chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neuropathy flared up very painful in feet hands and breast ..Right arm has numbness on skin but painful under skin from hand to elbow ..what seems to react like tendonitis .
Temperature of 103 the night the IZ's were given. Fever persisted 24-72 hrs. Redness and swelling at right thigh injection site.
Shot area swelled into a huge 3.5 inch hard ball under skin, alot of pain, heat , tenderness, redness; alot of pain; tenderness; redness; headaches; tiredness; nausea; joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:15 (at the age of 33-year-old), as dose 2, single for COVID-19 immunization administered at hospital. The patient's medical history included food allergy, Ginger, cinnamon, turmeric, all spice, nutmeg, drug hypersensitivity, dermatitis contact, rubber sensitivity, hypoglycaemia, food allergy from an unknown date and unknown if ongoing. Other medical history was reported as gurd, anxiety, depression, covid-19, PCOS, Immune difficulties, digestive issues, malabsorbtion, constipation. The concomitant medications included trazodone (TRAZODONE), docusate sodium (STOOL SOFTENER) taken for an unspecified indication, start and stop date were not reported. Patient was also taking unspecified Womens multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0172) from an unknown date in Mar2021, for COVID-19 immunization, ciprofloxacin and experienced drug hypersensitivity, hycosan and experienced drug hypersensitivity. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shot area swelled into a huge 3.5 inch hard ball under skin, a lot of pain (pain), heat, tenderness (tenderness), redness, headache, tiredness, nausea joint pain on 03May2021 18:00. Shot area swelled into a huge 3.5 inch hard ball under skin, alot of pain, heat, tenderness, redness. Was getting slowly worst every day untill day 5 when it started to get smaller. She kept applying ice and Benadryl cream. Also about 3 inches under her puncture area there was a fluid like pocket forming. It was about 2.5 inches round and squishy, also painful. 6 days out from shot and swelling of both balls has gone down 75% along with all other symptoms. She also had headaches, tiredness, nausea, joint pain. She had also noticed an increase in heart burn since my first shot in March, and period changes as well. The events were non-serious. No treatment was received for events. Outcome of the events was reported as recovered with sequelae on an unspecified date in 2021..  No follow-up attempts are needed. No further information is expected.
Two inch diameter of redness around site of injection with soreness at site on right arm. Using cold pack and Tylenol.
Client did not disclose that she received a Janssen vaccine on 3/20/2021 prior to vaccination.  This dose Pfizer dose was given as a 2nd dose.  After discussing with client, she clearly did not understand the guidance for booster doses.
VARIVAX was administered 27AUG2021 following a supported temperature excursion; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 5-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions, or allergies was provided.  On 28-JUN-2021, a temperature excursion involving varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T038830 has been verified to be valid, expiration date reported and validated as 17-NOV-2022) occurred. The vaccine was improperly stored at a temperature of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 27-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, administered dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) as prophylaxis (product storage error).  This is one of several reports received from the same reporter.
Patient received first dose of COVID-19 vaccine. She waited her 15 minutes and exited facility. Patient began experiencing SOB and tightness in her chest outside at her car. Patient came back inside and was evaluated by EMS. Patient taken to  ED for further evaluation.   Vitals: 97.8, 147/91, P 105, EKG PVC's
Adult TD was in advertently given to wrong age group.  Patient did not experience any adverse symptoms or reactions.  Monitored the patient for 15 minutes.
Patient was dizzy after injection, laid down and then breathig got slower. She was twitching for 30 seconds to 1 minute but it wast not a seizure. I called 911 right away and waited until paramedics came. Patient was wiht their parents who stated that she had not drank or ate anything all morning and vaccine was given at 11:30am. Never lose conscious but breathing was very slow.
Pt recvd 3 doses of Engerix-B & did not sero-convert;
sore arm; little tired; This is a spontaneous report from a contactable consumer or other non hcp.  A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), dose 1 via an unknown route of administration on 20May2021 as single dose for covid-19 immunisation. Medical history included stroke from 2019 that was caused because the heart valve, PFO, never closed when he was born so he had an occluder put in. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken once a day for an unspecified indication and ongoing. On 20May2021, the patient experienced sore arm and a little fatigue. He has scheduled to get the second dose on 10Jun2021. Outcome of events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
rash on right arm shoulder to wrist.  next day left arm. was in sun 2 to 3 hours and the left arm became swollen almost twice it regular size . Burning feeling.  a little oozing . Left torso affected also . inner legs hives.
Administration data from Pfizer indicated that the stability data supported using this product through October19. The manufacturer expiration date on the label indicated September 30.
pt got moderna shot, after about 20min she said she was nauseous and dizzy and requested us call 911 for ambulance which we did.  took her blood pressure it was 132/90 heart rate 85.
After about 2 weeks at the injection site (interstitial tissue) of the Janssen COVID-19 vaccine, extreme pain presented about 2 am, lasting a couple hours. This lasted more than 15 days. I would be awake for the day due to the extreme pain. I saw my doctor who initiated a nerve study. I was prescribed gabapentin, which made me extremely irritated and have poor balance. It only slightly muted my symptoms. I stopped taking the medication after only a few days, and a few more days later my symptoms subsided.
15cm area of erythema with 7cm central induration, not painful, mildly itching.
For about 5 hours after receiving the vaccine I felt like I couldn't catch my breath, my heart was racing and I was extremely dizzy.
Patient feeling faint and dizzy. Relieved within 10 minutes via cold compress and hydration.
Patient reports that approximately 10 hours after receiving 2nd dose of Moderna COVID vaccine, she experienced arm pain, fatigue, low grade fever and nightsweats and dizziness with strange sensation in chest. The following morning (<24 hours after dose), she presented to ED with sinus tachycardia (rates ranging 114 - 136).  She started continuous IV fluids and got 2 saline boluses.  Symptoms improved dramatically the second night after the vaccine. No medication was needed to improve heart rate or treat dizziness.
1) Approximately 2.5 + 2.0 erythematous indurated area around injection site from evening of injection at site of PREVNAR administration.  2)  48 hours after injection sudden onset of urticaria scattered over arms, legs, buttocks with many lesions around injection site + itching + fever.
Experienced slight headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Experienced slight headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
neuropathy pain on the 10 toes, no treatment, started a week after the 1st moderna vaccine on 3/22/2021 and lasted until as of today 8/20/2021
Headache, dizziness, extreme muscle ache in places like arms and legs and buttocks, nauseous.  Went to bed early with 3 extra strength generic Tylenol and woke up okay except for a sore arm (that wasn't a big deal).
Pt accidentally received a 2nd flu shot instead of her Pfizer booster.  No adverse reactions reported
Patient received 1st dose of Pfizer on 3/26/21 at a clinic held at pharmacy at his assisted living facility.  At the time patient experienced arm pain and swelling at the site.  Patient then got 2nd dose two months later on 5/06/21 and said that pain radiated from shoulder up to neck muscle and has pain turning his head
22JUL mom reports febrile episode approx 8hr p/vax 19JUL97;temp peak 103 ax;feb episode cont until 20JUL97 when pt was given Ibuprofen/APAP;mom reports Tuesday AM that pt taking fluids well but pt tongue sensitive to juice;
Arthralgia, sore throat,  dry cough, congestion, pain to back of head and neck, leg pain, lower back pain, fatigue, fever 100.7 on 12/23/20 12/26/20- developed chest pain neck pain left shoulder pain lightheaded and nausea at night-resolved next morning
ten hours after receiving vaccine I experienced light headedness and actually passed out.  I also experienced nausea, diarrhea, rapid,  shallow breathing (no difficulty getting air)
Death. Narrative: Patient was not previously COVID positive and did not have any predisposing factors (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 74 but no cause of death listed or notes of recent care. Patient was hospitalized with chest pain in 6/2020 and has h/o of severe multivessel CAD, HFrEF, and polysubstance abuse.
developed an ear infection a cuple days after; developed a generalized varicella type rash; This spontaneous report was received from a consumer and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, lot #, expiry date, route of administration,exact dose and indication were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, lot #, expiry date, exact dose and route of administration were not provided); and  hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, lot #, expiry date, exact dose and route of administration were not provided). All of those vaccines were administered for prophylaxis.  On 23-APR-2023, the patient developed a generalized varicella type rash. Caller stated her son has no other symptoms. Caller said she has applied benadryl (BENADRYL) cream to the sites. Caller mentioned her son developed an ear infection a couple of days after the varicella virus vaccine live (oka/merck) (VARIVAX). The patient started cefdinir (CEDSINIR) to treat the ear infection, but did not provide specifics about the dosage or course therapy. Caller was unable to provide any further clarifying details. At the time of reporting, the patient had not recovered from the event of generalized varicella type rash and an ear infection. No additional advere event was reported.  The reporter considered an ear infection to be not related to varicella virus vaccine live (oka/merck) (VARIVAX). The causal relationship between generalized varicella type rash and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported. The causal relationship between generalized varicella type rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. The causal relationship between an ear infection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. The causal relationship between generalized varicella type rash and hepatitis a vaccine, inactivated (VAQTA) was not reported. The causal relationship between an ear infection and hepatitis a vaccine, inactivated (VAQTA) was not reported.
About three hours after my shot I developed severe muscle cramps in my lower back all the way up to my mid back, this pain lasted 24 hrs. Around 5pm the day after my shot I had a 101 degree fever, a headache and still the severe back pain. I took Tylenol when I noticed I had a fever and went to sleep. I felt much better on Saturday the 10th, two days after my covid shot, but I did notice redness around the injection sight and still had a slight headache and fatigued.
5 DAYS AFTER MY SECOND VACCINE, I  FELT NAUSEA AND LOST OF APPETITE, IT PROGRESSED INTO GASTRITIS PAIN. STILL HAVE STOMACHE ISSUES. I WAS WATING TO SEE IF THEY SUBSIDE, HAVE BEEN CHECKING TO SEE IF OTHERS HAVE SIMILAR SYMPTOMS BEFORE GOING TO SEE GI
Pt recvd DTP/OPV/HIB 10SEP92 - pt exp low grade temp 6PM thurs PM (99.5) APAP & slept til 12NM; APAP-restless
TINGLING; LOSS OF CONCENTRATION; DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, and compazine allergy. 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 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling, loss of concentration, and dizziness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and CT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling, loss of concentration and dizziness was not reported. This report was non-serious.
By the evening of April 16th, I was experiencing a fever of 103.5 after already medicating an hour prior. On the 17th, my fever continued and I noticed vaginal bleeding. On the morning of April 18th, I went to the emergency room because I was still experiencing this bleeding, as well as bleeding from my nose. We came to the conclusion that I had an ovarian cyst rupture.
pt recv vax 2JAN96 & pt devel chickenpox w/over 200 lesions;
At around 10:30 AM on 3/29/2021, I began to notice some irritation and phlegm build up in my throat, as well as some tingling and numbness in my face. This lasted for approximately 30 minutes before subsiding. At around 8:00 PM on 3/29/2021, I began developing a fever and somewhat severe body aches that lasted until the morning of 3/31/2021. I also developed a somewhat severe headache on the morning of 3/31/2021 that lasted through 4/1/2021. The injection site was tender to the touch from the evening of 3/29/2021 until 4/2/2021, and my arm was also very sore during this same time frame. I also noticed unusual exhaustion from the evening of 3/29/2021 until 4/5/2021. During 3/29/2021-4/1/2021, I was taking Tylenol Extra Strength (1 pill every 6 hours or so) to help alleviate symptoms, but it only helped for about 3 hours in the 6 hour interval.
Power outage. Vaccine FLUMIST should have been discarded from stock 11/23/10. Discovered 12/7/10. Pt vaccinated 12/6/10 with FLUMIST.
Tremors start in the bottom of my shoulder blade on the right side and continues up into and down my right arm.
I had a sore throat, headache, cough, runny nose, body aches, lost of appetite.
Right leg pain with severe thigh muscle cramping causing immobility for about 20 minutes.
swollen arm; red spot; chills; headache; threw up; diarrhea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-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 (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up), DIARRHOEA (diarrhea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up) and DIARRHOEA (diarrhea) had resolved and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-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 (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up), DIARRHOEA (diarrhea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up) and DIARRHOEA (diarrhea) had resolved and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Suspected vaccination failure/ Shingrix vaccine on 8/5/2019 / second dose on 10/24/2019 / developed shingles a week ago; developed shingles a week ago; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix. On 24th October 2019, the patient received the 2nd dose of Shingrix. On 20th July 2020, 350 days after receiving Shingrix and 270 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she received 2 doses of shingrix vaccine and developed shingles a week ago from reporting date. No other information was reported. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting.
Admitted to hospital 2 days after second Pfizer covid vaccine. Presented with abdominal/chest pain, found to have a small subsegmental pulmonary embolus on CT scan. No history of prior PE or clots.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a mild outbreak of chickenpox with 20 spots on the trunk, mostly macular. Two of the spots had central vesicles.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 78-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported]. At the time of this report, no adverse event was reported. This case 201805453 was crossed linked to original case 201804863 due to same reporter.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with penicillin and sulfa allergy. On 19-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # K008079, expiration date 03-SEP-2015, subcutaneous, in the deltoid region of the arm. On 23-SEP-2014, the patient experienced the area around her ZOSTAVAX injection was painful to the touch, red, raised and about the size of a half dollar. Patient sought medical attention. No lab diagnostics were performed. The pharmacist recommended oral BENADRYL. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Patient is 15 & 11 months years old and was give FluBloK Quad 2020-2021
Patient developed a cellulitis reaction around the site of injection from the top of the arm to the wrist that was warm to the touch.
Child seen for well child visit on 6/20/06. Baby was well. She received MMR/PCV and Varivax. MMR/PCV given right thigh - Varivax on left thigh. Over next 24 hours, child got flushing episode with face suddenly turning red, low grade fever and then a blotchy macular rash on face, arm, legs. Site of PCV vaccine got reddened.
Patient presents to clinic on 8/30/10 at 0900 with c/o neck swelling and pain radiating to neck 3 days after receiving BOOSTRIX on 8/24/10 in her left deltoid muscle using a 1 1/2 in needle. Pt states "my arm started tensing up on Friday and the pain went to my elbow area first and then began to move up to my neck area. It doesn't really hurt at the injection site unless you push on that area. I took a GOODY powder on Friday (8/27/10), but by Sunday (8/29/10) it turned into a dull/aching pain and I began to notice my neck swelling. I have not had any fever and I have been putting heat on my neck."