chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arm, red to touch, itching from shoulder to wrist. Reported some swelling first on 9/8/2014. Advised to take BENADRYL and observe. Visited emergency room on 9/9 and given antibiotic.
Broke out in itchy skin rash at various parts of my body. Mostly upper body / head and neck area. No remedy yet.
light headed for 3-4 hours, it was an odd sensation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed for 3-4 hours, it was an odd sensation) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and LEVOTHYROXINE SODIUM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (light headed for 3-4 hours, it was an odd sensation). On 13-Jan-2021, DIZZINESS (light headed for 3-4 hours, it was an odd sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-033172 (Patient Link).
adult was administered pediatric dose; adult was administered pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 1st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: 13-SEP-2022 Reporter's Comment: The reporter was senior clinical manager. The reporter stated that, an adult patient was administered the pediatric dose of Engerix-B before the day of reporting. The reporter consented to follow up via mail. Additional Supportive Information: The reporter stated that, an adult patient was administered the pediatric dose of Engerix-B before the day of reporting, which led to underdose and adult use of a child product.
Myocarditis and Pericarditis.  Heart Beating very fast and irregularly.  I have a hard time laying down to rest because it feels like my heart is going to skip beats.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills) and NAUSEA (minor nausea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma (patient taking hydrox for glaucoma.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills), NAUSEA (minor nausea) and PYREXIA (fever of 100 and 101°F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills), NAUSEA (minor nausea) and PYREXIA (fever of 100 and 101°F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100 °F (High) 100-101°F and then came down to 99 after one day. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication taken by the patient included cholesterol medicine, hydrox for glaucoma. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up information was received and the outcome of the events were updated to recovered.
Patient had Flublok administered on 9/30/20.  On 10/5/20 she called into our clinical triage department and was given a same day appointment at our facility due to neck shoulder, & arm pain that began after the flu vaccine was administered.  She was given medications for the pain and referred to physical therapy.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017, lot # L043214 and expiration date 30-AUG-2017; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received rom the same source. Additional information has been requested.
Achiness on both sides of his neck, into his shoulders and where the clavicles meet in his chest (at the base of the neck).  Limited range of motion in both arms, cannot lift very high.
first dose 3/23/2021 and failed to follow up with the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose 3/23/2021 and failed to follow up with the second dose) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose 3/23/2021 and failed to follow up with the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose 3/23/2021 and failed to follow up with the second dose) had resolved.        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 medication information was provided. No treatment medication were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received on 26-Jun-2021 and contains no new information.
Patient reports 2 to 4 days after vaccine was administered SQ on his left arm, he started experiencing muscle and nerve pain from left side of hip to down in the legs. As on today, pain is still persisting. Seen by Dr. Is taking FLEXERIL 10mg TID from 5/27. Prescribed MEDROL Dose pack today.
About 12 hours after injection, I had nausea, body aches, and bad chills. These effects lasted about 7 hours.
not feeling right; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Peripheral Neuropathy" (unspecified if ongoing). Concomitant medication included: LYRICA taken for neuropathy peripheral. The following information was reported: FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "not feeling right".  Additional Information: After the first dose, she started not feeling right on Thursday, 04Mar2021, and she was better on Saturday (06Mar2021). It only lasted for a couple of days. The patient did not receive additional vaccines on same date of the Pfizer suspect. Adverse event did not require visit to emergency room or physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021358435 Same patient and drug but different dose and events
rash; This is a spontaneous report from a Pfizer-sponsored program received via a contactable consumer reported for a female patient (mother). A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) at a single dose for COVID 19 immunization. Medical history and concomitant medication were not reported. The consumer reported that mother had reaction to the first COVID vaccine. Had a rash and wanted to report reaction. The outcome of the event was unknown.  Information about lot/batch number has been requested.
This case was reported by a consumer and described the occurrence of fever in a 2-year-old male patient who received HAVRIX (batch number 523T3, expiry date unknown). Concomitant products included vitamins nos (Multivitamin). On 10th April 2015 02:30, the patient received the 2nd dose of HAVRIX (injection). On 8th May 2015, 28 days after receiving HAVRIX, the patient experienced fever. On 9th May 2015, the patient experienced walking difficulty, strength loss of, feeding disorder, fall and dizziness. On an unknown date, the outcome of the fever, strength loss of and feeding disorder were recovered/resolved and the outcome of the walking difficulty and fall were unknown and the outcome of the dizziness was recovering/resolving. The reporter considered the fever, walking difficulty, strength loss of, feeding disorder, fall and dizziness to be possibly related to HAVRIX. Additional information provided: The reporter's son developed fever, and then had difficulty walking, falls over while sitting, was dizzy, and loss strength (could not feed himself anymore). She reported that the patient has recovered from some of these side effects and he may be on the road to recovery for the other side effects.
Started shaking and feeling body vibrations  and tremors a couple of months after the 2nd Covid 19 shot/vaccine
From initial information received on 4/9/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 55 year old female patient received her fourth dose of IMOVAX RABIES, lot number W1419, administered in the left deltoid (route of administration not reported) on 3/8/04. Ten days later, the patient experienced trembling in her hands, which stopped only if when she sat on them. Reportedly, the patient's children also noticed that her head was shaking. The symptoms lasted seven days. The patient received a fifth dose of IMOVAX RABIES, lot number X0581, administered in the right deltoid on 3/22/04. The patient went to see a doctor on 4/8/04 and was told that it might be Parkinson's disease or her thyroid, but was not given any medication. The patient stated that the symptoms occurred half way through her vaccination series. Reportedly, she feels fine otherwise. The patient's recovery status is currently unknown. From additional information received from the reporter on 4/12/04, it was reported that the patient did not think the tremors were related tot he vaccine. It is unknown whether any diagnostic test were performed. The reporter had contacted the physician regarding this question but has not yet received a response. She agreed to forward this information when it becomes available. From additional information received on 5/7/04 from the initial reporter, the patient's physician said that the events had resolved and that he did not feel that it was a vaccine reaction. No testing was performed. The patient received a fifth dose of IMOVAX RABIES, lot number 0581, in the right deltoid on a unspecified date. No adverse event was reported following this vaccination.
Information has been received from a nurse concerning a 13 year old female who was vaccinated into the left arm with a 0.5 ml second dose of Gardasil. Subsequently, the patient experienced breast pain. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Pt developed moderate pain at injection site that woke her up 1-2 times during the night. She had difficulty raising her arm because of soreness. There was erythema about the size of a 50 cent piece, and it was warm to touch. The pain finally resolved 10/22/01.
Information has been received from a physician concerning a 55 year old male patient with abnormal aneurysm, hypothyroidism, undefined anemia and scleroderma who about 3 months ago, in approximately January 2009, was vaccinated with ZOSAVAX (Merck). About 6 to 7 weeks after vaccination (about 1 month ago) the patient developed a widespread itchy varicella like rash. On an unspecified date the patient was seen for an office visit. The physician stated that he was not interested in a DCR analysis. At the time of reporting that he was not interested in a DCR analysis. At the time of reporting the patient had not recovered. Additional information has been requested.
This spontaneous report was received from an administrator refers to 3 unspecified adult patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route of administration and lot # was not reported). On an unknown date (reported as recently), the patients had blood tests drawn to verify their immunity to hepatitis B and their titers came back negative. The outcome of the event was unknown. Additional information has been requested.
pt reports severe aching in joints & fever of 102 then diarrhea started 22OCT97;advised to see MD which did on 23OCT97;MD felt synd were not caused by flu vax according to pt;
SKIN: RASH: Location: upper legs and lower legs.  Description: multiple nonblanchable petechia 1-2mm in diam over 20 in number all over lower extrm, pt was sent to ER to r/o decreased platelett count on 6/27/15. Sencond visit on 6/29/15 noted the following patient is in for a follow-up on ER visit for reaction from vaccines. SYMPTOMS: Have improved. SYMPTOMS: The patient is still having the following symptoms: Skin: Petechia noted on legs, not "as red" but mother noted one faint one near right elbow. TREATMENT REGIMEN: has been completed.  (just observation) Patient has been seen at ER. ADDITIONAL COMPLAINTS (not related to followup): All other systems reviewed are negative.
pt recv vax 3NOV95 & 4NOV95 devel a silver dollar sized welt @ the inj site;pt has not yet recovered;
Swelling, redness to about 1.5 inches by 1 inch. Warm to touch. Sometimes itches
Hives. Have been persistent despite steroid usage and hydroxyzine. No angioedema, chest pain, shortness of breath, nausea or vomiting, or fevers/chills.
received the first dose / in November of 2019 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not reported. Till the time of report, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent follow up.
7-26-12 - Vaccinated. 7-26 - 7-28 - Red inflammation at injection site. 8-1 - Respiratory illness symptoms. 8-2 - Listless, vomiting, blood filled diaper. Required IV fluids, surgery for intussusception hospitalization.
Erythematous wheel at the injection site, itching still present 12 days later. Onset was within 30 min of injection.
She reports that her daughter developed scoliosis post vaccination of the GARDASIL; This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No information patient's medical history, current conditions and concomitant medications was provided.     On 22-NOV-2013 the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for human papilloma virus immunization (exact dose, route of administration, lot# and expiration date were not provided). On 22-JAN-2014 the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for human papilloma virus immunization (exact dose, route of administration, lot# and expiration date were not provided). On 02-JUN-2014 the patient was vaccinated with third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for human papilloma virus immunization (exact dose, route of administration, lot# and expiration date were not provided).       On an unknown date the patient experienced scoliosis. The outcome of scoliosis is unknown. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) regarding the event was not applicable.  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the event was not provided.
severe muscle aches; extreme lethargy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe muscle aches) and LETHARGY (extreme lethargy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced MYALGIA (severe muscle aches) and LETHARGY (extreme lethargy). At the time of the report, MYALGIA (severe muscle aches) and LETHARGY (extreme lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
Information has been received from a registered nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were vaccinated with improperly stored of PNEUMOVAX 23 (dose, route of administration were unknown, lot # L019836, expiration date 24-MAR-2017). These vaccines were exposed to 0.4 degree centigrade for 6 hours 30 min. A data logger was used to log temperature and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 9 year old female with reactive airway disease who was vaccinated with a dose of varicella virus vaccine live (lot 1285J). Concomitant therapy included montelukast sodium. On 7/2/04, the patient presented to the office with a rash on her torso hands and face that was itchy. Diphenhydramine HCl was prescribed. On 7/6/04, the mother reported that the child had a headache and a low grade fever over the weekend. She also had 3 vesicular lesions on her face, 4 on her head, 20 on her torso and a few on her feet and legs. Medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 7/2/04, there was a rash on the torso that was suspected varicella. There were 3 lesions on the face, 4 in her hair, 20 on her torso, and a few on her feet. She was seen by a physician and treated with diphenhydramine HCl. No labs were done. This event resolved spontaneously on 7/8/04. Additional information is not expected.
patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient who received the J&J COVID-19 vaccine back in May, and on 10-Aug-2021 received the first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Co-suspect vaccine was J&J COVID-19 vaccine. The patient received the J&J COVID-19 vaccine back in May and on 10-Aug-2021 received the first Moderna shot.   Reporter did not allow further contact
PT reports sweating and stomach cramps 10 minutes after vaccination. PT was pale and diaphoretic upon arrival. PT did not eat prior to vaccination. Vitals checked and monitored.  1742 LYING BP 112/71 HR 65 Sp02 96% 1754 LYING BP 117/75 HR 60 Sp02 100% 18:03 STANDING BP 132/86 HR 66 Sp02 100%
pt w/t105, irritable admitted to hosp to r/o sepsis; mom refused spinal tap; day 6 hosp pt pos RSV;
THE PATIENT STATES THAT THE VACCINES WERE ADMINISTERED TOO HIGH UPON SHOULDER AND NOW IS HAVING ROTATOR CUFF ISSUES ON BOTH SIDES.  HOWEVER AS THE ADMINISTRATOR I REMEMBER DOING 2 FINGERS BELOW THE SHOULDER ON EACH SIDE AS MY PLACEMENT AND PATIENT STILL IS HAVING THIS ISSUE
I felt a lot worse with my arthritis. I got to the point I could not even walk with my foot. I started medication for it. And then in August 16th I had a heart attack. I had problem with the blood flow at the bottom right of my heart so they put a stent on it. The arteries has become very difficult to handle since. My psoriasis is blooming again since the booster I took in September.
I GOT THE VACCINE ON MONDAY  THE PAIN STARTED IMMIDIATLEY OF THE TIME OF INJECTION BUT THE SEVERITY INCREASE BY FRIDAY AND I HAD TO CALL THE NURSE FOR MEDICAL ADVICE AND WAS INSTRCTED TO TAKE TYLENOL . TODAY MONDAY I WENT TO THE CLINIC TO HAVE THEM LOOK AT IT AND WAS TOLD BY THE DOCTOR THAT MY TENDON WAS MORE THEM LIKLY HIT. THE PAIN IS SO BAD IT IS FROM MY ARM , NECK AND TO MY HEAD.