chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 3, I suddenly had head numbness from 9/9:30am ?-2:30pm... at least 5 hours!!! Right side head and back of head... very strong numbness... it never happened b4 in my life ...but I could act normally, vision was ok, speaking was ok On May 5, late afternoon  but forgot the time  .I was standing before desk, suddenly felt feet, legs, walls, floor shaking overlapping for 6-7 seconds ... then normal again  It never happened to me before in my life!!!so frightening
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2014,the patient was inoculated at with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by a nurse practitioner for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed famciclovir(FAMVIR) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 21-NOV-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
diarrhea, vomiting, blood in stool, nausea, loss of appetite
Onset of vertigo with vaccination, which resolved after 5 days and then recurred again on 4/20
Start over one day after injection, developed swelling and redness down the arm with warm patchy ecchymoses on the lateral arm close to elbow
Case number PHEH2014US005834, is a combined initial and follow up spontaneous report received from a pharmacist on 20 Mar 2014 and on 24 Mar 2014 respectively. This report refers to a 28 year old male patient. His past medical history and concomitant medications were not reported. He was bitten by a dog on the inside of his right leg and the bite wound was very big. He underwent surgical debridement of the bite wound. The patient was vaccinated with the first dose (day 0) of post exposure series of RABAVERT (batch number: 52400c) intramuscularly on 13 Mar 2014. He also received HRIG (human anti-rabies immunoglobulin, other manufacturer, batch number: not reported) on 13 Mar 2014. He was diagnosed with MRSA (methicillin resistant Staphylococcus aureus) infection on 15 Mar 2014. He was treated with Augmentin and clindamycin (manufacturer: not reported, batch number: not reported). The patient missed the day 3 dose of post exposure series of RABAVERT (booster dose missed). The reporter also stated that the patient might have had a prior MRSA infection a long time ago; however, it was not confirmed. The outcome of the event was reported as condition improving. The seriousness of the event was not reported and the pharmacist stated that the event was not related to the administration of RABAVERT.
Cellulitis - pt had fever, chills, swelling around injection site and a large area of cellulitis. Vaccine was given on lower area of arm.
About  11 hours after receiving the injection, I experienced shivering and fever. The shivering lasted about 5-6 hours but the fever continued into the next day. Also experienced fatigue for about 48 hours.
9cm x 9 1/2 area of erythema, swelling and heat on upper left thigh without mass, streaking or palpable inguinal node.
WEAKNESS, NAUSEA, VOMITING, LOSS OF APPETITE, CHILLS,
Spoke with patient 7/3/11. Arm bright red, itchy from injection site to elbow (3 inch wide). 7/6/11 less red & swollen, but still 3-4 inch wide.
HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Patient woke with swelling and redness surrounding injection site.  She consulted her pharmacist and used Benadryl and Ibuprofen with resolution of symptoms.
Patient experienced pain and swelling throughout the entire left arm down to the wrist. This occurred at 5am the following morning after the vaccine administration.
hot injection site; my injection site became swollen; red injection site; i also developed diarrhea; i had the normal arm pain for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (i also developed diarrhea), VACCINATION SITE WARMTH (hot injection site), MYALGIA (i had the normal arm pain for 24 hrs), VACCINATION SITE SWELLING (my injection site became swollen) and VACCINATION SITE ERYTHEMA (red injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced MYALGIA (i had the normal arm pain for 24 hrs). On 15-Jun-2021, the patient experienced DIARRHOEA (i also developed diarrhea). On 20-Jun-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE SWELLING (my injection site became swollen) and VACCINATION SITE ERYTHEMA (red injection site). On 15-Jun-2021, MYALGIA (i had the normal arm pain for 24 hrs) had resolved. At the time of the report, DIARRHOEA (i also developed diarrhea) had not resolved and VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE SWELLING (my injection site became swollen) and VACCINATION SITE ERYTHEMA (red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  No concomitant medications were reported.   Patient reported no changes in her diet or anything.
states developed mild sore throat 6/19/2022, tested positive on binax rapid antigen test 6/21/2022
AFTER 5 MINUTES OF RECIEVING VACCINES PATIENT FAINTED.PATIENT WAS STANDING UP AND HIT THE FLOOR FACE DOWN.PATIENT RECOVER CONCIESNESS IN ABOUT 30 SECONDS AND CALL TO 911 WAS ACTIVATED . SHE  WAS TAKEN TO THE HOSPITAL FOR EVALUATION C/0 NECK PAIN,JAW,AND  HEADACHE.
pt recv vax 3APR98 & 7APR98 pt exp a rash on arms in the morning & by the afternoon & rash had progressed to face, back & stomach;30APR98 pt exp dizziness & was seen in ER;lab analysis revealed inc blood sugars;pt hosp;dx diabetes;
About 2 years subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash with less than 50 lesions and no complications. No treatment. This was considered a mild breakthrough case of chickenpox.
Information has been received from a registered nurse concerning a 19 week old female patient with no known allergies or pertinent medical history who on 16-JUL-2008 was vaccinated with a second dose of ROTATEQ vaccine live (human-bovine) (lot # 659773/0020X). The patient received her first dose of ROTATEQ vaccine live (human-bovine) on 01-MAY-2008. Concomitant vaccinations on 16-JUL-2008 included PEDIARIX, PREVNAR and Hib conj vaccine (OMPC) (MSD). It was reported that the patient was given her second dose of ROTATEQ vaccine live (human-bovine) and spit it out. It was noted that some of the vaccine splashed into the patient's eyes, but there were no ocular symptoms reported. It was also noted that the patient was crying, but the nurse said it was because the patient had received several injections. Medical attention was sought in the office. There were no lab studies performed. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. 12/03/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow-up information indicated no new information. Follow-up information has been received from a child health supervisor concerning this 19 week old female patient with no known allergies or pertinent medical history who on 16-JUL-2008 at 11:00 AM was vaccinated orally with a second dose of ROTATEQ (lot # 659773/0020X). Concomitant vaccinations on the same day at 11:00 AM included a second IM dose of PEDVAXHIB (OMPC) (MSD) (lot # 657701/0821U), a second IM dose of PEDIARIX (lot # AC21B13BA) and a second IM dose of PREVAR (lot # C65930). There was no illness at the time of vaccination and no adverse events following prior vaccinations. It was noted that the baby's eyes were immediately flushed with eye wash fluid. The mother reported there were no side effects noted. There was no redness or drainage at the time of the incident or afterwards. The baby was not taken to the clinic or the hospital. At the time of the report, the baby recovered. It was noted that the baby was well. Additional information is not expected.
COUGHING; DEHYDRATION; SORE; BURNING UP LIKE CRAZY; THIRSTY AND WAS DESPERATE FOR WATER; SHIVERING; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and alcohol user (not when patient got vaccinated. Patient does nowadays.), and other pre-existing medical conditions included: Patient did not have known allergies. No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 19 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the patient experienced coughing, dehydration, sore, burning up like crazy, thirsty and was desperate for water, shivering, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration, and fever, had not recovered from coughing, and the outcome of sore, burning up like crazy, shivering and thirsty and was desperate for water was not reported. This report was non-serious.
Upon administration of Gardasil #3 vaccine to sitting pt, pt immediately passed out, just before I could pull the needle out of her arm. I caught the pt as she was collapsing (pulled the needle out of her arm), and she started snoring (I couldn't see her face so at first I was concerned she was having a mild seizure). She was out cold for approximately 15 seconds. When she woke up she did not remember where she was at first, I laid her down, and she reported having a very strange dream. She was pale and clammy. I had her lay down for the remainder of the visit and took her vitals twice - once immediately after laying down and once before leaving the office. I gave her a glass of water and a snack. Pt reported feeling better by the end of the visit.
This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received original shingles virus vaccine two years or more before the date of reporting). On 26th October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, 30 days after receiving SHINGRIX, the patient experienced back pain, muscle pain and general body pain. On an unknown date, the outcome of the back pain, muscle pain and general body pain were recovering/resolving. It was unknown if the reporter considered the back pain, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The reporter asked Could he or she be suffering from a side effect one month after receiving vaccine. For the past week from the date of reporting, the patient experienced severe lower back pain, left side muscle pain, whole back pain, not as severe and other numerous body aches and pains which started about the same time. A day or two before the date of reporting, the events started getting slightly better.
Herpetic rash outbreak on chest appearing approximately 4-weeks after receiving 2nd dose of Pfizer COVID-19 vaccine.
Had the 2 shots and still got them/suspected vaccination failure; Got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the 2 shots and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient via interactive digital media.  The patient had the 2 shots and still got them try driving from  to. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Six days post vax, the patient experienced bilateral ankle swelling. This symptom was diagnosed by a rheumatologist as inflammatory arthritis felt to be secondary to Lymerix. Patient was treated with NSAIDS. Lymerix was discontinued.
periorbital edema & wheezing; treated w/Epi SC followed by DPH & Prelone;
Dizzines, headache, and vomiting x5 3 hours after HPV vaccine was given. Looked disoriented.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
Pt had pain in shoulder. After 2 weeks of pain she went to the ER for treatment. She has been doing PT.
This spontaneous report as received from a consumer refers to a 16 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot # not reported). The consumer reported that she read an article in a foreign newspaper that claimed the patient's ovaries were damaged by the GARDASIL vaccine. The consumer stated that this article appeared in a web site and was dated 09-AUG-2013. The outcome of the event is unknown. Additional information has been requested.
FLU-LIKE SYMPTOMS, CHILLS, FEVER, COUGH, BODY ACHES, NAUSEA
twitching in the eye; tingling in the feet, legs and left side of face; Swelling on the left side of the face; Pain in feet and legs; felt like was going to fall; dizziness; off balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Improvement) since 01-Jan-1993, Allergy to animals (Allergy to cats), Pollen allergy, Dust allergy and Food allergy (Allergy to Shrimp). Concomitant products included LOSARTAN from 01-Jan-2013 to an unknown date, TRIAMTERENE from 01-Jan-1993 to an unknown date, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) from 01-Jan-2020 to an unknown date and VITAMIN D3 from 01-Jan-2020 to an unknown date for an unknown indication.    On 16-Aug-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021 at 10:45 AM, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall). On 08-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in feet and legs). On 11-Oct-2021, the patient experienced PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face). On 11-Oct-2021 at 5:30 AM, the patient experienced BLEPHAROSPASM (twitching in the eye). On 17-Aug-2021, DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall) had resolved. At the time of the report, BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) had not resolved and PAIN IN EXTREMITY (Pain in feet and legs) 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 considered DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face), SWELLING FACE (Swelling on the left side of the face) and PAIN IN EXTREMITY (Pain in feet and legs) to be possibly related. No further causality assessment was provided for FEELING ABNORMAL (felt like was going to fall).    Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received, contains patient demographics, event swelling in face and pain in leg, medical history and concomitant medications added.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. There is no notable medical care the patient received recently within the hospital that would help determine cause of death. Details surrounding death uncertain. Patient was 84 and had h/o diabetes and coronary arteriosclerosis w/ CABG x 4.
Red bullseye appearance around injection site after more than a week from injection;  sore and stiff arm on the day of injection
fever up to 102 x 5d; redness & swelling @ inj site; n/v x 5 days w/myalgias; as of 19OCT, deltoid tenderness w/swelling persists
- Started feeling fatigue and soreness near injection site about 8-10 hours after injection - 10-30 hours after injection increasing intensity of all body muscle soreness, joint aches, skin sensitivity to touch especially on torso and cold/shivering extremities, headache and severe fatigue. - 30-48 hours after injection symptoms steadily reduced with the shivering and skin sensitivity first then aches and soreness and finally fatigue and headache. - 48+ hours after injection all symptoms has stopped
Large red circle area, warm to touch, indurated 8 x 7.5 cm left thigh.
HAS THEM IN BOTH LUNGS; This spontaneous report received from a consumer via a company representative concerned a 40 year old female. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced has them in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of has them in both lungs was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with PNEUMOVAX 23 that were stored improperly. No adverse effects reported. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administration were unavailable at this time; however, lot numbers and expiration dates were available: PNEUMOVAX 23, lot # J011998, expiration date 12-FEB-2015. This is one of several reports received from the same reporter. Additional information has been requested.