chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All my shots had been Moderna, but now I had Pfizer; a little bit dizzy; 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 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 2, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 3, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 4, Manufacturer: Moderna), for COVID-19 immunization; Moderna (Dose 5, Manufacturer: Moderna), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2023, outcome "unknown", described as "a little bit dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Sep2023, outcome "unknown", described as "All my shots had been Moderna, but now I had Pfizer". Additional information: The patient noticed a lot of dizziness and it's making patient's life worse.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 10-DEC-2012 (lot # 672834/0131AE, exp.: 26-OCT-2014). This is one of the report from the same source, linked reports. Additional information is not expected.
extreme fatigue; muscle pain; chills; fever; side effects made him cancel seeing patients; This case was reported by a consumer and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  with an associated reaction of no adverse event.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, muscle pain, chills, fever and activities of daily living impaired. On an unknown date, the outcome of the fatigue, muscle pain, chills, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fatigue, muscle pain, chills, fever and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced extreme fatigue, muscle pain, chills and fever. His side effects made him cancel seeing patients.   No additional details were available. Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013449:same reporter US-GLAXOSMITHKLINE-US2021AMR014070:same reporter
Stay sick all that night; Red bump below site of injection; Red bump below site of injection; Quizzes that day; At night vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Stay sick all that night), VACCINATION SITE INDURATION (Red bump below site of injection), VACCINATION SITE ERYTHEMA (Red bump below site of injection), NAUSEA (Quizzes that day) and VOMITING (At night vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, COPD and Seasonal allergy (Allergy in summer time.). Concomitant products included IPRATROPIUM BROMIDE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, METOPROLOL, VITAMIN D NOS and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 08-Mar-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (Quizzes that day). 08-Mar-2021, the patient experienced VOMITING (At night vomiting). On 09-Mar-2021, the patient experienced ILLNESS (Stay sick all that night), VACCINATION SITE INDURATION (Red bump below site of injection) and VACCINATION SITE ERYTHEMA (Red bump below site of injection). At the time of the report, ILLNESS (Stay sick all that night), VACCINATION SITE INDURATION (Red bump below site of injection), VACCINATION SITE ERYTHEMA (Red bump below site of injection), NAUSEA (Quizzes that day) and VOMITING (At night vomiting) outcome was unknown.            Patient stated HCP  had sent medicine to stop vomiting and being sick. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD21-050946 (Patient Link).; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site nodule, vaccination site erythema, nausea and vomiting are consistent with the known safety profile of the vaccine.
Myalgia Fatigue, swollen lymph nodes in left armpit. Narrative:
wasn't able to swallow well; I had swelling of my tongue that started on Saturday; blood vessels formed and burst under the tongue; blood vessels formed and burst on the side of the tongue; swelling was so close to roof of mouth; left arm and shoulder were really painful and she couldn't lift her arm; left arm and shoulder were really painful and she couldn't lift her arm; left arm and shoulder were really painful and she couldn't lift her arm; This is a spontaneous report from a contactable consumer or other non-HCP. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration on 28Feb2021 03:30 as DOSE 1, 0.3 ML SINGLE (at the age of: 68-year-old) for covid-19 immunization  The patient medical history and concomitant medication was not reported. Vaccine is not Administered at Facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Physician Office was visited on 09MAR2021. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. No Family Medical History Relevant to AE was reported. On 28Feb2021 the patient experienced  left arm and shoulder were really painful and she couldn't lift her arm. On 06Mar2021 17:00 the patient experienced she had swelling of her tongue that started on Saturday. On 06Mar2021 the patient experienced swelling was so close to roof of mouth, blood vessels formed and burst on the side of the tongue, On 07Mar2021 the patient experienced wasn't able to swallow well. Therapeutic measures were taken as a result of the patient had swelling of her tongue that started on saturday, wasn't able to swallow well, swelling was so close to roof of mouth, blood vessels formed and burst on the side of the tongue, blood vessels formed and burst under the tongue as Benadryl, states she is on that everyday, twice a day. She is hoping the swelling will go down. The outcome of event left arm and shoulder were really painful and she couldn't lift her arm was recovered on 01Mar2021 while outcome of event blood vessels formed and burst under the tongue was not recovered. The outcome of rest all event was recovering. Description of complaint: Caller was reporting an AE with the Covid vaccine. She began to get a swollen tongue and she wasn't able to swallow well because the swelling was so close to roof of mouth. States her tongue started to swell up too. States she took Benadryl but it is still swollen, but not as bad as it was Saturday. She states that she took one Benadryl immediately and waited and gave her husband instructions to call 911 if she couldn't swallow. Then 30 minutes later took another half. She took 1.5 Benadryl total and it started to get better and not as swollen.
Information has been received from the authors in a literature article concerning a 3 year old female patient who was vaccinated with PCV (23-valent) (manufacturer unknown) and had received 13-valent PCV 1 year earlier. No concomitant vaccines were reported. The 3 year old girl with sickle cell disease type hemoglobin SS SCD was brought to the emergency department with pain and swelling of the right leg 1 day after administration of PPSV23 (manufacturer unknown). She was febrile (39.3 degrees C), with a WBC (white blood cell) count of 17.2 x 1000/mm3 that showed leucocytosis on admission (also reported as 17.2 x 1000/mm3 before immunization). The patient was hospitalized for 2 days and received empiric ceftriaxone. She was afebrile during her entire admission, and her swelling markedly decreased after 1 day so that she was without pain on discharge. This is one of several reports from the same literature (1506USA013115, 1506USA013114, 1506USA013112 and 1506USA013113). Additional information has been requested.
Full body rash, hives and blisters. Started out localized on back of head and neck.  Now covers full body. Dizziness, chest pain, swollen throat and back of the base of my skull. Rapid heart rate and difficult my breathing. Loss of voice. Chills, body aches and pains. Stingy, burning and stabbing sensations all over. Transported by paramedic to ER. Given Epi shot, Benadryl and steroids.
11:20am: received vaccine  11:40am: started feeling a little shaky  1:00pm: slight headache  7:15pm: some slight aches and pains  1:00am: moderate aches and pains begin  2:00am: aches get a little more severe, chills start  3:00am: aches and chills are severe, mild fever develops, medications taken aren?t helping  5:00am: aches and chills slightly better after ibuprofen and Tylenol, finally able to fall asleep 6-10am: in and out of sleep 10am: wake up, aches and chills are back at about 90%, take more medication  11am: nausea, verge of vomiting  12:30pm: same symptoms plus onset of rapid weakness and heartbeat between 94-116 while laying in bed  1pm: nausea, aches, chills continued, no sign of symptoms letting up  2:46pm: still experiencing the same side effects
The Patient experienced dizziness within 5 minutes of being immunized at approx 5pm. Patient sat and sipped water. He complained of worsening dizziness with headache. Patient was asked to lie down with feet elevated.  Ambulatory care was called and patient was assessed.  Vitals were normal at 5:15.  Patient advised to remain in prone position for observation.  Patient had worsening  of dizziness and headache.  EMT's were called at approx. 5:40.  Patient taken by EMT's at 5:55--per doctor of pharmacy
Day two after receiving the shot, I woke up with soreness under my left arm. After examining my underarm I realized that it was swollen the size of a softball.  Assuming it is the lymph node that is swollen.
Received vaccine 11/1/10 after 12 hours, (L) arm sore, myalgia.
p/vax pt exp a rash on upper chest, face, neck, back & both arms, also felt hot within 1hr following vax then recurred the following day.
I had an acute anaphylactic reaction to a yellow jacket sting.  Within 20 minutes of the sting, my whole body was swollen and airways began to constrict.  I received epinephrine, type 1 and 2 antihistamines, and steroids, and the symptoms resolved.  I am reporting this because I was stung by a yellow jacket in the same location a year earlier (pre-vaccine) and had no reaction.  I had never had an anaphylactic reaction.  Clearly, other factors could have caused the new response to what appears to be the same stimulus, but receiving an MRNA vaccine designed to stimulate immune response seems like a suspect worth investigating.
1015 c/o of stomache, numbness of hands (hands better - stomach hurts after 30 min) afebrile 110/68 - 88.
Repeated events of vertigo that are still happening now 2-3 times a week, 6 months post injection
vaccine was administered "incorrectly" and the the lump "needed to be drained."; "lump on her deltoid."; This spontaneous report as received from a company representative and refers to a 24 year old female patient.The patient medical history, concurrent condition and concomitant medication were not reported. On 24-JAN-2022, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U032636, expiration date 26-OCT-2023, intramuscularly (strength and dose were not reported), as HPV prevention. On an unknown date in 2022, the patient experienced lump on her deltoid (vaccination site mass). The patient went to family practice doctor, who informed her that the vaccine was administered incorrectly (product administration error) and the lump needed to be drained. The treatment was given for the event. The outcome of the event "lump on deltoid" was reported as not recovered. The causality assessment was not provided.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 69-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-JAN-2012, the patient was administered the ZOSTAVAX by a healthcare provider at a clinic (lot number, dosage and route of administration not provided). On or about 29-FEB-2016, the patient was treated by a physician at a physician's office for the following injury resulting from the patient's ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to himself, loss of services, loss of consortium, and economic losses. The outcome of Herpes zoster was unknown. Herpes zoster was reported as related to ZOSTAVAX. Additional information has been requested.
Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid onset (~6 hr) nausea, vomiting, and encephalopathy with cortical blindness and altered level of consciousness on 3/15/2021. Found to have diffuse white matter hyperintensities on MRI brain.  No spinal cord involvement. CSF analysis with lymphocytic pleocytosis.  Negative infectious workup. Started on high dose steroids and plasmapheresis for presumed autoimmune encephalitis. Slow improvement in symptoms for the first 10 days following initiation of steroids (present day).
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 at 11:00 as dose 3 (booster), single (Lot number: 301558A) at the age of 70 years, in right arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history. Patient had no Known allergies. There were no concomitant medications, also reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 27Apr2022, outcome "not recovered" and all described as "tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive; (05May2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 27Apr2022 to 02May2022. Clinical course was reported as, Patient took a full course of paxlovid when she tested positive for Covid with active symptoms. 3 days after finishing 10 doses of paxlovid, she tested negative. 5.5 days after finishing the paxlovid on 07May2022 at 06:00, Patient developed fever & full symptoms once again. Her physician treated her with another 10 doses of Paxlovid (2nd course of paxlovid). Patient recovered from symptoms on 10May2022.
A third dose of Shingrix was given to patient on 10/14/22.  The first dose was given 02/08/22, second 05/11/22, third 10/14/22.  Pt. presented to pharmacy on 10/17/22 with signs and symptoms of headache, cold sweats at night, fatigue, muscle/joint pain, arthritis flare, red injection site with movement, body aches and temp 97.5 . He has been taking 2 Advil twice a day as needed and it only works for a short time. I offered to make an appointment with his primary care physician and he accepted. He is to be seen at 3 pm on 10/18/22.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 28-JUN-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects reported.; Sender's Comments:  US-009507513-1708USA002800:
Initial information received on 28-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who experienced burning, burning and MENACTRA vaccine on 20-Jun-2018 in the left arm subcutaneously instead of IM, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via subcutaneous route in the left arm. The patient developed a non-serious burning following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient developed a non-serious burning following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was also a case of actual medication error due to inappropriate route of vaccination. (Other relevant tests included No lab data). Final diagnosis was MENACTRA vaccine on 20Jun2018 in the left arm subcutaneously instead of IM, burning and burning. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for burning, as Unknown for burning and as Not Applicable for MENACTRA vaccine on 20Jun2018 in the left arm subcutaneously instead of IM. 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.
Patient presented with 2 day history of left sided chest pain, described as constant moderately severe pain, worse with deep inspiration, improved by nothing. Doees not radiate. No associated SOB. Does endorse lightheadedness. Additionally reports diffuse myalgias the past two days.
Pt recvd 3 doses of Engerix-B 29NOV90, 27DEC90, & 28MAY91 & it was determined that pt was a non-converter; no treatment given;
Hives, itching, skin blotches 10/29/09 at 04:30. BENADRYL relieved symptoms.
This case was reported by a other health professional via sales rep and described the occurrence of headache in a 19-year-old male patient who received BEXSERO. On 6th June 2016, the patient received BEXSERO. In June 2016, less than a week after receiving BEXSERO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO and experienced persistent headache. The GlaxoSmithKline representative did not provide the lot number of expiry date of the vaccine.
with Fibromyalgia my daily pain was 3-4 constant, since the second Covid vaccine has been 7-8/10 for the last 9 months, which I have had to increase medications to try to work. I also had left breast pain for most of that 9 months also.
Patient is a ER nurse. She got the first dose on 11/2/2021. She was ok at the time of vaccination.  After 45 minutes she was at work and started breaking out into hives and has a anaphylaxis reaction
Tonic Clonic Seizure lasting 4-5 minutes. Ambulance was called and immediate transport to Emergency room.  This is the first ever Tonic Clonic seizure for the patient.  Once we returned home we found additional stains under the pillow when changing the sheets indicating additional potential incidents in the previous week.
Patient became diaphoretic and passed out within minutes of receiving vaccination.  She woke within seconds.  Returned to baseline within 15 minutes.  Patient stated this has happened before with blood draws and other vaccinations.  She was released into the care of her driver/sister after returning to baseline.
On 02/15/2023 I contacted my Physician for what I thought was Pink Eye. I was told to come into the office for an eye exam and was told that I had an ulcer in both eyes. I was given antibiotic eye drops. However I had an allergic reaction to the antibiotics as I am allergic to CIPRO drugs. I was also diagnosed Neuropathy of the eye. The Ulcers have left scars but are not affecting my vision. I have had dry eyes prior to this episode. My Dr. also suggested that I may have an autoimmune disease that may be affecting my eyes.
patient developed a rash that began with Herald spot around 2 weeks after first vaccine - and then full body rash that has persisted - she believes it may be "inverse pityriasis rosea"
Rash & welts - 9/7/2020 - 9/10/2020 Swollen, red skin on thighs down to calves - 9/8/2020 - 9/11/2020 Red streaks across various parts of body (trunk) 9/7/2020 - 9/11/20202 Itching 9/7/2020 - 9/11/2020 Using ice packs and cold compress on affected areas 2 Benadryl 25 mg every 4 hours 9/8/2020 - present
heaviness in breathing/shortness of breath; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, heaviness in breathing/shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12-JAN-2021, the patient experienced event, heaviness in breathing/shortness of breath.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event, heaviness in breathing/shortness of breath was not reported.   On 13-JAN-2021, the outcome of event, heaviness in breathing/shortness of breath was recovered.