chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2022, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; pain is in my armpit; Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; Pain in the knees/ paint in joints; The site became swollen and very painful; I was so scared; The site became swollen and very painful; skin was reddened on her upper arm and then the redness went down the arm; couldn't lift my arm for 4 days; even my nose felt strange; This spontaneous report, was received from a 73-year-old female patient referring to herself. The patient's concurrent conditions, concomitant medications, and drug allergies or reactions were not provided.  Historical vaccinations included pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) in 2019.   On 29-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, dose, administration route, lot number, and expiration date were not provided).         On the same day of vaccination, the injected site became swollen and very painful (vaccination site swelling and vaccination site pain). Also, she was very scared of the pain and felt that it was an inappropriate response (feeling abnormal).    On 31-OCT-2020 (reported as two days later), the patient reported to have a rash all over her arm, and it was starting to spread. Also the rash was reported as red and itchy (rash pruritic and rash erythematous).  The patient also experienced pain in her armpit, knees, fingers, and feet joints (arthralgia and axillary pain). That lasted for 2-3 days. The patient couldn't lift her arm due to the pain (application site joint movement impairment).       Additionally, on an unspecified day in 2020, the patient experienced erythema and nasal discomfort   The outcome of the events was not provided as well as the causal relationship between the events and the suspect vaccine.        .
75 years received 1st dose of Bexsero after patient had a splenectomy; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 75-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: Registered Pharmacist reported that the patient age was 75 years and he received his 1st dose of Bexsero after patient had a splenectomy.  No reports of side effects was given. The consent to follow-up was declined. Additional supportive information: The patient received his 1st dose of Bexsero at the age of 75 years, hence inappropriate age at vaccine administration was captured.
Soreness was immediately felt but not painful.  The problem was, a few weeks later I noticed that I had much more limited range of motion without pain.  I noticed it first when trying to scratch my lower back with my left hand.  Also in putting on shirts or jackets (having to reach behind my back to insert arm into sleeve (since I always put my dominant (right) arm into its sleeve first.  The pain is usually very sharp and then the shoulder feels stiff.  Eventually - within 5 to 10 seconds it will subside.  the shoulder feels week as well.  I do work out, and had done so the day after my shot...but I did not over exert my shoulder in the process... it was a normal workout.  The pain and limited range of motion still persists to the present day, and has not diminished.  I visited an Othropedic doctor on 1/25/21 to have it looked at.  Xrays were taken but nothing abnormal was detected.  The doctor gave me an anti-inflamatory medication (Meloxicam 15 MB) but this has only yielded mild relief and I have been reluctant to take it.  I intend to to to my general practitioner doctor to inquire about next steps.  MY MAJOR CONCERN is that this was the first of two doses... and now I am reluctant to go back for the second one.. which I need to take within the next three months or so.
Patient has history of fainting after blood drawn but not from receiving vaccine from her memory. Patient received first covid-vaccine and was sitting down on a chair at a waiting area. 10 minutes later, she was sliding down her chair and her eyes were rolled up. Pharmacist and friend caught patient and slowly had her lie down on her back. 911 was called and patient's head was turned just in case of a seizure. Patient had pulse but had no conscious for about 3 minutes. Consciousness came back in few minutes and she was able to respond back to pharmacist. EMT arrived and took patient.
Provider ordered a tdap intermuscular however tech administered vaccine via intradermal route on right FA.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BioNTech Vaccine on 1/23/2021 and 2/13/2021. Presented to ED on 8/16 with complaints of syncope and right shoulder pain. Patient had been diagnosed with COVID on 8/13, with his main symptoms being fatigue/tiredness, cough, nausea. On 8/27, patient was agonal breathing (after he removed his bipap); patient was intubated and placed on mechanical ventilation and moved to ICU.  On 8/29, patient became more hypoxic in respiratory distress with dyssynchronous hypotensive Afib with RVR.  Patient received decadron x 6 days, baricitnib x 8 days, doxycycline x 7 days, Micafungin started on 8/26, started vancomycin and meropenem on 8/28. Patient expired on 8/29/21.
Approximately 2 weeks later developed what I thought was hives on left side my neck and left. Lots of itching and it became extremely painful. After visiting the doctor on 5/27/2021, I was advised I had a bad case of shingles. Was given medication for 10 days and steroids.
Received vaccine at 1259, remained for 15 minutes without symptoms and returned to work. At approximately 1600, felt itchy and discovered hives covering body. Went home and took Benadryl.  When spoke with at 1900 stated that her hives were still there but improved.
Intense Vertigo and tachycardia lasting for approximately 2 hours post injection, nausea/motion sickness lasting 5 days post injection
Public Health Nurse gave MD wrong dose/type of H1N1. Patients should have received 0.25 ml preserv free and instead she gave MD 0.5 ml H1N1 with preservative, Sanofi UP013AA multi dose vaccine.
patient only received a partial dose. (under dose; This case was reported by a pharmacist and described the occurrence of accidental underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th August 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that during administration the syringe malfunctioned and the patient only received partial dose, which led to accidental underdose. The pharmacist declined to provided patient information, lot number, expiration date, and his location. The reporter did not consent to follow up.
none prior to getting COVID vaccine - was sick in March, 2020 unknow if COVID infection or not - with in 2 hours of getting COVID Moderna vaccine on01/07/2020 she started a sore throat and instant headache migraine type for 2 days continues with a mild throbbing headache at this time of 01/18/2021. also has light sensitivity, tried Toradol did not help headache, had COVID test and Strep Throat test,  both were negative. unable to taste or smell all food taste bland. continues as of this writing.
Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Dry, ichy throat, lips, mouth and tongue; Tight throat and tongue some minimal; Tight throat and tongue some minimal; Swelling in tongue and throat.; Swelling in tongue and throat.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old, non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in left arm on 17Mar2021 at 08:30 (age of vaccination 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication includes vitamins C (MANUFACTURER UNKNOWN), b12 (MANUFACTURER UNKNOWN), multi vit (not coded) (MANUFACTURER UNKNOWN), omega 3 (MANUFACTURER UNKNOWN), all for an unknown indication since an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took aspirin in the past and experienced drug allergy. On 17Mar2021 at 09:15, the patient experienced dry, itchy throat, lips, mouth and tongue, tight throat and tongue and some minimal swelling in tongue and throat. No therapeutic measures were taken for the adverse event. The clinical outcome for the events dry itchy throat, lips, mouth and tongue, tight throat and tongue some minimal swelling in tongue and throat was not recovered.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps) and PARAESTHESIA (Right hand tingles a little) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient current condition included IVS unspecified. Concurrent medical conditions included Excessive eye blinking, Asthma, Chronic bronchitis, Type 2 diabetes mellitus, Migraine, Obesity, Brain tumor, Fibromyalgia and Neuropathy. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps), PARAESTHESIA (Right hand tingles a little), PAIN IN EXTREMITY (Severe pain in legs / Severe pain in arms), HEADACHE (Headache), VACCINATION SITE PAIN (Pain and soreness at the injection site) and MYALGIA (All over body pain and ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps), PARAESTHESIA (Right hand tingles a little), PAIN IN EXTREMITY (Severe pain in legs / Severe pain in arms), HEADACHE (Headache), VACCINATION SITE PAIN (Pain and soreness at the injection site) and MYALGIA (All over body pain and ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient tested herself negative. No concomitant medications were reported. Patient did not experience any side effects in her first and second Moderna shots. Patient did not experience similar events in the past. Patient called her HCP and the pharmacy where she got her booster dose for events.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L003775 with expired date 04-FEB-2017, lot# L013827 with expired date 21-APR-2017, lot# L017145 with expired date 13-MAY-2017, lot# L017997 with expired date 19-MAY-2017, dose and route were unknown). No concomitant medication was reported. The nurse could not tell how many of each lot number of this vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Large rash (majority of upper arm) at the site of the injection approximately 10 days after receiving the vaccine. Dermatologist prescribed Triamcinolone 0.1% cream for treatment.
On 4/10/00, the pt presented with a fever of 104 and an injection site reaction that consisted of erythema and tenderness in an area 5 1/2 inches by 4 inches. The pt sought unspecified medical attention.
A non-serious, spontaneous report of vertigo, dizziness, nausea and headache has been received from a Physician concerning herself, a 36-year-old female subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 10-Oct-2009. On 12-Oct-2009 the patient experienced vertigo, dizziness and nausea lasting 48 hours. The symptoms were reported to be so bad as to require an IV. The patient did not report occurrence of fever, although she also had a headache at time of reporting on 15-Oct-2009. The patient recovered from the events of vertigo, dizziness and nausea on 14-Oct-2009. The outcome of the event of headache was not resolved.
Headache, body aches/ pain all joints, moderate fatigue, redness/pain/swelling at injection site, fever of 101.4 (F).
Patient's husband reported to the pharmacy that she was having a hard time breathing.  When I reached the patient she had already taken two puffs of her albuterol inhaler.  She said it felt like her throat was closing so 911 was called.  She continued to labor in her breathing and said her lips were tingling.  She was no longer able to talk and she took one more puff of her albuterol inhaler.  Then she began gasping and an epinephrine 0.3mg pen was administered.  Paramedics arrived and took her to the hospital.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: ADVAIR, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19  (Paxlovid - Treatment start date: 16Nov2022, Treatment stop date: 20Nov2022).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
My arm is really great, it was just sore for a day; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his/her vaccine on Friday. The patient stated he/she had no effects, his/her arm was really great, it was just sore for a day. The outcome of the event was recovered.  Information about lot/batch number has been requested.
dizzy, fever, lt arm swollen & sore;fever began last noc;atarax, advil, augmentin given;
Extreme fatigue, muscle aches, headache, light-headed, weakness. Still very fatigued.
mild firm swelling of the left thigh under the DTAP and HIB injection sites from the day after the vaccines were given. Some eczema overlaying the vaccine site.
Herpes zoster diagnosis in two-dose varicella vaccine recipient. Rash was unilateral, one dermatome (left side of back). Diagnosed at Health Center by Dr. on 5/19/14. Onset date unknown. Treated with acyclovir.  Also infected with Staph. No pain noted.
Patient reports arm tingling down from elbow to hand of left arm.  A little numbness in left hand.  Few hours later patient reports numbness moving down to arm and hand and up to eye with somewhat lessening on the lip. Patient currently experiencing some tingling on the right arm.
Moderna Bivalent was inadvertently administered to this 17 year old patient.  No immediate adverse events upon administration or with 30 mins thereafter.  Contacted patient the following morning and experiencing commonly expected AEs (muscle aches and fatigue).
Approximately 10.5 hours after receiving the Moderna COVID , dose 2 immunization, I had really bad chills, using 5 blankets to get warm. I has a fever 100.4. Headache, my knees and hip were very painful. I felt disconnected mentally, and dizzy. I could not eat or drink, then I vomited 6 times. I had at take a sick day from work because I was in bed with these symptoms.. On 2/27/21 I  am beginning to drink and move around in the house. The chills come and go.  The headache persists. The knee and hip pain is improving.
PATIENT EXPERIENCED REDNESS, SWELLING, AND WARMTH AT THE INJECTION SITE THE MORNING AFTER VACCINATION. THE SIZE OF THE SWOLLEN AREA WAS SIZEABLE ACCORDING TO PATIENT, AT 6INX4IN. OVER THE FOLLOWING 72HRS THE SWELLING HAS DECREASED AND PATIENT IS ONLY CURRENTLY EXPERIENCING MILD WARMTH AND ITCHING AT INJECTION SITE. PATIENT DID ICE THE AREA ON/OFF THROUGHOUT THE FOLLOWING DAY AFTER VACCINATION TO HELP WITH THE SWELLING.
He developed a low-grade fever that evening (5/9/17) after his shot (which I understand is a normal reaction). However, that morning he pooped mucous. Shortly after the odd mucous type of bowel movement, he developed hives that was all over his body and face. The hives lasted for three weeks. After two weeks of no improvement Dr. advised I apply hydrocortisone to help him with the hives. A week later they subsided.
WITHIN 2 MINUTES, I BECAME DIZZY AND LIGHTHEADED - ALMOST FAINTED. WITHIN 15 MINUTES, MY TONGUE BEGAN TO SWELL I HAD A HEADACHE &  GENERALLY FELT "OFF." FOUR DAYS LATER, MY ARM IS STILL SLIGHTLY SWOLLEN, PAINFUL, ITCHY & RED  AND THE HEADACHES HAVE NOT SUBSIDED. I TOOK A BENADRYL UPON RETURNING TO MY OFFICE AND FOR THE NEXT 2 DAYS.
I had my vaccination on 10/28/2022. I had a stroke on 11/20/21. I was sent to the ER where they performed a CAT scan MRI blood panel and angio. I was admitted to the hospital for 4 days. I was also diagnosed with Parainfluenza virus type 3 with symptoms appearing 7 days prior with a UTI.
Information has been received from a Licensed practitioner nurse concerning to a 15 year old female patient with chronic myeloid leukemia and not known allergies. On an unknown date the patient was vaccinated with dose one of GARDASIL 9 (dose, lot number and indication not reported) without any reaction. on 18-SEP-2015, the patient was vaccinated with dose 2 of GARDASIL 9 (Lot number not reported), intramuscular for human papilloma virus immunization. Concomitant therapies included SPRYCEL. On 18-SEP-2015, the patient experienced injection site erythema. The patient did not report any additional symptoms. No treatment was given nor lab diagnostics tests were performed. No cancer, congenital anomality, death, disability, life threatening nor overdose were reported. The outcome of injection site erythema was unknown. The relations between injection site erythema and therapy with GARDASIL 9 was not reported. Additional information has been requested.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2016, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster for which he was treated at the facility. The patient claimed damages as a result of injuries to themselves, loss of consortium, loss of services and economic losses. The outcome of the herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.