chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 59 year old female patient. The patient's concurrent conditions included blood sugar issues and pain from previous injury. The patient's concomitant therapies included FLUCELVAX, alogliptin, levocetirizine dihydrochloride (XYZAL), hydrochlorothiazide, estradiol (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), simvastatin (ZOCOR), lisinopril, gabapentin, metoprolol tartrate, meloxicam (MOBIC) and levocetirizine. On 02-OCT-2017, the patient went to the pharmacy at 4:00 and at 4:09 was vaccinated with the first dose of ZOSTAVAX 19400 PFU at a dose of 0.65 ml / once, subcutaneously back on the right arm,  for the prevention of shingles, lot number N012614 and expiration date of 16-MAR-2018 reconstitued with water sterile diluent (lot number and expiration date were not reported). It was reporter that the day of the vaccination the patient was not on any immunosuppressant therapy, had no illness and was feeling fine. On 04-OCT-2017, reported as two days later or 24 hours after the administration of zoster vaccine live (ZOSTAVAX), the patient developed tenderness, pain, neck pain and rash on her back and flanks. The reporter stated that the patient returned to the pharmacy a week later with a possible rash and redness at the injection site. It was also mentioned, that the patient came into the pharmacy a few days after the vaccination and told about the reaction, the pharmacist returned her with the medical doctor and on a visual inspection he diagnosed her with shingles. Furthermore, the patient received treatment to the aforementioned events. At the time of the report, the outcome of the events shingles, rash and redness at the injection site was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with ZOSTAVAX.
No adverse effect; received first dose of gardasil 9 7 years ago and that she received the second dose of the series today; This spontaneous report was received from medical assistant referring to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reaction/allergies and concomitant medications were not reported. On 11-NOV-2012, (reported as 7 years ago) the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and on 11-NOV-2019 (reported as today), the patient received second dose of the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R024259, expiry date: 30-MAY-2021, for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported in the patient. The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Donor received 2nd/5 rabies vaccinations on 8/27/07. She did not report any problems with 1st/5 on 8/24/07. After 2nd vaccination, on 8/23/07 while sleeping donor began to c/o night sweats, chills and headache symptoms "come and go", but have not completely resolved as of 8/31/07. Donor stable when presenting to center, no additional complaints. Donor removed from program. No further vaccinations given.
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL. The patient fainted after receiving GARDASIL. No additional information. Additional information has been requested.
THE PATIENT WAS FEELING FAINT AND TRIED TO LAY DOWN AND PASSED OUT ON THE WAY TO THE FLOOR. IT WAS A VASOVAGAL RESPONSE. WE HAD HIM LAY ON THE FLOOR FOR ABOUT 10 MINUTES. BP WAS 82/71 PULSE WAS 62. WE GAVE HIM A GATORADE AND A WATER. AFTER 30 MINUTES HE WAS FEELING NORMAL AGAIN. HE REFUSED MEDICAL HELP. HIS EMERGENCY CONTACT WAS NOTIFIED. HE LEFT FEELING FINE AT 2:15PM.
It popped up. It was on his neck on the right side. It wasn't there before the shot; It's sore; lymph node swelled up really quick; This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (It popped up. It was on his neck on the right side. It wasn't there before the shot), NECK PAIN (It's sore) and LYMPHADENOPATHY (lymph node swelled up really quick) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     Allergies and past history was not reported. Patient had not tested or diagnosed positive for covid-19.  Previously administered products included for Prophylaxis: Prevnar (perhaps 1-2 months ago (Pneumonia prophylaxis)) in 2022. Past adverse reactions to the above products included No adverse event with Prevnar.    On 16-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced LYMPHADENOPATHY (lymph node swelled up really quick). On an unknown date, the patient experienced NECK MASS (It popped up. It was on his neck on the right side. It wasn't there before the shot) and NECK PAIN (It's sore). At the time of the report, NECK MASS (It popped up. It was on his neck on the right side. It wasn't there before the shot) and NECK PAIN (It's sore) outcome was unknown and LYMPHADENOPATHY (lymph node swelled up really quick) had not resolved.            No concomitant medications were reported.  On 03-Mar-2021, patient received the 1st dose of Moderna COVID-19 vaccine (lot number: 024M20A). On 01-Apr-2021, patient received the 2nd dose of Moderna COVID-19 vaccine (lot number: 001B21A). On 24-Nov-2021, patient received the 1st booster dose of Moderna COVID-19 vaccine (lot number: 939909). On 11-Jun-2022, patient received the 2nd booster dose of Moderna COVID-19 vaccine (lot number: 054A22A). On 16-Oct-2022, patient received the booster dose of Moderna COVID-19 vaccine, Bivalent. It was reported that a day and a half later, his lymph node swelled up really quick. The patient would have a examination with his doctor on 11-Nov-2022.  No treatment medications provided.   This case was linked to MOD-2022-670592 (Patient Link).
I am submitting this report because I did not download the app until day three post vaccination. The app would not allow me to report my vaccine reaction retroactively to include the previous days. Twelve hours post vaccination: slight chills without fever, severe headache, nausea and fatigue Twenty four hours post vaccination: severe headache, moderate nausea and fatigue Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: symptoms resolved (*Correction: I believe I may have recorded the date for vaccine #1 incorrectly on the form I previously submitted regarding a reaction to my second vaccination. When asked if I had received any previous vaccinations within the past 4 weeks, the correct date for my first Covid-19 vaccination should read 12/28/2020, 10:00 am)
Patient complained of dizziness and lightheadedness. Assessment revealed facial pallor and diaphoresis. Vital signs were assessed at 10:35 and were as follows: BP: 102/70; HR: 30, irregular, O2 100% on RA, RR WNL. Patient was given 8 oz of water and placed in supine position in vehicle with legs elevated for 5 minutes.
No additional adverse events; patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a 24-month-old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 04-DEC-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S008575 with expiration date on 16-SEP-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced one temperature excursion of -9 to 8 degrees Celsius (C) (-6.9 C) and another one of -9 to 8 C (-0.2 C), both excursions were ongoing. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported.
A 37 year old, female patient (with no known allergies) developed a bruise at the injection site, stiffness in the left arm and pain the clavicle and left scapular area, approximately 8 hours after she received Adacel (lot number C2688AA) intramuscularly in the left deltoid on 19 March 2007. She also received Engerix B (GSK, lot number AHBVB28BA) intramuscular in the right deltoid and PPD (Parkdale, lot number 30723) in the left forearm on the same day. At the time of the vaccinations, she denied any illness and was not on any medications. She has difficulty lifting and states it is progressively getting worse.  At the time of the report, she had not recovered. Follow-up information received on 18 April 2007. The patient did not have any illness at the time of the vaccination. The reporter left several messages to check on the patient, however she did not return the calls. As far as the reporter was concerned, the patient is recovered.
Chill, Uncontrollable shaking, fever (101.4), high pulse (130)
Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet.  These occur throughout every day, on and off.   We are now at week 5.
Erythematous maculopapular rash on bilateral hands and some in the areas of his popliteal fossa, some on his feet as well
Patient reported to the ED on 10/13/21 stating symptoms of weakness, chest pain, shortness of air with exertion, body aches and chills began that morning. No issues were reported on 10/12/21. EKG was normal. Chest x-ray was normal. Lab testing CBC, Troponin, electrolytes, renal values, urine specimen and glucose were all within normal limits. She was instructed to take OTC medication for symptoms and was dismissed from the ED that same day
Booster; she developed an inflammation under the left armpit (same arm where she received the vaccine). I got a ball she indicates that she has pain; she developed an inflammation under the left armpit (same arm where she received the vaccine). I got a ball she indicates that she has pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), AXILLARY MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "she developed an inflammation under the left armpit (same arm where she received the vaccine). I got a ball she indicates that she has pain".  Additional information: It was reported that, the caller was a consumer. She stated that, the day after receiving the Covid 19 Pfizer vaccine Booster, she developed an inflammation under the left armpit (same arm where she received the vaccine). Stated that, she got a ball she indicated that she has pain, the pain was not excessive but it hurts sometimes. Enquired that, was this normal. Should the patient call her doctor or not. Stated that, 3rd dose was administered on Wednesday, 08Dec2021. Stated that, the patient was going to wait and if not, she will talk to the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
THE VACCINE WAS ADMINISTERED TH PATIENT 20 DAYS PRIOR HIS 18 BIRTHDAY. THE SIDE EFFECT WAS HEADACHE.
Patient came in with history of idiopathic anaphylactic reaction. Pre-medicated with Benadryl 25mg PO at home. Received 2nd Pfizer injection at 3:00 pm. Approximately 15 minutes post administration slight throat tightness. Vital signs stable. BP: 160/60; HR: 71; O2: 98. Received Benadryl 25mg IM at 15:40. 2nd set of vitals: BP: 140/90; HR: 78; O2: 100. Continued to monitor. Patient stated she did not feel better after 15 minutes after the Benadryl injection. No complaint of any new symptoms. Vitals 20 min post Benadryl IM: BP: 158/60; HR:79; O2:100. Difficulty swallowing and worsening of throat tightness. EpiPen injected at 4:11 pm in left thigh. Vitals before administering EpiPen: O2: 100; pulse: 79; BP: 158/60. The ambulance was called and arrived at 4:15 pm. The patient stated she was not feeling better after EpiPen; therefore Solumedrol IV administered. Patient taken to the hospital at 4:30 pm. Vitals at the moment of hospitalization O2: 98; pulse: 85; BP 135/90.
Patient's daughter called in to report to Health Department that her father has dementia and has received 4 COVID vaccinations.  He received 3 Pfizer's and 1 Moderna.  No side effects noted.
Injection site: pain and tenderness, swelling, lymph node swelling, redness  General:  Fatigue, headaches, muscle/joint pain, feverish and chills without an actual fever  All side effects have been very manageable.
Fever ranging from 101-103 degrees beginning the PM that pneumonia and flu vaccines were administered. Denies local reaction. Follow up on 04/21/04: "Spoke with caregiver regarding fever noted after receiving Flu and Pneumovax injections on 10/21/03.  Caregiver stated that later that evening after receiving vaccines, pt developed a fever ranging from 102 to 103 degrees.  The caregiver did not, she stated take pt to the doctor for a consultation, but, the fever did break by the next day.  The caregiver stated that there was on inflammation noted at the injection site, and pt is better now."
Shingles; Intense pain at the injection site; Pus filled blisters that spread from the arm to the shoulder and neck; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, immediately after receiving Shingrix, the patient experienced shingles, injection site pain and vesiculopustular rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, injection site pain and vesiculopustular rash were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain and vesiculopustular rash to be related to Shingrix.  Additional details were provided as follows: The patient was approximately 70 years old. The patient received the first dose of Shingrix two months ago.  Immediately after, he started intense pain at the injection site and a breakout of shingles with pus filled blisters that spread from the arm to the shoulder and neck. The next day the doctor treated him with an anti viral and it disappeared within a couple of days.  The patient was hesitant and afraid to take the second dose based on this experience.
2 hours after administration of DTaP, Hib, MMR, Varivax and IPV, child developed itching and rash on head. Brought to clinic. Very small papules observed forehead and posterior neck, eventually cheeks and anterior neck (next 15"). Benadryl 25 mg po given. Itching resolved and papules faded some but not completely in next 15". No respiratory problems.
About 2 hours after high dose flu vaccine was administered in clinic, patient reported dry cough, chest tightness, and difficulty swallowing. Bilateral eyes red, itchy, with drainage. She developed full body chills later after being seen in the emergency department.
I had a little tenderness at the injection site after receiving the vaccine for a few days. I was exposed to COVID-19 while visiting a friend in the hospital. The hospital had about 42 positive cases. I tested positive for COVID-19 on 10/25/2022. This was my third time having COVID-19 so I took over the counter medication. I did contact my doctor, but I was doing what I needed to do to get better. I didn't have as much fear this time because I knew what to expect.
Information has been received from a physician concerning a healthy female child who in approx 2000 was vaccinated with a dose of varicella virus vaccine live. The physician reported that the pt was vaccinated at about 2 years of age and has been diagnosed with varicella rash a few times since vaccination (age unspecified at time of rash). A recent titer on 01Jun05 was negative for varicella antibodies. The pt currently (approx 02Jun05) has a rash which does not look like varicella. Additional information has been requested.
Tachycardia-heart rate 148 for 45 minutes  Metallic taste in mouth  Lower abdominal pain (cramp like)
WALKING WITH HELP OF CANE; OFF WORK X ONE WEEK; TIREDNESS WITH WALKING; DISORIENTATION; UNABLE TO DRIVE; NERVE PAIN TO LEFT SIDE; DIZZINESS; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's past medical history included throat problem, and concurrent conditions included multiple sclerosis, non smoker, non alcoholic, and cephalosporins allergies, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient experienced drug allergy when treated with cefaclor for drug used for unknown indication, drug allergy when treated with amoxicillin, bupropion, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Details not with caller) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: gabapentin (capsule, oral, batch number: UNKNOWN expiry: UNKOWN) 300 mg, 3 times every 1 day, from 18-MAR-2021 for multiple sclerosis. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced nerve pain to left side. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced unable to drive. On 14-MAR-2021, the subject experienced disorientation. On 14-MAR-2021, the subject experienced tiredness with walking. On 15-MAR-2021, the subject experienced off work x one week. On 16-MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) NEGATIVE. On 16-MAR-2021 20:30, Laboratory data included: Blood test (NR: not provided) NEGATIVE, and MRI (NR: not provided) NEGATIVE. On an unspecified date, the subject experienced walking with help of cane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of gabapentin was increased. The patient recovered from disorientation, and unable to drive on 18-MAR-2021, and off work x one week on 19-MAR-2021, and had not recovered from nerve pain to left side, dizziness, tiredness with walking, and walking with help of cane. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
7AUG91 pt temp went up to 102 approx 2hrs p/shot, vomited x 1; @ 5PM temp up 102.8; 1010PM temp 104 vomited x 1; c/o h/a; Taken to ER; Given ATB x 4 days;
ischemic event causing temporary blindness in rt eye.  Days leading up to event  twitch above rt eye.
This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 51-years-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Product: Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nose is bleeding. Caller, inquiring on behalf of her husband, would like to know whether their side effect; bloody nose, was related to the COVID-19 vaccine. She stated they already reported AE to previous agent. Caller reports that her husband received the Pfizer covid vaccine yesterday at about 1:00. At 10:00, last night, his nose started bleeding and has not stopped. He received the vaccine on his left side and only the left side of his nose is bleeding. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st dose sinovac-2nd dose Moderna; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose sinovac-2nd dose Moderna) and PYREXIA (Felt feverish) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 vaccination.    Concurrent medical conditions included Thyroid cancer.   On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started COVID-19 VACCINE (unknown route) 1 dosage form(s). On 28-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose sinovac-2nd dose Moderna) and PYREXIA (Felt feverish). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose sinovac-2nd dose Moderna) had resolved and PYREXIA (Felt feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.  Treatment medication was  not reported.  The patient had 1st dose Sinovac marzo 2021, 2nd dose Moderna and was going to have the third dose.