chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncope was observed; This is a spontaneous report from contactable physician. This report was received via a sales representative. This physician reported similar events for 3 patients. This is 1st of three reports.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope was observed on an unspecified date between 6 months and 12 months ago. Event took place after use of product. The outcome was unknown.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019217421 Same reporter/drug/event, different patient;US-PFIZER INC-2019217420 Same reporter/drug/event, different patient
I have spots that fit shingles but I had 2 shots about 2 years ago; I have spots that fit shingles/ I have symptoms; spots where there is a blister; fever of 99.5 at spots; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin warm. On an unknown date, the outcome of the vaccination failure, shingles, blister and skin warm were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin warm to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had spots that fitted shingles. The patient also had fever of 99.5 degree Fahrenheit at spots where there is a blister. The patient received the shots about 2 years ago. The patient asked if there were over the counter medications for treating the symptoms.
COVID-19 Disease 3 months after the 2nd monovalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 Disease 3 months after the 2nd monovalent booster dose) in a 49-year-old female patient 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Disease 3 months after the 2nd monovalent booster dose). At the time of the report, COVID-19 (COVID-19 Disease 3 months after the 2nd monovalent booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.
Made me sick for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made me sick for a couple of days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007DZ10) for COVID-19 vaccination.     The patient's past medical history included COVID-19, Pneumonia in December 2020 and Hospitalization (was hospitalized for COVID-19 and pneumonia). Concurrent medical conditions included Blood cholesterol abnormal and Heart disease, unspecified.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (Made me sick for a couple of days). At the time of the report, ILLNESS (Made me sick for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received on 11 May 2021, patient hung up when asked to provide email address so no new information was received.
Within 4 hours of vaccine Had a rash on face, ears, chest and arms.  Lasted for 30 minutes and then dissipated .    24 hours later, chills and flu like symptoms with some chest congestion/cough
pt was administered covid19 Pfizer vaccine and was told by rph to stay for 15 minutes for any side effects or reactions. After about 5 minutes, pt stated started feeling light headed, dizzy, and sweaty and not feeling good.  She was given some water at which point she stated she was starting to feel tingly all over. Paramedics were called and came within 5 minutes.  About 15 minutes later pt was able to walk out of the pharmacy with paramedics and drive home.
Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Information has been received from a registered nurse (R.N.) concerning a 12-month-old male with no medical history or allergies, who on 11-APR-2006 was vaccinated subcutaneously in the left thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (+) varicella virus vaccine live.  Concomitant vaccination given on that same day, included a dose of Hib conj vaccine.  On the same day of vaccination, 11-APR-2006, the patient developed a "red spot" at the injection site.  Medical attention was sought and no treatment was recommended and no laboratory or diagnostic tests were performed.  At the time of the report the "red spot" at the injection site persisted.  No product quality complaint was involved.  Additional information has been requested
Patient is 2 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Initial case received from a dermatologist on 08 July 2011. A 31-year-old female, with a history of erythromycin sensitivity, received an intramuscular right hip injection of ADACEL (lot number C3518AA) on 18 March 2011. Of note, the recommended site of vaccination for ADACEL is the deltoid; the gluteal muscle is not recommended for administration. The patient subsequently developed a rash at the injection site in March 2011. On 24 June 2011 she was noted to have a 3cm bleeding, draining cyst on her right hip. She underwent a biopsy and culture; results were pending. The patient was diagnosed with "atypical bacterial rash'. The event remained ongoing at the time of the report.
Initial report received on 25 August 2008 from a health care professional. A 4 year old female patient, with no medical history, received on 21 August 2008 a right thigh intramuscular 0.5 ml injection of IPOL (lot number A0836-2), a right thigh intramuscular 0.5 ml injection of TRIPEDIA (lot number U2291BA), and left thigh injection of MMR (Merck lot number unknown). The patient had no illnesses at the time of vaccination. On 22 August 2008, one day post-vaccination, the patient's right thigh was red, swollen, hot to touch, and itching. The recommended treatment was cold compresses. At the time of the report 25 August 2008, the patient's recovery status had not been reported, but the patient was to follow-up with the physician on that day. Follow-up information was received 01 October 2008 from a health care professional. the reporter confirmed that the symptoms of redness and itching extended two inches from the injection site and corrective treatments consisted of TYLENOL and BENADRYL. The duration of the event was confirmed to have lasted one week and the patient recovered. The patient had received a total of three prior doses of IPOL (lot numbers not reported) on 13 November 2003, 26 January 2004, and 22 March 2004 respectively, with no adverse events experienced. No additional information was provided.
pt recv vax in 1993 or 1992;recent lab eval revealed lack of seroconversion;
Information has been received from a nurse practitioner concerning a female who on 24-OCT-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (0.5 mL). On 24-OCT-2007, immediately after receiving the vaccine, the patient became dizzy and nauseous. The patient was rushed to the emergency room by ambulance. No further details were provided. At the time of this report, the outcome of the events was unknown. The reporter felt that the events were serious for an other important medical event. Additional information has been requested. This is an amended report. The route of intramuscular was added to the report. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse practitioner concerning a 21 year old female student with anxiety who on 24-OCT-2007 at 1:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (0.5 ml) (lot # 658490/0802U). There were no illnesses at the time of vaccination and no adverse events following prior vaccinations. On 24-OCT-2007, at 1:15 PM the patient experienced lightheadedness and nausea times one and a half hours. The patient was rushed to the emergency room by ambulance. An EKG in the ER was noted to be normal. The patient subsequently recovered the same day. In follow-up the nurse practitioner did not report the events as other important medical events. No further information is expected.
Tested positive for Covid 12/22 at home test, positive rapid and PCR 12/23. Fever, sinus congestion, severe fatigue for 3 days then lessening symptoms
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0934. MD made aware.  No harm to patient or adverse reactions.
Kinrix administered to a 3 years and 3 months patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FN5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: The nurse reported that a 3 years and 3 months old patient received a Kinrix dose. The reporter consent to follow up. Additional Supportive Information: The 3 years and 3 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration
injection site swelling; Hurts; Fever; chills; Headache; Feels cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FEELING COLD (Feels cold). At the time of the report, VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (Hurts), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FEELING COLD (Feels cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.7 f degree Celsius (High) high.     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 by the reporter.  No treatment medication was reported.
This case was reported by a healthcare professional and described the occurrence of insufficient dosage in subjects of unspecified age and gender who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (BOOSTRIX) for prophylaxis. The subjects' medical history, concurrent conditions and concurrent medications were not provided. On an unspecified date in July, August and September 2006, subjects received an unspecified dose of BOOSTRIX. A nurse reported that she had approximately 160 immunizations where the BOOSTRIC vaccine potentially had one tenth of a cc less in each vial.
I woke up at midnight, feeling really cold. Then I started to shake. I called the nurse line and started stuttering. I was instructed to go to urgent care. By then I was convulsing. I was nauseous. I was giving an IV, Tylenol, zofran, toradol, and Ativan. I got to the ER around 1 am. I was released about 4 am. I was prescribed Motrin. I continued to have headaches and nausea. I called my primary. Have a follow up visit on 2-12-20, she felt that the side effects were normal. I still had headaches and nausea went back to the same ear who treated me (Community Hospital) I had a CT scan and blood work, all is normal. I continue to have nausea and headaches. I take one Motrin 800 at night when I go to sleep.
Patient returned about 2 hours after vaccine complaining of chills, chest pain, dizziness and light headedness.
Received vaccine at 5:20 p.m.  At 7 p.m. left arm began throbbing and became painful.  Associated redness.  She took ibuprofen and applied ice.  This a.m. 9:10 a.m. 5/13/08 - pain improved but still present.
On 7/24/00, the family noticed the pt's right side of face not moving when child smiled. Saw physician on 7/25/00 and dx with Bell's Palsy.
in and out of consciousness; blood pressure was 170/112; severe chills; UTI; A spontaneous report was received from a consumer, concerning a 98-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/ chills, blood pressure was 170/112/ hypertension, was in and out of consciousness/ consciousness fluctuating, chronic heart failure/ cardiac failure chronic and urinary tract infection (UTI).  The patient's medical history included were chronic heart failure and urinary tract infection. Concomitant medication included was apixaban.  On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, same day of receiving vaccine, the patient experienced severe chills, blood pressure was 170/112, and was in and out of consciousness. She was hospitalized and remained at the hospital.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. However, advanced age, history of chronic heart failure and concurrent underlying urinary tract infection may remain as risk factors. Further information has been requested.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 67 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 not reported, batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028555 and 20211028561.
p/vax pt devel volvulus/intestinal obstruction;misdiagnosed by 2 pediatricians;lost 150cm small intestinal;s/p 6 surgical procedures; currently on TPN; disabled now
Mother brought child to the clinic at 3:00 P.M. on 6/14/2013 to see the nurse. Child was taken to Immunization Room, it was noted that a circular red area approximately 2 inches by 1 1/2 inches was visible. This was the area where the Kinrix (Dtap-IPV) vaccine was administered. The site was slightly swollen, warm and slightly splotchy looking. Child complained of pain and itching at site. No visible area of skin breakdown or drainage at site. Mother informed nurse that the family had been applying cold compresses to the site. Encouraged mother to use the cold compresses when needed. Called phone number and spoke to grandmother and informed grandmother that it would be reported, and the family may receive a phone call requesting further information about the incident. The grandmother told me that the child had a high fever but did not know how high as she did not take the temperature, and that the child was in a lot of pain. Informed grandmother and mother if the problem worsened or new problems arised to take the child to his doctor. If the family was worried about the reaction to notify the child's doctor.
Information has been received from a male consumer who on 15SEP2010 was vaccinated with a dose of PNEUMOVAX 23, lot #5632Y, with an expiration date of 12NOV2010. It was reported that the consumer had an adverse reaction to the vaccine and experienced shortness of breath, flushing and low back pain. Subsequently, the patient recovered from shortness of breath, flushing and low back pain. Additional information is expected.
Received VARICELLA vaccine 8/17/09.  On 8/28/09 broke out in VARICELLA -like- rash (spots, 0 vesicles).
Mom reported to clinic on 5/16/07 afternoon stating child had been running fever x 2 days and had swollen (L) arm since receiving immunizations. Child's (L) arm was reddened from halfway up from elbow to deltoid and hot to touch. Denied any pain. No drainage noted. Referred to her MD was seen that afternoon.
Patient reported on 12/20/20 that she feels pain at the injection site, she feels a "hard spot" and that spot is brownish color.
Patient's husband reported that the next day wife has redness, swelling, warmness and sagging skin on the inside of the upper left arm. This pharmacist did not see patient's arm.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 8th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Two hours after vaccine started having loud ringing in ears and swelling in my tongue, continued to the next day. Called Dr. and was given a prescription of prednisone that night. Next day went to Dr. and had blood work drawn. It showed inflammation in Liver, and Cholesterol was high. Prednisone helped as I started to feel better.
Per Dr on 11/08/2018, Mom calls reporting fever rectally 103.1 after 6 mo shots (not given at clinic as he was post-circ). No rash and not acting unwell. No URI sx. "didn't do well with last shots", low grade fever and fussy at 4 mo. TYLENOL and ibuprofen now recommended, then alternating every 4 for TYLENOL and 6 for ibuprofen.
pt developed sore arm immediately after shingles #2, still very painful 3 mos after shot. Tolerated #1 ok.