chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Pfizer Dose 3 30Nov2021, Moderna Dose 4 21Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 19Apr2021 as dose 2, single (Lot number: FL3302), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 56 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jul2022 as dose 4 (booster), single (Lot number: 060A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022, outcome "unknown", described as "Pfizer Dose 3 30Nov2021, Moderna Dose 4 21Jul2022"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". 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.
This spontaneous report has been received from a medical assistant via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were unknown. On 31-AUG-2018 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route, strength, batch/lot # unknown; expiration date May 2018) for prophylaxis. No adverse effects were reported. The patient did not seek medical attention. No treatment was given. It was unknown if lab diagnostics/studies were performed. No product quality complaint (PQC) involved.
received Pentacel instead of Tdap with no AE; received Pentacel instead of Tdap with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional and physician via call center via the Regulatory Authority (Reference number- 00814410).  This case involves a 32-year-old (unknown gender) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (wrong product administered and product administered to patient of inappropriate age)   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination.  On 11-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ414AA and expiry date: 12-Mar-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "She is requesting information on how to proceed with the patient"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Following the first dose that I received on 1/8/21, days following I only had a sore arm at the injection site. Approximately 10 days after receiving the vaccine my left arm broke out in hives which were warm to the touch. I contacted my primary physician and I was advised to take Motrin and benadryl. These symptoms went away within a day. On 2/5/21 I received my second dose of the vaccine. That night I was noticing a little swelling and soreness at the injection site. The following day the swelling got worse. The swelling spread from my elbow to almost all the way up my arm. It was swollen, red, warm to the touch, and irritated in some areas. I took Motrin, benadryl, used ice and heat on and off to try to reduce the swelling. By 2/8/21 my arm had not improved and now I saw having shooting pains go into my fingers and if my arm was positioned a certain way my hand would go numb. I contacted my doctor on 2/8/21 and a telemed appointment was schedules for later that day. Following the appt I was prescribed an antibiotic. After I few days of being on the antibiotic the swelling, irritation, as well as numbing decreased by the day. After about a week of being on the antibiotic all symptoms went away.
3/1/21 R facial Droop / R sided weakness, drooling & not able to taste well DX: Bells Palsy Rx: Prednisone 40mg x 5 Days Valtrex 1000mg TiD x 7 Days.
Swollen lymph nodes noted to left axilla 7/15/2022, day after receiving Covid booster; also developed soft tissue swelling down left side below axilla; no fever note; some left arm pain per parent reporting event. MD exam noted 2-3 mildly enlarge lymph nodes under left axilla/armpit, soft nontender boggy swelling below armpit in axillary line; MD recommended treatment of cool pack to affected area.
Pt seen at MckayDee Medical Center on 10 Aug @ 0850.  He received the vaccine 10 days prior.  He was having local reaction on Rt deltoid and postular rash on torso and upper shoulder area.
Initial information was received from healthcare professional on 20 November 2013. This case concerns 50-100 patients (age and gender not reported) whose medical history and concomitant medication was not reported had received FLUZONE ID (batch number: UT4722AA and UT4721AA) on deltoid on 07 October 2013. The patients experienced more complaints of soreness overall. The patient was more pronounced scaling at 1-10, average complaint of 4/7. One patient had redness, warmth and discomfort with touch, swollen to 1/2 inch. This patient was injected near her old smallpox scar that she received as a child. Another person was treated for anaphylaxis. Pain was from arm to wrist, headache, breathing difficulty. The patient went to emergency room for steroids and was released; was doing well. No laboratory details were reported. The corrective treatment was not reported. The list of documents held by sender: None.
Information has been received from a physician concerning a 6 year old male who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck). There was no concomitant medication. "Soon after the second vaccination", the patient developed an injection site reaction which was described as a warm, swollen injection site arm and vesicles around the injection site (time frame not reported). The patient returned to the physician for treatment of reaction. The physician used symptomatic treatment. At the time of the report, it was unknown if the patient had recovered from the events. Additional information has been requested.
chicken pox like rash/hive like, occuring mostly at nite. treated with anithistamine, may need steroid..
Information has been received on 02/26/2002 from a physician concerning an adult male who was vaccinated with a dose of varicella virus vaccine live. Subsequently, three to five days post-vaccination, the pt developed "varicella lesions." The pt sought unspecified medical attention. There was no other info provided. Additional info has been requested.
20-30 min after 2nd vaccine I was extremely tired and had to rest the remainder of the day.  Around 2am on 4/8/21 I began having chills and extremely sore joints all over.  It felt like I had the flu.  By 10am on 4/8/21 I was feeling much  better!  I had COVID from 2/3/21-2/28/21
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ARTHRALGIA (joint pains) and MYALGIA (body ache all over) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 30-Jan-2021, the patient experienced ARTHRALGIA (joint pains) and MYALGIA (body ache all over). The patient was treated with MELOXICAM on 30-Jan-2021 for Joint pain and General body pain, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) 01-Feb-2021 for Diarrhoea, at an unspecified dose and frequency. On 01-Feb-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ARTHRALGIA (joint pains) and MYALGIA (body ache all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On 13-MAY-2014, the patient was vaccinated with 1 dose of VAQTA (lot # J011385, Expiry date : 10-MAR-2015) that were stored outside of the recommended storage temperature. The concomitant medications were not reported. No adverse effects were reported. The outcome of vaccinated with above temperature excursions and no adverse effects reported was unknown. This case is linked to case # 1405USA009669. Additional information has been requested.
nausea; vomiting; This is a spontaneous report from a contactable consumer or other non hcp.   A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Caller states her daughter received the second dose of the Comirnaty Vaccine today and is vomiting. Caller asking if there are any contraindications to administering any particular medications to treat her nausea and vomiting after receiving the Comirnaty Vaccine. Outcome of the event was not recovered.    The Lot number for BNT162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
First shot: extremely tired (2-3 days), fever of 100 (1 day), heavy chest feeling (3 days), body aches (3 days), pain in entire right arm (5 days), insomnia (2 nights). Second shot: extremely tired (2 days so far), fever of 100 (1 day so far), heavy chest feeling (2 days so far), extreme body aches (2 days so far), EXTREME PAIN in left arm, EXTREME dizziness, insomnia.
pt recvd vax 2OCT95 & w/in 2hrs of vax pt devel vomiting, chills, dizziness, high fever, severe tenderness over the liver area in the rt upper quad, dehydration, & liver enlargement;subsequently hospitalized x 2 days;3OCT95 serum alk 642;
Information has been received from a 73 year old female nurse practitioner with penicillin, codeine and MOTRIN allergies who on 27-MAR-2009 were vaccinated with a dose of ZOSTAVAX (Merck), subcutaneously. There was no concomitant medication. On 01-APR-2009 the patient experienced swelling, redness, and hardness at the injection site; she also experienced headache, fatigue and general flu like symptoms. No laboratories studies performed. The patient sought medical attention at the clinic. The patient had not recovered. Additional information has been requested.
Initial unsolicited report received from a pharmacist on 05 Oct 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI697AB, expiry date: 06 May 2017, dose not reported) via intramuscular route in the left arm on 05 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify), any other vaccinations within 4 weeks of vaccinations and illness at the time of vaccination was reported as none. Concomitant medications were not provided. On 05 Oct 2016, few hours following the vaccination, the patient experienced tingling in fingers of vaccinated arm as well as immobility to that arm. Lab data and corrective treatment was not reported. The patient's outcome was reported as unknown. List of documents held by sender: none.
PATIENT HAD TIGHTNESS IN CHEST, BUT WAS ANXIOUS BEFORE GETTING THE VACCINE AND FORGOT HER INHALER.  IT WENT AWAY AFTER 20 MINUTES.
Subsequent to receiving one dose of varicella virus vaccine live, pt experienced 1 chickenpox lesion a the injection site. The pt also experienced diarrhea.
Patient reported tingling and numbness to left arm while in post observation @ 13:20. After having patient was an additional 15 minutes, side effects slowly subsided. Patient stated that she was better and problem has resolved.
tested positive on Saturday; tested positive on Saturday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 17Sep2022, outcome "unknown" and all described as "tested positive on Saturday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2022) Negative, notes: He tested negative for COVID-19 on Thursday; (16Sep2022) Negative, notes: He tested negative for COVID-19 on Friday; (17Sep2022) Positive, notes: Eventually tested positive on Saturday. The patient got the updated Pfizer Biontech COVID-19 booster on Thursday 08Sep2022. The following Wednesday 14Sep2022 he began having some COVID-19 symptoms, he just noticed a slight cough like when you have allergy by Thursday morning he referred that he knew something was happening and he was getting sick. He tested negative for COVID-19 on Thursday and Friday but eventually tested positive on Saturday. The patient wanted to know since the vaccine had not been in his body for at least 15 days and he had COVID-19 now, was it still going to create antibodies and help him or not. The patient wanted to know whether he should consider getting another updated vaccine before six months or he should assume that the infection would create the antibodies as the vaccine would.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Joint inflammation, weakness, fever of 100 (for first ten days), injection site reaction (at first).
Patient stated that within the 15 min time frame he started having chest pains. He waited for about  another 3o mins. He was still felling discomfort so he went to the emergency room. They ran some test and sent him home. He was advise to follow up with PCP.
Pt.'s grandmother states that after receiving the 2nd dose of Moderna 06/16/2021, started experiencing with extreme weight lost and slight cough. Primary visit (Blood work, X-rays, Chest X-ray) showing Thyroid levels elevated. Specialist seen 06/29/2021, Ultrasound continuing current medications. Follow-Up visit scheduled for 07/16/2021. Still experiencing extreme light-headness, weakness, loss of appetite.
Covid arm (ongoing since day after vaccine) about 1 inch below injection site. Area is puffy, red and intermittently itchy
pt got second dose of covid vaccine on Friday 08:00 and pt got body aches and fever that night at 19:00,. pt had body aches and fever Saturday night as well. pt noticed a huge lump under armpit on right side where she got the shot, lump is not red or warm to touch, lump is size of golf ball.
12/09/20 at 3:00 AM fever, and shaking chills, headache, body aches -- Tylenol dose for fever taken. Symptoms continued for 2 days. Soreness site of injection, hot, red currently since vaccination
Red swollen Rt thigh feels hot 10.2 cm x's 2 days.
p/vax pt legs became blotchy, turned purplish & had a dusky appearance w/in minutes of vaccine;pt was seen by MD who noted that only the lt leg appeared as mom reported;
pt. recvd. dose of vax & developed measles rash,cough,coryza,conjunctivitis,& Koplik spots.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced mild symptoms with no complications and no complaints.
Hives, swollen face and lymph nodes in upper right arm, itchiness, redness at injection site.
Pain, swelling, and soreness 1 day after the vaccine. Then pain, swelling, soreness, warmth, and redness 2 days after that has gotten worse. Itching started today, nine days after the vaccine.
It was indicated on the consent to vaccinate that he had previously only received the first dose of Moderna vaccine on 2/5/21 with no indication of an adverse reaction such as anaphylaxis.  For this clinic, we were conducting both Janssen and Moderna.  However, the pharmacist mistakenly gave this patient J&J instead of Moderna.
Just had some tiredness; 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 62-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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), for COVID-19 immunization, reaction(s): "Just had some tiredness". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Just had some tiredness".  Additional information: The caller states he took the Pfizer-BioNTech COVID-19 Vaccine primary series 1 and 2. He states he just had some tiredness and then received his first Pfizer booster dose and "got a headache for 4-5 days, 2nd booster had no side effects. The caller just got my 3rd Pfizer booster dose last week on 05Jan2023, I felt very bad after 3 hours my shoulders, arms ached and I had headaches and at night I got a fever and woke up at night with chills and fever and took Tylenol and and then I was sweating. caller states he Got up in morning. Just tired and had a little pain over my left chest and 3rd or 4th day my heart was beating very fast and then went away. Yesterday, the chest pain came back and lasted all day and my BP (Blood pressure) was 179/96 and last night the pain went away at 12:00 and at 3am I went to (Withheld) and for an hour or so I had chest pain. I just wanted to call and see if anyone else had these symptoms, then I wouldn't worry so much. His wife just a little tired and sore after the Pfizer booster vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024481 same patient and reporter, different dose and event;
Ee stated upon observation entrance, that she would be observed until 10:15am r/t "anaphylaxis" to Morphine.  Informed us that she became "itchy" for "3" days prior to the 1st dose on 12-16-20.  Ee c/o "itching" to this nurse @ 1005.  Benadryl 25mg given @ 1005.  Remains to c/o "itching" @ 1015.  Ice pack applied to chest to relive itching @ 1015.  Around 1025 Ee stated she felt "relief of itching".  This nurse also gave Ee (1) Benadryl 25mg to take w. Her.  Ee stated she was feeling better @ 1034.  Left observation @ 1035.
chills; fever; pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection). At the time of the report, CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection) outcome was unknown.            No concomitant information was reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Pain radiating from the tips of one hand to the tips of the other along with chest pain like a truck was setting on it!
SORE THROAT; CHILLS; FEVER; LOST OF APPETITE; This spontaneous report received from a parent concerned a female 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 28-MAR-2021 to left arm for prophylactic vaccination. the batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced lost of appetite. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost of appetite on 01-APR-2021, was recovering from fever, and had not recovered from chills, and sore throat. This report was non-serious.
Experiencing sun sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 13:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INCASSIA; ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]. The following information was reported: PHOTOSENSITIVITY REACTION (non-serious) with onset 19May2021, outcome "not recovered", described as "Experiencing sun sensitivity". Therapeutic measures were not taken as a result of photosensitivity reaction.  Additional information: 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. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency care visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.