chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially started as weakness in entire right arm (after the first covid shot) from shoulder down to fingers 3 and 4 which started tingling and going numb. After the second covid shot, the muscles in the arm started deteriorating rapidly to the extent I could not even raise my arm at all. This spread further to the wrist, and back of the shoulder.  The entire arm has thinned out and shows massive muscle loss. All this time, my left arm was normal. However after my covid booster on the left arm, it too started deteriorating and became similarly weak with severe muscle loss. Now I'm left weak, unable to button my shirt or even hold a pen to write.
Patient complains of achiness in the joints that causes a lot of discomfort. Patient states that it is not necessarily pain it is a lot of aches.  Patient has been using the TYLENOL and CBD for treating symptoms. Symptoms are still ongoing.
This spontaneous report as received from the consumer's parent via a company representative refers to a 13 year old male patient. The patient's current conditions or medical history were not reported. Approximately in February 2014, reported as last week, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot and expiration date were not reported). On an unspecified date in February 2014, within 24 hours after receiving his second injection of GARDASIL the patient developed a severe headache. The patient's headache lasted 24-48 hours. At the time of the report the patient was recovered form severe headache. Additional information has been requested.
Received MMR on 3/16 in left upper arm.   3/19 started with severe back and neck ache, extreme neck tightness, severe right sided headache, sore throat, elevated temperature of 99.7, sweaty palms.  Mostly resolved in 24 hours.  Low grade headache remained.  In the evening of 3/26 extreme joint pain in the knees and ankles, thoracic back area, extreme tightness in neck.  Morning on 3/27 swollen glands, rash on cheeks and front of ear, at jawline, below and behind ear; small rash patch on back, knee and ankle pain, loss of appetite.   5pm on 3/27 started with increasing headache, chills, fever of 101.7, back of eye pain, ear pain.  Fever was reduced with Tylenol.  3/28 improved symptoms except eye and ear pain.  Labs drawn which show sharp reduction in white blood cells from 3/7 prior to vaccine.  3/29 seen at urgent care for eye pain, follow up with eye doctor.   3/29 afternoon - spotted rash on upper chest, neck, jaw line, stomach which resolved over the course of several hours.  3/30 at 9:00 rash returned more severe in upper chest, neck, along jawline, few on legs, cheek and stomach.
After pt received the flu shot at about 6 pm, the patient stood up and was talking to sister about the vaccine then fainted, banging her head on the table, leaving a scrape/injury where she banged her head.  Pt regained consciousness about 1 minute or less later, but was confused about where she was and what just happened. Pt drank some water, and ate some crackers after regaining consciousness. The mother then called 911 and pt was taken out in a stretcher with EMT.
After a couple  days of symptoms That had subsided , developed a quick headache, light headedness with shoulder and chest pain on the left side. The pain was radiating toward the breastbone area. Waves of chest pain.
A non-serious spontaneous report of a patient received expired FLUMIST was received from a health professional concerning a 37-year-old male patient. The product expired on 23-Feb-2011. On 25-Feb-2011, the patient received FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
The day after injection, patient experienced extreme soreness. The next morning, the entire right arm was bright red except for the injection site.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 77-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 21-AUG-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from her use of zoster vaccine live (ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Pt unable to move legs; 16 hrs post vax showed posturing, inc rt LE tone & asymmetric reflexes;
Vertigo/dizziness, severe upon arising from bed, lessening as day goes on Slight headache at back of head Slight tinnitus  Fatigue Yawning
pt developed shortness of breath/cough/hives after receiving covid vaccine - 50mg diphenhydramine administered in R delt exp 07/2022, lot 070110 - EpiPen 0.3mg in L Lat Quad - Pt improved and breathing well at time of EMS transfer
Injection site pain, skin hard, redness- ongoing  Sore throat, headache, neck pain, ear ache, muscle aches and cramps,  extreme fatigue,  dizziness-all ongoing  Right calf pain-started 7/4 and ongoing  Shortness of breath started 7/4 ongoing  Chest tightness and heavy feeling started 7/4 ongoing  Trouble sleeping,  jerking  movements/spasms in hands/legs ongoing  Blurred vision and light sensitivity ongoing  Nausea started 7/4 comes and goes
Fever,  Pain at the whole of the injection Body aches Lack of sleep due to pain
Pt received the Bivalent Dose for her second dosage instead of the Primary Vaccine Dose. She received her first dosage and came for her second dosage. She received a Bivalent dose instead of the original.
Inconsolable, decrease feeding, right thigh firmer than left, erythema over injection site. Tx: Tylenol.
scratchy throat then fullness in throat, no tongue swelling Narrative:  Patient had own Epi-Pen due to anaphylaxis to bee stings. She administered a dose to self and was also provided a cetirizine 10mg one time dose.
Left arm localized swelling, erythema, ecchymosis with warmth. Area is 11x9 cm with central area of induration without fluctuance. Started 1 day after vaccine and has persisted for 10 days. Appears more inflammatory but will treat as cellulitis as patient reports it is worsening.
Upper right arm became swollen, red and painfull 10 days after the shot was given. Went to urgent care doctor and was told there was an infection from the shot or a reaction from the shot. Doctor gave my an injection of Rocephin 1g IM. I was prescribed 500MG of Keflex PO 3 times per day. Symtoms got worce and went back to primary care doctor. Doctor stated that I should continue with the same treatment and return for further tests if  the condition did not get better.
Pfizer was given for first dose 5/4/2021 at 11:01am EW0182
The evening after the vaccine, the patient developed fever, chills, aches/ pains that lasted through the next day. 2 days after vaccine, pt developed what is described as arthritic pain in her fingers, thumb, neck, waist. Pt reported it to me on 02/04/2019 and says the arthritic pain travels from place to place and hands were worse while I was talking to her. She states that ibuprofen helps with the arthritic pain. Pt spoke to her physician on 02/04/2019 and physician counseled her that the pain is due to the vaccine and should resolve by the end of this week.
Patient developed a rash that spread. On April 28,2016 he felt run down and tired. The rash grew and has a knot. On April 29, 2016, the rash was approximately 3 by 5 inches. He stated he feels better today, April 29, 2016. He refused to go to a doctor or urgent care.  He said he will watch the rash.
received a dose of Boostrix by accident; a patient of 6 years and 7 months of age received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Boostrix by accident) and inappropriate age at vaccine administration (Verbatim: a patient of 6 years and 7 months of age received a dose of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 27-Oct-2023 A medical assistant called to inform that the patient was supposed to receive a DTaP dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Boostrix accidently instead of DTap at an inappropriate age , which led to wrong vaccine administered and inappropriate age at vaccine administration.
Missed second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
PATIENT C/O SLIGHT SWELLING IN THROAT AND DIFFICULTY SWALLOWING.
Seizure 11/22/05 following (that evening) immunizations received eariler in day. Mom pre dosed child with tylenol prior to receiving shots at 2 pm. Additional dose tylenol given thru evening. Mom didn't recall exact temperature. Mom say's child stopped breathing but seizure and breath resumed by time paramedics arrived after she called. Taken to  CHP (hospital) for eval in ER. Diagnosis : fever seizure vs vaccine fever reaction. Diastat supp ordered for homeuse prn. New to area not established yet with Pedi MD. Fever ceased 11/28/05
after injection. patient stood up and fainted. the patient hit his head on the floor. staff elevated legs on chair. patient regained consciousness. LOCx4., responsive, warm to touch, Denies headache, SOB, lightness and dizziness. EMT arrived at 0906: vital within normal limits. 0910 Fire EMT arrived. patient's mother refuse to go hospital.  Vitals: @0906 1st, 130/62, 96% O2, 77 HR and Glucose:  105. 2nd vitals @ 01917: 130/64, 99% O2, HR 93. NP;  NP reassessed  and released patient after 30 minutes inn observation.
Got shot on Wednesday afternoon. It developed body ache and joint pain by late evening.  Thursday morning got Mild fever the whole day.  Used tylenol in the evening and everything was good by Friday morning.
Monday night Fever and chills Tuesday - Sat Pain in elbows and shoulders and back EKG Wednesday  Bad pain Thursday and Friday 4:30 am Sat admitted to Yale : heart attack back dated to Tuesday. Needed 1 stint
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, ethnicity and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date of AUG-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (coronavirus 19 infection). As per the reporter "I had J&J vaccine in March, got COVID in August, got real sick but not hospitalized for COVID but stayed one night monitoring my heart. Had infusion of monoclonal antibodies." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint: 90000196798.; Sender's Comments: V0: 20211017004-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211017344-Covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a consumer concerning his 56 year old wife with "no pertinant medical history" who, six months ago, was vaccinated with a 0.5ml dose of varicella virus vaccine, live. Concomitant therapy included estradiol and celecoxib (Celebrex). Her arm became red and sore, which lasted  for a week or two. It was reported that she recently discovered that she has a high value single strand DNA. Medical attention was sought and the outcome was reported as not recovered. No product quality  complaint was involved. Additonal information has been requested.
Narrative:  PATIENT REPORTED INJECTION SITE SWELLING UP TO 3 INCHES IN DIAMETER. VERY ITCHY AND WARM TO TOUCH. OCCURED 1 WEEK AFTER VACCINATION. TOPICAL HYDROCORTISONE CREAM FOR ITCH WAS INEFFECTIVE.
Pt recvd DTP/OPV on 21MAY91 & w/HIB on 28MAY91 & 6 hrs following vax pt devel t103, uncontrolable crying, which lasted approx 4 hrs, swelling & induration @ inject site;
This spontaneous report was received from a nurse who is also the patient) via a company representative reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On unspecified date in 2008, the patient was vaccinated with a dose of GARDASIL intramuscularly (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that on an unknown date "it hurt" (pain).  The outcome of pain was reported as recovered on an unspecified date. No treatment was given for the adverse event. No product quality complain was involved.   The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.
The patient returned to the clinic approximately 36 hours after injection with large, localized swelling at the injection site. No fever or other symptoms. Swelling was 6-8 cm in diameter, elevated 2-3 cm. Treatment was Benadryl, 4 hours of ice to site. Site is left upper arm.
Headache, Myalgia, Nausea, bodyaches, and pain at the insertion site Narrative: Mild adverse rxn. after first dose.
Diarrhea every 15 minutes for 4 days, fatigue, day 5 vomiting began and lasted continuously for7 hours. Was able to treat with Zofran to stop. Diarrhea continued for 3 more days for a total of 8 days of diarrhea post-vaccine.
After receiving her vaccine client stated she has a red spot on her right lower arm.  BP 130/78, HR 87, O2 Sat 97%.  Client states she feels better Client discharged home.
Patient came in on 9/10/17 and stated she had itching, minor swelling, minor rash, and tiredness after receiving the Tdap vaccine. She took over the counter allergy medication and said that it helped and today was the first day she felt better.
Fever; Chills; Headache; The patient received third dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: 301558A) via an unspecified route of administration in the left arm on 13Oct2021 at 16:15 (at the age of 57-years-old) as a dose 3 (booster), single for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications received within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL1284) via an unspecified route of administration in the left arm on 30Dec2020 at 14:30 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL1283) via an unspecified route of administration in the right arm on 16Jan2021 at 12:00 as dose 2, single for COVID-19 immunization. On 14Oct2021 at 04:30, the patient experienced fever, chills and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events fever, chills and headache were resolved on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Swollen left leg, shortness of breath, painful upper left thigh diagnosed with blood clots
Patient received COVID vaccine on 6-17-21 and HPV on 6-18-21. On 6-19-21 he developed a diffuse folliculitis type eruption on trunk and extremities. It is not itchy or reddened.
1st does of covid vaccine was 6 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st does of covid vaccine was 6 weeks ago) 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 PRODUCT DOSE OMISSION ISSUE (1st does of covid vaccine was 6 weeks ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st does of covid vaccine was 6 weeks ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Patient was given an undiluted 0.3 ml dose of Pfizer COVID19 vaccine by MA in clinic. Patient has been contacted and informed of this error, no adverse reactions reported. Will follow up daily with this patient for the next 4 days, patient given my cell phone number to call at any time with questions or concerns and educated on signs/symptoms that need medical attention.
Kinrix was administered / DOB: 02-JAN-2020; Kinrix was administered instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 was provided as follows: Kinrix was administered to the 15-month-old patient instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The health care profession inquired how they should proceed. The reporter did not consent to follow up.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 08-Sep-2021, vaccine was moved to fridge and vaccine administered post 30 days from the initial stance arrive at facility. No treatment medications were reported.
PATIENT EXPERIENCED EXACERBATION OF ASTHMA SYMPTOMS. HE NEEDED TO USE HIS INHALER MORE OFTEN, AND WAS WOKEN UP FROM SLEEP WHEEZING (WHICH IS NOT NORMAL FOR HIM). HE WAS ABLE TO CONTROL HIS SYMPTOMS WITH HIS INHALER, AND HE STILL WANTS TO RECEIVE HIS SECOND DOSE.
Urticarial rash on forearms and upper chest which started that evening patient got flu shot. It wasn't treated until the next afternoon when patient came to clinic reporting an itchy rash. Diphenhydramine 25mg. and hydrocortisone topical 1% cream were used to treat the symptoms. Patient took another dose of diphenhydramine 25mg. at home and continued to use hydrocortisone lotion. The next morning patient reported great improvement in symptoms, although some rash is still present. (12/7/2017).
Pfizer on 3/4 and 3/25. Positive on 8/19 and 8/23 admitted 8/23