chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid on 16Sep2023 to 20Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-SEP-2014 the patient was vaccinated with PNEUMOVAX23 INJ (route, dosage, dose number and lot number unknown; expiration reported as 22-AUG-2014). The pharmacist reported the patient inadvertently received an expired dose of PNEUMOVAX23. No adverse effects reported. Additional information is not expected because there was no permission to contact the physician.
Received Vaccine on 1/8/2021.  Reported on 1/19/2021 that on 1/16/2021 developed hives, heart racing, dizziness.  Called 911. had an anaphylactic shock.  had o2 and steroid treatment.  She feels better now and would like to return to work.
Had shot and got shingles/shot doesn't always work/Suspected vaccination failure; Shingles seve enough for me, awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and got shingles/shot doesn't always work/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles seve enough for me, awful). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient interactive digital media. The reporter was sorry to inform that shot did not always worked. The patient had shot and got shingles and he/she could also have them again and it may made them less severe but his/her were severe enough and lasted about a month and it was awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Night following day of vaccination states started with rash-hives-around arm pits and continued until she had hives "head to toe" went to Hospital ER on 2/27/2021 states she received a steroid shot. Spoke with patient on 3/1/2021 and she was still dealing with hives and "itching" also. States she was instructed not to receive second dose of the vaccine by the Emergency room doctor.-Received vaccine on 2/25/21--reaction started on 2/26/21--seen in ER on 2/27/21--reported on 3/1/21.
Large red welt, 1.5" diameter, slightly raised, warm to the touch, some soreness and itchyness.
restriction of motion in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "restriction of motion in her left arm".  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): PFIZER INC-202201368440 same patient and event, different drug and dose;
administered Moderna Covid-19 vaccines beyond the 30 day use by date; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 026B21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2022 at 4:40 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Feb-2022 at 4:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported.  Expiry date of the vaccine was 05 Jul 2022.  The vial was initially stored in the refrigerator on 19 Jan 2022.  The vials did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up document was received and contains no new information.
Fever persisted for 2 days following vaccination, highest recorded temp 100.6 - treated with acetaminophen 1000mg q4-6h. Headache, chills, malaise, localized injection site reactions: erythema, tender/painful to touch, light swelling, diameter of erythema at the widest point about 5 inches,
had my final Covid vaccine around 11:40 am. I started to feel dizzy, faint, with a tightness in my chest/throat. I felt jittery inside and felt like i had to take deep breaths in to catch my breath and my heart rate was elevated. It would come in waves so I went home to rest. My heart started elevating to 122 while just walking to the bathroom. Ended up at urgent care. They gave me Benadryl and Toradol. I felt better instantly. No more shortness of breath but I keep on experiencing heart racing. My heart rate has gone as high at 183 while laying in bed. If sitting/resting I range between 80-95, walking to kitchen etc 108-130.. and have gotten as high as 156. Since midnight my rate ranged from 47 to 162. I just want to make sure there is nothing i should worry about.
The patient had COVID-19 in July 2020. In August 2020, he developed a whole body pustular rash. He was then admitted for an "asthma exacerbation" and found to have hilar lymphadenopathy. He was treated with several courses of prednisone for his asthma during the next few months. Within few days of his first dose of the COVID19 vaccine he developed fever and severe exacerbation of his rash (which thought to be acne at that time) that resulted in hospitalization on 6/7/2021. Interestingly, he received his second dose of the meningococcal vaccine (MCV4P, Menactra, lot # U6877BA) on 6/7/2021. The patient has been treated with antimicrobials (both antibiotics and antivirals, completed course) and high-dose corticosteroids (both oral and IV) and is slowly improving. He has severe skin scarring.
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: swollen right breast-Medium, Systemic: Lymph Node Swelling-Medium
was sick with my 2 vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (was sick with my 2 vaccines) 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 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick with my 2 vaccines). At the time of the report, ILLNESS (was sick with my 2 vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Patient was sick with two vaccines. Patient received booster on 11 Jan 2022.
Received Pfizer vaccine at 12.15 PM.  At about 05.00PM that eveningI started itvhy rash on my chest and back. I also had Very bad headache allnight long. Second day I had leg cramps and numbess on arms.  Also felt lethargic. Felt hot and sweaty--no fever. Third day I  developed  nausea --quite pronounced.   Very tired though I slept  almost 8 hours the night before. Also---Chills, very tired, blurry vision.  Joint pain and a little dizzy.  Feels like I will be getting  a Flu in a day or so,
Started as swollen red lump that became increasingly itchy,  warm and sensitive as it began spreading across and down arm.  Very achy by end of  day.  Have pictures if needed.
Dizzy, near-syncope, fevers, chills, myalgias, weakness, local pain and redness, parasthesias, diarrhea, confusion.
COVID test result Positive / throat, cough, nasal congestion; COVID test result Positive / throat, cough, nasal congestion; This is a spontaneous report from a contactable consumer (patient).    A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Jun2021 (Lot Number: EW0191) and dose 1 via an unspecified route of administration, administered in Arm Right on 20May2021 (Lot Number: EW0187), both at single dose (at the age of 15 years old) for COVID-19 immunisation.  Medical history included known allergies: Penicillin. There were no concomitant medications.  The vaccines were administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Jul2021, the patient experienced sore throat, cough, nasal congestion. COVID test result was positive on 01Aug2021. Post vaccination patient was diagnosed with COVID-19. Patient did not receive any treatment for the reported events. The outcome of the events was recovering.
pt recvd vax; pt devel flu-like illness; allergy; urticaria; arthralgia; sweating; asthenia/fatigue; rhinorrhea;
to get Botox injection for her Dystonia; got her 1st dose of Covid vaccine last 04Jan and was scheduled to have her 2nd dose on 22Jan; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a 62-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her 1st dose of Covid vaccine last 04Jan2021 and was scheduled to have her 2nd dose on 22Jan2021, but she had an appointment 2 days prior this to get botulinum toxin type a (BOTOX) injection for her Dystonia. The patient wanted to know if it's ok for her to get 2nd dose of Covid vaccine after getting botulinum toxin type A. Outcome of the events was unknown.
Night of event was unable to get my breath breathing was extremely hard. Freezing and shivering terribly . Not sweating or running temperature. By time medical help arrived symptoms we?re getting better.did not go to er at this time. Was checked out by emergency responders.main symptom was just unable to get my breath no matter how hard I tried.
Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Pfizer Covid-19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 Vaccine.   On 20-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced PRODUCT PREPARATION ERROR (Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years). At the time of the report, PRODUCT PREPARATION ERROR (Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that pfizer orange top vaccine for the 5 to 11 age group (lot FL8094) that was diluted with the Moderna Covid-19 Vaccine for ages 6 months to 5 years (lot AS1414B). No treatment medications were reported.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Knot below injection site as well as redness-Medium, Additional Details: Patient came into the pharmacy and reported Shingrix Vaccine caused knot on left arm as well as redness below injection site. Days 2 and 3 were the worst but reports left arm very sore and unable to move without pain. He is recovering but will be contacting primary care provider on monday to report reaction.
allergic reaction; face grossly swelling, more on the right side; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction and facial swelling. On an unknown date, the outcome of the allergic reaction and facial swelling were unknown.   It was unknown if the reporter considered the allergic reaction and facial swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient received Shingrix and experienced allergic reaction and facial swelling which was more on the right side. The reporter consented to follow up.
Papulovesicular rash various stages of healing less than 30 lesions total.
MILD SIDE EFFECT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included naproxen sodium. The batch number was not reported and has been requested. On an unspecified date, the subject experienced mild side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effect was not reported. This report was non-serious.  As per follow-up information received on 25-Mar-2021, reporter and vaccine facility details were updated.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-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.
Pt "felt feverish, but not too high", did not take w/thermometer; Had very high pitched cry, evening of immunization 29APR91 lasting for 30min; Pt had not cried like that before or p/this epidose; Seems more active than before;
Headache, Myalgia, Fever, (Temperature 100.8) Narrative: Chills, aches, fatigue, headache, temperature 100.8 for 2 days. (Missed 2 days of work, plans to return to work tomorrow.)
malaise & nausea (queasiness); swelling, redness, induration @ inject site;
Got scared and backed out from getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got scared and backed out from getting 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression, SIMVASTATIN (ZOCOR), CLONAZEPAM (KLONOPIN), FUROSEMIDE (LASIX [FUROSEMIDE]) and HYDROCODONE for an unknown indication.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got scared and backed out from getting 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got scared and backed out from getting 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Nurse inadvertently administer tetanus (ID) instead of PPD had hard red area 14x18mm. After week had sm blister area. Sent over to health dept to check area. Then area became dray scaly.
Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue, and heel numbness. The heel numbness began the night of the injection. Patient said half of their left foot and heel felt numb. Patient states that the numbness has fully resolved by the next morning, 1.21.2021. Patient encouraged to call PCP with worrisome or bothersome problems. Patient encouraged to call back with any new changes or questions about the vaccine.
Several episode of increased tone, or is this tonus, body stiff, arms extended, face red, fussy, 1 second of increased tone, 10 minutes fussy.
This was an administration error. All documentation provided to us shows that the patient received 3 doses of the Moderna Vaccine. 1st on 12/20/20, 2nd on 1/20/21, and 3rd on 2/23/21. Patient/LTCF has not reported any adverse side effects
Patient called stating he got ill exactly 12 hours after receiving his vaccination around 3:00 in the morning. He stated he was running a fever and started vomiting profusely, but he is fine now and feels good now. He called this nurse around 2:00 pm. I heard him coughing over the phone and asked him if he had been tested for flu or covid and he became slightly agitated and said "I will just be honest with you this cough is a marijuana cough. I got sick because of the shot." I asked him how high his temperature got, and he stated, "I don't know I just started shaking so I knew I was running a fever". I asked him if he wanted to see a provider and he said, "No, I just need a note to give to work that states that the shot made me sick". I let him know I could give him a note that he was here for an appointment, but he would have to see the provider to get a diagnosis and a letter about him being sick. I let him know that I would put the note in his chart, and he could come pick it up from medical records or he could go on his patient portal to print it off. He stated "fine" then hung up.
received the first dose last October 2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose in October 2020).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 05-AUG-2022 Reporter's comment: This case was reported by the patient's spouse. The patient had a question about Shingrix two dose series. The patient asked whether he/she could receive the second dose now. It had been greater than six months. Although the patient's primary care physician was recommending to start the series over. The request for consent to follow-up was granted. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient had a previous dose of Janssen, but got a dose of Moderna on this day.