chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hepatitis B; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEPATITIS B (medically significant), outcome "unknown", described as "Hepatitis B". Caller wants to have information about the Paxlovid. He mentioned that he had Hepatitis B. Paxlovid is not an active product. He is inquiring for Paxlovid indication of use for those people who had a history of Hepatitis B. He added that he already got the Covid-19 vaccine but he did not mention the brand of the vaccine. He also requested to be anonymous. No information gathered. Provided PMI contact number and hours of operation. Call got disconnected while connecting the call to PMI. Unable to gather the first and second dose date. No transfer was made. Submitted Manual AE form since the caller mentioned that he had Hepatitis B but it was not mentioned if this happened before or after receiving the Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It started that same day after receiving dose 2 vaccine, almost 20 sec after getting the vaccine, my throat starting close up, had difficulty breathing, my heart was beating very rapid. I stood up and got dizzy. They ask me to sit back down and after doing my throat stop feeling tight. They didn't need to do an Epi Pen because after 20 mins I start breathing ok. They told me I shouldn't drive, so I got a ride. I couldn't walk.  So, I had to see a Cardiologist because my symptoms didn't get any better. My heart was still beating very fast. I notice I was getting winded. I got my vaccine in March, but I didn't get any better until June or July 2021. The doctor said that he didn't know why my body reacted like that. I am now pregnant.
Patient states that roughly 24 hours after receiving his 2nd dose he had an earache, headache, pain and stiffness in his joints, felt depressed and on the very of feeling almost psychotic,
Patient has not had any adverse reactions that we are aware of, but patient was given an incorrect dose/vaccine. Patient was given the powder portion of the vaccine but was mixed with sterile diluent, not the diluent in the box.
sick from work; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick from work".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the day after power was lost in the middle of the day at 12:00 pm and had to placed all vaccine in a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. This case is reported for patient 11 out of 26 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Patient 1
Started with headache and chills, leading to nausea dizziness, and cough.  Symptoms worsened the following day.  On 11/18 went back to doctor and received flu test. Tested positive for both A and B type flu viruses.
Patient has a bruise that keeps getting bigger and bigger at injection site (per pt). Also has flu like symptoms. Patient informed to see MD ASAP (12/28/13) when called pharmacy.
Fever of 100 degrees, naursea, headache, soreness at injection site and all over body, pain behind eyes and brain fog
BAD SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious.
Swelling of the lymph node under my right arm,  which is the arm I received the shot. Significant swelling and tenderness. No other symptoms.
Muscle ache; headache; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, muscle aches/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) headaches. On 11 Feb 2021, the patient experienced the event(s) muscle aches.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headaches, muscle aches was unknown.
Patient felt a small bump above her left clavicle starting on sunday afternoon. She said it was size of fingernail, felt tender, and mild pain. She was unsure if it was related to vaccine. Symptom onset began on 3/20/22 but it is mostly resolved as of 3/24/2022 per patient.
Arrhythmia, shortness of breath, pounding in the chest, cramps and numbness in the legs.
This case was reported by a consumer and described the occurrence of eye swelling in a 58-year-old female patient who received (ENGERIX B ADULT (batch number 3FZ74, expiry date unknown). Concurrent medical conditions included drug allergy (causes vomiting). Concomitant products included CRESTOR and LASIX. On 14th May 2015, the patient received the 2nd dose of ENGERIX B ADULT (intramuscular) 1 ml. On 14th May 2015, 2 hrs after receiving ENGERIX B ADULT, the patient experienced eye swelling, throat constriction and facial swelling. The patient was treated with BENADRYL and prednisone. On an unknown date, the outcome of the eye swelling was not recovered/not resolved and the outcome of the throat constriction and facial swelling were recovered/resolved. It was unknown if the reporter considered the eye swelling, throat constriction and facial swelling to be related to ENGERIX B ADULT. Additional information provided: The patient reported that she went to the emergency room on 14 May 2015, she was treated and discharged home. On 15 May 2015, she experienced eye swelling again and was prescribed BENADRYL and prednisone. The patient planned to continue follow-up with her physician.
Almost passed out in bathroom, had to get help to get back to bed. Foot cramps. Had been to the bathrroom 3 times that night w/ pale clear urine. Had a small dinner the evening before. Drank Gatorade the following morning.
pt recv vax & w/in 24 post vax;exp a pruritic sandpaper like rash on torso (front & back), arm, & abd;also exp nausea;pt recovered;
Pt received ADACEL vaccine on 8/25/09: Lot #C3248AA Sanofi Pasteur. The pt called on today 8/27/09 to report headaches since receiving vaccine.
Restless sleep; I was nauseous; No energy; Dry cough; Had a temperature the day after the shot 99.8.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "I was nauseous"; ASTHENIA (non-serious), outcome "recovered", described as "No energy"; COUGH (non-serious), outcome "recovered", described as "Dry cough"; PYREXIA (non-serious), outcome "recovered", described as "Had a temperature the day after the shot 99.8."; SLEEP DISORDER (non-serious), outcome "recovered", described as "Restless sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient have had a bad week after this 3rd shot. Patient was nauseous. No energy restless sleep. Had a temperature the day after the shot 99.8. Normal temperature is 97.4. It had been a week now, also a dry cough if patient did not drink enough and slightly raised temperature. Today 7 days gone patient felt pretty well, sugar level in normal limits.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red spots/rash upper torso;front & back was dx as pitoryasis rosea;
'Covid Arm'   Red, Swollen, itchy.  Patch about 4"x6" near injection site.  I would not call it a rash, but a skin/muscle reaction.
Patient came for second dose of Pfizer vaccine. Moderna 6 mo-5 yr 0.25 ml was administered instead of Pfizer 5 yr- 11 yr 0.2 ml. First Pfizer orange cap 5yr- 11yr dose  was administered 8/3/22.  Patient's mom is aware and is waiting on response from CDC and from response of pediatrician of possible symptoms.  We are contacting CDC and will have pediatrician call mom back.
No event. Pt had negative pregnancy test 17JUL when test given and returns today 24JUL with positive test. Pt was pregnant at time of vaccine anthrax but B HCG was negative.
24AUG89 pt vax w/hepta B; exp h/a, flu-like illness, general hives on back & legs w/welts & itching.  Hives resolved & reoccurred then resolved again.
This spontaneous report was received from a pharmacist, concerning a 60 year-old female patient of unknown age. The patient did not have concurrent conditions, medical history or drug reactions or allergies. Her concomitant therapies included AMBIEN, EFFEXOR, vitamin D (unspecified) and omeprazole. On 28-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency and route were not reported) lot # M038350 with expiration date of 06-DEC-2017, for prophylaxis. On 03-APR-2017, the patient went to the pharmacy with a "2-3 inch rash on her left arm, red, slightly raised no blisters". No treatment was given and no laboratories were performed. The pharmacist was interested in Varicella Zoster Virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of the report, the patient had not recovered from the adverse events. The causality between the adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Body ache; Fatigue; Fever of 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F). The patient was treated with TRAMADOL at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 100.2 Fever of 100.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Rash breakout on my neck, around the collar that traveled to my chest and under around my breasts to my armpits -
patient developed very red arm-was treated by doctor  on april 26 -diagnosis of cellulitis by md -was given prescription of keflex
booster; feeling great pain in her left leg and could not even walk, her leg was feeling hard; feeling great pain in her left leg and could not even walk, her leg was feeling hard; her left leg is swollen and painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 10:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 Immunization; Bnt162b2 (dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "not recovered", GAIT DISTURBANCE (non-serious) with onset 21Nov2021, outcome "unknown" and all described as "feeling great pain in her left leg and could not even walk, her leg was feeling hard"; PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "her left leg is swollen and painful". Therapeutic measures were taken as a result of pain in extremity, gait disturbance, peripheral swelling.  Clinical course: It was stated she received Pfizer COVID-19 vaccination booster (3rd dose) on Sunday 21Nov2021 at 10:30 AM, in her left arm. After one hour, or less than half an hour on the car, she started feeling great pain in her left leg and could not even walk, her leg was feeling hard. She is still feeling a lot of pain, even after taking 800 mg ibuprofen, and her left leg is swollen. She mentioned that she did not experience side effects after the 1st and 2nd doses of the vaccine. Now her left leg is swollen and painful, yesterday she went to see a stomach doctor who did not know what was going on. Caller wanted to know if someone else reported this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergic reaction at site of injection, itching, pain, redness, and swelling.
Patient complains of having sore and swollen arm at and below injection site. Arm is warm to the touch.
Little swelling on my lip; This case was reported by a consumer via interactive digital media and described the occurrence of lip swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was unknown.   It was unknown if the reporter considered the lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had shingles before. The patient received the dose of Shingrix and experienced almost all of the symptoms including a little swelling on lip. The doctor told patient that to not to take the 2nd dose.  The patient asked about any protection with 1st dose.
Initial COVID vaccine Moderna, second and third COVID vaccine Pfizer. Incorrect vaccine given for second injection
nose, throat and sinus congestion; nose, throat and sinus congestion; nose, throat and sinus congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: unknown), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious), SINUS CONGESTION (non-serious), UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "not recovered" and all described as "nose, throat and sinus congestion". Additional information: The patient called to ask if it was OK to take the booster dose next week. She was currently experiencing nose, throat and sinus congestion. Two doses of the COVID vaccine had been taken.  The lot number for BNT162b2 was not provided and will be requested during follow up.
3 days developed shingles. Confirmed by PA on 2/17/2012.
24 hours after vaccination: low grade fever, chills, moderate HA. Cleared after 24 hours then recurred on day 3 associated with atrial fibrillation, lightheadedness, and mild chest discomfort. The atrial fibrillation has now continued for 48 hours (never has occurred before - usually 1-2 hours). Chest discomfort is positional (improving after naproxen). Now at 5 days out chills etc. have resolved b still have the cardiac symptoms and lightheaded.
I had 2 gallbladder attacks, one 2 weeks after my 1 shot and then another attack 2 weeks after my 2nd shot. The 2nd attack put me in the hospital for 3 days.
Pt reported to me on 3/18/2021 that a few hours after receiving her Janssen dose she started to have a heart rate of 122 bpm at rest and 144 with exertion that lasted for 2.5 days.  (Day 0, 1 and 2).  She reported she had severe muscle aches and difficulty breathing.  She did not seek medical care and her symptoms were resolved when she called me on March 18th.  I instructed her to get medical care if her symptoms began again.
Patient reported vomiting, severe muscle fatigue, muscle pain, fever, nerve pain in neck and leg which caused difficulty walking. Patient reports symptoms began ~10-12 hours after vaccine and lasted 36 hours. He reports no lasting side effects and did not seek medical care and has fully recovered at time or reporting.
After the booster it was red and tender, the next day when I woke it was red and my arm swell and tender and hurt so bad. The next day it was red from the injection site over the back to the other arm and by the neck. Lymph notes were swollen . Looks like cellulitis on my arm. All cleared up after a week.
Patient received the vaccine on 2/1/2021 in her left arm. On Friday 2/5/21 she developed a markedly enlarged painful right submandibular lymph node that progressively enlarged until it was difficult for her to open her mouth. She has also had left ear pain but a normal exam. No fever. No tooth pain. No sore throat
Patient was given the incorrect vaccine of the Moderna Bivalent Booster shot when she should have received the regular shot of the series for her second dose.
Bad chills, huge hives (whelps) longer than silver dollar, very painful at shot site and whelps. Could not move arm Saturday from 12AM to Sunday, shot admin, Friday 10/8/04 about 3:30PM. In bed Saturday, hurt on Sunday, Dr on Monday. Very ill from midnight Fri 8th to Sun 10th AM. Could not get up without extreme difficulty should have called Sat 9th for emergency appt. Had no one to take me. 18 miles away. Couldn't drive.
Pt vaccinated with Pneumovax/DT developed 3" diameter erythematous area rt deltoid hot to touch. Pt denies elevated temp. generalized hive areas covering trunk, arms & to hips that itch badly.
10/25 - Developed red whelps on right arm, left leg, & trunk. Examined by CRNP, negative Woods lamp test. Dx. - systemic allergic rxn.
Patient was a new patient to the clinic. Immunization record difficult to read and patient had only received 2 Dtap recently. Also the date of birth was incorrect in the chart making the child 6. So INFANRIX was given. After giving we noticed the patient should have received Tdap instead due to the patient being 7 yrs old. Provider notified. Appt given to patients parent to revaccinate. No adverse reaction.
Mother called answering service at 01:56, that baby is screaming in pain. On call doctor referred baby to ER where the baby was coded and passed away at 07:30.
Large rash at site of injection. Red, swollen, and itchy. Also experienced cough, nausea, elevated body temperature. Cold compresses provided some relief for rash, Tylenol for elevated temperature.