chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right eye got really red, she felt like she had a film on it/like a film on my eye and it is red.; she felt like she had a film on it/Film came back and it looks like a film but when I tried to rub it off and it does not come off/on and off sensation of having a film on her eye; eye is red, and hurts/My eye is bothering me; This is a spontaneous report from a contactable consumer (patient) via Pfizer Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as Dose number unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Mar2021, later that evening her right eye got really red, she felt like she had a film on it. It went away on its own that night. Today it was really red and bothering her. She stated she wondered if she had pink eye, but she had no discharge, only her eye was red, and hurted and she had this on and off sensation of having a film on her eye. She wanted to know if this had been reported before. So, yesterday she had a spot on her eye, like a film on her eye and it was red. It had been red the whole time but last night the film went away. But today, later on in evening, the film came back, and it looked like a film but when she tried to rub it off and it does not come off. So, she was not sure what it was, and her eye was bothering me. So, she was not sure if that was the side effect from the vaccine. She did not have it before she got the vaccine." The outcome of the event eye was red and hurted was unknown and the outcome of other events was not recovered.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Possibly given into the lower part of the deltoid muscle; Local redness; Pain and tenderness; A spontaneous report was received from a physician concerning a 50-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced local redness, pain, tenderness and was possibly given the vaccination in the wrong spot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the lower part of the deltoid muscle intramuscularly for prophylaxis of COVID-19 infection.     The date of the vaccine was not reported. However, the healthcare professional (HCP) reported the vaccine was given incorrectly and in the wrong spot. The patient, also, developed local redness, pain and tenderness. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event outcome of the vaccination being possibly given in the wrong spot was considered resolved. The outcome of the events, local redness, pain and tenderness, were not reported.    The reporter's assessment of causality for the events was not provided.; Reporter's Comments: This case concerns a 50-year old, male patient. The patient's medical history was not provided. The patient who experienced an expected  event of injection site pain, injection site erythema and an unexpected event of product administered at inappropriate site. The event occurred on an unknown date, after administration of the first dose of mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start of the event, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 69 year old white male with a codeine allergy who on 18-OCT-2005 at 7:10 pm was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651523/0604R).  Concomitant vaccination on 25-OCT-2005 intramuscularly seventh dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (lot U1B33BA).  It was reported that it had been 9 years since the patient received his first dose of pneumococcal 23v polysaccharide vaccine.  On 19-OCT-2005 at 5:00 pm the patient had swelling and redness of the deltoid/upper arm after vaccination.  This was also described as " a somewhat severe local site reaction".  Unspecified medical attention was sought.  The patient recovered in " a day or two", on 29-OCT-2005.  There was no product quality complaint involved.  Additional information has been requested.
Pain at the injection site with redness and a kind of ball; Injection site redness; Pain at the injection site; High temperature; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Pain at the injection site with redness and a kind of ball), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (High temperature) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Pain at the injection site with redness and a kind of ball), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (High temperature). At the time of the report, VACCINATION SITE SWELLING (Pain at the injection site with redness and a kind of ball), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (High temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Resident receive influenza vaccine on right arm (deltoid) around noon on 10/23/17; that evening felt warm/feverish and during night became confused and weak and fell in his room. He thinks he was on the floor for about 30 minutes (he denies laying on his right arm where he had received the flu vaccine). Nursing evaluated him and found him weak with a low grade fever (100.2), nausea, general body aches, chills, lightheaded/dizziness, diaphoresis, confusion. He was sent to the local hospital and found to have an elevated CK which increased to 19,000 and a small bump in his Creatinine. Patient was diagnosed with Rhabdomyolysis and AKI. Resident was given IV fluid at the hospital. Temp. at the hospital 101 per resident.
tiredness; injection site pain; Difficulty breathing; swelling of throat (feels that way),; Dizziness; weakness; feeling unwell; nausea; fever; chills; headache; This is a spontaneous report received from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727) via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 as a single dose (at the age of 63-years-old) for COVID-19 immunisation. The medical history included type 2 diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and levothyroxine (SYNTHROID) all for an unknown indication from an unknown . The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 21:30, the patient experienced difficulty breathing, swelling of throat (feels that way), dizziness, weakness, feeling unwell, nausea, fever, chills, headache, tiredness and injection site pain (vaccination site pain). The patient did not receive any treatment for the events. The clinical outcome of the events difficulty breathing, swelling of throat, dizziness, weakness, feeling unwell, nausea, fever, chills, headache, tiredness and injection site pain (vaccination site pain) were not recovered.   No follow-up attempts are needed. No further information is expected.
Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the injection; Typical soreness where the shot was; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, on 24May2021 13:00 as 1st dose, single dose on left arm for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the shot on typical soreness where the shot and Is the same side as the injection has not really had any side effects until this morning. On the same date he got the shot he had some tenderness at the site. The patient experienced left armpit is swollen and tender and is the same side as the injection on 27May2021. The events assessed as non-serious. The patient initially stated this was subsided, but clarified it was still ongoing even though he initially said he had no side effects until today as well. If he touches it, it was still tender. Outcome of the events Is the same side as the injection and Typical soreness where the shot was resolving while outcome of the remaining events was unknown.  Information on Lot/Batch number is available; Further information has been requested
Localized swelling, hot to the touch , soreness - all one week out.  Was initially sore the two days then disappeared. Returned this weekend.
On the 9th day after vaccination, my left arm started itching in the early evening  (Jan. 12).  Next morning, Jan. 13, I noticed that there was a large, round area at the injection site (size of a tennis ball) that was red.  It no longer itched.  Later, I put cold compress on site.  Did not appear to be swollen.  But it was very warm to touch. I called primary doctor and am still waiting for call back.  On Jan. 14, upon waking, the redness had diminished in intensity, but not in size.  Still warm, but not as warm.  By mid-day, redness decreased more, still warm, but appears to be going away.  No other symptoms or side effects.
He tested positive for Covid last night; He mentioned he already completed his vaccination and his booster; He said he has a lot of mental conditions; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare p-professional) for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: Unknown) as dose 3 (booster), single, (Batch/Lot number: Unknown) as dose 2, single and (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "he tested positive for Covid last night", DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "He mentioned he already completed his vaccination and his booster", MENTAL DISORDER (non-serious) with onset 10Mar2022, outcome "unknown", described as "He said he has a lot of mental conditions". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: He mentioned he already completed his vaccination and his booster. He said he has a lot of mental conditions. Then the caller said that he already has a prescription for Paxlovid and he took it to his Pharmacy but they do not have it. He was asking what he can do to obtain it.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
pain in left arm, fever (100.6 in the a.m. Normal for me is 97.7 in the a.m.), aches, shivers
pt recvd vax & the day p/vax exp nausea, hot flashes, & flushing;pt called or was seen by MD;
My throat swelled so much that difficult to breathe and swallow.  Also had a fever, dizziness, weakness, and rapid heartbeat, very high blood pressure, bloodshot itchy eyes, congestion. Went to emergency room.  They gave me some medications and monitored me for a few hours. Taking prescription steroids Benadryl.
Pt received ZOSTAVAX on 7-10-13, went to see PCP on 8-5-13 and diagnosed with a rash thought to be shingles. Pt unsure of exact onset.. few days prior to 8-5-13 visit with PCP. Treated with VALTREX 1gm Q12 hours x 10d and Pred 40mg QD x 5d.
pt recv vax & in 1996 pt titer was checked & revealed a lack of seroconversion;
missed the second dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable. The age group was selected as an adult as per vaccine indication. The patient missed the second dose of Shingrix, which led to incomplete course of vaccination. No lot number or expiration date provided. No additional information provided. The reporter consented to follow up.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: shortness of breath-Mild, Additional Details: Per pt's father, pt started complaining about chest tightness and shortness of breath starting 3-4 days ago.
Out of nowhere started shivering and literally shaking, I was so cold that even getting under the blankets didn't help. My temperature went from 100.4 to 100.6 in a matter of minutes. My normal discomfort and pain from the arthritis was worse and I got very tired. Swelling and redness at the injection sight as well.
very shaky; cannot even drive; feeling funny; Anxiety; Do not know what is happening today, they feel light headed here and there, they were fine before and were able to drive, but now unable to even drive.; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (very shaky), IMPAIRED DRIVING ABILITY (cannot even drive), FEELING ABNORMAL (feeling funny), ANXIETY (Anxiety) and DIZZINESS (Do not know what is happening today, they feel light headed here and there, they were fine before and were able to drive, but now unable to even drive.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (very shaky), IMPAIRED DRIVING ABILITY (cannot even drive), FEELING ABNORMAL (feeling funny), ANXIETY (Anxiety), DIZZINESS (Do not know what is happening today, they feel light headed here and there, they were fine before and were able to drive, but now unable to even drive.) and NAUSEA (nauseous). At the time of the report, TREMOR (very shaky), IMPAIRED DRIVING ABILITY (cannot even drive), FEELING ABNORMAL (feeling funny), ANXIETY (Anxiety), DIZZINESS (Do not know what is happening today, they feel light headed here and there, they were fine before and were able to drive, but now unable to even drive.) and NAUSEA (nauseous) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications included vitamins. Treatment information was not provided.
Information has been received from a woman concerning her 18 month old son who was vaccinated with MMR II at 15 months of age. At the time of his 18 month checkup, the pt experienced loss of language. Additional regression followed. He developed severe bowel problems. At the time of the report, he had a form of colitis which had yet to be determined. He also experienced severe pain, bloody stools and or diarrhea, every day, and almost no language. The loss of language was considered a "Significant Medical Event". No further information is available. Per follow-up report, the lot number of 629553/1784H was added to the lot number field. No further information is available.  Follow up on 04/06/2001: "Patient date of birth, adverse event onset date/time, vaccine administration date/time is not provided."
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis.  In August 2007 the subject received unspecified dose of Engerix B (unknown).  In August 2007, 4 days after vaccination with Engerix B, the subject experienced not responding to therapy and lack of effect.  Results revealed a positive hepatitis B surface antigen.  At the time of reporting the outcome of the events was unspecified.
3 hrs after shot patient had "chills/shaking" episodes and fever 102 degrees. TYLENOL given every 4-6 hrs around the clock and fever lasted for 3 days. Patient had consolable crying episodes.
Immediate metallic taste in mouth; Less than 10 minutes in, a tightening of the throat
This initial non-serious spontaneous case, initially received on 06-OCT-2017, reported by other health professional and concerns a 47-year-old adult male patient. Patient's medical history and concomitant medications were not reported. On 06-Oct-2017, the patient received AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator temperature was 37 to 35 degrees with the lowest being at 12 degrees for 1 minute. (explicitly coded as incorrect product storage) (dose: 0.5 ml, batch number: XF33308, route of administration: intramuscular, anatomical location: left deltoid). Not sure if it was the probe that has the problem or the refrigerator. Patient received vaccine that underwent temperature excursion (explicitly coded as drug administration error). No adverse event was reported. The outcome of the events was not reported. The reporter assessed this case as non-serious. Follow-up received on 18-Oct-2017: Added vaccine administration details (route of administration: intramuscular, anatomical location: left deltoid). No adverse event was reported. Narrative amended accordingly. Insignificant case correction received 06-Oct-2017: the description coded for 'incorrect product storage was incorrectly taken as 'AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/Patient received vaccine that underwent temperature excursion' was changed to 'AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/ [Patient received] vaccine that underwent temperature excursion. The description coded for 'drug administration error' was incorrectly taken as '[AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being 12 degrees for 1 minute] / Patient received vaccine that underwent temperature excursion'. Was changed to / Patient received vaccine that underwent temperature excursion.
Patient woke up the morning after his injection with left arm weakness, numbness, and swelling. His left arm was his injection site. Symptoms lasted for several weeks but have resolved
On 12/23/2001, nine days post vaccination, the patient developed a painful erythema,edema, which was warm to the touch at the vaccine injection site. Treatment consisted of a z pack #1. All symptoms diminished by 12/25/2001.
Pain in arm; tiredness; Headaches; Congestion; Mood swings; Extreme fatigue; Upset stomach; Running nose; Sore throat; Fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 at 11:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, allergy to nuts and nickel. Concomitant medications included zolpidem tartrate (AMBIEN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and valaciclovir hydrochloride (VALTREX), all for unknown indication and from unknown date. Prior to the vaccination, the patient was 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 COVID vaccine. On 13May2021, the patient experienced pain in arm and quick onset tiredness which lasted for few days. On day 4, the patient experienced running nose, sore throat, fever, body aches and from day 5-7, patient experienced headaches, body aches, congestion, fever, sore throat, mood swings, extreme fatigue, upset stomach. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events pain in arm, tiredness, running nose, sore throat, body aches, headache, congestion, fever, mood swings, extreme fatigue and upset stomach was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient had no information about previous COVID-19 vaccination doses. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. Company Comment: This is a spontaneous case concerning patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of pulmonary embolism, which occurred on an unknown date after a dose of mRNA-1273 vaccine (unknown COVID-19 vaccination schedule). No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-735564, US-MODERNATX, INC.-MOD-2023-735503 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735564:Invalid case US-MODERNATX, INC.-MOD-2023-735503:Same reporter