chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paresthesia; eye and lip twitching has gone away; leg problems have gone away; It was awful awful for months and months; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) reported for herself that: A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 14:30 (Lot number: EN6206) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PARAESTHESIA (non-serious) with onset 12Mar2021 20:30, outcome "recovered" (2021), described as "paresthesia"; MUSCLE TWITCHING (non-serious) with onset 12Mar2021 20:30, outcome "not recovered", described as "eye and lip twitching has gone away"; LIMB DISCOMFORT (non-serious) with onset 12Mar2021 20:30, outcome "recovered" (2021), described as "leg problems have gone away"; FEELING ABNORMAL (non-serious) with onset 12Mar2021 20:30, outcome "recovered" (2021), described as "It was awful awful for months and months". The events "paresthesia", "eye and lip twitching has gone away", "leg problems have gone away" and "it was awful awful for months and months" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had one dose of Pfizer on 12Mar2021. Could she get a second dose still. She had paresthesia starting 6 hours after first shot for 3 months. She was Leary of getting 2nd shot but now her job requires fully vaccinated and she would like to get the 2nd dose. It had been slightly over six months since the first." She wanted to know if she could still get the second dose. Her MRI was negative. She was hoping she didn't have to start he series over again." She saw a General Practitioner and a Neurologist.  No prior neuro symptoms before getting the vaccine. She still had minor symptoms. The majority of the symptoms went away in a month. The eye twitching and lip twitching lasted an additional month. By three months 90 % of the issues had resolved. She didn't have any heat or cold sensitivity anymore. She just had minor leg twitching/ tingling. It was all on her right side. Her right eye and corner of her right lip both twitched on and off daily for two months. She has never had any tingling or numbness in limbs.   Follow-up attempts are completed. No further information is expected.
EMS called for pt who was in cardiac arrest; CPR done; intubated; never achieved ROSC; hx of pt being positive for COVID
I WOKE UP WITH SEVERE ACHEA AND PAIN IN MY NECK, SHOULDER, BACK, AND THIGHS.  I TOOK 1 5MG OXYCODONE HCL PILL THAT SUCCESSFULLY RESOLVED THE PAIN IN A FEW HRS.  NO RECURRENCE OR  OTHER PROBLEMS SINCE THEN
Myoclonic jerks, also had vomiting and loose stool with fever to 100.7.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Nausea. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Nausea, METOPROLOL SUCCINATE (TOPROL) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Aug-2021. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 22-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient reported chest heaviness and like weighted  and felt like heart was tight and pressured breathing hard patient contacted primary care dr and did make appointment to doctor . referral made to cardiologist three days after that and before appointment made symptoms resolved. symptoms were 10 days or so total
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This spontaneous report from a contactable nurse reporting same events under the same suspect product for 19 patients. This is one of 19 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced positive with COVID-19 on 03May2021. It was reported that 19 residents in the long term care facility where the reporter work were fully vaccinated and are positive with COVID-19. Some were not doing well at all. The events was serious for being hospitalization, life threatening. The events result in Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 on 03May2021 with positive result. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021548296 same reporter, vaccine and AE, different patient
Hives on one side of face, the side she got the vaccine; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via The Agency (Reference number- 00428151) and transmitted to Sanofi on 13-Jan-2021.   This case involves a 73-year old female patient who experienced hives on one side of face, the side she got the vaccine (urticaria), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Past medical history included allergic reaction (hypersensitivity) (she put sunscreen all over her face for a yard sale and after the yard sale she saw she had an allergic reaction).  Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing drug hypersensitivity (she was allergic to Sulfur and praba)  On 23-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: unknown and expiration date: unknown] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced non serious hives on one side of face, the side she got the vaccine (urticaria), (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for 9 days and EPINEPHRINE (EPIPEN) for Urticaria.  On an unknown date, the patient recovered from urticaria (reported as hives lasted for 9 days).  The patient wanted to know if any of the components of the vaccine contain sulfa or PABA similar to sulfur to cause this reaction and if taking Benadryl before receiving a vaccine would prevent any potential side effects. Patient stated that she was surprised that hives lasted for nine days because she read the hives would only last for three days. The patient also stated that her doctor told her the hives could not be a side effect and that she must have touched her face.   There will be no information regarding batch number in this case.
This is a spontaneous report from a contactable consumer (patient reported). A 60-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunization. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Medical history included arthritis and pain. He had pain and arthritis in both his legs, ankles and knees since before the vaccination. The patient's concomitant medications not reported. A few days ago, 6 weeks after his 2nd dose, patient experienced exacerbated pain in both his legs, ankles and knees; but it became way worse after he received the vaccine. He always has aches and pains throughout his body (normally). He believes his weight isn't helping and his age caught up on him. Outcome of the event: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Pain at injection site, immediate but worsened w time, mild the next day.  Nausea, chills, malaise, muscle and joint pain-started 15 hours after vaccine and lasted about 4-5 hours  Fever up to 101.2- after nausea mostly resolved, lasted overnight  Headache -24 hours
i was bitten by a tick 3 weeks after 2nd shot. the tick died. i have never had a tick die after biting me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:30 (Lot number: en6208) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1,, vaccine location=Left arm}], lot number=en6208,), administration date: 09Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ARTHROPOD BITE (non-serious) with onset 21Apr2021 08:00, outcome "recovered", described as "i was bitten by a tick 3 weeks after 2nd shot. the tick died. i have never had a tick die after biting me". Therapeutic measures were taken as a result of arthropod bite.  Additional information: The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination and had not been tested for Covid-19 since vaccination. The patient had not received any other vaccine in two weeks or four weeks prior to Covid-19 vaccine. The patient had received treatment with  doxycycline to counteract potential infection from  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-FEB-2016, the patient was administered improperly stored PROQUAD (Merck) (lot # L002420, expiration date: 23-JUL-2016, dose and route of administration were not reported). Administered dose of PROQUAD underwent temperature excursions at 4 Celsius degrees, for 18 days, from 04-FEB-2016 until 22-FEB-2016. Information about the previous temperature excursions was not reported. Data logger was not involved in this particular situation. The reporter stated that the PROQUAD (Merck) was stored improperly due to product confusion, M-M-R II and the PROQUAD (Merck) look exactly the same on the top of the box. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
light headedness; really tired; could not move; really weird surges; brain fog; dizziness; head chills; cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), HYPOKINESIA (could not move), ADVERSE EVENT (really weird surges), DIZZINESS (light headedness) and FEELING ABNORMAL (brain fog) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0300A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), FEELING ABNORMAL (brain fog), DIZZINESS (dizziness) and CHILLS (head chills). On 24-Mar-2021, the patient experienced HYPOKINESIA (could not move) and ADVERSE EVENT (really weird surges). On 25-Mar-2021, the patient experienced DIZZINESS (light headedness) and FATIGUE (really tired). The patient was treated with LORATADINE (ALAVERT) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Mar-2021, NASOPHARYNGITIS (cold) and CHILLS (head chills) had resolved. On 24-Mar-2021, HYPOKINESIA (could not move) and ADVERSE EVENT (really weird surges) had resolved. On 25-Mar-2021, DIZZINESS (light headedness) and FATIGUE (really tired) had resolved. At the time of the report, FEELING ABNORMAL (brain fog) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
tested positive for COVID on 30Mar2021 09:00; tested positive for COVID on 30Mar2021 09:00; This is a spontaneous report received from COVAES from a contactable nurse (patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 31Dec2020 09:15 (Lot Number: EK9231) as single dose, second dose via an unspecified route of administration, administered in left arm on 22Jan2021 09:00 (Lot Number: EL8982) as single dose for covid-19 immunisation. Medical history included allergies to sulfa. The patient received other medications within 2 weeks. Patient was no pregnant at the time of vaccination. The vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent rapid Covid test twice for COVID-19 on 22Mar2021 with result of negative. Reporter reported that tested positive for COVID on 30Mar2021 09:00.  The event outcome for events was recovering.; Sender's Comments: Based on the information currently available, vaccination failure with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Red, raised, blanching, blotchy lesions on head, torso, upper and lower extremities. Afebrile; stable vital signs. Responded to Benadryl but recurrent over about 1 week period.
Left arm administration 1 and 2 doses.  After 2nd dose my left foot tingled/numb about 20 min after and subsided.  By 8pm I was tired, headache starting. By midnight body aches, mild fever and head worsening. Awoke Sep 1 fever 102.5, excruciating headache/ice/tylenol, unrelievable. Body aches, chills.  This subsided by Sept 2 mid-day.  Left toes tingly again. Sept 3  a 4x 3 in rash appeared left arm, swollen slight pain no itch. Not at injection. About 3 in lower.  Subsided 24 hrs.  Sept 5 felt left  pinky and ring toes cramping/moving. Different than normal cramp. Got phone to video and left big toe began moving sideways on its own. No cramping. Continued for 4 or 5 minutes. Tendons/arch simultaneously moving/flexing on its own for same time. This continued on and off through eve of Sep 5.  Occurred 4 or 5 time over next 2 days.  Over past month since Left two toes randomly cramp while resting,  at least 2x daily then stops.
It was two days after vaccine had lots of sputum went to get tested for Covid. The doctor started me on antibiotics and inhaler about week.
Diffiulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Diffiulty breathing) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPNOEA (Diffiulty breathing). At the time of the report, DYSPNOEA (Diffiulty breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored ROTATEQ, 2 ml, oral, lot no. L033693/ expiration date- 31-MAY-2017 (incorrect product storage). No concomitant medication was reported. No adverse event. It was exposed to temperature of 75.5F for 3 hours 7 minutes. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Severe inflammatory response developed 2 days after vaccine. Right wrist became swollen and painful at joint. Right hip/lower quadrant painful, tender-to-touch with problems bearing weight on hip. Burning feeling of gut. Severe headache. Eyes swollen with red/inflammation to left eye (slight blurriness to vision in that eye). Tachycardia. Red splotches to chest/back. Symptoms remained for approximately 48 hours. Except right wrist pain, still continues after 1 week. The right quadrant/gut burning still active but lessened. If continues; will see GI specialist.
Sore arm; Chills; Tiredness; This spontaneous case was reported by a dentist and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Tiredness). On 08-Jan-2021, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Tiredness) had resolved.        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.   No Concomitant medications were provided Treatment information provided as cold compresses
mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 15 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2014, the patient was tested mumps IgM. The results were postive for mumps at bilateral site. It was considered probable mumps parotitis. The patient required admission to the ward. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience. Literature report:  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Information has been received from a physician concerning a 42 (also reported as 34) year old female patient with allergy to "several antibiotics" (tetracycline, erythromycin) who on 16-DEC-2008, was vaccinated with a first dose of RECOMBIVAX HB and a second dose of RECOMBIVAX HB on 19-JAN-2009, (lot #, dose and route of administration unknown). It was reported that the patient after receiving her first dose of hepatitis vaccine noticed her throat "itched" but went away shortly (within minutes) after with no treatment. When she received her second dose, she immediately experienced difficulty breathing. The physician stated that this "got worse" and the patient went to an unspecified Emergency Room where she received antihistamines, an "H2 blocker", and steroids (all drugs unspecified). Patient was not admitted. The patient "did not feel well" for 24 hours after receiving the vaccine. Patient is recovering now but she is still on steroids. The physician considered difficulty breathing to be immediately life threatening. Follow up information was received from a physician concerning the 42 year old female nurse with allergy to penicillin, sulfa, codeine, LODINE, tetracycline and erythromycin who was given the vaccine in another office and seen in another emergency room (ER) after reaction. On 22-JAN-2009 the patient recovered. The physician had no further information to provide. Additional information has been requested.
Pt stated shortly after receiving the vaccination : 1) His right knee swelled and the swelling was still an issue one month later 2) He has been left with an uncomfortable feeling below his left clavicle that is still troubling him, esp when coughing 3) for 6 days following the vaccination he had "vibrations" in his left facial and head areas
The morning after receiving the vaccine, her lips started swelling, and she had body aches and fever.  Today (3 days after the vaccine) the fever is gone but her lips are still swollen and painful, I recommended she take Benadryl and call her primary care doctor for follow up.