chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PUI said he started to feel weak on 08/05/2021 and decided to go get tested for COVID but never received the results from that day. He stated he was still feeling weak and also dehydrated so he went to the hospital to get seen and found out he was positive for COVID. PUI is hospitalized at Hospital since 08/10/2021 but his vital signs are good and he is feeling back to his self but said the doctors are just keeping him there to keep an eye on him.
Severe shoulder pain following the treatment loss of mobility of right shoulder and extreme pain, loss of sleep, family Dr states bursitis and rehab needed.
This spontaneous report as received from a pharmacist refers to a 29 year old male patient. The reporter stated that on an unspecified date in February 2014 the patient was vaccinated with second dose of GARDASIL. Pertinent medical history and concomitant medications were unknown. The reporter did not know when the patient received his first dose of GARDASIL. No adverse effects reported. The outcome of the events was unknown. No additional information provided. Additional information has been requested.
This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011307: US-009507513-1706USA011669: US-009507513-1706USA011671: US-009507513-1706USA011668:
Information has been received from a pharmacist concerning an approximately 68 year old male pt who on 04Oct2003 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  The pharmacist reported that three hours later the pt's arm was swollen from his upper arm to forearm. The pharmacist reported that he had referred the pt to a health care facility, but the pt declined. Additional information has been requested.
Woke up 5/2/14 with "hives from waist to chin". States she took ibuprofen for arm pain and after prompting states she "reacted like this once before to ibuprofen with codeine". Recommended she call her physician.
inflammation; MCP and PIP joints and SI joints started burning close to 3rd week; MCP and PIP joints and SI joints started burning close to 3rd week; This is a spontaneous report from a contactable physician reporting for himself. A 57-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, in Hospital, administered via intramuscular route in left arm on 22Dec2020 (Batch/Lot Number: EJ1685) as single dose, and the second dose via an unspecified route of administration, administered in right arm on 01Feb2021 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. Medical history included allergy to penicillin and benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin and metoprolol tartrate, both taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with CVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 20Jan2021, close to 3rd week, the patient's MCP (Metacarpal, Carpal and Phalanges) joints, PIP joints (proximal interphalangeal joints) and SI joints (sacroiliac joint) started burning and the patient also experienced inflammation on an unspecified date. He had had some minor SI pains intermittently before but none with hands. It continued hurting enough so the patient started taking condroitin sulfate/glucosamine hydrochloride (OSTEOBIFLEX) and fish oil and more paracetamol (TYLENOL) for inflammation. After the second vaccine on 01Feb2021 the symptoms have been getting worse. Now the patient's hands burn all the time, at times bad enough that they keep him awake. The patient has red nodular areas on some of his knuckles and a distinct nodule at the proximal ulnar aspect of his left 4th finger PIP that is uniformly erythematous. Not all knuckles have the same degree of burning, but all, including thumbs, have it. The SI is more variable and at time does not bother the patient, but the hands get swollen and tight to close everyday. The patient plan to start some prednisone the following day due to the progression of the burning, moreover the events were treated with glucosamine, paracetamol (TYLENOL), ibuprofen, fish oil and turmeric. The event "MCP joints, PIP joints and SI joints started burning" had not resolved yet at the time of the report, whereas outcome of the event inflammation was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a patient who received BEXSERO. Co-suspect products included FLUARIX QUADRIVALENT. On an unknown date, the patient received BEXSERO at an unknown dose and FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site pain to be related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination of the patients was not reported. It was reported that the practice had multiple reports from 10 to 15 patients, who had experienced redness, swelling, and pain at the injection site, which lasted about 2 to 3 days, after receiving FLUARIX QUADRIVALENT and BEXSERO vaccine. At the time of reporting, both product and patients information were not available, but might be available upon follow up. The reporter has given the permission to contact again. This was one of the 5 cases reported by the same reporter.
5-11year orange top vaccine given to 13 year old. Also was beyond use. Drawn up on 8/18 at 8 am and given on 8/19 at 9:30am. Patient family notified of invalid dose and error. Will return for repeat vaccination.
My arm was hurting, but I was fine until I broke out in a rash at the injection site. It itched really bad and was like hives. They were at the injection site, on my chest and my back. I went to the ER and I was given a shot of steroids, a prescription for Prednisone and told me to take Benadryl. Around that Saturday, it was completely gone.
At 30 minutes post vaccination, patient felt dizzy; tingling of tongue and lips. Doctor observing patient, assessed VS. 12:10pm - BP 145/74, HR 75, O2 sat 98%. 12:27pm - BP 120/68, HR 67, O2 sat 99%. Patient discharged. Home at 12:29.
Sore throat; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that twice for the patient too, six months apart. Sore throat and fatigue for a couple of days was all.  No treatment information was reported.
Fever, chills and shortness of breath on 02/07, 4 hours after receiving Fluzone High Dose 2013-14 PFS.  Arrhythmia triggered and corrected by pacemaker on 02/08/2014 at 12:30 PM.
17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Out of 17 patients this Case for patient 12. Concomitant medication not reported.  No information about previous COVID-19 vaccination doses. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Dose administered after 30-day Use By Date or after manufacturer date of expiry  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, contains reporter details was updated.
Two small pea size welts just above the MMR injection site. Red, warm to touch. Ice applied to site, swelling decreased within 15 minutes. Pt denied itching or pain at site.
Patient vaccinated with a booster without her card. She was vaccinated prior to confirmation of series completion. She booked 2 appointments. Reportedly, she was told she needed to restart her series, however this was not fully confirmed by clinical staff. She was vaccinated as follows: 3/25/2021, 1/12/2022 and 2/2/2022. The 2/2/22 dose is invalid.
Extreme pain for seven weeks in left arm and should. Unable to move arm in certain ways, loss of physical control (like grasping objects), sharp pain, numbness in hand and arm.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore right arm on an unspecified date. The outcome of event was unknown.
The patient came to the pharmacy to see if he needs another bivalent dose. Upon reviewing the database and his patient profile, I discovered that he was inadvertently given a 2nd bivalent dosage of Moderna Bivalent (by myself) in November 2022, although he had already received a Pfizer Bivalent dose in September 2022. At the time a 2nd bivalent dose was not approved. Currently determining if patient requires an additional bivalent dose at this time.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 30-Dec-2013. It was reported by health professional that the patient was inadvertently administered expired FLUMIST QUADRIVALENT on 30-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Information has been received from a nurse practitioner concerning an 18 year old female with no allergies and no drug reactions, and a history of low blood sugar who on 07-AUG-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient had been experiencing nausea and fainting on 08-AUG-2008. The patient sought medical attention at the office. At time of reporting, the patient had not recovered. Additional information has been requested.
headache, vomiting, body aches, fever and shivering four hours after injection. Unable to do any daily activities for 4 days (fever continued until day 3 and returned on day60. On 6th day developed aching wrist joints and rash with swelling from foot to buttock area bi-laterally. Sent by PC doctor to ER for work-up for rash. Chest X-ray, blood cultures, lab tests were taken. ESR and C-reactive protein tests were high. Diagnosis was made of leukocytoclastic vasculitis. Rash began to resolve by 5 days after onset. PC did follow-up labs that showed continued inflammation.
10-28-09 - H1N1 LA IV administered. 11-1-09 - C/O fever 102-103 per mother. 11-4-09 - Fever subsided; c/o ear, throat pain - seen by PCP. 11-5-09 - Started on Z-Pack - teen passed out taking pills - mom reported to PCP - currently c/o nausea and headache.
Approximately 14 hrs later pain in arm, chills, headache, nausea, stomach discomfort, heavy chest, slight fever,  joint aches and fatigue
COVID-19 positive quick test; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 positive quick test) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (COVID-19 positive quick test). At the time of the report, COVID-19 (COVID-19 positive quick test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test positive: positive quick test.     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.   Concomitant product use was not provided.  Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 positive quick test) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (COVID-19 positive quick test). At the time of the report, COVID-19 (COVID-19 positive quick test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test positive: positive quick test.     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.   Concomitant product use was not provided.  Treatment information was not provided.
Intense pain, swelling and hardening of left breast. It started on Tuesday 4/6 and was almost completely resolved by Saturday 4/ 10
I woke up feeling just really crappy. My back and my sides were hurting. I was very sick to my stomach and did not get off the couch for a whole day. I went to the Dr and they found blood in my urine. I had a fever. I think it was 101. They prescribed me some medicines and I started feeling a little better. I started using my inhaler because I felt like I couldn't breathe. I had a lot of tightness in my chest. It felt like it was coming over me in a way. It felt like something was pressing on my sternum. When I would try to take a deep breath, everything hurt. I would get these waves of funk. My muscles would randomly contract in my leg. My entire leg was having spasms where I couldn't walk. Then the next day it happened with my other leg. It was like giant Charlie horses in both of my legs. I was thinking maybe I was magnesium and potassium deficient. I started taking vitamins for that. I was still not feeling great. I was sitting on the couch and my husband noticed that on the bottom of my foot there was a target lesion. It was white in the middle. It looked like a blister with a circle of black around it. I thought maybe I just hurt it on my own. Then he noticed more lesions all over my foot. It was all over both feet. He suggested I get it looked at so I went to the dermatologist. The dermatologist said that it was a target lesion and it was part of my immune response to the vaccine. He gave me some steroid cream and told me to apply it for 2 weeks. I then noticed on my arm that target lesions began forming where my surgery scar is. I also developed a UTI. I felt like my bladder was not emptying all the way and my back was hurting. They are starting to kind of go away, but they are still visible. I called Dr. and he asked me some questions. He wrote me a prescription for the next week. He said my immune response basically started at my feet and worked its way up. I am still having drainage and shortness of breath. I feel so sick I just want to lay on the couch. My mother had the same reaction. I also developed a rash on my chest.
3hr post vax pt became violently ill w/vomiting, dizziness, weakness-ER by amb;
Red, swollen and hurt and the injection site for more than 3 days, then swollen traveled down to elbow.  Patient claimed it's hurtful and patient can't sleep.  Patient went to see doctor and was prescribed antibiotic for it for 10 days.
pt recv vax 14FEB96 & exp severe body aches, an inj site rxn, characterized by redness, swelling, & erythema, & has devel a node in the clavicle area that is swollen;pt was improving as of the date of this report;
aches; low grade temperature of 100 degrees; tired / feeling tired; nauseous feeling; This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th March 2021, less than a day after receiving Shingrix, the patient experienced pain, slight temperature, tiredness and nausea. On an unknown date, the outcome of the pain, slight temperature, tiredness and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain, slight temperature, tiredness and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix and experienced aches, a low grade temperature of 100 degrees Fahrenheit, tired and nauseous feeling.  The patient reported that all these symptoms were ongoing and not resolved. The reporter consented to follow up. The patient declined to give address, email and fax number. The patient was unable to provide a full address, email, or fax number for pharmacy and was also unable to provide a dose, lot number, or expiration date for the shingrix vaccine the patient received.
upper arm swelled to 2x normal size, was red & hot to touch, devel welts, could not move it w/o severe pain x 2 dyas; took 1 wk for all soreness to go away;in bed for 2 dasy w/nausea, chills, fever, h/a, aching in pelvis (felt like in bone)
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 24Feb2021, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021, the patient was supposed to have the second dose. On 15Mar2021, 2 days before the 2nd vaccine, the patient went to the doctor and was tested positive for Covid so was told she could not get the vaccine. She did the quarantine and felt better but just had a little cough. She was still testing positive though. She questioned when would she get the second vaccine. The outcome of events drug ineffective and cough was unknown whereas of COVID-19 virus test positive it was not recovered.  Information on the lot/batch number has been requested.
03/01 Onset of symptoms 2 hours post vax, developed flat red rash covering entire body, itching. No difficulty breathing. Returns to health department 03/03 to report reaction. Parent reports symptoms much improved. Red rash seen on back, arms, hands - no itching at this time. Parent reports child taking Benadryl cold medicine at home.