chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination administered more subcutaneous than intramuscular.; A spontaneous report was received from a consumer of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) more subcutaneous than intramuscular.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of event, the patient received one of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.    On an unspecified date, the patient received a dose of vaccine more subcutaneously than intramuscularly. Treatment information was not provided.  Action taken with mRNA-1273 in response to event was not reported.  The outcome of the event, vaccination administered more subcutaneous than intramuscular was resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
7 days after receiving the first pfizer shot, patient was participating in football practice, doing drills and exercises he has been doing for months. All of a sudden, patient felt like his throat was swelling up and he was coughing up mucous. He started experiencing sharp, tingling pains all throughout his chest. EMS was called and responded to the scene. He was given supplemental oxygen and put on ECG monitoring and O2 monitor. After approximately 30 minutes the episode subsided and he was released from EMS care home. 8 days post first shot he was still experiencing fatigue and not feeling normal.
10 days after the vaccine 1st dose,  my arm became very red, hot, itchy and swollen and there was a large circle about 6 inches around the vaccine site. No fever.  I called the doctor and was prescribed antibiotics (can't remember the name) and after a few days, it started to go away.  I went in for a routine  mammogram 1/27/2021 and they found an abnormality on the left breast of the mammogram.  I had to follow up with another repeat mammogram and an ultrasound on 2/9/2021 which also detected the same abnormality.   On 2/19/2021, I had a needle biopsy.  The results of the biopsy, there were not abnormal cells and to repeat another mammogram in 6 months.
REDNESS, SEVERE PAIN, SWELLING, SENSITIVITY, FELT WEAK FOR THE ENTIRE WEEK AFTERWARDS.
ACUTE CORONARY SYNDROME, UNSPECIFIED 5/10/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
itching and rash and tinging within an hour of injection.  Later developed welts on chest and back.  Gone by next day.  Reported to us one week after event..  No treatment .
Ct was vaccinated on 1-5-13 at 2pm and claims that she has extreme pain at the injection site. She reported bruising and shooting pain. She reported this event on 1-21-13. She has only been taking ALEVE to relieve the pain but has not been seen or treated.
received an expired dose of TENIVAC with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot U6669AA; expiry date:15-May-2022)  via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event received an expired dose of tenivac with no reported adverse event.   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 the 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.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (17Jul2022) positive, notes: 10 days after treatment still positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The Patient was treated with Paxlovid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 min after patient received vaccine patient bent over and felt dizzy. After taking vitals patient reported that he felt as if he was going to vomit.  Patient was assessed by provider, after several minutes patient felt better.
Pt received Meningococcal vaccine 2/8/13. On 2/6/13 at 12 noon she developed 102 degrees fever, body aches, redness and swelling at site of vaccination.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 13th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient stated that he experienced pain and soreness at the injection site which lasted for 1 day. No further details were provided. The reporter did not give consent to follow-up. For tolerance to 2nd dose, refer case US2018GSK223652.
she had a sore arm and a little nausea for a few hours; she had a sore arm and a little nausea for a few hours; This is a spontaneous report from a contactable healthcare professional (the patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no underlying conditions. The patient's concomitant medications were not reported. After the injection, the patient had a sore arm and a little nausea for a few hours but felt great now and looked forward to completing the series. She was happy with the vaccine. She will soon receive the second dose. The clinical outcome of sore arm and a little nausea was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient received Pfizer bivalent vaccine instead of monovalent vaccine for her first dose of the COVID vaccine series.
Patient also received a PPD skin test that day (negative). Later on, around the end of the day, the vaccination area was red, swollen and puffy. It got more puffy/irritated/hot over time.
Patient has had a history of an egg allergy as a kid, so she takes prednisone prior to flu immunizations to reduce any signs of allergic reaction. To prepare for this vaccine, she premedicated with prednisone from Monday-Friday. While sitting in observation, she notice that her heart was racing- at that time her heart rate was 132 bpm, and she was advised to go to the ED for further evaluation. Upon arrival at ED, her HR had reduced to 106 bpm at 0958.  She was monitored and discharged at 1013 at which point to returned to work as a nurse without problem.
I got symptoms like allergies but I don't know if they were allergies or not. Nothing that I thought wasn't more seasonal than anything else. The worst was extreme macular aches and pains and severe join paints. Muscles spams and cramps to the point of muscle tearing. Nothing has changed for me and time has gone on and I'm not getting them muscle spasms or pains. I'm not sure if the headaches I was getting was in relation to it or not.
Client arrived requesting Moderna booster and was given Pfizer in error.  Attempts to reach client have been unsuccessful.
Seizures; black-outs; neurotrophy; arteriosclerosis; GERD.
Experience achiness; Sensitive skin; Inappropriate age at vaccine administration; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rheumatoid arthritis (had full rheumatoid arthritis flare with after 1st Shingrix in the fall, refer case US2022AMR031120) and Xeljanz with an associated reaction of arthralgia (received Xeljanz 5 mg by mouth twice a day from 19th August 2021 and had her middle knuckle on her left index finger felt a little poofy prior to early January when she started school and the joints of the middle finger of her right hand flaring due to increased typing, refer case US2022AMR031120).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain, sensitive skin and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain, sensitive skin and inappropriate age at vaccine administration were unknown.   The reporter considered the pain and sensitive skin to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR031120  Additional details were provided as follows: The patient self-reported this case. The patient reported that she just had her second dose of Shingrix, earlier than recommended age, which led to inappropriate age at vaccine administration and she just experienced expected side effects from Shingrix such as achiness and sensitive skin. The reporter did not consent to follow-up. No additional details were reported; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR031120:Same Patient
Pt given vaccine - within several minutes pt was pale, weak, near fainting, diaphoretic.  Helped to bed & kept til pt was able to walk on her own 30-40 minutes later.
Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Medium, Additional Details: Several minutes after covid booster patient reported feeling unwell. Looked pale and sweaty. And he reported feeling sweaty himself. A minute later he started vomiting. Lasted for a few minutes and than patient reported feeling much better. He did not want me to call ambulance or EMT. He stayed alittle longer and said he was completely better and left.
FLU LIKE SYMPTOMS; SORE ARM; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced flu like symptoms. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, fever, nausea and sore arm was not reported. This report was non-serious.
red-sore-burning sensation, sore throat w/exudate, swollen, h/a, myalgias, fever
I'm still feeling... I'm still feeling extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:1), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I'm still feeling... I'm still feeling extreme exhaustion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lost her sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her sense of taste) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included AMOXICILLIN for an unknown indication.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced AGEUSIA (lost her sense of taste). At the time of the report, AGEUSIA (lost her sense of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional information was received from initial reporter and no new information
Testicle soreness; Scrotum swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 21Mar2021 at 00:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and supraventricular arrhythmia. The patient did not take any concomitant medication. The patient had no known allergies. 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. On 25Mar2021 at 12:00, the patient experienced testicle soreness and scrotum swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events testicle soreness and scrotum swelling was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US022014, is an initial spontaneous report received from a health care professional (materials manager) on 31 Oct 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Tinnitus-dose 4 of series. Never had tinnitus in my life or after dose 1 Pfizer. I got tinnitus after dose 2 Pfizer. Improved. Saw ENT normal audio gram. Boosted with Moderna 3, no new tinnitus. Strong tinnitus returned within 2 hours of Pfizer 4. Hearing fine. Had normal audio gram precovid shots
pt recvd Engerix-B 20FEB92 & 6APR92; 6APR92 pt exp severe burning pain @ inject site;
"feels mentally sick"; horrible earaches; felt bad; shakes; headache; hip hurts; balance is bad; feels dizzy; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), MALAISE ("feels mentally sick"), BALANCE DISORDER (balance is bad), DIZZINESS (feels dizzy) and EAR PAIN (horrible earaches) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypotension.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ILLNESS (sick), BALANCE DISORDER (balance is bad) and DIZZINESS (feels dizzy). On 24-Feb-2021, the patient experienced EAR PAIN (horrible earaches), FEELING ABNORMAL (felt bad), TREMOR (shakes), HEADACHE (headache) and ARTHRALGIA (hip hurts). On an unknown date, the patient experienced MALAISE ("feels mentally sick"). At the time of the report, ILLNESS (sick), MALAISE ("feels mentally sick"), BALANCE DISORDER (balance is bad), DIZZINESS (feels dizzy), EAR PAIN (horrible earaches), FEELING ABNORMAL (felt bad), TREMOR (shakes), HEADACHE (headache) and ARTHRALGIA (hip hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants or treatment medications were reported.
Itchy face.  Developed small bumps/rash under mouth and on left side cheek.  Rash was itchy, warm.
The 2nd dose of the SHINGRIX shot caused a headache and fever. Fever ran from 2am until 7am. Headache started around 2am as well and I still have it at noon.
1/16/2021( first dose) LOT first (011J20A); 2/13/2021 (second dose) second (028L20A); patient reported she woke up today 02/14/2021 @0700 to sorness amd pink color around the area of injection. dizziness is gone , but the pink color around the injection site and the sorness still present
Pt was given MENACTRA and HPV in (R) arm. Seconds later was given Tdap in (L) arm and immediately fell forward off table and hit face on floor. Seizure for less than 20 seconds. Broke off tooth in process. Pt with hx anxiety with vaccines especially.
After the second does that night I had a really bad headache and felt like I was getting sick. It was hard to focus on doing work and bright lights and loud noises made the headache worse. The next morning, I felt very fatigued and got very tired after even walking short distances. The headache was much lessened but still present. Advil was taken for the headache that night and the next day and helped a bit. Just rest was the most effective. My arm was sore for a couple days after each dose and went away over time. Period was late, as it was due in-between the doses but did not arrive until the day after the second dose (This could have been stress related but is very abnormal)
Arm soreness.  The next morning I woke up very dizzy to the point of almost falling.  I was sick on my stomach, had a fever 100.4; headache and was very tired.  I slept most of the day.  I felt somewhat better on Sunday, however that evening when I went to bed I got very dizzy again while laying down or turning over in bed.  Headache has returned on Monday.  Still dizzy.  This worries me because I did not have these symptoms with the previous 2 injections.  This was my booster shot.
Red bump developed above elbow, 8 inches from injection site. Redness gone but a tiny nodule still remains. Itches once in a while but its been 5 weeks.
pt recvd vax 10MAR94 @ 5PM while swinging in swing eye rolled back in head & arms & legs jerked for about 10 seconds, acted strange out of it for about 20 secs more than was fine;
Pain in left deltoid where shot was administered that occurs off and on lasting about a day and then goes away for 1-3 weeks and then comes back. Cycle repeats infrequently.
No adverse event; Patient that got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient that got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient that got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient that got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient that got vaccinated after BUD).    Patient registry ID was reported.  No concomitant medication information was reported. No treatment information was provided.
After receiving the booster with Pfizer I developed hives within 90 minutes of the shot, which have gotten seriously worse and spread all over my body. I?m addition to chills, body aches and fatigue
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported regarding three patients who have received doses of PNEUMOVAX23 of lot number 0709AE, expiry date 04-JAN-2014, have experienced injection site reactions in the injection arm. On an unknown date in late August or early September 2013, the patient was vaccinated with PNEUMOVAX23 (lot # 0709AE, expiry date 04-JAN-2014, dose 0.5 ml, via intramuscular route in deltoid muscle of the arm. Other suspect therapies included influenza (manufacturer unknown) received in same administration session in the opposite arm. On an unknown date in 2013, the patient experienced similar events (reported as adverse effects fit the same description) as the other 2 patients, namely arm soreness and difficulty moving her arm. The outcome of events was reported as resolved. The pharmacist requested a lot check for 0709AE, expiry date 04-JAN-2014. This is 3 of 3 reports from the same reporter. Additional information has been requested.