chrisvoncsefalvay/vaers-outcomes huggingface dataset:
preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I was itchy all over for a few nights; weird lump in my armpit by my breast; 3rd time CMV has reactivated; 3rd time CMV has reactivated; Anafalactic shock; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0158), via an unspecified route of administration in left arm on 26Apr2021 14:45 (at the age of 36-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a hospital. The patient received first dose of bnt162b2 (Lot no: ER8729) on 05Apr2021 at 14:45 in left arm for COVID-19 immunisation and experienced cytomegalovirus (CMV). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included CMV; HELLP syndrome and preeclampsia, all when she delivered her son 3 weeks early and pregnant. Concomitant medications included ferrous sulfate; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and unspecified prenatal vitamins. The patient reported 3 rd time CMV has reactivated in 2021. After 2nd vaccine dose (on 26Apr2021), soreness at shot site and joint pain. Late that night, chills, 104.0 fever. Next day (on 27Apr2021), 103 fever took paracetamol (TYLENOL) 4-6 hrs. Third day after (on 29Apr2021), 103 fever, still joint pain, & preeclampsia level migraines. Still had Rx migraine meds but couldn't mix with fever reducer. So took leftover oxycodone from having a baby at midnight and 05:00. Next day/4th post shot day (30Apr2021), severe migraine, fever staying around 100.something. So the patient took migraine medicine, melatonin (3 mg a few times that night). The melatonin was kinda helpful. In 2021, the patient was itchy all over for a few nights (been in anafalactic shock 3x prior so the patient knew it wasn't that) joint pain, now she have a weird lump in her armpit by her breast that hasn't gone away. Almost woke her husband to go to hospital because of migraine. The case was considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event axillary mass was not recovered while for the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case
Incomplete course of vaccination; received the first and second doses of Twinrix six months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HAB (Twinrix) (batch number 4KF75) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 11th August 2022).   On 17-JAN-2023, the patient received the 2nd dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 17-JAN-2023, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the first and second doses of Twinrix six months apart). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2023 The reporter reported that a patient received the first and second doses of Twinrix six months apart and wished to know what information was available.  They provided limited information about patient, vaccines and event. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccinations schedule. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: Unknown) dose was not reported, 1 total administered on 24-MAY-2021 to left arm for prophylactic vaccination. Age at time of vaccination 46 years old. No concomitant medications were reported.  On an unspecified date, patient experienced symptoms fever, chills and feeling really tired which led to suspected covid-19 infection. On 17-JAN-2022, patient did rapid antigen test, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive and that indicates suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232955.; Sender's Comments: V0: 20220554257- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Severe shaking/shivering total body symmetrical, headache frontal bilateral. I did not feel hot to touch. There was no sweating, no nausea, no dizziness, no myalgia, no pain except in upper arm at and near site of injection, no vomiting, no difficulty breathing, no hives, no rash. I didn't feel cold but tried to fix my shaking by heating the house holding on to heat pads and adding  bed covers. I was too shay to drink anything or take a temperature as my arms were wildly moving and my legs were so unsteadies to prevent walking to get to phone or kitchen. After it was over there were no other effects. Shivering/severe shaking lasted for 6 hours from 7 pm Oct 24  until 2 am Oct 25 I discussed this reaction with my physician Dr on Oct 30 at an annual visit because I was planning to get a Flu vaccine. I am holding back on flu vaccine this year in case I have developed some sensitivity to vaccines.
Started with a very localized rash in the chest. After a couple days red marks started to appear all over the upper body (chest and belly). They are extremely uncomfortable and painful and it is almost impossible to sleep.   Started taking antihistaminic (Zyrtec) but symptoms continued to evolve, spreading to other areas of the body and getting more itchy and painful. Went to a minute clinic at Pharmacy and got a prescription for a Triamcinolone Acetonide Ointment USP, 0.1% and started taking Zyrtec (1 time a day) combined with Benadryl every 4-6 hours (varying depending how bad symptoms were).  Symptoms continued to worsen. Went to a dermatologist which made a biopsy and got a prescription for Clobetasol Propionate Cream USP, 0.05% (2x day), Prednisone treatment (30 days) and Hydroxyzine 25mg (1xday).   Started treatment recommended by the dermatologist today (12/08/2021).
c/o worsening hives on Moderna vaccine area since 1st dose on 12 May. denies fever, chest pain, BLE pain. last Zyrtec and Tylenol last night. take Zyrtec regular base for allergy.
Blinking, grimacing, does not know colors as well as before.  No staring, local seizure activity, myoclonic jerking.
Latent hives; flashing; vertigo; This is a spontaneous report from a non-contactable Other HCP. This 35-year-old non-pregnant female Other HCP reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on left arm on 27Jan2021 12:00 PM at single dose for COVID-19 Immunization. The patient's medical history and Concomitant medication were not reported. Historical vaccine included first dose of COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. On 29Jan2021, the patient experienced Latent hives, flashing, vertigo. The patient did not receive any treatment but resulted in doctor or other healthcare professional office/clinic visit. The outcome for the event was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient reported experience shortness of breath and some anxiety after receiving second dose of vaccine. She was received in the observation room and made comfortable. She was encouraged to take in slow deep breath and relax to help with the anxiety and shortness of breath. Serial vital signs were collected on the patient.  Patient verbalized relief from her symptoms. She was discharged at 5:18pm in stable condition
This spontaneous report as received from a Register Nurse refers to a twenty unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 20-NOV-2014 (dates of administration were unspecified), twenty unspecified patients were vaccinated with a dose of PROQUAD (Merck) which underwent a supported temperature excursion, subcutaneously, lot number reported as K012918, expiry date 28-FEB2016 (dose was not reported). No adverse effects reported. There was no concomitant medications provided. This is one of two reports received from the same reporter. Additional information has been requested.
PALE, CLAMMY, NAUSEATED, NO VOMITING.  AT ALL TIMES ANSWERED APPROPRIATE QUESTIONS WITH APPROPRIATE RESPONSES.  WAS SEATED AFTER IMMUNIZATION GIVEN FOR OBSERVATION.  JUST LEANED PATIENT BACK ON AUDITORIUM CHAIR.  MONITORED BP AND ICE PACK PLACED ON CHSET.  PHONED MOM'S CELL AT 3:38 PM, CLIENT DOING WELL.
About 1 week after the shot, my arm started itching at the injection site. It is not red. I?m on day 3 and still itchy.
pt recv vax 930AM 9OCT96 & approx 5PM presented to med dept w/fever, pallor, severe malaise, myalgia, joint pains & diff in walking;tx w/APAP & fluids were forced;
There was an area of marked cellulitis to below, but proximal to injection site of Dtap. It was hot to touch and swollen. Treated with Tylenol and motrin, bactrim, and hydrocortisone cream. Improved.
On 5/5/2021 @ 0915 pt, received the 1st dose of the Pfizer COVID vaccine Lot # EW0167 Expiring 5/9/21. At 0920, pt was observed losing consciousness in the observation area. Per report from pt sitting behind her in the observation area "she hit her head on the floor when she fell." EMT (Name), EMT (Name), Lead Nurse (Name) and Co-lead Nurse (Name) present. 0923 VS- BP: 82/54, P:61, SpO2: 99% at room air. Pt alert and oriented x3 to person, place, and time. Pt complaining of feeling weak, dizzy and lightheaded. EMT (Name) elevated her legs to put her in Trendelenburg. Pt tolerated well. No signs or symptoms of closed head injury and pupils equal, round, and reactive to light accommodation. Pt shared that she had not eaten or drank since 5/4/2021 at around 5pm. Pt also shared that she "can't remember if I told the nurse but this happens sometimes when I give blood or get injections... this also randomly happened at a birthday party when I was about 16 years old." 0932- Pt sitting in zero gravity chair eating "goldfish" crackers and drinking water. Pt states she feels "better, but not great. The back of my head is a little bit sore" Pt was educated on when to seek emergency intervention, signs and symptoms of a closed head injury, and it was advised by Lead Nurse and Co-Lead Nurse that she follow up with her PCP today. Pt was also educated that since she has a history of fainting with needles that when she returns for her second dose that she advises her nurse of that so proper safety measures are taken. Pt verbalized 100% understanding. 0943- Vital signs BP 90/62, Pulse 70, Respirations 16, SpO2 100% at room air, pt calm and stable. Pt left the facility @ 0948 in a wheelchair for safety. Pt was with her boyfriend and boyfriend stated he would drive her home and take her to follow up with her MD later today.
Lightheadedness; Injection site inflamed; tenderness; Body aches; Headache; Chills; Injection site painful with pain scale of 6; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), VACCINATION SITE INFLAMMATION (Injection site inflamed), TENDERNESS (tenderness), PYREXIA (Fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (Fever). On 01-May-2021, the patient experienced DIZZINESS (Lightheadedness), VACCINATION SITE INFLAMMATION (Injection site inflamed), TENDERNESS (tenderness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Injection site painful with pain scale of 6). At the time of the report, DIZZINESS (Lightheadedness), VACCINATION SITE INFLAMMATION (Injection site inflamed), TENDERNESS (tenderness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Injection site painful with pain scale of 6) outcome was unknown and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 103.2 (High) temperature was 103.2F at around 5:30 PM. On 01-May-2021, Body temperature: 100.2 (High) fever with temperature of 100.2F and 100.8 (High) fever was down to 100.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Itching; Fever; extreme headaches; Chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection). At the time of the report, PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 2nd patient out of 5 patients as described by the reporter.  Concomitant and treatment medications were not reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects. Three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748404, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received that contains significant information: Batch number and event details were updated. On 06-Nov-2023: Live follow-up received that contains non-significant information: Reporter information and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Patient 1 out of 3 US-MODERNATX, INC.-MOD-2023-748403:same reporter Patient 4 US-MODERNATX, INC.-MOD-2023-748404:same reporter Patient 5 US-MODERNATX, INC.-MOD-2023-748352:same reporter Patient 3 US-MODERNATX, INC.-MOD-2023-748215:Reporters case
Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood leaving my arms and legs, began to feel feint. Laid down on ground with legs elevated. Began shaking. Called 911. Was taken to the hospital by ambulance. Once at hospital, felt arms and legs were numb. After a period of time going through testing at the ER, feeling returned to all but left leg. Stayed overnight, went home on 5/6/2021. Strength returned to left left over the next several days.  Since 5/6/2021. Have been dealing with increasing debilitating anxiety, as well as photosensitivity, insomnia, and other related issues since returning home.
Angina presented initially with exertion during daily routine exercise with some shortness of breath, and heart racing. I stopped workout and soon was able to catch my breath and heart stopped racing but the chest pain did not subside. on a pain scale from (1-10) My pain would remain a 4 and would climb to a 6 with a deep breath or some movements. This pain remained a few days
Rash over weekend of 01-17-14. Rash kept growing per mom.
ADVISED PARENT OF DOUBLE ANTIGEN GIVEN. PARENT STATED COULD NOT COME IN FOR OFFICE VISIT UNTIL 2/15/17.
p/ recv vax in 6/96 pt in 3/98 devel chickenpox
during f/u foster mom claims pt was fussy & cried from 3PM-7PM @ which time took pt to MD vax given 130PM same day 13MAY93; also c/o sore rt leg red & swollen & fever 102; erythromycin for ear infect of 3 wks; also teething;
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 12-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
REDNESS, WARMTH, RASH LOCALIZED FROM UPPER SHOULDER TO ELBOW, FLU LIKE SYMPTOMS.
Miscarriage - baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the mother report.  A 35-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 35-year-old administered in arm left on 18Apr2021 09:15 (Lot Number: EW0164) at singe dose, dose 1 via an unspecified route of administration at the age of 35-year-old administered in arm left on 28Mar2021 15:00 (Lot Number: Er8732) at single dose for covid-19 immunisation. The patient medical history was not reported. There was no Covid prior vaccination. Concomitant medications included estradiol (ESTRACE), progesterone. There was no other vaccine in four weeks. On 23Apr2021, 14:00, the patient experienced miscarriage - baby stopped growing 5 days after shot, confirmed with ultrasounds on 26Apr2021 and 06May2021. The event resulted in doctor or other healthcare professional office/clinic visit. Last menstrual date was 10Mar2021. There was no Covid test post vaccination. There was no treatment for event. The outcome of event was recovering.; Sender's Comments: Linked Report(s) : PFIZER INC-2021512724 baby case
Red swelling after 24 hours. Pain to touch for 3 days. Swelling raised injection area warm to touch and itchy still 1 week after.
2 uncapped vials thawed out in room  temperature placed back in the refrigerator and administered to 22 patients next day; 2 uncapped vials thawed out in room  temperature placed back in the refrigerator and administered to 22 patients next day; A spontaneous report, was received from a nurse concerning, 22 patients who received Moderna's COVID-19 Vaccine and who experienced two uncapped vials thawed out in room temperature, and placed back in the refrigerator and administered to 22 patients the next day/Product temperature excursion issue and Out of specifications product use.  The patients medical history's were not provided. concomitant product use was not provided.  On 17-Feb-2021, prior to the onset of events, a Healthcare Provider had 2 uncapped vials of mRNA-1273 (Batch numbers unknown) thawed out in room temperature (around 70 degrees Fahrenheit) for approximately two hours. These vials were placed back in the refrigerator (4-5 degrees Centigrade) for approximately 24 hours.  On 18-Feb-2021, 22 patients received a dose of mRNA-1273 intramuscularly for COVID-19 prophylaxis and were administered vaccine from the previously thawed vials.  Action taken with mRNA-1273 in response to the event was unknown.  The reported event, Two uncapped vials thawed out in room temperature, placed back in the refrigerator and administered to 22 patients the next day, outcome was considered resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of product storage error and out of specification product use for mRNA-1273 administered to 22 patients, (lot # not provided) with no associated AEs.