chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine 5/19/15 the next day fever and not feeling well. 5/28 patient started with rash on back and belly. Red raised bumps with a lighter ring around each spot. 5/30 rash spread to head and face and more severe on trunk of body. Went to a urgent care. They said it was a "MMR rash" from the vaccine it will go away on its own no treatment given. They instructed mom to have provider report the reaction.
Information has been received from a RN nurse concerning a 22 year old white male with an allergy to beef who on 07Dec04 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 644389/0035N). Two to three days later, on approx 09Dec04, the pt developed a fever and redness and swelling at the injection site. On 10Feb05 at 15:00PM, the pt was vaccinated IM in the left deltoid with a second dose of hep B virus vaccine rHBsAg (yeast) (lot 648211/0864P). There was no illness at the time of vaccination. The pt again developed fever, redness and that time a persistent cough several days after the vaccination, on approx 14Feb05. Unspecified medical attention was sought and the pt recovered both times. The nurse was unsure whether the pt would be given the next dose. A product quality complaint was not involved. Follow up information was received from the RN who reported that the pt stated that he started having flu symptoms, a temp and was achy on 12Feb05, approx two days after receiving the second dose of hep B virus vaccine rHBsAg (yeast). The pt saw a nurse practitioner on 23Feb05 for ear pain, clear sinus drainage, and a sore throat. The diagnosis was seasonal allergies with allergic rhinitis. No diagnostic lab tests were performed. Subsequently, on an unspecified date, the pt recovered. No further information is expected.
The patient said she was allergic to thimerisol because she always had swelling and redness when she got the flu shot out of a multidose vial. She said last year she got the preservative free vaccine from a different store and did not have a reaction for the first time in her life so she wanted the preservative free vaccine. I asked her to call me if she had any reaction to the vaccine this year. She called the next day stating the same reaction was happening to her arm (swelling, redness, and hot to the touch). She said she wasn't worried because this is what always had happened to her in the past except for last year. She stated it usually takes her 48 to 72 hours for her arm to return to normal and she would be getting the vaccine again next year.
On June 13, 2021 I was admitted to Emergency Room for severe abdominal pain and vomiting.  This was 2 days prior to me starting my menstrual cycle.  While the ER doctor could find nothing specific wrong, I proceeded to be in significant pain for the next 3 days, and then exhausted for the 3 days after that.  I bled heavily and lost 11 lbs.  Although I had experienced somewhat heavy periods prior to my COVID-19 vaccination, I had never experienced such extreme pain.  I continue, even now, to have severe abdominal pain prior to my menstrual cycle, during my menstrual cycle, and during ovulation.  Sometimes the pain is so severe I vomit.  I am no longer losing a significant amount of weight but I also have less of an appetite because of these painful episodes.  I am having to take prescription strength pain medication to be able to live my life during the time prior to my menstrual cycle, during my menstrual cycle, and during ovulation.  I've had two ultrasounds, a colonoscopy, an endoscopy, a pap smear, and blood drawn.  Nothing is showing up as being wrong.  Last week I had an IUD placed as an attempt to ease this pain.  I have no idea if this is associated with the COVID-19 vaccine but it is worth looking into because my life is still not back to normal and the only difference was getting that vaccine two months prior to the pain starting.
Worsening tachycardia, shortness of breath on exertion, diaphoresis, fatigue
Pt developed hives under her arm, later spread to entire trunk and arms. Over 24 hour period. Benadryl given.
Itchy rash around 2-3 inches in diameter in bend of left arm -- same arm where received vaccination.  If there would have been pain I would have thought it was shingles.
FOOT CRAMP; WEAK LEGS; NOT FELT GOOD/ FELT A LITTLE BIT LOUSY; FELT VERY COLD; FOOT PAIN/ HARD TO GET IN AND OUT OF CAR DUE TO FOOT PAIN/ ARM SORE/ ARM STILL ACHED A LITTLE BIT (UPPER ARM); RASH ON FACE (BOTH CHEEKS, FOREHEAD, AND NOSE); JOINTS SORE; HEADACHE; FEVER; TENSED UP ALL TENDONS IN FOOT; TROUBLE WALKING NORMAL; This spontaneous report received from a patient concerned a 61 year old female  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: Unknown), 1 in total, dose was not reported (dose number in series was 1) on 03-APR-2021 for prophylactic vaccination (unspecified manufacturer) and her arm was really tired and did not feel good for 3 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, 1 total, administered on 20-NOV-2021 14:00 to left arm for prophylactic vaccination (dose series was 2). No concomitant medications were reported.  On NOV-2021, the patient experienced tensed up all tendons in foot, trouble walking normal and her left side hurt as she took booster vaccination on left arm. On 21-NOV-2021,the patient feeling very cold but woke up on 24-NOV-2021 feeling warm and she mentioned she was using 2 blankets and a sleeping bag on top on her head which was very hard ,when she got up in between 7:30 to 8:30 in the morning, she could not stand on her foot due to pain /hard to get in and out of car due to foot pain and all her joints and arm was sore and still ached a little bit(upper arm). she also had headache and rashes on her both cheeks, forehead, and nose and felt a little bit lousy. On 23-NOV-2021, the patient experienced weak legs. On 24-NOV-2021, the patient experienced foot cramp.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not felt good/ felt a little bit lousy, and headache on 23-NOV-2021, and felt very cold on 24-NOV-2021, was recovering from foot pain/ hard to get in and out of car due to foot pain/ arm sore/ arm still ached a little bit (upper arm), joints sore, and rash on face (both cheeks, forehead, and nose), had not recovered from foot cramp, and the outcome of weak legs, trouble walking normal and tensed up all tendons in foot was not reported. This report was non-serious.
pt recvd vax & 3 days p/vax exp stiff neck & soreness in upper extremities; resolved in 48 hrs;
Vaccinia autoinoculation TNTC pustules surrounding ~2x4" area around initial injection site.
States she was seen at Emergency Room for redness, swelling, itching and pain at injection site. Stated the Physician told her that the vaccine gave her Chicken Pox at the injection site.
Rash, fever, chills,  localized redness and swollen shoulder. Very painful and hot to the touch.  Called the nurse hotline and was advised to go the emergency room. Was given antibiotics and pain medicine. Was told if no change in 3 days to go back in. Antibiotics and pain medicine did not help so I had to return and pay for another round of antibiotics and pain medicine. This vaccine cost me and me family money and time we will not get back.
Pt exp h/a the evening of the shot; next AM had high fever to 102, nausea, h/a, dizziness till 26MAY92; took APAP & gravol as needed; lost 4 days of work due to s/s;
Chills; Aching from head to feet; severe headache; leg cramps; Nausea; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: En6204) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "headaches" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: Bnt162b2 (Dose number: 1, Brand: Pfizer, Lot number: EN6023, Administration date: 26Feb2021, Administration time: 06:30 PM, Vaccine location: Right arm), administration date: 26Feb2021, when the patient was 67 years old, for COVID-19 Immunisation, reaction(s): "Chills", "Aching from head to feet", "severe headache", "leg cramps".  The following information was reported: CHILLS (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Chills"; PAIN (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Aching from head to feet"; HEADACHE (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "severe headache"; MUSCLE SPASMS (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "leg cramps"; NAUSEA (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Nausea"; DIARRHOEA (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Diarrhea ".  Clinical course: Chills that lasted for hours Aching from head to feet, severe headache, leg cramps, after the first vaccine this started on Saturday around 6:15 pm and lasted all day on Sunday. The second vaccine I had the same symptoms along with Nausea and diarrhea. this started at 11:30 pm on 19Mar2021 and lasted through 21Mar2021. I called my pharmacist and she suggested I take Tylenol and stay in bed. Patient has not taken any other vaccine in four weeks. Medication in two weeks reported as yes. Patient was not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunization; 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: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Aug2022, stop date: 21Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had Paxlovid for covid-19 treatment started on 05Nov2022 and stopped on 09Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
SHAKING; FELT LIKE WHEN HE HAD COVID BACK IN OCTOBER WHERE HE WAS HOPITALIZED; VERY LOW ENERGY LEVEL; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced shaking, felt like when he had covid back in october where he was hopitalized, very low energy level, nausea, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, nausea, fever, headache, very low energy level and felt like when he had covid back in october where he was hopitalized was not reported. This report was non-serious.
This spontaneous report was received from a 79 year old female patient regarding herself. Information on medical history was not provided. The patient had no drug allergies. The patient current condition included high blood pressure.Concomitant therapies included Lisinopril (manufacturer unknown). The patient stated that previously approximately in 2017 ("about a year ago") she had received a dose of PREVNAR 13. On 25-SEP-2018, the patient received an unspecified influenza virus vaccine inactivated (unspecified) (reported as "flu shot") in the morning at a pharmacy (full demographics not provided) and then returned to the same pharmacy in the evening around 17:00 to get a dose of PNEUMOVAX 23(dosing details, lot# and expiry date unknown by reporter) via intramuscular route for prevention of pneumococcal disease. It was reported that the same evening after receiving the PNEUMOVAX 23 vaccine she started to experienced "extreme heat and redness in the right arm (the site of the PNEUMOVAX 23 injection) which got worse at night and started spreading" and by approximately 27-SEP-2018 (reported as Thursday) at 11:00, it was so swollen that she could not move it and was applying ice bags and taking ibuprofen(manufacturer unknown) and went to the physician. The patient sought medical attention. The physician diagnosed cellulitis and prescribed cephalexin(manufacturer unknown) 500mg twice a day and sent the patient for an ultrasound to rule out a blood clot which was completed on 27-SEP-2018 and revealed no clot present. The physician instructed the patient to keep applying ice and to keep her arm elevated above her shoulder. The outcome of cellulitis was reported as recovering (reported as "on the following days it started to get better" but "it was not quite completely resolved").  Causality assessment for the event was not reported. No product quality complaint(PQC) was involved. Upon internal review, the event cellulitis was determined to be medically significant.
Full body raised red rash, (except face). Diffuse large papules covering buttocks, arms, legs, chest and back. Referred to dermatologist who prescribed steroid therapy, both parental and oral.
Nausea, dizziness, headache, fever of 102, chills, fatique
Fully vaccinated with booster.  COVID breakthrough infection with inpatient hospital stay.  Asymptomatic
More than 6 months since 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient self reported this case. The age at vaccination was not applicable for this report. The patient enquired what if longer than 6 months had passed since his/her first Shingrix vaccination. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
I had been exposed to COVID-19 and at the time I tested positive did not have any symptoms. By later that night I got a low grade fever of 99.8,F and had a cough, the fever went away then came back the next night then left. The cough got worse and congestion started and got bad. Oxygen dropped for a couple days then everything started to gradually get better.
Fever, chills, headache, nausea, muscle aches, joint aches, arm swollen and sore.  Started 11 hours after shot and still ongoing in the morning.  Not much sleep.  Tylenol bringing fever down.
Patient state on the evening of Feb. 5th, 2021 she noticed some discomfort and mild redness at the injection site.  She reports she later woke with increased pain, redness, swelling and the area was hot to the touch.  Patient states today (Feb. 9th, 2021) the area is greatly improved with no discomfort noted.  Patient was instructed to follow up with PCP prior to receiving the second dose. Patient verbalized understanding.
This case was reported by a healthcare professional and described the occurrence of Influenza vaccine (unspecified), manufacturer unspecified), FLULAVAL. Concurrent medication included unspecified antibiotics. She had a medical history of rash on the face and neck. On an unspecified date in 2010 the subject received a dose of Influenza vaccine (unspecified, manufacturer unknown). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza. Outcome and attribution of the event to vaccination with Influenza vaccine was not known. On 31 August 2011 at 12:00 the 8 year old subject received a dose (dose 1 for 2011) of FLULAVAL at 0.5 ml in the left arm. This was the wrong vaccine for administration as FLULAVAL is not indicated for use in subjects under the age of 18. No additional details were provided. It was reported that this event occurred in three siblings. See linked sibling cases A0943409A and A0943422A.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 13th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
This case was reported by a consumer and described the occurrence of expired vaccine used in a 25-year-old female patient who received TWINRIX (batch number AHABB260AB, expiry date 14th November 2014). On 19th December 2014, the patient received the 1st dose of TWINRIX .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 25 year-old female patient received today (12/19/2014) the first dose of a series of TWINRIX that had expired on 11/14/2014.
rash left arm/reddening left arm injection site; Neck pain; sore left arm at the injection site that worsened; reddening left arm injection site; burning left arm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (sore left arm at the injection site that worsened), INJECTION SITE ERYTHEMA (reddening left arm injection site), INJECTION SITE PAIN (burning left arm at injection site), NECK PAIN (Neck pain) and RASH (rash left arm/reddening left arm injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE PAIN (sore left arm at the injection site that worsened), INJECTION SITE ERYTHEMA (reddening left arm injection site) and INJECTION SITE PAIN (burning left arm at injection site). On 26-Apr-2021, the patient experienced NECK PAIN (Neck pain). On 28-Apr-2021, the patient experienced RASH (rash left arm/reddening left arm injection site). The patient was treated with HYDROCORTISONE ACETATE (HEMORRHOID) (topical) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (sore left arm at the injection site that worsened), INJECTION SITE ERYTHEMA (reddening left arm injection site), INJECTION SITE PAIN (burning left arm at injection site), NECK PAIN (Neck pain) and RASH (rash left arm/reddening left arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include  blood pressure, anxiety and acid reflux medications. Patient was advised to use ice as treatment and also instructed by her healthcare provider to use a warm compress.
Extremely swollen area on the injection site the next day of the third Moderna vaccine. Itchy. Have been applying hydrocortisone topically for 2 days with no improvement. Also taking Zyrtec by mouth. Still not resolved.  Seems to be getting bigger.   Also got them same reaction with the first and second dose of Moderna, but this time it seems more aggressive.