chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 03-OCT-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (lot#1879866 with an expiration date on 30-OCT-2023) (strength was not provided).  The nurse reported that the patient received improperly stored vaccine (product storage error).   The dose of vaccine was exposed to a temperature excursion of 55.8 degrees Fahrenheit (°F) during a time frame of 44 hours. There was no prior temperature excursion and no adverse events were reported.
This spontaneous report was received from a nurse regarding a 6 month old female patient. The patient's had no relevant medical history, drug history and concomitant medications. On 15-AUG-2016 the patient was vaccinated with ROTATEQ at a dose of 2 ml, orally from lot # L029615 with 15-MAY-2017 which was exposed to temperature excursion (incorrect product storage). After receiving vaccination, no adverse effects were reported thus far. She had no relevant laboratory data. At the time of this report, it was unknown if patient would continue ROTATEQ. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient developed hives on the thigh on which the IPV and Hib vaccines were administered.  The hives resolved on their own in about one minute.
red patch/red itchy spots/redness of the skin/area turns red; itches/itchy/itchiness; Rash as red; Warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to latex" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BETAXOLOL taken for blood pressure abnormal. Past drug history included: Aspirin, reaction(s): "allergic to aspirin". The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "red patch/red itchy spots/redness of the skin/area turns red"; PRURITUS (non-serious), outcome "unknown", described as "itches/itchy/itchiness"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "Rash as red"; FEELING HOT (non-serious), outcome "unknown", described as "Warm to the touch". Therapeutic measures were taken as a result of erythema, pruritus, rash erythematous, feeling hot.  Additional information: Patient was wondering if it was a side effect of the vaccine if you get a red patch that itches and then goes away. Reporter states that he received Pfizer Covid 19 vaccines primary 2 shots in Feb2021 and third in Apr2021. Sometime after these vaccines he began noticing red itchy spots that come and go from time to time on his body, they can be anywhere. Patient does not have any issues with them while he sleeps, he states that they are aggravating during the day. He states that started on hands and around his fingers and then moved other places. He has seen that break out in some areas on different parts of his body, and it does not have scabbing, or anything involved, he relays that the only thing that helps is lotion, washing hands more, and sometimes they just go away by themselves. States right now he is itch free. Also states that he can no longer wear jewellery. He will put on a watch and within 30 minutes he started getting red and itchy, at which point he removes them, and it goes away in a short time. He described the rash as red, itchy, and warm to the touch. He was wondering if it was a side effect of the vaccine if you get a red patch that itches and then goes away. Patient has seen his primary care provider and a dermatologist and states that they did not provide much help. But he has heard that some of the COVID-19 vaccine shots, not necessarily from Pfizer, can contain small pieces of metal. Vaccination facility type: Consumer stated, they were giving that up the, he does not remember the name of the location. If he had that card with him, he could tell.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337845 same patient/event, different vaccine dose;US-PFIZER INC-202201337846 same patient/event, different vaccine dose;
excessive irritability-mom reports inconsolable x3hr post vax;(suspect pertussis response);
Just a small amount of facial burning; This is a spontaneous report received from a contactable other health care professional. This 55-years-old female patient received  second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via intramuscular route of administration in left deltoid on 11Jan2021 (at age of 55-years-old) as single dose for COVID-19 Immunization. Patient medical history include allergies sinuses, JRA (Juvenile rheumatoid arthritis at age of 16), GERD (Gastroesophageal reflux disease 2years ago),PSVT (Paroxysmal supraventricular tachycardia,15 years ago).Patients concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number:E49899 & Expiry date not reported) via intramuscular route of administration in left deltoid on 21Dec2020 at 13:40 as single dose for COVID-19 Immunization. On unspecified date , patient experienced  just a small amount of facial burning, intermittent for 24 hours with second dose. No treatment received for event. The outcome of event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
BODY ACHES; STIFFNESS; FELT BAD ENOUGH TO STAY IN BED; CHILL; FEVER OF 101.4; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 patient experienced body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) fever of 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. This report was non-serious.
I did not have a reaction to the vaccine. I tested positive for COVID-19 with a home test on 09/06/2022 without prior symptoms. I had a sore throat and a fever. I got a PCR test at my doctor's office which was positive for COVID-19. My doctor recommended aspirin and ibuprofen for the fever. I was given a prescription for PAXLOVID but never got it filled. The fever, sore throat, aches and chills lasted for three days. The fatigue and grogginess lasted about fifteen days.
14 year old female received Booster dose of Pfizer RTU at 3:18pm. While waiting the 15 minutes after vaccination patient's mom came to the Pharmacy because her daughter was feeling dizzy and was pale. I proceeded to give her an ammonia tablet to sniff and proceeded to check her BP (71/44) Pulse: 50. This was at 3:23pm. 9-1-1 was called and we proceeded to move the patient to the immunization room to lie down on the floor and put her legs up on a chair. She started to gain color again and started to feel better. She drank 2 or 3 sips of water with a little salt that her brother brought. Dizziness started to go away and she wanted o sit on the chair. I took her BP again (98/65). Suddenly, she had the urge to go to the bathroom. While she was at the bathroom, emergency responders arrived at the pharmacy. When her mother brought her back, she was dizzy again and paramedics put her on the stretcher and moved her to the ambulance. Patient's mother told us that her daughter tried to vomit in the bathroom, but she couldn't. They all left to the hospital.
Patient reported to pharmacy to receive first pfizer covid vaccine. They filled out the form for the pediatric pfizer vaccine, and we did not verify the date of birth before administering the pediatric dose.
Initial unsolicited report received from a non-health care professional (patient) on 8 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number, dose, dose number were unknown) via intramuscular route in left deltoid on 7 October 2015. Patient's medical history includes Allergies to penicillin, various metals, sulfa drugs, nitro iodine and concomitant medications was not reported. It was reported that, on 7 October 2015 (same day after vaccination), on an unspecified time patient developed facila rash and eye swelling. The patient had received Fluzone HD vaccine last year (unspecified). Lab data was reported as unknown and benadryl, zyrtec were the corrective treatment. The outcome of the events were unknown at the time of this report. List of documents held by sender: none.
Narrative:  Based on history of allergic reaction to other vaccine (flu/tetanus) patient was observed for 30 minutes post vaccination. It was noted at about 30 minutes post vaccination that the patient was extremely drowsy and complained of dizziness. The patient was transferred to the Emergency Room were he was further observed until his signs and symptoms were no longer present. Patient's blood pressure was noted to be a little low at 90/59 and a fluid bolus of Normal Saline was administered. Patient was discharged home after about 2.5 hours of observation.
pt recv vax & inj stung; next day very sore; pain has cont until now; pain does not wake @ noc; pt states WSS of 50% of strength in lt arm w/lump but tenderness rt @ inj site; tx by pt excedrin extra strength;
This spontaneous report as received from a pharmacist via a company representative refers to a 73 year old female patient. On 20-JUL-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010105 and (expiration date 15-NOV-2018), 0.5 ml, subcutaneously for prevention of pneumococcal disease. On 20-JUL-2017 (reported as immediately following the injection), the patient experienced headache.  On an unspecified date in July 2017 (reported as within a week of the injection), the patient experienced rash. The outcome of rash and headache was reported as recovering. There was no product quality complaint involved.
I HAD TERRIBLE BODY/BONE PAIN.  IT STARTED WITH SOME NAUSEA WITHIN 3-4 HOURS AFTER VACCINE WAS ADMINISTERED.  I WOKE UP AND MY LEFT ARM WAS VERY PAINFUL AND MY BODY ACHED.  IT WAS PAINFUL TO WALK AND SIT UPRIGHT.  LATER THAT EVENING, AROUND 8-830, THE PAIN JUST STOPPED.  MY LEFT ARM IS STILL VERY SORE AND TENDER TO TOUCH.
once I stop testing positive for the antibodies of the vaccine, will my symptoms improve; once I stop testing positive for the antibodies of the vaccine, will my symptoms improve; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team and legal division. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "once I stop testing positive for the antibodies of the vaccine, will my symptoms improve".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient received Moderna #1 on 12/30/2020 and Moderna #2 on 01/27/2021. The patient's antibodies on 08/04/2021 were 1775.0 (U/mL). The patient proceeded to take the Moderna booster on 9/10/2021. After receiving the vaccine, patient experienced body aches, fatigue and "flu-like symptoms." On 11/03/2021, antibodies dropped to 129.3 (U/mL). The patients antibodies were checked again on 11/11/2021 and were only 118.1 (U/mL).
Patient was seen on 25 Sept 2009 due to hives 3 days afer receiving Fluzone Free 6-35 months.
Chest pain  High BP  Low BP  Tachycardia  Dizziness  Ear ringing  Faint  Fatigue
pt recv vax & 12hr later pt reported redness, pain, swelling @ inj site;area cont to expand until Sunday;pt took DPH & iced area;
12/18  VACCINATION 12/19 WOKE UP, RINGING IN BOTH EARS.  CALLED PCP, CONSULTED ENT ABNORMALITY - L INNER EAR; HIGH DOSE STEROIDS, 10 DAYS, 60 MG/DAY.  WEEK 2; TINNITUS GOT WORSE. DR. PRIMARY CARE PHYSICIAN MEDICAL EXAM ON 1/6/2021 INJECTION OF STEROIDS.
On 04/27/2000 the patient experienced 3 pustular spots on the forehead and a fever. On 05/02/2000 the patient recovered.
This spontaneous report as received from a Licensed Practical Nurse refers to a 65 years old male patient. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. The patient sought unspecified medical attention. There was no lab diagnostic studies performed. It was reported that PNEUMOVAX23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX23. This is one of several reports from the same source. Additional information has been requested.
developed a rash; very itchy; She said she had the feeling of needles all over her entire body and face, along with a hot feeling; her neck, chest, and upper back are a purple-red color; difficulty seeing; macular degeneration; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EN9581), via an unspecified route of administration on 20Feb2021 09:15 (at the age of 85-years-old) in right arm at single dose for covid-19 immunisation. Patient had allergies and asthma for years. There were no concomitant medications. Patient reported she got her first COVID-19 Vaccine on Saturday, 20Feb2021. She said she developed a rash on Monday (22Feb2021), and was very itchy. She said she didn't have the rash on her legs. She said she had the feeling of needles all over her entire body and face, along with a hot feeling on 22Feb2021. She said she was contributing her rash to the COVID-19 Vaccine. She asked if she got the second COVID-19 Vaccine, would the rash occur again, and would the rash be worse. The caller said she was scheduled to receive her second COVID-19 Vaccine dose on Thursday, 11Mar2021. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. She had macular degeneration and had difficulty seeing in Feb2021. She clarified she felt like her face had needles going through it. She said her neck, chest, and upper back are a purple-red color on 22Feb2021. She said she was so uncomfortable that it was hard for her to wear clothes, and she had to sleep in the nude. Treatment: she was taking diphenhydramine hydrochloride (BENADRYL) and her daughter gave her an over-the-counter cortisone cream in a tube to use for her rash. She said she just started using the cortisone cream today (25Feb2021). She said she did not have the Benadryl and cortisone cream tube with her to provide the UPC/NDC Numbers, Lot Numbers, and Expiration Dates. She planned to call her doctor to see if he will give her something for the rash once she was finished speaking with Pfizer. The events did not require emergency room or physician office. Outcome of macular degeneration and difficulty seeing was unknown, and outcome of other events were not recovered.
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
SWOLLEN CHIN GLANDS; NAUSEA; HEADACHE FELT LIKE MIGRAINE; COULD NOT SLEEP; FEVER; LEFT ARM FELT WEIRD AND PARALYSING KIND OF SENSATION; FELT LIKE LOOSING ARM AND COULD NOT FEEL FINGERS AFTER VACCINATION; RAPID HEARTBEAT; FELT LIKE MOLTEN LAVA FLOWING AND HOT SENSATION IN LEFT ARM; DIZZINESS; LOWER GASTROINTESTINAL DISCOMFORT; BODY ACHES; NUMBNESS OR LOSS SENSATION OF FACIAL AREA ESPECIALLY CHIN AREA; SWEATING FROM BACK TO NECK AREA; CHEST TIGHTNESS; SENSITIVITY TO LIGHT AND SOUND; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included crohn's disease, vertigo, and heart murmur. The patient experienced drug allergy when treated with macrogol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21a, and batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced left arm felt weird and paralysing kind of sensation. On 06-MAY-2021, the subject experienced felt like loosing arm and could not feel fingers after vaccination. On 06-MAY-2021, the subject experienced rapid heartbeat. On 06-MAY-2021, the subject experienced felt like molten lava flowing and hot sensation in left arm. On 06-MAY-2021, the subject experienced dizziness. On 06-MAY-2021, the subject experienced lower gastrointestinal discomfort. On 06-MAY-2021, the subject experienced body aches. On 06-MAY-2021, the subject experienced numbness or loss sensation of facial area especially chin area. On 06-MAY-2021, the subject experienced sweating from back to neck area. On 06-MAY-2021, the subject experienced chest tightness. On 06-MAY-2021, the subject experienced sensitivity to light and sound. On 06-MAY-2021, the subject experienced could not sleep. On 06-MAY-2021, the subject experienced fever. On 06-MAY-2021, the subject experienced headache felt like migraine. Laboratory data included: Body temperature (NR: not provided) 99.6, 97.6. On 06-MAY-2021 18:00, the subject experienced nausea. On 07-MAY-2021, the subject experienced swollen chin glands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm felt weird and paralysing kind of sensation, felt like loosing arm and could not feel fingers after vaccination, rapid heartbeat, felt like molten lava flowing and hot sensation in left arm, dizziness, headache felt like migraine, lower gastrointestinal discomfort, fever, body aches, numbness or loss sensation of facial area especially chin area, sweating from back to neck area, chest tightness, sensitivity to light and sound, swollen chin glands, and could not sleep, and the outcome of nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
The night of the vaccine child started having a slight fever, became fatigue and very tired. The next day she started vomiting a lot and wouldn't eat nor drink. Her became unbalance and kept falling down. She started having difficulty speaking. As the days went on her balance became worse and always tired. When she did eat and vomit it all back up. As she was trying to walk she kept falling down. Took child to the ER.
Hours after injection over all skin tingle/sleeping tingle. Went away after 6-7 days. Now 3 months later extreme intense skin itching without rash or reason. Right leg numbness/sleepy tingle
4/27 11pm started to feel cold chills and aches, Sore at injection site 4/28 2am fever started, aches increased, Sore at injection site 4/28 7am fever of 101.9, nausia, stomach aches, cold sweats, body aches, Sore at injection site 4/28 noon 98.9 temp, stomach aches and "queezy" feeling, Sore at injection site 4/48 9pm stomach ache, and queezy, Sore at injection site 4/29 stomach ache continues with queezy feeling. tmep is 98.8, Sore at injection site  Question 20 is answered on this area I am currently writing it with the stomach ache and sore at injection site. (is marked no since my fever is gone)
During Health Assessment patient reported that he had received an entire vial (approximately 5.0mL) of the Anthrax vaccine while receiving his third scheduled dose. Reported localized soreness at vaccination site (L deltoid) for one and a half weeks, as well as, a headache lasting approximately 3 days post vaccination. Currently all symptoms have resolved and no reoccurrence express at this time.