chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT HAD BLACK OUT AFTER 10 MIN OF RECEIVING THE VACCIE FOR 1-2 SEC.  PT LAID DOWN AND FEET UP. SHE WAS OKAY AFTER 5 MIN. CHECK THE BLOOD PRESSURE , WAS 130/68 AND PULSE 78.  PARENTS WANTED TO CALL 911. PARAMEDIC CAME AND CHECK THE VITAL. PATINET LEFT AT 3:00 PM 7/9/21
This spontaneous prospective pregnancy report, was received from a physician, concerning a female patient or unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 14-MAY-2018, the 28 weeks pregnant patient was inadvertently vaccinated with a dose GARDASIL 9 1 dose, for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported). The patient's last menstrual period was calculated to be 30-OCT-2017. The estimated date of delivery was calculated as 06-AUG-2018.
Following first dose given 02/15/2021 Early March, horizontal double vision upon awakening lasting about five minutes.
shortly after vaccination, pt developed hives all over her body and had SOB.  11:40am BP 158/110 P 130. c/o lump in throat, 50 mg. Benadryl administered, 911 called.  11:50am BP 160/120 p150. Pt transported to ED and they administered epinephrine(per pt).  9/10/21 followed up with pt and she is still taking Benadryl but no more epi needed.  will f/u w/PCP. Told her to go to ER if symptoms return.
Patient seen in our office 08/23/2005, complained of possible vaccine reaction.  On exam right thigh (knee to groin) was warm, red, and swollen.  No complaint of pain or itch, but patient was limping at that time.  Ice, elevation, and oral Benadryl was recommended, and follow up in 24 hours on 08/24/2005.  Patient presents with still warmth and redness to same area, but decreased swelling and minimal to no limp.  No complaint of pain or itch.  Recommended close monitoring and follow up if no resolution in 2 days.
Fever; Little bit chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Little bit chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptoms of fever and her kidney was not functioning properly). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, THYROID and DICLOFENAC for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (Little bit chills). At the time of the report, PYREXIA (Fever) and CHILLS (Little bit chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     The patient is taking the concomitant medications on a regular basis. She mentioned her husband passed away from COVID-19.   This case was linked to US-MODERNATX, INC.-MOD-2021-073737 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073737:Second dose
Muscle and joint aches, fever (100.8), chills, extreme fatigue lasting for approximately 16 hours. Treated with Tylenol
After the 2nd DTaP vaccine inconsolable screaming for 4 hours.  After the 3rd DTaP vaccine 11/4/10 she became limp and has hypotonia.  She still screams in the middle of the night often.
lots of pain have it bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that the worse thing he/she ever had going on seven weeks had the old vaccine. The patient had lots of bad pain. The follow-up could not be possible as no contact details were available.
Upon receiving the injection, cl experienced itching at the site applied ice. Benadryl 25 mg PO monitored vs for 25 minutes.
nausea; headache; This is a spontaneous report from a contactable other hcp (Patient).  A 57-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Age at vaccination: 57-years-old) as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included multiple sclerosis, asthma both from an unknown date and unknown if ongoing. Concomitant medication included glatiramer acetate (GLATIRAMER ACETATE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/lot number: EL1284) in Arm left on 14Jan2021 (Age at vaccination: 57-years-old) for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Caller is a medical assistant who received her second dose of Pfizer-Biontech Covid19 vaccine on 05Feb2021. She reports nausea that lasted for 6 days following vaccination, but is more concerned about the consistent headache she has been experiencing since receiving the second dose. She is going on day 14 and now of having headaches, she states it comes and goes and could be mild to severe, which I have to treat. Upon date it was reported that Last dose 05Feb2021 and on 06Feb2021 she felt nausea for 5 days and still experiencing headaches, mostly on base of the skull. Patient did not receive any treatment for the events. Since the vaccination patient was not tested for COVID-19. The outcome for the event nausea was resolved on an unspecified date in 2021 and for remaining event outcome was reported as no resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
an 8 year old received Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 13-SEP-2023, the patient received Infanrix. On 13-SEP-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8 year old received Infanrix).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 A nurse reported that an 8 year old received Infanrix which led to inappropriate age at vaccine administration. No symptoms reported. The reporter consented to follow up via mail.
2 pts showed "weakly positive not protected" 3 months p/ the last in a series of 3 vaccines.
Central Retinal Artery Occlusion, Permanent  loss of vision in Right Eye due to Blood Clot on 5-27-2021
A pharmacist prospectively reported the occurrence of burning sensation (rash) in a pregnant female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's date of last menstrual period, estimated due date, or weeks of gestation at time of vaccination were not reported. On 31 October 2006 the subject received an unspecified dose of Fluarix during an unspecified trimester of pregnancy. On or after 31 October 2006 and on or before 06 November 2006, less than one week after vaccination with Fluarix, the subject experienced a rash on both of her thighs. The pharmacist reported that , "the rash was not itchy, but it did burn". The subject was treated with diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 06 November 2006, the rash had improved. The pharmacist considered the rash to possibly be related to vaccination with Fluarix. Follow-up information received on 21 November 2006 indicated that the subject was 28 years old. Her last menstrual period was on 28 August 2006. The event began on 01 November 2006 and was resolved by 06 November 2006. In the reporter's opinion, the event was considered to be related to treatment with Fluarix.
Burning inside at injection site; quarter-sized round ring described as "bull's eye" at injection site; Redness at injection site; Flu-like" aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like" aches), VACCINATION SITE SCAR (quarter-sized round ring described as "bull's eye" at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning inside at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease in 1999, Sjogren's syndrome, Psoriatic arthritis, Cancer (Cancer survivor) in 2011 and Allergy NOS since an unknown date. Previously administered products included for an unreported indication: INFLUENZA VACCINE.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like" aches). On 07-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 08-Mar-2021, the patient experienced VACCINATION SITE SCAR (quarter-sized round ring described as "bull's eye" at injection site). On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Burning inside at injection site). On 07-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like" aches) had resolved. At the time of the report, VACCINATION SITE SCAR (quarter-sized round ring described as "bull's eye" at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning inside at injection site) had not resolved.            No relevant concomitant medications were provided.  No treatment information was provided
Patient reports abdominal pain and significant diarrhea the day following  Fluzone HD vaccination.  Patient also notes  blood in the stool.  Patient was recommended/referred to urgent care or other care for evaluation of bloody stool. Patient called in this morning and it is unclear if she is seeking care for her symptoms.
Pt vaccinated with MMR developed flu-like symptoms - severe headache, fever of 101.5, weakness, no energy, where shot adm doubled in size & was hot to touch w/red discoloration. Rash over entire body dx as measles 13 days /p shot was adm.
Since taking vaccine have had chills, slight fever, headaches, fatigued and tiredness with sore muscles for 13 days since vaccination on 4/1/2021
i got the vaccine on the tweleve of march twenty twenty one. and on the fourthteen of march around ten pm. i woke up from a nap with a nasty coughing fit. i couldnt breath,i started to cough up blood. it lasted for 5 minutes at least. then again two hours later i woke up coughing and with a extremly painfull chest pain. my chest felt like it was being compressed. after that i was fine. except for the occasional pain on my arm from the vaccine shot.
Alcohol abuse with sever alcohol intoxication, ETOH level 381 at 1:30 in the afternoon. Chemical counselling offered. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
No adverse event occurred. Vaccine was given to 17 year old, approved for 18 and older.
Had major chills and nausea a few hours after the injection.  That was gone next day.  Two days after the injection I developed a whole body rash.  Contacted my health care provider and was told to take Benadryl.  Rash went away within hours of taking the Benadryl and there were no further adverse effects.
94 yo Female patient reported dizziness and stomach pain 7 minutes post vaccination. v/s taken BP 156/76, HR 101, SPO2 97%, RR-21. T 98. Patient stated no PO intake. Water given for rehydration + tolerated. Patient observed and RRT responded and took over. Patient taken to ER for further evaluation with s/o Pt v/s retaken BP 142/72 HR 86 SpO2 98% on room air. RR 21 T 98
Nausea, vertigo, weakness, vomiting, blurred vision. Positive OSVS. Sitting - HR 72, BO 104/74. Standing - HR 72, BP 98/75. Transferred to hospital ER.
patient presented on 4-14-21. Received 2nd Covid shot on 3.26-21. Soon after 2nd shot developed AN EvulsioN. Would Would Not heal. Pt was put on Bactrim DS and DR told pt. to Report as adverse Reaction. 4-17-21 pt. stated Dermatologist change to Clindamycin Staph A infection
the patient was inadvertently administered dose of Daptacel that had expired on 17 July 2021/no AE; Initial information regarding an unsolicited valid non-serious case was received from the other Healthcare Professional (HCP) via medical information (Reference number- 00730261).  This case involves a five-year-old female patient who received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination.  On 13-Aug-2021, the patient received a fifth dose 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5643BA, expiry date-17-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (same day).  It was reported, "HCP called to ask for information on managing 3 patients who had inadvertently been administered an expired dose of Daptacel. Two of the patients were administered the expired dose on 03 Aug 2021, and the other patient was administered the expired dose on 13 Aug 2021".  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. 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.
1/26 vaccination, high heart rate, and flushed, two days after shot sever pain around shoulder blade, went to PCP doc said he thought it was inflammation around rib ca
Patient became lightheaded after COVID vaccine.  Was allowed to lie down on exam table.  Clinical staff did vitals - normal   Pale.  HR 72,  Regular Heart regular rate, no murmur   About 15 minutes later, had eaten a little, drank a little juice.  Felt back to normal
50 y/o F patient presents to clinic and refers generalized urticaria covering her entire body 2 weeks after being vaccinated with her second dose of pfizer.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm 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 was not reported. Concomitant medication(s) included: ESCITALOPRAM, start date: 01Jan2020; ADDERALL, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse who heard from a mother that her daughter was vaccinated with GARDASIL vaccine (yeast) and is now experienced hair loss. The hair loss looked like patches of "bold spots" down to the scalp. The patient's hair loss persisted. The patient sought unspecified medical attention. No further information is available.
Immediately upon receiving the vaccine I felt a tingling in my arm. About 8-10 Minutes afterwards I began to lose my vision and hearing as the room closed in around me. I began to sweat profusely. My husband called over the lady who administered the vaccine and she looked concerned. I threw up in a grocery bag. I went home and had to rest for several days. Had pain at the site and my left arm was sore for a week.
Per system, patient received two doses of Moderna COVID-19 vaccines on 1/21/2021 and 2/18/2021, subsequently diagnosed with COVID-19 at our hospital on 12/31/2021
Shoulder pain, limited range of motion.  Passive pain that flares up overnight, resulting in waking up to extreme soreness.  Ongoing for 2 weeks since 2nd Moderna injection.
T 100.0 by 230 pm 29Jan91-had been given Tylenol q4h & immediately /p vax pt con't to be fussy-cried high pitched-eating less-diarrhea-T 101-mom states pt had a seizure(rigid head back)on Wed 730 pm-1Feb91 fussy-MD would NOT see, vaxs @ PHD
I started to have muscle aches and fatigue. I was already in Quarantine because family members were already Positive. The next day I had chills, a cough and night sweats. The night sweats were so bad I had to change my bed cloths. I only had a low-grade fever. I felt awful for two days. I did not lose my sense of Taste or smell. It has been 10 days and I am still a little fatigued. I consulted my doctor but I was not prescribed any medications. I took a home tested and then I tested Positive for COVID-19 on the 5th day.
Pt. reported a few hives on face, chest and arm a day after the vaccine was given.
consumer vaxed OCT92 & exp an allergic reaction described as a terrible itchy allergy; itching disturbs sleep @ noc; condition has lasted for 4 months & has not resolved @ time of report; 9FEB93; seen by dermatologist-tx was unsuccessful;
Chills, fatigue, headache, vomiting, fever, trouble breathing, nausea.  3 days now.
Information has been received from a female health professional who was vaccinated with HPV vaccine 0.5ml. Subsequently the patient experienced extremely sore nipples that lasted 4 days. The patient recovered from extremely sore nipples. The health professional plans on receiving the next two vaccine injections. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow-up information has been received from a 25 year old female secretary/receptionist who is the patient (previously reported as a female health professional).  On an unspecified date, the patient was vaccinated with a first dose of GARDASIL 0.5 ml.  Subsequently the patient experienced extremely sore nipples and slight breast tenderness, starting the day after injection, and lasting approximately 4 days.  04-JAN-2007 the patient was vaccinated with her second dose of GARDASIL.  On 05-JAN-2007 the patient experienced slight breast tenderness and extremely sore nipples that lasted for approximately 4 days.  The patient plans on receiving the series of vaccine injections.  Additional information is not expected.
Parent called and spoke to telephone triage nurse. Chief complaint of vomiting - per the parent this "happens each time the patient gets a vaccine". Home care advise was offered over the phone for the vomiting, but parent declined home care advise as patient's symptoms had resolved. Parent was instructed/informed that due to length of time between onset of symptoms and time of vaccinations was unlikely related, parent still wanted to inform PCP since this happens with "every vaccination".
pt recv varicella vax in 7/96 & in 4/98 pt devel mild case of chickenpox. lab tests performed on pt
On May 1, 2022, my daughter had fatigue, sore throat, runny nose. We took her in to Labs and the ran a rapid antigen COVID-19 test that came back positive. No medications were prescribed at this time we were advised to give her over the counter cold and flu products. She was feeling better in a week. A few days later on May 25, 2022, she started feeling ill so we went back to Labs where she was diagnosed with a sinus infection. Antibiotics were prescribed at this time.
Facial/lip swelling, cough, wheeze, shortness of breath, sore throat
mom states pt cried screamed high pitch for 45 mins; called MD during screaming episode & said secondary to pertussis;
Patient had Zostavax immunization on 10/16/12. Two days after immunization, patient reported hot, stinging, itching, painful area around injection site of right arm with 1 1/2" x 3" swollen area with white ring around it. Patient called the pharmacy to report reaction, and then called her PCP on 10/19/12. PCP instructed patient to take 25mg diphenhydramine daily and to go to med center if symptoms do not improve or get worse by 10/21. Patient also used aloe topically to reduce itchiness. Patient also reported having general itchiness on multiple areas of her body around the same time as the reaction in her arm, which lasted about 12-24 hours. Patient's symptoms began to improve upon beginning diphenhydramine on 10/20/12, and resolved completely by 10/23/12.
Stiffness, numbness, limited range of motion , swollen ,and muscle spasms. Can not pick even five pounds up with that arm/hand.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Shingrix (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included ADACEL. On 26th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 26th May 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain and pharmaceutical product complaint were unknown. The reporter considered the injection site pain to be almost certainly related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the right arm. On the same day, the patient received the 1st dose of Adacel concomitantly. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving Shingrix injections since January 2018 and said that this last batch of Shingrix might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.