chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT COMPLAINS OF PAIN IN LEFT ARM AFTER RECEIVING BOOSTRIX AND RECOMBIVAX HB, TO THE POINT SHE HAS TROUBLE SLEEPING REPORTED TO PHARMACY 8:40PM ON 5/15/15. REFERRED TO PHYSICIAN FOR EVALUATION.
Nausea; lower back aches; pain in her right arm; pain in her right arm and right shoulder; it spread to her collar bone to the top of her breast.; collar bone pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of dermatitis contact (On 12th March 2019, 1st dose received. 1st dose recieevd on 12th March 2019, refer case id US2020021631).   In February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, less than 3 months after receiving Shingrix, the patient experienced bone pain. On an unknown date, the patient experienced nausea, back pain, pain in arm, shoulder pain and breast pain. The patient was treated with cefixime (Flexeril (Cefixime)) and paracetamol (Tylenol). (Dechallenge was positive). On an unknown date, the outcome of the nausea, back pain, pain in arm, shoulder pain, breast pain and bone pain were unknown.   It was unknown if the reporter considered the nausea, breast pain and bone pain to be related to Shingrix. The reporter considered the back pain, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced after receiving the 2nd dose, she experienced nausea and lower back aches.  The patient experienced less than a week after receiving the 2nd dose of Shingrix, she developed pain in her right arm and right shoulder and it spread to her collar bone to the top of her breast.  The patient was wondering if this pain might be related to the Shingrix vaccine.  The patient went to see her doctor for this pain and she was at the time of report taking Flexeril and Tylenol. The reporter consented to follow up. Emergency room visit required
blurred vision; irritation; initial light sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; EYE IRRITATION (non-serious), outcome "unknown", described as "irritation"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "initial light sensitivity".  Additional information: Company Info Customer Verbatim: Hi- Is there a place to report adverse reactions to covid vaccine. Since getting my first dose I have been experiencing issues with my eyes, blurred vision, irritation, initial light sensitivity. Have there been other reports of this? Kindly advise.  Follow-up (17Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed a rash on the back of my neck. about 2 weeks after the shot. It is slightly bumpy (almost like goosebumps) and itches a little with slight burning. The whole area was red. It started suddenly and seems to be settling down and is much milder now.
Information has been received from a physician via a company representative referring to a 15 month old female patient. Concurrent condition and medical history of the patient were not reported. On 13-MAY-2016 the patient was vaccinated with one dose of VARIVAX (lot # L025206, expiration date: 07-JUL-2017 (dose and route were unspecified). On the same day, the patient experienced fever, vomiting, blisters and a rash for an unspecified reason. The patient did not seek medical attention. No treatment was given for the events, and no lab diagnostics studies was performed. The outcome of the events was reported as recovered/resolved on an unspecified date in May 2016. Additional information has been requested. Additional information has been requested.
Information has been received from a pharmacist concerning a female who on 19-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664274/0959Y, SC). Started on 23-MAY-2010 the patient "had been in bed feeling weak, sweaty, with a backache and headache". There were no labs or diagnostic tests performed. The patient called the pharmacist for medical attention and not recovered at time of reporting. Follow up information received from a pharmacist concerning the 70 year old female with osteoarthritis, allergic reaction to alendronate, cephalosporin, penicillin, sulfa, codeine, quinolones, nonsteroidal antiinflammatory drugs and opioids, "pen" and no illnesses at time of vaccination, who on 19-MAY-2010 at 3:30 pm was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 664274/0959Y, SC) in the left arm. On 21-MAY-2010 (previously reported on 23-MAY-2010) the patient stayed in bed for a few days, feeling weak, sweaty, a backache and headache. The patient was not hospitalized. On 01-JUN-2010 the patient recovered. Additional information is not expected. The patient had a history of drug hypersensitivity while on prior therapy with alendronate (manufacturer unspecified, WAES 1007USA01397).
Patient received a dose of Adult Pfizer due to error with patient placement and chair swapping. Unaware of any major side effects due to the error. Patient returned to the pharmacy on 2/24/22 for the second dose and the kids Pfizer was given in accordance with CDC guidelines.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # M023169 with expiry date on 13-JUN-2018 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47.22 degrees Fahrenheit for 5 minutes and more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47 degrees Fahrenheit for 5 minutes. Data logger was involved. There was no previous excursion reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012792.
Pt recvd HIB/DTP 19NOV91 & approx 5 hrs following vax had fever 103 & sz; hospitalized 3 dyas, tx inclluded ATB:
PT DEVELOPED A LOCAL REACTION DESCRIBED AS A RASH AT THE SITE OF THE VACCINE. THIS APPEARED 10 DAYS AFTER THE VACCINE PT DENIES ANY CONSTITURIONAL SS, IE DYSPNEA, FEVER  PT IS SCHEDULED TO RECIEVE SECOND INJECTION FEB 3, 2021
Approximately 2 hours after receiving Anthrax vaccine, pt had severe headache, body ache, vomiting that evening and the next morning.
Severe swelling and pain  of upper right arm. Still very noticeable after 6 days.
Patient complained of pain in the right collarbone, she called when she got home and said the pain had resolved. No further complaints.
Pfizer #1 given on 12/28/2020 EL0140 exp 3/21, second dose was unable to give due to illness and then was not able to leave facility to obtain later.
at 5:28 patient stated that she didn't feel well after receiving the 1st dose of Moderna vaccines. nurse escorted pt to chair and notices pale appearance.  Pt. became diaphoretic and stated shaking. Pt. drank water and was given ice chips . Pt. stated she needed to vomit and she was given trash can and vomited x 1. Pt. continued to drink water. Vitals take, BP 81/43 HR: 49 in the RT arm. Pt encourage to drink water. Nurse asked if Pt had any history of Hypo-tension and she stated yes. At 5:35 BP retaken 86/50 HR 47 Pt legs elevated and paramedics are called.  5:40 Pt BP retaken 99/57 HR 61 Pt continues to stated she is feeling a little better. pt encourage to drink water and that the paramedic were on their way. Paramedics arrived and obtained new vitals BP 98/62 HR 65. Paramedics did EKG and repeat vitals BP 116/76, O2 is at 100 %, BS 116, HR 65. Pt refused to go the hospital stating I feel so much better. Pt stated she was medication for Hypotension but stopped taking it about a year ago without doctors orders, on her own. Pt was with family member and family member encouraged to drive home and notify PCP about what took place. Paramedics stated EKG and vitals are normal. Pt discharged and feeling better.
Dizzy, headaches, chest hurts, awful metal taste in my mouth, arm sore and has muscle spasm in area of injection.
Moderna COVID-19 Vaccine EUA    Five days after vaccination  I got severe  swelling around my eyes and some swelling on my face.  Swelling still remained  thru day six and  still remains as I begin day seven after vaccination.
Had some itching on day 2 but it went away.  Around February 19, I noticed the itching had returned along with swelling in a larger area than the itchy area from day 2.
Fever within hours of shot. Fever (last) 4-5 days. Severe, multiple hives day 3.
Felt anxious, with chills/tingling in feet. BPs 174/77 (pulse 71), O2 sat 98%. Final BP 134/75.
Following vax, the pt became weak and was assisted to the floor. At 10:33 B/P was 142/88. At 10:35 B/P was 140/96 and P 80. The pt began feeling better. At 10:40 B/P was 136/92 and P 64. The pt experienced pain on the left side of head.
Immediate pain to lower left side of head Tingling sensation in mouth then metal taste. The taste lasted for at least 24 hours and even dumbness around mouth.
there were 2 drops on her arm/leaked out and dropped down; there were 2 drops on her arm/leaked out and dropped down; there were 2 drops on her arm/leaked out and dropped down; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2022, the patient received the 2nd dose of Shingrix. On 14th October 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's comment: Pharmacist called from a doctor's office and stated that upon receiving the second dose of Shingrix to the patient, two drops of vaccine leaked out and dropped down her arm. No additional details were available (lot number and expiration date). The reporter consented to follow-up via email. Additional Supportive Information: Upon receiving the second dose of Shingrix to the patient, two drops of vaccine leaked out and dropped down her arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. The case US2022153065 was identified as duplicate of US2022153066. The case US2022153066 would be voided, and all the future correspondence would be added in this case US2022153065 which stands as a case of record for this patient.
Patient describes receiving vaccine on 11/7/16 and on the next day she had redness and swelling in the area of injection.
Rashes on the underside of left and right arm, arm pits and below armpits on left and right side of body and slowly spreading to breasts.
Information has been received from a consumer concerning her 14-month-old female daughter with no pertinent medical history or allergies who in January 2003, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) 3 days later was diagnosed with chickenpox. There was no concomitant medication. On 08-OCT-2007 the patient was diagnosed with a second case of chickenpox. The patient sought unspecified medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
p/vax sz, went limp x 20min, crying x 20';measles like rash;crying spells x 2 high pitch;crying spells, unusual, high pitched cry;
Pt has he of Graves Dx; swelling occurred on the other ankle as well as hips, wrists and shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of graves' disease in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix. On 24th January 2021, 4 days after receiving Shingrix, the patient experienced graves' disease (serious criteria GSK medically significant) and swollen joints. On an unknown date, the outcome of the graves' disease and swollen joints were unknown.   It was unknown if the reporter considered the graves' disease and swollen joints to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 61 or 62-year. The reporter stated that, the patient received dose of Shingrix and 4 day later had swelling of right ankle, then swelling occured on other ankle, hip, wrists and shoulder. The reporter stated that, the patient had Graves disease. It was unknown if the reporter consented to follow up.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The nurse reported that since 09-MAR-2016 the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route not reported, lot number L014420 with expiration date 23-FEB-2017, lot number L019835 with expiration date 23-MAR-2017 and lot number K021881 with expiration date 30-JUL-2016) that had been improperly stored (temperature: 47.1F and time frame: 30 minutes). It was reported that there was a previous temperature excursion with 48.7F for 30 minutes. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Ischemic and Hemorrhagic Stroke (April 30,21),  Stroke (May 4, 2021) Stroke (February 25, 2022)
Patient reports that starting approximately 6 hours after her injection she experienced fever, chills, body aches that lasted through the night and a headache on the 2nd day. The fever was measured at 101 degrees fahrenheit. the fever/chills/body aches from the night were gone by the morning and the patient reported feeling better but had a headache.
Pain at injection site for approx. 48 hours.   Felt flu-like tiredness with slight fever for on first night.
Every bowel movement has been that of diarrhea and numerous in times of day; Persistent diarrhea; Weakness; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Aug2021 at 19:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's last menstrual period was on 21Jul2021. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 25Aug2021 at 17:00, the patient experienced persistent diarrhea and weakness from the event date listed to current time of report. Every bowel movement had been that of diarrhea and numerous in times of day. The events did not result in doctor or other healthcare professional office/clinic, 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 persistent diarrhea, weakness and every bowel movement has been that of diarrhea and numerous in times of day was not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A physician reported that a female inadvertently received an ID injection of TD Toxoids Adsorbed, Purogenated on 8/1/00. The next day, she developed an injection site reaction characterized by redness and swelling.
Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection site; This is a spontaneous report from a contactable consumer (patient) reported that a 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 22Jan2021 11:45 at a single dose for Covid-19 immunization. The vaccine was administered at the workplace clinic. The patient medical history included allergic asthma, and had known allergies with penicillin both from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medication included melatonin taken from an unspecified date for an unspecified indication. On 30Jan2021 08:00, the patient experienced raised, redness, swelling, tender at injection site. As treatment, patient took Tylenol capsules. The outcome of the events was not recovered.
Diabetic ketoacidosis; This is a spontaneous report from a contactable consumer. A contactable consumer reported for her nephew.   A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 33-years-old)  at single dose for covid-19 immunisation.  Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, impaired gastric emptying from an unknown date and unknown if ongoing, ulcer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced diabetic ketoacidosis on an unspecified date.  The patient died on 21Mar2021 due to diabetic ketoacidosis.  An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Diabetic ketoacidosis
reconstituted with a no GSK adjuvant and given; reconstituted with a no GSK adjuvant and given; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th November 2020).   On 29th March 2021, the patient received the 2nd dose of Shingrix. On 29th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details was reported as follows: Patient received Shingrix reconstituted with a no GlaxoSmithKline adjuvant which led to as inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. No other information was available.
Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A three year old male patient, with no pre existing medical history, had received an intramuscular, left thigh injection of Fluzone, lot number U2239AA, on 03 November 2006. He had previously received four doses of influenza vaccine with no reported adverse effect. Other medications included Claritin as needed. Two weeks post vaccination, the patient developed bruising. Seventeen days later, laboratory testing showed a decreased platelet count of 19,000. The patient was diagnosed with idiopathic thrombocytopenic purpura. At the time of this report, the patient had not recovered. Additional medically relevant information was not provided.
Patient received the flu vaccine at school - shortly after getting the vaccine the patient complained of sore throat and stomachache - temp. noted by parent of 102 - unknown if symptoms are related to the flu vaccine.
Rapid onset of shingles around left buttock and scrotum. Currently being treated with Valtrex.
Vaccines received on 10-16-15. That evening had an 8 minute febrile seizure. Experienced respiratory distress, intubated and transferred to hospital ICU. 1st febrile seizure at age 6-7 months of age. 2nd febrile seizure one week later. 3rd febrile seizure April 2015. 4th febrile seizure on 10-16-15.
Arm pain lasting 9 days; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm pain lasting 9 days) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain lasting 9 days). At the time of the report, PAIN IN EXTREMITY (Arm pain lasting 9 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Shots are mildly painful in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter had reported for himself/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient stated that, the shingles shot was mildly painful in arm for four days but better than shingles. No other information was provided. This case is linked with US2021AMR104410, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103693:2nd dose US-GLAXOSMITHKLINE-US2021AMR104410:same reporter
Pt developed chills, coughing, sneezing, and sweats within 20 minutes after vaccines administered. Had temp to 103, positive cough producing copious mucous within one day.
patient complains of lingering pain 3 weeks later. Keeping patient up at night. She has tried cold and heat and tylenol.
Full-body hives, particularly on neck, chest, stomach, and upper thighs, and arms. Painfully itchy. They got worse as the day progressed on May 1 and were helped by Benadryl. Woke up and they had subsided, but came back the night of May 2. They returned again less forcefully tonight.