chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood pressure went up; Heart rate went up; He felt warm sensation when vaccine was going in the body; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure went up), HEART RATE INCREASED (Heart rate went up) and FEELING HOT (He felt warm sensation when vaccine was going in the body) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up), HEART RATE INCREASED (Heart rate went up) and FEELING HOT (He felt warm sensation when vaccine was going in the body). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure went up), HEART RATE INCREASED (Heart rate went up) and FEELING HOT (He felt warm sensation when vaccine was going in the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
some liquid spills out; some liquid spills out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (some liquid spills out) and DEVICE CONNECTION ISSUE (some liquid spills out) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some liquid spills out) and DEVICE CONNECTION ISSUE (some liquid spills out). At the time of the report, UNDERDOSE (some liquid spills out) and DEVICE CONNECTION ISSUE (some liquid spills out) 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 relevant concomitant medications were reported by reporter Treatment information was not provided
Patient came into Pharmacy to receive 1st dose (monovalent) Pfizer vaccine. Pharmacist did not indicate that this was the bivalent vaccine. Pt received this dose on 11/05/2022 and went home.  At home patient immediately went to bed. Her bilateral joints were in excruciating pain, heart racing and had difficulty breathing. Her chest and back where in immediate pain even while lying in bed. She also started coughing and had intense chilling. Pt is unsure if she had a fever.  These symptoms occurred for approximately 2 weeks. Pt did not call 911.
VACCINE WAS ADMINISTERED FROM  A VIAL THAT WAS EXPOSED TO  A TEMPERATURE OF 35 DEGREE  FAHRENHEIT FOR 4 HOURS; 5  DOSES FROM THE SAME VIAL WERE ADMINISTERED TO 5 PATIENTS; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 22-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 22-JAN-2022, the patient experienced vaccine was administered from a vial that was exposed to a temperature of 35 degree Fahrenheit for 4 hours. On 22-JAN-2022, the patient experienced 5 doses from the same vial were administered to 5 patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered from a vial that was exposed to a temperature of 35 degree Fahrenheit for 4 hours and 5 doses from the same vial were administered to 5 patients was not reported. This report was non-serious.
Recv'd Pneumovax on 11/2/99.Within 12 hrs began to dvlp fever,arm soreness,& redness around inject site.Within 24-36 hrs began to dvlp cellulitis of lt deltoid area of shoulders & vomiting. Ultimately, rqrd 5 IV antibiotics to tx in hosp.
red area 5 in x 5 in below injection site and elbow, skin hard not flexible when pinch, slightly swollen.  Started Friday 4/16/21.  Called Dr office 4/20/21. Received call back today.  Seems skin is more flexible this morning.  Still red and slightly swollen.
Very sore arm starting at time of vaccination and still very sore 2 days later. Serious body aches lasting at least two days. Fatigue. Nausea. Feeling like you got hit by a bus. Tylenol makes no noticeable improvement.
muscle pain in her left upper arm that has lasted for 10 weeks.; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported muscle pain in her left upper arm that has lasted for 10 weeks(myalgia).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious muscle pain in her left upper arm that has lasted for 10 weeks (myalgia) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was muscle pain in her left upper arm that has lasted for 10 weeks..   It was recommended to take aspirin, however the patient did not take aspirin because she had also taken a "blood thinner" and cannot take aspirin so she "toughed it out.  At the time of reporting, the patient outcome was reported as Recovering / Resolving.   Information on the batch number was requested.
given in the back area of the left arm; not in the deltoid/into the fat; was given a subcutaneous injection; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number FZ453, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season (subcutaneous) and Fluarix Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The action taken with Fluarix Quadrivalent 2022-2023 season was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The quality manager reported that patient was given a subcutaneous injection of Fluarix in the back area of the left at, not in the deltoid. No symptoms were reported. The reporter stated that there might be more patients involved once she reviews all the records. The reporter consented to follow-up via email. This was 1 of 2 linked patients, reported same reporter. Additional supportive information: The patient received Fluarix injection via subcutaneous route at inappropriate site, which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The case US2022155536 was identified as duplicate of US2022155534. The case US2022155536 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient; Sender's Comments:  US-GSK-US2022155535:same reporter
Narrative: Admission Diagnosis:COVID-19 pneumonia, COPD exacerbation DIAGNOSIS: Primary Diagnosis: Pneumonia Secondary diagnosis: COVID-19. dyspnea, COPD
JANSSEN COVID-19 VACCINE WAS ADMINISTERED TO THE PATIENT AS  A BOOSTER DOSE, IN ERROR.; This spontaneous report received from a pharmacist concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 12:45 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 20-AUG-2021, the patient experienced janssen covid-19 vaccine was administered to the patient as a booster dose, in error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine was administered to the patient as a booster dose, in error. was not reported. This report was non-serious.
arm sore; feel tired; chills; menstruation when already menopause; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (menstruation when already menopause) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 030B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (menstruation when already menopause) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), FATIGUE (feel tired) and CHILLS (chills). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (menstruation when already menopause), PAIN IN EXTREMITY (arm sore), FATIGUE (feel tired) and CHILLS (chills) outcome was unknown.            No treatment medications were reported. Patient did not take any OTC medications for symptom relief.  Company comment: This Spontaneous case concerns a 52-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Postmenopausal bleeding. The patient experienced menstruation when she was already menopause 1 day after receiving the third dose number of mRNA-1273 vaccine. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-406646, MOD-2021-406538 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 52-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Postmenopausal bleeding. The patient experienced menstruation when she was already menopause 1 day after receiving the third dose number of mRNA-1273 vaccine. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Case called to report a fever of 102 @ 1 pm on 01/12/2021, body ache, and soreness at injection site. Fever was decreased with Tylenol the same day.
Sore throat, cough and cold developed into bronchitis, fever that never went over 100 symptoms improved after 11 days and 3 days later came back started the same way but sore throat was worse and I called my doctors office and they couldn't fit me in so told me to go to urgent care.  Dr. there (name on previous page) took one look at my throat and agrred that I definitely had a throat infection and ordered antibiotics at local pharmacy and I picked them up on the way home.  Within 4 days I started feeling much better but cough is holding on still.
This patient has had a breakthrough COVID infection.; This patient has had a breakthrough COVID infection.; This is a spontaneous report from a contactable consumer (Pfizer colleague). This consumer reported similar events for two patients. This is the 2nd of two reports. An adult female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. This patient had had a breakthrough COVID infection on 18Sep2021. It was unknown if treatment received. Covid test on 20Sep2021 was positive. Outcome of the event was resolving.   The report was assessed as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101234262 same reporter/product/event, different patients
Mild low grade fever, no palpable induration or tenderness.  Warmth and redness over upper legs and thighs. Erythematous circular pattern of skin change bilaterally. Mild cellulitic change.
Information has been received from a physician concerning a 33 year old patient who on 09/21/1999 and 10/19/1999 was vaccinated with a first and second dose, respectively of Varivax. On 05/04/2000, the patient sought unspecified medical attention and had blood tests performed which showed no immunity to varicella. In FOLLOW-UP, the physician reported that the patient received a third dose of Varivax and failed to seroconvert.The physician stated that "the antibody level was 829, far less than the 99 needed".
bell's palsy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BELL'S PALSY (bell's palsy) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BELL'S PALSY (bell's palsy). At the time of the report, BELL'S PALSY (bell's palsy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was provided  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
cellulitis of right arm, low grade temp of 100.2 reported at home, headache
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a  patient of an unknown age and gender 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 an unknown date, 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 VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported The case is cross linked to MOD21-080147  and MOD21-080185   This case was linked to MOD21-080185 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Event updated; Sender's Comments:  MOD21-080185:Wife's case
Patient is a resident at a LTCF. Walgreens went to their facility to do three off site COVID vaccine clinics that were spaced at least 21 days apart per our CDC contract. Patient received 3 doses total of Pfizer. They were vaccinated on 1/08/21, 1/29/21, and 2/19/21. The facility has been notified of this incident. At this time, no adverse affects have been reported.
7pm 12/14/08 received flu shot 10pm 12/14/08 throat started feeling tight and full. Also had red, watery eyes and swelling of the eye lids. Treatment, OTC BENADRYL 50mg.
Swelling R Knee with 2 observable lumps.  Swelling in ankle with extreme heat.  Seen  family practice physician, sent to hosp for doppeling for suspected clots.  None noted.  Swelling persist in R knee and marked weakness in L knee and hips.
The patient did not have any adverse effects. Two vaccines, the DTap and the Hib, were both administered in error.
I had a sore throat and cough when I woke up in the morning. I felt really fatigue and had body aches. I took cough suppressants and my daily medications to help reduce my cough. I went to the clinic to get tested on 05/02/2022, and it came back positive for COVID-19.  I quarantined for 10 days and have felt better since then and just returned back to work on 05/16/2022 after my PCR test came back negative on 05/12/2022.
Pt came in for flu shot. She listed allergies to CODEINE-SULFA but no allergies to chicken, eggs, gelatin, NEOMYCIN, etc. When asked if she had a reaction to vacc in the past she said she didn't know but only had prob w/allergy shots and had never gotten flu shot. We discussed allergic Rxn symptoms, pt said she was pregnant. After shot-pt complained of dizziness, tightness in throat. After monitoring of about 20 min called paramedics to assist and assess. Pt left without giving update on condition.
All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered.
10-3-16-patient given 0.25mL flu vaccine. 11-8-16-patient given 0.25mL flu vaccine. Provider will call parent and recommend revaccinating with correct dose.
Not feeling well day after shot; This is a spontaneous report received from a non-contactable consumer (patient). An adult of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling well day after shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA006234: US-009507513-2001USA009323: US-009507513-2001USA009326: US-009507513-2001USA009327:
First DVT in an 85-year-old ambulatory female on daily ASA.  Also found to have pneumonia at the same time.  Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours.  Normal O2 sat.  Pt was evaluated and seen in memory care where she currently lives.  Treatment:  ASA discontinued, Eliquis and Levaquin started.  Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.
Vaccine recipient c/o near syncope to RN monitor in the vaccination clinic.  Cool, pale, dry skin.  She placed her head on the table and asked for help.  RN monitor requested assistance.  Patient had strong pulse, no respiratory difficulties, no hives noted but was unable to stand.  ED Charge nurse notified and ED RN transported patient to the ED via gurney without incident.