chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster)), for COVID-19 immunization. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "has sinus problems". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nauseous; Stomach ache; Runny nose; Tired; I did not feel good; This is a spontaneous report from a Pfizer-Sponsored program, received from a contactable nurse  A 75 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization and oral palbociclib (IBRANCE) from 02Apr2021 at 125 mg daily cyclic for 21days for an unspecified indication. Relevant medical history and concomitant medications were not reported. It was reported that patient received second dose of vaccination and she did not feel good, was nauseous  had a stomach ache, runny nose and tired. At the time of the reporting event outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two days after vaccination, I woke up feeling like I had the flu. I was sore, had fatigue, body aches and joint pain but no fever. That became worse over the following week. I went to the doctor 1 month after vaccination. She said my symptoms were worse and that it was probably a reaction from the vaccine and there was not much to be done except wait it out. I had a similar reaction to the first vaccine as well. It did not get better until 5 months after the 2nd vaccine.
After the shot he started coughing, and been fatigue; After the shot he started coughing, and been fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (After the shot he started coughing, and been fatigue) and FATIGUE (After the shot he started coughing, and been fatigue) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (After the shot he started coughing, and been fatigue) and FATIGUE (After the shot he started coughing, and been fatigue). At the time of the report, COUGH (After the shot he started coughing, and been fatigue) and FATIGUE (After the shot he started coughing, and been fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment medications were reported.
Erythema and swelling of L upper thigh measuring 8 x 7 cm oval.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of an unspecified age, ethnicity and gender received PREVNAR, intramuscular on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown. The action taken in response to the event for PREVNAR was not applicable.
My daughter got Sanofi Pasteur's intradermal flu vaccine as part of a pilot program.  She hated it.  She got an itchy rash that lasted for days. They gave participants a survey immediately after the shot, before she was aware of this reaction.  So she could not give accurate feedback.  They were only interested in positive feedback.  They also "bribed" participants with a gift card.
SYMPTOMS:   July 29th, 2021 Chest Pain (heaviness)  July 31st, 2021 Palpitations / Arrhythmia   July 29th-October 17th: Continued chest pain, and palpitations ongoing; seems to be aggravated with physical activity; however palpitations can occur when lying down as well. Chest heaviness on and off (bricks on chest), would often persist a maximum 3 days.    October 18th-Nov 4th; CONSTANT chest heaviness, sometimes burning sensation, sharp pain with physical activity and palpitations with physical activity, and when lying down.   November 5th-Present Day; chest heaviness and pain. Worse in the evening. Palpitations while lying down, or when stressed/engaging in physical activity. Standing and walking more than a few minutes is strenuous.   DATES  Emergency Visits: July 29th, Aug 7th, Sept 11th, Sept 13th, Oct 19th, Oct 27th; 2021 Begin seeing Cardiologist: Aug 14th Hospitalized: October 27th- November 2nd   TESTS  Aug 14th 48 hour Holter Monitor  -Diagnosed with Extrasystole -Beta Blockers Prescribed: Bisoprolol (to be taken as needed)   Aug 17th Blood-test  -elevated CRP: 25   Sept 23rd  MRI  -small amount of Fluid in Tissue around heart  Oct 27th ECG -ventricular tachycardia   Nov 2nd MRI -myo-pericarditis  IMPRESSION:  1. Normal biventricular size and global systolic function.  2. In comparison to prior study, and in addition to the nonspecific inferior hingepoint LGE, there is subtle/low intensity subendocardial LGE at the mid to basal inferior segments of the left ventricle. This finding, in retrospect, could have been present in the prior examination, as described (image quality in the current study is improved). No positive T2-weighted criterion to suggest ongoing myocardial inflammation. Stable mild pericardial enhancement. Overall, findings are suggestive of pericarditis with minimal myocardial involvement. 3. Stable small pericardial effusion.  Initial Interpretation By: (Privacy) Verified By: (Privacy) Reviewed With: (Privacy)   CURRENT MEDICATION (started October 29th)  Bisprolol 5mg Naproxen 250mg Colchicine 0.6mg Pantoprazole 40mg
Patient passed out after receiving the vaccine. She had no problems  with the first vaccine but has had a history of passing out with other vaccinations. Patient had just gotten to the waiting area after receiving her vaccine and sat down and her mom caught her from falling from the chair. Mom held her for a few minutes as she went in and out of consciousness. When she came back to we laid her on the ground. Patients BP was taken as she started to feel better and was 120/74. Patient and mom stayed with us as she gradually started to feel better. Mom drove her home.
At 2:00 am following the shot I started having severe body aches. At approx 3:15 am I started having severe chills and my body couldn?t stop shaking
2MAY96 pt entered clinic for cold management;exam found lt lateral thigh w/ 3x .75cm hyperpigmented firm mass;MD concerned w/findings;
bottom lip swelled and then upper lip swelled; cheeks swelled; cheeks swelled and then in went to eyes; developed some spots; itching spots under breast and on leg; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (bottom lip swelled and then upper lip swelled), SWELLING FACE (cheeks swelled), EYE SWELLING (cheeks swelled and then in went to eyes), RASH MACULAR (developed some spots) and RASH PRURITIC (itching spots under breast and on leg) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A9761B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (tested positive for COVID 19 2 months ago) in July 2022. Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced LIP SWELLING (bottom lip swelled and then upper lip swelled), SWELLING FACE (cheeks swelled), EYE SWELLING (cheeks swelled and then in went to eyes), RASH MACULAR (developed some spots) and RASH PRURITIC (itching spots under breast and on leg). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (bottom lip swelled and then upper lip swelled), SWELLING FACE (cheeks swelled), EYE SWELLING (cheeks swelled and then in went to eyes), RASH MACULAR (developed some spots) and RASH PRURITIC (itching spots under breast and on leg) outcome was unknown.            Concomitant medication included Arthritis medication. On 19-Mar-2021, patient received first dose of Moderna Lot number. 029A21A, second dose was received on 31-Mar-2021 with Lot number. 028A214, 1st booster dose on 22-Oct-2021 with Lot number. A4426A and 2nd booster dose on 16-May-2022 with Lot number. 033A22A for COVID-19 vaccination.
Hep B vaccine was given to wrong patient.  There were 3 male siblings in the same room and the hep b was meant for the middle child and was mistakenly given to the oldest sibling.
This spontaneous report has been received from a pharmacist, concerning an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inadvertently vaccinated with an adult dose of VAQTA intramuscularly for prophylaxis (frequency, lot number and expiration date were not provided); Moreover, the reporter could not provide the lot number of the administered VAQTA and provided the lot number that was currently using (Lot # R000180 with expiration date 21-MAR-2019). No adverse effects were reported.
On 8/9/11 received Tdap & meningococcal vaccines. That night had lip numbness and couldn't completely close right eye. Seen 8/15/11 - symptoms improving. Diagnosis - Bell Palsy.
Within hours of vaccination patient developed a fever of 105 degrees, high pitched screaming, limp and weak body and a febrile seizure.  When we called Dr. she told us it was to be expected and that her illness was not related to the vaccination.  8/19/2008 Neurodevelopmental assessment received dated 8/15/207 with Assessment:  Sensory integration disorder.  Pragmatic language disorder. Speech delay impairment.  Idiosyncratic language.  Feeding dysfunction.  Repetitive behaviors.  Hyperactivity.  Insomnia and sleep disturbance. Discussed causes and tx of Autism. Infant developed high fevers, lethargy and high-pitched crying following immunzations and were stopped at 6-9 months. Met developmental milestones until ~11-13 months. Had several words but stopped talking until 22 months. Currently with  feeding issues, sensory issues, language delay and abnormalities, social interaction problems, repetitive behaviors and sleep problems.
9 days after receiving varicella and mmr injections, pt had onset of hives under right arm and left groin area; these became generalized over body. no fever, taken to prompt care, given zyrtec. hives lasted 3 days.  11 days after hives appeared, pt had 8 pox, followed by spontaneous recovery.
Patient received the vaccine Saturday around noon, and that evening she began complaining of muscle aches, shaking, headache and fatigue (she described as general flu like symptoms), which continued into Sunday morning.
Patient was admitted because of tripped and fell while walking with walker at home.  Patient is complaining of left knee pain.  He was transferred to the emergency department by MMR.  He denies any significant back pain or hip pain.  Denies any neck discomfort.  No chest pain shortness of breath fever or chills.  X-ray shows left distal femur fracture so now patient is admitted for further evaluation and possibly surgery.  Dr. is been consulted.     Hospital Course:    Few hrs before surgery go with screen test came back positive.  Patient have a no respiratory symptoms his chest x-ray was negative.  No significant concern with inflammatory markers either.  Surgery was postponed and perform next day.  He was placed on a vitamin C vitamin D and zinc.  Also started on doxycycline.  Patient had a period of confusion and agitation which is improving.
Reporting administration error per Agency.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are  deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted pfizer to attain expiration dates directly from them.   No adverse reaction reported from the patient at the time of vaccination. No adverse reaction reported since the administration of vaccination.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-FEB-2013, the patient was vaccinated with GARDASIL (dose, route and lot not reported). The physician stated that while she was injecting the GARDASIL, she noticed a leak from the syringe. After inspecting the syringe, she noticed a crack in the syringe. Physician reported that the patient might had only received a partial dose of GARDASIL. No adverse event symptoms reported. The reporter considered the event was not related to GARDASIL. Additional information has been requested.
Site became red afternoon of shot date, gradually became bigger.  Intially raised about 1 1/2 x 1 1/2 now 3 3/4 x 3 inches.  Red, blistery.  Grandmother applying cool compresses.  Scratches - apply Hydro-cortisone cream to site.  5/10/05 talked to caretaker reports called doctor - gave Benadryl.  Site bigger, but fading light pink now and she says it feels better.
Asymptomatic COVID-19 infection, possibly related to the stroke follow-up with family doctor.  ED to Hosp-Admission Discharged  5/28/2021 - 6/2/2021 (5 days) Hospital  MD Last attending ? Treatment team Lacunar stroke  Principal problem    HPI: 80-year-old lady admitted with left-sided weakness     Hospital Course: Patient was admitted with left-sided weakness.  MRI showed a 9 x 8 mm acute lacunar infarction in the right thalamus.  This was the likely cause of the patient's left-sided weakness.  Patient has asymptomatic COVID-19 infection diagnosed May 13.  The stroke may have been a late effect of a hypercoagulable state induced by COVID-19.  In any case the patient's deficits rapidly resolved and by the day of discharge she was at her baseline.  She had no difficulty walking or functioning.  She was seen by physical and Occupational Therapy who felt that she was safe to go home.   To prevent this from happening in the future we are increasing her atorvastatin from 20 mg to 40 mg daily.  She is already on warfarin.  She was seen by the neurology service and they did not recommend making any other changes especially in view of the patient's history of gastrointestinal bleeding.  On the day of discharge she was feeling very good and eager to go home.  I think this is reasonable.
Booster dose. Vaccine administered on 11/01/21. Vial expired 10/11/21. Vial was kept in freezer until 10/30/2021 and removed to fridge on 10/30/2021 for administration on 11/01/2021.
Shortly after being vaccinated I started having symptoms of muscle fatigue, weakness and joint pain. It concentrated mostly in my shoulders, but also affected my arms and legs. These pains are continuous and still bother me over a year later. I go get massages to help with the pain.
As I was pulling my left arm out of sleeve, told I didn't need to as she pulled blouse off my shoulder and gave shot.  Shot felt very painful and got rogressively sore that evening with trouble lifting  or moving my arm.  Realized bandaid was on shoulder where shot given. Returned to office next day as too painful to move are.  Given Rx for Flexeril, Ibuprofen, and then 4 days of Prednisone.  Had left shoulder x-ray done and started physical therapy around Nov.2 and am still going 3 times weekly.
Pt was given their 2nd dose of Pfizer COVID vaccine at 16 days after their 1st dose. No adverse effects noted.
Pt was administered H1N1 flu vaccine intranasal instead of intramuscular, no symptoms of flu noted as of 12/16/09. Thinking that this is protocol no MD order in place
Pt. experienced difficult swallowing breathing 20 minutes post administration.  Provider evaluated airway, deemed stable for transport to ER.  Pt. reports similar episode when exposed to meat products.  Pt. prescribed EpiPen, Medrol dosepak, and hydroxyzine and released from ER.
On 8/22/2022 I had a sniffle, really light allergy symptoms. I test on 8/22/2022 with a COVID-19 home test and it was negative. I would have been infected on 8/20/2022. On 8/23/2022 I tested again, and it was positive. I called my doctor and was prescribed the antiviral, PAXLOVID. And I started having more symptoms extreme migraine, fever, chills and sweats, congestion. But it was mostly done by the afternoon the next day, on 8/24/2022 I was fine. A week later I had a rebound, 9/8/2022, I tested positive again. I had negative testing between. I just had the sniffles. I just tested again before I went to a funeral.
24 hour after vaccine patient reported erythema, edema, and pruritis at injection site.  Reported with first vaccine had mild injection site reaction but reaction with second dose was more severe. Denied systemic symptoms including but not limited to sore throat, fevers, chills, sweats etc.  discussed on the phone, mark the outside edge of the swelling with the pen. Start taking Bendryl every 4 hours as needed. Hold hydroxyzine while taking Bendryl. Increase Pepcid to 20 mg twice daily for 7 days. Apply cool compresses to the site. If the area gets larger, or you develop systemic symptoms, report to the ER. Pt reported that symptoms start to improve the following day without worsening.
This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender. The patient's current condition, pertinent medical history and concomitant therapy were not reported. On 09-DEC-2021 the patient was accidently vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), lot # S037499 and expiry date 20-NOV-2021, 1 dose, (Frequency and route of administration not provided) for prophylaxis (expired product administered).
Sore left shoulder 24 hours; Flu like symptoms beginning  24 hours after second injection
Irritable, decreased self-soothing, decreased eye-contact, increased startling to noises. Symptoms lasted 5 days and then slowly improved over the next few days.
Patient presents to the ED with wife c/o dizziness, inability to focus, optical migraine on Tuesday, and fatigue. COVID was detected on nasal swab
2/15: onset of mild cramping, increased BM frequency          constinued through 2/28/2021 ->  2/28 pm: DRAMATIC INCREASED DIARRHEA, CRAMPING, NAUSEA. 3/2/21: DIAGNOSED C diff with COLITIS, STARTED TREATMENT.
administration error - dose administered  2 mins beyond the 2 hr time frame after puncturing vial and placed in room air.  no issues with person receiving dose
Patient received the covid19 (Pfizer) after shot patient complained of chest pains, called emergency services and was promptly taken to the hospital.
mixing error occurred, patient may have been given just diluent. Have been unable to contact patient to revaccinate.
Myalgia, Fever, Rash, HYPERtension, chills, fatigue Treated with OTC Theraflu, Nyquil, Tylenol, and used prescription inhaler PRN. Event occurred from 2/3/21-2/5/21.
autoimmune reaction; upper arm being very itchy/sore and felt some lumps as the day progressed, she developed more; upper arm being very itchy/sore and felt some lumps as the day progressed, she developed more; very hot and "hivey", bright red; very hot and "hivey", bright red; This spontaneous case was reported by a  and describes the occurrence of IMMUNE-MEDIATED ADVERSE REACTION (autoimmune reaction), VACCINATION SITE PRURITUS (upper arm being very itchy/sore and felt some lumps as the day progressed, she developed more), VACCINATION SITE MASS (upper arm being very itchy/sore and felt some lumps as the day progressed, she developed more) and URTICARIA (very hot and "hivey", bright red) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (autoimmune reaction), VACCINATION SITE PRURITUS (upper arm being very itchy/sore and felt some lumps as the day progressed, she developed more), VACCINATION SITE MASS (upper arm being very itchy/sore and felt some lumps as the day progressed, she developed more) and URTICARIA (very hot and "hivey", bright red).            Reporter did not allow further contact
shingles 4 days after 1st dose; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles 4 days after 1st dose). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023 The reported enquired if the patients could get shingles after Shingrix vaccine.  The reporter enquired about when could patient receive second shot once developed shingles.
Pt was given expired Heplisav vaccine. Vaccine expired 09/17/2022 and vaccine was administered 10/20/2022. Dynavax was contacted for recommendations and stated that their research shows that Heplisav is still potent 30 days after expiration date and re-vaccination status is left up to the health care provider. RN immunization coordinator, notified of the above and stated to go ahead and re-vaccinate patient. Attempted to contact patient 10/28/2022 when error was discovered but was unable to reach patient. Patient contacted 10/31/2022 and made aware of error and need to re-vaccinate. Pt denies any adverse reactions and was re-vaccinated on 10/31/2022.