chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1.  Seven years post-menopausal:  started having REAL menstrual cycles  which lasted 7 days, every other week for 5 1/2 months, then stopped,
Person called reported having a reaction to the H1N1 vaccine. Stated she had chills and nausea for three days after receiving the shot. Felt bad, stayed in bed for about 3 days.
pt recvd vax; 3 hrs later,mom brought pt back, c/o a 10 mins episode of "shivering";unusual whimpering & n;no vomiting but ha;sxs began approx 45 mins p/ vax;physical assessment unremarkable & pt dismissed home w/warning signs & precautions
Pt had PNEUMOVAX on 2/1/17, to (R) arm. Over next couple of days pt developed sunburn type rash to whole body and cough. (R) arm swelled at injection site, warm to touch, tender. Temp of 101-7. As of 2/8/17 symptoms improving.
BODY ACHE; EXTREMELY TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHE) and FATIGUE (EXTREMELY TIRED) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (BODY ACHE) and FATIGUE (EXTREMELY TIRED). At the time of the report, PAIN (BODY ACHE) outcome was unknown and FATIGUE (EXTREMELY TIRED) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624592 (Patient Link).
Fever 100.4, chills, headache. Took Ibuprofen  to reduce fever.  The following  night took  cold and flu  medicine.
Pt received the COVID 19 Moderna Vaccine on 12/29/20.  On 1/03/21 PT reported to her supervisor that she had developed symptoms and had been tested for COVID-19, which came back positive.   Received bamlanivimab infusion on 1/4/21.
Information has been received from a 72 year old male pharmacist with no medical history or allergies who on 28-AUG-2007 was vaccinated IM with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant therapy. The pharmacist reported that on 28-AUG-2007, he experienced pain that shot up his arm (unspecified), up the shoulder and down which lasted approximately 90 seconds. The pharmacist indicated that he was a little sore the rest of the day, but recovered the same day. No laboratory/diagnostic tests were performed as medical attention was not sought. This is one several reports from the same source. Additional information has been requested.
Pain in her left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in her left shoulder) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in her left shoulder). The patient was treated with IBUPROFEN ongoing since an unknown date for Arthralgia, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date for Arthralgia, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Pain in her left shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  Treatment details included Ibuprofen and Tylenol combined.   This case was linked to MOD-2021-066923 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional info received
Information has been received from a consumer concerning a approximately 15 months old male with egg allergy, peanut allergy and beef allergy who in October 2007, was vaccinated with VAQTA. It was reported that the patient received a number of vaccines on this same day. It is unknown at this time the name of the other vaccines that the patient received on that day. In October 2007, after receiving the vaccines, redness, swelling and rashes developed on both of the patient's legs in the areas of the injection sites. Subsequently, the patient went to a restaurant and ate some beef. Thereafter, the patient broke out with hives on his body and he was taken to a local hospital where he was admitted and discharged the same day. It is not certain if the hives were due to any of the vaccines he had or were due from the beef he ate. It was reported that the patient's mother is going to check with the physician's office about the specific vaccines that her son had back in October 2007. It was reported that the patient recovered from the event. No product quality complaint. Additional information has been requested.
pt recvd vax;to clinic w/ maculo papular confluent rash over trunk, neck,back,buttocks genitalia;afebrile & apparently has no oth sxs; mom states pt broke out about MN last noc;apparent adverse rxn to MMR;
headache, fatigue, body aches, joint pain, arm pain, sinus swelling, chills x 48-72hrs; also left sided face/neck/chest/axilla/supraclavicular moderate swelling w/ headaches and neck pain
This non-valid spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 16-NOV-2017, the patient was vaccinated with expired dose of M-M-R II (albumin status of rHA) (dose, route of administration and site of administration were not provided) lot # L041455, expiration date 22-OCT-2017. No adverse effects were reported. The outcome of the event was unknown.
Patient states she didn't feel good 20 min after vaccine but she went to work. Morning of 3/23/16 states she felt like she had a fever but she didn't take it, felt worn down, achy. At 1000pm 3/23/16 she had a 103 degree F temp with body aches, chills, fatigue. The morning of 3/24/16 states temp was 97.9 degrees F and she went to work but now felt run down again and like she has a fever but hasn't taken it yet. Client called the HD once she left work today and was headed home. RN informed her that her symptoms last night are similar to flu symptoms and flu is going around right now in our area. RN advised to consider going to the Dr. to be tested for the flu. RN informed her that she would complete a VAERS report and send in.
Stiffness muscle; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness muscle ) and PAIN IN EXTREMITY (Pain in arm ) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (She had surgery in her left arm.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness muscle ) and PAIN IN EXTREMITY (Pain in arm ). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness muscle ) and PAIN IN EXTREMITY (Pain in arm ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR on 08-May-2021 included no new information. Consumer doesn't want to provide email ID over phone and She doesn't have access to fax.
22jan90 pt vax hepta B.  after 5 min pt ex weakness, vertigo, lightheadedness, nausea.  pt presented to er and ex. shortness of breath w/ chest tightness.  pt treated w/ benadryl, sus-phrine. pt then devel. rash around neck.   See worm...
Improper booster dose given. - Pt had completed a primary series of Janssen in May and was eligible for the Moderna booster of 0.25mL.  Pt received 0.5mL of Moderna Vaccine   Pt has shown no ill effects of increased dose.
Patient received the first dose of the vaccine as a booster (Half dose); This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received the first dose of the vaccine as a booster (Half dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Patient received the first dose of the vaccine as a booster (Half dose)). At the time of the report, UNDERDOSE (Patient received the first dose of the vaccine as a booster (Half dose)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. A patient received the first dose of the vaccine as a booster (Half dose). The second dose was a full dose. No treatment medications were reported.
Pt recvd 2 doses of Engerix-B & following 3rd dose exp a rash all over & ?edeam;
This spontaneous report as received from a licensed practical nurse refers to a 16 year old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2016 (also reported as 10-JUN-2017) when the patient was 16 years, was vaccinated with (Oka-Merck) PROQUAD lot # M004895 expiry date 26-JUL-2017. No adverse events were reported. Additional information has been requested.
Information has been received from a health professional concerning a healthy 9 year old female who on 10-MAR-1997 was vaccinated with a dose of varicella virus vaccine live (lot# 621192/1550D). On 16-MAR-2004 the pt experienced breakthrough described as a mild rash and itching. Medical attention was sought and the pt was treated with Benadryl. No product quality complaint was involved. The nurse also reported another pt (WAES0404USA02192) who experienced breakthrough after vaccination with varicella virus vaccine live. Additional information has been requested.
p/vax at 4PM pt had hypotonic-hyporesponsive episode x 20min;  then had another episode 6PM for 15-20min; described as unresponsive, limp, apnea for 10-15 seconds;purple lips;
severe painful colon cramping; Severe Spasms; Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (severe painful colon cramping), MUSCLE SPASMS (Severe Spasms) and DIARRHOEA (Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced GASTROINTESTINAL PAIN (severe painful colon cramping), MUSCLE SPASMS (Severe Spasms) and DIARRHOEA (Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea). On 25-Feb-2021, GASTROINTESTINAL PAIN (severe painful colon cramping), MUSCLE SPASMS (Severe Spasms) and DIARRHOEA (Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Doctor prescribed muscle relaxers to take 12 hours before receiving the 2nd dose and she received the 2nd dose 25 Mar 2021. First dose reaction was so bad that on a scale of 1 to 10 she had a 15 reaction.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporters address added. Second dose information added. Reporters first name updated. Reporter type and occupation were updated.
NO REACTIONS TO THE VACCINE. VACCINE WAS GIVEN BY MISTAKE TO A CHILD THAT WAS TO OLD FOR THE VACCINE.
got the shingles shot and then got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient got the shingles shot and then right afterwards got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
pt described 1st feeling shaky & noted that arm was red, swollen & itchy;felt heart was racing & throat felt funny;lasted for 3hr then began to poss;pt did not seek an medical attention;
she had large raised, red area around injection site, today looks less swollen; she had large raised, red area around injection site, today looks less swollen/left arm swollen; left arm hard; caller is thinking the vaccine was admistered subcutaneously and not in the muscle/felt like the injection did not go into her muscle; This is a spontaneous report from a contactable consumer(patient) via a Pfizer Sponsored Program Support.  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number:ER8731) subcutaneous, administered in Arm Left on 16Apr2021 07:50(at the age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included overweight, migraine. Concomitant medication included naproxen sodium, sumatriptan succinate (TREXIMET) taken for migraine, start and stop date were not reported.  The patient previously received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number:ER8727) Injection administered on Arm left on 23Mar2021 for COVID-19 immunisation and imitrex for migraine. Patient had the second vaccine Pfizer on Friday and when she was given injection she jumped. The patient is thinking the vaccine was administered subcutaneously and not in the muscle Stated that it did not feel like it went into her muscle at the time. Patient had large raised, red area around injection site Stated that since Friday it was swollen. Stated that it was swollen Friday, Saturday and Sunday and has went down a little bit. Stated that she is afraid it went in subcutaneously. Clarified that it is her left arm that was affected and stated again that she is afraid if the second dose did not go in correctly that she is not fully protected. Stated that she did not feel the same kind of expansion like the first dose. Patient took Imitrex injections and has the same type reaction. Stated that she does not think that it goes into the skin. It was more than five years ago that she had this happen and was taking them. Stated that she stopped taking Imitrex. Stated that she takes a different medication now because she is scared of the shot. Later stated that she still takes Imitrex but that it has something added to it and is called Treximate now. Patient Stated that she put ice on her arm and took some Tylenol. The outcome of the events Incorrect route of product administration was not recovered and for Vaccination site erythema unknown and for all other events recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up (19Apr2021): This is a follow-up spontaneous report from a contactable consumer includes: age, age at vaccination, historical vaccine, past drug, concomitant medication and new event(Pain in extremity) were added.
His neuropathy is off the hook, really bad; Condition aggravated; Severe pain in his arm; A spontaneous report was received from a consumer concerning a 62-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced symptoms of neuropathy gone through the roof and really bad and pain in arm.  The patient's medical history states he has an autonomic nervous system problem. Concomitant medications were not reported.  On 26 Feb 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 022M20A) for prophylaxis of COVID-19 infection.   Patient received the vaccine on 26 Feb 2021 and reports that day he had severe pain in arm for around a week. His neuropathy is off the hook and really bad. Treatment for the events were not provided. Lab tests mention 2 negative COVID tests in Mar 2020, but he was not tested for antibodies he says.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, neuropathy gone through roof and really bad, was considered unknown. The outcome of the event pain in arm was considered recovered on 05 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Describe Event, Problem, or Product Use Error: Patient stated that Pfizer-BioNTech COVID-19 Vaccine caused her MS symptoms to flare up. Patient said she only completed one dose of the vaccine as she was advised by neurologist not to take and further doses of the vaccine.
received / first dose on Dic 3rd 2020 / never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd December 2020).   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 did not consent to follow up.
Information has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a 26 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. On 09-SEP-2008 was vaccinated with a second dose of GARDASIL. The patient is pregnant. On 22-OCT-2008, an ultrasound was performed to the patient in order to determine estimated gestational age (EGA) and the results showed, intrauterine pregnancy (IUP) of 8 weeks (LMP was on approximately 27-AUG-2008 and estimated delivery date: 03-JUN-2009). The patient has not had previous pregnancies. In August 2008, a status post colposcopy showed a negative biopsy and negative for herpes simplex 2 (HSV2). Follow up information received from a physician indicated on 21-MAY-2009 at 40 weeks from her last menstrual period the patient gave birth to a normal male, who weighted 8 pounds and 7 ounces; his Apgar score was 8/9. During the labor the patient experienced maternal fever. Follow up information received from a health worker indicated that the patient had a normal pregnancy without complications and that the patient delivered a healthy male without congenital defects. Follow up information indicated that the patient had a C-section on 21-MAY-2009; the physician who delivered the patient's baby indicated that the patient had a "term pregnancy, arrest descent, fetal tachycardia and maternal fever"; it was also confirmed that the patient had cephalopelvic disproportion. It was also reported that on 22-JUN-2009 the patient had a follow appointment with the physician for an incision check and the patient had recovered. On 29-JUN-2009 the patient had a follow up visit with the physician. The patient was diagnosed with mastitis of the left breast. The reporter did not know if the patient recovered from mastitis. The patient had cancelled her follow up appointment scheduled for July 2009. Upon internal review, cesarean section due cephalopelvic disproportion was considered an other important medical event. The baby's experience has been captured in WAES # 0810USA04882B1. Additional information has been requested.
When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started irritating a little bit. So then i left it alone because I didn't now if that was part of a reaction. When i got home i still had the odor in my mouth. i drank cold water and it went away. I waited. I felt sore on my arm but it wasn't that bad but as the hours went on it started getting more sore and painful. My arm was sore up to my shoulder and the back. After that the pain started traveling towards to my chest and i started getting pain in my chest. i took Tylenol (1 500 mg extra strength at 11:15 PM). So i waited 15 minutes to go to sleep. i got up the next day and everything was the same, i started putting ice on it and gave it time. I took another Tylenol but the pain was in my chest again a little bit. The third day the pain didn't come back in my chest and from then i was alright. I also started getting an itch.
Shortness of breath, Dizziness, Chest tightness, Fatigue, General weakness and Fever. Fully vaccinated Covid-19 case
headache, body aches, chills -- starting around 4 a.m. and gone by 11:00 a.m. same day.
I HAD A FEELING OF "SWIMMER'S EAR" AND BLOCKAGE OF SCAR TISSUE IN MY RIGHT EAR THAT THE ENT I GO TO SAID WAS NOT THERE IN MY OCT. 2020 VISIT. MY HEARING WAS MUFFLED AND LED TO THE PURCHASE OF A HEARING AID.
We received the following information on 20 NOV 2007: An adult male patient was vaccinated with an influenza virus vaccine, batch-no. and manufacturer unknown in October 2007. A thrombotic thrombocytopenic purpura was reported one week after the vaccination in October 2007 and the patient was hospitalised. The patient has not yet recovered on date of report. It seems to be unlikely that Fluvirin was used as this vaccine was not distributed to the market in this season.
about 5-10 mins p/vax became very pale, felt dizzy-nl BP/pulse x 3