chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning and then pain gave me the shot somewhere other than my muscles; pain on the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route, administered in left arm on 27Feb2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route, administered in right arm on an unspecified date as dose 1, single for covid-19 immunization. She got her first Covid shot 3 weeks ago on her right arm. She had no pain in her arm, no symptoms on her body. Then she went to yesterday to get her second Covid shot. First of all, well her first shot was done by a pharmacist. Her second shot she did not realize it until she gave her the shot, she took alcohol pad and wiped her left arm, her shoulder and then she took an envelope and wiped around to dry the alcohol. Since when was a tech allowed to give because she did not think anything other in beginning however her left arm where she gave her shot yesterday since then it was burning and then pain, burning and then pain. She had no other symptoms, no other physical symptoms. Now she was wondering the girl gave her the shot somewhere other than her muscles because it was just unbelievable that she had burning and pain in another arm and nothing was 3 weeks ago and no other symptoms. First of all is Pfizer allowing technicians in a pharmacy to give a shot. The patient had the second dose on the day of reporting and her arm experienced burning sensations followed by pain on the injection site. She also asked if a pharmacist technician is allowed to administer the vaccine. The outcome of events was unknown.  No follow-up attempts were possible. Information on Lot/batch number could not be obtained.
SkinRash, Rash, NauseaVomiting, bruising at inj site lasted 1/20/21-2/7/2021 Narrative:   Other Relevant History:
14 days after receiving the 2nd vaccine, I developed mastitis rapidly in my right breast. I am not nursing, pumping, or pregnant. Treated with 10 days of antibiotics and it resolved within 7 days.
developed SOB, decr O2 to 82% sat, admitted to hospital on 12/17/2021
Received the injection at 9:30 a.m.  By 3:00 p.m. I developed a headache.  By 6:30 p.m. I started experiencing chills & body aches. By 8:00 p.m. I had 102.9 fever, my entire body was achy & chills.  I was unable to walk from my bed to the bathroom.  By 6:00 a.m. on 4/1/2021, I had a 100.1 fever, chills & headache.  When I woke up at 10:00 a.m. the fever was gone but still have the lingering headache and fatigue.  From the onset of symptoms I was taking 2 Motrin every 5-6 hours.
This spontaneous report as received from a pharmacist via company representative refers to a 66 year old female patient. The patient's medical history included shingles. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial. On an unknown date, six weeks after receiving ZOSTAVAX the patient had a second case of shingles. The reporter stated that this second outbreak of shingles was just as bad as her first case of shingles. The outcome of shingles was unknown. Additional information has been requested.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills, fatigue Narrative:
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022; Expired dose administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 003B21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The patient did not reported adverse reaction.  Treatment information was not provided by the reporter.
05/31/2022 I had been waking up with cramps in my legs much more than normal. I was out to lunch that day and when I walked to the car, my left leg had a major cramp and I had to walk the parking lot for 35 minutes, but it never eased up. It eased up enough after that where I could ride home. For the next two weeks, my legs were sore, heavy and it was hard for me to walk and sleep. I contacted my doctor on 06/07/2022 and was able to get an appointment that day.  He took me off my cholesterol medication. That seemed to help. He had me take magnesium, but that did not help.  Bloodwork was done, but was normal. He stated my magnesium might be a little low, so he increased my dosage. I went back to my  PCP on 7/05/2022 and he prescribed muscle relaxers and told me to go back to my exercise classes. I slept better after that. I took a 4-hour trip in the car which was very painful. I went to see my doctor again who referred me to an orthopedist. He took x-rays and has ordered an EMG and an MRI to see if it is nerve or muscle related. He did not comment on x-ray results.
After taking the vaccine, my Primary Doctor at the Clinic call to tell me I have cancer in my left kidney. After further tests, I was sent to the Cancer Center where they operated and removed 3/4 of my left kidney.
pt recvd vax & inject site indurated, redness & swelling; keflex rx given 28sep94;
Both vaccines administered at 2:02 pm, at approximately 2:05 pm patient said she is feeling dizzy and almost immediately experienced vasovagal syncope. Team Alert called and team monitored patient, vitals taken. Patient released after monitoring.
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 33-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 04Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bilateral mastectomy with implant reconstruction" (unspecified if ongoing); "bilateral mastectomy with implant reconstruction" (unspecified if ongoing); "capsular contracture" (unspecified if ongoing); "endometriosis diagnosed through laparoscopy" (unspecified if ongoing); "endometriosis diagnosed through laparoscopy" (unspecified if ongoing); "Alllergies: Tree nuts" (unspecified if ongoing); "Allergies: Eggplant" (unspecified if ongoing); "Allergis: seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 12Jan2022; ALBUTEROL HFA, start date: 01May1995. Past drug history included: Vicodin, reaction(s): "Allergies: Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: Rebound in symptoms and positive test after 4 days of negative tests; (Aug2023) Negative, notes: Rebound in symptoms and positive test after 4 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient treated with Paxlovid from 10Aug2023 to 14Aug2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FLU REACTION; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (FLU REACTION) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free (1 in 2 wk). In 2022, the patient experienced INFLUENZA (FLU REACTION). At the time of the report, INFLUENZA (FLU REACTION) outcome was unknown.            Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt reports that she got severe vertigo starting 1d after vaccination which last for 1w then spontaneously resolved. Pt reported this when she presented for 2nd dose and she requested that I write a VAERs report.
After about 8-9 hours from shot, developed a fever, nauseousness and extreme fatique. Have been sleeping all day (now  5pm)  with fever and fatigue remaining. Unable to get out of bed.
Patient called and reported that she woke up at 3am the morning after the vaccine. Stated her face was flushed, pounding headache and she was burning up. She felt ill and reports her heart was beat 120 bpm. Patient states that she washed her face and went back to bed without checking or recording her temperature. She called the clinic the next morning to report the incident. She reported that the symptoms had resolved other than feeling malaise, mild headache and fatigue.
Information has been received from a physician concerning a 4-month-old male who on 29-MAR-2007 was vaccinated PO with the second 2.0 mL dose of Rotateq (lot number not provided). The physician reported that on 09-APR-2007, the patient developed bloody diarrhea. Unspecified medical attention was sought. A CBC revealed a high blood count. On approximately 30-APR-2007, the patient recovered from the bloody diarrhea. Upon internal review bloody diarrhea was determined to be an other important medical event. Additional information has been requested.
Severe pain with movement of left arm and shoulder at certain angles, unable to reach, lift. Limited use of left arm. Deltoid area and shoulder. Uncomfortable to sleep, and do routine activities such as washing hair or putting hair up in a ponytail. Sometimes when triggered with movement, pain is so excruciating that tears are part of the reaction. The nurse who administered the vaccine mentioned she was going to change the needle from a 19 gauge because it had the wrong needle. I am not sure if this is due to improper administration.
A report had been received from a Health Professional concerning a female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that multiple patients received FLUMIST Quadrivalent and tested positive for Flu A. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
Pain set in immediately lasting 4 days. Headache occurred from evening of administration, continued for 4 more days, became severe on day 3, pt. took IBU for pain.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On an unknown date, also reported as "after being vaccinated with VARIVAX", the patient developed chickenpox, described also as a varicella like rash, rash all over his entire body, on his feet, torso, legs, arms and chest. The patient was prescribed an acyclovir by a physician (dose, lot and expiration date unknown by reporter), on an unspecified date to treat the chickenpox. The reporting pharmacist inquired what to put samples in that were taken from rash. It was also reported, that he patient's mother and sister now also have chickenpox and are taking an unspecified anti-viral to treat the chickenpox. The outcome of varicella was unknown. The relatedness between the event and VARIVAX was not reported.
THROAT TIGHTNESS, FINGERS WARM. EPI GIVEN. TRANSFERED TO  ER
Facial spasms. Lip drawing up. Sensation of throat closing. Headache. Fatigue.
Within 15 min after injection, Pt broke out in hives all over body. Referred to PMD or ER. Seen at Medical ctr. with itching, red rash, swollen Right wrist due to hives. Tx'd with Benadryl 12.5 mg po, continue as needed through night.
On 05/24/2022 I had extreme fatigue and coughing. Since I was in a rehab for a fracture in my body on the left side. I was going through so much so I thought I was just exhausted from everything that happened to me. On 05/25/2022 I test myself with a COVID-19 home test which was positive. I called my doctor who prescribed me with an infusion for 3 days.
This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml in an unknown arm. Immediately after vaccination with TWINRIX,  the subject experienced an achy sensation at the injection site that traveled down the arm to the wrist (pain radiating down arm). It was reported that the achy sensation resolved within 5 minutes as if it was from the injection. In the reporter's opinion, the events were probably related to treatment with TWINRIX. The reporter stated that this has been a trend that has been noted in multiple subjects receiving TWINRIX.
Dtap administered at well visit #5 Left deltoid, within 30 min of vaccine child screamed, lots of head pain, vomited x1 afebrile, within 12 hrs Left deltoid large red area 15x20cm tender.
very itchy left arm; arm is red; swollen, it feels like a ball is hanging; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (swollen, it feels like a ball is hanging) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No medical history was reported.     On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (swollen, it feels like a ball is hanging). At the time of the report, VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (swollen, it feels like a ball is hanging) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was reported. No treatment was reported.
I had the awful taste in my mouth but it did not effect the taste of food. I had a slight fever for about a day, I checked my temperature and it was 98.6 which is technically not a temperature but my normal body temperature runs about 94. Once I received a positive COVID test I was prescribed Paxlovid.
Swollen at injection site; Itching at injection site; Hives towards neck; Tiny muscle pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tiny muscle pain at injection site), INJECTION SITE SWELLING (Swollen at injection site), INJECTION SITE PRURITUS (Itching at injection site) and URTICARIA (Hives towards neck) in a 31-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. Concomitant products included METHOTREXATE, MELOXICAM, Plaquenil and Folic acid for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Tiny muscle pain at injection site). On 29-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swollen at injection site), INJECTION SITE PRURITUS (Itching at injection site) and URTICARIA (Hives towards neck). At the time of the report, INJECTION SITE PAIN (Tiny muscle pain at injection site), INJECTION SITE SWELLING (Swollen at injection site), INJECTION SITE PRURITUS (Itching at injection site) and URTICARIA (Hives towards neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Steroids
Arthralgia, lymphitis of right under arm, sore back and front, layed in bed most of the day resting, comfort care provided at home.
After second dose, lips became extremely swollen. I had lip injections (Juvederm Volbella) on March 15th.
Received 1st dose ever of flu vaccine on Tuesday 12/16/03 09:30.  Mom noticed hives, Wednesday AM 07:30 12/17/03 on torso only.  Looked reddish in color with blister like center.  But fades to nothing.  When pt gets warm, hives come out again by Friday, hives appearing on hands, face and legs also.  Called PMD, was told not a reaction to flu vaccine.  Could give Benadryl.  Did give Benadryl every 6-8 hours since then.  As of 12/23/03 PM, still had a few hives outbreak with cool bath this AM.
second shot is not administered with 35days interval/Second shot was not administered/it's been five months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second shot is not administered with 35days interval/Second shot was not administered/it's been five months) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second shot is not administered with 35days interval/Second shot was not administered/it's been five months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second shot is not administered with 35days interval/Second shot was not administered/it's been five months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
Patient had apparent seizure activity. Patient crying in short, high pitched yelps; went limp, eyes rolled back in head, foaming and drooling from mouth, unresponsive. Episode lasted a few minutes and patient was taken to ER. Event description taken from hospital intake record. Episode is described by hospital as "Apparent Life Threatening Event".
experienced some arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "experienced some arm soreness". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient Claims that she had a severe reaction to SHINGRIX Vaccine." Very High fever over 24 hours, dizziness, and just feeling sick." Swollen arm/red from injection site to the top of shoulder.
Severe muscle ache from waist to ankles in both legs. Severe muscle ache in left arm and left ribs. lump formed on right side of neck.  Severe chest pains and shortness of breathe resulted in getting a heart condition called pericarditis.
Chills, weakness, joint pain, headache, fever, stomach upset, nausea.
Narrative: COVID infection after completion of COVID vaccine series 12/30/2020 Pt c/o congestion and breathing issues but no fever 12/30/2020 Pt seen in facility c/o cough, congestion, loss of taste and smell, and myalgias for a few weeks; received Outpatient COVID test -->COVID positive 12/30/2020 Pt admitted to hospital for suspicion of COVID PNA; received remdesivir 5-day course and dexamethasone 10-day course 01/16/2021 Pt discharged from hospital on home oxygen 02/19/2021 Pt had post-hospital follow-up 02/22/2021 COVID vaccine dose #1 03/17/2021 COVID vaccine dose # 2 06/21/2021 asymptomatic COVID positive as result from pre-op swab test 06/22/2021 Clinical resolution of COVID diagnosis (ASYMPTOMATIC)
After being in Menopause for 4 years I started a light period in April  for 6 days and started again this month with blood clods
TECHNICIAN HAD ADMINISTERED THE MODERNA DOSE AFTER THE BUD FOR THE VACCINE STABILITY. NO OTHER REACTION, OUTCOME, OR TREATMENT AT THIS TIME.
Severe chills followed by excruciating pain making me unable to move or even hold my phone to call for help. The chills caused muscle spasms that seized most of my body and I could not sleep or move for approximately 10 hours. Afterward pain subsided enough for me to get up and take some ibuprofen so I could sleep. Now I just feel lethargic with a mild headache and some lower back pain but the chills and spasms are gone. I thought I was going to die last night and would have gone to the ER had I been able to call for help.