chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Wednesday Sept 25, I obtained a first vaccination at Pharmacy at about 11.30 am. The second vaccination is due after December.  I am worried that I had significant side effects from the vaccination, and I would like to share those symptoms with you. ? At about 2.30 pm [3h since vaccination] the spot of vaccination on my arm was swollen and quite panful. I know that this can happen, and it didn?t worry me.  ? At 4 pm [4.5h since vaccination] I got short awkward flashes of short sharp headache in the back of my head. Never had those before.  ? At 8 pm [8.5h since vaccination] I started to feel tired and I start to feel muscle pain and muscle tiredness.  I took an ibuprofen. ? At 10 pm [10.5 h after vaccination] I went to bed because I was very tired. ? At 12.30 [13 h after vaccination] I woke up shivering, I had severe muscle pain in all large muscle, pain in all joints, and pain in bones, from my toes to my neck. With 3 thick blankets I was able to feel less cold. I probably had a fever, but I did not check my temperature. ? At 1 am [13.5 h after vaccination] my heart was racing, although I was in total rest in bed. With my phone I measured 98 ? 110 bpm.    I also felt somewhat dizzy and slightly confused, almost as if you have severe flue. I had to walk carefully to not fall. ? At 7 am [19.5 h after vaccination] Muscle and joint pain remained, despite 2 ibuprofens. Felt lack of energy, also very heavy sweating. ? At 12.30 pm [24 h after vaccination] still sever pain in all large muscle groups, some bone and joint pain, a mild but sharp weird headache and a general feeling of not being well. The spot of the vaccination is very painful and hard and slightly swollen. ? At 5.00 pm [30 h after vaccination] similar symptoms as 12.30 pm, but somewhat reduced. ? At 8 am [45h after vaccination [ I noticed a red rash on my chest and back. The rash did not itch or was not painful. I typically see such a rash when I had a virus infection. ? The rash started to disappear after 2 days [90 h after the vaccination]
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself.  A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
NauseaVomiting 1/11-1/13 nausea and fatigue 1/13 hypersensitivity lower back and mild fatigue, intermittent nausea Narrative: 1/11-1/13 nausea come in waves, but manageable, little fatigue 1/13 hypersensitivity lower back down (like when having the flu if someone touches it hurts), mild fatigue. Intermittent nausea and then feels okay.
Intestinal pain, antibiotics (Flagyl and Cipro for 10 days), continued intestinal pain, ER visit on 4/10/2021, CT scan showed appendicitis, appendectomy on same day
Erythema/edema (R) upper arm - 2 x 4 cm yesterday - 9 x 12 cm today. Given BENADRYL 25 mg TID. Returning tomorrow for recheck.
Began 5-13-15 10 am w/(L) arm sore/red itch. Observed (L) arm 120 mm/65 mm red, warm, rasied, 1+tender, R arm 40x20 mm warm with red and pain-both at site of injection. Rx KEFLEX 250 mg/5 ml, 5 ml TID, BENADRYL.
Soreness at injection site began within an hour (hours 1-100+). After 12 hours, extreme chills started, followed by alternating chills and sweats overnight (hours 12-40) combined with extreme muscle soreness all over (hours 14-48), fatigue (acute hours 12-48 then mild from 48-72), nausea (hours 14-36), mild heartburn (intermittent, day 2-4+), pounding heart (day 3, briefly during exercise but didn't seem normal or safe) and abnormal awareness of heart (day 2-4+ either very mild "pounding" or anxiety-related).
soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Batch/Lot number: unknown) at the age of 69 years 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) with onset Feb2021, outcome "unknown", described as "soreness in arm".  Additional information: When probed concern, Patient stated just wanted to report the side effects from Pfizer shot and had no problems with the first shot except from soreness in arm which was when patient got the first shot (03Feb2021) all this patient had soreness in arm, so there was no problem with it there. Patient received second dose on 24Feb2021. When probed for vaccine (first and second shot) LOT# patient stated Pfizer it looks like EL8. As patient was not willing to proceed the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Menstrual period started 1 week early and has lasted 12+ days, 7 days longer than normal for patient. Patient still on period.
bivalent vaccines was administered the vaccine was beyond the BUD.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.).    No concomitant medications was reported.  Bivalent vaccines was administered. The vaccine was beyond the BUD. No reported symptoms.  No treatment medications was reported.
Labored breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored breathing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Labored breathing). At the time of the report, DYSPNOEA (Labored breathing) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment medication were not provided by the reporter.   This case was linked to MOD-2021-182518 (Patient Link).
I started having severe balance issues on the 10th and rapidly "progressed" to extreme weakness. I could not walk 50 feet to my parked truck without assistance and even that took me about 30 minutes. After getting home I collapsed on the garage floor and it took me 30 minutes to crawl into the house and finally get seated into a chair with the assistance of my wife. The next morning (3/11) I could walk around the house a bit (without walking stick or walker for help) but I am still a bit weaker (than normal). I have had Parkinsons for about two years but I have never had such an instance of weakness or profound immobility. I have not seen my doctor yet and will wait a while to see if conditions worsen.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "Fibromyalgia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nsaids, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment and previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2.
Adverse event: Vaccine administered 16 days after beyond use date and less effective. Treatment: Pt is receiving another dose in office as recommended by Pfizer.
The patient has pain in her upper left arm, with a burning sensation down to the elbow. The patient's temp has been 101F for 2 days. There is swelling at the injection site. The patient is breathless, and feels "a weight on her chest". The patient has general body aches. The patient is self-medicated with Tylenol and has had the flu shot in the past without problems.
Hives started next day approximately 25 hours after vaccination. My hives were mild and went away after a few hours. I did contact my physician listed to inform her. No treatment was needed because they did go away on their own.
Itching in area of injection down to elbow on left arm with hives/rash upset stomach 9/8/09.
Diarrhea; Throat irritation; Sneezing; Allergy; This spontaneous case was reported by a physician and describes the occurrence of THROAT IRRITATION (Throat irritation), SNEEZING (Sneezing), HYPERSENSITIVITY (Allergy) and DIARRHOEA (Diarrhea) in a 69-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 Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 22-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation), SNEEZING (Sneezing) and HYPERSENSITIVITY (Allergy). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, THROAT IRRITATION (Throat irritation), SNEEZING (Sneezing) and HYPERSENSITIVITY (Allergy) had not resolved and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
From initial information received on 12/8/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 46 year old male patient received a dose of TD ADS ADULT, lot number U1347AA, administered IM in the left deltoid on 12/3/04 for travel purposes. The patient was not sure how many previous doses he received prior to the last booster. An unspecified amount of time later in December of 2004, the patient developed a deep muscle pain rated as a 7 on a scale of 1 to 10 with 10 being the worst. Per the reporter, the pain is persistent and still continues. The patient previously received a dose of TYPHIM VI, lot number X0771, administered in the right deltoid, a dose of IPOL, lot number X0521, administered in the right arm and a dose of Hepatitis A vaccine, lot number AHAVA020BA, administered in the left deltoid on 11/5/04. Per the reporter, the patient did not recover from this event.
patient did not receive the second dose injection; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, 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 (patient did not receive the second dose injection). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose injection) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.
got sick; fever; chills; couldn't walk upstairs; This is a spontaneous report from a contactable other health professional received from a Pfizer COVID Vaccine Program. An adult male patient in his forties  received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got sick, fever and chills. It was reported that, the reporter has not seen anybody, they've, like, started to pull weird stuff that have happened three weeks later, there's like a, an, uh, obstetrician who had some blood platelet thing and they're trying to figure it out. But they're not really sure if it's related. They stated that, old people usually don't have a side effect. Stated that, [name other] got sick after the second one, too. Stated that, he got chills, fever and got sick after the second one. Stated that, dr had to send home the other day as the patient couldn't walk upstairs. The outcome of events was unknown. The causality was reported as related.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 15th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient developed a mild case of Shingles sometime after receiving the Shingrix. Emergency room visit required.
Developed dyspnea, sore throat and hives all over with difficulty swallowing 2 hours after vaccines were given went to ER and treated for anaphylaxis.
Vaccine administration error.  The patient received moderna as her first dose on 05/14/2021.  The patient was given Pfizer as a 2nd dose on 09/28/21.  Mixed MRNA vaccines.
Within the first 24 hours a hard uneven lump (about 1.5 inches in diameter), heat around/on injection site, and soreness, and mild itching developed. By 48 hours, soreness peaked and the lump remained with warmth and itching when the area was touched with slight pressure. Between the 2nd and 14th day, the lump was still present (still 1.5 inches in diameter) with mild itching. I began to develop a dry cough, shortness of breath, severe fatigue, and muscle fatigue that lasted from day 5 to day 11 following the Moderna injection. I went to get a COVID test and the results came back negative. After the 14th day the lump went down but now there is a discoloration of the skin where the lump was located that is still present 23 days after the first injection.   I did not use any medications or treatments to heal the adverse event nor sickness symptoms following the injection.
Confirmed Breakthrough; COVID-19 (Pfizer) 1; 86 Years 8 Months 02/26/2021; Pfizer; EN6201; COVID-19 (Pfizer) 2 86 Years 9 Months; 03/19/2021; Pfizer; EN6198; COVID-19 (Pfizer; 3; 87 Years 4 Month; 10/14/2021; Pfizer FF2590
No adverse side effects were reported with the administration of the vaccine; HCP called to report a TE for VAXNEUVANCE  which was also administered to a patient; This spontaneous report was received from a medical assistant and refers to a 16-month-old male patient. No information on patient's medical history, current conditions and concomitant medications was not provided.      On 21-JUN-2023 the patient was vaccinated with improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # W039033 and expiration date 01-OCT-2024, 0.5 milliliter in the left thigh for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).Temperature excursion was 49.1 degrees Fahrenheit (F) for 34 minutes with two previous excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes. ; Sender's Comments:  US-009507513-2307USA004472:
On 01/13/2023, she developed a rash on her right arm. It started to spread, so we called her pediatrician and they asked us to take her to urgent care. They did a CBC blood test and a PT and an INR blood test. The results were normal and they said she had a viral rash. It started to fade the next day and was gone two days later.
Initial information has been received from a registered nurse concerning a 71 years old male patient with hypertension and a history of arthritis (AAA), thyroid nodule, prostate cancer, hypercholesterol, tobacco user, erectile dysfunction and shingles (2009). On 02-OCT-2012, the patient was vaccinated with PNEUMOVAX23 intramuscularly in the right deltoid area (dose, lot number were not reported). Other suspect therapies were not reported. Concomitant medications included FLUZONE (lot number 04496AA), aspirin, VIAGRA, Omega-3, hydrochlorothiazide (manufacturer unknown) and low dose statin (unspecified). The patient had not acutely illness at the time of vaccination. On 05-OCT-2012, 3 days after the vaccination, the patient developed low grade fever, thumb swelling and bilateral wrist swelling. The patient received non-steroidal anti-inflammatory drug (unspecified) (NSAIDS) as corrective medication. Laboratory investigations were none as per reporter. On an unspecified date, the patient recovered from the events. The patient sought medical attention by contacting a doctor at the health department. Additional information has been requested.
Patient with no known medical conditions on no home medications found down by his wife in the yard, pulseless. She initiated CPR and called EMS.  He was found to be in VFib. He underwent an estimated total of 40 minutes of CPR/ACLS before obtaining ROSC.  He was admitted to medical center and was found to be too unstable to proceed to cath lab. He was started on targeted temperature management to 36C for 24 hours before rewarming to normothermia. He suffered severe refractory shock, requiring norepinephrine, vasopressin, phenylephrine, and epinephrine at maximum doses of each plus stress-dose steroids as well as continued intermittent arrhythmia requiring amiodarone infusion. He suffered severe heart failure, requiring dobutamine infusion. He was also treated with broad spectrum antibiotics empirically for suspected severe aspiration pneumonia, as he required high ventilator support including FiO2 100% and PEEP 12.  He also suffered renal failure with progressive oliguria to anuria and electrolyte abnormalities. Despite maximum efforts, patient continued to require high levels of support. It was deemed that this was not a survivable injury and after 5 days family elected to withdraw life support.