chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included Epstein Barr virus (auto-immune) history years ago and allergic reactions to alcohol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date in Aug2021, the patient experienced headache every day since the day after the shot, it had been over 2 weeks at the time of report. The patient never had a history of headaches before. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event headache was unknown at the time of this report.
Blood pressure was elevated; right eye is cloudy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was elevated) and VISION BLURRED (right eye is cloudy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, LISINOPRIL and AMLODIPINE for Blood pressure high.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was elevated) (seriousness criterion medically significant) and VISION BLURRED (right eye is cloudy) (seriousness criterion medically significant). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure was elevated) and VISION BLURRED (right eye is cloudy) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment:Very limited information regarding this events has been provided at this time. Further information  has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information  has been requested.
Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration at the left arm on 29Dec2020 18:45 at a single dose for COVID-19 immunization. Medical history included anxiety, asthma, seasonal allergies, known_allergies: PCN and dairy allergy. Concomitant medication included celecoxib (CELEXA, 40 mg) and cetirizine hydrochloride (ZYRTEC, 10 mg). On 30Dec2020, the patient experienced sore left arm for 24 hours. Additionally, she had ache body and headache for 12 hours. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has 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 had Nasal Swabs for COVID-19 on 05Jan2021 and 06Jan2021, both results were negative. The outcome of the events was recovered on an unspecified date in Dec2020.
Shortly after the second dose of the Pfizer COVID vaccine patient developed signs of Type 1 diabetes.  Mostly excessive thirst.  Patient was not ill anytime close to prior to this and has been perfectly healthy up until this.  No family history of diabetes.  Diagnosis confirmed 08/12/2021, 2 months after second vaccination.
Feeling of weakness; feeling of overall fever; Site of injection is very hot; Injection site red; Injection site a little tough to the touch; Side Effects; This case was reported by a consumer and described the occurrence of feeling hot in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On 3rd September 2019, less than a day after receiving Shingrix, the patient experienced feeling hot and adverse drug reaction. On 4th September 2019, the patient experienced feelings of weakness. In September 2019, the patient experienced injection site warmth, injection site erythema and injection site induration. The patient was treated with paracetamol (Tylenol). On 4th September 2019, the outcome of the feeling hot was recovered/resolved. On an unknown date, the outcome of the feelings of weakness was unknown and the outcome of the injection site warmth, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the feeling hot, feelings of weakness, injection site warmth, injection site erythema, injection site induration and adverse drug reaction to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. On Tuesday evening, the patient had feeling of overall fever (but no high temperature was registered on thermometer) until midday on Wednesday. The next day morning, the patient had feeling of weakness.  The patient stated, till the time of reporting, the site of injection was very hot, red and a little tough to the touch (60 plus hours post injection). The other side effects were gone about 30 hours post injection. The patient had been taking extra strength Tylenol to help and was icing the injection site.  The patient asked if these were typical reaction occurs after vaccination and also asked if GlaxoSmithKline have any suggestions for it.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-SEP-2015, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-AUG-2016, the patient was treated at an urgent care for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. Additional information has been requested.
After flu shot, a large rectangular red area formed which was itchy and hot to touch and remained like this for 48 hours. After 48 hours, the area became black and blue.
A patient received the first dose of Gardasil without meeting qualifying criteria. He is a 65 year old male. He had no reaction to the vaccination.
Metallic taste in mouth continuing after vaccination; Joint pain in knees and elbows-non existent prior to vaccine; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 05Nov2021 (Lot number: FE2590) at the age of 51 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FE3650; Anatomical location: Left arm), administration date: 11Oct2021, when the patient was 51 years old, for COVID-19 immunisation.  The following information was reported: DYSGEUSIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Metallic taste in mouth continuing after vaccination"; ARTHRALGIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Joint pain in knees and elbows-non existent prior to vaccine". Therapeutic measures were not taken as a result of dysgeusia and arthralgia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to a 60 year old patient of unknown gender. On 04-JUN-2015, the patient who was indicated for ZOSTAVAX was vaccinated with a dose of VARIVAX (Merck) (dose, strength and route were unknown, lot # L002870, expiry date: 27-JAN-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Had relatively severe reaction to all three doses; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Had relatively severe reaction to all three doses) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (Mild) since 2021, Asthma since 2019, Environmental allergy since 2010 and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, FLUTICASONE PROPIONATE (FLOVENT) and ALBUTEROL [SALBUTAMOL] for Asthma, LISINOPRIL for Hypertension, MONTELUKAST and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Had relatively severe reaction to all three doses). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Had relatively severe reaction to all three doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658313 (Linked Report). This case was linked to MOD-2022-658313, MOD-2022-666062 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2022: Significant follow up: Reporter, Patient address, Narrative, history, and medication updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658313:
Info has been received from a health professional concerning a male, "in grades 3-5", who was vaccinated with a dose of varicella virus vaccine live. "Recently", since November 2005, the pt experienced a chickenpox outbreak. Unspecified medical other information was provided. Additional info has been requested.
Onset of mild headache 8-hours post-injection. Extreme fatigue, generalized muscle soreness, increased soreness at injection site. Rest, stayed home, no physical activity, no NSAIDs or prescription pain-relievers. Constellation of symptoms increased in intensity and was most intense 24-36 hours post-injection with low-grade fever and chills. Forty-hours post-injection all symptoms resolved. No further symptoms noted. Resumed normal AODL.
After vaccine patient had a fainting and vomiting episode. There was no respiratory compromise and patient recovered by lying down and cold compresses to forehead and apple juice. Resolution within 15 minutes. Vasovagal reaction.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 05/24/2022. I contacted my doctor via telehealth and was given a prescription for ZITHROMAX and a cough medicine. As of today, I am feeling better with no lingering symptoms.
Fatigued, Headaches, Swelling in the lymph nodes in the same arm as the injection size of a golf ball, Muscle pain, Joint pain, Chills, Brain fog.   Time Course 9-19-2022 continuous
Croup began the evening he received the flumist vaccine. 11/09/2007 MR received for DOS 10/31/2007 for D/C DX of Croup.  Pt presented to ER with abrupt onset of inspiratory stridor which responded quickly to racemic epinephrine and steroids. Transfered to current facilty where pt has not required any additional epi. Discharged on steroid taper. PE (+) respiratory stridor, otherwise WNL. Impression: Croup
This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 25-FEB-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048460 and expiry date 14-JAN-2017) (dosing details unspecified) and improperly stored RECOMBIVAX HB (lot # L042846 and expiry date 15-SEP-2017) (dosing details unspecified) which underwent specific temperature excursion of: Temperature: 47F, Time frame: 25 hours, Data logger: There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 01-APR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot number K020214 with expiration date 25-MAR-2016, (dose, anatomical location and route were not reported). There was no concomitant medication reported. Additional information has been requested.
Information has been received from a physician concerning a 13 year old female who on 06-JUL-2007 was vaccinated with the first dose of GARDASIL (lot# not provided).  Subsequently the patient developed a firm nodule on her arm close to the injection site about half centimeter in size.  Physician saw the nodule yesterday (03-Apr-2008) when patient visited the clinic.  It was unknown when the patient developed the firm nodule.  Medical attention was sought by visiting the physician.  The patient's outcome was unknown.  Additional information has been requested.
This non-valid spontaneous report was received from a nurse, and refers to unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that between 26-NOV-2018 and 07-FEB-019, one patient received improperly stored VARIVAX (lot # R017640, expiration date 20-JUN-2020 and lot # R02241, expiration date 14-JAN-2019), and two patients received improperly stored PROQUAD (lot # R014353, expiration date 18-NOV-2019), both for prophylaxis (route, dose, and anatomical location were not provided). The doses of VARIVAX and PROQUAD were exposed to a temperature excursion from -9 Celsius degrees (degrees C) to 8 degrees C (-4.8 degrees C) during a timeframe of 52 minutes and 30 seconds, which was detected by the data logger. The vaccines were reconstituted with properly stored sterile diluent. There were no previous temperature excursions. Lot number R02241 is an invalid lot number for VARIVAX.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two different places.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to office, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
w/in 4 hrs post vax, pt presented to ER w/fever of 105, admitted; tx IV ATB; Pt has not been d/c to date;
can take any pain killer after vaccine?; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (can take any pain killer after vaccine?) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (can take any pain killer after vaccine?). At the time of the report, PAIN (can take any pain killer after vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
Patient had grade 3 diarrhea (CTCAE) approximately 27 hours after vaccine administration. Symptoms subsided about 5 hours after they began and after a dose of loperamide (imodium) and an increase in fluid intake. Given the patient's age, hospitalization would have been necessary if symptoms had continued.
GREAT AUNT OPENED DOOR ON EXAM ROOM AFTER FLU VACCINE WAS GIVEN, ABOUT 3-5 MINUTES  AFTER VACCINE WAS GIVEN, SHE SAID SHE NEEDED A NURSE. GREAT AUNT STATED THAT "PATIENT FELL OUT OF HIS CHAIR, JERKED A COUPLE OF TIMES AND WET HIMSELF." GREAT AUNT WANTED PATIENT SEEN AT THE EMERGENCY ROOM, AMBULANCE WAS  CALLED AND PATIENT WENT TO HOSPITAL.
memory loss, distant feeling, hazy.  Felt symtoms one day after receiving vaccination.  More intense symtoms lasted for 4 days following reception of the shot.  Symtoms tapered downward in intensity after the initial 4 days of intense reaction.
Patient states she started getting redness at the site on June 8. The vaccine was given to her on june 5.  She went to the MD on June 10 and they prescribed her antibiotics
still itches a bit; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (still itches a bit) and VACCINATION SITE RASH (rash at the site of the injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the site of the injection). On an unknown date, the patient experienced PRURITUS (still itches a bit). On 30-Jan-2021, VACCINATION SITE RASH (rash at the site of the injection) had resolved. At the time of the report, PRURITUS (still itches a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided   Reporter did not allow further contact
Nauseous and chills (flu like symptoms for 20 hours) Still has body temperature issues.  Gets very cold and shakes periodically still Still has a sore arm
pt recv vax 29SEP95 & 13SEP96 pt devel a subclinical case of chickenpox w/45 lesions, minimal itching & no fever;pt feeling fine;
felt weakness and slight shortness of breath like she had just ran around the block; muscle weakness in the legs, knees down feel weak like the blood has been drawn out/ her lower legs just feel weak; felt weakness and slight shortness of breath like she had just ran around the block; heavy duty nausea twice- at 4pm and 9pm but did not vomit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated fifteen years ago she had an allergic reaction to the flu shot, with a huge amount of swelling in the arm with a very quick onset. She was given a subsequent shot and then was fine. She was fine with the pneumonia shot. She did have a cortisone shot in the knee that gave her heart palpitations and a red face. On 11Mar2021 (Thursday), patient received the first dose of the Pfizer vaccine and on the same day she experienced heavy duty nausea twice-at 4pm and 9pm but did not vomit. Then on late Saturday (13Mar2021) she felt some nausea and felt weakness and slight shortness of breath like she had just ran around the block. She experienced muscle weakness in the legs, knees down feel weak like the blood has been drawn out. She feels fine walking but that her lower legs just feel weak or "bushed." At the time of reporting, outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
tired; weak; This is a spontaneous report from a contactable consumer who reported for his wife (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unwon route for Covid-19 immunization. Medical history included autoimmune condition, Type 1 Diabetes Mellitus, Graves Disease (hyperthyroidism), some eczema.  Patient got the diabetes later in life like 6 years ago from having her immune system compromised.  Patient was perfectly healthy. Concomitant drugs included levothyroxine sodium (SYNTHROID) and insulin.  Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. After the shot, patient was tired and weak for a couple of days.  Outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I received the Pfizer Bivalent booster on 12/1/22 at 11 am. I am a 72 year old female being treated for Afib. I had not had an incident of Afib since 9/12/22. At 10:06 pm the evening of 12/1 I started with an irregular heartbeat. I did an EKG on my watch and it indicate that I was in Afib. Fortunately it did not last too long that evening - just a few minutes. However, on the evening of 12/3/22 I hadan extensive Afib incident. I did 2 EKGs - one at 10:11 pm and one at 10:47 pm. They both showed Afib. The first showed an average of 116 beats per minute and the second showed an average of 105 beats per minute. I took my evening dose of Eliquis at the onset of the problem. I did not have any other symptoms with the irregular heartbeat. This incident continued much longer than a usual Afib event for me. It did not end until 11:30 PM. I did not see my cardiologist about the incident. I was considering going to the ER when it stopped. I am wondering if there could be a relationship between receiving the booster and the triggering of this Afib incident.