chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tachycardia; metallic taste in mouth; Dizziness; Short-term memory issues; erratic BP/HR; erratic BP/HR; difficult word finding (verbal); severe exhaustion; nausea; shakiness; autonomic dysfunction/possible dysautonomia; hyperadrenergic; exaggerated immunological response to the vaccine; felt strange/brain fog; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. This report concerns events occurred after the first dose of BNT162B2. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), administered in the right arm, on 08Jan2021 at 11:45 AM (at the age of 51-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination. Concomitant medications were reported as none. No other vaccine received in four weeks; no other medications received in two weeks. The patient previously took erythromycin and aspirin and experienced known allergies; the patient was sensitive to progesterone: tachycardia, and cipro: headaches. The patient felt strange but okay at first, on 08Jan2021. Starting two days after vaccination, on 10Jan2021, severe exhaustion, nausea, shakiness; no fever, injection site was not sore/red. 10 days later, on 20Jan2021, evolved into tachycardia, brain fog, difficult word finding (verbal), short-term memory issues, dizziness, metallic taste in mouth, erratic blood pressure (BP) and heart rate (HR). Patient could not get the second dose due to the severity of side effects. Currently, five months later, she still had not fully recuperated, although she still was (hopefully) improving. For the first time in her life, she had taken beta blockers. She had seen a variety of specialists (cardiology, neurology, hepatology, immunology...). The thought was that she had an autonomic dysfunction, hyperadrenergic, exaggerated immunological response to the vaccine started on 08Jan2021. Hopefully not permanent. She was currently not back to normal yet. Other medical history was reported as possible dysautonomia, that was diagnosed just as a result of the reaction to BNT162b2. She was otherwise healthy. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care visit. The patient had tested for COVID post vaccination and included COVID test type: nasal swab on 20Jan2021 and on 28Jan2021, both resulted negative; COVID test type: blood test on 12Mar2021 resulted negative. The events were treated with propranolol. The patient had not recovered from the events (as reported).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529184 same patient/drug, different dose/events
Chicken pox like rash - occurred 2 weeks after shots. Strongly resembles. On penneal area and spreading to truck and back.
(L) arm - erythema (9 x 15 cm area), 1 cm area induration in center - (L) deltoid region. Had DTAP and IPV in this arm. Seen in office 7/8/16.
Approx. 4 wks after receiving vaccines (MMR, varicella, Hep A, Hib and flu), patient developed fever (Tmax 101.3 F) and rash on anterior trunk (lower half) and right upper thigh. Rash may be a modified varicella rash.
Pruritus and rash; onset the day after administration and was treated with prelone syrup.
right eye swelling Narrative: employee states: on Friday 1/8/2021 her right eye started swelling and has been swollen all weekend long. She is not experiencing any burning, draining, or redness- just swollen. She has been using antihistamine drops which seems to be helping.
Varicella given Lt thigh. Nurse giving the vaccine did not hold leg and she pulled out. Was then given another varicella in same area.
Sudden onset fever, respiratory stridor and respiratory distress. Had tonic clonic seizure on 10/31/12 8am.
Information has been received from a physician concerning a 14 year old patient who on 05-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot# not reported). The physician reported that the patient had a episode of syncope within 2 minutes after the vaccination. Everything resumed as normal. There were no long term effects. Additional information has been requested.
The next day started to throw up, had fever, felt achiness. Thought that pt was getting a cold but stomach pains began 4-5 days after shot. Had a doctor appt. Strep testing was negative. Improved a bit but stomach pain did not go away. Went to GI specialist, started pt on elimination diet, took stool samples, treated with LEVSIN/PREVACID/ZANTAC, tried for awhile. Stomach x rays showed that pt was backed up diagnosis was small intestinal bacterial overgrowth. Also put on triple antibiotic therapy. FLAGYL/omeprazole/doxycycline. Neurology testing was done for leg and arm and overall body pain. Dizziness got worse so GI doctor tested for POTS (postural orthostatic tachycardia syndrome). Neuropathy, not able to sweat, nerve dysfunction. Unable to go to school normally; can only go for a couple of hours. Unable to walk for prolonged time or distance. Suffers from headaches, severe abdominal pain, nausea daily. Sore throat and hair loss; loss eyebrow. Diagnosed with dysautonomia.
Case number PHEH2014US024284, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 37 years old female patient. Medical history and concomitant medication were not reported. Her previous vaccinations (unspecified) were well tolerated. She was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
A consumer report has been received. The report concerns a 41 year old, female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Oct-2014. The patient experienced loose stools, cold sweat, sinus infection and runny nose which started on 02-Oct-2014. The outcome of the event of loose stools, cold sweat and runny nose is unknown and at the time of reporting, the event of sinus infection was ongoing. The report was considered to be non-serious by the reporter. The company physician assessed the reported events of fever, productive cough, headache, body aches, sore throat and fatigue as symptoms of sinus infection.
Dizziness and lightheadedness beginning 12 hours after injection, lasting for total of 12 hours. Chills and shaking beginning 12 hours after injection and lasting two hours. Nausea and vomiting, diarrhea, beginning 14 hours after injection and lasting 10 hours.  Fainted and fell three times, not sure how long was out before regaining consciousness. Symptoms were similar after 2nd shot but significantly milder (no vomiting, fainted once). Headache and low energy the next day.
Severe chills starting 10:30 pm on 10/26/21  continuing until 9am 10/27/21.   1:30 am  10/27/21 got up , extreme dizziness and passed out on floor.   Went back to bed, still chilled with leg and foot cramps.
This spontaneous report was received from a physician via an office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
allergy; left arm pit lymph node was swollen like a grapefruit; All of my joints, except my elbows, are freaking killing me now/ shoulders were the worst; negatively impacting my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "left arm pit lymph node was swollen like a grapefruit"; ARTHRALGIA (non-serious), outcome "unknown", described as "All of my joints, except my elbows, are freaking killing me now/ shoulders were the worst"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "negatively impacting my life". Therapeutic measures were taken as a result of hypersensitivity, lymphadenopathy.  Additional Information: After second shot of Pfizer vaccine, the patient left arm pit lymph node was swollen like a grapefruit for 3 days. It felt like crap for about a week. "No more "boosters" for this guy". The patient stated that all of my joints, except my elbows, are freaking killing me now; shoulders were the worst. The patient felt like decomposing after the shots. The patient never had an allergy in life, but now was having it. The patient stated "Oh, and I get to take Zyrtec now; thanks so much for negatively impacting my life".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient with history of 3 COVID vaccines who had incidental positive COVID test found upon admission to inpatient rehab unit.  Asymptomatic throughout stay.
Arm hurt so much; Arm hurt so much it was hard to move if; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient's arm hurted so much and it was hard to move if for about a week. Till the time of reporting the arm still hurted and this was 3 months later. The patient inquired about whom should he/she contact.
nurse gave an expired pentacel to a patient with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and nurse gave an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (with an unknown expiry date, strength, lot number) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date, reporter reported nurse gave an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, This situation is reported as a medication error due to administration of expired product to a patient.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurse gave an expired pentacel to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Systemic reaction with fever, chills, myalgias, and arthralgias with local inflammation and induration and erythema.  Began the day after injection and continued for two days
She cried and was fussy for a week straight after her shot. Also she ran a fever that day. She was fine in the morning and she started about 1 1/2 after shots.
SYNCOPE. FELL DOWN FROM THE SEAT. WAS RESPONSIVE BUT COMPLAINED OF HEADACHE. HEADACHE RESOLVED AFTER RESTING FOR FEW MINUTES
Employee was given vaccine appoximately around 12:30 p.m. Employee stated feeling dizzy,disoriented and nauseated around 12:50 p.m.. Employee thought it was because she had not eaten prior to recieving the vaccine so she ate a full meal around 1:30 p.m. Employee was then given saline  to see if any symptoms were alleviated. Employee stated feeling better after being adminstered saline but soon after the employee started feeling dizzy again. Employee stated she went to the bathroom to vomit. Employee then went to managements office to sit down due to still not feeling well.
A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022 at 3:06 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022 at 3:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A single dose of Moderna Covid-19 vaccine was administered beyond 12 hrs post puncture.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up document received contains no new information.
Information has been received from a health professional concerning a 32 year old female, with no medical history and no allergies, who was vaccinated with a first and second dose on 10-JUN-2002 and 08-JUL-2002, respectively, of Varivax. It was reported that a varicella titer on 16-MAR-2006 was negative. It was reported that at the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
first dose of Shingrix but not the second within the recommended time; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix but not the second within the recommended time). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-AUG-2023 and 16-AUG-2023 The reporter enquired that, what should a patient that took the first dose of Shingrix but not the second within the recommended time frame? MI did not speak with the Health Care Provider, so please follow up with the Sales Representative for more information.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
L sided heart palpitations; This is a spontaneous report from a non-contactable pharmacist. A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via intramuscular on 08Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. It was unknown, whether the patient had other vaccine within four weeks; prior to the vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient had been tested for COVID-19. The patient medical history was not reported. Concomitant medication(s) included rivaroxaban (XARELTO); tamsulosin hydrochloride (FLOMAX); metoprolol tartrate; docusate sodium (STOOL SOFTENER); levothyroxine; furosemide; omeprazole; potassium. On 24Feb2021, the patient experienced L sided palpitations after COVID-19 vaccine 08Feb2021. First episode lasted 4-5 hours: Blood pressure -113/78 mmhg, Heart rate- 78, O2 consumption - 96 and oxygen saturation: 96 %. Happened a few hours after second dose of vaccine as well (01MAR2021). The patient visited to doctor or other healthcare professional office/clinic visit for adverse event. He visited PCP and was stable. It was unknown, whether patient recevied any treatment. Outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
5ml syringes that had been provided by  Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Mom describes 7-(?) episodes lasting 10 seconds each of eyes becoming wide open and staring, body stiffens similar to a startle reflex.
w/in 12hr diffuse then erythema-cheeks, arms, legs, trunk-no hives;lt conjunctival infection;erythematous tonsillar pillars;fever >38.5;DPH;
Systemic: Bell's Palsy-Mild, Systemic: Lymph Node Swelling-Medium
bad reaction; bumps all over; bad reaction with rashes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE REACTION (bad reaction), URTICARIA (bumps all over) and RASH (bad reaction with rashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported by reporter.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (bad reaction), URTICARIA (bumps all over) and RASH (bad reaction with rashes). At the time of the report, INJECTION SITE REACTION (bad reaction), URTICARIA (bumps all over) and RASH (bad reaction with rashes) outcome was unknown.            no concomitant and treatment medications are provided.
Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced Bell's palsy on the left side of my face...and had minor heart pain...was dizzy...had loss of balance...slurred speech, I had all of the symptoms of a stroke. Later in that same morning the swelling starting going down, so I waited to go to the emergency room...did not want to spend the money for all of the tests. I woke up the next morning and still had heart pain, so I decided to go to emergency room .
Ouch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 15-MAR-2023, the patient received Shingles vaccine (unknown arm) and TETANUS VACCINE (unknown arm). On 15-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: Ouch). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported he or she received Shingles vaccine and Tetanus vaccine in the other arm and experienced pain ouch. Follow-up would not possible as no contact details were available.
I received vaccine about 4:00 PM. I felt fine until I went to bed about 10:30 P.M. I got extremely teeth chattering cold and could not get warm and began to have a small headache. I awoke about 2:30 A.M. and was extremely hot. I went downstairs to bathroom and the next thing I know my wife is shaking me to wake me up laying on the floor. My wife said she heard me fall and discovered me in the bathroom floor. She woke me up and I stood up and exited the bathroom and collapsed in the hallway. My wife awoke me again and I didn't know what occurred. My wife called 911 and EMS responded and assessed my condition. I explained everything that occurred and that I had my J&J vaccine hours earlier.  My vitals were taken and my condition was evaluated. I had a bad headache that felt like my head was in a vise and my knees and chins hurting a bit from the fall I was fine. I just did not recall collapsing either time and I was distraught when my wife woke me both times. That's what I was informed by my wife. I don't recall anything after urinating to being woken up by my wife and I was on laying on the hallway floor and my wife was on the phone with 911.
Palpitations, high heart rate, blood pressure went up. Felt flushed, nausea.
pt vaxed & began crying shortly p/arrival home; pt was unconsolable & taken to ER by mom;
BODY PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced body pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body pain was not reported. This report was non-serious.
pt complained of red rash , uneven border  , hot and hard to touch  few days after shot