chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within hours of the Saturday, 1:30 PM injection, fatigue, headache, and worsened muscle & joint pain were experienced. That evening/night, high fever and chills (in addition to all listed above) began, as well as loss of appetite (all he ate all day was a dish of vanilla ice cream) and nausea. Sunday , vomiting began accompanied by abdominal pain. This has continued through until this reporting on Tuesday at 1PM (over 48 hours in duration at this point). With the exception of a little ice cream on Sunday, he has been unable to consume food since lunch on Saturday, which he ate immediately following his injection. He has been unable to hold down even small amounts of ginger ale.
Information has been received from a nurse, for (Oka/Merck) VARIVAX, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's medical history and relevant past drug history was unknown. On 16-MAR-2015, the patient was vaccinated with (Oka/Merck) VARIVAX injection (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date in 2015, the patient was pregnant after receiving (Oka/Merck) VARIVAX. The patient's pregnancy had not been confirmed at the HCP office. The last menstrual period (LMP) and expected date of delivery (EDD) was not known. The pregnancy outcome was unknown. No adverse effects reported. Additional information is not expected as there is no reporter's contact information.
Left elbow redness, swelling from just above left elbow into mid forearm, warm to touch. Levaquin 500MG PO QD for 7 days.
This spontaneous report was received from a nurse referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 15-SEP-2017, unspecified number of doses of M-M-R II lot number M000768, expiration date 05-JAN-2018 were stored in temperature of 10 degrees Celsius for 1 hour and 12 minutes. 26-SEP-2017, one dose of improperly stored M-M-R II lot number M000768, expiration date 05-JAN-2018 (dose, route of administration and were not reported) was administered to the patient. No adverse effects have been reported. There was no previous excursion reported. Data logger was involved. Product quality complaint was not involved.
Information has been received from a physician concerning a pediatric patient who in 1999 was vaccinated with a dose of varicella virus vaccine live. In 2003 the patient had a "mild breakthrough" . Subsequently,the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. On 21JAN2004 it was reported that the patient was unknown. No further information is expected.
This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a  patient of unknown age and gender. On 07-JUN-2013 the patient was vaccinated with a dose of GARDASIL (lot # H021608, exp. date 13-AUG-2013) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1C for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1306USA007793, 1307USA006245, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250. Additional information has been requested.
Expired GARDASIL 5/27/17 given 6/7/17. No adverse reaction.
drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am.; drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 at 10:20 as dose number unknown (booster), 0.3 ml single (Lot number: GJ3277, Expiration Date: May2023) at the age of 59 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 30Nov2022 at 10:20, outcome "unknown" and all described as "drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am". Additional information: Pharmacist from [Facility name withheld] is calling about a 59-year-old female patient who received the bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine today but was inappropriately stored.  Product was drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am.
Bell's palsy; This is a spontaneous report from a contactable pharmacist. A elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration on an unspecified date as a 1st dose single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the description, the caller was a pharmacist who called on behalf of a patient who received the first dose of the Pfizer covid vaccine and developed bell's palsy. The caller stated that the patient is an elderly with a high risk for covid 19 infection and the caller was looking for guidance on second dose of the Pfizer Covid 19 vaccine for patients who develop bell's palsy after the first dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's palsy and the suspected vaccine BNT162B2  cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
denied further adverse event; the patient was administered ROTATEQ on 06-MAY-2021 that expired 01-MAY-2021; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was reported.  On 06-MAY-2021, the patient received an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660994, expiration date: 01-MAY-2021, at dose of 2 milliliter, orally for prophylaxis. The reporter denied further adverse event.
Red and swollen left deltoid (site of Quadracel Injection). No fever, streaking or rash Mother instructed to watch the site and to follow up it the redness/swelling worsens.  Upon follow up by phone, mother states the site was iby the following day.
1 1/2" deep red & blistered center 5 1/2" x 10" outer lighter red area arm swelled from shoulder to elbow red-heat full of hear-itching achy, unable to sleep, headache, felt unwell. The swelling & redness continued for 5 days.
Client states she feels lightheaded and that she feels like she is going to pass out.  Pt sitting in chair in lobby, pale looking.  Encouraged slow deep breaths in her nose and out her mouth while fanning then pt.  Assisted by RN w/ a cool wash cloth to forehead and garbage can b/c pt state she feels like she is going to vomit.  Pt vomits large amount of undigested food.  Sstate she is feeling a little better.  Color improving to a light pink.  Client given juice to drink.  Client assisted back to clinic room laying down on table for 10 minutes w a cool fan on her.  After 10 min client states she is feeling better.  Cont to drink juice. Pt goes back out to waiting room and instructed to sit for 10 more minutes and to notify us if she feels lightheaded again.  Verbalized understanding.  After sitting for 10 minutes pt states she feels good enough to leave.
first dose, sore arm for a day or 2; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Muscle achiness" (unspecified if ongoing), notes: Verbatim: Muscle achiness; "high blood pressure" (ongoing), notes: Verbatim: high blood pressure; "breast cancer", start date: 2016 (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: series of 3 months of chemo. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "first dose, sore arm for a day or 2". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has high blood pressure, she takes a prescription blood pressure med for that, she takes supplements like vitamins on her own. No further information provided. She does have a history of breast cancer that developed in 2016 she went through a series of 3 months of chemo and she is being monitored for the cancer. She has been checked regularly for 5 years by her chemo lady and the surgeon. They check her every 3 months, so she is being monitored for that. She does not know if that makes any difference but it was what they called an aggressive, invasive triple negative type cancer. They described it as invasive and aggressive but she had one small lesion and they decided it was a grade 1 but she researched it online and that type has a higher percentage of coming back sooner than 5 years. She does not know if that has any bearing but she has had yearly chest x-rays and mammograms and those have been negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476097 similar report from same reporter
Skin felt hot and itchy and turned red and blotchy on neck, face, torso, arms and upper legs. Took BENADRYL and it went away. Symptoms reappeared at 3:00 am July 4 waking me up. Took BENADRYL and symptoms went away.
Initial case received on 05 August 2010 from the patient's mother. An 18 year old male patient received a left deltoid intramuscular injection of MENACTRA (lot not reported) on 05 August 2010. Approximately "15 minutes later" on the way home, the patient experienced nausea. He then curled up in a ball, clenched his fists, became tense and "stiff as a board" lasting for a few minutes. After that he was sweating and complained of a headache. The patient had no illness at the time of vaccination. He received no vaccinations within 4 weeks. Pre-existing medical conditions included possible allergy to cherries and apples. No other medical history was reported. Medications included CLARITIN as needed (PRN), but he was not on currently. At the time of this report, the patient continued to have a headache and stated he felt "like he was run over by a truck". He also complained of a sore throat. Documents held by sender: None. The mother also reported an adverse event for her daughter, which is captured in case number 2010-04269.
On day of injection arm was sore with some muscle pain across chest briefly.  Neck and shoulder pain. 3 days later swelling and severe pain in lymph node in armpit area on injection arm.  Full body muscle and joint paint following that with feeling warm no temp was taken.  Basically it felt like I got hit by a truck later that evening.  Feel very fatigued.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 17-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received Pfizer Peds (5-11) 0.2 ml dose and should have received Pfizer grey cap 0.3 ml dose.  This was dose #1.  Patient received appropriate Pfizer dose for dose #2.
pt states she has had no physical reaction to the covid vaccine.  She has been celibate for four years.  She gave blood the first of May 2022 and has since received a letter dated 5/20/2022 stating she had syphilis.  She says there is no way this is possible and the only thing that she had was the Covid vaccine.  She is going to her PCP for blood test to confirm this diagnosis.
Saturday had chills and body aches. Have a reddened, swollen area to injection site. Warm to touch. Still present at this time.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
"Large, red, swollen welt at injection site, pt stated she was having trouble breathing and felt like her throat was swollen. Pt said happened a few hrs after shot, she used an EPIPEN, started BENADRYL next day.
Initial unsolicited report received from nurseon 16-Oct-2015. This case involves an 11-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number: U5309BA, expiry date: 30-Jun-2016) in left deltoid on 14-Oct-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 15-Oct-2015, one day after vaccination, the patient experienced red and puffy left arm pit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from nurse on 20 January 2016. No additional information provided. Reporter states that trail with parent was done and no complaints were voiced.
Red, swollen area at injection site about 3 inches in diameter.  Feels warm to the touch and like a bruise when touched.
R09.02 HYPOXIA 4/26/2023 ATHEROSCLEROSIS OF AORTA
Arm was painful for day of and 2 days after injection-on Wednesday (3 days after arm went completely numb. Advised pt to f/u w/MD.
This person got the Covid 19 vaccine and died 3 days later; This is a spontaneous report from a contactable consumer. An 80-years-old male patient received dose of BNT162B2 (reported as COVID 19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included prostate cancer and chemotherapy. The patient's concomitant medications were not reported. The reporter stated she knew a radiology technician who mentioned the patient that was going through chemotherapy at age 80 for prostate cancer. This patient got the Covid 19 vaccine and died 3 days later. She thought it was a bad call for this patient to get the Covid 19 vaccine. She stated some people might think that because of being immune compromised those people might succumb to the Covid 19 virus. She asked in certain patient populations, like if someone is receiving chemotherapy, is it recommended that the Covid 19 vaccine be given. The report was serious with seriousness criteria-results in death. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: This person got the Covid 19 vaccine and died 3 days later
Severe Headache all day. Headache subsided with Tylenol 500mg  taken in the evening the day after the shot. This was the worst headache I?ve ever had. 100 degree fever. Excessive thirst. Chills. Muscle and body aches.  Pain at injection sight.
pt reacted to vax & devel erythema, hives @ area of inj w/some tenderness & pruritus noticed day p/vax;
I am a immunization nurse at this location.  I gave 2 of the first 4 Covid vaccinations given at our location.  Then I received dose # 5.  It was easy.  I did a couple of things and then returned to my desk.  As I sat down, my arm started feeling very heavy.  I was unable to send a text.  I told staff that I was feeling funny and that I was going to the other room to lay down.  Staff followed me and took my Pulse 100 and BP 164/ 82 (high for me!)  .  I felt shaky, but my hands were not shaking.  Put a wet cloth on my head and laid there a few minutes, telling staff stories and laughing at my BP.  When I sat up, my BP was 126/74 and pulse was 80.  I stood up for a minute or two, then my legs got heavy and I sat down for a few more minutes.  I went to the bathroom and came back to my desk, but was weak and tired.  I ate and drank some fluids.  Because it was snowing  and I live 25 miles away, I accepted a ride home from a co-worker.  I walked across the parking lot without problems and talked all the way home.  At home, I was tired, but had a sandwich and talked on the phone.  I would still describe myself as tired, but functioning.
Continues to have pain around the injection site in her right arm; Continues to have pain around the injection site in her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (first dose received around Spring 2019.refer linked case US2020166806).   In July 2019, the patient received the 2nd dose of Shingrix. In July 2019, immediately after receiving Shingrix, the patient experienced injection site pain and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had pain around the injection site in her arm. The pain was not on the injection site.  The pain was off and on and pain was there mostly when she wakes up from her sleep. The follow up consent was granted; Sender's Comments:  US-GLAXOSMITHKLINE-US2020166806:1st dose
feeling sick with covid symptoms; feeling sick with covid symptoms; feeling sick with covid symptoms; This is a spontaneous report from a Pfizer Sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient felt sick with COVID symptoms on 03Feb2021. Second dose is scheduled 11Feb2021. Patient wondered when she should receive the second dose of the vaccine. The outcome of events was unknown.  Information about batch/lot number has been requested.
slight metallic taste" on the back and sides of her tongue; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 15 minutes after the patient received her first dose of the Pfizer-BioNTech Covid-19 Vaccine in Jan2021, she noticed a "slight metallic taste" on the back and sides of her tongue. She wanted to know if this was a common side effect and if there have been reports regarding it. Outcome of the event was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Started running fever on 4/18/11 around 4:30 pm and had headache. Fever 102.0 degrees 6am 4/19/11. No c/o headache this AM. Mother has given him Ibuprofen this am. She was instructed to give him tepid bath or sponge bath. Continues Ibuprofen and TYLENOL alternated as per Dr. If fever increases and continues to contact Dr. If disoriented, neck pain, increased fever, increased HA go to ER or call ambulance.
Diagnosed with autoimmune hepatitis in October 2021; c/o dark urine, abdominal distension, general malaise, elevated LFTs
I flinched and tightened up my arm at the time of injection.  I got all common side effects within 5 hrs. of injection on 08/07/2021. Chills, aching body, headache, fever, terrible back and leg pain. Plus weakness, and lack of energy, that is still happening as I fill out this form. Runny nose, and sore throat the 2nd and 3rd day after injection.  These side affects were worse than when I actually had the virus. I am filling this form out on 08/10/2021 at 1:38 pm.
I am perimenopausal and have not had a period in almost 11 months. I started a light period on 4/22 in the morning with light cramping and it continued to be light all day. By 4pm I started to have painful abdominal cramps that became severe. I took about 8 doses of OTC naproxone between 5:30am-8pm but still experienced severe pain that kept me immobile from about 5pm to 9:30pm when I fell asleep. I woke up Friday 4/30 with continued light bleeding. At about 9am the bleeding became profuse for about 10 minutes soaking my pad and pants. Then it returned to light bleeding. This is not a typical period for me.
Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol, Remdesivir In-patient
PATIENT MISTAKENLY RECEIVED A FOURTH DOSE OF GARDASIL. DOSAGES GIVEN OF GARDASIL 9 ON 6/1/16, 8/9/16, AND 12/16/16 SHOWED NO ADVERSE EFFECTS. DOSAGE GIVEN ON 8/8/17 CAUSED LARGE WHEAL AT SITE WITH SIGNIFICANT ITCHING AND URTICARIA. APPLIED TOPICAL STEROID TO SITE.
fevers, cough, elevated trop 1.45, low voltage EKG, possible myocarditis 10 days post vaccination with the 2nd dose.  Also tested positive for COVID 19 with CT of  35 (had COVID in April) - unclear if this is reinfection vs vaccine effect