chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed uncontrollable chills, night sweats, severe headache and dizziness, nausea, diarrhea and insomnia. Body aches in neck and lower back - then the next day took Tylenol and had severe fatigue and tiredness. Now 5 days later still have brain fog and dizziness and fatigue
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus anticoagulant disorder" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ENOXAPARIN SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Anti-viral details indicated that COVID 19 Treatment Paxlovid from 06Sep2022 to 11Sep2022 for treatment of COVID-19. On 16Sep2022, symptoms of COVID returned, positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About a week after he received his booster he developed symptoms of a cough, sore throat and nasal congestion. Due to his asthma we took him to his allergists where they his assessed asthma. It was slightly low but not severe. The symptoms seemed to get better over the course of two weeks. Then around  07/01/2022 the symptoms returned and he received a negative COVID-19 test and Strep test. He was seen at urgent care and they concluded that it was viral but couldn't conclude what the sore throat was. They didn't give him any medicine.
Initial report was received 12 October 2011 from a health care professional in a country. A 4-year-old male patient had received DTAP (manufacturer unknown, lot number, route, site and date of administration not reported) six years ago, and an unspecified amount of time later, the patient developed erythema multiforme. Outcome was not reported. At the time of this report, the patient was 10 years of age. No additional information was provided at the time of the report. The patient experienced a similar subsequent event which has been captures in case number 2011-09949. Documents held by sender: None.
Dizziness Narrative: dose 1- 30 to 45 min after vaccine lightheaded and dizzy; foggy till 4/10/2021
Flu like symptoms:  muscle aches -quads, bi-ceps & shoulders; chills; fatigue; headache, nausea Thursday May 30th.  Fatigue, muscle aches and loss of appetite Friday May 31st.  Fatigue and loss of appetite Saturday June 1 2019.  Treated as I would the flu - rest, warm liquids, gel advil for body aches.  Slept a lot over the course of the 3 days.  Did not call my doctor, just assumed it was the shot.
pt was inadvertently given HBOC instead of Hep B on 13JUL94;pt was inj w/3.5ml in each buttock (tot: 7 ml=14 doses) of HBOC;19JUl devel redness & swelling of each buttock 6x5cm on rt;5x4cm lt;rx w/APAP & ice;20JUL pain & swelling to legs
patient reported severe dizziness, couldn't stand up and urinated in the bed. Symptoms started around 10:00pm on day of vaccination. Said they seem to be improving  when he notified us the next day 6/19/2020 at 4:40pm
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 6:54 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. No treatment drug details was reported.   This case was linked to MOD-2021-402935 (Patient Link).
Product Availability; This case was reported by a nurse via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. 2 people on patients wait list had ironically gotten Shingles.  Both had suggested that If the patient would have given them the shot this was not have happened. The patient would not give out patient's information.  But, general questions were fine. The reporter consented to follow up. This case has been linked with US2019220446 and US2019GSK238612, reported by same reporter.
Reported by phone. Complain of rapid heart rate for one hour following immunizations. Reports rash on left chest, and  left arm onset 6 hours after injection. Woke up this morning with joint tightness. Took Benadryl last night. Advised Benadryl today, Ibuprofen for joints and see own doctor.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "non alcoholic fatty liver" (unspecified if ongoing), notes: non alcoholic fatty liver; "fibromyalgia" (unspecified if ongoing); "anemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "sclerosis of sacrum in pelvis" (unspecified if ongoing), notes: sclerosis of sacrum in pelvis; "increased brain pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (Oct2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: There were no other medication in 2weeks.Anti viral details included brand paxlovid, with treatment start date 27Sep2022 and stop date 05Oct2022 for COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: redness on the left arm going down to the elbow, patient describes as if somebody chopped into her arm.
pt c/o of sharp pain lt neck & face radiating to forehead 15 mins p/inject; c/o also of nausea, visual disturbance & myalgia over 48 hrs period;
Hives on scalp, neck, trunk and arms and legs. GERD like symptoms came on for the next few weeks, with a feeling of heartburn and something stuck in my throat. Took Allegra for one month and kept hives at bay. Tried OTC stomach meds.  After not taking one dose of Allegra, I broke out worse than first time and have been full of hives and itchiness.  Lips swollen one day.  Doctor suggests Allegra 2X day, Benadryl and omeprazole for stomach /GERD reaction.  Fewer hives once I started a stronger dosage of antihistamines, but still breaking out daily on different parts of my body.  Hard to sleep when itchiness occurs.  It has been just over 2 months with hives and GERD.
Swelling left leg (16 x 1cm 9 cm induration), redness, warm to touch, limping
Pt had received last Dtap-HIB on 03/2/1999, which resulted in ER visit for reaction to shot (thigh became hard tender to touch, red blotches at the injection site). Received Dtap booster on 02/08/2002 and was later seen in office on 02/15/2002 with rash at the injection site and radiating down same leg. Mom said that the pt had hardness/tenderness at the site several days after the booster but not as bad as before.
I waited for 30 minutes instead of the standard 15 minutes (due to how I responded to the 1st vaccine). I immediately became lightheaded. I took 800 mg ibuprofen every 6-8 hours at the time of the vaccine until 1/12/22 when I had an appointment with my neurologist. The first 24 hours I had gotten severe headache/migraines, violent shaking/chills, extreme fatigue/body aches with a strange aura feeling. The 24-48 hours I felt like I had been in a horrible car accident with extreme body pain, horrible migraine and unable to get out of bed. The 48 hours - 1/12/22 when I saw my neurologist the body aches improved but I continued with severe headache/migraines with "pressure" in my face, mild body aches, fatigue, exhaustion and mild joint pain. On 1/12/22 at my neurologist appointment, he instructed me to discontinue taking ibuprofen and prescribed me a 9 day tapered Dexamethasone prescription (I had taken 2 cycles of this after my first COVID vaccine due to similar adverse reactions). Unfortunately, this steroid treatment has not given me any relief but has only caused GI and skin related issues. I continue to experience all the same issues listed above. My neurologist is now considering an IV infusion treatment to "break" my headache/migraine due to this hyper response to the vaccine.
Pt. states that after receiving the 2nd dose of Phizer 08/05/2021, started experiencing dizziness, confusion, numbness the surrounding area of the head, continuing to migrate to the left arm and forearm, in the throat area, and drowsiness. Feeling is continuing to migrate through the left side.
Patient had an initial small localized reaction with induration and erythema but after 5 days developed an urticarial rash inferior to the injection site. no respiratory symptoms. the urticarial rash was about 9 cm in diameter and responded to Benadryl gel topically.
Allergic reaction to the vaccine; Have like a nerve down on my shoulder and down my arm and down my forearm; It is like a pain on my back down; Have like a nerve down on my shoulder and down my arm and down my forearm; It is like a pain on my back down; I broke out in hives. I had it on my left back, on my left arm; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration on 30Jan2021 at noon (at the age 79-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood cholesterol increased (High Cholesterol), gout and hypertension (High Blood Pressure) from an unknown date and unknown if on-going. Concomitant medications included allopurinol (ALLOPURINOL) taken for gout, losartan (LOSARTAN) and simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. Patient got a hold of somebody today and talked to her here at Pfizer (Further clarification was unknown, hence checked as initial report). She said she wanted patient to talk to the medical group and so patient call this number. Patient did not know, could find patient in computer because patient typed everything told her. Patient had a Pfizer vaccine on 30Jan first vaccine. Patient had it at noon, next day, broke out in hives. Patient had it on left back, on left arm. Patient had lot of hives. Patient called up a nurse at ER hospital and went to (Hospital name withheld). The doctor told, he said, patient have an allergic reaction to the vaccine. He said he gave prednisone but he said that would kill the vaccine. So he said what I want you to do is if you can wait till Monday and take it around noon and then you will have 48 hours for vaccine in you. Patient waited for Monday and he said if you get any-more hives make sure you take it then. Well, Patient got more hives. So patient had 5 days of 40 mg on each day, each morning patient took that for 5 days. Patient still have the hives. Patient was doing okay. Patient had like a nerve down on my shoulder and down arm and down forearm, that developed that patient never had before. It was like a pain on back down. So, patient just want to know Patient did not want to take second shot. Patient was afraid to take the second shot because patient was allergic to this one. Treatment include Prednisone. The outcome of the event urticaria was unknown while other events were unknown.   Follow-up attempts completed. No further information expected.
10/15/2020 experienced cramping in legs and pain, unsteady on feet and pins and needles in feet. 10/16/2020 difficulty walking and bearing weight, no balance while walking, knees bucking Went to ER on 10/16 based on physician input of primary doctor's medical exchange
Right deltoid swelled and turned red, 6 x 9 cm area within 24 hours of injection.
No adverse event followed vaccine. Pt. age 10 11/07/2007 given Tdap 8 months too soon.
measles vaccine associated pneumonia in pt. with Hodgkins lymphoma treated with chemotherapy.
Patient was admitted from the Emergency Room for a reaction to a Pneumovax vaccine given on 11JAN2011. He had fever to 102 degrees, headache, confusion, and swelling and redness on the upper right arm at the site of the vaccination. Analysis of cerebrospinal fluid taken during lumbar puncture in the Emergency Room was negative for signs of acute infection (meningitis). Patient received one prophylactic dose of ceftriaxone in the ER before the results of the lumbar puncture were available. Patient's temperature and headache improved with acetaminophen, naproxen, and intravenous fluids. His confusion also resolved rapidly as his fever was controlled. By the afternoon of the day of admission (13JAN2011), patient had improved significantly and was feeling well. His case was discussed with Dr of allergy/immunology who felt this was a vaccine large local reaction. He was discharged home with instructions to continue acetaminophen for fever, and naproxen and ice for pain.
It was a Moderna booster. Approximately 10/11 days after the vaccine, I started experiencing rash all over my body (hives). I was also experiencing joint pain, especially in my wrists
Rash and hives body, arms and legs. Severe itch, 6 Days
p/vax pt exp severe h/a;pt also exp mild nausea assoc w/h/a;
Hives all over my body. Not itchy the first day, starting to get itchy today (second day). This occurred about 60 hours (2.5 days) after receiving the second Moderna shot.
Symptoms started on day 7 After first vaccination. Symptoms included: headache which continued for 21 days, dizziness, blurred vision, light sensory issues, imbalance, night sweats, and tinnitus. Symptoms mostly resolve themselves In 21 days with the exception of tinnitus
Left arm, large red rash/patch/splotch that started as a bump and then after that dissipated, the red splotch has remained. Was somewhat warm to the touch, now is sometimes itchy.
pregnant; the most gnarly bruise, started at the injection site, it was really large, dark and purple; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple) and EXPOSURE DURING PREGNANCY (pregnant) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Fertilization (Genetically normal embryo prior to transfer for IVF). Previously administered products included for In vitro fertilization: Estrogen from 04-Sep-2020 to 20-Nov-2020 and Progesterone since 04-Sep-2020. Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 13-Feb-2021 at 3:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-May-2021. On 14-Feb-2021, the patient experienced CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 05-Mar-2021, CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2020, Pregnancy test: positive (Positive) Positive. On 28-Oct-2020, Ultrasound scan: (normal) Patient's ultrasound results were normal.. On 04-Mar-2021, Gestational diabetes: (Negative) Patient's gestational diabetes results were negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested positive for pregnancy on 14-Sep-2020 and estimated date of conception was 10-Sep-2020. Patient had two anatomy scans on 06-Jan2021 and 20-Jan-2021, results were not reported and scheduled for another scan on 01-Apr-2021. No treatment information was reported.
Four and a half hours after the first dose of Moderna my arm began to ache.  A severe headache followed.  12 hours post injection every joint in my body was in pain.  This continued throughout the entire week.  At 36 hours post injection I had severe chest pains. I went to urgent care and they ruled out any heart problems.  The chest pains lasted for two hours.  The migraine ended after 48 hours.  The body aches ended after 6 days.  I had the Covid 19 virus begging on 3/11/
weakness; Loss of appetite; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHENIA (weakness) and DECREASED APPETITE (Loss of appetite) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (weakness) and DECREASED APPETITE (Loss of appetite). At the time of the report, ASTHENIA (weakness) and DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter.  No treatment information provided.
Right side weakness in arm and leg along with pain in right foot. Hospitalized 10/31/21 .  Multiple MRIs and spinal tap done suspecting  multiple sclerosis or encephalitis.  One demyelinating lesion identify in brain.  No other lesions in spine noted.  Added nortriptyline and vitamin b12 tablets to treat symptoms.
Inflammation, erythema 2 x 3 cm area of injection visit site r upper arm. Will see his PCP today for evaluation
Chest pain; Coughing; Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), COUGH (Coughing) and DYSPNOEA (Trouble breathing) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CHEST PAIN (Chest pain). 09-Apr-2021, the patient experienced COUGH (Coughing) and DYSPNOEA (Trouble breathing). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown and COUGH (Coughing) and DYSPNOEA (Trouble breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
hypotension; dehydration; This case was reported by a consumer via other manufacturer and described the occurrence of hypotension in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced hypotension and dehydration. On an unknown date, the outcome of the hypotension and dehydration were unknown.   It was unknown if the reporter considered the hypotension and dehydration to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's family menber . The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient had hypotension and dehydration 12 hours after vaccination. The reporter asked if the patient should get COVID vaccine or not.
ED NOTES 1/25/22: Patient first noticed blood in L PNT 5 days ago on 1/20, which persisted for 2 days and then stopped. It restarted last night (1/24). Has not noticed clots. Also reporting chills, nausea with her pain (back/"kidney" pain), decreased appetite, shortness of breath, and headache.  Regarding COVID, her son who lives her tested positive about 19 days ago. She had a sore throat 2 weeks ago, which has since resolved. She suspects that she got it from her son as she does not leave the house much beyond that, gets her groceries delivered. They had attempted to quarantine as much as possible with living on separate floors and masks in the house. She did also undergo a PNT exchange 1/5/2022. When her son tested positive, she did do a home test, which was negative at that time. She did not get another test after her sore throat.
Patient fully vaccinated (Moderna) but not boosted admitted to the hospital on 01/31/22 with COVID-19 and associated hypoxia. Patient was discharged on 02/17/22.