chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the two shot vaccine at 68 and still got internal shingles/ suspected vaccination failure; internal shingles; nerve damage inside; severe pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received at the age of 60 years).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The patient got the vaccine at age of 60 years but was told that patient needed the new vaccine because that one was no good.  The patient got the two shot vaccine at age of 68 years and still got internal shingles and had been in severe pain for a year from the nerve damage inside. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Had the delta-variant; Had the delta-variant; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A 69-year-old female patient (reporter's sister) received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at left arm on 26Feb2021 (Lot Number: EL9266) at the age of 68 years as single dose and dose 1 via an unspecified route of administration at left arm on 05Feb2021 (Lot Number: EL9269) at the age of 68 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer explained her sister (patient) who also got the Covid-19 vaccine the same days she did have the same symptoms she did. Her sister (patient) had the delta-variant from Sep2021. Consumer started to have covid symptoms on 08Sep2021 she had a stuffy nose, stuffy ears, slight fever, drainage, and sore throat. At first she thought it was just sinus issues, but the covid test had come back positive. She had tiredness, loose stools, headache, stuffiness, stuffiness in nose and ears really bad. Her twin sister (patient) had all these covid symptoms along with a lost of taste. Outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294617 same reporter/drug/AE, different patient.
This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 23-DEC-2003 was vaccinated with the first doses of VARIVAX (Merck) and MMR II (dose, lot number and route not reported). No concomitant medications were reported. The patient's second dose of MMR II was administered on 24-OCT-2007 and the second dose of VARIVAX (Merck) was administered on 30-OCT-2007. No adverse effect reported. Patient's outcome unknown. Additional information is not expected.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients were administered doses of improperly stored ROTATEQ, orally, lot# L046318 with expiration date on 28-SEP-2017 and lot# M007124 with expiration date on 05-OCT-2017 (doses were not reported). No adverse effects were reported. Administered doses of vaccines experienced a temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which lasted for 4 full days. No previous temperature excursion was reported. A digital data logger was not involved in recording the excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004376: US-009507513-1706USA004377: US-009507513-1706USA004378: US-009507513-1706USA002585:
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 10-MAR-2014, the patient was vaccinated with the second dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
she had a large blister in her mouth; This is a spontaneous report from a Pfizer-sponsored program SUPPORT. A contactable consumer (Mother) reported for a female consumer (Daughter).   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunization. Medical history, concomitant medications of the patient were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date in Feb2021, patient had a large blister in her mouth. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sometime following 2nd vax, the pt experienced a loss of appetite, a loss of muscle mass, a total wieght loss of 15 pounds, and frequent headaches. Additionally, the pt experienced tiredness and sleepiness. The exact date of onset of each of the adverse events was unknown. According to the reporter, the pt did not received any treatment for the adverse events nor has he seen a physician since 7/99. Additional information has been requested.
No additional adverse effect reported.; one female patient received improperly stored PROQUAD; This spontaneous report was received from a nurse referring a 4 years old female patient. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 14-NOV-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012470 and expiration date 20-OCT-2020; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent highest temperature above 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.2 Fahrenheit) for a duration of 1 hour and 10 minutes. There was no previous temperature excursion and the call was because of data logger.
Within 30-60 minutes after vaccination he experienced numbness of his lips and face following by rapid onset of swelling of the lips and face. He then developed a rapid heart beat with shortness of breath. He then developed a lump in his throat with a throat closing sensation with worsening of shortness of breath.  He elected to stay home without seeking medical attention. The shortness of breath attenuated over the next few hours but rapid heart rate continued for two more days
Developed severe vertigo 2 days after receiving second Moderna Covid19 vaccine. Vertigo was so severe I was unable to stand up or walk safely without assistance. The vertigo lasted 3 days before slowly subsiding.
Pt's mother called stating child had imms on 07/22/2002. After imms. child unconsolable. Mom gave Tylenol drops 0.8ml and slept for 10 hours straight. Mom states child was hard to wake up. Mom went to ER instead of clinic 07/24/2002.
Large area of redness and swelling, like a band around the outside of her arm, felt warm to the touch but no bumps. Also felt leg stiffness and slight pain.
This spontaneous non-valid report has been received from a physician assistant referring to an unspecified patients of unknown age and gender. No information was provided regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M036292, expiration date 17-AUG-2018, and lot# N024566 with expiration date 07-SEP-2019, (strength, dose, frequency and route of administration were not provided) for prophylaxis and PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The doses of VARIVAX and PROQUAD, were exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. Follow up information was received on 29-MAY-2018. A telephone call was taken from the corresponding reporter. The reporter provided that there had been no reported adverse events following the administration of the vaccinations PROQUAD and VARIVAX. The patient identification information was not readily available at the time of the call. Additional information should become available in the future, the follow up correspondence process was reviewed. Additional information has been requested. Follow up information has been received from the medical assistant on 05-JUN-2018. The case became valid due to provided patient's information. The report was referring to 44 year old male patient. On 10-MAY-2018, the patient was vaccinated with a second dose of improperly stored VARIVAX subcutaneously in the left triceps (LT), lot# N024566 with expiration date 07-SEP-2019. The vaccine underwent temperature excursion on a freezer. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001194: US-009507513-1807USA001201.
03/13/2009 pt. called to report "hive-like rash" appeared on face within 2-3 days of 1st Hep-B vaccine given on 3-03-09. Rash now itchy and spreading to trunk, arms. Relates mult. allergies - environmental incl. molds.
0.5ml dose given 05/31/05 right arm. After 24 hours itching. At 48 hours significant itching, swelling, redness, and at 72 hours persists but improving.
Upon receiving 1st dose, pt ambulated to observation area w/ unsteady gait. Pt sat down in observation area w/ noticeable labored breathing, inspiratory stridor, cough, dyspnea.  Pt was pale and diaphoretic. Pt was offered vitals check by medical staff, pt refused, stating she recently had an AMI and this was normal for her. Pt stated she carried EpiPen due to latex and iodine allergies, and "if this was an allergic reaction," she "would have known by now." Pt was told to notify medical staff of symptom changes. Throughout her 15 minute wait, pt produced violent coughing and could be seen with noticeable SOB. Pt stood up and ambulated with unsteady gait for approximately 5 ft, where she stopped and was assisted into w/c. Pt was wheeled out to vehicle, where she was asked to stay for another 15 minutes given her symptoms, pt refused. Pt was offered vitals check, pt refused, stating she is "just a minute away from home" and if she would place herself "on low oxygen" upon arrival. Pt drove off, returning approximately two minutes later. Pt c/o throat swelling, SOB, w/ inspiratory stridor, hoarse voice, and violent cough. EMS was called at this time. EMS transported to local hospital.
Myalgia, Arthralgia, injection site soreness, fatigue, chill , sore throat Narrative:   Other Relevant History:
administered an expired dose; 41 years old patient received Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 1st July 2021) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: On 7th September 2021, the nurse administered an expired dose of Shingrix in right arm to 41 year old patient which got expired on 7th July 2021, which led to expired vaccine used and inappropriate age at vaccine administration. No other detail was available. The reporter consented to follow up.
Developed erythema, swelling and hives (localized to injection site) 1 day after injection. No tenderness. Treatment with BENADRYL.
patients experience "more of a burning effect" in the arm; This spontaneous report was received from a nurse via a field representative referring to unspecified number of patients of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown. The patients' concurrent conditions were not provided.  On unknown dates, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration unknown) (dose, frequency, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination).  The nurse reported in the last few months, she had noticed when hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringes were administered to patients, the patients experienced more of a burning effect in the arm then when she used the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vials. It was unknown if treatment was given for the event. The outcome of the event was unknown at the reporting time. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  This case was determined to be a non-valid case due to no patient identifiers provided.  Follow-up information has been received from the nurse on 21-AUG-2019. The patients' age was added as 11-14 years old. The patients' gender were female. The nurse reported that the patients were increasing complaining of a severe burning sensation when receiving the vaccine from prefilled syringe.  This case was determined to be a valid case due to the patients' gender provided.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1909USA001656:
administration of Shingrix adjuvant only portion of vaccine; administration of Shingrix adjuvant only portion of vaccine; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   On 26th April 2021, the patient received Shingrix. On 26th April 2021, 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 details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received only adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, she suspected 2 patients received only diluent because their office had more lyophilized vials of Shingrix than the vials of diluent but she had to wait to verify about exact administration with another clinician who was off work on the day of reporting. The reporter did not want to provide patient's date of birth (DOB) or initials until confirmed that Shingrix adjuvant was administered to patient. This case has been linked with US2021092592, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021092592:same reporter (patient 2 of 2)
Patient was pale after administration of yellow fever vaccine. Patient sat in her Mother's lap. Per Dr. patient became limp, stared in space and was not responsive to Mother calling her name and had arm raised. Per Dr. this patient had a petit mal seizure.
This study case was received from the investigator in a trial on 12 November 2012. A 19-year-old male subject received the following vaccinations on 30 August 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), ANTHRAX (manufacturer and lot number not reported), and a intranasal dose of INFLUENZA, LIVE (manufacturer and lot number not reported). The subject had no significant medical history. On 09 September 2012, the subject had an abnormal lumbar puncture (spinal tap). On 13 September 2012, the subject had a normal troponin I and an abnormal MRI (spinal cord). On 08 September 2012, the subject was diagnosed with encephalitis following immunization procedures. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot # 665300/1314Y) within the month of April 2010 from the same 5 dose vial. On unspecified date, the patient experienced very large redness wrapping around the arm and warmth/feverish at the injection site. The patient was treated with BENADRYL and ice and recovered. This is one of several reports received from the same source. The nurse is requesting a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
I got my second shingles shot which gave me the shingles / suspected vaccination failure; I got my second shingles shot which gave me the shingles; The pain breaking out is something you never forget; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had it in his/her 20's) and chickenpox (the patient had it about 6 years ago from the date of reporting and before he/she never had the chickenpox).   On an unknown date, the patient received the 1st dose of Shingles vaccine. In September 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient was currently in his/her late 60's. The patient stated he/she got 2nd shingles shot which gave him/her the shingles. The patient stated that the pain breaking out was something you never forget, and the physician swears that they did not give the live virus shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Patient was inadvertently given Pfizer dose #2 seven day early.  Dose #1 was administered 7/16/21 and dose #2 on 7/30/21.  Patient waited in observation for the recommended 15 minutes; no adverse events reported.
21OCT92 pt recvd vax & 930PM devel induration, burning, itching & redness @ the inject site; seen by MD treated w/Keflex;
Initial unsolicited report received from a nurse on 05 May 2016. This case involves 19-year-old female patient who was vaccinated with a first dose of YELLOW FEVER VACCINE (YF) (batch number- UF285AA, site of administration was reported as unknown) subcutaneously on 14 April 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was reported as unknown. Concomitant medications was reported as unknown. On 14 April 2016, same day following the vaccination, the patient had experienced flu like illness: chills, fever and headache for one week. On an unspecified date, one week later, the patient had experienced sore throat and lymph swelling. The patient required ER/doctor visit. Laboratory data and corrective treatment were not reported. The patient was recovered from events flu like illness: chills, fever and headache and was not recovered from events sore throat and lymph swelling. List of documents held by sender: none.