chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We were having a drive up COVID-19 vaccine clinic. Due to egg allergy he was instructed to wait for 30 minutes. About 15 minutes into his monitoring period medical staff was radioed for assistance. When I arrived at his vehicle he was alert, oriented, and breathing normally. He complained of sudden onset of bilateral anterior cervical lymphadenopathy. His face and neck had erythema. He stated due to eczema he normally had some redness but this was worse. At 12:21 he was given Epipen to left thigh IM. Vital signs HR 84, RR 18 BP 120/80 SP02 99%. At 12:25 he was given diphenhydramine 25mg IM left delt. Vital signs HR 92, RR 16, BP 160/100 SP02 99%. As Epipen was given, another staff was calling 911. Emergency services arrived at 12:33 and took over care. Patient was transported by ambulance to the University location. When he left via ambulance he was in stable condition.
Patient received wrong covid vaccine. He was seeking covid Pfizer bivalent booster and received covid pfizer monovalent vaccine Narrative: Patient presented to Occ health for COVID bivalent booster. He was administered COVID Pfizer monovalent vaccine instead of COVID Pfizer bivalent vaccine.
Received Pfizer vaccines on 2/23/21, 3/16/21, 9/28/21 tested positive for COVID 19 by PCR on 10/31/21 admitted to Hospital on 10/31/21 w/ ataxia, cough, confusion, metabolic encephalopathy underlying Parkinsons disease
@11:55am, patient received MGC/HPV VACCINE per PCC order. Right after patient received both vaccines, patient stated she's light headed then  went unconscious . Code Blue was paged overhead. Patient is sitting  in chair , placed patient on a lying position on her back with both  legs elevated. Multiple staff members came to help and responded quick. 911 was called.  Vital Signs 146/76,  pulse 76, 02 sat 67 % at 3L /min.   At 12:05 pm, transport arrived. Patient is alert , verbally responsive , stating " i still feel a little light headed". VS 124/80, pulse 77, 02 sat 99%  at 3l/min.   @12:18pm, transport left the building without the patient. Per patient, she feels better , just slight light headedness and per patient, she will stay here in the clinic .  Advised patient to stay in the clinic to be monitored until she feels better.   At 12:22 pm, patient is alert and verbally responsive. Denies pain, no SOB,  no light headedness. Per patient , she feels better. . VS 117/77, pulse 69, o2 sat 99%. Patient left the immunization clinic with her mother. Advised patient to report to his provider regarding the incident that happened today.
Patient had COVID-19 J&J vaccine 10 days ago at external facility Patient states that after vaccine she developed aches and headache The headache and upper body pain has not gone away The headache is dull and throbbing and is consistent Patient has not yet taken anything for pain relief  No other associated or neurological symptoms    Two nights ago patient awoke to palpitations Since then patient gets sharp shooting pain across the chest 1-2 times an hour Symptoms can occur at rest
I have Meniere's, it aggravated my condition with multiple dizzy spells with in hours of having the shot. The afternoon and two days later. I'm better today. And didn't need Doctor care.
Redness at site of injection. Prolonged (one week) soreness in upper arm, shoulder and elbow.  Mild headache. Fatigue.  Decreased stamina.
side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ANASTROZOLE for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE RASH (side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm). At the time of the report, VACCINATION SITE RASH (side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient received CERVARIX vaccine on 09/07/10 and vaccinated with GARDASIL vaccine on 09/22/11.
The day after injection the patient noticed a swollen, tender, red strip at site of injection.  The strip was approximately 5 inches long and 2 inches wide.  Patient also had a headache.  Headache has resolved.  Redness, tenderness, swelling improving but not completely resolved on day 5.
Donor reports soreness on second day after tetanus immunization (11/26/2022) in right shoulder and clavicle area . Assessed and did not feel anything unusual but donor reports pain 6/10 in clavicle area and states that same shoulder on right side always "pops".  Donor deferred from donating on day of report of soreness.  Will be sent to PCP  for further assessment
pt recv vax; had rash in area where shot given;did not spread all over body;MD felt rxn to vax;synalar cream prescribed;
patient received a pentacel vaccine as well as an act-hib vaccine on 25sep2018 (with no reported adverse event; Initial information received  on 05-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who received a /TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [Pentacel] vaccine as well as an HIB (PRP/T) VACCINE [ACT-HIB] vaccine (with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination.  On 25-Sep-2018, the patient received an unknown dose 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, suspension for injection (lot UI904AA, strength - standard, frequency - once, expiry date - unknown) via unknown route in unknown administration site and an unknown dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength, lot number and expiry date - not reported) via unknown route in unknown administration site for immunization, with no reported adverse event (extra dose administered) (latency: same day)  Reportedly, Caller states that she was entering vaccine information into the system on behalf of a patient that is new to her practice and discovered that the patient received a PENTACEL vaccine as well as an ACT-HIB vaccine on 25SEP2018. Caller contacted the facility that provided the vaccines and was given a lot number for the ACT-HIB. Caller believes that the lot number provided was for the Hib portion of PENTACEL and is calling to verify this. Caller does not believe that the patient received a full ACT-HIB vaccination as well as a PENTACEL vaccination but could not verify this on the VAERS system  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Patient reports hives after receiving first vaccination. Started on hand and "moved up [her] arm". No shortness of breath. Did not take any meds to help with the hives. Hives are still present today (4/10/2021), but are improving. Did not report ADE to physician  or healthcare provider. Hives were mentioned during check-in at which time VAERS report was filled out.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with doses of 0.5 ml GARDASIL, intramuscular on the following dates: first dose on 24-JUN-2014, second dose on 26-AUG-2014 and third dose on 15-OCT-2014. No adverse effect was reported. Additional information has been requested.
On 8/23/2019 @ 6:30 PM patient reported warmth, swelling and a tear drop size of redness at site of injection but no pain.  He then experienced a fever with chills.  (Actual temperature info not available)  He reports that it lasted until 3 PM Saturday afternoon, 8/24/2019.  He was then without any complaints after that and continues to be.  8/27/19 - warmth and redness gone, afebrile, slight puffiness at site but no complaints.
Unusual Digestive upset?nausea, cramping and diarrhea lasting approximately 12 hours and weakness lasting 24 hours.  Had no treatment and felt completely well in 48 hours.
redness at injection site; Body aches; headache / headache is worse.; fever of 99 degrees; muscle aches; tired; This case was reported by a consumer and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received Shingrix. On 21st September 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, general body pain, headache, fever, muscle pain and tiredness. On an unknown date, the outcome of the injection site erythema, general body pain, headache, fever, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, general body pain, headache, fever, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient Shingrix and experienced injection site redness, headache, muscle aches, tiredness and fever of about 99 degree celsius. The reporter mentioned that the day before reporting she felt better but on the day of reporting she felt all the symptoms and headache was worse.
The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the health department and the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required by the health department given the increase in dose administered.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (minor irritation in his injection site arm after each dose.) in an 87-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE IRRITATION (minor irritation in his injection site arm after each dose). At the time of the report, VACCINATION SITE IRRITATION (minor irritation in his injection site arm after each dose) outcome was unknown. No concomitant drug information was provided. No treatment drug information was provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received contains no new information.
? Wednesday, May 19, 2021:     ? 14:00 EDT - Patient got 2nd Pfizer vaccine.     ? 17:00 EDT - arm started to get sore.     ? 17:30 EDT - dizzy after sparring class.  Blood pressure 107/71.  Pulse 59 BPM.   Burping.  Gassy.  A bit nauseous.  Watermelon smelled like cut grass (awful).  Forcing myself to drink orange juice.  Tastes terrible, like Sweet Tarts (My wife says it's just me).     ? 20:30 EDT.  Found antidote.  Antidote is pie.  Cherry pie.  After kimchi chicken and smokra.  Update:  Feelin' fine. ? Thursday, May 20, 2021:     ? ~ 05:00 - hard relapse.  Arm very sore (8/10).  Fairly nauseous.  Almost regurgitation level.  At the same time I do feel hunger so I know it's not real nausea, yet I still can't eat.  Bad headache (7/10).  Muscle stiffness up the back and up to the neck, getting worse the higher you go; the neck is particularly bad.     ? By 9:40, temperature up to 99.6.     ? 11:57 temperature 100.7, blood pressure 125/66, pulse 79     ? 2:50 temperature 99.7     ? 3:30 temperature 99.6 ? Friday, May 21, 2021:     ? Update about yesterday (Thursday):  I ended up spending the entire day in bed.  Very nauseous.  Couldn't eat.  Spiked a high fever (my baseline is around 97.5° F).  Blood pressure fluctuated.  High pulse (mine is usually around 50 bpm).  Sore muscles on entire torso; pain in my lower back (above pelvis) makes it too uncomfortable to sit up.  Except for not vomiting or coughing, it felt like the flu.     ? Head still hurts (4/10).  Weak.  Tired.  Arm still pretty sore (3/10).  Was able to eat kimchi chicken for lunch and shawarma for dinner, but still not completely over the nausea. ? Saturday, May 22, 2021:     ? Left arm still sore in a 2" radius from injection site (2/10), but the rest of the arm is fine.  Still have the headache (2/10). ? Sunday, May 23, 2021:     ? About mid-afternoon, the headache finally receded.  Left arm still sore in a 1/2" radius from the injection site (1/10).
Narrative: 63yr received Moderna COVID vaccine booster in one arm and Fluad vaccine in other arm on the same day. Seven hours later after receiving both vaccines patient reported to caregiver feeling of "shaking" and cold which lasted several minutes. No other sx of fever, CNS changes (ie seizures), or injection site reactions noted.
This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (route was not provided) which were exposed during 63 hours excursion to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist via company representative refers to approximately 27 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported by the reporter. On an unknown date the patient was vaccinated with GARDASIL dose 2 (dosage, route, lot# not reported). No concomitant medications were reported. It was reported that on an unknown date the patient had received two doses of GARDASIL had turned 27 on an unspecified date before she could receive her third dose of GARDASIL. The pharmacist was discussing this occurrence because she was saying that the last reminder didn't come for the patient, and the representative suggested that the patient's turning 27-years-old before the third dose of GARDASIL was administered may be the reason the third reminder didn't come. The representative specified she did not ask the pharmacist if company could follow-up with her about this scenario. No adverse effect had been reported. The patient sought medical attention not reported. Additional information has been requested.
12:30 hives on chest, face & neck;dry throat & diff swallowing;itching neck, chest & scalp & middle & sides of back;MD gave epi & antihistamine po zyrotc
I can't hear out of one ear,; I feel like I have a really bad cold; I'm very tired; I feel really sick; and I'm concerned that I may have covid now; This is a spontaneous report from a contactable consumer(Patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had her first dose of the Pfizer BioNTech covid vaccine and concerned that she may have covid now. Since getting the shot she feels like having a really bad cold, can't hear out of one ear, she is very tired and feel really sick. She is not sure if these are side effects of getting the vaccine or if she has covid. The outcome of all the events was unknown.   Information about lot/batch number has been requested.
On 05/15/2021- my heart rate would go up to 150 bpm and subside. That would happen periodically. It did not happen every day, but it happened frequently.  For no reason, I would be sitting, without exertion, and it would go up. My resting heart rate is 65. I did not do anything about it because it did not last long enough. Initially it was occurring like daily. Shortly it gradually declined in frequency. It has not happened but once in the past month. Unknown, if my AEs have recovered because it happened yesterday, very briefly and it hasn't happened for a while.
Pt states that immediately after receiving flu vaccine that her arm started twitching. Pt has also experienced some tingling in affected arm since then, pt states it has not stopped and is around the clock. Spoke with pt on 12-30-13 and she will see physician on 1/1/14 if not resolved per his orders.
pain in her upper back; pain under the neck; arm hurt and she could not move it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 09:00 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 03Mar2021, outcome "unknown", described as "pain in her upper back"; NECK PAIN (non-serious) with onset 03Mar2021, outcome "unknown", described as "pain under the neck"; PAIN IN EXTREMITY (non-serious) with onset 27Feb2021, outcome "recovering", described as "arm hurt and she could not move it". Therapeutic measures were taken as a result of back pain, neck pain, pain in extremity.  Additional information: The patient asks if her symptoms may be related to the Pfizer-BioNTech COVID-19 vaccine or not. On Wednesday (03Mar2021) she noticed pain in her upper back, under the neck and she couldn't hold her head up. She took Aleve for the pain. It was described as pain similar to when the pillow was not well placed and after waking up the neck hurts. She wanted to know what should she do, can she get the next dose or not and asked what happens if she do not receive the second dose of the COVID-19 vaccine so she was referred to her Doctor for guidance related to the 2nd vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Wife called to report to pharmacy that husband experienced stroke-like symptoms. She called 911 and patient was taken to the hospital. Neurologist at hospital told her he believed symptoms aligned with severe booster reaction.
The patients doctor called and stated that the patient got a pneumonia shot and came into the doctor's office and had what appeared to be cellulitis, and the doctor called in an antibiotic (Augmentin 875mg)
Patient received the Pfizer Covid-19 vaccine at the age of 15. No known adverse reactions occurred. Patient did not receive their 2nd dose in the series.
Pt states approximately 6 hrs after flu shot given, had violent shakes, chills, fever 102 degrees, vomiting, nausea, body aches, fatigue. Took hot shower to warm up and ALEVE. Severe symptoms last 1 1/2 hrs. Next day low grade fever 100 degrees, 3rd day feeling fine - just tired.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies were not provided. On 13-SEP-2018, the patient was vaccinated with improperly stored PROQUAD lot # R001543 with an expiration date 15-JUL-2019 (dose, route of administration, anatomical location and albumin status were not reported). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) lot# R002036 with an expiration date 03-AUG-2020 (dose, route of administration and anatomical location were not reported), which was stored appropriately. No adverse effect was reported. Administered vaccine experienced the temperature excursion from -14 to -10 degrees Celsius for 11 days. There was no previous temperature excursion. A digital data logger was involved. This is one of two reports received form the same reporter.; Sender's Comments: US-009507513-1809USA008626:
Nerve pain in both ears woke me up.  It feels like a sharp pains or electric shocks.   It happens in both ears every few minutes and feels awful.  I can no longer sleep or function.  Using Motrin and hot compresses but only helps temporarily.
Patient seen in the ED on 6/18 for dizziness, generalized weakness, and dry cough. COVID-19 PCR test done on that day was positive. He was admitted to the hospital on 6/18-6/19. This meets criteria for vaccine breakthrough case review.
The first dose of vaccine was given IM, instead SQ. CMA revaccinated patient same day administering SQ (per RN instructions). As far as we know there were no adverse reaction.
Pt had vaccine in the office; mom nursed child for about 15 minutes in the office and noticed small red area at site of vaccination. Pt has two vaccines one in each leg and only the left thigh had reaction.
Itchy, swollen throat and neck at 1 am on 10/18/14. Pt took BENADRYL -> didn't help -> hands swelled up. Internal hives -> went to hospital -> they gave her steroids -> she had a seizure, got hot then passed out. Was discharged 10/20/14.
my left started twitching; eye pain; Heavy chest; very little sleep; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (my left started twitching), EYE PAIN (eye pain), CHEST DISCOMFORT (Heavy chest), INSOMNIA (very little sleep) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (my left started twitching), EYE PAIN (eye pain), CHEST DISCOMFORT (Heavy chest), INSOMNIA (very little sleep) and HEADACHE (headaches). At the time of the report, MUSCLE TWITCHING (my left started twitching), EYE PAIN (eye pain), CHEST DISCOMFORT (Heavy chest), INSOMNIA (very little sleep) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, on Friday, within 30 minutes after the vaccination, the patient experienced twitching.  No concomitant medication information was provided by the reporter. No treatment information was provided.
initially I had soreness at injection sight that started decreasing I began to have increased pain above the injection on my shoulder muscle. Any movement created pain, by Friday I couldn't move it without severe pain in the shoulder. I went to the Dr Friday the 8th at 3pm I received a LMN treatment and osteopathic treatment that relieved the pain some. Put on prednisone and a heating pad with zero movement.  Dr believed I had a underlying autoimmune inflammatory reaction