cuff and manually.   Tachycardia has continued, even at rest.
Patient was given oral vaccine of ROTATEQ. Within 10 minutes patient developed oral blister lesion on (Rt) side cheek/lower lip. Vital signs of patient were stable.
Mother said during the first overnight visit with dad pt's eyes rolled in the back of the head and pt. started seizing. Mother thinks it's due to pt. having a fever, however doesn't think that it is vaccine related. Mother thinks the event was hoax made up by the pt. father.
Approx. 10-15 minutes, post vax, the pt complained of itching all over her body. Her left ear was read. Treated with Epinephrine 0.3cc, SC, followed with Benadryl 50mg. Her BP was 118/72. After 5 minutes, the pt states itching was less but weak. Referred to MD. Taken per employer.