chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received smallpox vaccine on 31 Jul 07. 4 days later he had dull pain in his chest. Pt went to the ER and was released. The pain got progressively worse and the patient returned to the ER. The ER physician diagnosed him with myocarditis and prescribed meds to reduce the swelling.  10/22/2007 Records received for 2 ER visits 8/8/2007 and 8/22/2007 both for c/o chest pain. This pain is worst lying down and feels like L sided pressure. Increased with inspiration. (+) fevers up to 101'F. PE (+) for chest wall tenderness. DX: 8/8/07 Chest Pain.  DX: 8/22/07 Atypical Chest pain. 12/03/2007 MR received from military which includes chronological record and case summary by VHC with DX: Myopericarditis in association with receipt of primary SPV. Chest pain/pressure resolved by mid September 2007.
I experienced severe dyspepsia and broke out in hives.  This is similar to my reaction to dose 2 and with the same timing.  I took Prednisone which I still had left from my medical visit due to  my previous vaccine reaction.  I took it for 2 days.  It hurt to eat for a couple of days.  It felt like my esophagus was burned.
Arm is starting to get tired; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection), first dose via an unspecified route of administration, administered in arm on 28Jun2021 (Batch/Lot number was not reported) at unknown dose single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose like an hour ago. he had no issues right now from the vaccine. his arm was starting to get tired on 28Jun2021. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Vomiting last night around 9PM, pt. received vaccines (MMR, Var, HepA), developed a rash in the upper lip. Mom gave a dose of BENADRYL. Swelling subside, brought to ER, given ZOFRAN and sent home.
The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date; No Adverse event; Bivalent Moderna vaccine was administered to patient after 30-day Use by Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) 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 (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  No treatment medication was provided.  This case contains information for the 8th out of 19 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Patient stated that she had no adverse reactions to the vaccine itself, but developed a localized reaction to her allergy injections beginning one week after her first Covid vaccine.    After her next treatment (2 weeks after initial vaccine), she ended up having an anaphylactic reaction to her allergy injections.  Her allergist does not feel that this reaction was related to the Covid vaccine.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number-L011846, expiry date-16-JUN-2017, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccines for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and MMR II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. On adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed a small rash on the back after her 1st dose. A few days after she had the second dose, she developed a rash over a large area on her upper body including arms, neck, shoulder. She was agitated and shaking.  The patient went to her doctor 2 days later and was given a steroid shot and prescribed Medrol and Kenalog.  On the same day, we called the manufacturer about the patient's adverse reaction and received the case number 003381136.
Patient information was reviewed. Patient was asked if they ever had any form of severe reaction to anything they had had in the past. Patient did not state yes to anything other than having a reaction that was managed at home to shellfish as a child. They stated their throat had swollen as a child during the event. Patient was told that it was an anaphylactic reaction and shouldn't have been managed at home as a child by nurse and should have been taken to the hospital. Patient was told they would be monitored for 30 minutes after receiving the vaccine. Within 2-3 minutes after receiving the vaccine the patient reported tingling or burning around the site of injections. Within 5 minutes they stated to be feeling tired and that their arm had felt numb. After this the patient began starring into the distance and was unresponsive. Called for help and advice by turning around as patient had syncoped. Got nurses and other team members attention and had an epi-pen ready just in case it was needed. Patient began having notable distress with respiration and administed an epi-pen. Advised for a nurse to call EMS for patient and crash cart/oxygen was also obtaine dby the facility. Oxygen was required. Patient was not responsive after the first dose and was given a second as they remained un-alert with notable distress. The patient became alert a while after receiving the second shot and not long after that the EMS arrived to the event.
12 hours after  first Moderna vaccine,, extreme aches in both arms and feeling of inflammation in chest.. Symptoms lasted an hour before subsiding. Lethargic day after shot. 48 hours after second Moderna vaccine, body rash on upper body, front and back. Redness at site of injection, also on inside of elbows and inside of thighs. No side effects day of vaccine. First day after vaccine had fever(100°) and lethargy. Second day after vaccine, skin rash developed. Did not feel ill with rash.
Heaviness in my chest; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A non-pregnant, female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route and in the left arm on 11Apr2021 at 00:15, as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route on an unknown date, as a single dose for COVID-19 immunisation The patients medical history included kidney disorder from an unknown date. No concomitant medications were taken by the patient. 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 and since the vaccination, the patient had not been tested positive for COVID-19. On 13Apr2021, the patient experienced heaviness in chest and upset stomach. The clinical outcome of heaviness in chest and upset stomach was not resolved at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
Sudden onset of dizziness, lightheaded, nausea for 7 days straight slightly improved after but continuing to be dizzy and  nauseous
I woke up and was to tired to go I slept an additional 8-9 hours that day and 7 or 8 days later I devolved a rash I know now as Covid arm this did not clear until day 13 it was incredibly hot an sensitive to touch I did go to urgent care due tightness of breath and stabbing pain on my right side a chest xray was done including taking my vitals no discovery or conclusion was reached tightness on my right side comes and goes since then
about 3 months and 1 week after booster dose on 2/7/2022  experienced supraventricular tachycardia. This last for 40 min during a project at work at the hospital. Caffeine, stress, physical exertion , poor sleep the night before were all contributing factors at the time. Hooked myself up to a cardiac monitor to see cardiac rhythm in a rate of 210.  with regular QRS. Went to the ER and while waiting in the ER self converted. Went to triage obtained vitals and ECG which showed sinus tachycardia with possible left atrial enlargement (which could be stress transient related, never had left atrial enlargement)
pt devel a mild diffuse neuropathy involving both motor & sensory component of lt median & ulnar, rt ulnar nerves as well as rt ulnar sensory nerve;sx appeared approx 1mo p/vax;
Upset stomach; This case was reported by a consumer and described the occurrence of upset stomach in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had upset stomach. The reporter asked how long should it last. The reporter asked would the side effects be the same for the 2nd dose.
Client experienced syncopal episode immediately following vaccination of 2nd dose of (PEDS) pediatric 0.2cc IM Pfizer vaccine; client was sitting upright talking with vaccinating nurse and mother when became lightheaded, fell from chair onto floor; never lost consciousness; parent with client, moved to wheel chair and moved to EMS tent. Monitored for 30 minutes. Provided popsicle and water. Symptoms resolved and left with parent.
Information has been received from a nurse concerning a patient who on 21-SEP-2009 was vaccinated with the second dose of ROTATEQ (lot number not reported) and spit up some of the medication.  There were no adverse reactions reported.  At the time of the report, the outcome of the patient was not reported.  Additional information has been requested.
Left arm with swollen area about size of "fifty cent" coin. Middle has hard area. Redness on periphery.
Woke with severe headache, aching all over, soreness at site, temperature that rose over the day to 103.9
SKIN SENSITIVITY; BODY ACHES; FEVER OF 104; HEADACHE; TIREDNESS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced skin sensitivity. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced fever of 104. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin sensitivity, body aches, tiredness, headache and fever of 104 was not reported. This report was non-serious.  Version created to amend previously reported information on 12-MAR-2021. Upon review, following information was amended: The medically significant checkbox was unchecked.
Client went to another facility and stated he had not received the start of vaccines. He was able to get a Janssen vaccine on 7/12/2021 Lot 201A21A
the patient had pain in her hands and knees; the patient had pain in her hands and knees; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021083699). This case was split from master case 2021653604 for a patient taking BNT162B2 and experienced "the patient had pain in her hands and knees".   This non-serious solicited report (USASL2021083699) was reported to Amgen on 28May2021 by a consumer from a commercial program (PSP00180b, PSP00046b) and involved a  female who received bnt162b2 (BNT162B2, Solution for injection) on 02Apr2021 as single dose for COVID-19 immunization. No historical medical condition was reported. The patient's current medical condition included ongoing rheumatoid arthritis. The patient's concomitant medications included Enbrel for rheumatoid arthritis and methotrexate. No co-suspect medications were reported. On 02Apr2021, the patient took COIVD-19 vaccine. Five days later on 07Apr2021, the patient had pain in her hands and knees. The patient stated that her Enbrel has stopped working since she took the covid-19 vaccine. The patient's doctor advised that the vaccine was the reason her Enbrel was no longer working for her. The patient's nurse practitioner (NP) removed methotrexate from her regimen however patient was still having discomfort. The patient stated it was fighting the Enbrel and attacking everything inside her. No treatment information was received. Follow up has been requested for lot number. Outcome of the event was unknown.  No follow- up attempts possible. No further information expected.
Narrative:  Paramedics called and evaluated pt, he refused to go to ED. Symptoms improved, not taken anywhere. Vitals ok.
Admitted to Hospital 10/27/2021 Diagnosed with Transverse Myelitis
Was taking Plavix for prevention of stroke.  Initial examination lungs CTA, flushed, edema of lips and tongue. Uvula not deviated. Pt moved to observation area.  Initial vitals:   BP: 136/89, HR 99, 87% O2 on initial read, but when repositioned it was 91% at 14:42     EMS notified and first injection 3mg Epi pen injection given at 14:45;   911 called. Symptoms improved, but shortly after returned. Second epi injection at 14:56. BP: 136/89, HR 104, RR 18, 98% O2 at 14:55. Second epinephrine 3mg injection given at 15:00. BP 148/85, HR 91 at 15:00. EMS arrived and she was taken to Hospital at 15:03
Mother called to report that arm is very swollen from top of arm to elbow.  Area is itchy but no other symptoms.  TC to NP for advice for parent - Children's tylenol q 6 hours for 3 days, children's Benadryl  q 6hrs for 24 hours.  Cold compress to area 10 minutes every hour while awake.  Keep arm up on arm of chair/couch or on pillows.  Seek medical care if worsens today or does not begin to resolve by tomorrow.  TC to mother to relay information and let her know I would be making a Vaers report and that someone from their office may contact her. I will call her tomorrow to check on status.
I was approximately 6-weeks pregnant and suffered a miscarriage which began the following day after receiving the vaccine. Symptoms presented as fever (100.4), severe cramping, diarrhea, bleeding, body aches & chills, which lasted Saturday & Sunday following the vaccine (received on Friday).
Patient was given two vaccines. the menactra vaccine was expired. Expired in April 2022. Nurse giving vaccines was alone in pod without another nurse for second check. the vaccine was confirmed by the provider but dates were not checked. nurse contacted me by phone to explain what happened in the chart. verbal education was given over the phone about the second check reminders and to input the vaccine information in prior to administering. nurse was also provided face to face education again the next morning.
Severe headache and vomiting for over 24 hours. Severe pain in arm at injection site.
Most terrible headache ever, worse than my brain tumor, fever. Chills, followed by sore throat, congestion, feeling like my throat was Half closed up. Swollen lymph nodes. Took a steroid after weeks, helped somewhat, throat still feels like it is partially blocked. It is not mucus.
Child ran fever through the night. Mother did not take temp. No fever in AM. Child had runny nose next AM.
This spontaneous report was received from a physician, via a company representative, referring a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Unit (PFU), subcutaneously, "one time vaccination" (lot # and expiration date were not reported). It was stated that the vaccine was administered incorrectly at the wrong injection site. The patient sought medical attention by visiting doctor's office and was diagnosed with cellulitis; which was treated with unspecified antibiotics. There was not a product quality complaint (PQC) involved. At the time of reporting the outcome of cellulitis was reported as unknown. The causality assessment between cellulitis and ZOSTAVAX was not reported. Upon internal review cellulitis was determined to be a medically significant event. Additional information has been requested.
Pt reports rash & Hives to bilateral arms & back several hours after the 2nd dose of vaccine.  Pt reports using OTCC non drowsy antihistamine with good effect.   Pt instructed if s/sx persist & are not gone by end of the week to notify PCP
Client states 24 hours post administration fever, N/V, fatigue and pain to arm. Today one week later, still having pain to left arm - deltoid tender to touch and warm, decreased ROM as well. Plans to follow up with her PCP, seen by PCP. Seen by NP prior to leaving.
Fever 99.9 and shaking, after that 102.7 fever and tiredness.
30APR96 reports 4PM states high pitch cry 4 or 5 hr;pt taken to ER;
This spontaneous report was received from a physician assistant concerning a patient of unknown age and gender. Approximately on an unknown date in August 2011 (reported as about two years ago), the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date and route unspecified) by an unspecified physician. On 22-AUG-2013, the patient was vaccinated with the second dose of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Patients administered unpunctured vials stored in refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered unpunctured vials stored in refrigerator beyond 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered unpunctured vials stored in refrigerator beyond 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered unpunctured vials stored in refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow-up received contains: no new information.
A feeling of scratchiness in my left eye and some redness in both eyes is the main symptom which I feel is related to the Novartis injectable swine flu vaccine I received yesterday. There was also a feeling of being a little cold when I woke up, and some fatigue since waking up. It has been about three hours since I woke up and the scratchiness in my eye seems to be dissipating.
extremely itchy lichenoid rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "extremely itchy lichenoid rash".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Patient became faint for about 15 seconds then woke up fine. Was checked (provider) then discharged. Was watched for 30-45 minutes. Pt had clonic-tonic movements for about 30 secs and unresponsive. When responsive-pt knew who she was, mom and where she was. RN.