chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she broke out in hives from head to toe; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination 86 years) and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: SH6198) via an unspecified route of administration, administered on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced she broke out in hives from head to toe. Caller stated that 11 days after she got the first shot she broke out it hives head to foot. Caller who reports that 11 days after her first dose of the Pfizer COVID 19 vaccine she broke out in hives from head to toe. She reports, I have been on two rounds of steroids and I have had my second dose and I still have the hives. The steroid faded the hives somewhat but once I finished the steroid the hives came right back. The vaccine contains PEG and we think that is what caused the reaction. I have been in contact with the CDC and they told me to contact Pfizer. No one has any recommendations for me. patients allergist told her that she would have to have a monthly injection at the hospital of a medication called Zolair but we looked that up and it has many side effects as well. She had the second Pfizer vaccine and said that she has been on 2 rounds of steroids and they made the hives fade and took the itch away, but as soon as she stopped they came right back. Caller clarified that the steroids made the hives disappear. On an unspecified date the patient underwent lab tests and procedures which included blood test: normal, Blood work is not showing anything. Therapeutic measures were taken as a result of she broke out in hives from head to toe. The outcome of the event was reported as not recovered.  No follow-up attempts possible. No further information expected.
Patient completed two doses of Pfizer COVID vaccines in August 2021. She came to ED with one day onset of tachycardia, lethergy, nausea, pain, chills and admitted to the hospital on 12/25/21. She was tested positive for COVID PCR. Hospital day 4, She has been on Ceftriaxone, but it is for urinary tract infection. She has not had respiratory symptoms, and she has been on room air.
Approximately 25 minutes after vaccination the patient reported starting to feel itchy all over. 50 mg of Benadryl was administered to the patient. The patient was monitored for another 30 minutes to ensure the Benadryl was working. After the 30 additional minutes the patient reported feeling much better and left the store.
Big hard knot at injection site that is tender. I got home and was very cold. I started feeling sick to my stomach and nauseous. I had a fever. In the night I was so dizzy at 2 am when i got up to use the bathroom. I was covered in sweat. I almost called EMS.
Severe cramping to chest/My toes and calves are cramping/my right side of the chest was starting to cramp/ hands, fingers and his right ankle severe cramping.; Rght wrist has locked up; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number was not reported; manufacturer: Unspecified; NDC number and Expiry Date of Pfizer COVID 19 vaccine: Unknown) via an unspecified route of administration, administered in deltoid left on 27Mar2021 at 17:30 as dose 1, single (at the age of 59 years old) for covid-19 immunisation. Patient medical history and concomitant medications were not reported. No other products were reported. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was none, family history was none. The patient experienced severe cramping to chest/my toes and calves are cramping/my right side of the chest was starting to cramp/ hands, fingers and his right ankle severe cramping and right wrist has locked up on 29Mar2021. No emergency room or physician office visit. Prior vaccinations within 4 weeks were none. Relevant test was none. Patient questioned that I had my 1st Pfizer vaccine on 27Mar2021 5:30pm. Patient reported that he had severe cramping to chest, his right wrist has locked up. His toes and calves were cramping, and he woke up this morning and his right side of the chest was starting to cramp but he rubbed it before it got started. He called to report this to make sure this was a symptom of the vaccine. He not sure it is causing it but this is the only thing that has changed. His other medications have not. Disclaimer provided: Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: muscle pain. These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19. Vaccine was still being studied in clinical trials.1. Consumer reporting on side effects; states he got the first dose of the Pfizer COVID 19 vaccine 27Mar2021 at 17:30PM in the left shoulder. Reports last night he had in both hands, fingers and his right ankle severe cramping. He was asking that was it normal. Adds normally cramps just last a minute and then they are gone but these were coming and not stopping. It happened twice and it was painful enough to bring tears to your eyes. Adds today he was fine. He is planning to get the second dose on 17Apr2021. Adds the shot is the only thing new and he is thinking that is the cause of the cramps. The outcome of the events was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of grand mal seizure in a 80-year-old male patient who received SHINGRIX. The patient's past medical history included grand mal seizure (3 years before the reporting date, after having a stroke) and stroke (had several times, 3 years before the reporting date). Concomitant products included buspirone hydrochloride, calcium unknown, clopidogrel, phenytoin, aripiprazole, Lisinopril and chlorthalidone. On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th May 2018, 1 days after receiving SHINGRIX, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant), spaced out (serious criteria hospitalization), mucus discharge and fall. On an unknown date, the outcome of the grand mal seizure, spaced out, mucus discharge and fall were recovered/resolved. The reporter considered the grand mal seizure, spaced out, mucus discharge and fall to be probably related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. At 13:15, the patient received SHINGRIX on left arm. The patient had been doing very well over the past couple of years until this adverse event. The patient was at a meeting when he suddenly became out of it, put his head down with mucus running from his nose and mouth, and then fell out of the chair. In May 2018, the patient was taken to the hospital and stayed for 2 days. The patient's general physician had told him not to receive the 2nd dose of SHINGRIX.
Information has been received from a certified medical assistant concerning a 7 year old Greek male with no known allergies who on 10MAR1999 was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter noted that the child had a family member with leukemia going through chemotherapy. On 14AUG2003 the patient presented to the doctor's office with a rash, itching, some leg pain(unknown which leg), and a stomach ache. An antibody test was taken and the titer came back negative result for chickenpox. No other information is available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received a physician indicated that there was questionable exposure to varicella zoster 3 weeks prior to vesiculopapular rash, which is continuous with VZV. On 14AUG2003 the patient was tested for VZV IgM and VZV IgG because his sister had been on chemotherapy since May 2003 for leukemia and "she did not get VZIG when he presented with this rash". The results of the tests were negative. It was all noted that all titers were negative. The reporter indicated that the results indicate a different virus. Additional information has been requested.
client had vomit episode after receiving 2nd Pfizer Covid Vaccine.Client returned from restroom and informed EMT she had vomited and was still nauseous. Vitals at 1602: blood pressure 127/82, pulse 73, oxygen 100%. EMT gave client water. Per client had sat down in observation room around 1350. Per client had same reaction with 1st dose after she had left facility. RN joined EMT. Client informed RN  after vomiting she felt better. RN informed she would be kept longer in observation, client agreed. Per client no relevant medical history, no allergies or current medications. Vitals at 1607: blood pressure: 118/70, pulse 92, oxygen 99%. Per client symptoms had resolved. Vitals at 1612: blood pressure 121/72, pulse 64, oxygen 99%. Vitals at 1617: 120/74, pulse 68, oxygen 100%. Client left facility with steady gait at 1621.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 77-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included zolpidem tartrate (Ambien). On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th April 2018, 1 days after receiving SHINGRIX, the patient experienced vomiting and nausea. In April 2018, the patient experienced shivering. On an unknown date, the outcome of the shivering, vomiting and nausea were recovered/resolved. The reporter considered the shivering and nausea to be related to SHINGRIX. It was unknown if the reporter considered the vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient independently decided to walk-in to her retail pharmacy and ask for the vaccine. The patient had many vaccinations previously as related to her past work with the Peace Corps in the 1960's and had never had any reactions to any vaccination except to the SHINGRIX dose. The patient did not have other vaccinations that same day or within 4 weeks prior. The patient received SHINGRIX left upper arm (left deltoid) and she could not provide further dosing specifics. The patient had a dose of SHINGRIX in the series and then woke up in the middle of night with uncontrollable shivering which lasted for a while but she did not know exactly for what period of time the shivering lasted. The patient then went back to sleep, and that next morning of the day following the first dose, the patient had nausea and vomiting for about six hours, the patient felt fine by the next day. The patient agreed to contact her HCP (healthcare professional). The patient said her HCP would not mind that she got the vaccine but was not yet aware that she received it or of the reaction. The patient did not know the name of the pharmacist who administered the vaccination and assumes she was administered whatever the standard SHINGRIX dose might be. The patient did not take any of the nights following the first dose of Shingrix, because she only used it as needed when she was at high altitudes, and her home was close to sea level.
Information has been received from a physician concerning a 19 year old female with no medical history, who on 17-MAY-2007 was vaccinated IM with a first dose of GARDASIL (655165/0137U), on 17-JUL-2007 was vaccinated with a second dose of GARDASIL (Lot # unknown), and on 19-DEC-2007 was vaccinated with a third dose of GARDASIL (Lot # 659441/1446U). Concomitant medication for birth control. The physician reported that the patient received all 3 doses of GARDASIL and recently had a PAP test done and it came positive for high risk HPV on 18-AUG-2008. The outcome of the patient was not reported. The patient did not seek for medical attention. There was no product quality complaint. Additional information has been requested.
7 PATIENTS RECEIVED EXPIRED DOSES BEFORE NURSING REALIZED THE LOT NUMBER WAS EXPIRED.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patients were administered with doses of RECOMBIVAX HB (doses, routes of administration, lot numbers and expiration dates were not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
restlessness throughout body same night, next morning woke up with body aches, nausea, pain in joint/muscles, shaking , headache, fever 100. Took Tylenol arthritis
Severe migraine Brain fog Lymph node under left arm is extremely painful to touch Body aches
loud tinnitus/The noise in both my ears is intrusive and annoying; difficult to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: 9896) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VALSARTAN. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: Cipro"; Known allergies: azithromycin, reaction(s): "Known allergies: azithromycin"; Known allergies: protonix, reaction(s): "Known allergies: protonix". Vaccination history included: BNT162b2 (dose 3 single, Batch/Lot No: 8028, Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "Prolonged (lasting several weeks) episodes of loud tinnitus after each booster"; BNT162b2 (dose 3 single, Batch/Lot No: 8028, Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Difficult to concentrate", "The noise in both my ears is intrusive and annoying, making it very difficult to concentrate."; BNT162b2 (dose 2 single, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (dose 1 single, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 60-year-old, for COVID-19 immunization.  The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "loud tinnitus/The noise in both my ears is intrusive and annoying"; DISTURBANCE IN ATTENTION (non-serious), outcome "not recovered", described as "difficult to concentrate". Therapeutic measures were not taken as a result of tinnitus, disturbance in attention.  Follow-up attempts are completed. No further information is expected.  Additional information: The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior to vaccination. The patient did not tested post vaccination. Prolonged (lasting several weeks) episodes of loud tinnitus after each booster and patient's recent omicron booster. The noise in both ears was intrusive and annoying, making it very difficult to concentrate.  Follow-up attempts are completed. No further information is expected.
Upper left arm was sore from the time of 1st shot, with pain when I moved the arm toward back. Resolved with no medical intervention about October 1, 2021.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Mailed correspondence from Lederle Labs (HQ1206422MAY2001) received on 06/04/01. "A nurse reported that a 2 month old patient (gender not specified) received a first injection of Prevnar  (Lederle), and Tripedia (Aventis Pasteur Inc.), IPV (Aventis Pasteur SA) and Comvax (MSD) on 05/16/01. Within 12 hours, the child developed a fever (102-103 deg F) fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of three identifiable patients from this reporter who experienced events following receipt of Prevnar lot #474724. For information on the other 2 reports see CASE HQ111502MAY2001 and CASE HQ1206522MAY2001. The reporter was unable to to specify additional patients involved. Additional reports will be generated when identifying information is provided."
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's pertinent medical history or drug reaction/allergies was provided. On 30-SEP-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 lot # L007720 (expiry date 08-JUL-2016) intramuscularly (dose was not reported). Concomitant medications were not reported. Additional information has been requested.
Pt vaccinated with DTP mother noted baby to be hot, the appeared lifeless, limp with no color in lips. 15-20min later color returned. Taken to ER where fever 102 but otherwise appeared normal. Hospitalized & appears fine since.
Patient was admin less then recommended dose of moderna vaccine today secondary to syringe malfunction , we consulted CDC website and the guidance instructed not re-administer second dose since patient receive more that half of the recommended dose originally .
A few hours after the vaccine I felt really bad.  I had severe diarreah and abdominal pains which caused me to go to the ER d/t abdominal pain.  I was so severly sick, in bed and couldnt hardly move.  On Sat I was being transported  to the hospital when I got super nauseaed so my husband pulled over and I passed out and went unconscious and fell out the car onto the ground.  EMT was called and transported me to the hospital when a CT Scan and EKG was performed. I was given IV fluids, monitored and released after some time.  Over the next few days I felt absolutely awful.  On 4/15 I had a phone F/U visit with my PCP.  I still havent felt to myself to date and had to go back to the ER last night because I was so nauseaed and dizzy I couldnt stand or do anything and I am still having the diarreah also
Pt had TB test on 04/03/2002 at 11am. At 9pm the pt started to break out with rash on both arms. Went to ER at 23:16 due to rash. Taken Benadryl earlier. Was instructed to continue on Benadryl. Follow up with administrater on 04/04/2002.
Pt. was given Menactra on 7/14. After administration, discovered that he was given a meningitis vaccine on 7/11/08
Following a normal physician exam pt developed, mouth sores & then fever, Labs noted abnormal white Blood cells, over ensuing 1 week repeat Labs & specialist testing resulted in Diagnosis of acute myelogenous leukemia admitted for induction therapy.
Patient experienced a local injection site reaction. She said at first she had a white round silver dollar shape whelp where the vaccine was administered. She said that it itched and it hurt. Over the course of a week, the site started to look better then a red rash began to appear around the whelp and the whelp started changing colors to a dark red.
Pfizer / BioNTech / Paxlovid start date: 10Aug2022; Pfizer / BioNTech / Paxlovid start date: 10Aug2022; Symptoms returned on 19Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), on 30Jan2021 as dose 2, single (Batch/Lot number: unknown), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies Yes - Sulfa" (unspecified if ongoing), notes: known allergies Yes - sulfa. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies Yes - Aspirin", notes: known allergies Yes - Aspirin. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 19Aug2022 at 15:00, outcome "unknown", described as "Symptoms returned on 19Aug2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Paxlovid start date: 10Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: product=COVID 19 Treatment, brand=Paxlovid; (20Aug2022) Positive, notes: Tested Positive 20Aug2022 and 25Aug2022; (25Aug2022) Positive, notes: Tested Positive 20Aug2022 and 25Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.Clinical course: Anti viral Paxlovid was given from 10Aug2022 to 14Aug2022. Symptoms returned on 19Aug2022 at 15:00. No treatment was given. Tested Positive 20Aug2022 and 25Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a licensed practical nurse concerning an "over 40 year old" female patient who "three years ago", in 2007 was vaccinated with a dose of MMR II. The licensed practical nurse mentioned that 6 weeks after vaccination the patient experienced joint pain. At the time of reporting, the patient's outcome was unspecified. No further information is available.
pt brought by EMS to hospital with c/o increasing SOB and dizziness over past 1-2 wks; found to be hyperglycemic and positive for COVID; transferred to CCU for severe respiratory distress (O2 sats at 31%); placed on NRB with O2 sats now in the 80%; placed on FMV and later required intubation; DNR; pt's condition deteriorated and she died in the hospital
About 9 days after the vaccine, patient developed a fever and became extremely lethargic. The following day he developed a large welt at the injection site. Fever/ lethargy lasted several days.
1st Covid vax 3/12/21; pt. had severe headache x 2 days helped w/Tylenol.  2nd vax 4/5/21; pt. had fatigue, body aches, muscle cramps in legs and lower back, improved in 1 week with increased water intake; also had vertigo lasting a week.  She also is experiencing sweating day and night.  States her hot flashes were under control until she had the 2nd vaccine.  She called her PCP who advised Tylenol for aches and to increase water intake; also has taken AlkaSeltzer Plus Cold for 8 days with improvement of h/a and bodyache but pain returns when it wears off. States she still "doesn't feel well" and may go to urgent care for variant testing soon and was urged to seek care as she feels the need.