chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness and tingling in both hands; numbness and tingling in both hands; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness and tingling in both hands), PARAESTHESIA (numbness and tingling in both hands) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial carcinoma and Arthritis. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 08-Jan-2021 to an unknown date and PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPOAESTHESIA (numbness and tingling in both hands), PARAESTHESIA (numbness and tingling in both hands) and FATIGUE (fatigue). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) for Pain, at a dose of 10 mg. At the time of the report, HYPOAESTHESIA (numbness and tingling in both hands) and PARAESTHESIA (numbness and tingling in both hands) was resolving and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Positron emission tomogram: inconclusive (Inconclusive) Not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. Pertinent medical history included leukemia, lymphoma and "another unspecified immune compromised disease". Concomitant medications were unknown by the reporter. On an unspecified date, the physician administered ZOSTAVAX to a patient for prevention of shingles (route and lot # not provided). On an unspecified date, the patient developed shingles and dropped foot from nerve damage in an upper leg. The causality was not provided. The outcome of the events was unknown. The physician told the company representative that the patient had asked him "if he should sue". Additional information is not expected as the physician did not provide consent to follow up.
Slight dizziness the first day, and fatigue on the day of the vaccine, followed by fatigue on day 2, 3, and 4.  These did not impair my ability to do some limited work, but I did spend a lot of time in bed. Felt feverish, but the temp was slightly below normal, except once was slightly above (but all in a broad normal range).
Patient had onset of shoulder shrugging tics about 3 days after vaccination.  About 1 month after vaccination began having neck twisting tics.
Red rash on left arm from point of shot about 2/3 down left arm covering width of arm.  Occurred approximately a week after shot.  Area itches.  Have been using cortizone-10 cream to ease itching.  Area is fading.  2nd dose is scheduled for 2/18/21.
Approximately 12 hours (around 2am) after the 2nd dose, my upper body felt very achy, especially my arms and "core" body. I also felt cold, and had a headache.  I did not sleep well; however, I was too tired and muscles too sore to get up in the morning. I slept until around 1pm the next day .  At approximately 1pm the next day (about 23 hours after the 2nd dose).  I felt well enough to get out of bed and move around, but still very tired and went to bed early in the evening.  After the second night of sleep,  I woke-up refreshed the next morning and did not have any more symptoms.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Red rash below site, swelling, itching in various places, 5 days later still itches, stings
Red rash, pain, warmth and itching around injection site, severe facial flushing lasting for hours, joint pain, headache, fatigue
COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster) , single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
For two days after injection the site of injection was very sore, painful at site which finally went away Friday night. I was woken up by a numbness, and tinging sensation in left side of face that continued all day Saturday, and into Sunday. I also experienced fatigue, itching, and a tingling rash sensation in several parts of body on, and off.  On Monday morning I awoke without the facial numbness, and tingling sensations but i do have numbness and tingling in the right lower extremity.
Had them/ suspected vaccination failure; Had them; They are so painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had them/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had them) and pain (Verbatim: They are so painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by the patient via interactive digital media.  The patient stated that, he/she had them and they were so painful. He/She had thought because he/she had the shingle shot, it would protect him/her. But it does not, however they had a new shot now that would protect more, if your insurance company would accept it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
COLD LIKE SYMPTOMS; FEVER; CHILLS; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD LIKE SYMPTOMS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (COLD LIKE SYMPTOMS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, NASOPHARYNGITIS (COLD LIKE SYMPTOMS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (UNKNOWN ROUTE), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.
initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilateral ankles and joint pain to right foot specifically 2nd and 3rd MTP, back pain and headache.  Left arm pain, back pain and headache resolved within 48 hours. Patient has continued with moderate pain into right foot (2-3rd MTP joints), now with forefoot edema and erythema and continued bilateral ankle pain.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 28-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J001693 and expiry date 08-MAY-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness in arm). At the time of the report, MYALGIA (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported  Treatment information was not provided
sore arm that persisted for 4mo;the incident occurred several months back, unsure of pt name, lot unrecorded, pt was seen & dx w/rotor cuff tendinitis;
01/24/2019 1:00pm-Pt reported to Health Center Provider and HCM/RN that she had an allergic reaction 3-4 hours after receiving Hepatitis A and Influenza vaccinations at the Health Center 2 weeks ago on 01/14/2019. She states that she was lightheaded for a little while, her uvula swelled to 3 times its normal size, had severe body aches and some nasal congestion. Pt states that she went to her primary care physician who told her it was probably an allergic reaction to the preservatives in the vaccines. Nurse who administered the vaccines brought the vaccine boxes to show the patient that each box clearly stated "contains no preservatives.". Pt stated she wanted the reaction entered into her medical record. Pt was told that we will do this and file a VAERS report as it is a standard Premise practice. Pt was reassured and returned to work.
Pain at injection site; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 11th April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and muscle pain. In April 2019, the outcome of the injection site pain, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's husband The patient received vaccine in left arm. The patient experienced the symptoms on the same day when she received the 1st dose of vaccine. The injection site pain was lasted 3-4 days. The muscle aches and headache resolved within 2 days. The phone number or address was not available. The reporter consented to follow up. This case had been linked to the case US2019177121, reported for same patient.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 09-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Severe swelling and induration of upper arm at site of injection, requiring use of prednisone to prevent surgical intervention.
Scattered pustules / macules amongst posterior / anterior trunk, swollen axillary nodes, fatigue and general muscle aches. Dx: Generalized vaccinia infection.
"Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER covid-19 vaccine, self limited BP 110/83 O2Sat 100%  pulse 80,  feeling better, refused ER ,HX anxiety disorder"
Client presented to Wellness Center for booster.  She received a J&J in April.  She reports she was diagnosed with Covid in August and received monoclonal antibodies.  She has a reported hx of bilateral pulmonary emboli, initial diagnosis 2016. Reported hx of antiphospholipid syndrome, takes eliquis 2x/day.  She reported she was anxious and "about had a panic attack, thought you were going to tell me I couldn't get a vaccine...I'm a professional patient." This FNP reassured client and told her we were evaluating which vaccine would be best and which dose.  She states she "instantly felt better."  FNP reviewed pre-screening form to evaluate risks vs benefits, and to evaluate whether she should receive 0.25 ml or 0.5 ml.  Hx of antiphospholipid syndrome requiring methotrexate and sometimes high-dose steroids, "I was on 60 mg prednisone for a year about 2 years ago."  Decision was to administer Moderna 0.5 ml given severity of covid illness in August, and hx of immunocompromising medications and possibly needing additional dosing, either methotrexate or high dose prednisone.  Moderna 0.5 ml administered @ 1105 by OHA RN (we reviewed client's history together, as requested consult before giving the vaccine).  At 11:10, client reported SOB, with left sternal pressure and pain 3-4/10. Activated EMS.   11:12 121/70 98%RA  HR 78 RR 20 "difficult to tell what is anxiety or what is 'real.'"   11:15 Lightheaded, dizzy. Reclined chair. Skin warm/dry, color good.  116/64 100% RA RR20.  Pain in chest worsening 6/10.  11:20 Oxygen 2L/min via NC applied.  Felt hot/cold/nausea. 11:21 81 mg asa x 4  HR 78  RR22  BP 117/72 11:24 5/10 left chest wall pain\ 11:25 EMS & fire arrived 11:28  100% RA, RR20, HR 69  BP 110/64.  Pt stated, "something feels weird, I can't feel my legs but I can move my toes."  Pt able to walk to stretcher.  Pt left via gurney with staff.   Per staff report, pt got out of ambulance, walked up the hill, and left with her roommate.
Started breaking out in rash and hives 3 days after receiving shot. Both arms and torso.
I wanted to report to you an adverse drug reaction for patient 8-29-96.  He received 4 vaccinations on 9-23-08 in the evening around 6:30 pm, by 9:00 pm he was complaining of headache, body ache, stomach ache.  I gave him some MOTRIN and sent him to bed.  In the morning he still did not feel better and stayed home from school.  Last night he said he had insomnia.  He did have a low grade fever 100.8 while on the MOTRIN.  Naturally his arms are sore and he has reported to me twice that his hand on the left side went numb.  Of course my mind goes straight to Guillain-Barre Syndrome.  I had him stretch his arms and he said it went away, so I don't know if that is related.  He still feels lousy today so he is staying home again.  The injection site on his left arm (I think) does have some redness and swelling around it.  Let me know what I should watch for.  Thanks.
Nausea; Abdominal pain/Abdominal symptom; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age (Age: 28; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated she received her first COVID-19 Vaccine dose yesterday afternoon on 18Feb2021 and she was having really bad nausea and abdominal pain in Feb2021. She had a question. She asked if very bad nausea, and abdominal side effects are due to the COVID-19 Vaccine. Caller was advised she would be transferred to Pfizer Medical Information to have her question addressed. Serious: No. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female who was vaccinated intramuscularly on an unspecified date with a dose of GARDASIL vaccine (yeast) (lot# not reported). Subsequently the patient experienced nausea, dizziness and an "abnormal taste sensation in her mouth" sometime after the vaccination. The patient sought medical attention by calling the office. The patient's outcome was not reported. Additional information has been requested.
A report has been rec'd about pt who rec'd injection of  Acel-Imune on 6/28/01 and subsequently developed fever and redness and swelling at the injection site. These events required unspecified treatment in the emergency room. No further information was available at the date of this report. This report was rec'd from GlaxoSmithKline (ref no 2001021434-1). additional information rec'd on 12/18/01 provided concomitant vaccine and indicated that the child recovered. Information regarding this event has been forwarded to Aventis, manufacturer of IPV vaccine.
local redness, induration, warmth @ the site of inject; 4 hrs later had intermittent abdo pain 5PM to 6PM;
Symptoms: freezing, muscular aches (mainly in my upper back), dizzy, spacing.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1 and dose 2 of GARDASIL (lot # and dose not reported) on 18-AUG-2011 and on 21-AUG-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. There were no known adverse effects. Additional information has been requested.
sleeping for 12 hours, had elevated temperature 102 degrees F in pm , No appetite.
Patient c/o of  weakness, malaise, body aches 2 days after receiving Pfizer vaccine.
she had her Pfizer vaccine booster dose on Saturday 12/04/2021 around 5:50PM . She began to experience her symptoms around 12:05Pm on Sunday .she had fever, chills, body ached, feeling tired , weakness, and  feeling fainting  (NOT Falling), injection site swollen, hard bump at injection site. She went to hospital-ER. MD took down all her information and kept her in hospital for a day for observation over night . she was given Tylenol. She was released on Monday 12/6 and she returned to work on Wednesday 12/8/21.