chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; MUSCLE ACHES; HEADACHE; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, muscle aches, headache, fever, and extreme fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle aches, headache, fever, and extreme fatigue. This report was non-serious.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 22Apr2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and allergy to lobster (shellfish allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), atorvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 20:00, the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial information received from a physician. This case involves a male patient (reported as vaccinated at 7-8 years) who experienced narcolepsy, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s) and vaccination(s) were not provided. Family history includes both parents carry the narcolepsy gene. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious narcolepsy (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that both parents carry the narcolepsy gene so the patient would have developed narcolepsy at some point anyway. The patient was 7 or 8 years old when he got the vaccine and the parents state he developed narcolepsy soon afterwards. The physician states that because of this, they are now refusing other vaccines for their son (patient). (Other relevant tests included No lab data.) Final diagnosis was narcolepsy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for narcolepsy. List of documents held by sender: none. Sender's Comments: This case involves a child who presented with narcolepsy post vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, medical condition at the time of vaccination, laboratory investigations excluding other etiology would be needed to fully assess this case. Moreover, reporting physician states that both parents carry the narcolepsy gene so the patient would have developed narcolepsy at some point anyway. Based on available information the role of vaccine cannot be assessed.
headache; fatigue; Up all night with dry heaves; Dizziness; just not feeling well at all; Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; ASPIRIN 81; ZETIA; STATIN [ATORVASTATIN CALCIUM]. Vaccination history included: BNT162b2 (Suspect Products: Pfizer Covid 19 Vaccines, Third Dose or First Booster Dose: 01Dec2021 Lot: FH8030), administration date: 01Dec2021, when the patient was 80-year-old, for COVID-19 Immunization; BNT162b2 (Suspect Products: Pfizer Covid 19 Vaccines, Second Dose: 04Mar2021 Lot: EN6205), administration date: 04Mar2021, when the patient was 80-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Fatigue"; BNT162b2 (Caller states he has had the 4 Pfizer Shots for Covid, Suspect Products: Pfizer Covid 19 Vaccines, First Dose: 11Feb2021 Lot: EL9266), administration date: 11Feb2021, when the patient was 80-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Fatigue".  The following information was reported: PAIN (life threatening) with onset 11May2022, outcome "recovered" (14May2022), described as "Achiness"; DIZZINESS (non-serious) with onset 11May2022, outcome "recovered" (14May2022); RETCHING (non-serious) with onset 11May2022, outcome "recovered" (14May2022), described as "Up all night with dry heaves"; MALAISE (non-serious) with onset 11May2022, outcome "recovered" (14May2022), described as "just not feeling well at all"; FATIGUE (non-serious) with onset 12May2022, outcome "recovered" (13May2022); HEADACHE (non-serious) with onset 12May2022, outcome "recovered" (13May2022). Therapeutic measures were not taken as a result of pain, headache, fatigue, retching, dizziness, malaise.  Clinical course was reported as: Caller states he has had the 4 Pfizer Shots for Covid and the first 3 went fine but the 4th one he had a problem with. Caller states he was talking to his doctor's nurse about it and she said he should report it. Caller states he had a severe reaction to the fourth vaccine. Caller states he had a headache and fatigue which he had with the first 3 too but this one he was up all night long with dry heaves, dizziness, achiness and just not feeling well at all. Caller states he had Covid before any of the vaccines were available so he knows it is not a good thing to have. Treatment: Stayed in bed a lot. Did any AE(s) require a visit to: Emergency Room? No; Physician Office? No, but he called and she was going to get him in the next day, but he was feeling better by then so he didn't go.  It was None patient receive any other vaccines within four weeks prior to the vaccination. It was None patient had AE(s) following prior vaccinations. Family Medical History was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200720141 Same patient, same event, different dose
Tight chest pains, extreme nausea and upset stomach, diarrhea, dizziness
p/vax pt exp high temp 102-103 for 2mo of unexplained, abd cramps & abd f/u from MD reported no concurrent illnesses or post med hx;pt also exp hematuria x 1wk;fever 105.8 x1mo;also exp hepatosplenomegaly x1mo;fatigue, muscle & joint pain;60 day follow-up received on 10/25/00 provided no additional data.
N/V, RASH ON CHEST, PROGRESSED TO NECK AND LOWER JAW. DENIES ITCHING OR NO SWALLOWING DIFFICULTY.
Gave IMZ, turned to give next IMZ and patient fainted, fell out of chair to floor
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster with complications. On or about 16-JUN- 2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Feverish; cold chills; feel rough; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  The case was related to 2020SA314462 and 2020SA314438 (cluster case).   This case involves adult patient of unknown gender who reported of feeling feverish (Pyrexia), cold chills (chills) and felt rough (feeling abnormal), after being vaccinated with INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that every time the patient received a shot felt feverish (Pyrexia), experienced cold chills (chills) and felt rough (feeling abnormal), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.  There will be no information available on the batch number for this case.
Patient states that she has numbness/pain starting 2-3 days after shot.  She states that it is worst at night.  It starts in her shoulder and travels to the tip of her fingers.  She said that her finger will curl on occasion as well.  Her doctor stated that she should wait until symptoms resolve to get the second shot.  Patient stated that she did not want to wait for the second shot because she had to push back the date of her mammogram and doesn't want to push it back any longer.  She received the second shot on 9/1/21.  I spoke with the patient on 9/2 and she stated that she has a sore arm and that the numbness and pain is happening currently.
17 y/o pt felt light-headed w/ blurry vision.  Pt slumped down but did not lose consciousness or hit head.  Pt sat in immunization chair in booth for 15 min, drank some Gatorade that his father provided, and felt better.
PT GOT DIZZY, BP UP A LITTLE.PT WAITED AN HOUR THEN WENT HOME. TALKED TO HER LATER SAID HAD WORKED ALL DAY, JUST FELT A LITTLE FUNKY.
Patient report that she feels extreme weak, she has chills and cough. She is very congested and feels horrible
Scheduled for second COVID-19 Vaccine in 19 days; Had a serious heart condition; This is a spontaneous report from a contactable consumer. A male patient (consumer's brother) of an unspecified age received first dose of BNT162B2 (COVID-19 Vaccine, Solution for injection, NDC number: Unknown) via an unspecified route of administration on an unspecified date (Batch/lot number: Unknown, Expiry Date: Unknown) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that scheduled for second COVID-19 vaccine in 19 days and had a serious heart condition on an unspecified date. She was also concerned because she read online the COVID-19 vaccine may not be as effective if the second dose is received less than 21 days from the first dose. Her brother had his first COVID-19 Vaccine  and was scheduled for his second dose in 19 days. Wants to confirm this information. Had no NDC/Lot/Expiration to provide for her brother's COVID-19 Vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After getting shots, client's right arm was sore for several days and on 3-9-10 was running a temp 100.3 and couldn't raise her arm above shoulder height.  Advised to see doctor who gave antibiotics.  3-10-10 no fever and was able to go to school.
Pt presented to office on 5/21/08 with hx of cold sx and rash all over x 3 days. Exam: 50-75 vesicular lesions scattered all over. No history of fever. Aveeno, Benadryl, Calamine recommended. No ASA. Isolate, recheck prn.
Little achy; Cold; sore at injection site; This is a spontaneous report from a contactable other non-health professional. A 47-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3247, Expiration date: Unknown) via an unspecified route of administration, in arm left on 16Feb2021 at 11:30 as single dose for covid-19 immunisation. Prior to the vaccine the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for covid-19. Medical history included dose 1 of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3247, Expiration date: Unknown) via an unspecified route of administration, in arm left on 27Jan2021 at 10:30. No known allergies. Patient concomitant medications included atorvastatin calcium and colecalciferol.   On 17Feb2021 at 10:00 (after vaccination), the patient began feeling a little achy and cold. Nothing too extensive. Also sore at injection site. The outcome of the events was recovering on an unspecified date.
no adverse efect reported; patients received improperly stored dose of varivax; This spontaneous report was received from a Medical assistant regarding to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 03-APR-2019 the patient was vaccinated improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error) lot # N027618 and expiry date reported 04-OCT-2019 (strength, dose, frequency, route were not provided) for prophylaxis. No adverse effects reported (no adverse event). The medical assistant was described temperature and time frame details about varicella virus vaccine live (oka/merck)(VARIVAX).  Temperature total time in the range 6 degree Fahrenheit to 14 degree Fahrenheit (-14 degree Celsius) multiple excursions. Time frame cumulative 1 hour 3 minutes. It was also reported that temperature total time in the range 15 degree Fahrenheit to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) and time frame 32 minutes. Temperature total time in the range 47 degree Fahrenheit to 77 degree Fahrenheit (9 degree Celsius to 25 degree Celsius) total time frame 2 hours 39 minutes. The temperature excursion details was reported.  Temperature and time frame: -14 degree Celsius to -10 degree Celsius at 1 hour 3 minutes. Temperature and time frame: -9 degree Celsius to 8 degree Celsius at 1.3 Celsius 3 hours 11 minutes. It was reported that there was no product quality complaint. Digital data logger was involved. The outcome of product storage error and no adverse event was unknown.
Started having horrible pain in top left leg.; I have an injury to my back; My top legs feel tight and hard to walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 (Lot number: EW0161) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "fibromylia" (unspecified if ongoing); "rheutamoid" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "back and nerve injury" (unspecified if ongoing); "back and nerve injury" (unspecified if ongoing); "known allergies: macrodation" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; CALCIUM; VITAMIN C [ASCORBIC ACID]; ZINC; VIT D [COLECALCIFEROL]. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline". Vaccination history included: Bnt162b2 (1st Dose, vaccine location=Left arm, administration date=27Mar2021,, brand=Pfizer,, lot number=ep0161,), administration date: 27Mar2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Started having horrible pain in top left leg."; MUSCLE TIGHTNESS (non-serious) with onset 30Apr2021, outcome "not recovered", described as "I have an injury to my back"; GAIT DISTURBANCE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "My top legs feel tight and hard to walk". The events "started having horrible pain in top left leg.", "i have an injury to my back" and "my top legs feel tight and hard to walk" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, muscle tightness, gait disturbance.  Additional information: Patient did not received any other vaccine in four weeks. Patient received steroid as a treatment for AE. Patient did not had COVID-19 prior vaccination. Patient tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a 21 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 16-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Patient inadvertently received lower dose (for 5-11 year olds, 10 mcg) rather than age-appropriate 30 mcg dose
After receiving the vaccine I had waited for 15 minutes to be observed. I then went home. I had felt normal and fine. Then I was standing up in the kitchen cooking dinner. I turned and opened the fridge to get parsley out, and then after that I didn't remember anything. My daughter heard me fall and she said I was laying on the kitchen floor bleeding because I hit my forehead and chin on the counter top. She said I dropped like a rock, and I didn't make any noise. When I was talking to my daughter at the time of me cooking, she said I was mid sentence, and then I had stopped talking and then she heard the big crash. She said I was not breathing at all. She said she was shaking my shoulders, slapping my face, and calling out my name for 45 minutes. She said I was out of it while not breathing or moving. I wasn't moving or having any jerky movements. I remember waking up. and she was crying saying "Mama Mama what happened?" She was frightened so that's why I went to the ER on 3/21/2021. They didn't diagnose me with anything else except that I had an Atypical Seizure. They said I needed to have my PCP schedule me to see a neurologist because what I experienced wasn't normal. My mind wasn't clear. I felt fatigued and felt like something wasn't right with my body. I had no awareness while it was happening and hindered awareness after several hours of it happening. I've had seizures before but this one is atypical. My daughter has been home before a couple of times and experienced when I have had some of my seizures. She said this one was different. She said with previous seizures she could hear me breathing and making gurgling noises, but I wasn't making any type of noise this time. She is an adult. She is 34 years of age so she knows and understands what goes on when I have seizures. 2 days later after having the seizure I started to feel normal again. Ever since getting the vaccine I have been frequently having more seizures.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. Since 13-JAN-2016 doses of PROQUAD (Merck) (lot # L040412, expiration date 13-APR-2017), which were exposed to temperature outside of the recommended range (at -12.1 Centigrade for 15 to 30 minutes) on 13-JAN-2016, had been administrated (dose and route were unknown) to unspecified patients. There were no temperature excursion issues previously (incorrect product storage). Concomitant therapies were not reported. No adverse experience was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
1-24 hours lAter - facial swelling, 2- Over 24 hours hives like patch right shoulder - back 3 - 7 days later: abdominal-groin: sharp, painful extending lines of pain as if a spray of needles 4- breathing issue when reclining trying to sleep - have to stand
Shingrix: patient missed the 2nd dose. First dose was given a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix, a year ago, prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, patient received 1st dose of Shingrix, a year ago and date was not provided. No other details of vaccine/patient was provided. The VAERS details for 1st dose were provided. The reporter consented to follow up.