chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Vaccine exposure during pregnancy; Unspecified pregnancy complications; This is an observational study case, initially received from other health professional on 28-Oct-2019, concerning a 32-year-old, pregnant, female subject of body weight: 125 lbs, height: 66 inches and body mass index (BMI): 20.2, enrolled in a prospective observational safety study.  The subject's obstetrical history included one previous full-term live birth. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's relevant medical history included anemia. The concomitant medications of the subject included folic acid as vitamin and OB Complete (as reported) for vitamin obstetrics (OB) care and anemia.   The subject's last menstrual period (LMP) date was 24-Jun-2019, the estimated date of delivery (EDD) was reported as 30-Mar-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 12-Sep-2019, approximately at 11 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL (Flucelvax QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy').  On the same day, after vaccination, the subject experienced nausea and started therapy with Bonjesta (doxylamine succinate and pyridoxine hydrochloride) one tablet administered two times per day via oral route.   On an unknown date, after vaccination, the subject's pregnancy status was collected, and unspecified pregnancy complication was noted. No further details were provided.  At the time of initial reporting, the patient had not recovered from nausea, while the outcome of unspecified pregnancy complication was not reported.   The case was assessed as serious.  The reporter did not provide causality assessment.  Company comment: The subject experienced nausea and complication of pregnancy after vaccination with the suspect product Flucelvax QIV. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of anaemia and pregnant state may provide alternative aetiology for the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.; Sender's Comments: The subject experienced nausea and complication of pregnancy after vaccination with the suspect product Flucelvax QIV. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of anaemia and pregnant state may provide alternative aetiology for the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.
Information has been received from a physician concerning a 70 year old male who on 19-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 24-MAY-2008 the patient developed right leg pain.  On 29-MAY-2008 he developed red "splotches" on his leg.  The patient was seen in the office on 02-JUN-2008 and diagnosed as having shingles with L3, L4, L5 nerve root involvement.  There were no vesicles.  The patient had burning pain.  The physician reported that the patient appeared to have early or late shingles (the physician could not tell which).  The patient was prescribed FAMVIR.  At the time of the report, it was unknown if the patient had recovered from the event.  Additional information has been requested.
initially devel swelling over deltoid area 30min p/vax;over 24hr entire rt arm had edema;seen in ER devel severe urticarial rxn all over body;chest discomfort & facial edema;
Started getting headache which became really bad in a matter of minutes with a little bit of numbness at base of neck.  I rarely get headaches and it came so quickly and severe.  I have only experienced this previously when very ill.  I insisted my husband wake me up throughout the night to make sure it was OK.  It went away overnight and this morning is minimal.  I do have more than usual tenderness at injection site which started soon after getting the shot. I normally don't experience tenderness after the flu shot.
IGG antibodies; feeling ill; This is a spontaneous report from a contactable pharmacist.A female patient in her 50's received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) as Dose number unknown, single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced IGG antibodies and feeling ill.The patient underwent lab tests and procedures which included blood immunoglobulin G: positive and sars-cov-2 test: negative.The outcome of the events were unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Myalgia  Narrative: experienced injection site arm soreness next day. works as phlebotomist and was unable to perform job duties x I day. returned the work the following day 12-24-20.
I got my first shot in November and didn?t have any adverse reaction.  The second shot was given at 4:00 pm on March 10, 2022. About 7:00 pm I was feeling achy all over and my arm hurt at the injection site. I took a Tylenol Flu tablet  and that helped a little. When I got up the next morning I was still feeling achy and had chills.  I took a nap in the afternoon and started feeling better about 8:00 pm on Friday.  Today is March 12 and  I feel fine today, my arm is still slightly sore at the injection site.
later that day, pt subsequently devel severe vomiting, diarrhea & fever 102.5f; pt hosp
I started to feel numbness in my tongue and through my mouth and lips. I went to the doctor, and he did not give me any treatment or do any medical tests and to just come back in 3 months and then we will go from there. I do have arthritis in my joints, and I was wondering if it was something related to my nerves but he did not know.
Pt recvd vax on 10JUL92 & 4 hrs following vax devel tinnitus in both ears; following day devel sx of gastroenteritis; No further details were provided;
p/vax pt was sick;did not know what was wrong;dx w/juvenile diabetes 9/21;also has autism which mom feels is a result from vax;60 day follow-up states the pt had nausea, stomach pain, excessive thirst and bed wetting.
Breaking out; Fever Blisters on her face; Face is very hot; Tingling; Shivering; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 9th January 2020, 1 days after receiving Shingrix, the patient experienced tingling and shivering. On 11th January 2020, the patient experienced skin breakout, fever blister and feeling of warmth facial. On an unknown date, the outcome of the tingling, shivering, skin breakout, fever blister and feeling of warmth facial were unknown.   It was unknown if the reporter considered the tingling, shivering, skin breakout, fever blister and feeling of warmth facial to be related to Shingrix.  Additional details were provided as follows: It was reported that one day after receiving the Shingrix patient had tingling and shivering and 3 days after the vaccination patient started breaking out with Fever Blisters on her face and her face was very hot. The reporter did not consent to follow up.
7.5 - 8.5 redness, swelling BENADRYL no fever or itching, no SOB.
Case number PHEH2015US002907, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 2015. This report refers to a 33 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly at a dose of 0.5 ml on 14 Jan 2015. It was reported that before administration, the FLUVIRIN was stored at 34 degree Fahrenheit for 15 hours. No adverse event was reported following this maladministration.
approx 9AM pt was given vax 11AM mom reports pt began shaking, twitching, was warm to touch, lips turned blue, did not respond to verbal stimuli; eyes were open but not focused on anything;lasted 30-45mins & began to resolve; seen in ER;
This spontaneous case was reported by a consumer and describes the occurrence of FRACTURE (Fractured cheek bone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. Concurrent medical conditions included Steroid therapy (She is currently taking steroid). In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FRACTURE (Fractured cheek bone). At the time of the report, FRACTURE (Fractured cheek bone) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported. Patient received her 2nd dose APR2021 and the surgery was in JUL2021.
Initial report received from a physician via health authority on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch number 107522P1) on 29 Apr 2010. 24 hours after vaccination, the patient presented with sudden respiratory failure on 30 Apr 2010 and two hours later, the patient died. Medical history of the patient was unknown. Autopsy was performed and cause of death was stated as bronchopneumonia.
I have a rash on my arm at the site of the first vaccination,; Itchy rash; Like a round circle on my arm; looks like a big ringworm; This is a spontaneous report received from a contactable consumer (patient). A 68-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 15Feb2021 (at 68-years age) as single dose, and dose 2 via an unspecified route of administration, administered in right arm on 09Mar2021 as single dose for covid-19 immunisation. Medical history included diabetes from 2000 and ongoing, blood pressure high from 1976, that was 45 years ago potassium low, thyroid for 15 years, cholesterol from 15 years. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes, losartan (LOSARTAN) taken for blood pressure high; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, atorvastatin (ATORVASTATIN) taken for cholesterol; metoprolol (METOPROLOL) taken for blood pressure. Patient was taking Losartan before and also taking a HCTZ, two individual tablets but the doctor combined it to about 6 months ago. Patient took a 20 mEq. Patient took a lab test at her Doctor's office because she was diabetic. She took one every 6 months; I took it in February. It was 6.4. After receiving the Pfizer covid vaccine and patient experienced rash on her arm at the site of the first vaccination, an itchy rash and a round circle on arm; looks like a big ringworm. Patient thought it was after the first shot and before the second shot. Patient did not notice it until about a month ago. It was itchy for a while, then the rash became more dominant, and patient was able to notice it. It looked like a big ringworm. It was a like over a month ago. Patient had itch and she put Cortisone cream (treatment) on it. It was a triple antibiotic ointment, once or twice a day, depends on when it starts to itch, it was a cream. The outcome of event itchy rash was not recovered and unknown for other events.  Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.  Follow-up (21Apr2021): This is follow-up spontaneous report from contactable consumer. A 68-Years-old female consumer (patient) reported vaccination date, concomitant medication, relevant medical history and treatment information.  No follow-up attempts are needed. No further information is expected.
Migrating erythema 1/2cm assymettical to oval raised patches some with sm. pustules scattered over neck shoulder trunk arms legs.
Patient was given immunization at a school flu clinic. She received the FLUAD for 65 and older, rather than the Flucelvax or other age appropriate flu vaccine.. No side effects or adverse events were reported to the Pharmacy. Patient's parents have been left message on house phone to call us back so we can give the information to them.
15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and very swollen arm pit in the arm where i was vaccinated, today is day 2 of swollen painful arm pit.
Developed chicken pox/ fever and rash on 4-26-10 in patient ready for discharge extended hospital stay x 3 days. (Did have steroid burst x 3 days 4-8 and 4-11 5 day course).
Pain at injection site,Sudden onset of severe flu like symptoms, non responsive behavior led to 911 call at 2 am.  Symptoms improved, but fever/body aches continued until 8 am.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 07Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN, start date: 30May2022, stop date: 03Jun2022. The following information was reported: DRUG INEFFECTIVE (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: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral treatment was administered with Paxlovid. The therapy duration was from 30May2022 to 05Jun2022.  Clinical course: Adverse events are noted as nasal congestion, sneezing and body aches. No fever was reported. Event start date denoted as 07Jun2022, 08:00 AM. Outcome reported as recovering. No treatment was administered. Product COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
There was a covid vaccine clinic at the weekly showers available to unhoused people. Pt stated he would like to receive a covid vaccine. Pt completed screening form and marked that he had never received a covid vaccine before. We confirmed this verbally. The vaccine was administered. When I entered the vaccine into the database after the clinic, I noticed the pt had received two doses of Moderna (2/23/21 and 3/23/21) and a booster dose of Pfizer on 11/9/21. Pt is homeless and I have no way of contacting him to inform him he received an extra covid vaccine dose.
Patient in for WCC early in day. One day history of fever with pink eye that was being treated. Given DTaP #4; developed fever, lethargy, and petechial rash. Sent to ER.  Nurse follow up on 08/31/04 states: "Meningitis, Nausea, Vomiting, Fussy, Decreased energy, Septicemia."  Nurse follow up on 09/15/04 states: "meningitis, Nausea, Vomiting, Fussy, Decreased energy, septicemia."
Nausea; Stomach upset; Symptoms of flu; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), INFLUENZA LIKE ILLNESS (Symptoms of flu) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset) and INFLUENZA LIKE ILLNESS (Symptoms of flu). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), INFLUENZA LIKE ILLNESS (Symptoms of flu) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-125543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: The new event influenza like illness was added. The onset date of abdominal discomfort and influenza like illness added and the outcome of the events updated as recovering.
Several days after PREVNAR shot--developed weakness (R) shoulder-now able to lift over her head only with help of her other hand shoulder initially was sore over (R) supraspinatus muscle-(R) hand is fine-not weak or numb. Concern re: rotator cuff tear.
Feels like he has flu; Diarrhea; Extremely sore right shoulder/ it's worse this time; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like he has flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (Extremely sore right shoulder/ it's worse this time) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Feels like he has flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (Extremely sore right shoulder/ it's worse this time). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like he has flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (Extremely sore right shoulder/ it's worse this time) outcome was unknown.            No concomitant medications provided.  No treatment medications provided.   This case was linked to MOD-2021-320078.   Reporter did not allow further contact
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 11-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004089: US-009507513-2306USA004090: US-009507513-2306USA004082: US-009507513-2306USA004088: US-009507513-2306USA004086: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004083: US-009507513-2306USA004084:
Patient reported experienced itching on the Left hand extending to wrist during post-vaccination observation.  Patient went home and self-monitored her symptoms.  At around 1:30pm, she noticed rash/itching on the upper body including both arms and abdomen, torso. She denied pain and other symptoms. Patient was advised to seek PCP consult.
PUI had a fever, chills, diarrhea, nausea, etc. starting on 7 around 7.28. She still has some cough and is getting taste and smell back as of 8/10. PUI was admitted to the hospital on 7/30 and was discharged on 8/3. She is diabetic and went from type 2 diabetes to type 1 since she now takes insulin, so the hospital wanted to have her admitted and taken care of just in case of complications. She was given antibiotics while she was in the hospital. PUI is fully vaccinated with the Pfizer vaccine.
No adverse reaction reported. Pt is 12 yrs old, so he is eligible for pfizer dose for 12 and up, but he received pfizer pediatric dose for 5-11 years old.  It was first dose.
Racing thoughts, inability to concentrate, mood swings, confusion, severe insomnia, hyper activity, irritability, explosive anger, etc.
Blotchy red rash on face and all over body; Underneath the skin is like a pink rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Blotchy red rash on face and all over body) and SKIN DISCOLOURATION (Underneath the skin is like a pink rash) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Blotchy red rash on face and all over body) and SKIN DISCOLOURATION (Underneath the skin is like a pink rash). At the time of the report, RASH ERYTHEMATOUS (Blotchy red rash on face and all over body) and SKIN DISCOLOURATION (Underneath the skin is like a pink rash) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.
a patient was administered a dose of improperly stored ROTATEQ; No adverse effects reported; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions/allergies, and concurrent conditions were not disclosed.  On 07-NOV-2019, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally as prophylaxis (strength and dose number were not provided; valid lot number S005876 expiration date 25-NOV-2020). It was reported that this vaccine had been on a temperature excursion and was stored above 47°F (46.9F) during 37 minutes; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.