chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scalp begin to itch; Raised hives on my scalp which spread to my face and upper back; This is a spontaneous report from a contactable other HCP. A 45-years-old female patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 09Mar2021 at 16:00 (at the age of 45-year-old) at a single dose (1ST DOSE,SINGLE) for COVID -19 immunization. The patient medical history and concomitant medications were not reported. No allergies were reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks.The patient's scalp begin to itch and raised hives on my scalp which spread to her face and upper back within 20 minutes on 09Mar2021 at 19:30. She took a Benadryl and did not get any relief. She said that 30 min later she took another Benadryl and got relief in about 10 minutes. No COVID prior vaccination. No treatment was received. No COVID tested, post vaccination. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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.
No adverse event. but the patient received a Moderna booster.  They should not have received a booster or Moderna because they are under 18.
Mother stated pts arm was red and hard, this was his # 3 HPV-9.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, drug allergies, concurrent conditions and concomitant therapies were not provided. On an unknown date, (reported as previously) the patient was vaccinated with GARDASIL, (strength, dose, frequency, route of administration, lot# and expiration date were unknown by the reporter) for prophylaxis. Subsequently, on an unspecified date, the reporter stated that the patient was in the office to continue the series with GARDASIL 9 (strength, dose, frequency, route of administration, lot# and expiration date were unknown by the reporter) for prophylaxis (interchange of vaccine products). No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.
Patient did not have any adverse effects or symptoms from dose.; An expired dose of PROQUAD was given today, 02May2022; This spontaneous report was received from medical assistant and refers to a 12-month-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported.  On 02-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/once, lot #T034613 (rHA), expiration date: 10-APR-2022 (expired product administered), administered for prophylaxis (strength, and route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  No adverse symptoms were reported.
3/22 very severe tightening of neck muscles and neck ache  3/23 woke up w very tight neck and head pain.  As the day progressed, experienced pain/inflammation in leg muscles and body.  Headache worse.  Brain fog.  Slow to focus eyes.
ended up getting COVID before her antibodies; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (ended up getting COVID before her antibodies) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID] and LEVOTHYROXINE for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COVID-19 (ended up getting COVID before her antibodies). At the time of the report, COVID-19 (ended up getting COVID before her antibodies) outcome was unknown. Not Provided      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.   Patient received monoclonal antibody infusion as treatment.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
No adverse events reported. Just found out after the fact that the patient wasn't 18 but 16.
Swelling and pain; Swelling and pain; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; Chills, soreness on her arm, nausea, headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Swelling and pain), VACCINATION SITE SWELLING (Swelling and pain), CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches) and NAUSEA (Chills, soreness on her arm, nausea, headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Swelling and pain), VACCINATION SITE SWELLING (Swelling and pain), CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches), NAUSEA (Chills, soreness on her arm, nausea, headaches) and HEADACHE (Chills, soreness on her arm, nausea, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2021, CHILLS (Chills, soreness on her arm, nausea, headaches), MYALGIA (Chills, soreness on her arm, nausea, headaches), NAUSEA (Chills, soreness on her arm, nausea, headaches) and HEADACHE (Chills, soreness on her arm, nausea, headaches) had resolved. At the time of the report, VACCINATION SITE PAIN (Swelling and pain) and VACCINATION SITE SWELLING (Swelling and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included cholesterol medication and thyroid medication.  The patient stopped taking regular medications.
HPV injection given at 1540. Patient experienced a brief LOC (<10 sec) post injection at 1541. Slumped in chair and hit forehead on medication freezer in the Pediatric Immunization Room.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (1 single shot, lot # was not reported). On an unknown date patient developed a rash, was in a lot of pain and went to the ER (demographics unknown). The patient was not admitted into the hospital. The patient received VALTREX and NORCO (doses/frequencies/manufacturers unknown) to treat the event. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Fatigue and tired; Tingling sensation; Tightness in the chest; Wheezing with slight cough; Wheezing with slight cough,did not have a persistent cough and the cough did intensify; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough), COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify) and FATIGUE (Fatigue and tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 003C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation). In April 2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough) and COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify). On an unknown date, the patient experienced FATIGUE (Fatigue and tired). On 13-Apr-2021, PARAESTHESIA (Tingling sensation) had resolved. At the time of the report, CHEST DISCOMFORT (Tightness in the chest), WHEEZING (Wheezing with slight cough), COUGH (Wheezing with slight cough,did not have a persistent cough and the cough did intensify) and FATIGUE (Fatigue and tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal.         Patient is taking medications for the side effects.   This case was linked to MOD-2021-359055, MOD-2021-358982, MOD-2021-358738 (Patient Link).
Developed fever 104, couldn't stand up, trembling, dizziness, "eyes rolling", vomiting started in the evening and lasted all night long, did not lose consciousness, slept a lot.  Went to emergency room that evening, no labs done.  ER doctor stated it was from vaccinations.  Fever gradually came down, 102 the next day.  Was able to keep down Motrin alternated with Tylenol the next day.  Temperature came down with the antipyretics.  Was "back to normal" after 3 days.
Chills; Headache; Deep body aches; Fatigie; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 27Feb2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and fibromyalgia. Concomitant medication included levothyroxine, liothyronine (NP THYROID); taken for unknown indication from an unknown date and unknown if ongoing. 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. On 01Mar2021 at 12:00, the patient experienced chills, headache, deep body aches and "fatigie". The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, headache, deep body aches and "fatigie" were not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
red spots from left elbow to wrist, red spots ongoing for 6 months; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots from left elbow to wrist, red spots ongoing for 6 months) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 013M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (Recent change in status such as improvement or worsening: No change reported), Immunocompromised (due to white blood count lower than average), White blood cell count low (Paitent is immunocompromised due to white blood count lower than average) and Thyroid disorder. Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In October 2021, the patient experienced RASH MACULAR (red spots from left elbow to wrist, red spots ongoing for 6 months). The patient was treated with TRIAMCINOLONE for Red spotty rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (red spots from left elbow to wrist, red spots ongoing for 6 months) had not resolved.            Concomitant medications also included thyroid medication and hormone replacement therapy.  It had been stated that the dermatologist did not make any diagnoses of the red spots. It had been reported that symptom worsened. The reporter stated that the red spots were not itchy and not raised on the skin. It was also reported that the patient did not have any reactions to the first and second Moderna primary series doses but the reporter believed that the patient had a reaction to the Moderna booster doses. .   This case was linked to MOD-2022-538964 (Patient Link).
Her mother had a couple falls within a couple days; Her mother had 2 ankle fractures from one of the falls; This is a spontaneous report from a contactable consumer or other non-hcp. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6204; Expiration Date: Jun2021) via an unspecified route of administration (age at vaccination 71-year) in Right Arm on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history included crohn's disease from 1980 to an unknown date; pulmonary fibrosis (diagnosed 2 years ago), fibromyalgia (for at least a decade), arthritis, stress fracture, ankle fracture, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks) was reported. As patient's daughter reported, her mother had a couple falls within a couple days on 28Mar2021; her mother had 2 ankle fractures from one of the falls in 2021. The caller said her mother had a fall, and her mother had not gotten her second COVID-19 Vaccine dose. The caller asked if her mother should start over with getting the COVID-19 Vaccine, or could her mother get the second COVID-19 Vaccine dose. Person stated she gave the caller the number for Pfizer Medical Information. Reviewed and confirmed the transferring agent's report details with the caller. Reported she didn't believe that her mother's fall was related to her mother's first COVID-19 Vaccine dose. She said there was too much time that had gone by between when her mother received her first COVID-19 Vaccine dose and her mother's fall. Stated her mother said she believed she received her first COVID-19 Vaccine in her right arm because she was left-handed but was not positive. Reported her mother had past stress fractures and did not realize she had 2 ankle fractures. She said she called EMS the following day of her mother's fall, and her mother didn't have surgery on her foot right away because she had too much swelling. She clarified her mother had surgery on her one foot at a later date. Reported her mother was in a residential care facility for 2 months and had to cancel her second COVID-19 Vaccine. She said her mother was unable to get another COVID-19 Vaccine appointment during that time, and the residential care facility her mother was in used a different COVID-19 Vaccine. Her mother not getting her second COVID-19 Vaccine was strictly a timing issue because she was unable to schedule a Pfizer COVID-19 Vaccine while at the residential care facility. The adverse event ankle fracture leads to visit Emergency Room/Physician Office. Her mother had surgery one her foot, and her mother was in a skilled nursing rehab center for 2 months. No further details provided. Her mother was still in recovery with Physical Therapy and Occupation Therapy being done at home. Therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events was recovering.  Follow-up attempts are needed. Further information is expected.
8cm erythema, edema and tenderness over Left mid-deltoid.  + Pruritic.  No anaphylaxis, no angioedema, no wheezing.
Modern s COVID-19 Vaccine EUA.    Approximately 25 min after receiving the shot(11:25 am) my Body became very hot, weak, lightheaded, dizzy, brain went foggy and my heart rate increased.  This lasted until about 9:00 pm that night.
PATIENT DEVELOPED ERYTHEMA MULTIFORME 5 DAYS AFTER VACCINE WAS ADMINISTERED. WAS SEEN ON 04/02/2018 AT OUR OFFICE AND PRESCRIBED BENADRYL AND PREDNISOLONE.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 02-MAY-2018 the patient was vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis; dose, strength, frequency and route of administration were unknown;  lot # N025704 and expiration date 16-DEC-2018. ZOSTAVAX was reconstituted with a properly stored sterile diluent. The patient experienced no adverse events. ZOSTAVAX had a temperature excursion of 24 hours; there were no previous temperature excursions. Data logger was not involved.
Information has been received from a licensed practical nurse concerning a 76 year old male patient with hypertension, benign prostatic hypertrophy and with no drug reactions or allergies who on 22-SEP-2010, was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 665708/0651Z). Concomitant therapy included lisinopril-HCTZ. It was reported that on the evening of 24-SEP-2010, the patient saw the doctor for an injection site reaction of the left arm with inflammation, redness and tenderness to touch. The patient was treated with cephalexin for diagnosis of Cellulitis. Lab diagnostics studies were not performed. The patient was seen on 01-OCT-2010, and the area was clear. The licensed practical nurse stated that it was the first time he had received PNEUMOVAX 23 and he did not receive other injections on 22-SEP-2010. The doctor was requesting a lot check because of the above symptoms. On 01-OCT-2010, the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Starting ab 11PM the day of the shot....very sore injection site, entire body aching, fever,  fits of uncontrollable shivers, chills, stomach pains and pounding headache. All symptoms gone by 11AM the day after the shot.
scratchy throat; fever of 100.0 [units unspecified]; Headache; Nausea; body aches; Diarrhea; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient started to receive bnt162b2 (BNT162B2; unknown lot number and expiration date), via an unspecified route of administration on 16Dec2020 to 16Dec2020 single dose for an unspecified indication. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included levothyroxine. The patient reported that she had scratchy throat several minutes (reported as 02:30 AM) after receiving the vaccine (16Dec2020). It did subside but then 14 hours after receiving the vaccine, she had different symptoms, She had a fever of 100.0 [units unspecified], headache, nausea, body aches and diarrhea. The events did not cause hospitalization/ prolonged hospitalization. The patient has not received other vaccines in the last four weeks. The facility where the most recent COVID-19 vaccine was administered in a hospital. There was no treatment received for the adverse events. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous prospective pregnancy report was received from registered nurse refers to a female patient of unknown age. On 04-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route not reported). On an unknown date, the patient had quarter size reddened area at injection site. The patient was found to be pregnant. The estimated date of conception was on 17-JUL-2012. The patient enquired if it was safe to have contact with 1 and half year old and a new born expected on April 9th (estimated due date). The outcome of the event was unknown. Additional information is not expected.
woke up and all of a sudden felt like I had pulled several muscles the left side of my neck and shoulder. But I hadn't done anything. Pain progressed as did stiffness within an hour to the point that I can barely move my neck without significant pain to neck and down into shoulder. It has been like this for almost 5 hours now and has not improved.   Prior to this - the day and night i got vaccinated I felt fine. the following day I had a pretty bad headache. And then this morning this new thing happened. I am not worried about the headache as that is normal. I am worried about this severe pain and stiffness that is localized in one part of my body and is not going away.
Vomiting four instances over the course of an hour and a half three hours and 45min after administration of the vaccine.
high fever 105 not controlled w/anything from 15NOV-18NOV95;pt's fingers/toes turned blue & shook w/chills during fever;congestion in chest, fever of 102 or under & measles rash during dates of 18NOV95-22NOV95;loss of appetite, irritable
Patient received Moderna initial dose in January and did not report it to the vaccinator. She received the Pfizer for her second dose on 3/3/21.
ON THE RIGHT ARM (PNEUMOVAX SIDE) PATIENT WOKE UP NEXT MORNING WITH USUALLY SORENESS BUT AFTER 2 OR 3 DAYS HE DEVELOPED A SIGNIFICANT LUMP AND REDNESS AND STILL DISCOMFORT. NOW 2 MONTHS LATER HIS RIGHT ARM IS STILL PAINFUL UPON USE OR IF HE TRIES TO SLEEP ON RIGHT SIDE. HE IS GOING TO HIS PCP FOR REGULAR CHECKUP AND IS GOING TO DISCUSS THIS WITH HIM.
Tested positive for Covid-19 on 1/26/2022.   3rd dose of Pfizer vaccine on 10/08/2021
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018, for prophylaxis. On an unknown date the patient experienced no adverse event.; Sender's Comments: US-009507513-1708USA004110: US-009507513-1708USA004111: US-009507513-1708USA004112: US-009507513-1708USA004113: US-009507513-1708USA004114: US-009507513-1708USA004115: US-009507513-1708USA004127: US-009507513-1708USA004117: US-009507513-1708USA004118: US-009507513-1708USA004119: US-009507513-1708USA004120: US-009507513-1708USA004121: US-009507513-1708USA004122: US-009507513-1708USA004123: US-009507513-1708USA004124: US-009507513-1708USA004125: US-009507513-1708USA004126: US-009507513-1708USA004109: US-009507513-1708USA004108: US-009507513-1708USA004116: