chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arrives via POV c/o progressive weakness for past week.  Recent hospitalization for "lung infection" non-covid related.  Daughter arrives reports she has had low oxygen readings at home. The patient is an 89 year old female with hx CKD III/IV, HTN, and CHB s/p PPM placement, recently admitted 12/3-12/5 and 11/19-11/23 with recurrent hypoxia, bronchitis 2/2 viral URI.  Pt presented today to the ER d/t worsening SOB over approximately the last 4 days, low O2 sats measured in the mid-/upper 80's on RA at home.  She went to urgent care, but then was redirected to the ER, where she tested COVID positive.  Pt states she was visited by a vaccinated granddaughter over the holiday who tested positive for COVID on 12/27.  She notes she has had multiple visitors who have had respiratory symptoms, although she is unaware of whether they have tested positive.  Her daughter and SIL, with whom she lives, have tested negative to date.  Pt reports feeling generally weak since her recent hospitalization.  She notes some nasal drainage which is actually improving, pressure "behind" her ears at times, some HA; no fevers/chills/sweats.  She had a couple of episodes of nausea/vomiting in the last 2 days.  She denies constipation/diarrhea/abdominal pain or difficulty with urination.  Pt is fully COVID vaccinated, boosted ~10/2021 according to her daughter.  Pt's daughter reports pt has had roughly 10 lbs wt loss in the last 1 month. Discharged on 1/2/2021 with family and on home oxygen.
patient got immunization on 10/17, came to pharmacy with large erythematous welt where vaccine was administered. suggested hydrocortisone ointment along with benadryl and to follow up with physician
CHILLS; FEVER; This spontaneous report received from a patient 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 08-APR-2021 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 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a 10 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several report from the same source. Additional information has been requested.
13x7 cm area of localized induration, mild tenderness L ant thigh. 2x3 cm area mild erythemia R thigh.
4 hrs p/inject pt felt very tired & slept for 1 hr when woke flet clammy & still very tired; t99.8; pt took APAP & 3 hrs later felt nausea;
Early onset, moderately significant left shoulder joint & localized injection site pain starting within 2 hours after receiving vaccine. Placement of bandaid and confirmed site of vaccine administration) concerning for being given too high up on the left shoulder, very close to /possibly superior to deltoid muscle and very close (if not at) left acromion  at anterolateral aspect high up on upper arm/shoulder . Treatment: Tylenol prn for pain
Moderate pain at injection site for 4 days after first dose.  Fatigue and headache x 1 day.   Moderate pain at injection site for 3 days after second dose.  Joint and muscle pain the day after the second injection.  Low grade fever 99.2 degrees Fahrenheit -99.7 degrees Fahrenheit x 1 day.  Moderately fatigued with headache x 4 days.
Chest neck and face broke out in red blotchy rash. Hot to the touch. Inside of throat felt warm. Light headed. Nausea.  Throat tightness. Happened a few minutes after administration of vaccine.  Waiting in the waiting area for approximately one hour. Waited in vehicle longer. After 4 hours felt almost normal.
This is a spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerning a 46-month-old (reported as 3 years 10 months), male child. The patient's current condition included allergies. The patient's concomitant medication included ZYRTEC for an unknown indication. On 05-Nov-2018, the patient (under 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252680, expiry date: 30-Jun-2019 and anatomical location: not reported). At the time of this report, the patient had not reported any adverse events and was being monitored for side-effects and adverse effects. The reporter assessed the case as non-serious.
she was tired all day and her arm was aching; she was tired all day; on her arm that was 3 inches in diameter that is red, feels hot, and tingly; on her arm that was 3 inches in diameter that is red, feels hot, and tingly; on her arm that was 3 inches in diameter that is red, feels hot, and tingly; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix (left arm). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: on her arm that was 3 inches in diameter that is red, feels hot, and tingly), extremities hot feeling of (Verbatim: on her arm that was 3 inches in diameter that is red, feels hot, and tingly) and erythema of extremities (Verbatim: on her arm that was 3 inches in diameter that is red, feels hot, and tingly). On 29-AUG-2023, the patient experienced pain in arm (Verbatim: she was tired all day and her arm was aching) and tiredness (Verbatim: she was tired all day).The outcome of the pain in arm, tiredness, tingling of extremity, extremities hot feeling of and erythema of extremities were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, tingling of extremity, extremities hot feeling of and erythema of extremities to be related to Shingrix.   It was unknown if the company considered the pain in arm, tiredness, tingling of extremity, extremities hot feeling of and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was the patient who received Shingrix on Monday. She stated that on Tuesday, she was tired all day and her arm was aching.  On Wednesday, her arm was still aching.  At the time of reporting, she noticed an area on her arm that was 3 inches in diameter that was red, felt hot and tingly. The reporter did not consent to follow-up.
Administration Error: A 45 year old male patient receives second booster of the Pfizer vaccine.
Constant crying for approximately 24 hours after vaccines.  Stops for short periods only.  Parent took temperature, rectal 100.  Gave bath temperature after was 96 rectal.  Child then acted like self, stopped crying.  No further difficulties.
Red hardness on her arm which "was hot"; Red hardness on her arm which "was hot"; Bad headaches; fatigue (she couldn't leave the bed); Red hardness on her arm which "was hot"; High fever (102°); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), VACCINATION SITE INDURATION (Red hardness on her arm which "was hot"), PYREXIA (High fever (102°)), HEADACHE (Bad headaches) and FATIGUE (fatigue (she couldn't leave the bed)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Asthma.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (High fever (102°)). On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), VACCINATION SITE INDURATION (Red hardness on her arm which "was hot"), HEADACHE (Bad headaches), FATIGUE (fatigue (she couldn't leave the bed)) and VACCINATION SITE ERYTHEMA (Red hardness on her arm which "was hot"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Jan-2021, VACCINATION SITE WARMTH (Red hardness on her arm which "was hot"), PYREXIA (High fever (102°)), HEADACHE (Bad headaches) and FATIGUE (fatigue (she couldn't leave the bed)) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red hardness on her arm which "was hot") and VACCINATION SITE ERYTHEMA (Red hardness on her arm which "was hot") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Heavy eyelids, sleepy, tightening in throat and chest, heavy legs, and arms heavy. Called 911 and was taken to hospital. Elevated blood pressure. Pt was not hospitalized, but was seen in the ER only. EMTs administeered for baby ASA. NTG. No further treatment required. Pt stated her heart felt "fluttery" and she "just didn't feel right".
Information has been received from a pharmacist concerning a 73 year old male patient. The patient had no drug reactions and allergies. On 15-MAY-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous). Concomitant therapies included unspecified medications. On 26-MAY-2015, the patient was given a prescription for MEDROL for a 6 day course for an unspecified reason. The reporter stated that the patient had not started MEDROL yet. The patient had sought medical attention by an unspecified way. The outcome of the event was unknown. Additional information is not expected as no consent to contact physician.
Site: Pain at Injection Site-Medium, Additional Details: arm still aching where shot was given. aching started 2 weeks after injection
Presented to ER with C/O itching starting at her hands & progressing all over body. Generalized redness over face, chest & arms. Slight anxiety & changes in voice. Rx with IV BENADRYL & SOLUMEDROL. Rx given for MEDROL DOSEPAK, PEPCID & ATARAX & EPIPEN.
Patient reported that there was swelling at injection site and arm was very sore. Some redness at injection site. No treatment that I know of.
some swelling, warm at site of injection lasting 48 hours; reaction was redness, some swelling, warm at site of injection lasting 48 hours; warm at site of injection lasting 48 hours; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure (taking medicine daily).   On 25th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced injection site swelling, injection site erythema and injection site warmth after vaccination. The patient asked when should get the 2nd dose to complete the vaccination. The patient was taking blood pressure control meds daily.
My lips and tongue became swollen, I became hoarse and wheezy and had to use my inhaler, my heart raced, I became dizzy and shakey.  I became extremely anxious
As a patient, I am very grateful for being given the vaccine as a Native American and tribal person.  I have never had this rash of this type AT ALL in my entire 47 years (now 48 since I had a birthday after the shot on April 21st). However, I had a very bad reaction to the first shot with a rash across my stomach.  It did not itch.  However, it was a long, spread out rash across my lower left "trunk" area of my lower pelvic region with a focus on the left side, but some on the right.  There are still some oval shapes there.  They used to be read, but are now brown and oval.  They have left a permanent scar.  It WAS alarming at first, but was ONLY MILDLY itchy at worst, so fortunately it was not painful.  Now, it looks like it is going to leave a permanent scar.
Patient seen for physical 8/30/16. Patient said his joints are achy, sweating profusely, chills, headache. No arm redness, no swelling, not hot to touch. Pt seen for appt. 8/30/16, called office 9/1/16 11:24 am.
Severe neck pain. Loss of almost all of my mobility in my neck. Pain would be described as crushing pain.  As of today, neck pain has reduced maybe 25% with over the counter medications on board.
Missing work; Nauseous; Headache; Chills; Extreme fatigue; Not feeling well/ felt sick; Couldn't get out of the couch; Diarrhea; Sweating at night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well/ felt sick), DECREASED ACTIVITY (Couldn't get out of the couch), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating at night) and IMPAIRED WORK ABILITY (Missing work) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MALAISE (Not feeling well/ felt sick), DECREASED ACTIVITY (Couldn't get out of the couch), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating at night), NAUSEA (Nauseous), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Missing work). At the time of the report, MALAISE (Not feeling well/ felt sick), DECREASED ACTIVITY (Couldn't get out of the couch), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating at night), IMPAIRED WORK ABILITY (Missing work), NAUSEA (Nauseous), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Extreme fatigue) 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.  Treatment information was not provided.   This case was linked to MOD-2021-076982 (Patient Link).
Dry, wheezing cough; by 8 AM 12/11/2016 cough is more intense, more frequent, and productive; sensation of restriction in chest; headache; respirations 27/minute; resting heart rate 78; temperature unknown but at or near normal (98.6) by estimate; blood pressure unknown but not noticeably elevated; no chills as of 12:32 PM 12/11/2016; mild muscular soreness at injection site (left deltoid); patient self-administered 400 mg guafenesin approximately 11:30 AM 12/11/2016, 600 mg Inuprofen, and menthol cough drop; and used existing CPAP for improved breathing. Will report changes/outcome subsequent to this report.
I am experiencing localized inflammation around the injection site that is raised and itchy, red and hot. It is red at the cite and a raise circle around the injection site. It has grown in the days since it has began.  It started like a 1 inch redness and is now about 3 inches.  It appears to continue to get larger.  The course of it began around the 18th of January and 3 or 4 days later it remains and is getting bigger.  I have a low grade fever of 99 but no aches or any other discomfort.
04/22/2021 STARTED GETTING INTERMITTENT HEADACHES WITHIN THE CROWN HEAD, WITH A PAIN NUMBER 7 , WITHIN A PAIN SCALE 1-10.  Did a virtual PCP appt. , no meds were prescribed, was advised to call COVID hotline.   ADVIL - UKNOWN MG, 3X PER DAY.
I had a terrible pain in my leg between the knee and the groin; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), first dose via an unspecified route of administration, administered in left arm on 21Feb2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date approximately 14 hours later after her vaccination, early morning, she had a terrible pain in leg between the knee and the groin and it lasted for couple of minutes but it was very severe and she didn't know whether she should report this or not."  She stated "my height is 5 feet 6 inch, I think I am shrunk and my weight is 210, more or less". Outcome of the event was unknown.
Vaccine expired 7/26/22, administered the next day 7/27/22. Phone number on file is no longer working, unable to reach mother to inform her of incident and next course of action.
Information has been received from a registered nurse concerning an 18 year old female patient with no medical history or allergies who on 25-JUN-2007, was vaccinated IM into the left deltoid with a first 0.5ml dose of Gardasil (Lot # 658100/0525U). There was no concomitant medication. On 30-JUN-2007 5 days later, the patient developed hives all over the body and her throat felt like it was closing. It was reported that the patient went to the emergency room and was given in IV and unspecified steroids. The patient was discharged on steroids and BENADRYL. Subsequently, the patient recovered. No product quality complaint was involved. The reporter felt that the hives all over the body and throat closing were considered to be immediately life-threatening and other important medical events. Additional information has been requested.
Approximately 17 hours post immunization, the patient developed a large, hardened area where vaccine was administered. About 8 hours later, she felt nauseous. About 10 hours later, she developed a stiff neck, headache and temperature of 101 with chills. Her left arm developed spasms running down her arm which have lasted until the present. On 5/22 she developed a rash at and around the injection site which was warm to the touch.
Within 24 hours after TD developed fatigue, pain in shoulder where injected and erythema. Pain described as 5 of 10. On exam + erythema, no induration, no welts.
Fever for 2 days up to 102 degrees.  Loss of appetite, agitation, confusion, diarrhea, hallucinations, irritability, mood/mental changes when she tries to sleep.  Wakes up 30-40 times per night very confused and crying stating that the "house is shaking"...very agitated.
Rash; This is a spontaneous report from a contactable consumer (patient reported herself). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number/NDC number/Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient also took carbamazepine (TEGRETOL, Batch/lot number/NDC number/Expiry Date: Unknown) via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash. It was reported that, "caller scheduled for first dose of vaccine at the end of this month. Previous allergic reaction to Tegretol, contains polyethylene glycol. Reaction 2002/2003 painful rash. Potential adverse event". Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had an appointment on 25Feb2021 to get her first injection. Caller said that she had been looking at the information online concerning the vaccine. A while back she took Tegretol and reacted from it. Caller did not have a NDC, Lot, or expiration date for the Tegretol. Caller said that it had been a long time since she took it. She took Tegretol for 4-6 months and she got a terrible, terrible rash from it. This was in 2002-2003. She said that it took a year to get rid of the rash. Caller said that the Covid-19 Vaccine and the Tegretol both contain Polyethylene Glycol and when you look at the information online, it said not to get a mRNA vaccine if you are allergic to Polyethylene Glycol. Caller said that she wanted to make sure that this was still the up to date information. Outcome of the event was unknown.  Information about lot/batch has been requested.
This spontaneous report was received from a medical assistant concerning a 13 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of Wistar ra 27-3 M-M-R II (dose, therapy type, Lot # and expiration date not reported) for prophylaxis. Concomitant therapy included the diluent (dose, Lot #, expiration date not provided). On an unknown date, 5 months after the first dose, the patient received the second dose of Wistar ra 27-3 M-M-R II. No adverse effects were reported.
This spontaneous report as received from a 22 year old, non-pregnant female patient. Patient's medical history and concurrent conditions were not reported. On 06-FEB-1994, the patient was vaccinated with a first dose of M-M-R II (lot number, expiry date, dose, route were not reported). On 23-JUN-1998, the patient was vaccinated with a second dose of M-M-R II (lot number, expiry date, dose, route were not reported). Concomitant medications were not reported. On 05-FEB-2015, the patient had "titers" test performed, and the results confirmed that she was not immune against the measles. The outcome of the event was not reported. No treatment was given for the event. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Itchy rash on both left and right upper arms. Symptoms subsided after taking Benadryl 25mg
p/vax pt exp swelling, redness & local irritation @ the inj site & fever;
Extremely tired. Left arm is tender at injection site. On 01-10-22 woke up to red, painful rash on both eyelids and around both eyes. Also, a very tender lump under my left arm pit area occurred.
4 hours afterwards became extremely dizzy. Subsided & felt better approx 30 hrs later. One week later, became extremely dizzy again. Went to ER for work up. Not admitted, was told it was adverse reaction to first vaccine.