chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: Pine nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Sep2023) negative; (28Sep2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment started on 23Sep2023 and ended on 27Sep2023.  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 current information available the causal association between the events DRUG INEFFECTIVE, COVID-19 and suspect drug BNT162B2 cannot be excluded completely.
Both of my eyes were swollen when I woke up the morning of 10/09/2014 about half shut. They have been lke this for about 48 hours now despite multiple doses of Benadryl.
did not show up for their scheduled third dose of IMOVAX with no reported adverse event; Initial information received on 01-Feb-2022  regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown demographics who  did not show up for their scheduled third dose of imovax with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Dec-2021, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On 30-DEC-2021 the patient developed a non-serious did not show up for their scheduled third dose of imovax with no reported adverse event (product dose omission issue) 15 days following the administration of RABIES (HDC) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (did not show up for their scheduled third dose of IMOVAX with no reported adverse event).  At time of reporting, the outcome was Unknown for the event did not show up for their scheduled third dose of imovax with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Aside from pain in her arm (which she expected), she felt like someone literally beat her body.; chills; sweats; ached; she felt terrible/ she felt like someone literally beat her body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) 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 24Nov2021, outcome "recovered" (2021), described as "Aside from pain in her arm (which she expected), she felt like someone literally beat her body."; CHILLS (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "sweats"; PAIN (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "ached"; FEELING ABNORMAL (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "she felt terrible/ she felt like someone literally beat her body.". It was unknown if therapeutic measures were taken as a result of pain in extremity, chills, hyperhidrosis, pain, feeling abnormal. Additional information: The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. Prior to vaccine the patient was not diagnosed to Covid-19 vaccine. Since vaccination the patient has not been tested for Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore muscles in left arm and shoulder starting day after injection, continuing as of date of report. Difficulty raising arm. No injection site topical reaction. Treated with ibuprofen.
Caller reports that the patient missed her third dose of the GARDASIL 9 series; the patient is 56 years old, and was 56 years old when she received her first dose; No additional AE reported; This spontaneous report was received from a medical assistant referring to a 56-year-old female patient. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The patient was 56 years old when she received her first dose (Product administered to patient of inappropriate age).  The patient missed her third dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (Inappropriate schedule of product administration). No additional AE reported (No adverse event).
severe weakness, nausea, extreme diarrhea, fever, muscle aches all over, headache, shakes, Chronic cough much worse than ever and still is.
No adverse event; A dose was inadvertantly administered to a patient after its expiration date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient 's patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 28-FEB-2022, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rha) (M-M-R II) 0.5 ml/ once (lot # t006166 was valid and expiration date was 19-FEB-2022, anatomical location and vaccination scheme were not reported) for prophylaxis. The caller confirmed the MMR II dis not experience any temperature excursions prior administration. No additional AE nor PQC reported.
9/9/2021 had 2nd vaccination 2 days later - 9/11/2021 - developed a sore in L mouth and R arm (entire arm) swelling and cellulitis. he was treated w/ clindamycin and this did not improve symptoms. 3 days later went to hospital and was given RX for bactrim and levaquin x 7 days. after antibiotics, symptoms resolved. 10/21/2021 he noticed L jaw swelling and warmth again. diagnosed with salivary gland infection ,  jaw cellulitis and thrush. given RX for clindamycin and diflucan
RECEIVED PEDS PFIZER DOSE W/O DILUTION PER MOM JUST ARM DISCOMFORT
Pt recvd Hep B vax on 16APR92 & 2 wks p/vax showed an elevated SGOT;
developed chest pain and nausea, diagnosis of acute myocarditis, being treated with Naprosyn 250mg BID
Pt fainted right after sitting down after the vaccine was administered. I called his name and he responded and slowly sat up. He said he was feeling better, so I helped him into the chair. I sat with him for about 15 minutes and he was alert and seemed completely fine. I asked if he had ever had a problem after a vaccine, and he said that he fainted once after a vaccine more than 20 years ago. (He claimed on question 4 of the questionnaire that he had never fainted after a vaccine.) I had him call for a ride home and for someone to pick up his car. He waited another 45 minutes and left. I checked on him frequently throughout the hour he was here and he reported he was fine each time.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 5/22/2021 and 6/19/2021. Patient presented to ED on 10/18/2021 with complaints of general malaise, diarrhea, and fever. Hospitalized for sepsis, Covid-19 + upon admission. Received: dexamethasone, remdesivir, baricitinib, broad spectrum antibiotics, paralytics, methylprednisolone, prednisone, and vasopressors. Required mechanical ventilation on 10/24/2021 with continued respiratory decompensation. Patient developed bacterial infection with pseudomonas aerugenosa. Patient's renal function also continued to decline requiring CRRT. On 11/10/2021, CRRT clotted off and patient unstable. Patient receiving norepinephrine and vasopressin with maxed ventilator settings and episodes of V tach. Patient was changed to DNR per husband's wishes and patient expired on 11/11/2021 at 0003.
swelling and redness around site right deltoid. Possible reaction to DTaP or IPV
face itches; flared up (hot, red) and spread; localized redness, hot, hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (localized redness, hot, hard to touch), INJECTION SITE WARMTH (flared up (hot, red) and spread) and PRURITUS (face itches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (localized redness, hot, hard to touch). On 04-Jan-2021, the patient experienced INJECTION SITE WARMTH (flared up (hot, red) and spread). On an unknown date, the patient experienced PRURITUS (face itches). At the time of the report, INJECTION SITE ERYTHEMA (localized redness, hot, hard to touch) and INJECTION SITE WARMTH (flared up (hot, red) and spread) had not resolved and PRURITUS (face itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information include zyrtec
after waiting for 15 minutes patient stood up and said she stood up too fast then walked down the aisle and was coming back and fell face first on floor husband came to pharmacy for help and I instructed him to roll her over on her back she was shaking and very cold so we covered her with blankets. she said she wanted to go home but we called 911
The night of receiving the vaccine, I developed chills and myalgia that progressively got worse into the morning.  Then I developed a fever of 38.6
Patient presented to the pharmacy on 11/18/23 to report a significant allergic reaction to the vaccines received on 11/3/23. Patient reports she woke up on 11/5/23 with a severe rash and itching. Based upon the photos she showed me, the rash covered her entire body. She reports that a dermatologist prescribed prednisone (60mg), hydroxyzine, and triamcinolone ointment. She reports she is doing better but has not fully recovered as of yet.
I had the vaccine. Still had the shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had shingles shots and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Patient started with left upper arm erythema, pain, swelling 8pm 2/18/19. Symptoms migrated to forearm. I saw the patient today (2/21/19) and other than mild erythema, swelling on the forearm  proximal to the elbow, and mild pain her symptoms are much improved. No problems, pain or erythema at injection site. Patient had been applying ice, keeping it elevated and Ibuprofen 400 mg. No signs of systemic allergy or anaphylaxis.
EPILEPTIC SEIZRE. BIT TONGUE. HOSPITALIZED ON 8/19/21 AFTER EMS TRANSFERRED FROM HOME TO HOSPITAL. TREATED SWOLLEN TONGUE AND PERFORMED DIAGNOSTIC TESTING. SEIZURES RE-OCCURED AGAIN ON 12/24/21, 01/09/22 AND 5/22/2022. NO HOSPITALIZATION FOR THOSE 3 TIMES. BIT TONGUE AGAIN ON ALL OCCASIONS. TONGUE IS NOW ENLARGED &  WAS DIAGNOSED WITH EPILEPSY AND PUT ON LAMOTRIGINE MEDICATION TO CONTROL SEIZURES.
Case number PHEH2014US001212 is an initial spontaneous report received from a medical assistant on 13 JAN 2014. This report refers to a 12-year-old female patient. Her medical history and concomitant medications was not reported She received only Men A lyophilized conjugale component of MENVEO (batch number: A12094) reconstituted with a sterile diluent instead of MenCYW-135 liquid  component intramuscularly on 09 DEC 2013. No adverse reaction reported following this administration error.
This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates, those patients received doses of improperly stored vaccines: RECOMBIVAX HB (lot# M032649, expiration date: 11-NOV-2018; dose and route of administration were not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006077: US-009507513-1702USA006079: US-009507513-1702USA005322.
It started with some pain in my leg so I assumed I was just tired. The next morning, everything got worse; I had 101F fever, pain in my eyes, nausea, body aches and chills, and loss of appetite. I took an at-home COVID-19 three days which came back positive. Once I noticed it was positive, I scheduled a PCR test at pharmacy on 01/12/2023 to confirm that I had COVID-19. Once the results came back positive as well, I scheduled a telehealth appointment online. The physician first assumed I had the flu, so prescribed me Tamiflu. I began improving the next few days, but not so much. I continued resting and hydrating and recovered pretty soon after.
PATIENT WAS VACCINATED ON 01/21/2022. PATIENT WITH A SECOND DOSE ADMINISTERED ON 09/20/2021 AND THE REINFORCEMENT WAS ADMINISTERED BEFORE 5 MONTHS. A FAMILY MEMBER WAS CALLED TO VERIFY THE MINOR'S HEALTH STATUS.
101 fever, chills, muscle and body ache, nausea, fatigue, muscle weakness and pain, headache, pain at injection site. Started with extreme nausea about 15 hours in. Other symptoms followed shortly after. Back to good health 24 hours later.
Fever of 102.8; Chills; fatigue; head and body aches; body aches; This is a spontaneous report from a contactable consumer (patient). A 29- year-old male patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3248) via unknown route of administration on left arm, at 05:45 on 01Feb2021, at single dose for COVID-19 immunization. The patient medical history included Coeliac disease and gluten allergy. The concomitant medication included finesteride, iron, biotin, niacin and zinc. The patient experienced fever 102.8 centigrade, chills, fatigue, head and body aches at 18.30 on 01Feb2021. The patient didn't receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination and after vaccination. The patient received COVID-19 vaccine at workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021.
Employee states she received her second vaccination on Friday, January 22nd at 11:30 am to left deltoid. Noticed redness that day. Has become more red and swollen each day. States 1/4 of arm is swollen. Very red and hot to touch. Does not fell like she has a fever but has not checked. Note: Vaccine documentation record indicates that vaccine given on 1/18/2021, not 1/22/2021
Headache, nausea, diarrhea, sore arm, very tired and loss of bladder control.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, nausea. Worst I've ever felt in my adult life, like my whole body was rebelling against me.  Long-term (for roughly 10 days after both shots): Serious shortness of breath, irregular and very high heartbeat, extreme fatigue. Couldn't do any physical activity without immediately becoming out of breath (normally very healthy and active). Heart would race unpredictably, reaching 120 bpm (normal resting for me is 60-70). General malaise. Felt more like 80 years old than 40. Was unable to do normal physical activity and work for weeks.  Feeling better overall, but still sometimes feel like I get tired unusually easily and heart behaves strangely now and then.
Patient received the first of a 2 series Covid-19 Moderna shot at 3:55PM Tuesday 6/15/21. After a few minutes in the waiting  area she confronted Pharmacy Technician about feeling  faint. She then fainted at 4:00PM and Pharmacy Technician caught her and lowered her to the floor. I assessed the situation (not an anaphylactic reaction) and dialed 911. Pharmacy Technician called her daughter and placed a cold compress on the back of Patient's neck while comforting her. EMSA arrived and took her to the hospital around 4:30PM.
GOT A PHONE CALL FROM THE PATIENT ON 10-11-20, STATING THAT AFTER 2-3 DAYS, SHE GOT AN ALLERGIC REACTION FROM THE VACCINE. PATCHES OF FLAT RED SPOTS ALL OVER HER BODY AND TONGUE SWELLED UP. SHE SAID NOT CAUSED BY ANYTHING SHE ATE OR SOMETHING SHE APPLIED ON HER SKIN. SHE SAID SHE TOOK BENADRYL FOR IT AND STILL TAKING IT. SHE SAID IT'S IMPROVING BUT CONTINUE TAKING IT ANYWAY TO RESOLVE THE RED SPOTS ON HER SKIN.
h/a, dry throat, body aches, hot flushed & sore stiff neck, shoulder pain, lethargy;
After receiving COVID vaccine, patient developed hard knot at injection site. Left arm, deltoid muscle.  Vital Signs: BP 190/110 HR 83 O2Sat 97  Skin Signs: Warm and dry  Initial Treatment: Assess vitals. Large hard knot instantly appeared at injection site upon vaccination. Site outlined for size.  3:35 PM Vital Signs: BP 118/102 HR 73 O2Sat 96  Skin Signs: Other - 2-3 cm swollen  Circulation: Cap Refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Ice pack applied  3:50 PM  Vital Signs: BP 130/94 HR 80 Resp 18 O2Sat 96%  Skin Signs: Other - Swelling unchanged Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Ice pack intermittently Notes:  Patient home to monitor. Swelling unchanged to slightly improved. Patient will monitor at home and see if worsens. Denies any other symptoms.
10 days after its dose (Sunday 1/31/21: increasing discomfort at injection site followed by 6" long x 3" wide area of swelling & redness & feeling hot. It gradually resolved over the next 4 days. Treated with heat and Benadryl.
a patient came in for a booster dose and was administered an expired dose by mistake, with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a patient of unknown age and gender who came in for a booster dose and was administered an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] by mistake, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (expiry date: 29-May-2022; lot number; strength; frequency not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, a patient came in for a booster dose and was administered an expired dose by mistake, with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine.  It was unknown if there were lab data/results available.  Action taken: Not applicable  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Twitches/seizures which lasted about 1-2 minutes multiple times throughout the day for about 3 to 4 weeks after receiving Hep B shot
Fever blisters are severe again; This case was reported by a other health professional via call center representative and described the occurrence of fever blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fever blister (had history of fever blisters).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever blisters are severe again. No other information was provided. The reporter stated that the fever blisters not occurring regularly, but at the time of reporting, once one was gone, another pop right up.
caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021.  Stated he felt like she was lifting weight blocks.  She went to Medical Center ER and was discharged and fell and in the parking lot.  Pt came back to same ER 2 days later and was admitted w/ Guillain-Barre dx.  Pt was then treated with IV Immunoglobulins.  Labs; Sodium 132. BUN7 , Albumin 2.7, Glucose 112, WBC 3.5 HGB 10.4