chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (age reported as 50 with no units provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior to vaccination " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter provided the following information: Family of 5 who were all vaccinated with Comirnaty ranging in ages of 50 (received primary series and booster) with other family members receiving primary series (ages 50, 20, 17, 13) all developed mild to moderate COVID. No family member was hospitalized.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200203970 Same reporter, Different patient;US-PFIZER INC-202200204041 Same reporter, Different patient;US-PFIZER INC-202200204042 Same reporter, Different patient;US-PFIZER INC-202200204043 Same reporter, Different patient
After receiving Pfizer booster, Pt felt itching on both arms, upon assessment hives were noted on chest and both arms. BP 143/72 HR 107 RR 18 O2 sat 99-100% RA Temp 97.9 F.  Per Dr., Zyrtec 1 tab given. Pt felt better after taking Zyrtec and ice pack application. Pt left with her husband without itching or hives.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 26-NOV-2015 at time- 18:03, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
@1340 client c/o rapid heart rate. Vitals obtained @1341: 114/85, 200 HR, 98% Room air.  Called placed by (Site Superivsor) to 911 @1344. Client is AAOX4. NAD. Denies any other symptoms. Repeat vitals @1350: 124/86, 197, 98% RA. Fire engine arrived @1355. Facility completed and EKG, inserted a PIV to RAC 18g, started a IVF bolus of NS 0.9% and attempted the Vasal Vagual Manuver without any import net of heart rate. EMS vitals: 112/74, 192 HR, 19 RR, 100% RA. Ambulance rescue arrived @ 1405. Client agreed to be transported to the hospital for further treatment. Paramedics assumed care @1408. Client left AAOX4. NAD. Skin WNL, Respiratory WNL. No acute changes in condition. Patient transport to ambulance without further incidient. Other staff present RN, EMT, Site Supervisor.
Case number PHEH2014US025334, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 65-year-ild female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 20 Oct 2014, the patient was vaccinated with 0.5 ml FLUVIRIN (batch number: 145701, expiry date: Mar 2015) intramuscularly into left deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error (incorrect storage of drug).
Drowsy, fatigue, March 2021-April 2022 received treatment for Aplastic Anemia (bone marrow transplant) because of the Pfizer vaccine. Bruising very easy (very low platelet counts and low to no white or red blood cells working). Migraines horribly (never had them before). Memory loss. Getting fatigue very often and fast. Weak.
Patient was given SHINGRIX dose without proper mixing. Patient received only adjuvant, without antigen being properly added. Patient noted she did have soreness at injection site. Per manufacturer, proper dose was given 3 days later in opposite arm and patient was counseled.
Pt started to have sob, swelling of throat, and difficulty speaking. Pt was given 50mg of oral benedryl and 911 was called. Pt soon started to feel better after the benedryl and refused further medical treatment from paramedics.
Injection site red and swollen, hot. One dose of ADVIL did not help. Seems to be getting worse. Advised patient to call doctor.
pt came from another country and had no shot records or even away to get them so mom over phone and aunt that was in office with him wanted to re vaccinate  him because the school wouldn't let him start without out them. pt had a catch up Plan that doctor always wrights down for us so we can order the vaccines ( I don't know the catch up plan so i don't figure those out the dr does) i gave the vaccines that dr ordered and then 5 days later kiddo came in for 4 or 5 more.
Series completed outside the recommended window of 21-42 days (second dose administered on day 62).
In reviewing the system - it was discovered that based on documentation patient may have received a mixed series of COVID vaccine.  The patient is documented in our computer system to have received Pfizer Covid Vaccine Lot EN6206 on 3/12/21  and Moderna Covid Vaccine Lot 021B21A on 4/2/21.  Only Pfizer was administered in clinic on 3/12/21 and Both Pfizer and Moderna were being administered in clinic on 4/2/21. Patients vaccine care noted pfizer for both doses but lot numbers were as above with Moderna lot as second dose.  The patient was notified of this and was consulted by our ID physician.   Many checks and balances are in place to prevent such errors ? but based on documentation feel patient may have received a mixed series.
pt recvd vax; devel gen rash w/ approx 30 lesions, low grade T & itching;
This is a spontaneous report from a contactable other health professional via medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given a 0.3ml of pfizer vaccine without it being diluted on an unspecified date. The reporter wanted to know how this effects patient's vaccination status and if a second dose needs to be given.  Information on lot/batch number had been requested.
Shortly after recieving the shot I developed fluid filled bumps on both my thumb and pointer finger of my right hand.
Horrible vertigo all day on day 2, causing nausea and vomiting.  I experienced all the more common side effects also, which were sore arm at injection site, fatigue, body aches, chills the first night.   This was much worse than with the first dose.   I had never had vertigo before this shot and it was so awful that I only could get out of bed to throw up or go to the bathroom. I sipped water when I could but did not eat all day.  Every time I moved the whole room/world spun. Day 2 was the worst of the vertigo, but the sensation did not completely leave me for a full week.  It lessened a bit each day. Makes me fear getting the COVID-19 vaccine, or others, if they contain same additives.  While I do not have the same dizziness,  I still feel a tad weird on occasion.
Developed a fever of 103 at 3:30 PM on the day of the vaccination. Fever of 102 and higher continued, despite treatment with acetaminophen and ibuprofen, for 3 days. Beginning around 7PM on the day of vaccination she also began vomiting and refusing to eat. On the second day after vaccination, she developed diarrhea. Vomiting, diarrhea, and low-grade fever (100.6 or lower) continued until the 5th day after vaccination (4/18/2011).
This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for GARDASIL was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pain, redness, swelling, malaise, headache, sore throat, itching, hot at injection sight, fatigued, pain upon movement with some immobility, injection given sub q instead of IM.
Patient was given 0.25ml instead of 0.5ml of the Moderna Bivalent vaccine
S&S: itching, flushing, tongue swelling, hands swelling/cramping, headache within half an hour of injection. Meds Given: ibuprofen, BENADRYL, prednisone. Patient had decrease in symptoms and was discharged home with parent at 4:45pm 10/30/2017.
Havrix expired dose administration; This case was reported by a pharmacist via patient support programs and described the occurrence of expired vaccine used in a 65-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 14th July 2022, the patient received the 2nd dose of Havrix 1 dosage form(s). On 14th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Jul-2022 Reporters comment: The patient received an expired dose of the Havrix vaccine on left deltoid. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix vaccine, which led to expired vaccine used.
would now like to get the 3rd dose; received the 1st dose of Twinrix at 17 years old on 20Aug2008 and the 2nd dose at 20 years old on 20 Oct 2011; received the 1st dose of Twinrix at 17 years old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On 20-OCT-2011, the patient received the 2nd dose of Twinrix. On 20-AUG-2008, the patient received the 1st dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 20-AUG-2008, not applicable after receiving Twinrix and Twinrix and an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received the 1st dose of Twinrix at 17 years old). On 20-OCT-2011, the patient experienced drug dose administration interval too long (Verbatim: received the 1st dose of Twinrix at 17 years old on 20Aug2008 and the 2nd dose at 20 years old on 20 Oct 2011). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: would now like to get the 3rd dose). The outcome of the inappropriate age at vaccine administration, drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2023 The patient received 1st dose of Twinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinirx, which led to incomplete course of vaccination. The reporter did not have the lot/expiry date as the vaccine was given at a different clinic. The reporter consented to follow-up via email.
About 0800 the next morning my blood pressure shot up to 188/108 and I had the chills and a low grade fever.  I took an Availde blood pressure pill to assist with bringing my blood pressure down.  I was down in 1 hour of taking this drug.
Syncope episode after GARDASIL vaccine: walking off balance, then fell into a chair in the waiting room. Loss of consciousness for about 1 min., had a few tonic/clonic jerks, then went limp before regaining consciousness.
08/08/2003 mother reports arm being the size of a base ball until Sunday 08/10. Client had a fever up to 101 oral until Sunday 08/10. Client was also nauseated and this subsided Sunday 08/10/2003. Mom used hot compresses and Tylenol and Ibuprofen for relief. No MD visit.
Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vaccine; Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vaccine; This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 02Mar2021 12:15 in right arm for COVID-19 immunization. The first dose was on 09Feb2021 12:15 PM in right arm. Medical history was not reported. There was no allergies to medications, food, or other products. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced numbness and tingling of both legs and feet on 04Mar2021 01:00 which continued since day two of the second COVID 19 vaccine. There was no treatment received for the adverse event. The event was considered serious due to disabling/incapacitating. The outcome of event was not resolved.  The information on the lot/batch number has been requested.
developed A-Fib per EKG; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 90-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 90 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Transient ischemic attack" (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Old MI" (unspecified if ongoing); "Known allergy: PCN" (unspecified if ongoing), notes: Known allergy: PCN; "Known allergy: Sulfa" (unspecified if ongoing), notes: Known allergy: Sulfa. The patient took concomitant medications. Past drug history included: Plavix, reaction(s): "Known allergy: Plavix", notes: Known allergy: Plavix. Vaccination history included: Covid-19 vaccine (Primary series Immunization complete but Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (disability, medically significant) with onset 11Nov2022, outcome "not recovered", described as "developed A-Fib per EKG". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (11Nov2022) A-Fib. Therapeutic measures were taken as a result of atrial fibrillation. Additional information. The patient did not receive any other vaccine within four weeks of Pfizer vaccine. The patient received other medications (unspecified) with two weeks of covid vaccine. The patient was not diagnosed with covid prior vaccination. The patient was not tested with covid post vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ATRIAL FIBRILLATION and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I experienced chest pain since the week of the vaccine intermittent chest pressure and pain. I developed joint pain and knee pain which I am receiving treatment, I am getting physical therapy. I also have been having other joint pain since then. My hands are really sore with aches and pain. I underwent x-rays and EKG.   Today I am working with my physical therapist on the knee pain and hip pain.  My hands and base of my fingers are really sore, some more than others.
Pt felt bad and began running a fever. The next morning she called the pharmacy and stated she was feeling ill. Pt went to ER on Wednesday night and received IV antibiotics and a prescription for 5 days of oral antibiotics. Talked to pt on 10/9 and she is doing better. Arm is still sore and said the ER physician diagnosed "cellulitis."
Patient c/o itching around her throat area and right ear, after receiving Pfizer 1st dose. MD called advised give at Allegra 180 mg, and further observe.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-AUG-2014, patients were vaccinated with a dose LIQUID PEDVAXHIB (lot number J013944, Expiry date 13-AUG-2016, dose and route were not reported) that was improperly stored at 48F for 39 minutes. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
3/25/23 I felt like I had a runny nose and dry cough. Otherwise, I did not feel bad. I did not have a temperature. This went on for a while. On 3/25/23 I took an at home COVID test and it was positive. I called my doctor and was prescribed PAXLOVID. I began taking the PAXLOVID that night.
He had 3 Moderna + last one was Pfizer; Positive COVID test on 13Sep2022/with return of signs and symptoms on 25Sep2022; Positive COVID test on 13Sep2022/with return of signs and symptoms on 25Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Sep2022, outcome "not recovered" and all described as "Positive COVID test on 13Sep2022/with return of signs and symptoms on 25Sep2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "He had 3 Moderna + last one was Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive; (25Sep2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I began to have a high heart rate about hours after getting the shot then a fever came along and I had chills, and my lips were dry and I also had a headache. My heart rate  would barely stay below 100 BPM, even when laying down in bed. I developed a 102 F fever last night and took motrin, which helped lower it but I?ve also been having lingering throbbing headaches. My heart rate went to about 100-105 when while I took a nap but as soon as I got up and moved it jumped to 117, in the morning I went to use the bathroom and did nothing else and just that made it jump to 160. I have no trouble breathing. I was sitting in bed eating and my heart rate was around 123-130
The patient received TD vaccine intradermally in the right arm on 5/1/2010. On 5/2/2010. On 5/2/2010, the patient developed a local reaction of swelling, redness, and a knot at the injection site. Patient visited the doctor on 5/3/2010, and the reaction was still ongoing. Follow up obtained on 06/11/10: patient recovered, titer test showed that patient was protected against diphtheria and tetanus.
24hr post vax devel temp of 104 & SOB;dx: diffuse interstitial infiltrates, severe hypoxemia by arterial blood gas-pt underwent fiberoptic bronchoscopy w/transbronchial biopsy-revealed BOOP; rx high dose steroids
p/vax pt exp a mild case of chickenpox w/less than 30 blisters & no wheezing;
2 days post vax, the pt developed a rash on wrists, on V of neck, behind both ears and buccal mucosa in mouth.
after recv vax pt c/o intense itching, tenderness, redness, wheal approx 5 min p/inject
Client is 17 years old. Client wrote 18 years old on paperwork and listed DOB of 2/18/2003. DOB confirmed as 2/18/2004 in MCIR, EPIC and per client's mother.
2 inch circular redness around injection area.  Pain in arm when touched and a dull ache.
Patient received vaccination on 11/30/18 and developed shingles-like rash on 12/7/18. Patient went to MD office on 12/10/18 and MD diagnosed her with shingles and gave her an rx for an antiviral medication for treatment.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 040A12A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION, VALACYCLOVIR [VALACICLOVIR] and MIRTAZAPINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          No treatment was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076379 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076379:1st dose case
Angioedema of the face; skin sensitivity;  hives; joint pain; headache; fatigue