chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy rash all over body; felt run down; headache; stomach upset; slight chills; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 55-years), administered in arm left on 01Mar2021 as dose 2, single for COVID-19 immunization. Medical history included none from an un-known date and unknown if ongoing. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of ad-ministration, administered in arm left on unspecified date as dose 1, single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The facility type vaccine was reported as pharmacy or drug store. On 07Mar2021, the patient experienced felt run down, headache, stomach upset, slight chills. On 08Mar2021, experienced itchy rash all over body. It was further reported that almost week later, felt run down, headache, stomach upset, slight chills and then next day had itchy rash all over body. The treatment was received for all the adverse events with Benadryl. The clinical outcome for all the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Fever uptake to 100 F, chills, nausea, headache, sharp stabbing back and leg pain, muscle soreness, fatigue
I had normal arm soreness for about 3- 4 days. I thought it was gone then started to hurt again.  I asked my coworkers that got the shot on the same day if theirs still hurt and they said no. It continued to hurt over the weekend. When I went to work on Tuesday I was really complaining and pulled up my sleeve to show a co worker where it hurt. Thats when I found a large red spot that was hard and hot. That explains why I couldn't sleep on it the night before. Started a 7 day course of antibiotics that day.
7.8.21: Patient reported weakness, lightheadedness, fever, possible numbness/tingling (also s/p heart cath) 7.9.21: Presented to ED - fever, headache, myalgia, neck stiffness, weakness in lower legs, difficulty walking, numbness - left AMA 7.9.21:  Presented to ED - with generalized weakness - He was discharged on 7/7. He had noted BLE weakness during his admission and noted worsening of his weakness following his discharge. He returned to the ER on 7/8 but left AMA. He presented to ER on 7/9 with right arm and BLE weakness and MRI showed numerous small acute ischemic foci bilaterally. CTA was negative for significant stenosis or occlusion. He was evaluated by Neurology and felt that there was a high likelihood of cardioembolism as the etiology of his strokes vs cocaine. They recommended cardiac monitoring for evidence of afib as well as DAPT x 21 days followed by ASA monotherapy. He was noted to have an elevated troponin on admission and was placed on a Heparin drip. Cardiology did not feel that repeat cardiac cath was warranted. An Echo with bubble study was performed and showed EF 45-50%, diffuse hypokinesia, mild DD and no evidence of shunting. He has been accepted at hospital with plan for transfer there today.  Assessment / Plan  Multifocal stroke - suspect shower embolism vs r/t cocaine use - Echo - no evidence of shunt - per Neuro - DAPT x 21 days followed by ASA monotherapy - 30-day cardiac monitor at discharge  Elevated troponin Recent IWMI CAD Ischemic CM - EF 45-50%, diffuse hypokinesia Cocaine use with possible vasospasm - s/p Heparin drip - no indication for repeat cardiac cath per Cardiology - ASA, Plavix, Metoprolol, Lisinopril, Lipitor - Norvasc - counseled on cocaine cessation
Had suddenly didn?t feel good.   Passed out was out for five minutes,   Had a strange reaction when he came to, His vision was blurred,  he has vomited 6-7 themes.   I contacted the pharmacy where the sot was given and the clinic.   He refused to go to E R The have taken notes to this.  He sat in his recliner and took a nap.   Took temp he does not have a fever.  If his symptoms get worse I will call for ambulance.
9/16/02 Immunizations given afternoon. 9/18/02 AM Mother presents at office. Took child to ER with pain right deltoid, redness and swelling T-99.9. Diagnosed cellulitis right arm. Ancef IM. Prescription for Keflex.
c/o gen malaise 2 1/2 hr post vax w/light h/a;5PM devel intense frontal h/a, migraine like;relieved by Ibuprofen;next day malaise all day;
CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 72 year old of unspecified sex. 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: 04ZA21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and nausea on 05-APR-2021. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ-1614-PFIZER-2021), in left arm for covid-19 immunisation. The patient's relevant medical history included: "OCD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; LAMICTAL; BUSPAR; CLARITIN ALLERGIC; GABAPENTIN; IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: Positive COVID PCR test posttreatment with Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Additional information: The patient had no known allergies. Patient received treatment for COVID-19. Anti-viral details: Product=COVID 19 Treatment. Brand- Paxlovid. Treatment start date- 04Jun2022. Treatment stop date- 08Jun2022. Indication- Treatment of COVID-19. Other medication in last 2 weeks details: Wellbutrin, Lamictal, Buspar, Claritin, Gabapentin Ibuprofen. Adverse event: Positive COVID PCR test post treatment with Paxlovid. Return of sore throat, chest soreness, fatigue, nasal congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was erroneously given Rotateq at 1 yo well visit instead of varicella.
On 4/8 I woke up with a sore jaw on the left side.  Got better as the day went.  That night woke up with no saliva on that side of my throat.   Drank water but happened several times.  Next day same exact thing.  My back teeth on the left felt numb.  Same extremely dry on left side of throat and woke with less jaw pain.  Day 4 completely gone.
health effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (health effects) 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 VACCINATION COMPLICATION (health effects). At the time of the report, VACCINATION COMPLICATION (health effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Rash that really looks like Shingles; Vesicles; patient was followed and immunosuppressive treatment; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression (Patient under Immunosuppressive treatment).   On 20th February 2020, the patient received the 1st dose of Shingrix. On 20th February 2020, unknown after receiving Shingrix, the patient experienced labeled drug-drug interaction medication error. On 23rd February 2020, the patient experienced vesicular rash and vesicles. On an unknown date, the outcome of the vesicular rash, vesicles and labeled drug-drug interaction medication error were unknown.   It was unknown if the reporter considered the vesicular rash and vesicles to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine and 3 days after that started with the adverse reaction. The HCP described it as a rash that really looks like Shingles, and also mentioned vesicles. The doctor already knows that Shingrix was a non live vaccine. The patient was followed and immunosuppressive treatment. The reporter was concerned whether the patient can receive the second shot. The reporter consented to follow up.
I had discomfort in my chest, my left side was swollen, chills, weakness, cough, fever and headache.
Sore arm - slightly more sever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm - slightly more sever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0120M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (Sore arm - slightly more sever). On 16-Jan-2021, MYALGIA (Sore arm - slightly more sever) had resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-056303 (E2B Linked Report). This case was linked to MOD-2021-056303 (Patient Link).; Sender's Comments:  MOD-2021-056303:Case 1 of 2
flu like symptoms; nausea; chills; body aches; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and PROGESTERONE for an unknown indication, ESTRADIOL (ESTRADOT).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
5 months old female patient who received DTaP-IPV diluent separately and did not receive ACT-HIB powder portion of pentacel, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA257163 and 2019SA261801 (same reporter).   This case involves a 5 months old female patient who received DTaP-IPV diluent separately and did not receive ACT-HIB powder portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel] (lot: UJ060AA, expiry vdate: 04-Oct-2020, the outer carton is lot: UJ060AAA, expiry date: 04-Oct-2020) via unknown route in the left thigh, on 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique.  At a time of reporting the patient had no adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
Welts on left side of body and lower back; Itchiness under one breast; Rash at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts on left side of body and lower back), PRURITUS (Itchiness under one breast) and VACCINATION SITE RASH (Rash at vaccine site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts on left side of body and lower back), PRURITUS (Itchiness under one breast) and VACCINATION SITE RASH (Rash at vaccine site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts on left side of body and lower back) and PRURITUS (Itchiness under one breast) outcome was unknown and VACCINATION SITE RASH (Rash at vaccine site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Breakthrough case admission after three doses Pfizer 2/24/21 Lot# EN6202 Pfizer 3/17/21 Lot# EN6204 Pfizer 12/14/21 Lot# FJ1620
It is suspected that the patient received an inadequate dose at this administration. They presented and were potentially injected with an empty syringe (no air, just empty vanish-point).  The care team has attempted to contact the patient to determine if they have had any symptoms after injection, but have not been able to get in touch with the patient. We will continue to try to contact the patient.
Immediate syncope: loss of consciousness for ~5 seconds. Consciousness regained but physically weak. After 5 seconds, lost consciousness again, and became unresponsive for several more seconds before regaining consciousness. This repeated for several minutes until he became unresponsive (eyes were open, occasionally moaning, and occasionally shaking with seizure-like motions) for 30 seconds. EMT called at 6-min mark (never arrived). Then consciousness regained, patient A&Ox3 but still weak. Patient's eyebrow was bleeding and reported pain as if struck, so possible head injury during first fainting, though unobserved by RPh who was present. Patient remained alert after this but weak. after ~40 mins, reported paresthesia in left arm, which resolved after 15 mins, but then reported paresthesia in left leg, which again resolved after 20 minutes. Patient refused emergency transport and departed for home at 8pm.
Initial and follow-up information has been received from a licensed practical nurse concerning a 75 year old female who on 21-JUN-2007 was vaccinated subcutaneously with a first dose of PNEUMOVAX (Lot # 655766/0038U).  On 22-JUN-2007, the patient developed a "cellulitis-type reaction" with a 17 cm red, tender, swollen area on the left arm at the injection site.  The licensed practical nurse described it as a localized reaction and reported it resolved completely in 4-5 days.  The patient's date of recovery was reported as 28-JUN-2007.  Additional information is not expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.44. Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This case was reported by a consumer via out of hour services and described the occurrence of influenza in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza, chills, headache and muscle pain. On an unknown date, the outcome of the influenza, chills, headache and muscle pain were unknown. The reporter considered the influenza, chills, headache and muscle pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, muscle pain and headache. The patient stated that she had seen her physician and was diagnosed with the flu, but she thought it was just related to the SHINGRIX injection.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 29-JUL-2011 the patient was vaccinated with improperly stored VARIVAX lot # 669223/1564Z dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 75 year old patient (gender not reported) who was vaccinated with one dose of Varivax instead of Zostavax. Product confusion was ruled out, nursing error. Patient did not report any adverse events. There was no product quality complaint. Follow up information obtained from the physician indicated that there were no product confusion. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown dates, the patient received two doses of GARDASIL (dose, route of administration, anatomical location; lot# and expiration dates were not reported). On 23-JUN-2015, the patient received a dose of GARDASIL 9 (dose, route of administration, anatomical location; lot# and expiration date were not reported) to complete the 3 dose series of an human papillomavirus (HPV) vaccine. No adverse effects were reported. Additional information has been requested.
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium