chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For three days following the second shot, I was extremely ill and unable to work with chills, fever and body aches.  Following recovery and for the next three months, I felt fatigued and had frequent and increasing incidents with headaches and chest tightness.  On August 17th, I was admitted to the Hospital with chest tightness, severe headache and fatigue. My blood pressue was 162/96, and I was admitted overnight to the hospital.    Prior to the shot series, I had maintained 120/80 for the last 59 years. I am retired  and exercise 5 time per week.  I now take 5mg of Amlodipine every day to keep my blood pressure between 130/85 which is acceptable for Dr. and cannot be off med without spiking my blood pressure.
This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 61 year old not Hispanic or Latino, Caucasian male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient previously received first dose of Spikevax (elasomeran) (dose 1 of dose number in series 1) (form, route of administration, batch number, dose was not reported and expiry: unknown) administered on left arm on 11-FEB-2021 for prophylactic vaccination. The patient additionally received second dose of Spikevax (elasomeran) (dose 2 of dose number in series 1) (form, route of administration, batch number, dose was not reported and expiry: unknown) administered on left arm on 11-MAR-2021 for prophylactic vaccination. The patient additionally received third dose of Spikevax (elasomeran) (dose 3 of dose number in series 1) (form, route of administration, batch number, dose were not reported and expiry: unknown) administered on left arm on 28-SEP-2021 for prophylactic vaccination. It was unknown whether the patient experienced any adverse events after three doses of Spikevax (elasomeran) (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose was not reported, administered on left arm on 05-APR-2022 for prophylactic vaccination (which was Off label dosing frequency). The batch number was not reported and has been requested. Age at time of vaccination was 61 years. No concomitant medications were reported. On 16-APR-2022, patient experienced symptoms (confirmed Covid-19 infection) (dose number in series 2). Patient started Paxlovid on same day (16-APR-2022) for Covid-19 treatment, when she experienced symptoms and tested positive on RAT (Rapid antigen test) and PCR test. Patient took Paxlovid from 16-APR-2022 to 21-APR-2022. Patient experienced Paxlovid "rebound" on Day 10 (25-APR-2022). RAT cleared on 01-MAY-2022 (Day 16). Patient was currently experiencing long Covid symptoms 6 weeks after first symptoms. He received acupuncture for the treatment of the adverse event. It was reported that the patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed Covid-19 infection, and long Covid symptoms, and the outcome of off label dosing frequency was not reported. This report was non-serious. This report was associated with product quality complaint. 90000234531. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Patient felt that the second dose was empty; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient felt that the second dose was empty) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced UNDERDOSE (Patient felt that the second dose was empty). At the time of the report, UNDERDOSE (Patient felt that the second dose was empty) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient believed second dose was not received, but the pharmacist does not agree with the patient. Believes that the patient was confused because two syringes were used during administration of the vaccine. One syringe was used to pull and the other was used to draw. No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.        Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received. NNI.
pneumonia; This is a spontaneous report from a Pfizer-sponsored program, A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was currently taking antibiotics for pneumonia, almost done with the treatment. The patient was scheduled to get her second COVID-19 vaccination tomorrow (at the time of report) and asked if it was safe for her to do so. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
within a few minutes after receiving vaccine he had a brief visual disturbance similar to the ones that preceded his stroke in 2010 by a few days. Then in the evening of November 4th after finishing supper he found himself unable to talk (expressive aphasia) even though he understood speech and knew what he wanted to say. Family noted a right facial droop. ambulance called and arrived within about 15 minutes. By the time the ambulance got him to General Hospital he had fully recovered. He had a negative CT angioram of the brain. It was compared to the 2010 CT angiogram. Neurologist in ER found him to have entirely normal neurological exam.
Headache developed followed by fainting spell, narrowed vision, head and neck pressure, kaleidoscope eye and later progressed into migraine like symptoms. Debilitating head pain, sensitivity to light and sound and slight nausea. this persisted for four days before slowly fading in intensity. Slight headache and occasional swelling of head and neck pressure persist to this day.
We received from a consumer via the Medical Communication the following information on 09 JAN 2008: A 56-year-old man, born on 29 JUN 1951, was vaccinated with Fluvirin, batch-no 79897, i.m. on 19 NOV 2007. Ten days after the vaccination he lost 100% hearing out of the left ear and 40% out of the right ear. He has been diagnosed with vestibular neuritis. The patient has not yet recovered at the time of report (09 JAN 2008). We received additional information on 14 JAN 2008: The patient was vaccinated on 18 NOV 2007 at 01:30 p.m. Approximately 8-9 days later he developed vertigo which on 30 NOV 2007 developed in a "full blown vertigo". Approximately 12 days after receiving the vaccine (30 NOV 2007) loss of hearing was reported which worsened over time. This was initially evaluated by a physician on 03 DEC 2007 and initially treated with an antibiotic. He went to ER on 04 DEC 2007 and was treated with Antivert, 25 mg three times a day and discharged. On 11 DEC 2007, CT scan was completed and negative. MRI was completed on 12 DEC 2007 and was also negative. The patient has had additional physician visits and was diagnosed as having vestibular neuronitis and viral labyrinthitis. The patient has not yet recovered at the time of report. 17 JAN 2008: Conclusion based on batch review - The batch review cannot conclude the reason for the reported adverse reactions.
Tachycardia-Irregular heart activity during anesthesia. The surgery I was having was a cataract surgery. I wore a heart monitor for a week to confirm this starting on May 14th Up to and over 180 beats were recorded. My cardiologist told me he believes this is from sleep apnea, which I have not had the testing done for this yet.
Difficulty when talking; Difficulty in breathing; Felt weak; Difficulty to swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty to swallow), ASTHENIA (Felt weak), SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPHAGIA (Difficulty to swallow). On 05-Feb-2021, the patient experienced ASTHENIA (Felt weak). On an unknown date, the patient experienced SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing). At the time of the report, DYSPHAGIA (Difficulty to swallow), ASTHENIA (Felt weak), SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinner medicine.
After receiving COVID-19 Pfizer Bivalent Booster, I am still experiencing extreme hearing loss as a side effect. I have been asking people to repeat themselves, turning up the TV loud, and have gurgling/pressure in both ears. I can't make out words people are saying unless they talk very loud - this happened within a few days of receiving the vaccine.   I will be scheduling an apppointment with an ENT doctor  as soon as possible.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms and sleeplessness. On an unknown date, the outcome of the pain in arm, influenza-like symptoms and sleeplessness were recovered/resolved. It was unknown if the reporter considered the pain in arm, influenza-like symptoms and sleeplessness to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The call center representative stated that the patient was not able to sleep on his arm for a week since it was sore. The patient had flu like symptoms that lasted for couple days.
About 1 week after, pt had localized reaction of redness, swelling and tenderness. After two days started to decrease .
Developed chest pain on 1/6/04 resulting in cardiac cath and angioplasty with stenting. RCA proximal and distal lesions; will have CABG in 6 weeks. Medical records reviewed. Please add COSTARTS of CORONARY ART DIS, OCCLUS CORONARY, INFARCT MYOCARD.
Very slight sore throat around 7:00pm; resolved in a couple of hours.  Around 9:00 pm developed deep, intense body chills that lasted at least 3.5 hours. No fever.  Once the chills were gone, I got an intense headache around the back of my head and in my forehead between my eyebrows.  Difficulty sleeping through these symptoms. Woke up the next day and those symptoms were gone.   Fatigued the next day.  Took a two-hour nap Saturday afternoon and felt normal afterwards.
This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a 26-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3JE9F, expiry date 20th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient does not know which GlaxoSmithKline Flu vaccine of she received. However, according to the batch number and expiry date provided, the patient must had received FLUARIX QUADRIVALENT and after an unspecified time, she experienced an unspecified adverse event. At the time of reporting, any further information was not available.
On 8-18-14 at approximty 11:15 AM patient had Rc'd HPV and began a jerking movement of arm, color was pale. He told me he "gets low blood sugar and had not ate." Mother had soda in purse. I called in admin we placed patient supine in floor, cool compress to back of neck and head, legs placed in chair. Holding his head he drank soda BP was 120/70 manual by RN. 10 min assisted Pt to chair after finishs soda. Patient started feeling well. Mother request to proceed with with MENVEO. After given patient walked to car.
loss of vision; loss of hearing; balance issues; Information has been received regarding a case in litigation from a lawyer and the pt on 11-DEC-2020, referring to a currently 70 year old pt. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-JUN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: loss of vision, loss of hearing and balance issues. The outcome of loss of vision, loss of hearing and balance issues was unknown. The causality assessment between loss of vision, loss of hearing and balance issues with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, loss of vision and loss of hearing were determined to be medically significant events.
severe headache lasted almost 3 days High blood pressure with a racing heart   on the third day I received a prescription from my cardioligist the next I lost my sense of taste   as of 02/02/2021 (11 days) my taste has not returned
PER ASSISTED LIVING AT 6PM ON 05/05/2022 HE EXIBITED SHAKING AND HIS BP WAS VERY HIGH HE HAD NO FEVER AT THAT TIME  THROUGHOUT THE NIGHT HIS SYMPTOMS WORSENED STARTED WITH A FEVER AND WAS SENT TO THE EMERGENCY ROOM.  HE WAS THEN ADMITTED (FEVER AT 104)
sinus headache; pollen allergy; This is a spontaneous report from a Pfizer-sponsored Program. A non-contactable consumer (reporting for herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on an unspecified date at single dose, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date after getting first dose on a morning, patient experienced pollen allergy and a sinus headache and was asking if it was okay to take ADVIL and Ibuprofen. The outcome of the events was recovered.   No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Large blister, headache as soon as vaccine given, shoulder/arm stiffness/soreness, fever, itching.
Immediate hive like erythema at injection site. Lungs clear. BENADRYL given in office.
sore throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration on 06Feb2021 (at the age of 30-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, enquired, the caller received 1st dose on Saturday (06Feb2021). On Monday, her brother, whom she lives with, tested positive for covid infection. The caller stated that, on Sunday and Monday she experienced a sore throat on an unspecified date in Feb2021. The caller asked whether the sore throat was from the vaccine or covid infection. Stated that, would the vaccine on Saturday protect her at all. If COVID-19 test results come back positive, did she need another 1st dose or when to get 2nd dose. The outcome of the event was unknown.  Information on Lot/ Batch number has been requested. Follow-up attempts completed. No further information expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 11:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.48.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 9 AM and temperature was 32, total doses given for the day was not provided. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 30-Mar-2021 and was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46 and 4 PM: 44, 5PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
EXTREME MUSCLE  AND JOINT PAIN UNABLE TO CALM WITH ADVIL OR TYLENOL,   HEART POUNDING AND PAPULATIONS  GENERAL  FLU SYMPTOMS
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 10-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL injection (dose, frequency and route were not reported) lot # L040459 with expiration date of 06-APR-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
PATIENT RECEIVED IMMUNZATIONS LATE AFTERNOON N 9/6/22, MOM CALLED THE FOLLOWING MORNING 9/7/22 STATING PTS MOUTH FELT ITCHY, NOTED REDNESS AND SWELLING AROUND MOUTH AND MOVING DOWN INTO NECK. THIS HAPPENED AT SCHOOL AT SCHOOL APPLIED BENADRYL CREAM AT THE TIME WHICH HELPED.ALSO NOTED RED AND SWOLLEN LEFT DELTOID WHERE IMMS WERE GIVEN. ADVISED MOTHER TO MONITOR BREATHING, PT DENIED ANY SOB OR BREATHING ISSUES AT THE TIME. ADVISED TO GIVE BENADRYL AS NEEDED ALSO. MOM CALLED BACK TODAY 9/8/22 STATING ARM IS STILL RED, SWOLLEN, PAINFUL, HARD LUMP AT VACCINE SITE. NOTED HIVES/REDNESS AROUND MOUTH AGAIN AND NECK. BENADRYL HELPS. PT AT SCHOOL AND IS DOING FINE, NO BREATHING ISSUES. ADVISED TO CONTINUE TO MONITOR SX AND FOLLOW UP AS NEEDED. MOTHER WAS OFFERED A CLINIC VISIT FOR EVAL BUT DECLINED.
After 1st dose, my tongue felt inflamed, but not enough to cause trouble breathing.  After the 2nd dose, I was in so much pain.  I felt it acerbated the pain I previously  had that was not causing any issues at the time of the injection.  My entire body is still hurting and inflamed.  I finally went to my primary care physician to explain all the pain I am in.  He ordered blood work and found my C-reactive protein was elevated to 27.  I am now being treated with Mobic to decrease the inflammation in my body.  I am continuing to work in pain, but not able to do much after work due to the pain and exhaustion I have had since my 2nd shot.
Pain at the injection site; Heat at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2022, the patient received the 2nd dose of Shingrix. On 7th October 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix and experienced pain, heat and redness at the injection site. The reporter gave medical disclaimer and referred to health care professional. The reporter spoke per package insert and content and after call survey offered package insert. The reporter consented to follow up.
Information has been received from a nurse concerning a female with no allergies who on 20-JUL-2007 and on 24-SEP-2007 was vaccinated IM 0.5 mL with the first and second doses of GARDASIL (lot# Not reported) respectively. It was unspecified if the patient had any adverse events after the first or second doses. On an unknown date, the patient received the third dose of GARDASIL (lot# not reported) IM 0.5mL. After the third shot, on 25-JAN-2008, the patient started "shaking" and vomiting. The patient went to the Emergency Room of a hospital and had "an anaphylactic reaction" while there. The patient was not admitted to that hospital but was "transferred" and admitted to another hospital for the "anaphylactic reaction". Subsequently, the patient recovered from the anaphylactic reaction while she was in hospital. In follow-up, it was reported the events happened in 2008 and patient's name and details could not be recalled. This is one of several reports from the same source. No further information is available.
Confusion, Dizziness, Headache, Diarrhea & Nausea Vomiting Narrative: woke up at 0200 after the injection, felt like he was confused, brain fog. Headache, took some Tylenol and was able to get back to sleep. Seems like it comes in "waves".