chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Strong headache; This is a spontaneous report from a contactable consumer, the patient. An adult male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 14:00 the patient experienced strong headache since the third day after the first dose of vaccine. It had been 10 days almost and he had headache every day and this kind of strong headache never happened before.  The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strong headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had a headache and then my blood pressure was high. I seen my doctors and they prescribed me with a diuretic Hydrochlorothiazide 12.5mg and Losartan 50mg. My blood pressure is controlled now.
Patient taken to ER on 9/30 with vomiting and rash on face and arms.  Patient had follow up appointment on 10/3.  According to FNP patient now had vesicles on arms, legs, and back.  Provisional diagnosis of chickenpox given.
This case was reported by a pharmacist and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with Engerix B for prophylaxis. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject experienced allergic reaction and rash. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with Engerix B. ON 10 October 2007, follow-up received from the pharmacist noted that he had no contact from the subject. He had just been questioned by a physician.
THERE WERE NO ADVERSE EVENTS TO REPORT. THIS REPORT IS BEING FILED BEACUSE THE PATIENT WAS ADMINISTERED A BOOSTER DOSE FROM A VIAL OF MODERNA VACCINE THAT HAD BEEN OUT OF THE REFRIGERATOR FOR MORE THAN 12  HOURS.
Patient reports that after leaving clinic on 09/12/06, she experienced seizure while driving, no loss of consciousness, but loss of motor functions.  Reports she was under control with use of Keppra but medical doctor discontinued the medicine since 2/06.  This was the first seizure since.  At clinic she received PPD and also Depo Provera shot.
Patient frequently recreates in the mountains. Patient received booster vaccination Tuesday morning, and then drove Wednesday afternoon to a mountain cabin at about 10,300 ft amsl.  Began having symptoms of fatigue and headache around 8 p.m. Wednesday and then full-blown altitude sickness symptoms through Thursday at about 1 p.m.  Patient has history of altitude sickness at much higher elevations (ascending mountains at 13,000 to 14,000 ft amsl) but has never had a full-blown case of altitude sickness at such a low elevation before, and  considers it possible that the booster shot exacerbated or caused the altitude sickness episode.
mom noticed redness, heat, swelling @ vax site 2 days p/vax; site was 6x8 cm & tender;
Mother states via phone call that child had fever of 102.0, vomiting, headache, and abdominal pain starting at 12AM on 6/11/2014. Mother took child to urgent care in am 6/11/2014. States that doctor drew blood (no results), instructed mother to push fluids and give ibuprofen for fever.
Pfizer Vaccine administered to individual under 12 years old; vaccine is only authorized for 12+.  No adverse event/outcomes noted.  Parents of children misrepresented their age when making the children appointments to get the vaccine.  Registration noticed the children were under 12 years old when they were looking at second dose scheduling and noticed duplicate accounts with same info but different ages.  Per CDC and OHA guidance, second dose will not be administered.
Prominent bilateral parotitis with swelling and mild tenderness; also mild injection site tenderness and low grade fever. Symptoms virtually resolved about 12 hours after onset.
Myalgia Injection site pain, Malaise Narrative:  Other Relevant History:
Information has been received from a 53 year old female with no pertinent medical history and no known allergies who on 07/25/04 was vaccinated SC with a single dose of hepatitis B virus vaccine rHBsAG (yeast). There was no concomitant medication. On 07/26/04, on day after receiving the shot, the patient experienced muscle tension, chest pain, increased blood pressure, and generally feeling bad. It was noted that the patient has seen some improvement after day two, but is not fully recovered. She does not plan to get another dose of the vaccine. She sought medical attention and her physician did not recommend any treatment. There was no product quality complaint. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 330268D) at the age of 28 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. Patient had no known allergies. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: home test and came back strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid from 05Jul2022 to 09Jul2022 for COVID 19 Treatment. Patient felt better with 1 day after starting paxlovid. Patient completed 5 days and the symptoms were gone completely. 6 days after the last dose of PAXLOVID, patient started to have symptoms again, so patient took the home test and came back strongly positive. Patient was having worse symptoms than the first time. The first time I had sore throat only but now I have runny nose, congestion, headache, and fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Information has been received from a physician concerning a patient who was vaccinated IM with GARDASIL  vaccine (yeast). Subsequently the patient developed irregular menstrual periods after GARDASIL vaccine (yeast) was given. The patient sought medical attention. Additional information has been requested. This is one of two reports received from the same source.
Left deltoid swollen, red, warm to touch. Mother called when she noticed the reaction after his bath on 4-25-06. Seen in office today (4-26-06). L. deltoid still the same. No pain; no treatment.
This spontaneous report was received from the patient's mother via a company representative and refers to a 1-year-old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. On 17-MAY-2017, the patient was vaccinated with a dose of VARIVAX injection (dose, route, lot number or expiration date were not reported), for prevention of chickenpox. The vaccine was reconstituted with the Merck (MRK) sterile diluent (lot # and expiration date were not reported). On an unknown date in May 2017 (reported as "over the following weekend"), the patient developed a bumpy, pox-like rash across her body, consisting of 15 to 20 bumps. The patient's mother stated that the rash might actually be mosquito bites, but she was not certain. The patient's mother sought medical attention by contacting the physician. No treatment was given for the events and no lab diagnostic studies were performed. The outcome of the events was reported as not recovered at the time of this report. The causality assessment between the events and therapy with VARIVAX was not provided. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact the patient's physician.; Sender's Comments:  US-009507513-1706USA004798: US-009507513-1706USA004797:
Chills, headache, stomach ache, body aches lasted for about 12 - 14 hours.
Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss of appetite; light headedness; lack of energy; This is a spontaneous report from a contactable consumer (the patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in left arm on 06Apr2021 12:30 at age of 36-year-old at single dose for COVID-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) via an unspecified route of administration in left arm from 16Mar2021 12:30 at age of 36-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was very sick for 4 days: fevers which came and went, chills, sweats, nausea, loss of appetite, light headedness, lack of energy. As a result of his immune system being weakened, he wound up with Cellulitis which he was still fighting over 3 weeks after the shot. As the patient was normally a healthy male, it was strange that he would wind up with a bacterial infection. The patient also stated that after the second dose he experienced cellulitis in his left leg to thigh area. He went to emergency room for scan and to rule out clot. He thought he was immunocompromised and that was why he got the cellulitis in the leg. Caller wanted to get the compensation information to help with the bills. The events onset date was 06Apr2021 17:00. 2 rounds of antibiotics was received for the events. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included ultrasound with unknown result. The outcome of the events was recovering.
injected in her left arm / had tenderness there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 14:40 (Lot number: EN6199) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hearing disability", start date: 2018 (unspecified if ongoing), notes: uses speakerphone so she can hear instead of wearing a hearing aid; "osteoporosis prevention" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; D3; ALENDRONATE taken for osteoporosis prophylaxis. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "injected in her left arm / had tenderness there". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Clinical course of events: The patient got her first dose March 5th, this was injected in her left arm and had tenderness there. Patient did not get any other vaccinations the same days as her Pfizer COVID-19 vaccine, or in the four weeks prior and has not started new medications recently. Concomitant medication also included multivitamin.  No follow-up attempts are possible. No further information is expected.
A spontaneous report has been received from a Health Professional concerning a patient of unknown age and gender, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started during OCT 2014. Patient received FLUMIST Quadrivalent after vaccine taken outdoors on excursions, exposed to a wide range of temperature change which starting during OCT 2014. The outcome of the event of 5 patients received FLUMIST Quadrivalent after vaccine taken outdoors on excursions, exposed to a wide range of temperature change is unknown. The report was considered to be non-serious by the company physician.
History of vast-vagal responses to shots. Has happened at least 20 times. Apprehension. No other signs or symptoms. Released.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted in chair, when trying to lay down on floor she awoke and was very sweaty, dizzy and disoriented.  NP came to check blood pressure and oxygen levels, very low, 911 called and ambulance took her to ER to assess
In addition to pain at the injection site (right upper arm), both lower legs were SUDDENLY and extremely stiff.  Squatting down to retrieve anything was very painful and difficult.  Getting up required major effort to maintain balance and stand upright.  Required use of stationery object to assist in getting up.  This sudden onset of stiffness was quite unusual, as I had always been able to easily squat down and stand up easily prior to the vaccination.
Mom called around 1:00 pm to state child had a fever of 103 before giving Tylenol. Mom states to nurse who gave immunizations that morning that patient did not have a fever and was not sick.
The first 36 hours I only had a mildly sore arm.   Then suddenly without any provocation whatsoever, I got a severe nosebleed.  I pinched my nostrils for 10 min but had to try again for 20 min.  When that didn't work, I immediately started another 30 min of pinching, for a total of 60 min before it stopped.  This was followed by one of the worst headaches I've ever had, mostly on the right side and front of my head and face, even making my whole upper right teeth and gums hurt.  That lasted about 5 hours and I was fine in the morning.  Oddly, my husband also got the severe nosebleed, but his came 66 hours after getting the same vaccine as I, and at the same time.  But he had no other symptoms.  Our household humidity was at 35% at the time and neither of us had blown our noses or provoked it in any way.
Patient received vaccination after discussing with her about egg sensitivity. Her MD requested she receive shot. Pt came back to the pharmacy shaking and crying. We sat her down and had her take deep breaths and focus. She didn't continue to calm so we called 911 for assistance. They determined she was having a panic attack and eventually sent her home.
Chills, pain and rash at injection site, vomiting, fever of 101, no appetite, exhaustion. Symptoms less severe by day 2. Rash lasted about a week.
4 doses of vaccines were administered after they were under diluted, it was believed that with only 0.8 ml of diluent; 4 doses of vaccines were administered after they were under diluted, it was believed that with only 0.8 ml of diluent; This is a spontaneous report from a Pfizer sponsored program received from a contactable nurse. This nurse reported similar events for 4 patients. This is one of the four reports. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: PAA166078; Expiration Date: 17Oct2021), via an unspecified route of administration on 12Oct2021 (at the age of 74-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: not reported; Expiration Date: not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation and also received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: not reported; Expiration Date: not reported), via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunisation. It was reported that on 12Oct2021, 4 doses of PFIZER-BIONTECH COVID-19 VACCINES were administered after they were under diluted, it was believed that with only 0.8 ml of diluent as only 4 doses were drawn once mixed. The caller was wanting to know the Pfizer recommendation. The events were assessed as serious as per the reporter.; Sender's Comments: Based on plausible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported at risk events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101368323 Same reporter/drug/AE, different patient;US-PFIZER INC-202101368631 Same reporter/drug/AE, different patient;US-PFIZER INC-202101368632 Same reporter/drug/AE, different patient
Rheumatoid arthritis bad flare up; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4218689-00 (Agency).  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis bad flare up". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for RINVOQ(UPADACITINIB): The reporters causality for the event(s) of rheumatoid arthritis bad flare up was not provided.  PFIZER BIONTECH COVID-19 vaccine: Causality: 1) Rheumatoid arthritis flare up: (Rheumatoid arthritis)  Causality as per reporter (Drug/Vaccine) : Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event rheumatoid arthritis and the suspect drug BNT162B2.
Pt began to feel faint & turned pale and clammy. Pt ask to lie on exam table. He was given a cool wash cloth for his head & ice pack for site of injection. No irregular breathing or heart rate. (this was after MCV4)
5 TO 10 MINS AFTER RECEIVING THE VACCINATION PATIENT FELT DIZZY AND VOMITED.
The pt developed an area approx. 4.5cm X 3/5cm of induration and erythema with very slight pain at the right thigh site which occurred at 48 hours, post vax. Treated with cold pack and clinical monitoring. The pt's parents applied a warm towel. In the morning, as erythema had spread, the pt was brought to the clinic. No other symptoms. Came to clinic on 12/15/01. Patient's induration/erythema resolved when called patient back on 12/19/2001.
This case was reported by a pharmacist and described the occurrence of injection site rash in a adult patient who received FLULAVAL quadrivalent (batch number 99LN2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced injection site rash, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This case was reported by a pharmacy director. This case was 1 of the 2 cases reported for the employees of the pharmacy who experienced an adverse reaction after the vaccination. The two patients received the FLULAVAL QIV vaccine from different vials purchased at the same time. In 2015, the patient experienced large red rash,warm and puffy (swelling) surrounding the injection site of FLULAVAL QIV vaccine. The reactions lasted for few days. The reporter was not aware of any other issues regarding either of the vials containing the vaccine. This case has been linked to case US2015GSK155180, reported by the same reporter.
Clinic appointment for RUQ abdominal pain and emesis. Admitted to unspecified hospital, treated with IV protonix and IV fluids with K+.
Difficulty taking deep breaths, dizziness that felt more like vertigo (the floor and ceiling spinning whenever I stood or sat up), exhausted to the point that I could not sit up without falling asleep.  I slept 14hrs straight for two days after the shot.  Tired after walking down the driveway and back.  Entire body aching with excruciating pain but not the left arm where the shot was taken.  Headaches were bad as well.  No appetite.  The 3rd day afterwards I felt better but still very tired.  The 4th day still tired but better.  Tylenol, caffeinated coffee and lots of water seem to help me get through this.  The fifth day afterward, I am almost 100%  but dealing with running nose and eyes which may not be related to the shot.
Patient began to experience joint pain, right ankle swelling, petechiae to both legs and feet 24 hrs after injection. She developed lumbar spinal swelling 2 days after injection. She was admitted to the hospital and diagnosed with HSP. There is no prescribed treatment and it will go away on its own. Drs cannot confirm if the flu shot caused this disease to occur.