chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 24 year old female lactose intolerant with a history of asthma and no previous history of Guillan-Barre Syndrome who on 16-JUL-2007 at 11:30 am was vaccinated with the first dose of Gardasil (lot #654272/0319U), 0.5ml, IM left deltoid of the non-dominant arm (manufacturer unspecified). She planned on switching to NUVARING) on 22-Jul-2007. Her last menstrual period was on 19-Jun-2007. Concomitant medication was reported as none. On 16-JUL-2007 within five minutes of receiving the dose of Gardasil, as the patient was making her way to her next appointment, she felt lightheadness, and faint and she started to fall. She was lowered to the floor by the medical assistant. She did not hit her head or other body part or loose consciousness. Her blood pressure was 133/88 and pulse was 104. She was a bit diaphoretic. She was talking and able to take some water. An ice pack was placed on her forehead. She rested a bit on the floor and was then wheeled into the non stress test room where she rested on the lounge chair. Her blood pressure was rechecked at 117/79 with a pulse of 62. She reported feeling fine after about 5 minutes and was taking water. The injection site was without redness or swelling. She felt ok to leave and upon standing, did not feel dizzy. Blood pressuer was stable and she left the office. She was to stay well hydrated and follow-up in 2 months for the next injection of GARDASIL. On 30-JUL-2007, the patient called to report that she experienced pain in arm that the vaccine was administered and that she can not raise her arm. Left arm was weak and she was having problems raising it all the way. She could raise it to chest height, but not to her head. If she tried to raise it to her head, there was pain. She felt some tingling in her hand at times, but had full use of her hand. It was suggested that she try ADVIL 400-600 mg 3 - 4 times per day for 1 - 2 days to see if she notes any improvement. No product quality complaint was reported. On 24-Aug-2007 the patient reported the arm was better but was still having some residula discmfort with certain movements. She was advised to see her primary care physician for presistant pain after injection. On 24-Aug-2007 the paitnet was "mostly" recovered. . No product quality complaint was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.
Feeling a little SOB, history of asthma. Did not use inhaler in morning. BPs 175/79 (pulse 86), O2 sat 96%; 152/71, O2 sat 96%. Took albuterol.
Hot spot and redness at injection site five days after vaccine, within less than 24 hours of hot spot ended up with full body intense rash
Pt to ER c/o reaction to Varicella vaccine. Rash on Left arm and Back c/o itching. (1/19/09) Pt. given Rx for Prednisone 50 mg x 1 for 7 days.
Pt tested positive for covid on 9/13/21. Patient presented to the ED on 10/5/21 with altered mental status. His CT counts were not high enough during hospitalization. Patient was discharged on 10/8/21.
AVA # 1 13 Feb 2003 Left arm swelling on top of deltoid area the size of a fist. Area was red and painful and lasted a couple of days. AVA # 2 25 Feb 2003 Given SC in left arm. Pt reported increase swelling and discomfort. AVA # 3 11 Mar 2003 Given IM in right arm. Noticed increased swelling extending from shoulder to elbow. Skin was hard and warm to touch. Went to MD and was given antibiotics and took ibuprofen regularly. Had pain with movement. Redness lasted 3-4 days. AVA # 4 05 Sep 2003 Given SC left arm. States this was her worse reaction. Had "hard" skin from shoulder to elbow and swelling with redness from elbow to wrist. Had " extreme" pain Went to emergency room and was given oral steroids. Swelling lasted 3-4 days.
PATIENT VACCINATED AT 10:10AM, WAITED FOR 15 MINUTES.  FELL AT 10:42 AM WHILE ENGAGED IN RECREATIONAL ACTIVITY.  NO ANAPHYLAXIS.  NO FAINTING. AMBULANCE CALLED AND PATIENT TRANSPORTED TO  HOSPITAL.
About 24 hrs after 1st Moderna shot, patient presented with fever to 38.9, confusion , lethargy.  Negative infectious workup.  Defervesced and mental status returned to baseline after another 48 hours.
pt c/o loss of wareness of surroundings, left precordiac chest pain, weakness;
Doses administered after more than 1 temperature excursion; It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 57.59 No concomitant medication was reported.  On 30-Mar-2021,vaccine moved to fridge and vaccine BUD date was reported as 29-Apr-2021.  Condition of vaccine prior to administration was reported Not frozen.   On 31-Mar-2021,vaccine excursion time were 8am and 9am at 32,32 degree F temperature. On 03-Apr-2021,vaccine excursion time was 9am at 34 degree F temperature.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
mild hives after 2 days of receiving flu shot -- mostly on extremities, some on torso, not full body
RECEIVE THE ADJUCVANT ONLY; RECEIVE THE ADJUCVANT ONLY; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number NR2X5, expiry date 24th November 2023) for prophylaxis.   On 7th November 2022, the patient received the 2nd dose of Shingrix. On 7th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: The information for the adverse event was given and medical information was relayed about recommendations made by the vaccine coalition. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case was for 3 of 3 linked patients, reported by same reporter. Additional supportive information: The patient only received the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022170375:Same reporter US-GSK-US2022170376:Same reporter
Patient noted onset of painless, non-pruritic red bumpy rash at her face. Over next 2 days, rash progressed to involve trunk and upper extremities. Small aphthou ulcer inside upper lip. No other mucocutanoues lesions. No systemic c/o.
No Additional AE; Pharmacist called to report that PRIORIX sterile water/diluent was used to reconstitute MMRII and administered; This spontaneous report was received from a pharmacist and refers to a 3-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.    On 18-APR-2023 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U039549 and exp. Date 14-DEC-2023 for prophylaxis (exact dose and route of administration were not provided).  Other suspect therapies included water for injection (STERILE WATER) which was used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product preparation error and no adverse event).; Sender's Comments:  US-009507513-2304USA008628:
Mother states she felt a lump on left arm on vaccine site two days after vaccine was given. No other symptoms such as redness, fever or restriction of movement.
22 yo female with near-syncope s/p receiving 1st Pfizer COVID vaccine on 03/31/21 ~1:35 pm.  Pt immediately started feeling lightheaded/dizzy, weak, and nauseous.  She was hypotensive at 1:45 pm with BP of 66/44 and HR of 91.  She did not lose consciousness.  She was transferred to a recliner, given water, and was feeling better by 2:08 pm - her vitals improved to BP: 100/66 and HR: 86.  She was d/c'ed to her father at 2:15 pm.
Information had been received on 03-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX vaccine on or about 22-SEP-2009, administered by a physician at a regional medical center, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUN-2011, the patient was treated at a medical center emergency department, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 15-JUN-2011, the patient began a regiment of acupuncture therapy appointments for the treatment of shingles. The patient has been prescribed acyclovir, lidocaine (LIPODERM), gabapentin, and hydrocodone-acetaminophen for management of her painful symptoms. 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, and pain and suffering, and other damages. Additional information has been requested.
started having tinnitus after the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In NOV-2022, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tinnitus (Verbatim: started having tinnitus after the vaccine). The outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.     It was unknown if the company considered the tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 The case was self reported by the patient. The patient received dose of Shingrix and started having tinnitus after the vaccine. No additional information was provided. Not all information was available or collected or provided.
THE PT COMPLAINS OF SORENESS AT INJECTION SITE FROM THE BEGINNING BUT NOW IT HAS REACHED UP THE NECK AND DOWN THE ARM.  SHE SAID SHOT WAS GIVEN UP HIGH ON SHOULDER.  IT IS PAINFULL ENOUGH THAT NOTHING IS SHE HAS TRIED IS TAKING THE PAIN AWAY.  PT IS NOT ABLE TO SLEEP AT NIGHT.  I RECOMMENDED CONTACTING PRIMARY DR  AND TRYING IBUPROFEN.
Severe hives requiring eight Zyrtec and 8 Pepcid daily for four weeks.
Chills, headache, aches, fatigue, swollen arm, erythema,
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Patient stated that he had blurred vision.  He was taken to the Emergency Dept at the Hospital where his vital signs were monitored to include blood pressure, pulse and oxygen.  After 1 to 1.5 hours of observation, patient stated that he was no longer experiencing any symptoms.
Injection site reaction came back; The injection site reaction grew to be about 3-4 inches in diameter; itching at the reaction site; Localized reaction at injection site that was raised; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction came back), VACCINATION SITE REACTION (The injection site reaction grew to be about 3-4 inches in diameter), PRURITUS (itching at the reaction site) and VACCINATION SITE PAIN (Localized reaction at injection site that was raised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history updated).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE REACTION (The injection site reaction grew to be about 3-4 inches in diameter), PRURITUS (itching at the reaction site) and VACCINATION SITE PAIN (Localized reaction at injection site that was raised). On 03-Feb-2021, the patient experienced VACCINATION SITE REACTION (Injection site reaction came back). On 27-Jan-2021, PRURITUS (itching at the reaction site) outcome was unknown. On 30-Jan-2021, VACCINATION SITE REACTION (The injection site reaction grew to be about 3-4 inches in diameter) and VACCINATION SITE PAIN (Localized reaction at injection site that was raised) outcome was unknown. At the time of the report, VACCINATION SITE REACTION (Injection site reaction came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, Benadryl and ice for itching.
Patient stated right arm red and hot to touch, itchy down to elbow. Saw arm MD, was placed on Benadryl 50 mg PO QD for 7 days and Zantac (OTC) PO for 7 days.
This report of a special interest event is being submitted in an expedited time frame as requested by the FDA.  Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 14 year old son who experienced head cold and wheezing.  At 14 years of age, the pt received a dose on 12/09/03.  Seven to 9 days post-immunization, the child developed a head cold (nasopharyngitis).  The head cold resolved after 9 to 10 days without treatment.  On 01/03/04, he developed another head cold with wheezing.  The mother reported that the child's physician was contacted.  The physician prescribed an increased in the frequency of albuterol and Azmacort.  As of 01/12/04, the symptoms persisted.  No additional information was available at the time of this report.
Hives and constant itching. Unbearable. Disruptive to normal life. Not responding to antihistamines
Sore arm; Redness around the injection area; A little bit of swelling on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Chronic lymphocytic leukemia and Blood pressure high. Concomitant products included LEVOTHYROXINE, AMLODIPINE, SIMVASTATIN, TAMSULOSIN and ALPRAZOLAM for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at an unspecified dose and frequency. On 29-Apr-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) had resolved.            Patient had no allergies.  Reportedly, Patient visited a dermatologist and an allergist and doctors prescribed a medication (patient do not remember name), but stopped treatment about a week ago, because he felt like his skin was burning and his hands were peeling. Patient Stated that his life style remained the same, so the only different thing was the vaccine.  After getting the vaccine, patient experienced same symptoms after every vaccine for around 7 to 9 days.   This case was linked to MOD-2022-496478, MOD-2022-496529 (Patient Link).
Confusion, Headache, Myalgia, Numbness at LUE,LLE, BRAIN FOG Narrative: Employee has h/o adverse reaction to flu vaccine in the past, stated that she does not take flu vaccine. Employee to the first dose 02/10/2021, 240pm She stated that at 330pm she developed headache which lasted for 2 days 20/11 2021, she developed numbness at the injection site . that radiated to her ring finger, left leg , foot 02/18/2021 She related to worsening fatigue, shoulder Pain, brain fog
Evening of 5/5/14 developed fever of 102, fussy and mom noted red lesion just below bandaid on Rt thigh. PCV13 given Rt thigh 5/5/14. On exam erythema - tons flat warm rash confluent about size of quarter, injection site not inflamed.
Diarrhea; Stomachache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My daughter has had dizzy spells everyday since June 5, 5 days after receiving the HPV vaccine. She had very brief ringing in her left ear on June 5 and 6 that only lasted a few seconds and one other day near the end of June. Sometimes she only has one dizzy spell a day and sometimes more. She also states that she feels "off" and feels like her eyes are crossing. My daughter had an MRI which was negative. The Dr. has now recommended we go to see an ENT if the dizziness doesn't go away. My daughter still has dizziness at least once a day to this present day.
Patient accidentally received a third dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine). On 11-Aug-2021, EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine) had resolved.            no medical history was reported no concomitant medication were reported no treatment medication were reported Patient  accidentally received a third dose on 11 Aug 2021
2" rash flat red area around inj site rt arm;warm to touch;no SOB or wheeze;pt observed for 20-30min & rash began to fade;BP 120/62;
The immunization was administered the morning of 10/13/18 and in the evening the patient felt very tired and showered and went to bed. 10/14/18 she had a fever which she was able to keep controlled with alternating tylenol and ibuprofen. She said by Monday 10/15/18 her left arm was red, hot, swollen and itching. The itching was relieved with hydrocortisone cream OTC but a week later is still slightly red and itching so she reported this to the pharmacy. I recommended benadryl instead of hydrocortisone and told her the likely culprit was the PNEUMOVAX since she has successfully taken flu shot in the past.
Rash on arms, back and trunk.  Took benadryl but did not help.  Went to ER and received an oinment
Extreme aches & lethargy X 48 hours. Fever/chills X 24 hours. Tenderness at administration site X 36 hours.