chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received swollen lump on arm at injection site and headache that began to resolve 6/9/2010.  She reports no headache 6/10/2010 and only some soreness 6/10/2010.
past due for dose two / received dose one / in August on 2019 / have not received dose two; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No additional details were reported. The case was linked with case US2021AMR148564 reporter by same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR148564:Same reporter
Pt presented with fine rash on the face and rednes/swelling of both arms. Skin on both arms was warm to touch.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she just recently tested positive for  Covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
28yo medical student-vaccinated for travel 3/18/03. On 3/19 developed fever, headache, sore throat, myalgia, fever 103-101. Night sweats. Still symptoms.  Follow up 05/02/2003: "I did recover and now am traveling and have felt well the entire trip.  It seems that the diagnosis is still unclear.  The cultures from the rash showed staph and herpes, not zoster.  The staph may have been a superinfection but the herpes simplex was the oddball.  It appears to have been a primary infection and the cause of my pharyngitis as well.  My doctor did not seem to think it was vaccine related."
Narrative:  This patient received two doses of Pfizer vaccine and the booster on Feb/Mar/Dec 2021. The patient tested positive for COVID19 on 11 Jan 2022 and  was admitted to the hospital with dry cough, fever, and malaise. The patient was treated with remdesivir, dexamethasone, and azithromycin. The patient was discharged on 16 Jan 2022 in stable condition. Reported per EUA.
whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened also to the soles of feet/hands also became red and itchy; hands also became red; hives; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient (non-pregnant) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 11:45 at single dose at left arm for immunization. Medical history included known allergies: sulfa. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Immediately following vaccination, patient whole left arm was numb, the numbness slightly improved, but then only palms of hands were numb. Later that night, the numbness and itching happened also to the soles of feet, hands also became red and itchy, and then patient got hives that lasted 48 hours, but nightly hives after that, the hives would resolve after taking PO (per oral) diphenhydramine hydrochloride (BENADRYL), and then would come back again that night. Patient was still having them. The adverse events resulted in emergency room/department or urgent care. Outcome of events was reported as recovered/resolved with sequel. The report is considered as non-serious.  Information on the lot/batch number has been requested.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant product use was not provided by the reporter.  On an unknown date, the patient received Moderna bivalent booster dose that had undergone a temperature excursion. The dose was administered before it was known if the vaccine was ok.  Treatment information was not provided.  This case contains information for 37th of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient received vaccine on 6/29/17 and while leaving facility started experiencing chills and nausea. She was able to drive home but symptoms persisted and she developed dry heaves, back pain, and neck pain. Patient's mother notified the doctor on call and described symptoms but insisted her breathing pattern was not concerning at the time. Mom was advised to return to the office with patient for evaluation of symptoms. All 3 doctors in the office evaluated patient upon arrival. Her vital signs in the office were normal however despite monitoring for approximately 30 min she continued to complain of chills, nausea, and back pain. She was sent to the ER for further evaluation.
, Additional Details: PT ALSO REPORTED THE SITE OF INJECTIO TO BE HOT IN ADDITION TO RED AND SWOLLEN,  SHE REPORTED A DROP IN OXYGEN AS DETECTED BY A PULSE OX. MD DETERMINED THAT ARM WAS PRESENTING AS AN INFECTION AND PRESCRIBED BACTRIM DS, BID FOR 7 DAYS
Stroke/in her head on her left side; Blockage in her head, there was a blood clot in her head; Arm doesn't work; All she could say was I cant/still needs speech therapy; Really bad headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269; Expiration date was not reported) on the left arm on 04Feb2021 (13:21) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the public health department (not a military facility). The patient had a family history of five heart bypass surgeries (father); stroke (father); and stents (mother). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 14Jan2021 (when the patient was 68 years old) for COVID-19 immunization, and had hypersensitivity, rash and cerebrovascular accident. On 07May2021, the patient had a stroke (in her head on the left side). The patient was hospitalized from 07May2021 to 10May2021 due to the stroke. In May2021, the patient had a blockage in her head/there was a blood clot in her head; her arm did not work; all she could say was "I can't", and still needed speech therapy; and had really bad headaches. The events had resulted into an emergency room visit. The patient had received clopidogrel (PLAVIX) as treatment for stroke and blockage in her head/there was a blood clot in her head; and duloxetine ACL as treatment for the really bad headaches. The outcome of the events was recovering for 'stroke' and 'all she could say was "I can't", and still needed speech therapy'; was not recovered for 'really bad headaches'; and was unknown for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Facial hives appeared within 15 minutes after administration of vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 at 15:00 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), intramuscular, administered in arm right, administration date 07Dec2021 (Lot number: KA92R). Relevant medical history included: "allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 07Dec2021 at 15:15, outcome "recovered" (Dec2021), described as "Facial hives appeared within 15 minutes after administration of vaccines". Therapeutic measures were taken as a result of urticaria and include Benadryl.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event urticaria and the suspect drug BNT162B2 cannot be excluded.
Patient received vaccine on Tuesday 4/13/21 and on the following Thursday 4/15/21, she stated that she woke up feeling dizzy and faint.  She stated that she did pass ou and hit her head and that she broke out in a rash all over her body.  She went to the ER where they gave her Solu Medrol, benadryl and pepcid.  She was back at home when she called to make us aware of this.  She said that was feeling better and that the rash was almost gone
Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hours after vaccination.  Treated with acetaminophen and ibuprofen.  On 1/14/2021, forty-eight (48) hours after the vaccine administration,  rash appeared on trunk and neck.  Rash was red, warm not itchy and was treated with diphenhydramine oral and topical hydrocortisone.   Rash persisted for 24-36 hours.
PVaccine administered after more than 1 temperature excursion; PVaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (PVaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (PVaccine administered after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (PVaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (PVaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (PVaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (PVaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM, temperature was 29, at 10 AM it was 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021. 2 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM, 40, 10 AM: 29, 11 AM: 32, 12 PM: 43, 1PM: 43, 2 PM: 43, 3 PM: 46, 4 PM: 46 and 5 PM: 46.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a registered nurse and refers to a 16 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
On the 20th of January, eight days after I received the vaccine, the site of the injection became itchy, it developed into a large (2 inches in diameter) welt. It is warm and swollen. I just noted it yesterday, today it is still red, swollen and itchy.
Within 24 hours of administration, the pt described severe redness, swelling and itching involving nearly her whole arm.
on 10/05/05 Pt experience redness swelling at site and the red streaking upwards. This was on left deltoid.  She describes "violent pain" into her muscles and joints.  The joints involved are elbows, wrists, hands, hips and knees.  Pt has had difficulty sleeping.  She came in on 10/18/05 and had not let her provider know of her problem.
The patient states her arm was sore immediately after the shot and only continued to get worse and had a terrible night sleeping because of the pain. She is having trouble still raising her arm and has pain when she does. She no longer has pain when not lifting arm, pt called her doctor today who is giving her some gabapentin to see if it helps if a nerve has been affected.
Patient had varicella vaccine on 06/27/07,developed small area of redness,warm to the touch and some discomfort.Pruritis.
Patient received full dose 0.5 mls instead of half dose 0.25 mls  patient was not immunocompromised (no adverse event reported by patient)
pt recvd vax; 8 days later fell down & was unable to get up;taken to hosp & dx w/ encephalitis; pt was discharged; however, pt is in wheel chair;
Abnormal spotting between menstrual cycles. Occurred again in May 2021. No history of previous abnormal bleeding or spotting between periods.
This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. The patient's medical history was not reported. ON 26-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K0009810, expiration date reported as 10-OCT-2015 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
severe pain in neck; squeezing on a nerve; soreness in my arm; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the same symptoms as nurse (reporter). The nurse stated "I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. " The outcome of events was unknown.  Information on Lot/Batch number has been requested.
trouble with our voice/couldn't hit high notes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's received bnt162b2 (BNT162B2) (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: DYSPHONIA (non-serious), outcome "unknown", described as "trouble with our voice/couldn't hit high notes". The lot number for bnt162b2 was not provided and will be requested during follow up.
Note:  Time of flu injection and onset of adverse events are approximates -- very close to correct time.  Within a few minutes of receiving intradermal flu vaccine patient stated throat was feeling tight and started coughing.  No itching or rash but stated face was feeling hot. Face slightly flushed.  Lungs clear -- no wheezing. Breathing without difficulty but needed to clear throat.  BP 118/78; Pulse 84.  Given 50mg Benadryl IM at 8:38 AM.  Pt. started noticing less tightness in throat and face felt less hot within minutes.  8:45 AM Coughing much less -- states feels much better.  9:16 AM - BP 110/82; Pulse 72.  No coughing.  States feeling fine -- denies throat tightness or feeling in any way that is not her normal self.
1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021) had resolved.        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 reported. No treatment information was provided by the reporter.
Extreme nausea and vomiting, pounding headache, and diarrhea.
Starting 10/09/2022, I woke up with a headache and thought I was tired. My fatigue increased and I started developing a sore throat and cold like symptoms. The headache worsened and I took a test that evening (COVID-19 was positive). On Monday, the symptoms were increasing and I had a sore throat, fever, headache and fatigue. I called the doctor and I was put on PAXLOVID due to a lower immune response, having asthma and due to having the last dose 6 months prior. I started the PAXLOVID that day and my symptoms went away really quickly which was great. I finished it 10/15/2022 and on 10/17/2022 I tested negative. On 10/19/2022, I tested positive again for COVID-19 and I continued to test positive until 10/26/2022. I am unsure when I was negative because I stopped testing by then. I felt great after 10/19 but continued to test positive.