chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Congestion; Dry cough; Feeling unwell; Upper resp infection; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration from 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  but the agent is unsure what type. Patient received his first dose of the COVID 19 vaccine in Dec2020. The second dose is due tomorrow with the expected 21 day interval. He felt congestion and a stuffy nose with sore throat and a dry cough and was feeling unwell 10Jan2021. Patient thought he has a upper resp infection on an unspecified date in Jan2021. He didn't have fever or chills. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Increased heartbeat; quirky feeling in throat; Vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea). At the time of the report, HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 120 beats/min (High) developed an increase in heart rate upto 120 beats/ mnt.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE for an unknown indication. Patient gave consent for safety team to follow up with them   Reporter did not allow further contact
I was considered low risk for adverse events therefore was monitored for 15 minutes. As I left facility I started to have tingling and numbness in my right arm which is where I received injection. I then started to feel tingling and swelling in my mouth, tongue, and throat. I also noted some difficulty swallowing. I took 25 mg of Benadryl and monitored my symptoms. My symptoms resolved after 4 hours.
No symptoms reported/No additional AE/PQC; GARDASIL 9 was administered, but the patient was supposed to receive PREVNAR 20; This spontaneous report was received from a health care professional and referred to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUL-2023, the patient was wrongly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, frequency, anatomical injection site, lot #, expiry date, and route of administration were not provided) (wrong product administered); instead, the subject was supposed to receive pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) 1 dose, (strength, frequency, indication,formulation, lot #, expiry date, and route of administration were not provided). No symptoms were reported and there was no additional adverse event (AE) or product quality complain (PQC).
Massive headache, muscle and joint pain - particularly in the neck, shoulders, arms and knees, fever, chills and teeth chattering and fatigue. I also developedd a fever blister on my upper lip.  I only get them when I have a fever.  I'm on day 2 of adverse effects.  Headache and fever are gone but I still have the muscle and joint pain.  Still fatigued.  Took Advil yesterday but none today.  Drinking lots of water.
blood clots; This is a spontaneous report from a contactable consumer (the patient).   A 55-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jun2021 14:00 (Batch/Lot Number: EW0196) as single dose for covid-19 immunisation  .  Medical history included diabetes mellitus.  There were no concomitant medications. On 05Jun2021 the patient received the first dose of BNT162B2 vaccine (lot # EW0191). The patient experienced blood clots  (medically significant) on 03Jul2021 08:00 with outcome of recovering.  The patient underwent lab tests and procedures which included ultrasound scan: unknown results.   Therapeutic measures were taken as a result of the event including Emergency room/department or urgent care visit and treatment with  Eliquis, IV antibiotics & IVF. The patient was not pregnant at the time of the visit. Course of the event: After second COVID-19 vaccine developed blood clots to right elbow, right leg upper posterior and anterior, left leg upper anterior.  Follow up information has been requested.
Patient experienced soreness about 1 day after vaccination and slowly increased over the past few months, with noticeable concern beginning last month (early March 2023).   Patient's soreness and pain level has increased to where reporting it as an adverse event would be warranted.  Patient reached out to pharmacy on 3/31/2023.
Patient had acute/subacute CVA involving the posterior right temporal and occipital lobes on CT angiogram of the head and, diagnosed on 11/20/2022 by CT scan. She had seen her eye doctor, Dr. on November 18, after experiencing loss of peripheral vision sometime in mid to late October. Dr. exam caused her to suspect a stroke had occurred previous to this visit. Patient had also been taken to the ER on October 12 complaining of "head pressure." Nothing at that time was found by exam except very high blood pressure. She was discharged. She had a repeat occurrence of the head pressure on November 19 and went to the ER again. This time she was very ill  with high BP and blurred vision. The neurologist determined she had a stroke as described above. She was admitted to Hospital for a week. She was prescribed atorvastatin 40 mg tablet, clopidogreL 75 mg tablet,  and told to continue her regular medications. She was then sent to The rehab facility where she received PT for a week. She was discharged AMA and returned to Residence.
Tingling in lips, which I get when I'm having an oral Herpes outbreak.  I had slighltly 'bumpy' skin extending from my upper lip to the bottom of my chin for a few days, and then it resolved without treatment.  I typically get this type of outbreak about once a year, but usually in May.  I don't know if it was related to the vaccination but I know they're both herpes viruses so I thought it might be.  No treatment needed, and this wasn't anything more than annoying.  Just giving you the information in case you see a pattern.
Flu-like symptoms including low-grade fever to 100.8, rigors, malaise, fatigue, myalgias (full body, not just right deltoid vaccination site). Also painful and tender right axillary lymphadenopathy. Symptoms began the morning following the second vaccination in the series and have so far lasted for the full day. (Note: I am reporting the symptoms on the day I am experiencing them; they are improved from this morning but not yet resolved.) Notably I had no symptoms after the first vaccination in the series except for very mild transient tenderness of the right deltoid at the vaccination site.
14Feb91 pt vax w/ MMR; devel urticaria. Tx w/ Benadryl, APAP, + Tagamet. 18Feb91 exp joint pain in hands + other joints.  Pt tx w/ Ansaid.On 18FEb91 however, arthralgia became more severe & urticaria "just as bad".
This spontaneous report was received from a Vaccine Coordinator referring to an unspecified number of patients of unknown demographics. On 20-JUL-2017 and 21-JUL-2017, the patients were vaccinated with improperly stored PROQUAD (lot # N002325 expiration date 19-JUL-2019), subcutaneous for prophylaxis. It was also reported that the sterile diluent was properly stored. The temperature/time frame was 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes with a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours. (Digital data logger). No adverse events were reported. This is one of two reports received from the same source (Linked report MARRS # 1707USA009884). Sender's Comments: US-009507513-1707USA009884.
Increasing area of induration, macular, erythema, pain. No focal papular lesions. Area size 6 inches x 4 inches upper arm.
Fever, neck pain, swollen face.  The second night after the shoot, I sweat all night long, I never sweat like that when the  Air Conditioning is working, joint pain from my waist down.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that, since 08-JUL-2014 (exact dates not provided), VAQTA 25/0.5 (units not provided) was administered to patients after improper storage (dose, route, lot number and expiration date not reported0. No adverse effects were noted. The case is linked to case MARRS # 1407USA004179, 1408USA013888 and 1408USA013889 (same reporter link). Additional information is not expected because the reporter declined any further contact regarding the report.
Erythema at injection site within first 24 hours 12x10cm measured at 48 hrs. No fever.
This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The coordinator reported that, the patient vaccinated with the powder component of Shingrix reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter could not identity the patient or the vaccination date, but found 3 AS01B Adjuvant. The reporter consented to follow up. This case was linked with case US2021248437 and US2021AMR250027 reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021248437:Same reporter: US-GLAXOSMITHKLINE-US2021AMR250027:Same reporter.
1 week after varicella vaccine developed vertical 9 cm x 8 cm horizontal erythema inside of which are two areas of induration 2 x 2 cm on top 1.2 cm x 2.4 cm lower. Lowest one has 2 vesicles at 4 o'clock.
Pain and swelling at injection site (could move arm only with severe discomfort); fever and chills.
Hallucinations, Myalgia, Arthralgia, Fever, chills fever body aches Narrative:
Following administration of the flu vaccine, the patient seized up and began shaking for a short time, then stopped. It was not characteristic of either a seizure or allergic reaction. Patient reported blurred vision, nausea, and drowsiness for a significant time following vaccination, but was feeling somewhat better eventually. She was still escorted out with EMTs.
As I was administering the vaccine to the patient , second dose of pfizer, some on the vaccine squirted out onto me. Patient received more than half of the vaccine. Patient aware. Patient was observed for 15 minutes in observation. No adverse side effects.
While on a cruise, I started to notice I was coughing often and started to have a headache. I tested myself in the cabin and then I went to the medical area and tested positive both times. I was made to stay in my cabin for the last 3 days of the cruise. I was not given Paxlovid because my symptoms were minimal.
inflamed testicle; testicle infection/ got an infection in the testicles; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 21Jan2021 15:00 at single dose left arm for covid-19 immunisation.  Medical history included ongoing inflamed testicle, H blood pressure.  Concomitant medication included apixaban (ELIQUIS), venlafaxine, carvedilol, terazosin, lisinopril.  The patient was getting ready to take second shot on 14Feb2021, on 04Feb2021 patient started Sulfamethoxazole-TMP Ds Tablets for inflamed testicle. The patient had first shot of the COVID and did not have any problem. Since then patient got an infection in the testicles and then gave antibiotics (treatment) for the 4th of this month. So, the patient had 2, 3 doses of it. The patient was due to have second COVID shot on 14Feb2021 and patient am just trying to find out if patient should stop the antibiotics.  The outcome of events was unknown.
within minutes after the vaccine, I sat in the observation area and both my legs from my hips down to my feet started feeling numb and tingly. This lasted for over an hour. Honestly I did not report it at the site because I needed to get back to work.  I did not seek medical attention because my legs started to feel normal after about an hour. Additionally my period that I had already started became heavier that usual.  Normally I only bleed large clots of blood for a few days but this time it lasted for 5 days, large clots the entire time. Approximately 8 hours after my injection, all of the muscles in my body felt very crampy and achy and I felt extremely tired. The next day my throat was sore and but the aches and muscle cramps had improved but were still there. It took several days until I felt myself again.
Jaw pain; Jaw stiffness; Abdominal pain; lower back pain on left side. Pain started the entire lower back; severe stiffness; Pain when mouth opens; Still in pain when standing, or directly after getting up from sitting or laying down. Cannot stand straight right away; Still mild pain/Still in pain when standing, or directly after getting up from sitting or laying down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 12:00 (Lot number: EW0178) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Batch/lot number: EW0185, Lot unknown: False), when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: PAIN IN JAW (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Jaw pain"; JOINT STIFFNESS (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Jaw stiffness"; ABDOMINAL PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Abdominal pain"; BACK PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "lower back pain on left side. Pain started the entire lower back"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "severe stiffness"; ORAL PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Pain when mouth opens"; DYSSTASIA (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Still in pain when standing, or directly after getting up from sitting or laying down. Cannot stand straight right away"; PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Still mild pain/Still in pain when standing, or directly after getting up from sitting or laying down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in jaw, joint stiffness, abdominal pain, back pain, musculoskeletal stiffness, oral pain, dysstasia, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. No hospitalization Prolonged. No treatment for adverse events. No COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
This initial spontaneous case, was received from other non-health professional on 25-Oct-2017, concerning a 61-year-old, adult, female patient. The patient's historical conditions included hypothyroid and bone spurs. The patient's historical drug included: Flu vaccine, without any reactions. The patient's concomitant medications included: atorvastatin; ADVIL, TYLENOL for shoulder pain and SYNTHROID. On 24-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195129, expiry date: May-2018). On 25-Oct-2017, after 2 days of vaccination, the patient experienced redness about the size of a quarter, hardness, pain at the injection site and no treatment was taken. At the time of this report, the patient recovered from the events (reported as symptoms resolved within a couple of days). The reporter assessed the events as non-serious and considered the causality of the events as related. Follow-up received from the reporter on 21-Nov-2017: The outcome of the events (Injection site redness, Injection site induration and Injection site pain) was changed from not recovered to recovered (reported as symptoms resolved within a couple of days). The narrative was amended accordingly.
NEXT DAY, PATIENT EXPERIENCED DEEP BONE PAIN IN UPPER LEG PELVIS PUSLATING PAIN AND COULDN'T SLEEP. LASTED ALL NIGHT. SUNDAY DISAPPEARED AND THEN TUESDAY WENT TO WORK AND AROUND NOON HAD SHARP PAIN IN THE ANKLE AND COULDN'T PUTWEIGHT ON IT. LAST WEEK HAD SOME LEG PAIN. PAIN MAINLY IN LEGS.
Information has been received from a registered nurse concerning a male who in Oct 2005, was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed a severe local site reaction described as arm pain. Unspecified medical attention was sought. It was also reported that other pts experienced an adverse event Following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0510USA09350 WAES0511USA01104 and WAES0511USA01106. Additional information has been requested.
The evening of the vaccine, the patient reported onset of chills, nausea, headache and deep fatigue. The next day, she had an ongoing deep fatigue, headache, nausea and intermittent palpitations. All symptoms have resolved except for ongoing nausea, intermittent headaches and fatigue.
ITCHING; Hives on hands and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on hands and feet) and PRURITUS (ITCHING) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Drug allergy (Allergic to cephalexin), Sulfonamide allergy and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for Cholesterol, INSULIN LISPRO (HUMALOG) and METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Hives on hands and feet). On 10-Mar-2021, the patient experienced PRURITUS (ITCHING). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; TRIAMCINOLONE from 15-Mar-2021 to 01-Apr-2021 at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2021 to 01-Apr-2021 at an unspecified dose and frequency. On 29-Mar-2021, URTICARIA (Hives on hands and feet) had resolved. On 01-Apr-2021, PRURITUS (ITCHING) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other medications include Omega 3 acid. Patient reported that the reaction to sulfa or cephalexin lasted for 3 weeks, which will usually last for 5 to 7 days. patient reached out to doctor via patient portal online for advice and sent photos   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Significant FU - reporter Info added, Medical history and event information provided.
Forgot to get 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Forgot to get 2nd dose). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK receipt date 24-MAR-2023 The Healthcare Professional (HCP) had asked if a member (patient) forgot, if he had his shingles vaccine, could he get the series again. The reporter requested medical information (including product excursions or stability). Follow-up would not possible as no contact details were available. Till the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Red spot at injection site; Flaky skin at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes zoster.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema and injection site exfoliation. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site exfoliation was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site exfoliation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 76 years or 77 years. Injection site had redness and flaky skin, about the size of a pencil eraser. The redness was not raised. The patient was seen by her dermatologist who prescribed a steroid cream and after treatment, the red, flaky skin resolved. At the time of reporting the patient returned to the pharmacy and states the redness recurred.  The date of recurrence was unknown to pharmacist, but as of the time of this call the redness was ongoing.  The patient denied itching and pain, and states that at the time of reporting the reddened skin was not flaky. The reporter consented to follow up. The pharmacist did not provide further details.