chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not doing well with mild symptoms and severe symptoms; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable nurse reported for a male patient that: A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was not doing well with mild symptoms and severe symptoms. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.   (PRD/SRD01Sep2021): Follow-up activities closed. Batch/lot number not available.
headache 2 hrs. after administration and neck pain. Lasted for 5 days.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 20-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
SEVERE MUSCLE ACHES - LEGS, ALL OVER. SEVERE CHILLS HEADACHE FATIGUE ... FOR 2 FULL DAYS FOLLOWING SHOT
Patient reported the am of 3/19/21 at approximately 0730 facial swelling and tongue swelling. No respiratory distress noted. Patient was seen by the physician this am on site and examined patient and orders for Benadryl 25mg QID PRN for swelling was ordered. T98.4 P96 R19 BP 140/62. SPO2 95%. Smoker. Patients' symptoms started to subside after administration of Benadryl.
flu like symptoms; her hand was heavy; hands and feet are tingling; burning; kind of red underneath/face is kind of red; whole back broke out last night; rash; kind of like dermatitis; been having issues with hands and feet; itching on her back; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning) and ERYTHEMA (kind of red underneath/face is kind of red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-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 INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning), ERYTHEMA (kind of red underneath/face is kind of red), SKIN EXFOLIATION (whole back broke out last night), RASH (rash), DERMATITIS (kind of like dermatitis), SKIN EXFOLIATION (been having issues with hands and feet) and PRURITUS (itching on her back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning), ERYTHEMA (kind of red underneath/face is kind of red), SKIN EXFOLIATION (whole back broke out last night), RASH (rash), DERMATITIS (kind of like dermatitis), SKIN EXFOLIATION (been having issues with hands and feet) and PRURITUS (itching on her back) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable Caller wants to know if Benadryl is fine to continue taking No concomitant medication were reported    This case was linked to MOD-2021-238461 (Patient Link).
Received Td vaccine(MassBioLogics exp. 12-26-09) on 6-02-08 to left deltoid. On 6-03-08 felt pain, soreness and redness. On 6-04-08 had swelling, tender to touch, pain and slightly hard.Instructed to take Ibuprofen or Tylenol for pain and apply warm or cold compresses for comfort. Report to Health Management Services if symptoms do not subside
Warmth about the size of the palm; Itching at injection site; Injection site with redness; A spontaneous report was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching at injection site/ vaccination site pruritus, with redness/ vaccination site erythema and warmth/ vaccination site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced itching at injection site with redness and warmth about the size of the palm of the hand.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, itching at injection site with redness and warmth was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient got her 1st dose of Moderna vaccine 4 weeks ago (4/2/2021) but she is only 17 years old. After checking with the company policy, CDC guideline and patient's primary provider, it is ok for her to get her second shot today (4/30/2021)
Patient had PNEUMOVAX left arm on 9/5/12, called physician on 9/7/12 to report local redness 8 to 9 inches, hot, headache, neck stiffness, fever 101.8 patient was instructed to go to ED to R/O cellulitis and antibiotics.
Rash about 3 inches in diameter around injection site. No pain or itching reported. Area was warm to the touch.
arm hurt; pain in back of neck and same side of shoulder; pain in / same side of shoulder / elbow is throbbing; shaking; This is a spontaneous report from a contactable consumer. A 38 (unit: unknown) female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 19Feb2021 15:35 patient seemed fine, arm hurt, starting on Monday (15Feb2021) or Tuesday (16Feb2021) pain in back of neck and same side of shoulder. Pain was so bad yesterday that she was shaking, similar to pain in labor. Even her elbow is throbbing. Doctor prescribed Flexeril, its giving some relief to make pain bearable. Chiropractor said that pain level is too severe to treat, and it should be reported to Pfizer.  Before receiving the vaccine, had a wisdom tooth infection, full body rash from a staph infection from tooth infection spreading but before the vaccine. She did one month of amoxicillin, and one month of Bactrim. It was questioned whether the shooting pain in her neck a reported side effect of the vaccine. The outcome of the events was recovered.   Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Severe pain in pectoral muscles with radiation to back of arms and between shoulder blades, little to no relief with anti-inflammatory meds, ongoing.
Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifting arm; stiff neck; Feeling of having the flu; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via intramuscular route of administration, on 13Jan2021 at 09:15 AM (at the age of 42 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included gastritis, and COVID-19. The patient had known allergies to Bactrim. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included omeprazole 20mg daily, cetirizine hydrochloride (ZYRTEC) 10mg daily, vitamin D3 200 IU daily, and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) 20 billion live probiotic cultures. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 at 10:30 PM, the patient experienced temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu. All symptoms lasting 48 hours. The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had been tested for COVID-19 which included a blood test on 21Jan2021 which was negative.
This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed cellulitis after receiving SHINGRIX. The reporter was unsure of the dose number. The reporter did not see the patient or reaction. The reporter did not consent to follow-up.
Pain and mild swelling in left arm which had previously resolved lymphedema. Shot was administered in right arm.
Right sided Bell's Palsy 01/18/07-per staff at Dr.'s office, spoke with patient on 01/17/07-Bell's palsy resolving, right eyelid droop remains at this point with some sensitivity to light, wind and cold. Staff will follow up with patient in 3 weeks.  01/22/07-records received and reviewed.  DX: Bell's Palsy, 90% recovered. Has some residual eye dryness but can close it effectively. Sudden onset with right sided facial numbness and weakness. Pain in right anterior neck.
MUSCLE ACHES THROUGHOUT BODY,LEG PAIN, BACK PAIN, SCIATICA PAIN, SHOULDER PAIN- TREATMENTS INCLUDE: PHYSICAL THERAPY, ACUPUNCTURE, BIOWAVE, TYLENOL.  NONE HAVE BEEN SUCCESSUL
injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix (intramuscular) .5 ml. On 4th May 2019, 4 days after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was resolved with sequelae.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist inquired on behalf of the patient who reported spreading of injection site redness. The patient was complaining of redness spreading inside of arm.
Sore throat and swollen lymph nodes in neck. Last about a week. Currently symptoms have 90% subsided but lymph nodes on left side of neck are slightly tender to touch. Pain never reached 5/10 when swallowing. No issue with breathing
Pt presents to ED with mother c/o nausea and abd pain that started this afternoon. Pt was vaccinated and given a pill for typhoid for travel. Nauseas started after he took pill.
Sore arm at injection area. Full body aches, slight headache during the day and while sleeping. Intense lower body cramps from hips down. Woke up shedding 2 maxi pads worth of blood from vaginal area.
Weak feeling. Referral to MD. Refused testing at ER visit 10/7/02. The follow up received on 11/18/03 states cont with burning sensation bil legs. pt also has decreased strength inboth arms and cont's with numbness and tingling when he walks.
stroke;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4191475-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single and intramuscular, administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab, subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. Relevant medical history included: "Non-smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Oct2021, outcome "unknown", described as "stroke". The action taken for adalimumab was unknown.  Clinical course: It was reported that in Oct2021 the patient had minor stroke. No effects as of now showing. Added unknown medication but patient was doing well. Patient feels the vaccination caused it. He did not have high blood pressure and was not diabetic. It was unknown if he was enrolled in a Covid-19 Vaccine Trial. The action taken for adalimumab was unknown.  The reporter considered "stroke" related to bnt162b2. The reporter's causality for the event(s) of STROKE was not provided. opinion is that the event of STROKE is not assessable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Started out as a sore arm about 4 hours after getting the shot. Then progressed to severe body aches and a headache about 8 hours after getting the shot. Then after about 10 hours  post-vaccine it progressed into chills and a 100.0 degree fever. I took 2 Tylenol Extra Strength pills at 12 hours post-vaccine and the symptoms decreased significantly within an hour.  Still experiencing mild symptoms of all of the above.
Welt/bug bites that started on 3/30 on my legs. They burn & hot to touch. Then start to itch.
Hours later he had a 4 hour period in which he experienced intense dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6200) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back problems" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ivermectin for skin broke out, reaction(s): "Allergies", notes: He is allergic to Ivermectin,.The following information was reported: DIZZINESS (non-serious) with onset 09Mar2021, outcome "recovered" (Mar2021), described as "Hours later he had a 4 hour period in which he experienced intense dizziness".  Additional information: Caller states that he is calling about Pfizer Covid Vaccine. He has had side effects from both shots, but the side effects were more severe after the second shot, he is a 72 year old male. He is wondering what to do about the booster shot, he is still having the problems, he is afraid the booster will make it worse. Caller agrees to do the safety report stating that he is all for getting information out there, as thinks this would also be helpful to anyone else if they were to experience this. After the first dose, 6 hours later he had a 4 hour period in which he experienced intense dizziness but then it went away and he had no more issues. Allergies: He is allergic to Ivermectin, his wife thought the kids had bed bug and so when it came in contact with him his skin broke out and that was years ago.The caller did confirm he is 72-year-old currently and was 71 when the event occurred.   No follow-up attempts are possible. No further information is expected.
Fatigue - couldn't make it to bedroom to lay down x1 day, shaky/jittery, headache, cold, swelling and itching at injection site x2 days, red circular 3" diameter ring  circling injection site  remained on 3rd day.  Pt feels the adverse effects other than injection site reaction are decreasing daily and by tomorrow hoping to feel better.  Reaction is suggesting allergy; patient may switch to Pfizer if she ever gets another COV booster.
24hr after vaccine administration to right arm, developed rash that is urticarial, swollen right arm and subsequently developed leg and lip swelling. No other symptoms, no fever, yellow urine.   Examination today: swollen arm right side-especially right hand, bilateral legs, lip with urticarial rash on back on left upper chest. Some shotty lymph nodes post auricular and cervical. BP normal, pulse ox normal. Urine analysis sent. Treatment: Benadryl and Prednisone; with follow up in 3-4 days.
To ZOSTAVAX. Large area (2 inches x 3 inches) raised, red, warm/hot and swollen where vaccine administered (48 hours later) will ice tonight and call us tomorrow.
Symptoms didn?t start until about 6 hours after receiving vaccine. So day 1, It started with pain at injection site as well as neck pain, then fatigue, then EXTREME joint pain and chills, followed by high fever and headache. I could not sleep at all the first night of injection because the joint pain through my body was the most excruciating thing I?ve ever had to endure. The body aches were so bad that they even felt sore to the touch almost as if I was bruised from head to toe. I had to take an excedrin for the headache because it was almost as bad as a migraine and Advil later in the night to help calm down the fever and help me sleep. The following day, Day 2, was a little better I still had body aches but the joint pain wasn?t as bad and I was still very fatigued. Headache and slight fever continued throughout the day as well which I took Advil for. Also  noticed my ears felt plugged and slight pain which could be related to an ear infection I was treated for a week prior to the vaccine injection. Nausea and vomiting and shakiness occurred all day on day 3, and that morning I woke up with a headache but those were the only side effects felt on that day. My arm and joint pain, body aches and fever were all gone by day 3.
Vaccine administered sub-q and a few minutes later patient reported difficulty breathing. 911 was called and 1 dose of I.M. Diphenhydramine 50 mg administered. Pt was breathing and talking entire time until E.M.S. arrived. Rash was present on arm DF injection.
1st shot, seems lik I had all the symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (1st shot, seems lik I had all the symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (1st shot, seems lik I had all the symptoms). At the time of the report, VACCINATION COMPLICATION (1st shot, seems lik I had all the symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
muscle aches; chills; fever; vomiting; diarrhea; fatigue; nausea; body aches all over; soreness in arm where shot was administered; soreness in arm where shot was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 12:00 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: EFFEXOR. The following information was reported: MYALGIA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "muscle aches"; CHILLS (non-serious) with onset 14Jul2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "fever"; VOMITING (non-serious) with onset 14Jul2021, outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious) with onset 14Jul2021, outcome "not recovered", described as "fatigue"; NAUSEA (non-serious) with onset 14Jul2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 14Jul2021, outcome "not recovered", described as "body aches all over"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Jul2021, outcome "not recovered" and all described as "soreness in arm where shot was administered". Therapeutic measures were not taken as a result of myalgia, chills, pyrexia, vomiting, diarrhoea, fatigue, nausea, pain, pain in extremity, vaccination site pain.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Effexor XR. No covid prior vaccination. Patient was not covid tested post vaccination. No known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
During the vaccine injection the syringe malfunctioned and approx half of the vaccine was leaked. * full dose was not given.  No additional dose was given, the doctor was called and we decided it was best to leave as is.