chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sever vertigo; nausea; dehydrated; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had received first dose on unspecified date. Nine days later had "sever vertigo/nausea" on unspecified date. The patient thought it was his own stupidity doing yard work and getting dehydrated on unspecified date. The clinical outcome of vertigo/nausea and dehydrated was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
palpitations; High blood pressure; This is a spontaneous report from a non-contactable Nurse (Patient). A 70-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:30 AM as SINGLE DOSE for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history was not reported. Allergies to medications, food, or other products: Latex, bananas, melons, ragweed, tree pollen. Concomitant medications included spironolactone, propranolol, amlodipine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 21:00 The patient experienced high blood pressure and palpitations. The adverse event result: Emergency room/department or urgent care. No treatment received for the adverse event. The patient was not diagnosed with COVID 19, Prior to vaccination. The patient not has been tested for COVID19, Since the vaccination. The outcome of the events was recovering.  No follow-up attempts possible. As reporter denied to contact.
Patient registered for 2nd dose Moderna vaccine. Patient did not have card with him at the time of vaccination and was given Moderna vaccine.  When previous covid vaccine information was looked  it was discovered that he recieved Pfizer for his first and second dose.  Patient informed of this. Was observed for 15 minutes and no signs of any reaction noted. Patient was advised to provide his healthcare providers with this information.  Patient provided with a new vaccine card with all vaccines given and lot numbers.
Nausea, headache and waves of feeling very hot and dizzy started on day 7 after the vaccination and subsided after 12 hours. Day 8 a hard red lump the size of a quarter appeared at the injection site. Day 9 the redness and swelling increased to 2.5cm x 2cm and was very warm to the touch. Day 10 the redness and swelling increased to 10cm x 7cm and still very warm to the touch.  Day 11 redness and swelling was the same. Day 12 redness  was the same and swelling was improved. Day 13 redness and swelling were improved.  Day 14 redness and swelling improved significantly. Day 15 no swelling, slight redness.  Day 16 muscle tenderness and fatigue with use. Day 17 muscle tenderness and fatigue with use. Day 18 muscle fatigue with use. Day 19 no symptoms. Day 20 severe muscle fatigue and ache. Day 21 muscle fatigue with use.
Red, raised rash appeared that looks like a band and is itchy. The pain is minor.
pt recv vax 8MAR96 & on 9MAR96 pt exp stiffness & pain down the arm & neck described as burning in muscle going down arm & up to shoulder, sore throat, gen malaise & fatigue;
PATIENT WENT ON LEAVE FOR  OVER  3 MOS AFTER 1ST VACCINE, AND CAM E BACK FOR  2ND  VACCINE IN MAY HE HAD NO ADVERSE REACTION,    HE RECIEVED SHOT 2 ON MAY 12,2021 AND 3RD VACCINE  JUNE 2,2021..  HE WAS TOLD TO START SERIES OVER AND GET A THIRD VACCINE  AFTER  SECOND WEAS  DELAYED .
Arms hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arms hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arms hurt). At the time of the report, VACCINATION SITE PAIN (Arms hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Her husband had zero side effects and patient were on Moderna. Patient's kids got Pfizer and arms hurt. Patients first shot and her arm hurt for three days and then a week later and she looked and had a covid arm. The treatment medication was not reported by reporter.  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.
TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 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 09-APR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible headache was not reported. This report was non-serious.
pt recv vax 2APR98 & same day w/in 5-10sec p/vax pt started screaming;5min p/vax eyes glazed over;pt stated throat was bothering him;started frothing @ mouth & spitting x 1.5hr;wanted to throw up;given epi;started vomiting;02 given
Client received Pfizer dose after having already received a Johnson & Johnson dose 6 days earlier. Client denied having received previous COVID vaccine or any vaccine within 14 past days.
This is a spontaneous report from a contactable physician through a sales representative. This physician reported the same reaction for two patients. This is the second of two reports. A patient of unknown age, gender and ethnicity received on an unknown date a single dose of PREVNAR13 in arm. Medical history and concomitant medications were not reported. On unspecified date in 2014, within last 3-4 weeks before this report, both patients had like a reaction on their arms that their arms swelled up and they had a large reaction from the shot. After a week, the patient visited the physician and a treatment was provided. Outcome was unknown. Follow-up (05-NOV-2014): Follow-up attempts completed. No further information expected.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of musculoskeletal pain (first dose, for tolerance of 1st dose refer case US2019GSK001258). Concurrent medical conditions included spondylosis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shoulder pain, pain in arm, cold sores and unexpected therapeutic effect. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shoulder pain, pain in arm, cold sores and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the shoulder pain, pain in arm, cold sores and unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient has not had cold sores ever since, but after 2nd dose of SHINGRIX he had worst one. The patient's shoulder and arm hurts terrible after taking SHINGRIX injection. His spondylosis went away after second shot of SHINGRIX, it was an unexpected positive result of vaccine. The reporter did not give consent to follow-up.
10 week pregnant female (EDC 5/23/10) with complaint of headache and nausea approximately 2 hours after receiving H1N1 vaccination.  BP checked by family member and "OK" as stated by patient. Patient still c/o headache 2 days later, despite taking Tylenol.  Has since seen prenatal provider for evaluation and currently reporting no headache or nausea.  12/1/09 OB/GYN consult records received. Service dates 10/2/09 to 11/21/09. OB Visits. 12/15/09:  OB/GYN consult records received for dates of service 10/16/09 to 10/21/09. OB Visits.
This case was reported by a nurse via call center rep and described the occurrence of finger injury in a vaccinating other healthcare professional who intended to vaccinate the patient with ROTARIX oral suspension. On an unknown date, the patient received ROTARIX oral suspension 1 ml. On an unknown date, immediately after receiving ROTARIX oral suspension, the patient experienced finger injury, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the finger injury, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the finger injury to be related to ROTARIX oral suspension. Additional details were provided as follows: The age at vaccination is not applicable for this case. It was reported that, few of the staff have stated when they pop the top off of the vial with ROTARIX, the blue top comes off too causing a break in the vial glass and thus cutting the their fingers. It was reported that, this had happened three times so far. The staff has said that, occasionally when they push the liquid diluent into the vial, the transfer device pops off from the pressure and the vaccine sort of explodes, which led to inadvertent exposure to vaccine. The reporter wanted to know if this kind of scenarios were seen with other clinics and to see if their technique is wrong in some way. The patients were the other health care professionals.
This spontaneous report was received from a physician refers to an adolescent female patient of unknown age who on an unknown date, was vaccinated with the second dose 0.5 ml dose of GARDASIL (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that about a 1.5 weeks after vaccination on an unknown date, the patient developed a rash on her thigh and her shoulder. It was stated that it sounded that the patient's high and shoulder each had a different kind of rash. No treatment information was reported. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed a rash on her thigh and her shoulder was unknown for GARDASIL. Additional information has been requested.
Patient stated was 65 years old and paper verified by technician. Patient was actually 59 years old and should not have received the high dose
High fever treated with Tylenol, 4 hours Joint pain Arm site swelling and redness  Nausea
I had a really bad pain in my forearm, couldn't barely fold me arm closed; it was excruciating pain. I went to urgent care, sonogram on arm and my leg. They said my D-dimer was kind of high. They thought it was a blood clot, but they didn't find anything through an ultrasound looking for blood clots. I had the pain for about two weeks. They told me to take pain medications for it. I recently went back to urgent care because I had a lot of cough symptoms and headaches. They checked my lungs, they said my lungs sounded okay, and took my blood pressure, which was high, they gave me some cough drops and told me to go home and rest and told me if I felt worse to come back. The next day, I went to take a COVID test, but it came back negative. I still have cough symptoms. I have a lot of it and it's off and on; off and on. It might go away for a while, and then it comes back and I'm coughing for a week or two. And I have headaches and back pain, that goes hand in hand with the cough when it's there.
Myalgia, Fever, Chills, Fatigue, Headache Narrative:  Other Relevant History:
I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completely exhausted; My stomach hurt; couldn't eat; lost 2 1/2 lbs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration in left arm on 05Mar2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunization at pharmacy or Drug Store. Medical history included an unspecified allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atenolol at a dose of 50 mg twice daily, received in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number PAA156051, Expiration Date: not reported), via an unspecified route of administration, in right arm on 10Feb2021 at a single dose for COVID-19 immunization and experienced very tired for over a day. On 05Mar2021 after the second shot at 18:30 (reported as within 6 hrs), the patient experienced pain on the left side of her head above the ear and was freezing, had terrible chills for 2-3 hrs and had to be covered with several blankets. Patient did warm up, but completely exhausted into Sunday AM (as per report), her stomach was hurt, couldn't eat and patient lost 2 1/2 lbs. Patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment started on 25Aug2022 and stopped on 29Aug2022 for COVID-19.  Clinical information: No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
receive my second shot on July 8th I have been with side"; "muscular aches in all body; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (receive my second shot on July 8th I have been with side"), MYALGIA ("muscular aches in all body) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (receive my second shot on July 8th I have been with side "), MYALGIA ("muscular aches in all body) and HEADACHE (headache). At the time of the report, ADVERSE REACTION (receive my second shot on July 8th I have been with side), MYALGIA ("muscular aches in all body) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Temperature was up to 102 since 3 days ago..         No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
This case was reported by a physician via call center representative and described the occurrence of myalgia in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (1st dose received and experienced swelling in arm and pain in arm refer linked case US2018GSK121411). Concurrent medical conditions included tinnitus. On 26th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 12 hrs after receiving SHINGRIX, the patient experienced myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated. On an unknown date, the outcome of the myalgia, arthralgia and fever were recovered/resolved and the outcome of the facial swelling and red face were not recovered/not resolved and the outcome of the tinnitus aggravated was recovering/resolving. It was unknown if the reporter considered the myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced side effects after her second SHINGRIX dose in the series. About 12 hours after the injection the patient experienced myalgia, arthralgia, fever (the patient's body temperature was recorded as to 101 degrees). The patient was recovered from those symptoms as well as from swelling of face, redness on the face. The patient was recovering from worsening tinnitus in her right ear. Patient said that the only symptoms that she had with the first dose in the series was pain in the arm, swelling in the arm (refer case US2018GSK121411). The physician did not know exactly where the patient received the vaccine and he thought that probably at her pharmacy.
Red, swollen "baseball size knot" as stated per caregiver. Physician notified-ice applied. 9/24/12-patient is going to see physician-swelling gone-but patient has had a cough since the vaccination
pt recv vax 28AUG95 & 25APR97 pt devel a number of lesions;the reporter noted that according to pt mom it was not a mild case;pt was not seen by MD office;
Cellulitis in the right superior thigh, not sure which vaccine. Started 1 day after vaccination. Treatment with oral antibiotics (cephalexin) started on 3/22, 2 days after vaccination. It seems to have been injected superior to the typical vaccination site of the vastus lateralis muscle.
Abdominal pain, chills, fever, join pain, body aches, head ache
Patient was administered a vaccine that after administration was issued a recall after it had been given, it was not recalled at the time of administration
Severe body aches and sick headache, although did not vomit. Had temperature over 100, highest of 103.4. These symptoms  lasted at least for 12 hours.
Pain at injection site approximately 4 hours after injection Fever (101) and chills approximately 8 hours after injection Extreme exhaustion approximately 24 hours later
pt recvd vax & went limp, pale-fell back onto table-clenched tooth grimaced; had 1 min-2min sz; spontaneously;
Patient's niece reported that the patient's arm became sore, had stomach upset, fever the day after the vaccine. The following day the patient died.
Passed out in hallway after receiving vaccine. BP 90/30 then elevated to 98/60 took 15 mins to he able to sit up BP normal taken prior to exam 94/60 P 84
Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml. The children (age 5-11) received 0.3 ml x 41.9 mcg/ml = 12.6 mcg.
Redness, swelling, itchiness and pain that began as a spotty rash about 32 hours after the injection. It was approximately 3" in diameter. It has became redder, more swollen and has expanded to approximately 8" x 6".
got his first shot of HPV vaccine at 65 year old; Product origin unknown; This spontaneous report was received from a 65-year-old male patient and refers to himself via Pfizer. The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On an unknown date, the patient was high-risk category and he got the first shot of human papilloma virus (HPV) vaccine for prophylaxis (formulation, dose, unit, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). However, the manufacturer was unknown, and it was also not sure it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Product origin unknown).
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Unsettled,  day of vaccines, Day 3 piercing cry lasted approx 30 min
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male 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: 206A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient's wife reported that, on 20-MAY-2021, the patient's antibody test was negative with score less than 1 (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210551477 and 20210550960.; Sender's Comments: V0:20210551575-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I am 29 weeks pregnant. I am age 38, so I have had more testing but the baby has been low risk and healthy. Due Date: Nov 5th, baby weight is approx 3 lbs. As soon as I took the vaccine I could feel it move through my body and it began to itch in random spots, i.e. my toe, my back, arms, and then eventually my lips were itching. By 10pm the same night, I felt like the baby was shaking inside of me like I had too much sugar (almost a vibrating feeling coming from the baby) and I couldn't sleep. I also started to have some contractions for the first time.  The itching has continued throughout the next day and I have been very fatigued.
Morning of second day since injection: Low grade fever (99.7F), headache, body ache - lower back, ankles, hands wrist and both arms, chills, stiff/sore neck
Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotension upon getting up the day after the vaccine