chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First nighe:  chills  Next morning, to weak to sit up to get out of bed. Weak all day. Slept most of the day. Itching, burning red bumps down spine, mid back, resemble shingles. (I have had both shingles shots)  This lasted several days.   2nd night: sweats, headache 3rd night: sweats, headache remained weak and tired for a week
Patient had a 10 day history of swelling and pain in the affected arm after the injection.  He had the booster on 8/13/2019 on the left arm with a similar reaction but not as severe as with the first injection.
Chills; shakes; Slight fever (99.6 F); moderate fatigue; cold sweating; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 11:00 (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included one Kidney (his kidneys fused pre birth, fully funcitonal) and shellfish allergy. The concomitant medications for the patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 09:00 AM (at the age of 28-year-old) for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 09Feb2021 23:00, the patient experienced chills, shakes, slight fever (99.6 F), moderate fatigue, and cold sweating. No treatment was given for the events. The outcome of the events was reported as resolving.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Urinated 3 times on myself; It made me so sick; Headache; I thought my head would go split wide open; I have never had a headache like that before; Fever; No appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 as dose number unknown, single (Lot number: HG4629) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDRALAZINE; OMEGA 3 [FISH OIL]; ATORVASTATIN. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "Urinated 3 times on myself"; ILLNESS (non-serious), outcome "unknown", described as "It made me so sick"; HEADACHE (non-serious), outcome "unknown", described as "Headache; I thought my head would go split wide open; I have never had a headache like that before"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite". Additional Information: Concern: Consumer stated, "I took the COVID shot yesterday at 9 o'clock AM and during the night I could not hold my, I had urinated 3 times on myself and I had such a bad headache I thought my head would go split wide open, I have never had a headache like that before. I had fever and I am just kind of coming down now and it made me so sick." When clarified if the vaccine is Pfizer COVID-19 Vaccine, Consumer stated, "Yes." When paraphrased the concern, Consumer stated, "Yes, I mean I am just kind of coming up, I am just kind of getting myself together now. I did not have no appetite I have needed to take eat food some to take my medicine, so I ate a very, just a few bite to get the medicine down but I had no appetite. I don't see an expiration date, Nov2023 would that be it? It does not say expiration date." Other Medical conditions or concomitant medication: Consumer stated, "I am taking Hydralazine, Omega 3 and I am taking a Statin, it is a statin for cholesterol, the doctor says, I don't have a high cholesterol but they have given me because of my age, Atorvastatin." Prior Vaccinations (Within 4 weeks): Consumer stated, "Yes, I had got the Flu shot. No, I think it was last week or a week before last." When clarified if the patient got flu shot within 4 weeks of getting Pfizer COVID-19 Vaccine, Consumer stated, "No, it was not, last than 4 weeks".  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
chills; low-grade temperature; dizziness; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 17Dec2020 at 07:45 (at the age of 25-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. It was unknown if prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included cetirizine hydrochloride (ZYRTEC) and progesterone;estrogens (MANUFACTURER UNKNOWN) oral contraceptives. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills, low-grade temperature, and dizziness on 17Dec2020 at 08:45. The events were reported as non-serious. The events were reported to have occurred within 90 minutes of vaccination. The patient underwent lab tests and procedures, which included temperature: low-grade on 17Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, low-grade temperature, and dizziness was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.
patient said that she experienced a severe headache right after leaving pharmacy.  she went home and passed out for 3 days.  she said she ran a high fever as well.  even today (11/20/2021) she still feels shaky, weak, and has a dull headache.  patient said she did get a covid test 1 week after the vaccine and had a negative result
Patient reported hand tingling shortly after his vaccination. Patient has a history of colorectal cancer has has reported previous incidents with this same sensation, mostly after his chemo infusions. He states that the sensations start in his hands and eventually progress to other limbs and even his head. Patient states that currently he is having tingly feeling on both hands and on his head, at the same time. Patient denies tongue swelling, trouble swallowing, trouble speaking or trouble breathing. He has never had a vaccine reaction or an anaphylactic reaction before. Patient appeared diaphoretic upon interview and vasovagal. He was instructed to remove his jacked and denied a cool compress.  Patient waited an extra 15 minutes (30 total) and was still experiencing symptoms. Patient instructed to utilize Benadryl if symptoms continued and to call 911 and/or go to the ER if he experienced any trouble breathing. Patient explained that the tingly feelings progressed to the sides of his tongue, however he still denied trouble speaking, trouble swallowing, trouble breathing, swelling, and salivation.  Patient was offered an ambulance but refused. Wife was accompanying patient and stated that she would continue to monitor him and would be able to drive him to the ER if necessary. Patient's symptoms seemed to be improving as well. Ultimately, patient was counseled to f/u with primary care for questions regarding second dose and was advised to go to the ER if symptoms progressed or worsened.
Myalgia, Fever, SORE ARM, CHILLS, FATIGUE Narrative:  Other Relevant History:
"Covid Arm"   Low grade fever day after shot. One week later, itchy reddish rash woke me up. Rash spread larger for another week. Itching mostly at night. Was sore the first few days. Still hurts to touch today.
This spontaneous report as received from a medical assistant refers to a 62 year old female patient (who is also a nurse) with penicillin allergy and no pertinent medical history. The medical assistant reported that on 15-MAR-2012 the patient was vaccinated with ZOSTAVAX (lot # 1567AA, expiration date 05-NOV-2012), 0.65 ml, subcutaneously for physician recommendation and patient's occupation as a nurse. The medical assistant reported that on an unknown date (approximately in 2013) the patient got a mild case of shingles. The patient over the weekend of 31-AUG-2013 developed a rash. The patient had pain at an unspecified date (approximately in 2013) prior to the rash. Patient went to an unspecified regional first care center and called office to report. She received treatment with unspecified antiviral started on 03-SEP-2013. Laboratory tests were not performed. The patient's outcome was reported as recovering. Additional information has been requested.
Didn't notice the child was given two shots of the IPOL  , physician made appointment to watch over patient didn't make the appointment nor answer the phone.... contacted our immunization coordinator successfully and lady which was not successful kept calling and email waiting for a response....
Tinnitus - severe high-pitched ringing in ears, more pronounced in right ear. Has been constant since receipt of 2nd Covid-19 vaccination shot (now more than 3 months ago). Worse during night -- gets louder after laying down. Wakes me up after 3 hours, and have difficulty getting back to sleep.
pT RECEIVED SHINGLES AND INFLUENZA VACCINE 11/09/2022 APPROXIMATELY AROUND 11:30 AM. REPORTS NO ADV EFFECTS, JUST SORE AND NOT FEELING WELL DUE TO FLU VACCINE
Headache; little sore arm; Dizziness; balance problems; the balance is getting worse; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 73-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration, on 23Feb2021 (Lot number was not reported, age at the time of vaccination was 73-year-old) as a dose 2, single for COVID-19 immunization. The relevant medical history included pacemaker, blood cholesterol and thyroid from an unspecified date. Concomitant medications included levothyroxine 0.05 mg, one before going to breakfast, taken for thyroid and terazosin hydrochloride (HYTRIN) 10mg, at night before going to sleep, taken for an unspecified indication. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. On 23Feb2021 at 19:00, the patient experienced headache, little sore arm, dizziness, balance problems and the balance is getting worse. Consumer stated that he/she had the COVID about 4 months ago and was in the hospital for 9 days. He/she took our first shot 90 days later that and took our second shot on Tuesday, had every reaction mentioned on the paper; every side effect plus had one that was not going away which was balance problems and headache. Patient had a little sore arm, but the main thing was balance problem and feel like was falling over. He/she stated that the start date of experiencing the events was after taking the shot on Tuesday (23Feb2021). The problem started about 7 o clock in the night on 23Feb2021. When probed for the route of administration, stated upper arm into the muscle. Other medical conditions and concomitant medications included high blood pressure, had a pacemaker and took medication for cholesterol, things like that, took for his/her thyroid, took for his/her urinary something like that, took 20 different medications. When probed about still experiencing the event, he/she stated yes (not further clarified which events consumer was still experiencing). When probed about whether the event worsened improved or still persisting, patient stated the balance was getting worse, it came on later than other problems it has been last 3-4 days, it came on that night after the shot and had no muscle coordination and dizziness. When probed whether patient took any treatment for the events, he/she stated no. Patient took Tylenol. dose of Tylenol, stated 3 tablets, regular tablets every 6 hours and stopped it yesterday. Patient asked that how do find out this was the effect of shot. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recv vax;4dec95 devel papules & early vesicles,few cervical nodes & became achy & fluish w/ fever of 101;more than 50 lesions appeared w/in 24 hrs of varicella like rash,on face,scalp,neck,back & legs;rash redder than usual wild type
About 12 hours after shots, period of hyporesponsiveness, hypotonicity; no cyanosis per mom. Questionable duration of less than 5 minutes. Admitted to hospital. UGI positive reflux; started on Zantac/Reglan. Information from reporter:child has problems with reflux and has a milk protein intolerence.  He is otherwise a healthy child and has had no prior visits to HCP except for new baby check at 2 weeks of age.  There was no reported Adverse event after first Hep B vaccine given in hospital at birth.  Complaint of difficulty breating -- chest xray shows normal results, c/o reflux -- upper GI shows small to moderate reflux.  child was slightly tachycardic with a systolic murmur.  He was monitored for heart problems while hospitalized.  Diagnosis was choking incident due to reflux.
Headache so bad I had to go to the ER.  Brain fog, back pain,  body chills, upset stomach., high blood pressure.
Approximately 30min after vaccination he started having allergic reaction in left arm to shingrix vaccine with hives/redness over left arm extending to right side of neck/chest and back and face. No throat tightness, difficulty breathing, wheezing, tongue/lip swelling. Pt given benadryl and monitored x 1 hour with improvement in symptoms. he was cautioned s/s warranting ER. allergy list updated
NO ADVERSE EFFECT; Nurse reports a patient received a dose of PROQUAD, when the patient should have received their second dose of MMR II; Patient receiveied their first dose of MMR II on 08/28/2019 and received the dose of PROQUAD on 09/25/2019.; Nurse reports a patient received a dose of PROQUAD, when the patient should have received their second dose of MMR II; This spontaneous report was received from a nurse referring to a 7 years patient of unknown gender. The patient's current condition, pertinent medical history, concomitant medications, drug reaction/ allergies were not reported. On 28-AUG-2019, patient received their first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot number, expiry date, frequency, route of administration were not reported) for prophylaxis. On 25-SEP-2019, the patient was administered with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) of lot number R030804, expiry date 22-APR-2020, therapy type rHA(dose, strength, frequency were not reported) via subcutaneous route for prophylaxis, when the patient should have received their second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot number, expiry date, frequency, route of administration were not reported) for prophylaxis(interchange of vaccine products) (wrong product administered)(inappropriate schedule of product administration)(adverse event onset date was also reported as 26-SEP-2019). No adverse effects were reported. There was no product quality complaint (PQC) present. The outcome of the events was unknown.
insomnia, "racing thoughts"  seen in ER then admitted to psych ward at Mental Health Hospital "under parent's influence".  received treatment for 4 days, then discharged with no medical recommendations  current hormone disruption and breast cysts
Patient, at least 24 hours after the vaccine, had swelling, redness, warmth and discomfort throughout the majority of his upper left arm. The swelling, redness and warmth started below the injection site and was the majority of his arm down to around his elbow. We called the doctor a few hours after first noticing it and when it seemed as if it had swelled more, we were advised to keep an eye on it, administer a pain medicine to help his discomfort as well as swelling and that it should go down within 24-48 hrs. He woke up the next morning still swollen and compalining of it hurting, was given pain medicine again and just watched througout the day.The discomfort and swelling, etc has not detracted from his daily life. At this point (about 24 hours after noticing the reaction), he still has minor complaints about the discomfort, some swelling, but the color has returned to normal, it is not warm and the swelling has been reduced, although not completely gone at this point. The reason I marked question #20 as "No" is just that the reaction has not completely resolved at this point, although it appears as though it will.
warmth, erythema, swelling of entire anterior rt thigh (circumrence 40cm rt 36cm lt; treated as cellulitis w/Duricef but can't r/o large local rxn to DTAP;
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. Patient with allergy to codeine. On 30-SEP-2013 (also reported as one month ago) the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous for immunization, lot number and expiration date not reported. There was no concomitant medication reported. On an unknown date in 2013 the patient went to the pharmacy and showed the pharmacist a rash on her chest under her neck which looked like sunburn. The pharmacist stated that there were no vesicles of pustules present and the rash was not unilateral. The patient reported that it burns and was painful. On an unknown date the patient sought for medical attention and visit the pharmacy. No treatment was given for the event. The patient has not yet received any treatment. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
He started to have a fever at 12 pm that night and woke up alot thru out the night then I got him up at 10 am and sat him in his high chair to eat and he started to twitch and scream. I had thought that it may the chair had pinched him and I picked him up and he was still doing it for about 1 min. Then it stopped and we went on with our day. Another one happened about 2 pm and I was in the room and he started to scream. Again I went to the store with my mother and told her what was happening she said that it was just him getting scared and I told her that no it was not and then she saw it first hand. I called the doctor at that point and he said to take him in to the ER and I did and they didn't know why or what was causing it. They took blood and stool sample and gave him Tylenol and it went away for a little bit then came back. They admitted us at about 9 pm and we were there for a total of 6 days and 5 and still no doctor had any answer. He had a normal EEG and nothing then they put us on a video EEG and he had one in his sleep and we were went home with 2 diff meds to give him for them and still no answer. I was watching TV and saw the show and it sounded alot like my situation.
This spontaneous report as received from a pharmacist refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date (reported as 2 weeks after the vaccination), the patient developed warts all over her legs (further described as rash on top of thigh, in the armpits and all over the back; from the rear end down to the calf; individual warts; not pus-filled hives).  The outcome of the event was unknown. Causality assessement was not provided.
The patient requested and needed a TDAP shot. A flu shot was given in error. The error was discovered during the documentation phase and the employee called back in so that we could inform him and administer the correct vaccine. Patient has been monitored daily since the event for adverse reactions signs or symptoms.
Moderna COVID-19 vaccine had a storage excursion and was kept in the fridge for 34 days instead of the recommended 30 days.  Analysis by Moderna indicated the lot of vaccine maintained the activity necessary to protect against SARS-Cov2 at the time of administration.  No adverse events reported beyond normal s/e from vaccine.
itchy hive about 24 hours after the injection at the injection site; itchy hive about 24 hours after the injection at the injection site; This is a spontaneous report from a non-contactable physician (patient). A 62-year-old female patient received the second dose of BNT162B2 (COVID 19 ) via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: EW0162) at the age of 62-year-old as single dose for COVID-19 immunization. Medical history included allergy. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medication was none. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 27May2021 (Batch/Lot Number: EW0179) at the age of 62-year-old as single dose for COVID-19 immunization. On 24Jun2021,  about 24 hours after the injection, the patient developed a large very itchy hive at the injection site, even with antihistamines and pepcid (allergist suggested this). This took 4 days to go away and required topical steroids in addition to oral antihistamines to overcome the pruritis. Treatment was received. Caused/prolonged hospitalization was no. The outcome of events was recovered on 28Jun2021.   No follow-up attempts are possible. No further information is expected.
Pain at injection site radiating to neck and hands.  Had some tingling in fingertips only.  Physical exam showed intact strength, sensation and only pain over injection site without swelling or erythema.
Systemic: Chills-Mild, Additional Details: Approximately less than 5 minutes pt repoerted not able to see anything. Patient sad comfortable with his mom and was breahing fine and 911 was dialed and EMS came out and all vitals were good. Patient was able to see before EMS came and after being check by Ems he left with his mom and was okay.
Extensive confluent erythema on L thigh near injection site. Started 2 days ago. uUclear if just a reaction or if cellulitis. Presumption given for cephalexin antibiotic in case it does not improve on its own.
The wife of the patient came into MinuteClinic complaining that her husband develeped "hives" to bilateral lower extremities 24-48 hours after receiving the Influenza vaccine.  No difficulty breathing , any other symptoms at this time. The rash she reported was painful to him. Follow up received: Within 24 hours of vaccination I experienced hives from the waist down, primarily on the sides of my legs and buttocks.  Within 48 hours they had spread to my stomach and arms.  Today (7 days later) the bumps and redness are gone and all that is left are dots of scabs where the hives were.