chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had rash all over his chest; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number and Expiry Date: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Patient also took lisinopril (manufacturer, start and stop dates, NDC number and Expiry Date: unknown) as an ACE Inhibitor. Patient's medical history and concomitant medications were not reported. Patient had rash all over his chest after his first dose of the Pfizer COVID Vaccine. According to the doctor, the rash might be due to the Lisinopril. Outcome of the event was unknown. Investigation Assessment: Not Provided.  Information on the lot/batch number has been requested.
joint pain in her left shoulder/sore shoulder; A spontaneous report was received from a consumer concerning an 80 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced joint pain in her left shoulder/sore shoulder/arthralgia  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number:  Batch number not provided) on 4 Feb 2021 and the patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 11 Mar 2021, approximately one day prior to the onset of the symptoms, via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced joint pain in her left shoulder/sore shoulder.  On an unspecified date patient was treated with prednisone and tramadol.  No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was not applicable.    The outcomes of the events joint pain in her left shoulder/sore shoulder was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a licensed practical nurse concerning an 18 year old female with no pertinent medical history who on 22-JUN-2007 was vaccinated intramuscularly into the left arm with 0.5 ml of the first dose of the Gardasil (Lot 3 653735/0688F). There was no concomitant medication. Immediately after receiving the vaccination, the patient felt pain and fainted. Unspecified medical attention was sought by the patient. No laboratory or diagnostic tests were performed. The patient was observed for 1/2 hours and then was recovered and sent home. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Follow-up information was received from the physician.  The patient felt sharp pain and passed out for 15 to 20 seconds after receiving GARDASIL.  The patient looked pale.  The blood pressure measurement was 88/60 and pulse rate was 72.  The patient rested for 15-20 minutes.  The patient's repeat blood pressure measurement is 100/60.  The patient recovered on 22-JUN-2007.  Additional information is not expected.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, and route were not reported) lot number M041373; expiration date 18-NOV-2018, for prophylaxis. According to the reporter, RECOMBIVAX HB dose was exposed to the following temperature excursion: 1 hour and 13 minutes at -2.7 degrees Celsius (C). No adverse effects were reported. A digital data logger was involved. Additional information has been requested.
Patient was treated for COVID infection 11/2021. While this positive test was in the 90 time range where he was expected to have a positive test; his CT value was 21.4, which implies a higher infectivity risk, raising the suspicion this may be another COVID infection.
Narrative:  An84yo Female with CKD and HTN Per Nursing documentation, she received Pfizer Covid- 19 vaccine per policy and protocol without complication. first dose on April 17, 2021 and the second dose on may 8, 2021 However the patient presented to the ED on May, 8 2021 at 23:43 with chief complain of Chill and sharp pain in the right hip stating she was having a reaction to the Pfizer Covid vaccine which she received in the AM. Patient also reported she had mildly sore arm after the first shot Physician's documentation on May 9, 2021 described patient's symptoms as Chills, Myalgia and Malaise Tests and Labs done were reported as ( UA and CXR - clear, EKG WNL, POC chem 8 - patient believes SCr at baseline and K - WNL) patient to be d/c'd with acetaminophen PRN and given specific return precautions
Patient received 4 shots. Faint start having a seizure 30 seconds, hit the head when she fell. Patient recovery after 30 seconds PCP check patient, vital are good.
After first shot stared to hear blood pressure in ears; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0162, first dose) solution for injection intramuscular in the left arm on 14Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis (RA). Concomitant medications included methotrexate sodium, adalimumab (HUMIRA), and folic acid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After first shot the patient started to hear blood pressure in ears on 14Apr2021 at 15:30. No treatment was provided for the event. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (20Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651479 same patient/drug and different dose, different/similar event
pt recv vax 20DEC95 & 12JAN96 pt devel small measles-like lesions on stomach, arm & chest;no further details provided;
on 4/1/2021 my left clavicle was very sore.  then noticed it was swollen - looks like lymph nodes.  praying & hoping it will go away.   other than that, slight headache nite of shot & day after (4/1) was also extremely tired.  i did have the covid on 12/9 & it turned into pneumonia.
high blood pressure, body aches Narrative:  75 yo male with PMH prior covid19 vaccine 04/13/2020, HTN, BCC, Afib, knee pain, OSA, shoulder pain, hx of VTE, HLP, atherosclerosis, and gout reported having high blood pressure, body aches, and headache following second COVID19 VACCINE on 2/24/2021. Pt received the first dose without complication.
I noticed shortly after vaccine, the vaccine site was sore as with any vaccine in the muscle but that acute pain that lasted all the time went away but I noticed that at night when I slept on my left arm I can't do that anymore because my upper arm hurts when I rest my head on my arm and I noticed when I lift arm up and try to use muscle where I had the injection it's sore and it's not like searing pain but it's certainly sore and it's been like that since I've had the injection and hasn't gone away. I mentioned this to my Doctor and he said we could do a full shoulder work up at some time but it's not severe enough, it's just uncomfortable. I did have a mild reaction and small feeling of not being super well but I think I took advil for that feeling and feeling a little achy, but nothing other than that.
Actually, I have had 4 doses of the Covid-19 vaccine, but the 1st two were Moderna: 19Mar21 & 17Apr21, and the 3rd (30Nov21) & 4th (the 4May22 fourth Covid-19 vaccine dose) were Pfizer.   The adverse event was a positive Covid-19 test (with symptoms) on Friday, July 1, 2022 I was at a sleep-away camp: about 60 people (adults & kids) at the camp. Another counselor had a positive case on Tuesday, June 28, and I had been in close contact with that counselor, that day (28Jun22). My symptoms began at midnight on1Jul22, I tested positive @ 6:30am, I took 5-days of molnupiravir (from 4:30pm Jul1st: 1st dose). No side effects from the molnupiravir. I took Extra Strength Tylenol Cold & Flu (once every 12 hours) for two days. My symptoms: nasal congestion, a bit of a cough (off and on), no fever, my appetite was good, no loss of taste or smell experienced. I tested myself on July 7, 10, and 11. Tested positive on July 7 & 10, and negative on July 11. I have not tested since (as of 4Aug22).
This initial spontaneous report was received on 09-FEB-2018 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 08-OCT-2011, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2016, the patient was treated (by an unspecified healthcare professional) at a facility for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
chills; body aches; feeling tired; felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (body aches), FATIGUE (feeling tired) and FATIGUE (felt a little tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunisation.     Concurrent medical conditions included Drug allergy (sulfa allergy).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (felt a little tired). On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills), PAIN (body aches) and FATIGUE (feeling tired). At the time of the report, CHILLS (chills), PAIN (body aches), FATIGUE (feeling tired) and FATIGUE (felt a little tired) had not resolved.            No concomitant medication was available. No treatment Medication was available.  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-068474 (E2B Linked Report).; Sender's Comments:  MOD-2021-068474:
Information has been received concerning a pt who was vaccinated on 11/04/99 with first dose of varicella vaccine. On 05/09/00 the pt developed breakthrough varicella with a papular-vesicular rash on his extremities, palms of hands and side of feet and on his palate. On an unspecified date the pt recovered.
after vaccination with fever; headache; body aches; This is a spontaneous report from contactable nurse. This nurse reported similar events for 6 patients. This is 2nd of 6 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and body aches on an unspecified date. Event took place after use of product. It was reported that "6 staff call in the day after vaccination with fever, headache and body aches". The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient.
Within 30 minutes dizzy, faint and weak.  Within 45 minutes numb nose to numb cheeks to numb face to numb lips to numb mouth to numb throat. Difficulty swallowing and drooling noted. Halted with 25 mg Benadryl liquid oral dose. 24 hours after vaccine noted body aches, muscle and joint soreness. Low grade fever 99.8 p.o.  36 hours after temp climbing- peaked at 102 p.o. 48 hours later.  All s/s resolves in 72 hours
Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no history of drug reaction or allergies who three to four weeks ago (on approximately 26-JUN-2008 to 03-JUL-2008) was vaccinated with MENACTRA, then she received the first dose of GARDASIL (lot#: 660391/0063X). Immediately after the GARDASIL injection, she fainted. She hit her nose on a foot stool connected to the exam bed. Oxygen was started, blood pressure and oximetry were within normal range. She did not recall where she was but knew her name. She was transported to the hospital by ambulance where an X-ray of nose was negative. She also hit her lip and cracked one tooth. She was later seen by a dentist and the tooth was cemented. The reporter's office called the patient 24 hours later and she was oriented and remembered the situation in the office. Subsequently, the patient recovered. The reporter considered fainting and cracking one tooth to be other important medical events. Additional information has been requested.
Information has been received from a physician concerning an "over 60" year old female who in approximately December 2006, was vaccinated with a dose of ZOSTAVAX. Subsequently, 3-4 days after receiving ZOSTAVAX the patient developed numbness in her legs, lips and around her mouth, and a fever. The patient "could not walk" due to this event. The patient was referred to a neurologist to rule out Guillain-Barre Syndrome. The patient was also referred to an infectious disease specialist to determine if the event was vaccine related. At the time of the report the patient's numbness had improved but she was still spiking a temperature of 100-101 degrees. Unspecified "blood work" was performed. The patient was discharged from the hospital after 11 days as an inpatient. There was no product quality complaint involved. No additional information was available. The reporter considered the patient's events to be disabling and serious for hospitalization. Additional information has been requested.
Eight days after vaccine, moderate swelling and itching.  Warm to touch. Swelling as big as a golf ball and very hard. Took Benadryl x 2 days and symptoms subsided.
Patient show pictures of bruising and a large red rash around the injection site. Patient also complained of arm pain detailing limited mobility. The patient was advised to follow up with urgent care, which the patient did on Tuesday. Initial conversation pertaining to the adverse event was Monday morning. Per our conversation on Tuesday, symptoms began to subside but still remained.
Information has been received from a nurse concerning a female patient between 9-26 years old who on an unknown date was vaccinated with the second dose of GARDASIL. Soon after the administration, the patient experienced dizziness, headache, nausea, and suspected drop in orthostatic pressure. Unspecified medical attention was given in the office. On the same date as the administration, the patient recovered. No further information is available.
Left knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (Left knee pain). At the time of the report, ARTHRALGIA (Left knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Myalgia, Fever, Diarrhea, Tachycardia and neuropathy, chills, fatigue.
06/12/02, became dizzy and faint while shopping-to home and bed temp 102.4 restless sleep. 06/13/02, temp 100.2, sweaty, chills, achy-slept a lot to Dr's office, observe at home-temp decreased Ibuprofen to normal x a few horus. 06/14, 15, 16-symptoms same for fever, aches, sleep and some mild diarrhea on the 15th and headache on the 16th. 06/17/02, no temperature-returned to normal activities.
This spontaneous report was received from a pharmacist and refers to a 61-year-old female patient. The patient's medical history included shingles and anxiety. The patient's concurrent conditions included chronic pain. The patient's concomitant therapies included hydrocodone. The patient did not have any drug reactions and allergies. On 12-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in right deltoid region, lot# M042849 and expiration date: 18-JAN-2018 (dose was not reported), reconstituted with sterile diluent (lot# and expiration date were not reported). In October 2017 (reported as "on an unspecified date after receiving ZOSTAVAX"), the patient noticed a slight bump along with pain, swelling and redness at injection site. The patient stated that pain "felt like a pinched nerve" but denied any numbness or tingling. The patient stated that pain radiates from injection site up to shoulder level. The reporter was unaware if the patient sought medical attention or if any treatment was provided. The outcome of the events was reported as not recovered. The relatedness between the events, ZOSTAVAX and sterile diluent was not reported.
Narrative:  Patient expired due multiple underlying conditions (ALS), cause of death unknown. Long time patient
This spontaneous report was received from a 70 year old male consumer regarding himself with allergy to codeine and none medical history. The patient's concurrent conditions were not reported. On 21-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, (anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On 23-NOV-2014 (also reported as 23-NOV-2015), the patient suffered severe hearing lost in the right ear, then loss of hearing the left ear and also suffered from vertigo after vaccination. The patient was diagnosed with hypoactive labyrinth of the right ear. The patient sought medical attention and was hospitalized for one full day of observation, unspecified laboratory test and diagnostic tests were performed on an unspecified date. The patient received meclizine as treatment for vertigo. At the time of the report, the outcome of the severe hearing lost in the right ear, loss of hearing the left ear, suffered from vertigo and the patient was diagnosed with hypoactive labyrinth of the right ear was reported as not recovered. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of shoulder bursitis in a 37-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ADVIL. On 21 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced shoulder bursitis, inflammation of shoulder joint, shoulder pain and injection site tenderness. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Warm soaks and continued use of ADVIL was recommended. Follow-up information was received on 11 December 2008, via healthcare professional, who reported the events were unresolved. The reporting healthcare professional considered the events related to vaccination with FLULAVAL.
Within minutes of receiving the vaccine, the father says patient became slumped down in his chair, was drowsy, and he thought his son had passed out. Patient had become very pale in color, and his father says he was sweaty/warm to the touch.  He was conscious, but wasn't very alert.
Information has been received from a certified medical assistant stating that she was unpacking a shipment of hepatitis A virus vaccine inactivated (direct from the manufacturer) and the gelpack inside had leaked onto the contents. The caller states that on 07-DEC-2006, she was exposed to the gel on her hands and that is now experiencing itchiness on her body. Caller herself has itchiness on her chin and the tip on her tongue. There is no swelling. Called indicated that she will take Clarinex. There was no product complaint. It was unknown if the caller sought medical attention. Additional information has been requested.
Information has been received from a medical assistant concerning a 49 yr old white female with no known drug allergies who on 11/30/2001 was vaccinated with a first dose of pneumococcal vaccine-23 polyvalent intramuscularly in the right deltoid (lot number 641530-1351L). Post vaccination, the pt developed a local site reaction. The pt's arm was swollen, hot to touch, and bruised. Ice was applied and the pt declined intramuscular diphenhydramine (Benadryl). The pt was advised to go to the emergency rm if the problem worsened. On 12/05/2001, the pt recovered. The reporter requested a lot check of lot 641530/1351L. The records of testing prior to release had been checked by GMP Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was re;eased. The pt's husband also developed injection site swelling and warmth post vaccination with pneumococcal vaccine 23 polyvalent (see WAES01120220). No additional information is expected.