chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have never had migraines, now I get them every two weeks along with vertigo sometimes. My feet are always cold now. My feet tingle and feel like they are falling asleep. My hands feel like they are cramped in a fist from riding motorcycle all day and I do not own one. I am tired all the time. I usually only needed 4 to 6 hours of sleep and now I need 8 to 10. Sometimes I will start to feel tired and sit down and wake up 12 to 14 hours later. I have odd feelings in my chest like it hurts then it disappears all of a sudden.
rash on both legs, itching, fatigue, headache, muscle pain in arm where shot was given, chills, and warm forehead. Red spots on face. pain is arm last until Wednesday late afternoon. I still have rash on legs to date no itching.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198, Expiry date: not reported), via an unspecified route of administration in left arm on 28Feb2021 at 14:45 (at age of 73-years-old) as dose 1, single for covid-19 immunization in school or student health clinic. Medical history included high blood pressure, restless leg syndrome, intersitial cystitis, history of deep vein thrombosis. Concomitant medication(s) included donepezil hcl, taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; duloxetine hcl taken for an unspecified indication, start and stop date were not reported; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for an unspecified indication, start and stop date were not reported; metoprolol tartrate taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; memantine hcl taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Feb2021 at 22:00, the patient experienced sore arm. The event was assessed as non-serious. Therapeutic measures were taken as a result of sore arm. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Nausea and vomiting starting 3 to 4 days after vaccine and worsening each day to recent. Multiple bouts of vomiting in a session.
Second dose for child. Child had typical side effects until day 3 and woke up with rash on trunk, fronts and backs of legs, and buttocks. 6/1/22: sore arm 6/2/22: sore arm, headache, nausea 6/3/22: Extreme Fatigue 6/4/22: Rash on trunk, legs, and buttocks. Dark circles under eyes
(Saturday)rigors @about 730 PM with temp of 100.9.  Tylenol 650mg taken.    (Sunday)Body aches in the morning with temp of 100.5.  Ibuprofen 600mg taken.   Felt better about 3pm.   (Monday) Pain/discomfort to armpit and numbness to Left arm (Arm that injection was given)
Continuous cramp in deltoid muscle was initial symptom.  Neck spasms and headache followed later in the day/evening on 7/29/2015.  Hip pain and low back pain by evening and night of 7/29/2015.  All symptoms were on the left side; side of injection.  By 9:00PM on 7/30/2015 cramp involving left thigh lasting 10-15 minutes and making it very difficult to walk.  Headache, neck, low back, and deltoid pain continues to present 7/30/2015 11:10pm. Difficulty finding appropriate wording slight dizziness- 7/30/2015 200mg Advil taken at 11:11 PM 7/30/2015.
fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue). The outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt date: 17-JUL-2023 The physician reported that some patients had systemic adverse reactions/fatigue within 24 hours of receiving shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
After being exposed to COVID the first week of May,   I presented with a chicken pox type rash on my trunk and back.  The rash has been slowly spreading to my extremities and I have also had oral lesions appear.  I have had chickenpox as a child in the past when I was twelve.  Suspecting COVID after my son tested positive  I took a rapid Binax test on May 12 and it came back inconclusive which I then followed up with a salvia test the same day that came back negative later.  After trying a steroid burst prescribed by a dermatologist the rash did not improve and continued to spread.  I recently completed a CBC and CMP which showed an elevated eosinophil count and low anion gap.  I am not sure if this is a direct effect from the vaccine but I wanted to put my symptoms out there in case more dermatological events are reported.  The rash does not seem to respond to steroids either topical or oral but there is some minimal relief provided by topical Benadryl and oral hydroxyzine.
A titer showed a "suboptimal response" to the M-M-R II vaccination.; On an unknown date during childhood, a patient received a dose of M-M-R II, then on 08/29/2017, the patient received another dose of M-M-R II. Then on an unknown date after that, the patient received another dose of M-M-R II.; On an unknown date during childhood, a patient received a dose of M-M-R II, then on 08/29/2017, the patient received another dose of M-M-R II. Then on an unknown date after that, the patient received another dose of M-M-R II.; This spontaneous report was received from a pharmacist and refers to a currently 53 year old female patient. The patient's concomitant medications included levothyroxine and olopatadine hydrochloride (PATADAY). The patient's concurrent conditions included hypothyroidism and seasonal allergies. The patient's pertinent medical history and drug allergies were not reported. On an unknown date during childhood, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously for vaccination against measles, mumps, and rubella (dose, lot # and expiration date were not reported).  On 29-AUG-2017, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously lot # M006544, expiration date 03-FEB-2018 for vaccination against measles, mumps, and rubella (dose was not reported). Then on an unknown date after that, a titer showed a "suboptimal response" to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination (antibody test negative). On 05-MAR-2019, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously, lot # N023150, expiration date 24-AUG-2019 for vaccination against measles, mumps, and rubella (dose was not reported) (extra dose administered). The outcome of the occurred events was not reported. The causal relationship between the event antibody test negative and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Information has been received from a nurse practitioner concerning a 63 year old female with penicillin and codeine allergy who on 11-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), estrogens (unspecified) and calcium (unspecified). On 11-FEB-2011 the patient had cluster-like blisters around injection site and having a fever along with flu-like symptoms. TYLENOL (unspecified dose, frequency and manufacturer) was given for the symptoms. The patient visited on 15-FEB-2011 and reported that her symptoms were starting to get better, however the blisters were still visible. At the time of reporting, the patient was recovering. No further information is available.
warmth to touch; injection site reaction; knot at injection site; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th June 2019, 1 days after receiving Shingrix, the patient experienced injection site reaction, injection site lump and general body pain. On 7th September 2019, the patient experienced skin warm. On an unknown date, the outcome of the injection site reaction, injection site lump, general body pain and skin warm were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, injection site lump, general body pain and skin warm to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in left deltoid. On 27th June 2019 and day after Shingrix, the patient experienced injection site reaction. On 7th September 2019, the patient reported, she felt as she developed a delayed injection site reaction. All the events had resolved. The reporter did not consent to follow-up.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, less than a day after receiving SHINGRIX, the patient experienced swelling, erythema and induration. In September 2018, the patient experienced itching. On 17th September 2018, the patient experienced pain in arm, shoulder pain, sleeplessness, chills and limb discomfort. On an unknown date, the patient experienced swelling of fingers. On an unknown date, the outcome of the pain in arm, shoulder pain, swelling, erythema, chills, itching and induration were recovered/resolved and the outcome of the sleeplessness, swelling of fingers and limb discomfort were unknown. It was unknown if the reporter considered the pain in arm, shoulder pain, sleeplessness, swelling, erythema, chills, itching, swelling of fingers, induration and limb discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced some swelling, redness and hardness. Less than a week after receiving SHINGRIX, the patient experienced some itching when the swelling, redness and hardness started to go away in 3 days. Eleven days after receiving SHINGRIX, the patient's two middle fingers on her left had began to had pain that went up to her shoulder and could not sleep for 3 days. Less than a year, the patient's some fingers no her right had to swell which lasted a couple of days for which she could not use her hand. This had improved and the swelling was gone. The patient experienced some pain and chills for 2 months. The reporter saw a nurse practitioner but the patient said the nurse ignored her concerns. The reporter said that she was scheduled to have the 2nd dose on 6th November 2018 and she had reservations on whether she should get it. The patient wanted to know if there was any benefit from getting only one dose reservations on whether she should get it. The reporter consented to follow up. Emergency room visit required.
pt recv vax & appeared was going to faint-lowered to floor w/some assistance;color-pale, not diaphoretic, or cold & clammy;skin warm & moist;back sl arched;pt voided & became alert;
I stayed at facility after injection for 1/2 hour due to my allergies,   I left and about 10 minutes after leaving I started with Hives all over.  I did take 2 Benadry which I keep with me and I have an epi pen which I did not use.  I did not have difficulty breathing so I went home and took another Benadry before bed.  I did have pain and redness and swelling in same arm as well, which eventually resolved and hives resolved by the late evening.  I did have correspondence and notified the email I received after the vaccination.
parent reported lesions on entire body, diagnosed by physician on clinical symptoms 11/26/2005.
felt horrible; Exhausted; Muscle pain; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the parent.  A 26-years-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), when the patient was 26 years old, for Covid-19 immunization, reaction(s): "didn't feel so great". The following information was reported: FEELING ABNORMAL (medically significant), outcome "unknown", described as "felt horrible"; FATIGUE (non-serious), outcome "unknown", described as "Exhausted"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: Caller stated that her son felt horrible. He was just exhausted, had muscle pain, chills, just exhaustion, so that was why she wondered if the booster would be the same if that was what happened to him after the second vaccine. She asked if does the booster have twice as much medicine. She was a little bit scared for her son, but he was otherwise healthy. The investigation assessment was not provided.  No follow-up attempts are possible. No further information is expected.
Patient had s/s of redness and swelling with heat on the left deltoid area. She didn't complain of any itching or pain. The area of redness and swelling had a diameter of roughly 5 inches. On the following day the swelling moved down to the elbow area, but swelling around  the deltoid area has decreased.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was 11/29/2004. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 11/29/2005 which made the vaccine a contraindication.  No known adverse reactions noted.
covid; received his first dose on 18Apr2022, then he caught Covid and was unable to come in, he received his second dose on 02May2022; Initial information received on 09-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via Nurse.  This case involves a 20 years old male patient who experienced covid and inappropriate schedule of vaccine administered while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2022 , the patient received a dose 1 of suspect RABIES (HDC) VACCINE, powder and solvent for suspension for injection, 0.2 ml (lot T1E321M: expiry date 16-Sep-2022)  via intramuscular route in the left deltoid  and  On 02-May-2022 he also received 0.25ml dose 2  of the same vaccine  lot T1E321M via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported that the patient received his first dose on 18-Apr-2022, then he caught covid and was unable to come in, he received his second dose on 02-May-2022 (inappropriate schedule of product administration) (covid-19).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (covid).  At time of reporting, the outcome was Unknown for  both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Breakthrough case admission after 4 vaccines Pfizer 1/27/21 Lot# EL3248;  Pfizer 2/17/21 LOt# EM9810  Pfizer 9/8/21 Lot# Ew0179;  Pfizer 4/24/22 Lot# NO LOT #RECORDED in database
Information has been received from a physician concerning a 3-year-old male with a history of rash occurring twice on the left upper leg with no additional pertinent medical history and no history of drug reactions or allergies who on 16-AUG-2004 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (Lot # 648320/0115P). There was no concomitant medication. Subsequently, the patient experienced shingles on his left upper leg. There was noted to be about 20 lesions with itching and pain. The child's mother reported that this is the third time her child had such a rash in the same area. No laboratory or diagnostic studies were performed. The outcome at the time of this report was recovering. There is no additional information to report. There was no product quality complaint involved.
Well child screening on 2/8/2008.  Received immunizations at office visit.  Mother called nurse advice line on 2/9/08 at 1:35 pm and reported that her child's right lateral thigh was red, swollen and warm and painfull.  Size of an orange.
I experienced mild joint/muscle aches the day after receiving the 2nd shot.  The side effect lasted for only 1 day.; I experienced mild joint/muscle aches the day after receiving the 2nd shot.  The side effect lasted for only 1 day.; This is a spontaneous report from a non-contactable consumer. A 57-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EL3247) as for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID after vaccination. The patient reported that, the day after receiving the 2nd shot, on 20Feb2021 08:00, she experienced mild joint/muscle aches. The side effect lasted for only 1 day. The events recovered on an unspecified date in Feb2021 without any treatment.  No follow up attempts are possible. No further information is expected.
1 hour after receiving Bexsero became nauseated, sweaty, and achy all over.  Left deltoid wnl, other than tender to touch where immunization administered.
Pain noted at the injection site (Right deltoid) the next day that radiated to the underarm area. She noticed swelling of the right underarm area. Pain of the underarm was a 5 out of 10 lasted about 1-2 days. Now pain is a 2 out of 10 and the swelling persists. Pain at the injection site was an 8 out of 10 the day after administration and lasted x 3 days- has since stopped hurting.
After initial soreness in arm went away, there is now an aching in that arm and occasionally a burning/cold feeling that comes and goes. The pain seems to be getting worse and not resolving.
There was severe pain in the left arm for 48 hours; constant tingling in the left arm from the shot site down to my wrist; constant tingling in the left arm from the shot site down to my wrist; This is a spontaneous report from a contactable consumer reported for herself. A 59-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 27Sep2021 13:45 (Batch/Lot Number: FF8839) (at the age of 59-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  Medical history included Diabetes type 2 from an unknown date, neck surgery from 2007 to an unknown date.  There were no known allergies. The patient did not get covid prior vaccination. The patient did not get other vaccine in four weeks. There were no other medications in two weeks. There were no concomitant medications. Historical vaccine included the patient received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Batch/Lot No: EL1283) (at the age of 58 years old) as dose 1 single for Covid-19 immunization; The patient received second dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot No: EN5318) (at the age of 58 years old) as dose 2 single for Covid-19 immunization. On 27Sep2021 02:00 PM, there was severe pain in the left arm for 48 hours. Afterwards she had constant tingling in the left arm from the shot site down to her wrist. The events resulted in Disability or permanent damage. There was no treatment received. The outcome of the events was not resolved. The patient did not get covid tested post vaccination.
left arm is hard; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (left arm is hard) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m21a and 038k20a) for COVID-19 vaccination.     Medical history was not reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INDURATION (left arm is hard) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INDURATION (left arm is hard) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.
I started having stomach problems on about June 2021. I et constipation and can not go to the bathroom regularly. I have seen multiple doctors but I am now scheduled for an endoscopy on 05/19/2022 at 07:00am at Medical Group.  I also have acid reflux, GERD and a lot of stomach pain.