chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slightly itchy; Arm was enlarged the next day; headache; nausea; Arm got red; Arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE SWELLING (Arm was enlarged the next day) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to statins), Hyperlipidemia and Drug allergy (Allergic to sulfa drugs). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), EZETIMIBE, AZITHROMYCIN (AZO) and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm) and VACCINATION SITE ERYTHEMA (Arm got red). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE SWELLING (Arm was enlarged the next day), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE SWELLING (Arm was enlarged the next day), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Initial unsolicited report received from health professional (medical doctor) on 13-Dec-2017. This case involves a female patient of unknown age who was vaccinated with a gradient dose of 0.2ml dose of  FLUZONE QUADRIVALENT injection (batch number: UT5937LA, expiry date, route and site of administration were not reported) on 28-Oct-2017. Patient medical history and concomitant medications were not reported. On 28-Oct-2017, same day with in minutes following the vaccination, the patient experienced itchy throat, difficulty in swallowing, and red, watery eyes. Patient past medical history included flu vaccine of large local reaction and also 0.05 ml dilution dose, 0.05 ml full strength dose, 0.1 ml full strength dose and a 0.15 ml full strength dose of FLUZONE QIV vaccine. Lab data and corrective treatment were not reported. The outcome of the all events were unknown at the time of reporting. It was an actual medication error case due to wrong injection technique and vaccine under dose. 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 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. List of documents held by sender: none.
red patch down to elbow; sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes; headache; sore arm, aching arm; wiped out for about 18 hours, extremely tired; nauseated; vomited 3 times; diarrhea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm, aching arm), ERYTHEMA (red patch down to elbow), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes) and DIARRHOEA (diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Pneumonia. Concurrent medical conditions included Drug allergy (Fosamax). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (wiped out for about 18 hours, extremely tired), NAUSEA (nauseated) and VOMITING (vomited 3 times). On 10-Apr-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (sore arm, aching arm). On 11-Apr-2021, the patient experienced HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes) and HEADACHE (headache). In April 2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced ERYTHEMA (red patch down to elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE, PHENYLTOLOXAMINE CITRATE (SINUTABS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, aching arm), ERYTHEMA (red patch down to elbow), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes), DIARRHOEA (diarrhea), HEADACHE (headache), FATIGUE (wiped out for about 18 hours, extremely tired), NAUSEA (nauseated) and VOMITING (vomited 3 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.4 f - 103 f (High) 102.4 F - 103 F for about 4-5 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I have experienced extremely painful and bizarre menstrual cycles in the approximately 6 months since I received my second Pfizer COVID vaccine shot. I am not anti-vaccines, but if I had known the extent to which this vaccine would interfere with my menstrual cycle, I would have waited. I have had periods go missing, extremely painful cramps, periods that last for a day but are extremely heavy, spotting that has lasted daily for weeks, really a lot of very odd symptoms around my periods and I am hoping to god these are not permanent.
My daughter received the shot on 5/23/2018 and on 5/25/2018 she noticed a rash like area on the right side of her stomach. Cortisone cream was applied. It isn't painful nor itchy. By 5/26/2018, the rash was worse (more inflammed red and raised). Benadryl given.
Vaccine stored out-of-range in freezer for greater than 14 days. Offered revaccination. Patient will be back in 1-2 months to revaccinate.
This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observation study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012 (Table 4). All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. A copy of the published article is attached as further documentation of the patient's experience. This is one of 25 reports from the same source. Additional information has been requested.
11/4/2021 at 9:00 PM I experienced itching beginning on my shoulders and trunk. I took 50 mg Benadryl and went to bed. On awakening in the am I had full body hives excluding my hands and feet and significant periorbital swelling. I took another 50 mg dose of Benadryl and scheduled a clinic appointment. No new foods, skin care products, detergents etc noted.  At the clinic appointment she felt it was allergic and not likely topical due to facial involvement. Kenalog IM injection given. I feel it is unlikely due to Moderna vaccine since the length of time elapsed since receipt but put in an agency report out of an abundance of caution.
I administered the Zoster vaccine to the patient in the presence of an LPN. Vaccine administered subcutaneously. The vaccine was reconstituted with 0.5 ml versus the entire content of the diluent provided.
I experienced a breakthrough case of COVID-19 with fever, runny nose, body aches, coughing and swollen lymph nodes.
Patient was vaccinated and sat for about 5 minutes then left the pharmacy. He walked toward his car and fainted got up and fainted again. His breathing was ok but he seem weak. The paramedic took him to the hospital.
The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called and voice message was left. They are eligible get the new booster in 2 months time.
This spontaneous report as received from an office manager, referring to a multiple patients of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with multiple doses of improperly stored VARIVAX (which had a lot # of R002051 and an expiration date of 22-JAN-2020, N023956 and an expiration date of 01-SEP-2019, R017945 and an expiration date of 24-JUN-2020 and N029630 and an expiration date of 23-OCT-2019, R006221 and an expiration date of 29-FEB-2020, R010466 and an expiration date of 10-APR-2018; (dosage number and route of administration were not reported), for prophylaxis. Another batch of PROQUAD (which had a lot # of R006749 and an expiration date of 03-SEP-2019, R015740 and an expiration date of 02-DEC-2019, R006214 and an expiration date of 28-AUG-2019; (dosage number and route of administration were not reported), for prophylaxis, and had also been improperly stored. Another batch of M-M-R II (which had a lot # of N032747 and an expiration date of 20-NOV-2019, N027780, and an expiration date of 08-AUG-2019, R000554 and an expiration date of 08-JAN-2020, R002049 and an expiration date 22-JAN-2020, N026273 and an expiration date 21-SEP-2019, N025894 and an expiration date of 19-SEP-2019; (dosage number and route of administration were not reported), for prophylaxis. The office manager also reported the sterile diluent (unknown lot number and expiration date) used to reconstitute VARIVAX and PROQUAD did not undergo a temperature excursion. The vaccines experienced the following temperature excursions: -9°C to 8 °C (-7.4°C) for 1 hour and 35 minutes and -9°C to 8°C (-6.1°C) for 1 hour and 55 minutes. Previous temperature excursions were reported: -9°C to 8°C (7.6°C) for 13 hours and 46 minutes. The aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved and no adverse effects were experienced in any patients.
Presented to the ER 30 minutes after Flu injection with localized irritation.  Right side of upper arm, proximal forearm, shoulder and back all red itchy.  No shortness of breath, wheezing or difficulty swallowing.
pain in my rite legs; Had 2 shots still end up with the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In June 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced leg pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the leg pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and leg pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had 2 shingles vaccine shot and still end up with shingles, the patient had it since June 2021. Till the time of reporting, the patient still had a lot of pain in his/her right leg. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt received the first Moderna covid vaccine on 12/29 and contacted pharmacy on 1/20/23 to report a headache that  is bothering pt.  Pt states that the headache has been felt since the vaccine was given.  Pt was asked if vaccinated arm had pain or any symptoms, pt stated no symptoms past 2 days after receiving vaccine.  Pt was asked if pt had a covid test during the interval between the vaccine administration and reporting, pt stated they had not.  Pt stated they were going to go to MD office on 1/21.  Pt was followed up with on 1/22 and had not yet gone to MD office.
BELLS PALSY SYMPTOMS ON LEFT SIDE OF FACE .  Start PredniSONE Tablet, 20 MG, 3 tablets, Orally, Once a day, 7 days, 21 Tablet, Refills 0 Start Valacyclovir HCl Tablet, 1 GM, 1 tablet, Orally, Three times a day, 7 days, 21 Tablet, Refills 0
Serious sciatica attack with stabbing needle like pains to right foot.  Lasted for 16 hours.
21OCT rt arm swelled up, fever, sweats in noc, hurt all over, nausea & dizziness; tender arm in AM & couldn't raise arm, found large knot in armpit; arm got red, hot swollen-redness lt in 4d, swelling lasted 1 wk;
mild headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (mild headache). On 30-Mar-2021, HEADACHE (mild headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-169843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: This follow-up was received on 25-MAY-2021 which updated no new information.
The patient was admitted on 9/8/21 with suspected acute coronary syndrome.  She was seen by cardiology and felt to have type II NSTEMI likely secondary to dyspnea and recent Covid infection.   She
This is a spontaneous report from a contactable pharmacist. A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on Mar 8, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. In 2021, after the first dose of the vaccine, patient had itching on the back of her hands, neck, scalp and chest. The second day the itching was on and off. The back of her hands was what bothered her the most. The patient never had a rash, only itching. The patient was concerned about getting the second dose of the vaccine. The caller wanted to know if the patient should get the second dose of the vaccine. The caller was concerned for the patient because itching was a response but not considered critical. The pharmacy was not set up for acute events if something happened to the patient after the second dose. The outcome of all events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
COVID-19 vaccine booster; soreness on the arm became the size of an egg; elevated body temperatures; Malaise; body aches; first side effects of soreness and pain on the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Nov2021 10:00 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN (non-serious) with onset 18Nov2021, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome unknown; MALAISE (non-serious) with onset 18Nov2021, outcome recovering; PYREXIA (non-serious) with onset 18Nov2021 03:30, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 18Nov2021 07:00, outcome recovering. Relevant laboratory tests and procedures are available in the appropriate section.  Patient reported that Vaccine shot at around 10 am on 17Nov2021. Around noon first side effects of soreness and pain on the injection site. At 3:30am elevated body temperatures woke up patient on 18Nov. Malaise and body aches in the morning, resolving as time goes by. The soreness on the arm became the size of an egg around 7am this morning (18Nov). Also diminishing the size as the hours go by. COVID-19 vaccine booster. Event took place after use of product.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Low blood pressure 90/60 Fever Chills Elevated heart rate 110bpm Sweats body aches Dizzy
This spontaneous report was received from a consumer (patient's father) via other company (Pfizer) regarding to a male patient of unknown age. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On an unknown date, the patient might had got vaccinated with M-M-R II (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient had been sick for 7 years because of vaccines. The reporter had whole list of vaccines but did not provide. The reporter was aware that vaccines cause illness, there was a percent that does, and that was 1%. There was nothing specific that reporter wants to know. The reporter wanted to speak with someone about vaccines. The outcome of malaise was unknown. The reporter considered malaise to be related (reported as, because of vaccines) to M-M-R II.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Vaccine lot unknown reason was noted as misplaced/discarded. COVID 19 Treatment with Paxlovid start date on 31Aug2022 and stop date on 05Sep2022. The patient had Paxlovid rebound COVID on 31Aug2022 and recovering- no treatment was received.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient refers pain, redness and swelling in site of administration, 5 days after vaccination.
First of all, GRATEFUL to be getting the vaccine! Surprised how intense and how long lasting side effects have been. Terrible fever, headache, weakness, hives. Fatigue and fever hit first. On first shot (3/26) I'd felt tingles in my mouth (like dental novocaine wearing off) though I have no facial fillers, but do have 2 dental implants. 2nd shot was Friday 4/23/21 11 am, by 1 pm I felt something coming on, but then fatigue took over. Dozed, but by evening, terrible fever hit - lucid dream/nightmares of pain all night, it hurt to move or be touched, but I knew it was the vaccine and would pass. Eventually the fever lessened on Saturday, and I slept better, but the headache worsened -- a migraine settled in and seemed concentrated behind my eyes, at the sides of my face and base of my skull. Hives  came and went. My throat would get sore and then be fine. The headache pain was incapacitating through Sunday night -- I dozed when I could and was feverish but better than I had been. I sipped chicken broth and juice and put a warm wash cloth on my face to ease the pain. Finally I woke in the early hours of Monday and the headache was better, but then when I got up in the morning my eyes were swollen as if I were having intense allergies - big pockets of fluid behind the sockets and my whole face was swollen as it turned out. The fever came and went, the headache returned in the afternoon with eyes very red. I worked from home and did a little exercise (I normally exercise at least an hour elliptical each day, but didn't since Friday as I was too sick); I again went to sleep early and woke Tuesday 4/28 , feeling better still, but I'm sill foggy as if I just recovered from a long flu. I have more energy but waves of fever and fatigue still wash over me. This continued all week, with the headache preventing me from most activity until Saturday May 1st, a full week later, was the first day I felt okay again.
Fluttering of heart and chest pain starting around 10pm on the night that I received the booster, mild chest pain has continued on and off for a few days. It felt like my heart was skipping beats and making me need to cough because it was jumping in my chest. Fluttering continued throughout the night but resolved by the next day. Minimal chest pain has continued.
pt recv vax 18SEP95 & was dx w/chickenpox on 12DEC97;