chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; Rash kind of hives in upper chest and neck area; Rash kind of hives in upper chest and neck area; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1284) , via an unspecified route of administration on 06Jan2021 at single dose on left arm for COVID-19 immunisation.  Medical history included blood pressure abnormal, cholesterol abnormal.  Concomitant medication included atorvastatin for cholesterol abnormal, warfarin sodium (COUMADIN).  The patient stated that, " I got very bad rash it kind of looks like hives in my upper chest and in my neck area but that was like maybe 11 days later (17Jan2021) and I went to urgent care and they gave me prescription for prednisone, which is cleared it up but then I saw my primary doctor on Monday the 18th and my primary doctor recommends that I should not get the second vaccine, which I have an appointment for on Thursday and I am very confused, I don't know this is the reaction from the Covid vaccine. I just I am very confused and I would like feedback if I could get some, did anybody recorded any kind of allergic reaction like 11 days later, I got the first one I am due for the second one. I went to urgent care and they prescribed me Prednisone and Zyrtec for 5 days." Therapeutic measures were taken as a result of the events. The outcome of the events was resolved on an unspecified date.
No additional AE reported; Pt supposed to get MMRII and Varivax and she was administered Proquad instead of MMR II; Duplicate therapy with same active substance; This spontaneous report as received from a physician refers to a 12 month old female patient. Patient's medical history, concomitant medications, drug allergies or reactions were not reported.   On 28-DEC-2020,the patient was supposes to received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and  varicella virus vaccine live (oka/merck)(VARIVAX) in her wellness visit; however she  was administered  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency, administration route, lot number and expiration date were not reported) for prophylaxis instead of rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered and duplicate therapy error). No adverse events were reported.
I developed a fever of 102.9 and sever shaking resembling convulsions as well as nausea.  One week later I developed a lump in my upper right outer thigh.
ANXIETY; GENERALIZED PAIN; FINGER PAIN; FOOT ACHE; ARTHRITIC PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included eye surgery, lazy eye, and ovarian cyst removal, and concurrent conditions included penicillin allergy, and sulfur allergy, and other pre-existing medical conditions included the patient was on breath bio.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced arthritic pain. On 30-JUN-2021, the subject experienced foot ache. On 01-JUL-2021, the subject experienced finger pain. On an unspecified date, the subject experienced anxiety, and generalized pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety, arthritic pain, finger pain, foot ache and generalized pain was not reported. This report was non-serious.
I started experiencing lower back pain with no event prior to it. I had not gone out and done anything. With pain running down my leg. And that continued for 4 weeks before I went to see my doctor and she did put me on prescription medication, and it still hurts today.
rashes on the face and even in few places on body as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: ER8736), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0161), for COVID-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "rashes on the face and even in few places on body as well". The events "rashes on the face and even in few places on body as well" required physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Consumer stated, he just wanted to check in case after taking the Pfizer vaccination for COVID, Are there any non-side effect with respected to any skin allergy on face. Consumer didn't have Expiration Date. The patient had three dosages of Vaccination. The patient had no other medical condition and concomitant medication. No lab test was done. The consumer had consulted dermatologist, who actually prescribed hydrocortisone to apply wherever the rashes on the face and even in few places on body as well. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Anatomical site of vaccination consumer stated on arm left and right arm. Reporter stated, after taking the vaccination only he was facing the problem of rashes and everything and rashes are not going away from last two years after he got vaccinated for the second dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200893991 same product and event, different dose;
12 hours after shot - broke out in sweating, hot, so dizzy couldn't stand up - blood pressure dropped 85/54 - 12 hours later broke out in hives. Through heart off - blood pressure made big swings from very high to very low for several days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EJ1685), on 30Jan2021 as dose 2, single (Lot number: EL1283), on 01Oct2021 as dose 3 (booster), single (Lot number: FF8841) and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Patient received Paxlovid as Covid-19 treatment from 21Nov2022 to 26Nov2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: After 4 days of negative tests; (01Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Severe fatigue and muscle aches. Sudden onset of heavy period. Feel like I have the flu. Sweating, achy, fatigued. Progressively worse for 5 days.
PATIENT RECIEVED MODERNA SPIKEVAX,  FELT FATIGUE AND HAD COLD SWEATS
Localized rash on right thigh approx 6: x 5". Rash is papular and warm with irregular border.
Pt was given PENTACEL (DTaP, IPV, HIB) and by mistake also given IPV. Parents where given explanation of what happened and given ER warnings pt's mother stated understanding.
Swollen arm; This is a report obtained from a pharmacist through a Pfizer sales representative.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced swollen arm. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about batch number cannot be obtained.
Information has been received from a 22 year old female Healthcare worker who on unspecified day was vaccinated with a first 0.5 ml dose of GARDISIL (Lot # was not provided). The patient reported that after she received the vaccine, in the same evening she experienced nausea and vomiting. The patient sought unspecified medical attention. At the time of the report, the patient recovered on an unspecified date. No further information is available.
Weird chills; These symptoms include fainting / passed out on the floor, eyes rolled back; Chills were like shakes in my hand; Elevated heart rate (117); Weakness; Sweating profusely; Dizzines; Nausea; A spontaneous report was received from a 73-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed events, fainting / passed out/syncope, eyes rolled back/syncope, chills were weird/chills, chills were like shakes in my hand/tremor, heart rate was up/heart rate increased, nausea, weakness/asthenia, dizziness and sweating profusely/hyperhidrosis.  The patient's medical history included positive COVID-19 test on 11 Dec 2020. No relevant concomitant medications were reported.     On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Jan 2021, around 2'O clock in the morning, the patient experienced the symptoms including fainting, eyes rolling back, weird chills like shakes in her hand, sweating profusely, elevated heart rate (117), and other symptoms that occurred when she had COVID such as nausea, weakness, dizziness.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events fainting / passed out/syncope, eyes rolled back/syncope, chills were weird/chills, chills were like shakes in my hand/tremor, heart rate was up/heart rate increased, nausea, weakness/asthenia, dizziness and sweating profusely/hyperhidrosis was considered as resolved on 25 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
after shot, arm sore, felt ill for next 2 days. developed red swollen area on day 5,improved to small area on day 7. arm continued very achy with itchy spots along the arm. on 02/28/2021 developed large raised rash at site of injection,
Raised red, itchy welts. Similar to bug bites but no signs of punctures a few weeks after vaccination. Welts shrink until gone. Leaves dark mark. Prescribed prednisone 03/01/2013. Prednisone calmed down breakouts until prescription was finished.
Child began to feel nausea, began to projectile vomit. Complained of her feet tingling. Went to sleep, woke up on 1/1/16 very sluggish and fatigued. Fell asleep around 2:00, went to wake her up and she said her whole body was tingling. She attempted to get up and walk and could barely move her legs. Could only shuffle her feet. Tingles were also in her face. Went to local ER where she threw up again and still could not walk. Treated with IV fluids. Was in ER from 6:00 pm till midnight. Now experiencing stomach pain, excessive belching, nausea and being put on acid reflux medications. This was her 2nd shot. In hind sight I now know she reacted to the first one with flu like and bronchitis like symptoms and missed a week of school in August 2015, after the first shot was given.
17th - injection around 2pm at pharmacy and sore arm post shot 18th - sore arm, felt badly,   19th -  felt bad,  rash appeared on both arms - full length of forearms 20th - both  arms  rash worsened with rt. arm worse 21st - rash worsening and red appearing 22 nd - rash/blistering worsening and lots of red (took photos)
2:33 pt coughing and states SOB.  Taken to Triage 2.  Pt used albuterol inhaler.  Repeated dose as pt did not hold in and exhaled immediately.  2:43 pt states slightly dizzy.  Dr. at beside with EMTs.   BP 115/63 HR 97, 96% RA 2:51 BP 132/72 HR 85, 98% RA Pt states she is feeling better and ready to leave.  Meeting friend.  Stable for DC.  Pt provided instructions when to return to ER or call 911.  pt verbalized understanding and agreed.  Pt also told if this becomes annual immunization she needs to notify her MD of previous experiences.  Pt agreed.
I woke up on 08/13/2021 with a migraine, nausea and swollen sinuses. My eyeballs and skull hurt. I also had a constricted cough. I blew it off and thought maybe it was the air condition or the fires. I did a nasal wash and took some cough medicine but they didn't do anything. On the following Tuesday I fell asleep in my recliner and woke up at about 8:30PM burning up with a flush face. I had my thermometer right there and ran a 100.5. I took a picture of the thermometer and sent it to my brother. I went back to sleep and then woke up the next morning and took my temperature. My temperature was elevated at 98.8. Before I went to work I called my boss and ask what the procedure was for coming to work after a fever. I took that Tuesday off and then worked the rest of the week. I still felt like crap. I'm coughing more, I'm fatigued and have a headache. By Friday of the next week I was trying to get ahold of someone on what to do. I was waiting for that Monday 08/23/2021. Everybody was going to be back to work so I didn't want to go and contaminate everyone. The healthcare physician said I didn't need a referral and set me up with a zoom call regarding my symptoms. The doctor counted my dates from 08/13 and said based on my symptoms he asked me to get a nasal swab test. He said it was day 13 and was going to move my quarantine out to 21 days unless I feel better. I couldn't stand up long enough to make food. My neighbors and brother dropped off food for me. Just walking had me winded. I didn't go out and get my mail for an entire week because going to my front porch would have me winded. I would have to go outside to pick up the food off the porch for me then go sit down because I was so winded. The week before I went back to work was the worst. On 08/25/2021 was the worst. The only time my stomach felt better was after I ate food and that was for about an hour. Then after it would feel like someone was squeezing my stomach. Every few hours I would have a coughing fit. The first few days after work I had to stop stop up this ladder and get my breath to continue going. 09/15/2021 and 09/16/2021 I feel back to myself and a lot better.
Fever to 103 degrees, pain, erythema, induration in left proximal arm.
Extreme pain in left leg all night on 4/8, turned to more gradual coming and going pain since then Headache every night since 4/8, located in back of head between the ears area Dizziness/feeling like I may faint on 4/8, comes and goes since then Shortness of breathe, unsure of exact start date but has been around a week
Red rash at the injection site; A spontaneous report  was received from a Consumer concerning of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red rash at the injection site.  The patient's medical history and current condition were not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Red rash at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event red rash at the injection site was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Case previously recorded as MA2009-3909. Initial case report received via Med Com from a health care professional on 09 NOV 2009: A 3-year-old male patient, was vaccinated with S-OIV FLUVIRIN (batch no. 102040P1) on an unspecified date. No adverse event was reported. MedCom ref. no.: NA09-007878.
About 3" red circular rash over injection site with 2mm raised papules. In addition, increased pain and warm. SP 3 days of DTaP injection. This was on right thigh.
pt recv vax 5JUN97 PM & about 2hr later began to have fever that went to 104 & cried & screamed until 3AM the next AM;screamed & had a fever the next day;crying & fever stopped by 7PM 6JUN97;vomit several times p/eating during this period;
potential product confusion; Information has been received from the patient reporting on herself. The patient's age, pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  In November 2015, the patient received a dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), lot # K010574, expiration date 08-APR-2017, for prophylaxis (dosage and route information were not provided). The consumer reported a potential product information (no further information provided). It was also stated that the she was informed that she received the correct vaccine.
Bruise in the area of the vaccine and below the bruise a red circle that felt hot. When she went to the clinic they recommended an antibiotic for 7 days. They said it was cellulitis. After 5 days with the antibiotic the red circle disappeared.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received BNT162B2, administration date Nov2021 (Batch/Lot number: unknown, Expiry date: Unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Foods" (unspecified if ongoing), notes: known allergies: Foods. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101579093 same reporter/drug/event, different patient
Pain after vaccine administration; could not move arm after shot and hurt; Pain lasted 3-4 days; still hurts when changing shirt, lateral arm movement; has DR's apt on 12/17/18.
Patient injected undilute pediatric pfizer, filled out scrt, mom and md informed, child monitor. currently mom said kids are doing fine and will monitor kids for any issue. md had suggested to monitor breathing and if any issue to seek medical attention.
vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B22A NDC:80777-273-10) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    In September 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022).    No concomitant medication information was provided.  Caller said that there were informed 14 days later that it expired. Caller said that vaccine expired after the 30 days it was unfrozen on 11-Sep-2022. Vial size was 5.5 mL.  Vial did not undergo any temperature excursion.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660170; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660170:same reporter
Pressure behind the eyes, achy joints, swollen injection site, mild fever, chills, flue-like symptoms.
Per child's father, she vomited and began experiencing dizziness. She also experienced blurred vision and extreme weakness (had to be helped/supported while walking). Dad also reports "neurological symptoms" that lasted for about an hour. Symptoms started within 10 minutes of receiving vaccine.
Had shots around 10 AM at HD, went home and fell asleep and 1 hr. later woke up crying like in pain and has continued crying on and off. It is now 3:30 PM. Pt. was given Acetaminophen. Was seen by physician here at clinic.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.