chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; subsequently was noted that vax was beyond expiration date;at time of report no adverse experiences noted;
Metallic taste in mouth starting ten minutes after injection, reporting event approximately 8 hours later and metallic taste is still present.
pt recv vax;feverish & could not get out of bed;pt felt she had no strength on lt side;saw MD for numbness of her side,tingling in ear & throat numbness;
This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia and was an hemophilia A carrier. The mother's concomitant medications included prenatal vitamins and iron for borderline anemia. The mother had caffeine (1/2 diet Coke) from 31-Mar-2013 until 24-Dec-2013, wine (1/4 glass of wine, 0.25 serving 1 day) on the 07-Dec-2013, and had a respiratory infection between 22-Jul-2013 until 31-Jul-2013. On the 10-Jun-2013, the mother had a 1st trimester serum screen which showed that the PAPPA (pregnancy-associated plasma protein A) marker was low and on the 07-Aug-2013 had an ultrasound which saw a choroid plexus cyst. All other ultrasounds and tests were normal (see 2015053323). On the 15-Oct-2013, the patient received AFLURIA injection (batch number R53207) via the mother (intrauterine) 1 shot 1 day. On the 01-Nov-2013, the patient received BOOSTRIX (batch number not reported) via the mother (intrauterine) 1 shot 1 day. The patient was born at 38.3 weeks, with a birth weight of 3350g and Apgars of 8 at both 1 minute and 5 minutes. On an unspecified date, the patient was diagnosed with hemophilia A which was confirmed by haematology and paediatric records. The baby was also diagnosed with a hooded foreskin by urology. Outcome was not reported. Reporter comments: The reporter did not consider either of these major malformations but reported the events as congenital anomalies.
Redness, swelling, increased warmth, if rt upper arm. Blister rt. upper arm. Reaction began 24 hrs after administration. Blisters began >24 hours after.
pt recv vax; crying; swelling at inject site; cool compress given; client to ER for evaluation;
Pt had a heart attack while at home. EMS called and patient was coded with CPR and medications. Patient went to cath lab an received a stent and IABP was placed for cardiac support. Induced hypothermia protocol was started and pt remained unresponsive with myoclonus.
first vax almost a year ago, never got 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (1st dose received almost a year ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient never got the 2nd one. The patient asked did he/she need to start over or could he/she still get 2nd. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine, which led to Incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
patient states she got a huge hive and a lot of pain at the site that did not let her sleep
On the day of immunization, patient developed local reaction with swelling, redness, warmth. Reaction resolved over next 24 hours with cold compresses, elevation, Benadryl, Claritin. Patient had received pneumococcal vaccine in 2004 but did not recall when asked.
Sore throat, hot/cold flashes, muscle aches, fatigue, sore at injection site
Patient was given Dtap,Ipv and MMR in his right arm. The Dtap was given first IM in his upper deltoid and the Ipv was given 1 inch below that and the MMR was given sub q in the back fatty part of his right arm. The shots were given on Monday September 17, 2007 and his arm started getting red and swollen on Wednesday and his right arm where the Dtap was given was crusted over with what looked like two open chicken pox bumps that had pus in them and looked like they were infected.
real high blood pressure,my heart rate was elevated real high; severe ringing in ears. It was super loud and freaked me out; still waking up two or three times a night with severe ringing in my ear; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE MEASUREMENT (real high blood pressure,my heart rate was elevated real high), TINNITUS (severe ringing in ears. It was super loud and freaked me out) and SLEEP DISORDER (still waking up two or three times a night with severe ringing in my ear) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 045A21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-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 experienced BLOOD PRESSURE MEASUREMENT (real high blood pressure,my heart rate was elevated real high), TINNITUS (severe ringing in ears. It was super loud and freaked me out) and SLEEP DISORDER (still waking up two or three times a night with severe ringing in my ear). At the time of the report, BLOOD PRESSURE MEASUREMENT (real high blood pressure,my heart rate was elevated real high), TINNITUS (severe ringing in ears. It was super loud and freaked me out) and SLEEP DISORDER (still waking up two or three times a night with severe ringing in my ear) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had heart monitor test and adrenal test. Two days later same thing (ringing etc) happened again and again. From JAN until today patient had blood pressure thing which not got so high. Cardiac lab values(ECG,cardiac test,cardiac enzymes)reported and they did base one twice and wore heart monitor two days and don't had results. They increased blood pressure medication. concomitant medications include blood pressure medication  Treatment medication was not provided.   This case was linked to MOD-2022-452826 (Patient Link).
Administration Error 12 yo received pediatric formulation for 5-11yo as the second dose in the series.
PNEUMOVAX 23 vaccine was administered to a patient.  No additional AE's; PNEUMOVAX 23 vaccine was administered to a patient.  No additional AE's; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On 12-SEP-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T039322, for prophylaxis (strength, dose, route and site of administration were not provided). Vaccine expiration date was reported as 09-SEP-2022 (expired product administered).  The patient experienced no adverse event.
flu like sx, low grade fever, joint aches, fatigue w/in first two weeks p/vax;sx progressed & got severe over the following year;seen & treated in ER twice in early 1996;dx w/SLE in 1996;
rash on her stomach/spread to back,neck and arms,trunk; This is a spontaneous report from a contactable other hcp(patient).  The 21-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 12Jan2021 15:00 at single dose for COVID-19 immunization.  Medical history included none. She had no known allergy. Concomitant medication included ethinylestradiol/levonorgestrel (SEASONIQUE), ergocalciferol (VIT D), vitamin b complex (VIT B COMPLEX). There was no other vaccine in four weeks.  The patient experienced a rash on her stomach on12Jan2021 17:00. By the next day, it spread to back. It had now been 8 days since she received the first dose, and it had spread to neck and arms (still on trunk as well). The rash showed no signs of improvement and seemed to be spreading. Event was assessed as non-serious by reporter. Outcome of event was not recovered. There was no treatment. There was no COVID prior vaccination. Lab data included two Saliva PCR tests: negative both on 14Jan2021.  Information on the Lot/Batch Number has been requested.
Chills, headache, nausea, indigestion, joint pain, muscle pain, fatigue, exhaustion, brain fog, excessive sleep, loss of appetite and sciatica.
11FEB96 according to pt aunt pt had an illness w/cold-like sx, went to ER, t104, d/c p/4hr;couldn't breath well, nose stopped up;12FEB96 fever down to 101;6AM nl feeding, 11AM, found dead;
Mom noticed a rash on patient torso, red, bumpy, no other symptoms, no itching, no swelling.
Five minutes after injection tongue and throat felt some swelling.  Had me wait 30 minutes and seemed to subside so we went home.  2 days later same reaction. Took Benadryl and that helped after a while. Had 2nd shot on 02/17/2021 at Urgent Care and no immediate reaction, however 2 days later tongue and throat swelling.  Took Benadryl and went to Urgent Care.  Stayed 4  hrs but did not get any worse.  Came home and had same adverse reactions off and on for 8 weeks.  Went to Allergist and blood test showed high levels of Histamines.Have been taking Anti Histamine every day for 10 weeks and have had slight swelling of tongue only twice during that time.  Will see follow up with Allergist next week.
The patient was supposed to get covid vaccine booster but she received a flu shot because one of my technicians typed it as a flu shot instead. Patient didnt experience any side effects. I offered to give the covid vaccine to her, she said she will get it  friday.
A shot was given at school clinic by health dept RN. The patient's mother called and said she felt nauseous and had cramping in her legs and about 15-20 minutes after the shot. The patient was in PE class and running very hard when had difficulty catching her breath and vomited. Also stated she was nauseated the day before. The mother was advised to notify the family MD if any SOB. The patient went home from school at 10 AM, slept for 2 hours, had slight SOB, was going to see the MD.
shingles; other zoster-related conditions; Information has been received from a lawyer as part of litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant therapy were not reported. On or about 31-AUG-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a healthcare provider at a pharmacy (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, patient was treated by a physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
It appeared that approximately 5 minutes after the vaccines were administered, the patient blacked out, fell backward, and hit her head. When the patient's mother first picked up the child, the patient was not moving. Then the child began to seize, her body was rigid and tightened up. After approximately 2-3 minutes, the patient was able to stand. After standing, the patient vomited twice.
Soreness in arm where vaccination was received; Chills; Fatigue; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high, cholesterol high and allergy to penicillin medications(penicillin allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 at 12:00, the patient experienced soreness in arm where vaccination was received, chills, fatigue and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in arm where vaccination was received, chills, fatigue and loss of appetite were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 9 or 10 year old female who on 13May1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt came into the physicians office with a rash that was found to be chickenpox. It was also noted that children at the pt's school had broken out with chickenpox. No additional information was available. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 16 week who on approximately 23-MAR-2007 was vaccinated with the first dose Rotateq. The patient experienced infant received the first dose of Rotateq at 16 weeks of age. The patient sought unspecified medical attention. Additional information has been requested.
Swelling of lt hand w/welts on body & lip; seen 19MAY; treated w/DPh; 20MAY still has welts; cont DPH;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-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 31-Mar-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.50 for dose administered on 31-Mar-2021.  No concomitant medications were reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 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.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 at 9am with temperature 32 degrees Fahrenheit. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. 14 vials were moved to clinic. Product moved to clinic on 31-Mar-2021.  Vial was stored in cooler 1, on 31-Mar-2021, batch number 030B21A , Excursion duration at 8am 32, at 9 am 32, at 10 am 40, at 11 am 42, at 12 pm 43, at 1 pm 44, at 2 pm 46, at 3 pm 46, at 4 pm 44 and 5 pm 44 taken using a Fisher brand traceable temperature monitor in F at every hour.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received vaccination 5/19/11. Patient came into pharmacy on 5/22/11 complaining of her arm being sore, red and swollen. Also the patient complained of pain radiating down her left arm and into her left side of body.
Dizzyness, nausea, hives to both arms, fever 101.7, malaise.
Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL8982) via an unspecified route of administration on arm right on 15Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included occipital and trigeminal neuralgia, C5-C6 cervical cage, temporomandibular joint syndrome (TMJD), cerebrospinal graft. Known allergy: shellfish, walnuts, mustard, sweet potato. Concomitant medication included gabapentin, acetaminophen. The patient previously took penicillin B, phenergan and chloral hydrate (PHENERGAN), Codeine and linalool, all experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Jan2021 06:00, the patient woke up with a bad headache that triggered a neuralgia attack. It persisted for 24hrs. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
Information has been received from a health professional concerning a 71 year old female with gastroesophageal reflux disease, an allergic to ciprofloxacin hydrochloride (CIPRO) and pneumococcal 23v polysaccharide vaccine and a history of mastectomy with reconstruction for cancer who on 05-JUL-2005 was vaccinated subcutaneously in the right deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#649694/0386P).  Concomitant therapy included alendronate sodium (FOSAMAX), rabeprazole sodium (ACIPHEX) and "acebutolol".  On 07-JUL-2005 the patient called and complained her right arm was red, hot and swollen between the elbow and shoulder.  She denied shortness of breath or any problems breathing.  She was told to come in for an appointment but she declined.  The patient recovered on an unknown date.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from a pharmacist via company representative and refers to her friend of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dos and route of administration were not reported). On an unknown date, the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because the reporter did not want any follow up.
what began as memory loss and irritability was followed by loss of motor skills,  later diagnosed as Cruetzfeldt-Jakobs disease.  Death occurred early morning 10/29/2021.
she said she was getting lupus flare-ups; she said she was getting lupus flare-ups; Her wrist was swollen and hurting; Her wrist was swollen and hurting; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist reported for a 25-year-old female patient. A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route on 05Apr2021, as a single dose for covid-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. On an unknown date in Apr2021 (on Tuesday or Thursday), she said she was getting lupus flare-ups. The only thing she can attribute it to be the vaccine. Her wrist was swollen and hurting on unknown date in Apr2021. Reporter would like to know whether there was any correlation between the patient lupus flare-up (swelling and pain in the wrist) and the covid vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Lupus flare-ups, Swollen wrists and Wrist pain. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received vaccine and went to observation area. 5 minutes after, she reported feeling "out of body" and like her "limbs were not working with her body". She also stated that she saw blacks spots. Patient denied any previous vaccine reactions and any previous allergies. She did confirm that this happened once before when she was in college after receiving an antibiotic shot.  Patient denied lying down and a cot, however she did agree to a juice box and crackers. She denies diaphoresis, trouble breathing, trouble swallowing and any respiratory distress.  Patient advised to wait an extra 15 minutes and to let someone know when she was leaving. Patient started feeling better towards the end of the interview.