chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT ASKED FOR A SHINGLE SHOT TO TECH AT PICKUP. THAT TECH SENT HER TO DROP-OFF. THEN PT SAID "I WANT A SHOT" AND POINTED TO HER ARM. THERE WAS A LANGUAGE BARRIER. DROP-OFF TECH THOUGHT SHE WANTED A "FLU SHOT". SHE TYPED FOR FLU SHOT. IT WENT THRU INSURANCE. PT FILLED OUT FORM FOR FLU SHOT & WAS GIVEN A VIS FORM FOR FLU SHOT. RPH ASKED HER IF SHE HAD ANY BAD REACTIONS TO ANY VACCINES BEFORE. AND ANY ALLERGIES TO EGGS, FOODS, MEDS. OR ANY MAJOR MEDICAL CONDITIONS. SHE SAID NO. RPH DOES NOT RECALL IF SHE SAID FLU SHOT OR NOT. SHE GAVE FLU SHOT AND PT SAID THAT SHOULD SHE COME BACK FOR A SECOND DOSE. RPH SAID YOU ONLY GET 1 FLU SHOT A YEAR. PT SAID OH NO! I GOT A FLU SHOT LAST WEEK,  SHE WAS VERY UPSET THAT SOMETHING BAD MIGHT HAPPEN TO HER. WE INFORMED HER SHE MAY GET FEVER BODY ACHES PAIN IN ARM. BUT NO EVENTS SHOULD HAPPEN. WE TRIED TO REASSURE HER BECAUSE KIDS UNDER 8 GET A SECOND BOOSTER OF THE FLU SHOT WHEN GETTING THE FIRST TIME. WE ASKED IF WE CAN CALL HER DOCTOR FOR HER TO INFORM OF THE INCIDENT. SHE SAID NO. SHE ASKED TO LOOK AT THE PAPER SHE SIGNED. SHE REALIZED IT SAID FLU SHOT. SHE GOT EMBARRASSED AND LEFT. WE TRIED TO STOP HER ONCE MORE TO GET HER DR INFO AND SHE LEFT.
felling itching\got itching again, eyes, nostril,  throat, and bottom of the right foot; rush in some spot  on the left arm,; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (felling itching\got itching again, eyes, nostril,  throat, and bottom of the right foot) and RASH (rush in some spot  on the left arm,) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062e21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included METOPROLOL for Blood pressure, PREDNISONE, COLESEVELAM, LISINOPRIL, ESOMEPRAZOLE and VERAPAMIL for an unknown indication.    On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PRURITUS (felling itching\got itching again, eyes, nostril,  throat, and bottom of the right foot). 06-Sep-2021, the patient experienced RASH (rush in some spot  on the left arm,). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (felling itching\got itching again, eyes, nostril,  throat, and bottom of the right foot) and RASH (rush in some spot  on the left arm,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Woke up around 3am with full body shakes as if from a seizure or extreme panic attack. lasted for several minutes. Experienced extreme anxiety and yelled for help. I immediately began rubbing magnesium body butter into his feet, which seemed to help the shaking subside. Military base was notified, but no evaluation or testing was done. They referred him to a single therapy session and told him he was "stressed" and needed to exercise and meditate more.  The following day, he several days, he had severe headache, elevated heart rate, palpitations, brain fog, felt feverish, but with no fever... around day 3 he had a couple nights of intense night sweats, and afterward his daytime symptoms improved, but he continued to come home from work complaining of dizzy spells, brain fog, and feeling like he may lose consciousness.   Ever since the initial episode on Nov 7th, he has continued to wake up in the night with varying degrees of anxiety- sometimes feeling like he may start shaking again, sometimes just needing to grab my hand for reassurance. This was not happening before Nov 7th.  Also, he and I are currently sick with Covid- same symptoms, same severity- even though he should still be "protected" as he had his vaccination less than 8 weeks ago. So, it did nothing to help him, just make him sick.
Developed swollen lymph nodes on left side of neck and left armpit on 11/1/2021.  Developed tendon pain in bilateral feet, right knee, left hip, right elbow and right shoulder approximately 1 week later.  Placed on round of oral steroids by primary care physician in November and referred to orthopedic doctors for continued left foot and right elbow tendon pain that did not resolve.  Received cortisone injections in left foot on 12/9/2021, and right elbow on 1/5/2022.   Placed on another round of oral steroids in January 2022.  Admitted to hospital on 1/18/2022 overnight due to new onset episode of SVT with need to heart conversion with adenosine.  Continued tendon pain in right elbow and left foot with referral to outpatient PT in January 2022.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JAN-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, 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.
Patient failed to report full vaccination history and was administered a 4th dose of Covid-19 vaccine,  patient had a the following vaccines: Moderna Lot 025J20-2A 12/24/2020, Moderna Lot 030L20A 1/22/2021, Pfizier Lot FE3592 9/2/2021, and Moderna Lot 939905 10/20/2021. Patient reported no side effects from 4th vaccine, as of 11/5/2021.
I had shortness of breath; Mild pain radiating from my left shoulder blade; Mild pain radiating from my left shoulder blade to my left armpit; Mild pain radiating from my left shoulder blade to my left armpit and arm.; I received the vaccination Friday. Saturday I started noticing chest pain; Chest tightness; Mild pain radiating from my left shoulder blade to my left armpit and arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 23Apr2021 at 07:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. Concomitant mediations included flo vitamins (MANUFACTURER UNKNOWN) and one a day women's gummies (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bismuth subsalicylate (PEPTO BISMOL) on an unknown date and experienced drug allergy. The patient received the vaccination on Friday and that on Saturday 24Apr2021 at 08:00 she started noticing chest pain and tightness as well as mild pain radiating from her left shoulder blade to her left armpit and arm. The patient reported that on Sunday, 25Apr2021 it continued and had shortness of breath. This had continued daily for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, 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 events. The clinical outcome of the events chest pain, chest tightness, mild pain radiating from her left shoulder blade to her left armpit and arm shortness of breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
L injection site redness, no itchiness noted 3 cm diam - reddened area noted. Given 7.5 cc BENADRYL ELIXIR PO x 1 about 4:40 pm
Received a call from pt's sister - stating patient had fainted after receiving HPV vaccine and hit his head. Pt was assessed by medical team and sent home. She is now stating he has been vomiting. Recommended he go see PMD.
Relatively severe body aches & chills, but body temperature is averaging 95F. Feels like getting a bad dose of the flue. No runny nose, no unusual body functions other than the body feels very nervous and shaky.
Patient received her Booster at 14w1d gestation and began bleeding the following morning.  She had intermittent bleeding until 19w6d when she was found to have intrauterine fetal demise. She was examined that day due to decreased fetal movement.
Tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) 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 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID. On 24-Aug-2021, SARS-CoV-2 test: negative (Negative) She tested negative twice for COVID.     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.   Pharmacist wants to know whether patient tested positive for COVID-19 when second dose was given.  No concomitant medications reported.  No treatment information was reported by reporter.
This spontaneous report was received from a female patient of unknown age with no pertinent medical history and no drug reactions or allergies regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included ALLEGRA (reported as Allergra). On an unknown date, the patient developed a rash after receiving ZOSTAVAX. The patient sought medical attention (saw the doctor). No treatment was given. No lab tests were performed. The patient was recovering from rash (also reported as adverse event not improved). The relatedness for rash was unknown for ZOSTAVAX. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: En6207), in left arm and on 03May2021 as dose 2, single (Lot number: Ew0171) at the age of 35 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Nov2021 as dose 3 (booster), single (Lot number: 071F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alopecia Areata" (unspecified if ongoing); "Androgenic Alopecia" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 15Jul2019, stop date: 24Sep2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient used Paxlovid from 16Sep2022 to 21Sep2022 for anti viral (Treatment of COVID-19).
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium
congestion, cough, chest tightness, SOB, chest pain, nausea, vomiting, myalgias
FACIAL SPASMS ON RIGHT SIDE OF FACE FROM CHEEK DOWN TO LIP
pt recv vax 24APR95 & pt exp pain @ inj sit & pain down the arm;25MAR95 pt arm became swollen, red, hot & painful;pt recovered;
41 INCIDENCES WHERE  THE TEMPERATURES DROPPED BELOW 36F; 15 DOSES ADMINISTERED OUT OF RECOMMENDED TEMPERATURE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced 41 incidences where the temperatures dropped below 36f, and 15 doses administered out of recommended temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 41 incidences where the temperatures dropped below 36f and 15 doses administered out of recommended temperature was not reported. This report was non-serious.
pt had rash covering anterior thigh 1st couple of days (erythematous macular somewhat confluent); not usual swelling;
Sore arm.Small bruise at injection site.  Next day red patch started.  By evening the area grew.  The area was red, swollen, heated, and was approximately  4 inches by 3 inches.  Now known as ? Moderna Arm?.  Taking Tylenol and Benadryl
This spontaneous report as received from a registered nurse via field representative refers to a child patient of unknown age. On an unspecified date, the patient was vaccinated with a dose of GARDASIL injection (dose, frequency, route and lot # unknown). On an unknown date in 2013 (reported as "in the past year"), the patient fainted after receiving the dose of GARDASIL and fell, and "bumped their head". The outcome of the events was reported as recovered/resolved on an unspecified date. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Right after the vaccine I was exhausted for three days, needed naps, and I am a person who never naps. I had a sore arm for four days. No temperature. Really exhausted, particularly the first day after the vaccine. I also had a headache that went away; might have taken aspirin for that. Lack of appetite. Symptoms diminished some, each day of those four days after. I didn't work the second day after vaccine but could manage to work the next three days. Latest event: I sat down in an unusual way and I kind of got stuck there. I didn't want to disturb anyone to help me get up but finally I had to ask someone to help me get up. My back was hurting. The next day, I ended up with a little bump that hurt for four or five days that was on the surface. Now the bump is gone but there is another one that is a hard little knot on my lower back almost next to my spine, left hand side, about four fingers above the crack of my behind; feels like a little cyst. It was a little larger and, on the surface, when I called the nurse line, and now it's smaller. I talked to a doctor online virtual. I had to go to a trip and the doctor said to take ibuprofen while on my trip. I need to make an appt with my doctor to actually look at it. Now the bump doesn't hurt anymore. I can do my work and activities.
left arm also got red and was not as bad as this current issue and has resolved but she does not know and there are remnants of a circle there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 at 11:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Folliculitis" (ongoing), notes: Inflammation of hair in skin and has been to dermatologist and has that diagnosed about 2 years ago.; "Shingles" (ongoing), notes: Caller states she was diagnosed with shingles maybe 10-12 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot no: E11284), administration date: 13Jan2021, when the patient was 72-year-old, for covid 19 immunization; BNT162b2 (Dose 2, Lot no: E19263), administration date: 03Feb2021, when the patient was 73-year-old, for covid 19 immunization.  The following information was reported: ERYTHEMA (non-serious) with onset 26Aug2021, outcome "recovered", described as "left arm also got red and was not as bad as this current issue and has resolved but she does not know and there are remnants of a circle there".  Additional information:  States she has a long word and it is folliculitis and it is inflammation of the hair in the skin and got it from who knows what and she has been to a dermatologist and to different dermatologists and has had that diagnosed about 2 years ago. Caller states on her 1st booster of the Pfizer Covid vaccine on 25Aug2021, her left arm also got red and was not as bad as this current issue and has resolved but she does not know and there are remnants of a circle there and this also began the next day after her 1st booster dose. 1st booster dose was given in a park. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Family Medical History Relevant to AE(s). No Relevant Tests.States she does take Valtrex prophylactically when she remembers it because she does not know why she takes it and is a healthy 74-year-old who works out and has pets and tutors in the afternoons.
First day.....sore arm, feverish. Second day......achy, feverish, tired. Third day....felt better. Fourth day.....while skiing uphill had what we think was an asthma attack. Never had asthma. I'm in good physical shape. The following week I was lethargic and got worse as the week progressed. Actually ended up admitted to the hospital on 3/19 and given intravenous steroids. Was very sick, nauseous and unable to even sit up on exam table. Prior winter was diagnosed with cryptogenic organizing pneumonia as I'm convinced the pneumonia booster shot reactivated whatever was dormant in my lungs. They are not sure what I have but their best guess is hypersensitive pneumonitis.
metallic taste in my mouth/salty taste; metallic taste in my mouth and itseems like I can almost smell it whenI'm breathing; This is a spontaneous report from a contactable other healthcare professional, the patient. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) four days ago for an unknown indication. The patient was known allergic to nickel. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00 after taking the vaccination, patient felt metallic taste in mouth (salty taste), almost smell the same when breathing and eating. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the events metallic taste and metallic smell were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
the patient had their heart rate go up (after 15-30 minutes); panic attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001192 (RA).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "the patient had their heart rate go up (after 15-30 minutes)"; PANIC ATTACK (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 15Sep2023, it was reported that a patient started treatment on unreported dates with 4 doses of Pfizer BioNTech COVID-19 vaccine (primary series and two boosters) for COVID-19 immunisation. It was reported that after the last 2 boosters, on unreported dates, the patient had their heart rate go up (after 15-30 minutes) and had a panic attack. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300164032 same reporter/patient/AE, different doses;
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 10 year old female patient. The patient administered the vaccine on 18-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068: US-009507513-1704USA013406.
PATIENT HAD NO PAIN AT TIME OF INJECTION. THAT SAME EVENING SHE DEVELOPED SOME ARM PAIN. BY MONDAY AM, PATIENT SAID SHE COULD NOT RAISE ARM ABOVE HEAD AND ARM FROM ELBOW TO SHOULDER WAS RED AND WARM. SHE WENT TO THE EMERGENCY ROOM AND WAS GIVEN AN ANTIBIOTIC AND BENADRYL.