chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; FATIGUE; ARM SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of this reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: not reported) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced arm soreness. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on APR-2021, and had not recovered from fever, and fatigue. This report was non-serious.
shortness of breath; headaches; This is a spontaneous report from a contactable Consumer (Patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient 's medical history and concomitant medications were not reported. Consumer stated that consumer had the COVID Vaccine on Friday and had some bad side effects. Consumer had shortness of breath and a headache and consumer had to use his inhaler. Consumer wanted to know if consumer was a candidate for the second dose of the vaccine after having a "bad reaction" to the first? The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received form a registered nurse concerning an approximately 16 week (4 month) male with a history of gastroesophageal reflux, with no known drug reactions/allergies who on 19-JAN-2009 was vaccinated oral with the second dose of ROTATEQ (LOT # 663146/1450X).  Concomitant therapy included PREVACID.  On 19-JAN-2009, a few hours after receiving his second dose of ROTATEQ, the patient experienced 6-8 episodes of emesis.  The parents of the patient contacted the office by phone and the patient was prescribed BENADRYL and PEDIALYTE.  Subsequently, the patient fully recovered from the adverse event on 20-JAN-2009 in the morning.  It was reported that the patient sought medical attention:  contacted office by phone.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/13/2009.  Information has been received from a registered nurse concering an approximately 16 week (4 month) male with a history of gastroesophageal reflux, with no known drug reactions/allergies who on 19-JAN-2009 was vaccinated oral with the second dose of ROTATEQ (Lot #663146/1450X).  Concomitant therapy included PREVACID.  On 19-JAN-2009, a few hours after receiving his second dose of ROTATEQ, the patient experienced 6-8 episodes of emesis.  The parents of the patient contacted the office by phone and the paitent was prescribed BENADRYL and PEDIALYTE.  Subsequently, the patient fully recovered from the adverse event on 20-JAN-2009 in the morning.  It was reported that the patient sought medical attention: contacted office by phone.  This is one of several reports from the same source.  Additional information has been received from the registered nurse who stated that the 18 week male patient with soy and milk allergy, no illness at time of vaccination began vomiting after dose that evening (start date also reported as 20-JAN-2009).  The patient vomited several times and stopped by the morning.  However, the patient had allergy to soy and milk before and mom breasted infant.  The patient's mother had ingested soy that morning and prior day.  The reporter believed this was caused of vomiting not ROTATEQ.  No additional information is available.
We had a pediatric Pfizer clinic. Gave a 5 year old Pfizer Bi-valent for their 1st dose
This spontaneous report was received from a registered nurse via a company representative regarding an 11 year old female patient. The patient's medical history, drug reactions or allergies were not provided. On 03-SEP-2015, the patient was vaccinated with her first dose of GARDASIL (dose, route, lot number and expiration date were not provided). On 09-OCT-2015, the patient was vaccinated with her second dose of GARDASIL 9 (dose, route, lot number and expiration date were not provided). On 09-OCT-2015, after the administration of the GARDASIL 9, while still in the unspecified physician's office, the patient fainted. The patient started to recover and was given some apple juice. The patient then experienced another episode of syncope. The patient recovered while in the physician's office, the patient was considered fully recovered on 09-OCT-2015. There was no additional treatment. Additional information has been requested.
Eight hours after receiving my second shot I began to feel bloated and like I had mild food poisoning. During my sleep, after 11pm, I was awakened by an intense headache. I was fatigued and didn't want to go and get ibuprofen. I probably didn't take that for several hours. Then I took 600mg; about 3 hours later, 400mg; 400mg 3 hours later and another 400mg about 3 hours later. The headache was still intense, although diminished. I had body chills and intense heat, which normally would bother me, but not this time. I awoke at 11am but slept throughout the day. I next ate food -- a bowl of plain pasta -- about 7pm. I still had a headache and nausea. I went back to sleep, waking at 6am. My headache subsided; my digestion was mildly irritated. About mid afternoon took a short walk and felt fatigue afterwards, along with mild cold symptoms.
Patient reports after the 1st dose of Moderna, she experienced mild adverse reactions: arm soreness. Lack of energy and chills that lasted about 30 hours.   Patient reports after the 2nd dose of Moderna she experienced injection site reactions 6 days after the injection. She reports of a highly itchy/hot injection site, that was 5 inches around. She did not take any medication or apply topically aids. She did use a cold compress. Her injection site reaction has since been resolved.
After receiving the vaccine patient C/o facial and tongue numbness. Patient states feels like I had anesthesia. no SOB, rash, or difficulty talking. States funny tastes in the mouth. OB served. Patient is here for 30 minutes stated is feeling better.
Sudden onset of breathlessness, racing heart, extreme fatigue?-started 24 hours after shot and continued for almost a day, with a couple days of milder symptoms following
red eyes; feels them sore; red eyes, the patient felt them sore and there was yellow stuff coming out; swollen left arm; slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Dec2021, outcome "unknown", described as "swollen left arm"; PYREXIA (non-serious) with onset 13Dec2021, outcome "unknown", described as "slight fever"; OCULAR HYPERAEMIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "red eyes"; EYE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "feels them sore"; EYE DISCHARGE (non-serious) with onset 16Dec2021, outcome "unknown", described as "red eyes, the patient felt them sore and there was yellow stuff coming out".  The lot number for bnt162b2 was not provided and will be requested during follow up.
passed away; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority Support received from a non-contactable consumer. The consumer reported same events for two patients (two friends). This is one of the two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient took both doses and passed away on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  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-202101123407 Same reporter/suspect product/event, different patients; Reported Cause(s) of Death: took both doses and passed away
Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time).
@08;15 - Vaccinated @08:17 - lips tingling @08:19 - triage, lips mild swelling @08:27 - Zyrtec 10 mg given  @8:35 - numbness/tingling decreasing      Vitals: 67 HR, 99% O2, 165/92
Smallpox on 2/12/03. On 2/14/03, felt dizzy and lightheaded. BP of 90/45. Normal BP is 120/70. On 2/15/03, had muscle aches, fatigue, headache, and mild dizziness. Then on 2/16/03 PM, had difficulty breathing, tightness in chest, and chest pain. Was hospitalized and had an ECG. Results showed depressed ST waves suggesting possible ischemia. Went home. On and off chest pain. Went back to doctor on 2/26/03. Did more tests and ended in hospital overnight. Results showed a torturous heart artery. No other cardiovascular problems. No symptoms until got smallpox shot. Never got chest pain until smallpox shot.
Fever, body aches, congested, sore throat, asthma, migraine, no appetite, weak
1st dose Dec2021 and 2nd in March2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose in December 2021).   In March 2022, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. In March 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-May-2022 Reporter's comment: Pharmacist was inquiring about a catch up schedule for Engerix-B for an adult patient.  The 1st dose was administered in December 2021 and 2nd dose in March 2022. The reporter did not had any additional details (no patient demographics). Consented to follow up via postal. Additional Supportive Information: The patient received 2nd dose of Engerix-B later than the recommend interval, which led to lengthening of vaccination schedule. Note: Regarding the suspect formulation query was raised by the intake team meanwhile suspect was coded as Engerix B adult with Suspension for injection in pre-filled syringe.
Developed rash the next day to torso that spread to thighs and arms and has been taking OTC of Benadryl without improvement.
Pt. was 16 month old - not required to receive intranasal too young per manufacturer.
No adverse effect; the patient who was administered a PNEUMOVAX 23 vaccine on 28-OCT-2019 but he was not due for another one until after 18-DEC-2019; This spontaneous report has been received from a pharmacist via a company representative, concerning a 74 year old male patient.     The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. His historical vaccine included pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).   On an unspecified date in 2011 (also reported as "at age 66"), the subject was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  Then on 18-DEC-2018, he was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) but he was not due for another one until after 18-DEC-2019 (inappropriate schedule of product administration). No adverse effect reported.   In addition, it was reported that the doctor was very upset that they gave pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prior to the 1 year window, and wanted to know they would suggest a shot outside of the guidelines, how that happened.
Both Arm soreness, both hands soreness/ tingling, Dizziness, Nausea, Tingling of lips, large patches of painful itchy welts covering body including arms, torso, groin area.   Took benedryl for two days, welts subsided, soreness remained. Sought out medical attention from physician on 3/16 and was given a steroid injection and prescribed a steroid pack and OTC pepsid as well as continuing the use of benedryl.
Patient presented to COVID vaccine clinic for 2nd immunization. Patient was accidentally given undiluted 0.3mL dose of Pfizer immunization. Patient was informed of the error by the administering staff member. Patient was given warning signs of when to seek medical care and told of possibility of increased side effects from the higher immunization dose. Patient was also provided with the Covid line for any further questions or concerns. Medication safety officer alerted of event immediately. Will follow up with the patient tomorrow and again on Monday to ensure that they are not experiencing severe side effects from the vaccine. Medication event will also be reported to VAERS as per our EUA.
After 09/01/2021 I started experiencing an increased HR. I visited the ER in 10/2021 because my HR was about 160BPM I was put on a holter monitor for 3 day and I was diagnosed with Atrial Fibrillation . I was prescribed Eliquis and Metoprolol. I have had 13 episodes of AFIB since receiving the vaccination in 09/2021. I am currently scheduled for a Cardiac ablation.
Pt c/o swelling at injection site (size of football) (left arm) and pain level 20 from scale 1-10 with no relief from TYLENOL or ice packs. Advised pt to go to ER/urgent care for follow up.
within two hours flushed, sneezing, very hot, fever, headache, and felt "off". plus stiff and very sore right arm. had to take benadryl to stop reaction.
Fever of 104 degrees Fahrenheit starting about 12 hours post vaccination with severe chills and shivering lasting 6 hours. Extreme exhaustion starting 20 hours after vaccination and lasting until the following day. Fever of 101 to 102 (intermittent) 24-36 hours after vaccination.
Narrowed vision at bedtime; Achy; Weird dreams; Weak; Chills; A little nauseous; Low grade fever; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 19Apr2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown, if the patient received any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced narrowed vision at bedtime, little nauseous, low grade fever, weird dreams, chills, weak and achy. The events did not result in doctor or other healthcare professional office or clinic visit or emergency visit. No therapeutic measures were taken as a result of the reported events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events narrowed vision at bedtime, little nauseous, low grade fever, weird dreams, chills, weak and achy were recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Awoke with the worst migrane I have ever experienced, took over the counter aleve as well as exedrin migrane over the several hours before going to the ER at the Hospital.
got a rash all over body. rash is very itchy. was given:   ZyrTEC 10 mg oral tablet  triamcinolone 0.025% topical cream
Pain at time of injection. Was informed needle hit bone. Very sore after. Pain continued to worsen until arm was unusable. Went to dr 12/16/2013 and treated for tendinitis due to injection given in the wrong place.
Sudden Infant Death Syndrome: Child discovered with no pulse or respiration by mom, lying face down around 04:00. Ambulance was called and the pt was taken to the hospital with CPR in progress. At 05:13, the pt was pronounced dead.
She had the Pfizer COVID Vaccines and the Booster and she still got COVID; She had the Pfizer COVID Vaccines and the Booster and she still got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Caller stated she had the Pfizer COVID Vaccines and the booster and she still got COVID (in the middle of Sep2022). Stated she had gotten the vaccines way previously but she was surprised she still got COVID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "She had the Pfizer COVID Vaccines and the Booster and she still got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored PROQUAD (batch/lot number # L045676, expiration date 09-MAY-2017, batch/lot number # M007961, expiration date 15-AUG-2017, dose and route not provided). No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
2 days after vaccine started with headache.  Then body aches and TMJ symptoms.  Even my teeth ached.  Then next morning felt dizzy and nauseous along with headache.  Was very fatigued.  Loss of appetite.
Pt states that when she got the shot she thought the pharmacist hit a nerve because there was minor nerve pain.  But lately the nerve pain has been traveling up from her left deltoid to her left side of neck and that she has limited mobility of her left arm (can't raise easily above her head).
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF8020) at the age of 28 years for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 013M20A), in left arm and on 11Mar2021 as dose 2, single (Lot number: 011A21A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 Diabetes. Concomitant medication(s) included: HUMALOG; ADVIL [IBUPROFEN], start date: 05Jun2022, stop date: 08Jun2022. Past drug history included: Ceclor for Known allergies: Ceclor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: antigen test: (unspecified date) positive, notes: Day 13 (today): Persistent cough and congestion and starting to feel very fatigued again. I am also experiencing an increased feeling of brain fog. I took an antigen test at home and it was just slightly darker than day 12 but not by much; (14Jun2022) positive, notes: Days 6-8: I was feeling significantly better because most of my symptoms had lightened up or disappeared completely. I took an antigen test at home on all three days and each test showed a very very faint positive; (15Jun2022) positive, notes: Days 6-8: I was feeling significantly better because most of my symptoms had lightened up or disappeared completely. I took an antigen test at home on all three days and each test showed a very very faint positive; (16Jun2022) positive, notes: Days 6-8: I was feeling significantly better because most of my symptoms had lightened up or disappeared completely. I took an antigen test at home on all three days and each test showed a very very faint positive; (20Jun2022) positive, notes: Day 12: I started to have a more persistent cough in addition to a runny nose. I took an antigen test at home and the positive mark was significantly darker than days 6-8. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Vomiting, Diarrhea, 102 temp, pins and needles in palms of hands and bottom of feet. Vision issues. SOB. Lethargy.