chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE WAS THAWED THEN  REFROZEN AND THAWED AGAIN  BEFORE IT WAS ADMINISTERED TO PATIENT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose was not reported, administered on left deltoid on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine was thawed then refrozen and thawed again before it was administered to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was thawed then refrozen and thawed again before it was administered to patient was not reported. This report was non-serious. This case is associated with Product Quality Complaint, PQC number: 90000175087.
Syncope immediately after administration fell onto the left side then faced down gasping for air. Patient was immediately turned over to one side to allow breathing and then patient regained consciousness after 2 minutes. Patient  was monitored for 1 hour, reported nausea during monitoring and went home with assistance of a friend.
pt recvd vax 1130AM-rx APAP; noon-230 found emesis where sleeping; staring, no crying, limp, refused to eat, pale; recognizing & responded to mom by 4PM;
Erythematous papular rash over face, trunk, and extremities 10 days after injection.  Associated low grade temperature.  No treatment.
Severe lt shoulder pain p/recvd flu vax on 6NOV91; tx w/NSAID's & subsequently Prednisone w/no relief; referred to Orthopedic surgeon;
Mother reports day after receiving injection patient complaining of pain to right arm with redness, swelling, itching, describing area as orange size affected area. Patient mother took patient to Emergency Room for evaluation and treatment. Patient was diagnosed with local reaction to immunization. Patient was prescribed Benadryl 12.5mg, ibuprofen, and antibiotic to be taken twice daily by mouth for ten days.
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unknown date, the patients were administered with RECOMBIVAX HB (dose, lot number, expiration date and route were not reported), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen lymph node in arm pit; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine; Lot number: Ew0151), via an unspecified route of administration to the left arm on 07Apr2021 at 1130 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included Hashimotos. The patient had an allergy to Penicillin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Concomitant medication included thyroid medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced swollen lymph node in the arm pit on 08Apr2021, the size of a golf ball. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse event. The clinical outcome of the event of swollen lymph node was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
c/o general malaise off feeling had backache & kidney ache lasting 2-3 wk; c/o anorexia lasting a couple of days;
Client and mom report that client started having bloody noses every time he blew his nose starting 6/12/19 that lasted one week. Bloody noses stopped after one week. Client did not seek any medical evaluation or intervention.
The patient was to receive the age appropriate Pfizer Covid-19 vaccine (Marron TOP) but received the regular Pfizer Pediatric Covid-19 Vaccine (Orange TOP).   Confirmed with CDC NipInfo that patient will require two more age appropriate doses to complete series.
she broke out in shingles; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261 and expiry date: unknown), dose 1 via an unspecified route of administration on 23Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The caller was supposed to get the second shot on 13Feb2021 but the caller's doctor said to wait because she still had shingles. The patient medical history and concomitant medications were not reported. The patient experienced she broke out in shingles on an unspecified date. The caller wanted to know if the second dose of the vaccine was effective because she had shingles. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Fever, Diarrhea, Pain/Discomfort at injection site, chills Narrative:
tinglin to hands, wrist, some dizziness when she stands up. States she had a reaction to Pfizer vaccine 2 weeks ago, and was put on BB to slow her HR and BP.
Shivering,2 days tired 4 days, weakness3 days, chest tightness 4 days, injection sight pain 4 days Just rested and took tylenol first two days. Just feel off and foggy next 4 days.
In late January 2023 I realized I had the sound of crickets in my ears. I made an appointment with urgent care. I was referred to an ENT. I saw them today. A had a hearing test on April 6, 2023. It showed I had bilateral moderately- severe hearing loss. It also showed I have tinnitus in both ears. I was advised that others get hearing aids to help. I was told it is possible that the tinnitus is occurring to make up for the hearing loss.
Patient called on 12/4/15 stating pain in (L) arm from PREVNAR. As of 1/11/16 patient still reports (L) arm pain.
first and second dose four weeks apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022  Reporter's Comment: The patient self-reported this case. The patient received first and second dose of Shingrix just four weeks apart.  The patient simply reported themselves and several of their family members was receiving the first and second dose four weeks apart instead of the recommended minimum of 2 months for the second dose, after receipt of the first dose. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. This case had been linked with case US2022AMR084510, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084510:Same reporter
This case was reported by a consumer and described the occurrence of ears clogged in a 58-year-old female subject who was vaccinated with FLULAVAL. A physician or other healthcare professional has not verified this report. Concurrent medical conditions included asthma and food allergy. Concurrent medications included NEXIUM, ADVAIR and CARDIZEM. On 16  October 2008 at 13:30 the subject received unspecified dose of FLULAVAL at 0.5ml in the left arm. On 16 October 2008, 2 hours after vaccination with FLULAVAL, the subject's ears began clogging. She took BENADRYL. Then the roof of her mouth, which is usually smooth, puckered. The subject also began to experience laryngitis on 16 October 2008. The subject began to recognize that she may be having an allergic reaction. At 20:00 the subject took another BENADRYL and went to the emergency room. In the emergency room she received a PREDNISONE burst and prescribed oral PREDNISONE, PEPCID and BENADRYL. The consumer stated that these medications only temporarily relieve the symptoms. At the time of reporting the outcome of the events was unspecified.
5-6 hrs of unconsolable crying; the evening p/vax fever ?low high temp not takne;
This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 16-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019). Concomitant products included MENACTRA. On 24th April 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 24th April 2018, less than a day after receiving BEXSERO, the patient experienced swelling, induration and pain. On 1st May 2018, the outcome of the swelling, induration and pain were recovered/resolved. It was unknown if the reporter considered the swelling, induration and pain to be related to BEXSERO. Additional details were provided as follows: This case was reported by the Physician's Assistant (PA). On 24th April 2018, the patient received MENACTRA (batch number U5766AE and expiry date 2nd December 2018) concomitantly. The patient was administered BEXSERO in the left deltoid.
Sleepiness right after the dose.  Extreme muscle cramps/spams in leg and lower back about 20 after the shot. Tiredness, sore arm, and dizziness the first 12hrs 12hrs mark fever 101.9 and fainted, loss of conciseness for about 5-10 minutes.  Dry heaving while unconscious.  Woke up from fainting with a lot of dry heaving an proceeded to throw up and sweat vigorously. A headache set in right after the vomiting. Intense headache, teeth pain and sore neck.  Now, after almost 48 hrs  tremors in hands and blurred vision but all the other symptoms are gone.  I took Tylenol pm, and my regular Meloxicam and baclofen for the day.
contracted Covid; A spontaneous report was received from a pharmacist concerning a, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19.   The patient's medical history was not provided. No relevant concomitant medications were reported.  It was unknown when the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Pharmacist reported their patient got the vaccine and then contracted COVID-19. She wondered if the patient could get the second vaccine. Call back was made to reporter on 07 Jan 2021.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event was unknown.; Reporter's Comments: Although limited information has been provided as dosing details for mRNA-1273 and onset date of the event was not provided, based on the etiology of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event and the product use is assessed as unlikely.
Patient developed swelling  of trapezius muscle near clavicle on left side of neck within 24 hours of receiving 1st dose of moderna. There is still mild swelling at the site 5 weeks after dose but swelling has lessened significantly. Patient did receive 2nd dose of moderna without new adverse reactions or worsening of current adverse reaction . Patient states the swelling was not painful.
This spontaneous report as received from a physician refers to a 11 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-SEP-2007, the patient was vaccinated with VARIVAX (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.   On 21-SEP-2010, the patient was vaccinated with PROQUAD (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On 27-SEP-2016, 9 years 8 days after onset of therapy the patient experienced herpes zoster. The outcome of herpes zoster was reported as not recovered/not resolved. Causal relationship between the event and suspect vaccines was not provided.
I received the Moderna COVID-19 Vaccine EUA on February 24th and 01:30pm. I experienced a 101.5 fever 13 hours after the vaccine injection. I also experienced extreme fatigue, chills, body aches, foggy brain, stiff and sore arm, swollen lymph nodes in left arm pit, and a headache. I have a cyst near my left collar bone, and this is swollen  and painful. My fever last 48 hours. All other symptoms lasted 72 hours. After 72 hours, I am still experiencing brain fog, fatigue, and weakness.
Child came into clinic on 12/13/05 and received Pediarix, Hib & PCV.  Child returned on 12/29/05 for well child visit.  Received Pediarix, Hib & Prevnar again.  Child received extra set of vaccines.
Patient developed mild COVID (positive test) 20 days after receiving 2nd shot; Patient developed mild COVID (positive test) 20 days after receiving 2nd shot; This is a spontaneous report from a contactable consumer.   A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. No COVID prior vaccination. On unknown date patient developed mild COVID (positive test) 20 days after receiving 2nd shot. The outcome of the event was recovering.  Information about Lot/Batch number has been requested.
This is a 86y.o.female with history of hypertension, hyperlipidemia, diabetes, pacemaker for sick sinus syndrome, atrial fibrillation fibrillation who presents with chest pain and shortness of breath. She states she has had progressively worsening symptoms over the past couple of days. She is fully vaccinated with Moderna.  She denies any recent sick contacts. Denies fever, does report chills. COVID 19 positive. Chest x-ray no acute process. She was started on supplemental oxygen. Cardiology has been consulted as well as infectious disease.
This spontaneous report as received from a medical assistant refers to a 2 day old male patient. Medical assistant reported that a baby was given a dose of RECOMBIVAX HB (lot#, route and dose unknown) 5mcg/0.5ml on 05-MAY-2013 and another dose on 07-MAY-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. The outcome and action taken were not provided. Additional information has been requested.
11/09/07 1100 am Client called our office regarding a reaction to left arm from Tdap shot.  Client states 11/07/07 the next morning after the injection her arm was sore and then it started getting red and swollen.  Client stated she placed warm heat to injection site and took Benadryl this morning.  Encouraged client to see her physician for reaction.  She stated she would see how it did this weekend and go to the doctor next week if it was not better.
Large red swelling (size of a large chicken egg) at injection site, hot to touch, painful. Lasted 3 days; gone completely by fourth day.
get the shot and a day or two later get sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to case 2020SA296404 (cluster).  This case involves a patient of unknown demographics who got the shot and a day or two later get sick (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that he/she got the shot and a day or two later get sick (Illness).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Patient started bleeding after vaccination.  immunizer cleaned arm with alcohol swabs and applied pressure with gauze.  Patient stated she felt dizzy/faint.  Placed her on floor.  Placed a cold pack on arm and back of neck.  Called code white pharmacy.  AP came and called for Ambulance.  Ambulance came and took vitals.  Blood pressure was low.  Patient transported to hospital.  Patient was conscious throughout event and responded as needed.
Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine) in an 18-year-old male 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 (medical history was not reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine). At the time of the report, WRONG PRODUCT ADMINISTERED (Received second dose of Pfizer vaccine, but for first dose was vaccinated with Moderna vaccine) had 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 not provided by the reporter. No treatment information was provided.
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL, lot # K011562, expiration date 08-APR-2017, (strength, dose number, route and anatomical location were not reported). No adverse effects reported. The reporter stated that the vaccine was exposed to a temperature of 34F during 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
This patient received Tdap and varicella on 1 Sep 23 as part of a mass vaccination line.  The patient had no immediate side effects.  The patient had syncope due to hypovolemia 4 hours later and was evaluated in the emergency room.
pain and redness to left arm , under injection site that night 10/25/2019. Swelling and warmth 10/26/2019 morning. Continued to get worse. no fever, no headache. No rash.
Adrenaline rush, chills, fever, vomiting, headache, facial swelling especially around eyes.  Chills & fever from 9PM to 3AM the next morning was followed by vomiting 5/11 AM.  The headache and swelling lasted 4 days. 5/14/21 I was almost back to normal.
pt reports feeling light headed with mild nausea, after 1st pfizer vaccine dose. Similar occurrences with previous injection according to dad. Skin mildly pale, spit up a small amount, denies any recent injury, denies pain, dad denies loss of consciousness, skin warm & dry on discharge. BP 112/67 HR 94 O2 sat 100%. Left ambulating with her dad.
"Patient reports 8 days ago had first COVID vaccine. 4 days ago she had 2 episodes of diarrhea, 3 days ago HA. Better on Saturday. Yesterday and today every time she eats she had diarrhea. no fever/chills/body aches Tired today but up a lot of the past 2 nights due to her symptoms"
High temp, petechiae, neisseria meningitis. Still in hospital but doing better.   Nurse follow up on 05/25/04 states: " ADD: Tachycardia, Hypertension."
Beginning 04/08/21, soreness at the injection site. I began moving my arm and using the muscles as instructed. The soreness increased to the point it was uncomfortable to touch or lay on. By the next morning  at 8:00 a.m. I had joint pain, primarily in both hands and both elbows, headache, chills, muscle ache in thighs.  My a.m. temp was 97.7. By 3:00 p.m. my temp was 99.1 and my symptoms were the same only at a high discomfort level. I took 2 advil.  At 9:00 p.m. my temp was 99.4. My symptoms were the same  but my hands were so sore even when not moving there was pain. I took 2 tylenol. Sleeping was very difficult due the pain in my left arm and my hands.  On 4/10/21, at 7:00 a.m. my temp was 99.4. I had worse joint pain, muscle, pain, fatigue, injection site had a hematoma the size of a quarter. Took two advil.  At 12:00  p.m. my temp was 98.6. I took 2 tylenol and a  famotidine. My left arm was still sore from shoulder to elbow, tender to the touch and slightly warm, I was fatigued, my hands were very sore at the joints. At 4:00p.m. I experienced about 2 hours of diarrhea. At 7:00p.m. my temp was 97.9 My hands and joints were still sore but to a lesser degree. My left arm was sore and I had a slight headache. I started feeling better with more energy.  On 4/11/21 temp was 97.4. my arm  was slightly sore still fatigued.   My average morning temp is about 97.4.
HEADACHE-STOMACH ACHE-JOINT PAIN BACKACHE-NECK ACHE-ON 11/4-CHEST PAIN NAUSEA ALONG WITH OTHER SYMPTOMS TEMP 101 B/P 70 OVER 40 THOUGHT I WAS HAVING HEART ATTACK AMBULANCE CALL ENDED IN ER.
This spontaneous report was received from a certified medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot# L038534/expiration date- 19-AUG-2017, lot# 035637/expiration date- 09-JUN-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED AN EXPIRED DOSE OF PFIZER.  SHE HAD A SORE ARM.  SHE WILL BE IN TO BE REVACCINATED