chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I?ve had 2 rounds of the Moderns vaccine and now the booster. After each I developed and extreme pain in the inside of my leg I?ve never felt before. After the first vaccine I actually went to the ER fearful I may have blood clots. I?ve only had this pain happen 3 times in my life and it?s only been after the vaccine. It seems like it?s inflaming a nerve. My batches were 023m20a 3/4/21, 020b21a 4/1/21 and 939905 11/9/21
Pt denied being preg. 12/31/08.  Had US on Feb'2009 and was informed baby had problems and abortion done 3/18/09 at OB.
Head to toe body rash, up into hairline at the back of head, (did not extend to facial area)  Rash more pronounced on chest, upper back, back scalp, wrists, lower legs and feet Rash appeared raised, red and the itching was intense *took an antihistamine, Advil, and used a Benadryl spray on wrists and feet **rash subsided for the most part by the following day - just a few areas of splotchy remain and not nearly as uncomfortable
Shortly after receiving vaccine patient experienced redness, warmth & aches at injection site. This last a couple of days before a welt developed down the arm towards bicep area. This also was very warm. Patient iced areas and it all resolve 3 days after injection. Patient also experienced nausea.
Patient's bicep is all red and tendered. There is water retention aboved the elbow. The muscle is harder at the injection site.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 1, single (Lot number: 320308), in left arm and on 20Nov2021 as dose 2, single (Lot number: FJ8757) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2010, stop date: 15May2022; FLUTICASONE PROPIONATE (GLUCOCORTICOID) nasal, start date: 01Jan2010; VITAMIN D3, start date: 01Jan2010; CETIRIZINE, start date: 01Jan2010; MAGNESIUM, start date: 01Jan2010; GLUCOSAMINE & CHONDROITIN COMPLEX, start date: 01Jan2010. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine. The patient' other medication in 2weeks included product Fluticasone propionate nasal spray lot number TH8980, Vitamin D3, lot number VS210874, Cetirizine lot number=1LE1998C, Glucosamine & Chondroitin lot number 300012, Magnesium lot number 2451963. Antiviral details: Product COVID 19 Treatment, Brand Pfizer. Treatment start date was 16May2022 and treatment stop date was 17May2022. Lot number FY8927. Indication was treatment of COVID-19. Adverse event: Constant TERRIBLE stomach cramping and diarrhea. Way worse than the Covid symptoms. Adverse events start date was 16May2022, at 08:00 PM. The patient did not receive treatment and not recovered
Client states after receiving influenza inj 11/17/05 felt a soreness in her left arm throughout. Client felt soreness was normal until 11/19/05, felt pain under her left arm. Client states her underarm was swollen and felt hot to the touch, she also noticed redness there. These symptoms have continued everyday since then. Client states it is difficult to dress herself, she usually asks her husband to assist her. Client states she received the flu shot approx 5 inches down from the top of her shoulder, on 11/17/05. Client was advised to call her physician to evaluate her arm and under arm client states she will do so.
Mistakenly gave Moderna vaccine for 2nd dose after receiving Pfizer vaccine as 1st dose
Approx 6 hours after receiving vaccine on 4/11/03 developed a fever, sweating/chills, flushing, weakness, somnolence and pain/stiffness in arm (right), symptoms persisted for 2 weeks. Did not seek medical attention. Reported event upon presenting for #2 vaccine on 5/12/03. Advised not to receive #2 and #3 of vaccine.
"Onset 3 days ago. Location is arm, foot and leg. The describes it as erythematous. It occurs continuously. The problem is with no change. Associated factors include urticaria. Pertinent negatives include diarrhea, fatigue, fever, headache, joint symptoms, kerion(s) in scalp, pain, sore throat and vomiting. Additional information: Rash developed one day after receiving PNEUMOVAX vaccine. Rash is not pruritic. She denies angioedema, difficulty breathing, GI symptoms and presyncope. Denies reactions to vaccines in the past." Patient Plan Continue BENADRYL ALLERGY. Advised no pneumonia vaccines in the future. RTC if swelling in toes does not resolve within 1 week.
Extreme soreness in left deltoid where shot was administered. Still sore as of 11/5/2012. Pain when lifting arm over shoulder. Difficulty putting shirts on over head. Feels like someone repeatedly punching me in the arm. No treatment.
1. Pulsing pain at dose administration site at 11 pm.  -No treatment, went to sleep. 2. (12 hrs after administration).  Woke up at 1:00 am with severe chills.  Lasted 2 hours.  -Threw on sweats and another blanket, went back to sleep. 3. Woke up at 6:30 am with intense body and head pain.  "was a cant get comfortable in any position type of pulsing pain" Something im accustomed to when i get the Flu.  I rolled around in pain for 4 hours while trying to go back to sleep; it even hurt to breathe deeply. - took Tylenol at 11am and the symptoms never came back.  *Note.  I think i suffered so much pain in the 4 hours that it lasted with me until even now as i write this.  Hard to describe, but my entire body has had this tiny ache that has not gone away.  Not a big deal to me, but just wanted it documented.  I am selecting recovered even with that tiny ache still apparent because physical pain usually takes time to heal.  Assuming that's all it is.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out for a short time.....told me he normally has a vagal response to shots and not to be surptrised of he passes out.....patient fully recovered prior to leaving....he was monitored closely
flu; Based on information received on 23-Nov-2020, the report previously considered as non-valid became valid: [suspect vaccine clearly identified follow-up].  Initial information received on 24-Oct-2020 regarding an unsolicited non-valid serious case received from a consumer (patient) via social media.  This case involves male patient (unknown age) who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on the batch number was requested.  Follow-up information received on 23-Nov-2020 regarding an unsolicited non-valid serious case received from a consumer (patient) via social media.  Suspect was updated.; Sender's Comments: Follow-up information was received on 23-Nov-2020 changes the previous assessment of the case: This case involves a male patient of an unknown age who had influenza, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. However, patient's medical condition at time of vaccination, received concomitant medication, laboratory data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
trembling episode for <5min;eyes closed-happened twice once on 5/18//99 when child was drinking bottle, could not arouse pt, then fell asleep;also happened 5/19/99 when about to fall asleep trembled for 1-2min;
pt recvd vax 14JUL94 & by 15JUL94 t101-102 cont until Monday evening; returned to work Wed, fever of 100-101; elevated temp accompanied by sl h/a; no other sx; APAP taken for sx
Patient reports visible arm swelling at site of injection and are soreness. Also reports soreness/stiffness throughout neck and back on the side of injection, as well as muscle spasms.
Onset of fever (100.5); aches; headache; tiredness; muscle pain; chills; joint pain; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 14Jan2021 at 10:00, at single dose (left arm) for COVID-19 immunization. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food and/or other products. Concomitant medications included simvastatin and omeprazole (OMEPRAZOL). The patient received simvastatin and omeprazole within 2 weeks of vaccination. On 14Jan2021, at 22:00, the patient experienced onset of fever (100.5) aches, headache, tiredness, muscle pain, chills, joint pain, and was feeling unwell. The patient did not received treatment for the event. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.  Information about Lot/Batch has been requested.
she wants to know if her father can take ibuprofen for pain following the covid vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (patient's daughter). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain. It was reported that she (patient's daughter) wanted to know if her father can take ibuprofen for pain following the COVID vaccine. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Student Medical Assistant administered a child Hep B Vaccine to an adult. The adult will return to clinic and restart the Hep B series in 30 days.
Itchy dollar sized rash on her mid-back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Itchy dollar sized rash on her mid-back) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Itchy dollar sized rash on her mid-back). At the time of the report, RASH (Itchy dollar sized rash on her mid-back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment drugs were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 16-MAR-2013 at 11:20 am, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 125.50 hours (also reported "17 hours, -1, 359 2 admin"). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Severe, unrelenting migraine for over 24 hours, high fever with chills, nausea and dizziness.
Bell?s Palsy - onset six days later - trip to ER to learn  diagnosis  I?ve never had Bell?s Palsy before.
The nurse that gave the injection said immediately after injecting the medication the patient became anxious, short of breath, stated that her throat felt like it was closing and became red from the face down in all exposed skin that they could see.  They called a rapid response and the patient was given epinephrine from an EpiPen.  She also took 50 milligrams of Benadryl p.o..  She then was transferred to the emergency department for further evaluation.    Upon arrival to the emergency department patient does not have recall of the events just after the injection, she states that she feels that her upper lip is swollen, her throat is swollen and she is short of breath.  She seems very anxious and jittery from the epinephrine.  Nursing reports that at the scene she was unable to talk, in the Emergency Department she is able to answer questions and speak full sentences.  She states that she feels somewhat better on arrival however is not back to baseline.
Became diaphoretic and pale.  BP slightly elevated.  Assisted to a sitting position on the floor.  Provided with water and ice pack.   Stayed in vaccination area for an extended period of time for continued monitoring.
A horrible headache as bad as a migraine, headache; Some aches and pains; Headache; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (A horrible headache as bad as a migraine, headache), PAIN (Some aches and pains) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 22-Jan-2021, the patient experienced MIGRAINE (A horrible headache as bad as a migraine, headache), PAIN (Some aches and pains) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency.   On 22-Jan-2021, MIGRAINE (A horrible headache as bad as a migraine, headache), PAIN (Some aches and pains) and HEADACHE (Headache) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Tenderness began day of injection-AM of 30th, deltoid area painful, reddened, hot to touch, no temperature, no drainage. Decreased redness 10-01-09, 7:15 AM, cold compress applied several times 09-30-09, cont to apply cold compress 10-01-09.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: seasonal" (unspecified if ongoing); "Known allergies: environmental" (unspecified if ongoing). There were no concomitant medications received in 2 weeks. Past drug history included: Amlodipine, reaction(s): "Known allergies: Amlodipine". Vaccination history included: Covid-19 vaccine (Primary Immunization series completed;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (Lot: FT5400, start date: 26Apr2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The pain travels up to the shoulder and when I'm picking up an object during the pain I drop the object; It hurt my arm when I received it it started hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The pain travels up to the shoulder and when I'm picking up an object during the pain I drop the object) and VACCINATION SITE PAIN (It hurt my arm when I received it it started hurting) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037Z20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included METOPROLOL SUCCINATE (TOPROL), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LISINOPRIL (ZESTRIL), RANOLAZINE (RANEXA), CHLORTHALIDONE, AMLODIPINE BESILATE (NORVASC) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (The pain travels up to the shoulder and when I'm picking up an object during the pain I drop the object) and VACCINATION SITE PAIN (It hurt my arm when I received it it started hurting). At the time of the report, PAIN (The pain travels up to the shoulder and when I'm picking up an object during the pain I drop the object) and VACCINATION SITE PAIN (It hurt my arm when I received it it started hurting) had not resolved.            No treatment medication information was provided.   This case was linked to MOD-2021-289851 (Patient Link).
pt recv vax 26DEC95 & 3JUN97 pt devel chickenpox;
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
Fever, headache, body aches. Tylenol 7 PM fever resolved. All symptoms resolved by the next day.
WED: injection site pain, redness, heat, area around actual injection site pain, swelling,hardness but alarmingly hives/rash 2-3" diameter that afternoon.  THURS: Half inch Bigger by morning. Hotter, more pain, tenderness. clothes hurt to touch. Bendryl made me sicker/  sever dehydration./ Headche.  PCP & 2 Urgent Cares  wouldn't see me.  FRIDAY: EMT saw it at 48 hrs- 4" diameter, hot, red, hives, tachycardia, low fever (99.7 previously was 97.6)). Pharmacist recommended Zyrtec instead of Benadryl, Tylenol for pain and fever (it helped).  Shape, tenderness, pain, redness, heat/warm off and on in the meantime.  NOW TUES : hives expanding, toward inside of arm. no fever, very tender, intermittent stings like a bee sting. Can't put weight on it, like clothes, sleeping. Pharmacist  recommend file this report. Gave me package insert for inert ingredients. He said it is an allergic reaction.
Miscarriage; Pregnant at time of vacciation; Pregnant at time of vacciation; This is a spontaneous report from a non-contactable consumer. A 34-year-old female patient (16 weeks pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced miscarriage at a routine OBGYN visit on 19Feb2021. The patient was hospitalized for the miscarriage on an unknown date for 2 days. The clinical outcome of the event miscarriage was unknown. The patient had not had COVID prior to the vaccination and has not tested positive post vaccination.   Information about lot/batch has been requested.
Patient was supposed to receive 6 month PCV vaccine and reporter was supervising. MA pulled HPV vaccine and supervisor did not catch the error until after it had already been given to the patient. Supervisor was notified at 1530, Dr was notified at 1530, Poison control was called at 1600 and stated that vaccine was listed as not toxic and to monitor patient.  Several attempt to reach mother were made and mother was reached and  notified at 1645.  She reported that patient was fine.  Mother instructed to monitor patient for any abnormal vaccine reactions such as nausea, vomiting, extreme itching, difficulty breathing.  As per all vaccines there may be redness at injection site, soreness, fussiness, fever and fatigue but it any of those are extreme or last longer than 2 days she is to call right away.   At this point patient has remained without any abnormal symptoms.
Patient was not 12 years old when given vaccine. Parent identified child as 12 but he was 11 years 11 months. Vaccine given in error due to current vaccine age recommendations.  Patient was observed 15 minutes without side effects.
Vomiting p/mom picked up then passed out, pale, cool, clammy, P-40 BPM, unresponsive x 1min, gradually became pink, warm, crying w/in 5mins;
On evening of the day vaccine was given child developed fever of 102.  Next morning temperature was 101.7, also child had decreased activity level and was fussy.  Seen 03/10/04, was a little better, temperature 100.3, still somewhat fussy, crabby.
pt recvd doses 2 & 3 of vax & devel red spots all over; not raised; no elevated temp but was given APAP; no other s/s; lasted couple of days; spots size of pencil head & bright red;