chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible colds; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An 85-year-old female patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Terrible colds"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm". Additional information: The patient was concerned what she should do since her second dose was scheduled at the time of the report. She was experiencing terrible colds and also after her first dose she experienced sore arm. So, that was why she asked if she should continue getting her second dose that day or should she wait (a week) until she felt better. She lives two hours from where vaccination site, but she was just not feeling up to a two-hour drive due to the terrible cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash on hands, neuropathy in left hand and foot, headaches, fatigue, nausea, joint pain,  body aches, tachycardia, low and high blood pressure spikes causing fainting, brain fog, vomiting, memory and concentration issues, recurrent UTIS
Pain at site of injection (upper left arm) was severe for two weeks, then mild for a month
Felt sick; Delayed rash on chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick) and RASH (Delayed rash on chest and neck) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VALSARTAN, APIXABAN (ELIQUIS), LEVOTHYROXINE and DENOSUMAB (PROLIA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced RASH (Delayed rash on chest and neck). On an unknown date, the patient experienced ILLNESS (Felt sick). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt sick) and RASH (Delayed rash on chest and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included antihistamine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up information was received on 11 Jun 2021: added new event
It has felt like my skin has a massive sunburn. Everytime my clothes rub on me, I touch myself, someone else touches me, I lay down, etc my skin is in a lot of pain.
I went to get antibody infusion on 11/12/2021 at the clinic and my leg was swollen; the nurses told me to contact my doctor to get examined. They took me to the emergency room to get it examined and discovered there was a blood clot in my leg causing the swelling. They prescribed me Eliquis (blood thinner) to help reduce the swelling and tension in my leg; I was in the hospital for 4 days before being discharged home. They sent me home with at-home exercises to do to prevent future inflammation I've made a steady since then; I have a follow-up appointment  in April for an ultrasound to check the status of my leg and recovery.
I was given the flu shot on Monday, 10/30/00. Tuesday night, I was very sick. On Wednesday, I had nausea all day, I got so dizzy, all day, that I couldn't walk. I felt like I was walking sideways. Wednesday night, I had hives. The follow up states, "I also beside hive-sick and dizziness had a eyelid twitch lasting 5 weeks. Went to Dr. and he said somethingin that this shot did not like me. He gave me Claritin and Allegra."
After the 2nd Vaccine Shot I was very tired, chills and high fevers up to 103 degrees. My husband called doctor office , we were told to take Tylenol and  the fever broke the next day,  still weak. I had a sinus infection and was on a 5 day antibiotic the week I took the shot. On the last day I had the Covid -19 Vaccine 2nd dose and later came home and took the last antibiotic.  Did the anitbiotic interfere with the 2nd Covid-19 Vaccine?
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) (batch number 2MA5F, expiry date 30th June 2019) for prophylaxis. The patient's past medical history included shingles. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) .5 ml. On 31st January 2019, 122 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced shingles, tingling and rash. On an unknown date, the outcome of the shingles, tingling and rash were unknown. It was unknown if the reporter considered the shingles, tingling and rash to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were received as follows: The patient received SHINGRIX in the left deltoid and Influenza vaccine Quadrivalent 2018-2019 season in the right deltoid. After vaccination, the patient experienced a mild shingles outbreak on his head, which was further described as tingling and a slight rash. The patient was not diagnosed by the physician, but the patient self-diagnosed. The reporter consented to follow up.
Leakage occurred between needle and syringe upon administration. Patient notified. CDC errors document reviewed, booster dose re-administered per CDC guidance. Patient in agreement.
Large erythmatous plaque developed around site of MMR injection 24 hours after vaccine administration.  Patient has pruritis at site of swelling.
red spot rash on lt anterior thigh approx 2-4 in circumference-warm to touch-painful for pt to walk;
slight fatigue; trouble getting out of bed; verge of passing out; sick to stomach immediately; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to stomach immediately), DIZZINESS (dizzy), LETHARGY (trouble getting out of bed), VERTIGO (verge of passing out) and FATIGUE (slight fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Thalassemia minor (thalassemia minor-type B) since an unknown date, Neck discomfort (neck issues) since an unknown date and Pacemaker insertion (cardiac) (10-Feb.).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach immediately) and DIZZINESS (dizzy). On 08-Mar-2021, the patient experienced LETHARGY (trouble getting out of bed) and VERTIGO (verge of passing out). On an unknown date, the patient experienced FATIGUE (slight fatigue). At the time of the report, ABDOMINAL DISCOMFORT (sick to stomach immediately), DIZZINESS (dizzy), LETHARGY (trouble getting out of bed) and VERTIGO (verge of passing out) had resolved and FATIGUE (slight fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy bone marrow: unknown (Inconclusive) 24-feb. On an unknown date, Blood test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Event details were added and updated
first/last august but never followed up with the second shot.; This case was reported by a other health professional via Shingrix GSK and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in last August from the date of reporting).  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 reported as follows: The age at vaccination was not applicable for this report. The patient got the 1st Shingrix shot last August but never followed up with the 2nd shot.  The patient did not received the 2nd shot till the time of reporting which led to incomplete course of vaccination. The reporter asked did they start over with the series or just give 1 more shot. No contact details were reported.
COVID-19/tested positive after testing negative several times; COVID-19/tested positive after testing negative several times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 51 years, in right 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 included: "Diabetes" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER, start date: 04Jun2022, stop date: 16Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022 at 18:00, outcome "recovering" and all described as "COVID-19/tested positive after testing negative several times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Pfizer Paxlovid as treatment (Treatment start date: 25Jul2022, Treatment stop date: 30Jul2022, lot number: GC9452, as reported).
From telephone conversation with reported, it was stated that a 4 year old (2 of 4) was vacationed with Tripedia Lot # UO356AA (date not specified). Some time after the vaccination,  the patient developed a local reaction(date of onset not specified). Further information is requested. Linked cases:  U2001-00950, U2001-00957 & U2001-00958. From additional correspondence received on 09/18/01 it was reported that the patient, a 4 year old female received a Tripedia, an IPOL, and a Measles, Mumps, Rubella (MMR, Merck) vaccination on 08/11/01. Reportedly on 08/12/01 the patient developed severe swelling and redness and the injection site of the Tripedia vaccination and a fever. Reportedly the patient recovered from this experience.
This case was reported by a consumer and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site inflammation and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site inflammation and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site inflammation and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on Friday at 10.40 am at his primary care doctor's office. The patient's injection site had been red, inflamed, and very sore since then. The size of the redness was about the size of a cell phone or about 5 inches by 2 to 3 inches on his right upper arm.
This spontaneous report was received from a medical assistant referring to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004885, expiry date 23-OCT-2017) (dose and route not reported). The vaccine was exposed to temperature of 61 Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse effects and no product quality complaints (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
CHILD RECEIVED PFIZER ADULT DOSE AT AGE 11 BEFORE VACCINE APPROVED FOR CHILDREN (5/14/2021).  CHILD ALSO RECEIVED SECOND DOSE ON 6/18/2021, STILL AT THE AGE OF 11.
The adverse event I am reporting is swelling face. The start was the lip and nose area and now it is all the way to the eye area (right half of my face). Did some reading and some said it could be due to facial fillers. I never had facial fillers before. Other side effects that came are the same as many have reported. Fever and chills day after taking. Fever lasted for two days. Chills are still happening at night.
Gardasil given 11:45 L.A. Patient instructed to wait 15 minutes to be observed. 1210 Pt slumped over in chair, not responsive to voice. Lowered to floor-eyes open, pupils dilated, began clonic-tonic movements lasting approximately 10 seconds. Pt awoke immediately; dizziness, nausea, vomiting continued until transported to ER.
Child was Given 12 year and older Covid vaccine  dose 2. Was documented in his chart as covid vaccine dose 2 5-11 years. Patient did receive Covid vaccine dose 2 12 year and older.
My left arm had a raised red swollen rash 1 day after vaccine. This lasted about 4 days.  Then this went away and came back.  A week from my first vaccine my arm has become swollen, red and sore.  I've also been feeling very fatigued since this vaccine.
Pt got vax about 10AM 23OCT90 had APAP a/hand; pt started crying a high pitched cry 1/2 hr later screamed for 4 hrs & was restless; MD ordered APAP w/codeine; no fever or other problems;
Pt starting swelling, pain, and redness at the site of immunization around sunday a day after the immunizing date. Pt was advise to take otc analgesics and apply cold compress - if it doesnt resolve with 48hrs to get help from urgen care and or pcp
Fatigue started at 7pm on 10/22/2021. Body aches, fever (102 degrees Fahrenheit), and nausea started at 9pm on 10/22/2021.  At 10pm, intractable vomiting started until about 1am on 10/23/2021. Visited ER for intravenous Zofran and fluids. Subsequent migraine on 10/24/2021 and lingering nausea until 10/25/2021.
Patient walked in the next day reporting pain at last after the injection.  Unable to sleep. Took Motrin for the pain. Next day report swelling of arm. Walked into clinic approxmiately 1500.  Patient presented with minimal edema from right shoulder to elbow.  Edema from elbow to wrist and slight edema in fingers. Right arm warm to touch. Patient complained of itchiness. Some very faint areas of redness around elbow area. Advised patient to utilize ice on the arm and take Benadryl.
NAUSEA/VOMITING, REDNESS TO SITE, LIGHTHEADNESS/DIZZINESS.
The next day of vaccination I had my lymph node swollen on the axilla on my right arm. It lasted for almost 3 weeks.  Talked to a doctor where I worked & he said to massage the area.
Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and glands lasted for 2 days. Three days later, tremors feeling possible seizure but did not have one. Additionally stated to have muscle spasms, weakness and muscle contractures mainly right side extremities and lower back and pelvis area started. The muscle spasms have continued to occur just not every day any more. I had muscle spasms in my leg last night so would not say all symptoms have resolved yet.
MS symptoms; painful arms, legs,hands and feet; painful butt; painful chest; painful face; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "MS symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful arms, legs,hands and feet"; MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "painful butt"; CHEST PAIN (non-serious), outcome "unknown", described as "painful chest"; FACIAL PAIN (non-serious), outcome "unknown", described as "painful face"; PRURITUS (non-serious), outcome "unknown", described as "itching". The patient underwent the following laboratory tests and procedures: test: Unknown results. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: It was reported that patient had revolted immune system against the last booster Dec2022. Patient had MS symptoms but nerves are normal. Patient had every test. Patient lost 4 months of his life and afraid will never be normal again. Patient was not an antivaxer. Patient was the first one to stand up for the vaccine and on high doses of gabapentin and still feel the numb and itching and painful face, arms, hands, chest, butt, legs and feet. Patient just turned 68 and was an active person. Patient was scared for the rest of his life.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Started spotting the day after the shot and continued or a few days even though it wasn't time for my period.  A few days after that I noticed a spot on the inside of my right leg that was sore to the touch.  It turned black like a bruise and then a rash developed over the top of it.  The bruise was in a straight line and I never bumped into anything.  A few days later it started throbbing where I could see it visually pulsing.  Freaked my husband out.  I had blood tests done and they were normal.  My doctor who I talked to over the phone thought it might be a Thrombophlebitis so she had my take a high dose of Bayer and a small dose for a few days after.  The pain and swelling was much less even the day after taking the Bayer and it continued to get smaller until the rash went away.  I still have noticed I'm bruising more easily since the shot however and my periods which have been very heavy for years are now much lighter and shorter.
Starting menstrual cycle 10 days early (10/27); lasted 2 days longer than usual (until 10/3), heavier bleeding, and painful cramps. SECOND period started 10/12; immediately had intense painful cramps and heaviest bleeding I've ever experienced
your Covid vaccine caused me 30% hearing loss and tinnitus; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (medically significant), outcome "not recovered", described as "your Covid vaccine caused me 30% hearing loss and tinnitus"; TINNITUS (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: 30% hearing loss. Therapeutic measures were taken as a result of hypoacusis, tinnitus. Clinical course: Patient was acquiring today to hope to get a reimbursement for hearing aids because your Covid vaccine caused patient 30% hearing loss and tinnitus which patient's insurance did not cover.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male, unspecified age and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, 1 total administered on an 25-MAR-2021 to left arm for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, 1 total administered on 11-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-JAN-2022, the patient took rapid PCR (polymerase chain reaction) test and tested positive. On 22-JAN-2022, the patient took regular PCR (polymerase chain reaction) test and tested positive. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious This report was associated with product quality complaint: 90000215646, 90000215655, 90000215657. The suspected product quality complaint has been confirmed to be voided (did not meet criteria) based on the RA evaluation/investigation performed. This case is a duplicate of 20220204336 and 20220203694.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Vaccine was given and pt tensed up while shot was being given. Pt stated she had arm pain at injection site for a few days that eventually moved up to her shoulder area.  It has been 4 weeks since vaccination and pt's shoulder was inflamed on 10/25/21 when she came in for a pfizer booster shot. Pt states arm cannot be lifted above her head and is painful (~4-5/10) in certain positions. Pt was advised to go to PCP to have it checked out.
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving Nasal FLUMIST. Concomitant medications included Loratadine. FLUMIST started on 12-Jan-2013. The patient experienced tested positive for flu B. The patient recovered from the event of tested positive for flu B on an unspecified date. The report was considered to be non-serious.
Raised Bumps, itching, spreading. Went back to pharmacy and was advised to use topical benadryl and oral benadryl.
1PM 30AUG91 mom described "hives" on PT's legs that doubled in size & number "in 10 min"; TC to MD; MD rx'd DPH & cortisone cream; mom denied diffuculty breathing & other symptoms; 5PM PT to ofc; MD states hives nearly resolved;
swelling/tenderness lt shoulder & lt hand-redness @ site of inj lt shoulder;