chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 30 year-old male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: VACCINATION SITE PAIN (non-serious) with onset 14Apr2021, outcome "unknown", described as "have pain on the injection site"; FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "feeling really tired"; PAIN (non-serious) with onset 14Apr2021, outcome "unknown", described as "body hurts"; CHILLS (non-serious) with onset 14Apr2021, outcome "unknown", described as "chills". Additional information: The patient received the Pfizer Covid 19 vaccine and today (14Apr2021) he woke up feeling really tired, he had pain on the injection site, his body hurts and had chills. He was asking whether these side effects was of vaccine or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 63-year-old male. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 assessment was provided for UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.  No treatment information was provided by the reporter.  This case contains information for the 16 of 27 adult patients described by the reporter.
Severe all over body aches, extreme fatigue, shivering, shakiness, headache, suspected fever, fluctuating between hot and cold, nausea.
Gave patient 0.5 ml full dose vs. 0.25 ml booster dose during am clinic.  Discussed side effects later with pt over phone who was not concerned
Pt vaccinated with TD/MMR developed headache beginning in the AM of 14NOV90; Saw MD advised muscle relaxant & a tension reliever.
Several minutes after receiving the HPV, the patient became lightheaded/dizzy. She leaned against door and slid to floor. Alert. Pt assisted back to exam room to lie down. Within 5-10 minutes, patient better. Seen by CRNP and discharged.
Mother noticed swelling on the morning of 1/26/03. Child did not complain but parents took him to ER because the swelling involved his entire left arm. ER MD prescribed antihistamine (Atarax) and gave Rx for Keflex if child began fever. MD did not think it was cellulitis but just a reaction to the shot. On 1/27/03, mother reported that child is fine but still has swelling of left arm. No other symptoms.
red pinpoint papules in plaques primarily over left back from hips to neck, sparse on right side of back, sparse on axillary line left upper arm, barely crosses midline of chest, goes just over mandible of cheek.  rash started on day after admin of vaccines
This spontaneous report was received from a physician via company representative, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The physician informed that on an unknown date in 2014, (reported as "some time last year, 2014"), the patient was vaccinated with the first dose of GARDASIL (dosage, route, lot# and expiration date were not reported). Subsequently in2 015 (reported as "one year later"), the patient received the second dose of GARDASIL (dosage, route, lot# and expiration date were not reported) and then two months later, in 2015, received the third dose of GARDASIL (dosage, route, lot# and expiration date were not reported). No adverse effects reported. Additional information has been requested.
On 07-DEC-2018 the patient was vaccinated with the first dose of GARDASIL 9 and on 19-JUN-2019 she received the second dose.; The patient was diagnosed with Bell's Palsy; This spontaneous report was received from a nurse practitioner via a company representative, referring to a 11-year-old female patient. The patient did not had any medical history, current conditions, concomitant medications, drug reactions or allergies.   On 07-DEC-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular, for human papillomavirus prevention (HPV) (dose, strength, site of administration, lot # and expiration date were not reported).   On 19-JUN-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular, for human papillomavirus prevention (HPV) (lot# R017624, expiration date on 17-MAR-2021 (also reported as 27-MAR-2021) (inappropriate schedule of vaccine administered) (dose, strength and site of administration were not provided).   On 22-JUN-2019, the patient started to feel symptomatic and was seen in the emergency room. Consequently, the patient was diagnosed with Bell's Palsy (facial paralysis). There was no laboratories or studies performed. It was reported that the patient received treatment for the event (unspecified).   At the time of this report, the patient was recovering. The causality assessment between the vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and facial paralysis, was not reported.   Upon internal review, the event facial paralysis was considered to be medically significant.
Fainting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting). At the time of the report, SYNCOPE (Fainting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   Reporter did not allow further contact
Dizziness, fell asleep, vomiting and continued dizziness. This was over the course of about 10 minutes when paramedics then arrived and transported her for further evaluation.
after the first vaccine on 3/8/21 pt experienced blisters in her mouth She does not remember how long they lasted but they went away and came back three separate times. After the booster vaccine on 11/30/21 she got a light rash on her right arm and shoulder. This rash resolved but continued to have the rash spread to behind her ears, neck, and chin. This light rash also contained small pustules. She currently still has the rash behind her ears, chin, and neck.
A report has been received from a Health Professional concerning a 12 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that expired FLUMIST quadrivalent was inadvertently administered to three patients on 19-Dec-2014. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to three patients was unknown. The report was considered to be non-serious.
Pt came in for vaccination for COVID-19 at 4:03 . She received Moderna vaccine at 4:15. She experienced palpitation, worsening chills, headache, and presyncope. No loss of consciousness. Denies chest pain, shortness of breath but feels heavy to push air in and pulse OX 100%, No angioedema, No rash, No pruritus, No throat swelling, denies hoarse voice, or difficulty breathing. She traveled to MD on 12/14/20 to receive antibiotics. She was treated with Erythromycin  dose for 6 days from MD.   The patient was +COVID19 on 12/11/20 with fever, scratchy throat, congestion, cough, and SOB and was seen in urgent care on 12/13/20 where was DX + for COVID19. She was quarantine for 10 days when she was returned to work on 12/22/20. Her Chest X-ray was negative on 12/13/20. She was negative for nausea, vomiting, diarrhea. She denies any recent vaginal bleeding, or abdominal pain. Denies any history of cardiac disease, or history of arrhythmias. Denies any history of prolonged immobility, or history of clots.
sick; bedridden; able to eat; very high fever; body ache; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), BEDRIDDEN (bedridden), FEEDING DISORDER (able to eat), PYREXIA (very high fever) and MYALGIA (body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced BEDRIDDEN (bedridden), FEEDING DISORDER (able to eat), PYREXIA (very high fever), MYALGIA (body ache), NAUSEA (nausea) and HEADACHE (headache). On an unknown date, the patient experienced ILLNESS (sick). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), BEDRIDDEN (bedridden), FEEDING DISORDER (able to eat), PYREXIA (very high fever), MYALGIA (body ache), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            No concomitant medications was reported by the reporter.
Patient noted pain in her right neck since she got vaccine. It is treated with conservative measures which does help, but pain is lasting and can go up to a 7/10. She noted always there. She was observed for 15 minutes post vaccine without adverse effects. She noted this pain started when she got in car to go home.
feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; soreness and swelling at the injection site; she experienced palpitations when she went to bed; her arm was sore; maybe she was dehydrated; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , lot EL9269, expiration date 20May2021, via an unspecified route of administration on 05Feb2021 (at the age of 81 years old) as a  SINGLE DOSE in the right arm for covid-19 immunisation.  Medical history included ongoing High Blood Pressure Diagnosed about 35 years ago (1986) and ongoing Diabetes Type 2 Diagnosed about 20 years ago (2001).  Concomitant medication included oral nifedipine  from Sep2020 and ongoing at 30 mg, 1x/day for High Blood Pressure, ubidecarenone (COQ-10), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), acetylsalicylic acid (BABY ASPIRIN) one every other day.  Historical vaccine information included BNT162B2 on 15Jan2021, Lot number EL8982, Expiry 20May2021 first dose via injection into the left arm for COVID-19 immunisation at 81 years old. She had no reaction at all to the first dose. The patient's arm was sore the day of the vaccine on 05Feb2021. On 08Feb2021, she experienced palpitations when she went to bed. She got into bed and was trying to fall asleep, she started to get palpitations.She sat up and walked around, and took a acetaminophen (TYLENOL) and water, because she was thinking that maybe she was dehydrated in Feb2021 or something, and it seemed to go away, and she did fall asleep and she slept for several hours, very well. Then, around 7am this morning, the palpitations started a little again, but not as bad as last night. She had breakfast and then was okay again. Then she sat down in front of her computer, and the palpitations started again. The palpitations are not constant, they come and go. On 09Feb2021, the patient experienced feeling shaky but states this might be because she is nervous about the palpitations. On 09Feb2021, she experienced soreness and swelling at the injection site.  Treatment for palpitations was acetaminophen (TYLENOL). Outcome of her arm was sore, feeling shaky/she is nervous about the palpitations, soreness and swelling at the injection site and maybe she was dehydrated was unknown. Outcome of palpitations was not recovered
18NOV97 pt sent home from school w/T100.4;19NOV97, 20NOV97, 21NOV97 kept out of school by mom w/loss of appetite, nausea, diarrhea;22NOV97 red spots appeared on trunk;23NOV97 gen swelling including hands, feet, face, eyes;
The patients Father claimed the patients DOB was one date. We verified as our system showed another date. He confirmed it was date given. We proceeded to give her the vaccine. There was nothing remarkable about the immunization and the patient left after the recommended 15 min observation period. When we attempted to bill the insurance, the claim was rejected and a missing/invalid DOB massage was sent. We called the ins and confirmed the correct DOB . We called the patient and her mother confirmed she is only 11 years old.
Information has been received from a registered nurse, via a company representative, concerning a non-pregnant, 18 year old female patient, who on 16-APR-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not provided). On 16-APR-2007, "shortly after being administered the vaccine" the patient had an anaphylactic reaction, described as, she developed hives down both arms but did not have difficulty breathing; she also passed out. Treatment included Benadryl, and oxygen, and the patient was observed in the office for a "short time" and then went home. The patient then fully recovered (duration not reported). The nurse considered anaphylactic reaction and "passing out" to be serious, as life-threatening and as an important medical event. No further information is expected.
This 16-month-old male received 3 doses of Haemophilus b conjugate vax. Subsequent to the 3rd vax on 02/23/1995, she developed bacteremia and meningitis due to vax failure. Additionally Haemophilus influenzae type B was revealed by a blood culture and CSF. The pt's experience was considered to an "other medical event."  The pt's outcome was noted as survived."  No further information is available.
Sustained tachycardia at rest 120-130 heart rate  for two hours and high blood pressure accompanied it  on the morning of 2/4/21.  Resting heart rate for 24 hours was 100.
received their second dose a week after their first dose; This case was reported by a other health professional via interactive digital media (Shingrix  and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received the second dose a week after their first dose which led to shortening of vaccination schedule. The reporter asked if the patient would require a third dose in 2 to 6 months.
Patient complained of being cold and tired throughout the evening. Developed fever after going to bed around 8PM. Fever lasted 24 -36 hours.
pt recv vax 15AUG95 & 28hrs p/vax pt devel focal sz & head twitching which was described as involving lt sided weakness & a facial paralysis; when the MD saw the pt pt was irritable w/ lt facial paralysis but was awake & was not talking;
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-JUL-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-JUL-2022).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
12/27/2020  swollen lymph nodes below left clavicle, no pain
INFANT DEVELOPED VOMITING, DIARRHEA, AND ABDOMINAL DISTENTION 1 MONTH AND 1 WEEK POST VACCINE ADMINISTRATION, AND WAS DIAGNOSED WITH INTRASUCCEPTION REQUIRING EMERGENCY SURGERY.  10/3/08 Reviewed hospital D/C summary of 7/11-7/17/2008. FINAL DX: Intussusception, exp lap w/small bowel resection & primary anastomosis Records reveal patient experienced fever & persistent emesis x 3-4 days, constipation, lethargy, abdominal distended & taut, dark red stool.  Findings in OR included small segment of necrotic bowel which was resected.  Admitted PICU, PICC line placed & started on parenteral nutrition.  Gradually returned to normal BMs & diet advanced fo full formula.  D/C to home w/surgery clinic f/u. 10/17/08 Reviewed additional hospital records of 7/11-7/17/2008.  Included path report which reveals necrotizing entercolitis.
I awoke at on April 9th 4:30am with an acute pain in the left side of my chest. I thought that it may be due to how I was sleeping and took in deep breaths to try and alleviate it. The sharp pain persisted. I stood up and walked around but the pain remained. I felt it acutely when I took a deep breath or I tried to lie on my left side. The pain remained for many days later. It's intensity may have reduced but it was quite present. I spoke to a doctor on April 14th. At that time the pain was lingering but not inhibiting my exertions. I was prescribed Ibuprofen. On April 20th I went to Urgent Care to have my heart evaluated because the pain had not subsided fully. They performed an EKG and, on the next day, an X-Ray and found my heart to be normal. The pain eventually subsided but I do feel that a trace of it has lingered. I was unable to sleep on my left side for many weeks later.
I GAVE IMMUNIZATION AND ON 2ND SHOT, I ASKED ARE YOU OK AND SHE WAS ALREADY PASSING OUT OR FAINTING. ADMINISTERED O2 AND SMELLING SALTS-DID NOT FALL OR INJURE SELF-MOM AT SIDE.
Large red area about the size of a small grapefruit.  In the center it was hard like when you get a mosquito bite and it was hot.  This lasted about 2 weeks.  She also vomited the night of the injection and felt nauseous the next day.
I?ve had a headache every day since my first vaccine. I?ve never had consistent headaches like this before. I don?t know what to do.
Pale; listless - 40 mins; good pulses & BP; Excessive sleepiness - only woke for feeding over 24 hrs period.
weakness in arms,  can't use arms to get out of bed, cant put arms over head, cant put bra on, unable to feel hand when wiping bottom. Wrists,fingers, hands ache in morning until afternoon and at night the pain is more stabby.
Injection site reaction. Started 1 week after injection. Redness, hot to touch, large hard spot underneath injection, itching, throbbing. 5cmx9cm area
A few minutes after injection - red rash over hand, itching all over, BENADRYL given, pt worse, felt like choking, EPI PEN given, after 20 minutes pt left with mother. At 18:42 pm. pt went to ER for throat sx and small rash. Given BENADRYL & EPI again. Released from hospital at 20:29.
Patient felt lightheaded and states everything "went black" immediately after vaccination. Patient brought to lay down on cot. Vital signs stable. Patient states dizziness passed and she sat up and drank water/ ate a snack.
The patient's left leg developed a large erythema area, warm to the touch due to vaccination.
IPOL and Hep B given on 01/29/2002 at 5pm. He rolled his eye balls for 30-60 seconds. No unconsiousness or generalized seizure. At about 9am on 01/31/2002, low grade fever. Tylenol drops and cold sponge advised and instructed to call office if temp. increases.