chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in my tongue; spots before my eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling in my tongue) and VISUAL IMPAIRMENT (spots before my eyes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K020A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included PREDNISONE.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling in my tongue) and VISUAL IMPAIRMENT (spots before my eyes). At the time of the report, PARAESTHESIA ORAL (Tingling in my tongue) and VISUAL IMPAIRMENT (spots before my eyes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Patient Received first dose of moderna on 11/30/2021 and second dose on 12/21/2021.  Patient did not have the 28 day period between first and second dose.  patient notified no adverse events.
Information has been received from a physician concerning a female (demographics not provided) who on unspecified date was vaccinated intramuscularly with first dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed arthritis. Unspecified medical attention was sought. On unspecified date erythrocyte sedimentation rate test was performed, result was reported as "elevated". At the time of this report, the outcome was unknown. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who on 21-APR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot# 659435/1265U) in the left deltoid. There was no concomitant medication. On 24-MAY-2008 the patient was seen in urgent care for questionable mononucleosis. In June 2008, the patient developed myalgias and arthralgias. On 16-JUN-2008 the patient was seen by the physician and had the following laboratory tests performed: ANA which was negative, erythrocyte sedimentation rate 30 mm/hr, rheumatoid arthritis factor which was negative and urine culture (no growth). The patient's CBC was within normal limit on 24-JUN-2008. The physician reported that the diagnosis was arthritis. The patient was referred to a rheumatologist on 02-JUL-2008 and a positive sedimentation rate was noted. The patient was again diagnosed with arthritis. The patient did not receive any more doses of GARDASIL. At the time of this report, the patient had not recovered from the events. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
After two weeks from the  first dose of Moderna vaccine, left arm developed a red, raised, feverish, itchy patch.   Today, 4/3/2021 is the third day of patch.  It has become a little larger in size.   There is only the slightest pain.   Have not consulted my doctor.
This spontaneous report was received from a licensed practical nurse regarding a 14-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were reported as none. On 14-APR-2005, the patient was vaccinated with the first dose of VARIVAX, subcutaneously, for prophylaxis (also reported as vaccine) (dose, lot number and expiration date were not reported). On 17-APR-2008, the patient was vaccinated with the second dose of VARIVAX, subcutaneously (lot number: 1916U) (dose and expiration date were not reported). On an unknown date (reported as a couple of weeks ago), the patient was exposed to a family member diagnosed with shingles. On 04-DEC-2018, the patient began experiencing symptoms of chicken pox including myalgia, fatigue, a mildly itchy rash all over his body, sore throat, and red lesions with vesicles. No lab diagnostics or studies were performed. The patient sought medical attention and was seen in office. An unspecified treatment was given for the event. At the time of reporting, the patient was recovering from the event. The relationship between the event and the vaccine was not reported. Lot number 1916U has been verified to be a valid lot number for VARIVAX.
13 hours post shot, chills, 102.6 degree fever, throbbing headache, fatigue, injection site pain, and feeling very "heavy". This continued for 12 hours, and throbbing headache continued past other symptoms another 8 hours.
Within hours patient came down with a fever, nausea, fatigue, muscle pain, pain that radiated down both arms. Symptoms lasted for about 7 days
This spontaneous report as received from a nurse refers to a 85 year old female patient. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route unspecified). On an unknown date in June 2014 the patient developed lesions on her body, hands arms, scalp, neck and chest after receiving her ZOSTAVAX. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention via office visit. Additional information has been requested.
originally had Moderna for first two shots and first booster; month long hospitalization for pneumonia; ARDS; COPD; left arm 90% paralyzed; Believe left arm blood vessel poked by shot.; Arm black and blue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2022 at 15:30 as dose 4 (booster), single (Lot number: 59267102501W) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1 , (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization; Moderna (Dose: 2, (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization; Moderna (First booster, (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization. The following information was reported: ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, medically significant) with onset 11Aug2022, outcome "not recovered", described as "ARDS"; SKIN DISCOLOURATION (non-serious) with onset 11Aug2022, outcome "not recovered", described as "Arm black and blue"; VASCULAR INJURY (non-serious) with onset 11Aug2022, outcome "not recovered", described as "Believe left arm blood vessel poked by shot."; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) with onset 11Aug2022, outcome "not recovered", described as "COPD"; MONOPLEGIA (medically significant) with onset 11Aug2022, outcome "not recovered", described as "left arm 90% paralyzed"; PNEUMONIA (hospitalization, medically significant) with onset 11Aug2022, outcome "not recovered", described as "month long hospitalization for pneumonia"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 11Aug2022, outcome "unknown", described as "originally had Moderna for first two shots and first booster". The events "month long hospitalization for pneumonia", "ards", "copd", "left arm 90% paralyzed", "believe left arm blood vessel poked by shot." and "arm black and blue" required physician office visit.  Clinical course: Believe left arm blood vessel poked by shot. Arm black and blue. Also, left arm 90% paralyzed as of 30Sep. May have contributed to month long hospitalization for pneumonia, ARDS, COPD. Still in hospital. Had originally had Moderna for first two shots and first booster. This would be 4th shot with switch to pfizer. (Name withheld) was still in the hospital. No Covid prior vaccination. No Covid tested post vaccination.
Sore left arm for two days, headaches, sore joints, fatigue, listlessness, sleep disruption
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received BOOSTRIX for prophylaxis. On 21st February 2018, the patient received BOOSTRIX .5 ml. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced pain in arm, injected limb mobility decreased and swelling arm. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and swelling arm were recovering/resolving. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and swelling arm to be related to BOOSTRIX. Additional details reported as follows: The patient received the vaccine in the left arm. The patient experienced pain, swelling and loss of motion in the left arm. The patient required two visits to urgent care center. The patient was recovering at the time of reporting. The reporter was calling from attorney office to file a claim for personal injuries after vaccination for the patient.
According to the pt's mother the child developed shortness of breath, increased heart rate, swollen reddened injection site. He was taken to the doctor's office and monitered for several hours and discharged. Had a fever for  days after injection up to 103 deg. F.
Itchy and slight rash at site of injection in left arm.  Then itching and rash appeared on right arm.  Then on top of thighs, neck and back, knees and upper torso.  Urgent care recommended prednisone and first dose was taken 4/26/21.  Symptoms still present but reduced as of 4/27/21.
COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: F07218), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: EL3248) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022 at 08:00, outcome "not recovered" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (15Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: No other vaccine in four weeks. There were other medications in two weeks. No covid prior vaccination. No known allergies.
Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: This case was reported by the physician on behalf of his wife. The age at vaccination was not reported. The reporter stated that the patient experienced pain at the injection site, lasting almost 2 months.
Generalized papular eruption x 3 wks after MMR, became vesicular and pustular a week after; had bilateral inguinal adenopathy 10 days after vaccination.
Vaccination 1: (symptoms onset ~4-6hrs after injection) >>>following  morning: severe pain throughout entire body, swelling in hands/feet, chills, tiredness, brain fog, nausea, cold sweats, and fever. Vaccination 2: Allergic reaction about 30+ mins after vaccination after heading back to the car.  Cold, clammy, pale, disoriented, hives across skin, dry mouth,  and itchiness  >>>Next morning: severe pain throughout entire body, swelling in hands/feet, chills, tiredness, brain fog, nausea, cold sweats, and fever.
This spontaneous report was received from a registered nurse via company representative referring to a 21 year old female patient. Patient's medical history and concurrent conditions were not reported. On 22-JUN-2015, the patient was vaccinated with the 3rd dose of GARDASIL (lot # and expiry date not reported. Other co-suspect or concomitant medications were not reported. The Nurse reported that the patient experienced anxiety, chest pains and difficulty breathing after receiving her 3rd and final dose of GARDASIL on 22-JUN-2015. The nurse reported that sometime after the patient received her first two doses but before her final third dose the patient read numerous horror stories about side effects regarding GARDASIL. The physician and the nurse spent time talking to the patient as she was extremely anxious about getting the injection. After the patient calmed down she was administered her final dose of GARDASIL. They waited for 20 minutes before releasing the patient from the clinic. Twenty minutes later the patient called the clinic and said she thought she was having a heart attack. She complained of chest pain then said she couldn't catch her breath. The nurse said the patient was speaking just fine over the phone and referred to the Doctor for advice to see if an Emergency Room visit was necessary. The patient was advised to return to the clinic which she did. The physician examined her vitals and determined the patient was fine (no treatment was given). The office had had no contact with the patient since then so they are assuming she was no longer experiencing and adverse effects, but at the reporting time, the outcome of the event was uncertain. Additional information has been requested.
(1) Wed, May 12th - I woke up around 7:30am with pain in my right side near the rib cage/beneath my chest.  The pain was also in my upper right shoulder and trap/neck area. (2) Sat, May 15th - in the evening time around 7:30pm I was riding passener seat in a car and started having shortness of breath (constricted breathing) and immense pain in my right side near my rib cage/beneath my chest.  The pain felt like the worst muscle spasm I've ever encountered.  The pain was gripping and persistent.  It was hard to breathe and even harder to utter out a word or two.  This intense pain last for 45 minutes until I got home.  I admitted myself into the ER around 8:30pm.  Around 7 hours later and after a series of multiple tests I was told I have PE-blood clot in my lungs.   (3) Sun, May 16th - I was admitted in the hospital around 5:30am.   (4) Tue, May 17th -  I was discharged around 4:30pm
Use diluent from another vaccine to reconstitute Menveo; Use diluent from another vaccine to reconstitute Menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments: The clinic supervisor reported that the patient was administered a dose of Menveo. The dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked with US2023021303, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2023021303:Same reporter
Partial dose received, around half of dose was lost; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KR4T, expiry date 21st May 2024) for prophylaxis.   On 13th February 2023, the patient received the 2nd dose of Shingrix. On 13th February 2023, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's comments: The pharmacist stated that, a nurse had reported to her that, during administration of a Shingrix vaccine, there was a malfunction with the needle used and the patient only received a partial dose.  The nurse had estimated it to be around half of the dose was lost.  At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. No exposure was reported. The reporter had consented to follow-up. Additional supportive information: There was a malfunction with the needle used and the patient only received a partial dose, which had led to accidental underdose.
pulse was 118; slight, slight chest pain/she had chest pain so bad it almost took her to the floor; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (also reported as on the 15th) (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine on the 15th. On an unspecified date, the patient experienced slight, slight chest pain that day. The following day, she had chest pain so bad it almost took her to the floor and caused her to be hunched over holding her chest. It lasted for about 4 min. She went home after that and measured her blood pressure and pulse and noted her blood pressure was okay, but her pulse was 118 on an unspecified date. The outcome of the event slight, slight chest pain/she had chest pain so bad it almost took her to the floor was resolved on an unspecified date in 2021. The outcome of the event pulse was 118 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
No adverse event took place. When staff were checking on inventory they came across the fact and caught the error that the individual received the Pfizer monovalent vaccine instead of the BIVALENT vaccine.  Local Department of Health was notified, and instructed to notify the manufacturer for guidance and report to VAERS. Manufacturer was notified on 10/19/22. Manufacturer did not have any further guidance at this time, other than the individual is eligible for a BIVALENT boost on 11/22/2022.
Fingers still numb Heart racing Feels like a 50lb weight in my chest Everything hurts - incredibly hard to move Back feels like a truck hit me Diarrhea ended this morning  Headache gone Nausea almost gone
sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      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.   No concomitant medications were reported. No treatment information for the event was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089210 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089210:
Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Information has been received from a 66 year old female consumer concerning herself with high blood pressure and a history of thyroid disorder who on 09-NOV-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 664653/1337Y). On an unspecified date, the patient experienced sore arm and throat and felt congested. Couple days later the patient's condition was worsen. She visited the physician and was given IV (medication name and manufacturer unknown). At the time of this report, the patient had not recovered. Additional information has been requested.
Patient began feeling "unwell" about 30 minutes after administration. She admits to being nervous, but complained of new onset dizziness versus lightheadedness. The patient was placed in a seated position, but she continued to complain of dizziness and very mild nausea so she was laid supine. She eventually was able to sit upright, sit in a chair, and then stand following PO fluids. Her BP, HR, spO2 were normal throughout. She confirmed improved symptoms and was ambulated without issue. Patient reported resolution of symptoms about 25minutes after first onset and was released to home.
Needle reportedly broke during administration, vaccine material did not enter arm at full dose ("sprayed" elsewhere), however patient's arm became red and slightly raised at injection site following event suggesting some receipt of vaccine.  Need advice re: how to proceed - need to repeat dose #1 at full dose, and if so when?  Proceed to dose #2 at regular interval?
the rash also began to spread on his arms and legs; rash on his back; rash on his head; A spontaneous report was received from a consumer concerning a 67- year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on his head, rash on his back and rash on his arms and legs.  The patient's medical history was not provided. Concomitant medications were reported as blood high pressure medicine.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event rash on his head.  On 8 Feb 2021, the patient experienced the event rash on his back.  On 9 Feb 2021, the patient experienced the event rash on his arms and legs.Now it's more visible on her back. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on his head, rash on his back, rash on his arms and legs were unknown.  Based on comment, Rashes ( change listedness to listed and unlisted for monograph and factsheet)