chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a febrile seizure at home on September 13, 2020. She went to the Medical Center and was evaluated. No work up ensued and she went home.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, lot # reported as J005850, exp date is 17-AUG-2013, 0.65 ml/once). Concomitant therapies included lorazepam and methocarbamol. It was reported that the patient developed red, oblong, hard and warm area at the injection site (unspecified date in October 2013) after receiving the dose of ZOSTAVAX. Patient had sought medical attention via calling the pharmacist. No lab diagnostics studies were performed and no treatment was given for the events. The outcome of red, oblong, hard, and warm area at the injection site was reported as not recovered/not resolved. Additional information has been requested.
The dosage of the IMZ administered on 10/08/2022 and later on there was communication sent out that the expiration was shortened by a month from original expiry date. Patient had no symptoms and signs.
Pt developed a local as well as an itchy rash on her arms, legs, torso.
exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 80-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (-1 C for total amount of time of 25 min), which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
Patient received an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st October 2021) for prophylaxis.   On 22nd December 2021, the patient received Menveo. On 22nd December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Initial information was reported by a health care professional to Merck (Case ID 1-9368050839) and received by Sanofi on 08-Nov-2013: this was a invalid case as number of patients were unspecified. Unspecified number of patient, whose age, gender, medical history and concomitant medications were not reported, received FLUZONE (lot number, expiration date unknown, route and site of administration) on an unspecified date. On an unspecified date, patients received FLUZONE that was stored at 34 degrees F for 39 hours. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
FEELS LIKE SHE HAS MONO AGAIN; LEFT SIDE AND SPLEEN SWELLING; LEFT SIDE PAIN; FEELING CRAPPY; FLU SYMPTOMS/HEADACHE/CHILLS/LOW GRADE FEVER/ACHY; ARM PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced flu symptoms/headache/chills/low grade fever/achy. On 27-AUG-2021, the patient experienced arm pain. On 28-AUG-2021, the patient experienced left side and spleen swelling. On 28-AUG-2021, the patient experienced left side pain. On 28-AUG-2021, the patient experienced feeling crappy. On 30-AUG-2021, the patient experienced feels like she has mono again. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu symptoms/headache/chills/low grade fever/achy, and had not recovered from arm pain, feeling crappy, left side pain, left side and spleen swelling, and feels like she has mono again. This report was non-serious. This case, from the same reporter is linked to 20210860099.
Pt developed petechiae on buccal mucosa, trunk and extremities. Referred to ER for evaluation.
pt recvd vax;exp unconsolable crying 1 hr p/ vax; pt cry was high pitched x 4 hrs;seen in ofc same pm; not eating; afebrile' no tx initiated;no signs of infect present;
Hives at injection site, I never reported it to the nurse. It went away a day or two later. Then on June 9th 2019 I broke out in full body hives. I went to the doctor the next day, I mentioned to them that I previously broke out in hives the day of injection but they the two reactions weren't related. They gave me a small bottle of cream to put all over my body. They said it was probably a reaction to the milk I had that day, because we do not usually eat dairy. However, I found this to be untrue because since that reaction I have had dairy and have not had any reaction. My second reaction lasted 3 or 4 days long.
asthma; pre-diabetes; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported.patient previously received first dose bnt162b2 (BNT162B2, Solution for injection,Batch/Lot Number: not reported)via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation.On an unspecified date the patient experienced asthma, pre-diabetes. The outcome of the events asthma, glucose tolerance impaired was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SLIGHT FEVER; JUST TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced slight fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever and tired was not reported. This report was non-serious.
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
Upon awakening on the day after receiving vaccine she noted a red non-itchy rash on her neck.
The weekend of  03/26 experienced  high  fever of 102.6, extreme fatigue, chills and aches. Went for a covid test and was negative. The weekend of  04/02 the left arm which iOS where I got the vaccine was extremely red, painful and warm. The pain went into the armpit and breast area. I went to my doctor on 04/05 and was diagnosed with cellulitis.
sore throat on lt side, sneezing, coughing & fever; feel lousy;
I went from couch watching a movie to my husband helping me walk to the bedroom.  My body was locked i could barely move. I went  into a cold hypothermia chill, I could get warm. ( teeth chattering) My husband said I burning up hot on my body . I didn't think to take my temperature.  I was so scared. I've never had the flu ,or anything like this before  in my entire life. I called into work the next day , because  my job is physical.
He asked if he could get 2nd shot here even though he got 1st dose at the hospital. I told him yes, processed and administered the shot. I forgot to ask which kind he received for 1st dose and only noticed it once I went to complete his CDC card. He was not concerned. we consulted the CDC website and it said not administer any other doses.
PATIENT COMPLAINED DIFFICULTY OF SLEEPING, SWOLLEN AT THE SITE OF INJECTION, WARM AT THE AREA OF INJECTION, BUT NO FEVER. WE GIVE PATIENT ONE BOTTLE OF BENADRYL 25MG AND SUGGEST THE PATIENT TO TAKE 25MG EVERY 6 HOURS IF NEEDED. AND IF THE SYMPTOMS GET WORSE RECOMMENDED PATIENT TO SEEK A DOCTOR.
SkinRash PRUITIC RASH , ALSO HAD WITH 1ST DOSE MODERNA COVID 19 VACCINE , NO THROAT TIGHTNESS, SOB,NO ANAPHYLAXIS Narrative:
Bleeding/bled for almost a month straight/after that it was off and on; It almost ruined her marriage and broke a lot of her friendships; Turned her into the beast; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) and FEELING ABNORMAL (Turned her into the beast) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FA7484) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on) (seriousness criterion hospitalization), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) (seriousness criterion hospitalization) and FEELING ABNORMAL (Turned her into the beast) (seriousness criterion hospitalization). At the time of the report, HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) and FEELING ABNORMAL (Turned her into the beast) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The concomitant medications were not reported. The treatment information was not provided.  The patient reported that after the vaccine and the social circumstances she had been through she was admitted in the psychiatric hospital . She was drugged and was raped at the hospital . The patient also reported that she will not get second dose of moderna vaccine.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
allergic-like reaction; Hives itchy feeling; A little hard time breathing; Hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) 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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives). At the time of the report, HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) 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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives). At the time of the report, HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment details were reported.
fever blisters on the lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blisters on the lips) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included DOLUTEGRAVIR SODIUM, RILPIVIRINE HYDROCHLORIDE (JULUCA) and NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced ORAL HERPES (fever blisters on the lips). The patient was treated with DOCOSANOL (ABREVA) for Fever blister, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (fever blisters on the lips) was resolving.            concomitant medications include high blood pressure medication. No known food allergies reported, After the third dose, the caller stated 8-9 days later he had an adverse event similar to the reaction after the second dose.   This case was linked to MOD-2021-022476 (Patient Link).
Case previously recorded as MA2009-5502. Report received from a health care professional on 19 Nov 2009: Child under 4 years of age was vaccinated with FLUVIRIN on an unspecified date. No adverse event was reported. The outcome of the event was not rep[orted. Med-com reference number: NA09-008542.
The patient informed the vaccinator that he passes out during any immunization, TB test and blood draw.  The patient passed out approximately 5 minutes after the vaccine.  We laid him on the floor and elevated feet for 7 minutes then patient wanted to sit in a normal chair.
10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature) 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 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature). At the time of the report, PRODUCT STORAGE ERROR (10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment was provided by the reporter.
Immediate symptoms were extreme hunger (eating everything in sight despite being on Weight Watchers and having been perfect for a year and losing 28 lbs) and then the normal reactions (slight fever, mild body aches, etc) for a day or two. Got all better from that.   Then on day 4 after the 2nd shot, out of the blue, I got very moody and irritable for no reason. And I have been experiencing what feels like a biologically-based (rather than reaction-to-life-events-based) feeling of depression ever since. Along with that I have experienced: mild nausea wierd food cravings (for intensely spicy,sour, salty foods.. not usual for me) (Continued on continuation page, please read) Fatigue (had to start drinking coffee again to wake up in the morning, after not drinking or needing coffee for the past 10 years.   The main effect I've experienced is depression, which is NOT normal for me. I've always been a very upbeat person... even in the face of difficult or even tragic life events. My normal personality has always been set to "upbeat and cheerful". The shot seems to have reset this to "downbeat and apathetic" which is not usual for me and not helpful at all. I need my normal can-do personality to function in my life and work.   The depression started suddenly and for no apparent (life-based) reason, four days after my 2nd shot.  Have consulted my therapist on this and also my medical doctor. I reported it to V-safe and they told me to report it to you.  All of my symptoms would make perfect sense if I were... pregnant. But considering I'm 67 years old, 10 years past menopause, and haven't had a man in my life in many years, there's no way short of a Biblical  event that that could possibly be the case.   I continually feel hungry and like I can't get enough to eat. I am trying to continue my weight loss journey so that is especially hard. I'm slowly getting better from the depression, but it's been a long process. It doesn't seem like a therapy-based solution is the answer, more physiological.  I've been using the mushroom elixir coffees and supplements:  This has been the most helpful thing for me  I am very sensitive to medications and I don't take any Rx other than my three blood pressure medications. Have never taken (nor, till now, needed or considered) anything for depression.  I didn't have wierd food cravings when I was ACTUALLY pregnant.  But now it's like I HAVE to have sour lemon juice with pickle juice and hot sauce. I am not making this up.
Pt vaccinated with DTP/OPV developed high pitched screaming for several hrs after vaccine given. No other symptoms. No permenente effects noted on 4mo exam.
Severe pain in patient's Right arm.  Influenza immunization also received in same arm.
felt like I had lost body mass and I was flat as cardboard.; felt like an elephant was sitting on me; vivid, bizarre dreams; interrupted sleep; Sinking feeling at times; Feeling of having full blown viral infection; could not sleep well at all due to crazy body ache; could not sleep well at all due to crazy body ache; Fever 100.7F; massive fatigue; Every muscle ached; joint pain all over; persistent headache; shoulder pain; Neck pain; Distended Stomach; This is a spontaneous report from a contactable healthcare professional. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional migraines and the patient was allergic to penicillin and sulfa drugs. Concomitant medications included regular multivitamins (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously took ciprofloxacin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 21Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 21:30, the patient experienced fever 100.7 degrees Fahrenheit for 24 hours and massive fatigue, every muscle ached, joint pain all over, persistent headache, shoulder and neck pain, distended stomach. On 14May2021, the first night, he could not sleep well at all due to crazy body ache. On 15May2021, as the fever subsided, the patient felt like he had lost body mass and he was flat as card board, also felt like an elephant was sitting on him for 36 hours. On 15May2021, the second night, the patient had very vivid, bizarre dreams, interrupted sleep and the same dreams continued after falling back to sleep, the patient felt sinking at times and felt of having full blown viral infection. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measure was taken for fever and included treatment with tylenol. The clinical outcome of the events fever and felt like an elephant was sitting were resolved on 15May2021 and 16May2021 respectively, while the clinical outcome of the events massive fatigue, every muscle ached, joint pain all over, persistent headache, shoulder and neck pain, distended stomach, crazy body ache, lost body mass, vivid, bizarre dreams, interrupted sleep, felt sinking at times and felt of having full blown viral infection were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine error:  Medical Assistant administered a12 year old Covid vaccine to a 5-year-old patient.
Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated with Gardasil. Subsequently the patient experienced a worse condition than before of the papilloma virus. At the time of the report, the outcome of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.