chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; I'm 27 years old; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 27-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On 28th January 2020, 30 days after receiving Shingrix, the patient experienced shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The patient was vaccinated a month ago and got shingles. The patient was vaccinated at the age of 27 years which led to inappropriate age at vaccine administration. The patient inquired if he/she will be protected after the second dose.
She fainted and fell out of her chair.  She regained consciousness after less than 30 seconds.  She said she often passes out after getting a shot or giving blood.
improperly stored administered ROTATEQ; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 from prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023); no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:02429442
no adverse event; An improperly stored dose of PEDVAX HIB administered to patient.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 23-AUG-2019 the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot # S00352, expiration date 17-OCT-2020 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 36°F/2°C (35.4F) degrees Fahrenheit for 27 minutes, as recorded by a data logger. No adverse effect reported. "Lot number S00352 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate)."
PT RECIEVED BEXSERO VACCINE AND BACTRIM AT APPT 8/2/18 ARROUND 1420. PT TOOK FIRST DOSE OF BACTRIM AT APPROX 1500 AND THEN AROUND 1700 PT DEVELOPED NASAL CONGESTION, BILAT EAR PAIN, JAW PAIN AND BILAT HIP PAIN. APPROX 15 MIN LATER PT DEVELOPED CHILLS AND LOW GRADE TEMP OF 99.9, PT TOOK IBUPROFEN AT THAT TIME. APPROX 8PM FEVER UP 101.4, DEVELOPED FRONTAL HA WITH LIGHT SENSITIVITY AND NAUSEA, MOM GAVE TYLENOL AND BENADRYL AT THAT TIME. PT WAS FEBRILE ALL NIGHT, WITH TEMP STAYING AROUND 100.0, WOKE THIS AM APPROX 0800 WITH MILD LIP SWELLING WHICH HAS IMPROVED BUT NOW PUFFY AROUND EYES. MOM JUST NOTICED MILD RED RASH ON LOWER EXTREMITIES, NON PRUITIC. PT STILL C/O BODY ACHES, HA, THROAT FEELS A LITTLE SWOLLEN BUT NOT SORE.
(1) Started having hives on the third day & spread all over the body in 2 days & waxes & wanes. (2) Lips swollen on the 7th day.
Patient presented with a large swollen red rash under the injection site and is monitoring for further follow up with doc if needed.
elevated creatinine; elevated blood glucose; chest pain; pale skin; heart palpitations; shortness of breath; This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 22nd May 2019 18:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced creatinine increased and blood glucose increased. On 22nd May 2019 23:00, the patient experienced chest pain, pale skin, palpitation and shortness of breath. The patient was treated with prednisone. In May 2019, the outcome of the creatinine increased and blood glucose increased were recovered/resolved. On an unknown date, the outcome of the chest pain, pale skin, palpitation and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the chest pain, pale skin, palpitation, shortness of breath, creatinine increased and blood glucose increased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. At approximately 11pm of last night, 4 hrs. 30 min after receiving Shingrix, the patient developed shortness of breath, heart palpitations, chest pain and pale skin.  The patient went to the emergency room and found out that the patient's blood glucose levels and creatinine levels were elevated.  The patient was given prednisone and sent home around 4 am morning of this time of reporting.
I lost my sense of taste and smell on 4/11/2021 and have not regained either to date.
Acute onset supraclavicular lymphadenopathy (ipsilateral to injection, 7 days after injection)
Patient 3/16/21, 1430: Personally evaluated the patient and participated in her treatment. Please see his portion of the note for complete HPI, initial assessment and plan. Patient was sent to the emergency department from the Covid vaccination site. Only after receiving the vaccine, patient began having difficulty breathing, urticaria across her chest.  She was given 2 doses of IM epinephrine, EMS was called and she was brought to the emergency department. Arrival to the emergency department, she was tachypneic, no longer had a rash but did complain of some tightness in her throat.  She then began having nausea and vomiting. She was given an additional dose of epinephrine here and also given Solu-Medrol, Pepcid, Benadryl. Patient was closely monitored. She had initial improvement but then said she was beginning to have tightness in her throat again. On my exam, she is a mild pharyngeal erythema and edema. There was no stridor.  She was handling secretions with no difficulty. I ordered racemic epinephrine, albuterol, IV fluids and Zofran. After receiving all her medications her symptoms began to improve. Did not see an indication to intubate the patient at this time. Recommended admission she agrees. Case was discussed with the hospitalist and she will be admitted.
arm on the injection is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm on the injection is a little sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121120A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm on the injection is a little sore). At the time of the report, VACCINATION SITE PAIN (arm on the injection is a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment medication were Xycal for allergies 1 pill, Albuterol inhaler aerosol for seasonal allergies.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information included reporter details
felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; Tested positive for COVID after receiving the first dose of the COVID Vaccine; slight fever; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (the patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) via unspecified route of administration on the left arm/shoulder on 22Dec2020 at single dose for COVID-19 immunisation.  Medical history included gained weight since the pandemic started. The patient's concomitant medications were not reported.  Patient received first dose of the vaccine. She had symptoms right after she got the vaccine the next day, on 23Dec2020. She had a slight fever, body aches, and a headache, which she never gets. She had these for about 2-3 days, they lingered around, and kicked back up around 26Dec2020/27Dec2020. She also felt kind of tired. She got covid 19 infection tested on 02Jan2021 and the results came back positive on 03Jan2021. Patient was calling to report this and see what to do about the second dose. She was supposed to get her second dose next Tuesday. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
pt recvd vax 10FEB94 & mom notified MD of pt c/o pain & rash @ inject site; mom told to put ice on inject site, notify MD if not better in 2-3 days;
nausea / occipital headache.   R  arm soreness;  DM; BG 200 per patient;   TX - mask removal fresh air- smoke out of car;  educated; arm movement; Tylenol OTC if needed.   Recheck- much better, H/A resolved - playing on phone; mild nausea presents.
This case was reported by a nurse via call center representative and described the occurrence of worn out in a 79-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, FLOMAX, glucosamine, Vitamin D3, triamcinolone, MIRALAX, XALATAN, CARDURA, fish oil, Ketoconazole Topical Shampoo, metoprolol and TYLENOL. On 5th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced worn out. On 6th May 2018, the patient experienced vesicles and shingles. On an unknown date, the outcome of the worn out and shingles were unknown and the outcome of the vesicles was not recovered/not resolved. The reporter considered the worn out an vesicles to be related to SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The nurse reported about one of their patients. The patient did not receive the SHINGRIX vaccine at their facility but received at a local pharmacy. The reporter provided name of the pharmacy but could not provided contact information. The patient felt completely wiped out on the day of vaccination. On the very next day, the patient experienced vesicles on skin on the inner left thigh and sacrum. The patient was seen by the physician assistant (PA) in their office and PA concluded that, the vesicles look like active shingles infection.
On 1/6/21, I noticed a hard, red spot on my arm where I got the COVID vaccine. This red spot got bigger over the next 2 days and reached a maximum length of 3 inches and maximum width of 2.75 inches. It was warm to the touch. On 1/8 and 1/9 I also had a headache and fatigue.
itchy macular rash w/possible angioedema vs cellulitis @ 6cm radius from IM site;
Severe Headache 10/10 started 1 day after injection Swelling and pain of 1 eye leg cramps
Roughly 16 hours after receiving the second dose of the Pfizer COVID-19 vaccination I began experiencing abdominal cramping that I would normally associate with menstrual like cramping. The reason I found this to be abnormal is that I underwent an ablation procedure more than seven years ago and have rarely if ever experienced abdominal cramping since that time. Approximately two weeks after the injection I experienced what I could consider an abnormal menstrual cycle with bleeding that lasted four to five days. I found this to be strange considering I've not experienced any such menstrual cycle since undergoing the ablation more than seven years ago. Since the ablation procedure I could count the number of times, on one hand, when I've experienced any type of bleeding and those instances have produced such an insignificant amount of blood that I could not justify even wearing a tampon. In those handful of situations I spotted for 2-4 hours maximum. Fast forward two more weeks and here I am having a menstrual cycle and bleeding enough to wear a tampon.
knee pain; This case was reported by a consumer and described the occurrence of knee pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was unknown.   It was unknown if the reporter considered the knee 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 it was selected as adult as per the vaccine indication. The patient was not sure if she kad knee pain before her first Shingrix dose. The patient thought the knee pain was from aerobics, she states the pain started in left knee and at time of reporting both knees hurt.  The patient states her knees were hurting before the second shingrix dose which she received two weeks ago form the date of reporting. The patient need to take a methylprednisolone dose pack for knee pain. Was that safe to take the prednisone without causing problems with the vaccination that patient received, would it diminish the vaccine This case has been linked with case US2020AMR114277, reported by same patient for 2nd dose.
IMMEDIATE BRUISING TO AREA AROUND INJECTION. BY NEXT AFTERNOON THERE WAS A RAISED AREA 4X2 AT INJECTION SITE THAT WAS VERY WARM TO TOUCH AND SORE.
pt recv vax 29OCT98 & died post cardiac arrest;pt had no allergic or anaphylactic rxn immed to the vax;
Left arm sore and aching within 1 hour of shot. Possible fever (not documented). Within 24 hours, left arm throbbing and numb. 45% better in 4 days.
Generalized muscle aches and pains which began approximately 2-3 days after administration of 2nd Hepatitis A vaccine. Initially associated with headache and fever and malaise. Also associated with muscle fatigue and hot flushes. All symptoms have been steadily improving over 3-4 week course after vaccine administration. Fever and headache residual after 1st week of symptoms.
Received a booster dose instead of a full dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a booster dose instead of a full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received a booster dose instead of a full dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a booster dose instead of a full dose) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
9PM PARENT STATES THAT CHILD WAS VOMITING, SHAKING, AND UNRESONSIVE. CHILD WAS TAKEN TO ER- GIVEN DIASTAT AND KEPPRA. TRANSFERRED TO ANOTHER HOSPITAL. RIGHT EYE REPORTED TO TURN INWARDS. CT SCAN NEGATIVE. RELEASED FROM HOSPITAL ON 10/11/15. F/U IN PEDS OFFICE ON 10/12/15. F/U WITH NEUROLOGIST.
rash-first noticed around 5PM, itching, rash on inside upper arms, behind knees;
Myalgia, Arthralgia, Fever, chills, arm soreness Narrative:  Fever, myalgia, arthralgia, chills, arm soreness; took naproxen and tylenol.
Medication error: Pneumovax vaccine administered to 2mo infant instead of Prevnar. NO adverse side effects reported at this time.  We plan to continue with normal Prevnar vaccination as recommended by the CDC for a patient of this age as long as no adverse effects are reported.  This plan is based on recommendations from a call to CDC Info.  (800)CDC-INFO.  ID number of call and recommendation: 1-61622518.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FEEL LIKE SHE WAS OUT IN OUTER SPACE/FEELING AWFUL; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a female patient of an unspecified age, race, and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported,1 total was administered on an unspecified date in 2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2023, the patient experienced covid-19 infection and started treatment with Non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (tablet, route of admin, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for covid-19. On an unspecified date in 2023, after completing Paxlovid treatment the patient experienced different symptoms to that of she experienced for the first time and was back down again after being tested positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (Dose number in series 2). The patient hated Paxlovid as it was awful and was very intense and she also felt like she was out in outer space (Dose number in series 2) and few days later she felt like it had finally left her system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient recovered from feel like she was out in outer space/feeling awful, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230530647-Confirmed clinical vaccine failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
She always feels like she is coming down with a cold when she gets it; This spontaneous case was received on 11-Nov-2020 from other non-health professional (reference number: NVSC2020US019771) and concerned a female patient of unspecified age. At the time of this report the patient was 53-year-old.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient felt like she was coming down with a cold.  The outcome of the event was not reported.   The reporter assessed the event as related to influenza virus vaccine. The reporter stated that she always felt like she was coming down with a cold when she got the vaccine.  The case was assessed as non-serious.   This case is linked to the case 202006189 (the same patient).  Company comment: The patient experienced nasopharyngitis on an unspecified date after administration of influenza virus vaccine polyvalent. The patient's medical history and concomitant medications were not provided. Causality is unassessable due to lack of reported information.; Reporter's Comments: She always feels like she is coming down with a cold when she gets it.; Sender's Comments: The patient experienced nasopharyngitis on an unspecified date after administration of influenza virus vaccine polyvalent. The patient's medical history and concomitant medications were not provided. Causality is unassessable due to lack of reported information.
Headache, Chills and Fever. Chills began at 4pm with Headache appearing shortly thereafter. Fever began the next morning. Took Tylenol and Advil at intervals prior to the vaccination.
Approximately 2-3 minutes after vaccine administration patient experienced muscle tremors and shaking.  Mother suspected tremors and shaking were related to anxiety of vaccine administration. Patient was given water and allowed to rest. Symptoms resolved in approximately 10-15 minutes.
Missed third dose of Vivotif by 3 days; Spontaneous report received on 13DEC2019.  A pharmacist reported that an adult male consumer who "missed third dose of Vivotif by 3 days" (PT: Product dose omission), while being on Vivotif for immunisation. The consumer missed his third dose by three days, which was due on 09DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed third dose of Vivotif by three days (missed dose). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer missed third dose of Vivotif by three days (missed dose). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.