chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVERISH; MUSCLE ACHES; This spontaneous report received from a consumer concerned a 28 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 18:00 pm, the subject experienced muscle aches. On 1-APR-2021 13:00 am the subject experienced feverish. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 F. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feverish, and muscle aches. This report was non-serious.
doses were given after expiration date; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (doses were given after expiration date) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 04-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
during medical monitoring patient started feeling dizziness 5 minutes are receiving vaccine. Pt was monitored by on-site medics and released.
Pfizer Covid-19 vaccine administered on 04/08/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
3 inches diameter area at the injected site has discoloration. Pt has sensitivity reaction.
Upper left arm pain started about 6 hours after injection and was sever by the next morning.  Pain increases with arm movement Pateint was seen by her PCP on 8/9/2019.  Since symptoms were slightly resolving she was told to take Tylenol and ice area as needed. Although she describes pain is lessening it is still constantly there and increases to moderate to severe when she moves her arm.
Caller is experiencing eye swelling and rash at the injection site.; Caller is experiencing eye swelling and rash at the injection site.; the itchy burning drives me crazy; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced caller is experiencing eye swelling and rash at the injection site. (medically significant) on an unspecified date with outcome of unknown , caller is experiencing eye swelling and rash at the injection site (medically significant) on an unspecified date with outcome of unknown , the itchy burning drives me crazy (pruritus) (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of caller is experiencing eye swelling and rash at the injection site. (eye swelling), the itchy burning drives me crazy (pruritus).
No idea if it's related,  just thought it best to report.  Eyelids fluttering,  no pain or irritation, upper eyelid,  mostly right eye,  but both occasionally
Severe joint and muscle pain as well as muscle spasms in legs lasting through 11/07/2014.  Could barely walk or use my hands the pain was so bad.  Did not sleep on 11/05/2014 due to pain.  Injection site was swollen and painful and could not be touched or slept on for four days.  Went to Emergency Department either on 11/06/2014 or 11/07/2014.
5-28-09 Loss of felling in left arm, hand afterward and left arm had chills.There ia a golf ball size swelling to the upper left arm.
Patient stated "I am going to pass out." Patient received the Johnson and Johnson vaccine about 10 mintues prior to onset. Patient was located at the recovery station with her son. Patient began to hyperventilate and states she felt like passing out. Patient then went unresponsive and blood pressure was unable to be red. Epi pen was given in right thigh and EMS was called. Patient was transported via EMS to Hospital for evaluation with family members.
possible viral lung infection; everyone is assuming it's viral; an irritant from the rugs; This case was reported by a consumer via call center representative and described the occurrence of lung infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, 61 days after receiving Shingrix, the patient experienced lung infection (serious criteria GSK medically significant), lower respiratory tract infection viral (serious criteria GSK medically significant) and allergic respiratory disease. The patient was treated with prednisone. On an unknown date, the outcome of the lung infection, lower respiratory tract infection viral and allergic respiratory disease were unknown.   It was unknown if the reporter considered the lung infection, lower respiratory tract infection viral and allergic respiratory disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two months after receiving Shingrix, the patient developed a lung issue was assumed it as viral. The patient would also see an allergist since it might be an irritant from the rugs in her apartment being pulled up. Till the time of reporting, the patient had not missed the 6 month window and was on Prednisone treatment. The reporter did not consent to follow-up. The healthcare professional (HCP) information was not obtained.
Patient passed out at he front register about 5 minutes after receiving his 2nd COVID vaccine.  He fell down but did not hit his head.  He only lost consciousness briefly and felt better quickly.  We had sat him in a chair outside and waited with him until the paramedics arrived.  The paramedics checked his blood pressure, EKG, and blood sugar.  They checked him briefly and cleared him medically.  He will wait for someone to pick him up so he does not need to drive home.
I got "COVID arm" (delayed cutaneous hypersensitivity) 8 days after I got the injection.  The doctors office recommended that I take a Benadryl.  It helped, but  put me to sleep.
Patient was 16 and received the Moderna vaccine on 4/18/21, called clinic to schedule second vaccine. no A/E
Started with rash around belly and spread so went to ER.  They gave him steroid shot, Benadryl, and one other thing he could t remember. things got worse. Blood pressure got very low, dizzy, nurse couldn?t get a pulse ox reading, fingers turning blue. They thought he was having allergic reaction to shot. Gave him Epipen. He said things got better then
Pt given Moderna Vaccination on 09 Feb 2022.  No immediate reactions noted.  On 28FEB2022 SM began to experience chest wall pain with inspiration made worse with laying down.  Pain continued throuout the day and at 2200 went to Emergency Dept for evaluation.  Pts admitting diagnosis was Chest pain, Pericarditis,  Hypokalemia, Hyperuremia, Leukopenia, elevated CRP.  Pt was admitted for Cardiology consult.   Pt was inpatient from 28Feb 22 until 03Mar22.  Pt was discharged on Colchicine 0.6mg bid, ASA 81mg daily, famotidine 20mg bid, allopurinol 100mg bid.  Pt will be on these meds for 2 months.  Pt advised not to receive the second dose of Moderna vaccination.
12/11/12 - Wife reports pt. itching but BENADRYL helped. Talked with pt. - described as mosquito type bumps that come up randomly on body not just local at injection. Tx with BENADRYL. 12/13/12 Still same; contacted CDC ; prolonged reaction. 12/27/12 Reply from CDC.
Numbness in the inner thigh; This is a spontaneous report from a contactable consumer (patient daughter) from Medical information team. This team reported in response to query sent via email.   A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 06May2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Time dose was not provided. The patient's medical history and concomitant medications were not reported. Patient  previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Apr2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. No events occurred with first dose of vaccine. Caller said her mom did not have any other vaccinations the same days that she had the Pfizer COVID-19 vaccines, or in the four weeks before hand. No other products were taken. Caller stated that her mother experienced a side effect after having the second dose of the Pfizer Covid-19 vaccine on Thursday. On 06May2021, she was experiencing numbness in the inner thigh that night after the vaccine which she still has that, and she would like to know if there are any reports of this and what could she take. Enquiry stated that Pfizer is unable to provide treatment recommendations for individual patients, we suggest that you consult your physician regarding the symptoms. The patient did not receive any treatment. The outcome of event hypoaesthesia was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue, soreness at injection site Narrative:
Patient received vaccines, discharged from clinic, started having trouble in car before leaving parking lot, mom returned to clinic, child SOB, wheezing, retractions, pulse ox 87%, face red. O2 via nasal cannula, epinephrine given at 11:09AM. Transported to ER for further treatment.
5/18 - received Pfizer COVID Vaccine dose 1. 5/19-5/20 - very tired  5/20-5/21 - overall did okay 5/24 - woke up extremely nauseous, vomiting, fever to 100.6F -> increased to 102.5F, chills,  near syncope in shower so ambulance called and went to Emergency Department  5/25 - similar symptoms as the day prior but also had headache, continued extreme fatigue. Fever continued.  5/26 - diarrhea started, vomiting resolved, continued headache and fatigue. Fever continued.  5/27 - last day of fever.  Headache resolved 5/28 - diarrhea resolved.
mild hives on the chest a few hours after receiving the vaccine; her asthma kept flaring up with shortness of breath; her asthma kept flaring up with shortness of breath; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported for both herself and baby. This is a mother report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a breastfeeding mother. The patient experienced mild hives on the chest a few hours after receiving the vaccine and her asthma kept flaring up with shortness of breath. She took Benadryl and everything went away. Outcome of the events was recovered. The patient asked if she had side effects to the vaccine is it ok for her to get the second dose.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003624 mother/baby
This spontaneous report as received from a consumer refers to her sister, a 89 years old female patient with shrimp allergy. The patient was vaccinated with ZOSTAVAX on an unknown date in 2002. No other co-suspects were reported. Concomitant medications included: vitamins (unspecified). On an unknown date, early in 2002, the patient obtained shingles after receiving the ZOSTAVAX or during the early stages of the condition. The patient sought medical attention, no treatment information was reported. The outcome of obtained shingles is unknown. The relatedness for obtained shingles was not reported for ZOSTAVAX. Additional information is not expected.
I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times.  I had no  adverse events or symptoms with the 1st dose (lot ER732 IM RA). The 2nd vaccine 5/24/2021 (lot EW0187 IMLA),  the next day my arm was sore. I felt extremely tired all day.  The 2nd day, I had extreme fatigue and could not go to work.  My arm was still sore and I had flu like symptoms.  These symptoms lasted for 5 days.  I started to feel better for a couple days  and go to bed and wake up still completely exhausted.  I just wanted to sleep all the time. Since the 2nd vaccine, I have lost sense of smell and appetite and don't have the energy to do anything else.  I have lost a total 25 pounds since getting the vaccine.  My initial weight was 175 lb, my weight now is 149 lbs.  My other symptoms include: difficulty regulating my body temperature, cold sensitivity,  muscle pains in my hands, shoulders, chest and top of legs thighs. "I feel like my body is eating myself away."   I also have confusion, depression,  difficulty focusing and brain fog.
Information has been received from a nurse concerning a patient who on 06-JUL-2009 was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (subcutaneous injection) (lot # 663541/0335Y) and a dose of MMR II (MSD) (lot#, dose, route not reported).  On 06-JUL-2009 the patient experienced swelling and redness at the injection site as well as hives later that day. The patient was seen in the office on 08-JUL-2009 but it was unknown if therapy was prescribed.  The patient called the office on 09-JUL-2009 and stated the symptoms were getting worse.  No lab diagnostics studies were performed.  At the time of reporting, the patient had not recovered.  The nurse mentioned that 6 other patients, who all received VARIVAX (Merck) as a second dose, had reported similar symptoms.  The nurse was requesting a lot check.  Follow up information has been received from the same nurse concerning a 8-9 year old female patient who on 06-JUL-2009 was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (subcutaneous injection) (lot # 663541/0335Y).  The nurse confirmed they had had 9 patient who had all the same reaction from VARIVAX (Merck) lot # 663541/0335Y.  All patients were vaccinated "last week" 06-JUL-2009, and experienced different degrees of swelling, redness at injection site, and hives.  She also reported they had not had any ore since then, and all that reacted have recovered.  A lot check has been initiated.  A standard lot check investigation was performed for VARIVAX (Merck) (lot # 663541/0335Y).  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  This is one of several reports received from the same source.  Additional information has been requested.
Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 07Feb2021 14:15 (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient medical history included Hypertension, Atrial fibrillation, Mitral Valve Prolapse. No known allergies. The patient concomitant medications included Lisinopril, Metoprolol, Eliquis, Calcium, Biotin. On 08Feb2021 09:00 AM patient experienced fatigue, soreness at injection site, warmth at injection site, diarrhea. No other vaccine in four weeks. No COVID tested post vaccination. No COVID prior vaccination. No treatment received. The outcome of the event was not recovered.
Patient received 2nd dose of Pfizer COVID-19 vaccine at our COVID-19 vaccination area.  During the 15 minute observation period, patient reported feeling his tongue swelling and eye getting puffy. No SOB notes. Patient is an ICU physician in our med center. After 30 minutes of observation, he was discharged without any other issues.  Follow-up call done after 2 hours and he was fine. He went back to work.
This case was reported by a healthcare professional and described the occurrence of sore arm in a female subject aged between 20 and 29 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 23 October 2009, in the late afternoon, the subject received unspecified dose of FLULAVAL (5 to 6 ml, unknown, unknown arm). On 23 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced sore arm, fever and overdose. At the time of reporting, the outcome of the overdose was unresolved. At the time of reporting the outcome of the sore arm and fever was unspecified. On 26 October 2009, the nurse reported that the subject allegedly received five to six ml of FLULAVAL. She experienced a sore arm and a fever. The subject consulted a health care professional regarding the event(s). Follow up information was received on 18 November 2009 via the reporting nurse (employer). The nurse reported that a 32-year-old female subject (employee) received a dose of FLULAVAL (2.5 ml (5 doses)) in the left arm. The subject had a low grade temperature of 99-100 on an unspecified day in October 2009. Approximately on 30 October 2009, the events were resolved.
103° fever, chills, and severe headache lasted entire day after getting vaccine. Took Tylenol 500mg around 25 hours after vaccine, which helped.   Headache continued onto 2nd day after vaccine but not as severe as 1st day.
FIRST DOSE OF MODERNA GIVEN 5-17-2021, SECOND DOSE OF PFIZER ADMINISTERED 06-18-2021 BY ERROR
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-JUN-2015, the patient received improperly stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started feeling itchy at the vaccination site almost immediately following the vaccine. A cool compress was applied, urticaria continued and the area started to devlop erythema. Urticaria and erythema were localized to the injection site.  Patient was given 25 mg of liquid diphenhydramine. Urticaria was resolved with the diphenhydramine. No shortness of breath, or hives were noted. Patient is instructed to follow up with her provider before receiving the 2nd dose.
Am after shot, pt passed out at 6:00am. Noticed soreness & stiffness of neck, shoulder, back & R/arm, also, dizziness. Friday am, woke up & noticed R/arm swelling, progressing to below elbow & half of forearm. R/arm was red, hot to touch &
pt recvd vax; pt exp swelling & stiffness in both hands & had difficulty opening & closing her hands; tx motrin & soaking of hands;
47 year old patient was administered shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number 7m785, expiry date unknown) for prophylaxis.   On 24th May 2022, the patient received Shingrix. On 24th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: Health care professional (HCP) reported a 47-year-old patient was administered Shingrix.  She believes he was not immunocompromised. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The 47-year-old patient was administered Shingrix, which led to inappropriate age at vaccine administration.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were received doses of improperly stored RECOMBIVAX HB (lot # K008986, expiration date: 01-APR-2016, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
large hive-like reddened area around injection site. Patient has had lymph nodes removed from axilla due to breast CA
Patient stopped back several days after injection. He mentioned that the night he was given the injection he has bleeding in that arm. Patient is on blood thinner. Pt had a tiny drop of blood from the PREVNAR injection at time given and no bleeding from FLUZONE injection. Patient stated that the blood had dried up and he had no bleeding 1-2 hours after he was given the injection. Later night prior to bed he said his arm was bleeding and was unable to determine if it had been from the vaccine site or something else.  He continued bleeding on and off for 1 day. Two days after getting the injection he stopped by the pharmacy, the pharmacist inspected the site and there was no bleeding at that time. The pharmacist called the patient to follow up the next day and no bleeding at that time.
Patient presented on Saturday (3-4 days later) with slight redness, slight swelling, and warm to the touch injection site reaction. Was approx the size of the ring of a small cup (2-3 inch in diameter).....then 1 day later reported low grade fever that was alleviated by ibuprofen and/or TYLENOL. Temperature fluctuated between 99-100 degrees.
On 9/23 patient came in the pharmacy and complained of pain and brusing at the injection site. I asked her to talked to her MD.
Severe body aches / chills after first dose and extremely sore Left arm along with headache - lasted 24 hours and the next 24 hours I had fatigue
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced welts all over her body on an unspecified date with outcome of unknown.