chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle twitching at site of injection; Muscle twitching at site of injection; This is a spontaneous report from a Non-contactable consumer. A 30-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number:EL9262) via an unspecified route of administration in the left arm on 29Jan2021 at 12:30 PM (at the age of 30-year-old) as single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283) via an unspecified route of administration in the left arm on 08Jan2021at 12:30 PM as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included multivitamins taken for an unspecified indication start date and stop date was not provided. The patient had no known allergies. On 02Feb2021 at 05:00 PM, the patient experienced muscle twitching at site of injection intermittently continues for minutes. The patient did not received treatment for the adverse event. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for covid post vaccination. The outcome of both events was unknown.  No follow-up attempts are possible. No further information is expected.
Developed acute tinnitus in right ear which is constant ringing noise. The start was since Feb 2022
Facial swelling, itchiness around injection site, itchiness of ankles, wrists, face, hives
atrial fibrillation. I do not know if this was related to the vaccine or not.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The pharmacist reported that overnight at around 2 am, the patient awoke with fever, chills and all over body aches. In July 2018, the patient's body temperature was recorded as 102 unknown unit. The pharmacist stated that 0.7 ml was the dose of the SHINGRIX and then when asked to clarify, she stated that 0.65ml was the dose. When again asked for clarity she said they only used one vaccine. She also asked was not it the same 0.65 ml dose like ZOSTAVAX. When she was informed the dose was 0.5 ml, she states well that was what it was. This case has been linked to the case US2018GSK125535, reported by the same reporter for the same patient.
Patient is a 25-year-old male with no significant past medical history who returns to the clinic for further evaluation and management of chest pain temporally associated with recent smallpox vaccination (given on 9 Jan 2018). Please see my previous notes for complete details. Briefly, patient originally described receiving his smallpox vaccine on 9 Jan18 (Lot # VV03-019C) and did well until approximately 12 days later when he awoke in the early morning hours of 21 Jan with sharp chest pain and chest tightness. He initially went back to sleep, but the pain continued for the next day. He presented to his medic this morning who recommended calling the support center.  Patient described his pain as a 'sharp' midsternal chest pain, though more on the right mid sternal edge. The pain was worsened with deep breathing and associated with some chest tightness. He specifically notes that the pain was worse when leaning forward (not improved). He also stated the pain was somewhat reproducible with palpation, though this was a slightly different quality of pain.  He also endorsed a nonproductive cough during the previous 2 days. He denied any other systemic symptoms.  WAMC ED evaluation included a CXR and ECG that were reportedly within normal limits. Troponin wnl but CRP was elevated.   Interval History: He states he has done well other than 2 episodes of similar chest pain early in his course, but denies any symptoms in last few weeks. He is back to running 4-5 miles and denies any chest pain, dyspnea with this.  Repeat ECG by PCM wnl (early repol).  No new complaints or concerns.  SPV vaccine site with well-healed Jennarian scar.  ETS from the Army in <40 days.
Fever up to 102.3, pain in left side of abdomen, feeling of stabbing pain in both ears, pressure in head/headache, funny feeling swallowing in throat, small bruise at injection site.
Got vaccine in R arm. Within the hour had tremor/shaking of  R arm for several minutes.   Within one day had swelling and pain in supraclavicular lymph node . Couldn't move arm /shoulder due to exquisite pain.  No rash or fever.   Still with pain palpable swelling, tenderness, warmth and pain with ROM of neck.
This spontaneous report was received from a nurse and certified medical assistant referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, pertinent medical history and concomitant therapies. On unknown dates in 2017, the patients were vaccinated with improperly stored doses of with GARDASIL 9 lot # N002720 and expiration date 12-MAY-2019 (route, dose, dose number and anatomical location were not provided) for prophylaxis. Since April 2017, this vaccine was cumulatively exposed from 47 to 77 degrees Fahrenheit for 108 hours plus 32 to 35 degrees Fahrenheit for 195 hours and 15 minutes. Data logger was involved and there was no previous temperature excursion. No adverse effects reported. No Product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA011005: US-009507513-1706USA011006.
Patient received pneumo PRSV 12-10-13. Patient called complaining of pain "head to toe". States body hurts, joint pain and fever - non confirmed 12-11-13. Appt made 12-12-13. Patient canceled. Patient called 12-16-13, c/o sweating, achy, ribs hurt. Patient schedule appt 12-17-13 for 12-18-13. Arrived.
Headache, Fever, NauseaVomiting, Pain @ injection site, Chills
feeling needles sticking inside her body sticking her arms; itchiness; bumps; red area like an infection all over her arms and legs and left side of her face; little low grade fever; awful headaches like being kick by a horse, not regular headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face) and PYREXIA (little low grade fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #010a21a and #039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BENAZEPRIL and AMLODIPINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face), PYREXIA (little low grade fever) and HEADACHE (awful headaches like being kick by a horse, not regular headache). At the time of the report, PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face), PYREXIA (little low grade fever) and HEADACHE (awful headaches like being kick by a horse, not regular headache) outcome was unknown.            Patient reported that she was taking High blood pressure medications.  The treatment information was not provided.
expired dose of Daptacel was inadverently administered/no ae; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case is linked with 2019SA145256.  This case involves a 4 years old male patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation.  On 23-May-2019, the patient received a 0.5 ml third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown, lot: C5190AA and expiry date: 24-Apr-2019) via intramuscular route in left thigh.  It was an actual medication error due to expired vaccine used (expired dose of Daptacel was inadverently administered).  None adverse event symptoms reported.  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.
FEVER OF 102 (1/12-1/14), BODY ACHES, PAIN AT INJECTION SITE, JOINT PAIN (LOCKED UP), HEADACHE, NECK PAIN
diarrhea; felt "like I wanted to pass out"; vomiting; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 15:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "diarrhea"; PRESYNCOPE (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "felt "like I wanted to pass out""; VOMITING (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "vomiting"; DIZZINESS (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "weakness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
her sister also had the Pfizer Covid booster shot; She is still hurting too; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received bnt162b2 (COMIRNATY Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Oct2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of COVID-19 vaccine on an unknown date (Primary Immunization series complete but unknown manufacturer) for covid-19 immunisation. Other product was not provided. It was stated that her sister also had the pfizer covid booster shot on 26Oct2021 and the patient was still hurting too on an unknown date of Oct2021. The outcome of event reported as not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt got shot at 3pm and awoke at 4am with L hand and L foot numbness/tingling
Patient was given a covid vaccine on 9/12/2022 which had expired on 8/31/2022. State called. Vaccines were discarded. Patient called and made aware of situation and that would to be revaccinated. VARES form filled out and faxed.
Chills, sweating.  Temp 99 to 100 degrees beginning in early evening.  Achey, groggy, tired, nauseated.  Would feel fine during the daytime.  No redness or swelling at injection site.  The upper arm was a little sore the day of the shot but that disappeared.  Has never had a reaction to any other immunization.  12-13-10 patient is no longer running low grade temperatures at night.
Patient inadvertently received Pfizer 5year-11year covid vaccine instead of Moderna 6month-5year vaccine.
Information has been received from a certified medical assistant concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . Subsequently the pt's mumps titer was negative. Unspecified medical attention was sought. Additional information has been requested.
Had bad flu once ... AFTER VACCINATION/Suspected vaccination failure; Had bad flu once; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received flu vaccine and had bad flu once. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.; Sender's Comments:  DE-GLAXOSMITHKLINE-DE2021EME111766:
DECREASE LEG TEMPERATURE; PAIN IN LEFT ARM/LEG; DIARRHOEA WITH LOOSE STOOLS; STOMACH ACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced pain in left arm. On 11-APR-2021, the subject experienced left leg pain. On 11-APR-2021, the subject experienced Diarrhea with loose stools. On 11-APR-2021, the subject experienced stomach ache. On 13-APR-2021, the subject experienced decrease leg temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in left arm, left leg pain, and decrease leg temperature, and had not recovered from stomach ache, and Diarrhea with loose stools. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 13-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
muscle aches; Joint pain; Swollen lymph nodes; Headache; Sore arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (muscle aches) and ARTHRALGIA (Joint pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (muscle aches), ARTHRALGIA (Joint pain), LYMPHADENOPATHY (Swollen lymph nodes) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
Moderna vaccine was accidentally administered to patient under 18.  No adverse symptoms noted. Pt scheduled for Moderna second dose per guidelines. Education provided to staff regarding medication error.
itching; redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ERYTHEMA (redness) and SWELLING (Swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itching), ERYTHEMA (redness) and SWELLING (Swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Feb-2021, PRURITUS (itching), ERYTHEMA (redness) and SWELLING (Swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received: Contain Non significant information
got the flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non-health care professional ) .  This case involves an unknown age and unknown gender patient who had got the flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer ( with unknown strength, form, rote, batch number and expiration date ) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of got the flu (influenza) (unknown latency)   No lab data included  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  Outcome : Unknown
Nausea, vomiting, stomach ache, chills, body aches, headache, fever, left leg swollen at injection site, hard not at injection site, left leg pain. Treatment: Alternate Ibuprofen and Tylenol. Alternate hot and cold packs.
As I was being monitored after receiving the vaccine, I began to feel lightheaded. The pharmacy tech told me this was normal and it would subside in 24 hours, but it became more intense throughout the evening.  I also experienced tingling in the legs and arms (mainly the legs) for about 4 weeks.  In addition to the being lightheaded, I have been fatigued.  Within the past month, I sometimes see yellow spots that come and go and have become extremely sensitive when I am in the sun and hot temperatures which intensifies the lightheadedness.    Within the first two weeks of receiving the vaccine, I went to  (urgent care), my primary care facility, and the emergency room. I went to a neurologist in  early  April and am currently still  under his care.
Started immediately, Local muscular pain at injection site. Shoulder and neck, right side pain. Progressed over next two weeks with Chills, wheezing, nausea, and diarrhea.
This spontaneous report as received from a register nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M004330 with expiration date 26-JAN-2018, and lot #L048465 with expiration date 07-JUL-2018 (dosage and route of administration were not reported) for prophylaxis, which in November 2016, which were exposed to a prior excursion a total of time in the range -14°C to -10°C (-11°C) for a time frame of 15 minutes because of data logger. Additionally, were also exposed to a current temperature excursion of -14°C to -10°C (-14°C) for 25 minutes because of data logger. No adverse effects were reported. One of this excursion temperature was in November 2016. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005332.
Patient reported that 3-5 minutes after the injection his vision was gone and his hearing was diminished. He did not report this until 2:25. The symptoms resolved by the time he reported them to the nurse.  Denied dizziness, shortness of breath, chest pain, or any other problems. Said he has a history of "passing out" if he gets overheated, but this episode did not feel like those other episodes. Released to the care of his mother at 2:35pm.