chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/got both shingles shots 2 years, but have had shingles twice now; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and 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 was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received both shingles shots 2 years ago, but had shingles twice now in 2 months. The pain was real and it was horrible. For occurrence of 2nd episode of shingles, refer case US2021AMR241290. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241290:same patient, 2nd episode
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 30-APR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Contracted Covid-19.  Mild throat discomfort on 4/11/2021, identified exposure to siblings/family, all tested positive via rapid test same day.
COVID positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive after vaccination) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID positive after vaccination). At the time of the report, COVID-19 (COVID positive after vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  The patient had received the Moderna COVID-19 vaccine and was currently experiencing COVID-19. The reporter asked if the patient can be treated with the "defensa antibody treatment, 2 injections in the arm and 2 in the stomach area".; Sender's Comments: This report concerns a male patient with no relevant medical history who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever up to 102.6. Severe Myalgia and fatigue. Headache
Fever lymph node swelling arm pit with extreme pain body aches dizzy lightheaded pale. By the next day arm swollen. Collar bone lymph nodes swollen still has fevers body aches tearful.
27OCT94 c/o inc reddened area w/ sl swelling rt triceps area; redness is 4"x 5" pt states getting larger; some aching in shoulder deltoid area & extending to neck areas; pt advised s/sx of infection, use of heat or cold packs & antiinflamma
First dose / to a 38 year old / patient / Planed to be administrated on the same day of the call; Prescription and administration of a first dose of Shingrix to a 38 year old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received the 1st dose of Shingrix. On 6th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were reported as follows: The pharmacist reported that the patient had prescription and administration of a dose of Shingrix to a 38 year old patient, which led to inappropriate age at vaccine administration and off label use. The patient was planed to be administrated on the day of reporting. No further events were reported.  The reporter did not consent nor decline follow up.
rapid heart rate while resting; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (rapid heart rate while resting) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (rapid heart rate while resting). At the time of the report, HEART RATE IRREGULAR (rapid heart rate while resting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
I woke up with vertigo and increased heartrate. My heartrate continued to be elevated, especially at night, for about a month following the vaccine. I still experience a little vertigo from time to time--my doctor has diagnosed me with orthostatic hypotension.
sore @ inject site 36 hrs then swelling, welt 4.5 cm w/10-12 cm surrounding erythema; seen by ER nurse, t99.5, upper arm pain & warm w/swelling; had lump 5-6cm p/1 wk;
pt had pain in her right arm, headache, scratchy and fatigue the day of getting the vaccine.  The pain in her arm and the fatigue was getting worse.  Her left arm and hand started hurting and she had tightness across her back.  Her had pain in the left elbow. The pain was causing her a headache and to be nauseated.  On 4/8/2021 she went to Healthcare ER.  She had blood test and covid test with negative results.  She had an X-Ray of the elbow.  She was given medicine for pain and nausea. She was diagnosed w/ Arthritis of the elbow which she has never had before.  She was told to FU w/ PCP.  She saw her PCP the next week.  She was told to continue to take some pain meds she was already prescribed.  On 5/4/2021 the patient is still feeling very weak and fatigued all of the time. She still has pain in her both arms.  She says the arms are weak and heavy feeling.  She is finding it hard to function at the level she was before getting her 2nd dose of the vax because she gets too weak and tired.
It has now been more than 1 week since vaccination.  First couple of days were fine, but starting  26-FEB-2021, I've been exhibiting all of the following: Fever - Friday 98, Saturday (3 measures over 5 hours) 99.1, 99.3, 99.4, Sunday 98.5, Monday 99.4 (at night, work up in body aches), Tuesday(97.5), Wednesday 98.5 Chills - mild, 1-3 times. comes and goes through past week.  Occurs more at night.  Feeling cold - wearing sweat pants, two shirts, long sleeve shirt, sweater, during sleep.  Constantly add/remove clothes to regulate temperature. During day, have sweat pants + sweater on 78+ degree weather. Muscle pain - in back, moving daily. First started in right chest and back right shoulder, has now disappeared.  Now in middle of back, around spin area, hard and uncomfortable to sleep, taking IB profin helps alleviate pain, 2 to 3 tables over counter.  pain in throat around vocal box, could be due to sneezing, slight soreness to touch/aches. Feeling unwell - comes and goes, day starts fine, then around noon/1pm i get super tired and sleep.  Sleeping schedule is generally 10PM to 6AM + naps through day Lose stools - from 25-FEB to 27-FEB, cleared up on 29-FEB Coughing - started on 03-MAR-2021, slight about 1 to 3 times an hour. Headache - comes and goes, use IB profin only when trying to sleep, all other times i let it be.  Good news: No swelling at injection site No redness at injection site  No Swelling at injection site  Final notes: Just feeling up an down, not taking anything besides IB profin for pain management. I was going to work everyday pre-shot with out issue. Post-shot, not feeling well enough to report to work out of fear of spreading anything that i got. Weekend immune system. Slightly grumpy demeanure since sick and interrupted sleep patterns.
High fever 104 degrees 2 days after vaccine, dry cough and sore throat.
pt was screaming for over 3 hrs & had a t101; started w/fever & screaming 5 hrs p/shot; no fever or screaming in AM; pt was fine in AM;
Immediately after the vaccination the patient began to feel lightheaded and dizzy and reported feeling tingly. The patient was very sweaty and clammy and did seem to pass out for a few moments.  She slumped in her chair and was unresponsive for about 2 seconds. She then was responsive again and reported feeling nauseous and sweaty. Her blood pressure was obtained which was 80 / roughly 40 (hard to determine). The patient stayed responsive and did not pass out again. Due to the patient's low blood pressure EMS was called. EMS came to check the patient out and she declined further treatment in the emergency room.
Verbal Tourette's seems to have been triggered. Lots of loud and painful guttural signs - worse at night, but continuing during school day
she was awaken because the arm was itchy; in the morning she took a look in the mirror and it is red, it is like a wheel; tenderness in the arm.; soreness in the arm; A spontaneous report was received from a nurse concerning herself, who is a 78-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness in the arm, soreness in the arm, she was awaken because the arm was itchy, in the morning she took a look in the mirror and it is red, it is like a wheel.  The patient's medical history was not provided. Concomitant medications reported were atenolol 50mg, losartan 100mg, baby asrpirin for drug use for unknown indication.  On 03 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events tenderness and soreness in the arm. On 11 Feb 2021 she was awaken because the arm was itchy and was tender, in the morning she took a look in the mirror and it is red, it is like a wheel, it is still tender at the touch.  Treatment details included cortisone (roll-on),  Action taken with mRNA-1273 in response to the events was not reported.   On 4 Feb 2021 the outcome of events soreness in the arm was resolved. The outcome of events , she was awaken because the arm was itchy, she took a look in the mirror and it is red, it is like a wheel was unknown. The outcome of event tenderness in the arm was not resolved.
Large itchy rash on arm around injection site began around 9 days after first Covid vaccination. It is somewhat warm and swollen. It is currently the second day of rash and area continues to get larger.
First dose - a Medical Group; Reaction: Fainted at work, chills, body aches, fever, sweats, and weakness for 48 hours; Second dose; Reaction: Headaches for 24 hours, developed a red rash on left arm after 48 hours. Severe soreness and pain in left arm.
It was reported that a 30 year old female patient received aFluzone SV '01 -'02 vaccination, lot UO588AA, date of administration not specified. Sometimes after the vaccination, the patient developed a very sore shoulders on same side as injection with swelling and redness
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Weakness-Severe, Additional Details: Pt said after recieving vaccine and returning home they became very weak, lethargic and dizzy. family members had to take them to the emergency room.  Pt said ER doctors told her she had a reaction to the vaccine.
sunburn like rash on both arms, trunk, and back; not raised and does not itch
Fainted a couple minutes after shots received. Lost vision and partial hearing, but never fully unconscious. Lasted for a few minutes, asked to stay at office for 15 minutes to make sure ok.
Patient was diagnosed with HSP on 12/16/2021 after initially presenting with severe abdominal pain on 12/14/2021 and then developing the characteristic rash on 12/16/2021.
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 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:49 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 74.68. No concomitant medications were reported. Batch number 027L20A administered on 11-Jan-2021 underwent temperature excursion with temperature range of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 04-Feb-2021. 2 vials were sent to clinic. Product moved to clinic on 08-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Approximately 3-4 minutes after injection, patient stood up and said he didn't feel well.  Felt dizzy, lightheaded.  Took a step, fell to the floor.  Did not hit head.  Had a seizure while lying on the floor, lasting 1-2 minutes.  Felt okay for a few minutes, then had another seizure lasting 1-2 minutes.  911 was called.  Witness observed fixed pupils and sweating.  Patient taken by ambulance to local hospital.
KIND OF DRUNK FEELING; WHOLE BODY ACHING; URINATE EVERY HALF HOUR; "SEEING THINGS AS A THIRD PERSON"  LIKE SHES WATCHING IT; BAD HEADACHE; ARM WAS ON FIRE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced arm was on fire. On 15-MAR-2021, the subject experienced kind of drunk feeling. On 15-MAR-2021, the subject experienced whole body aching. On 15-MAR-2021, the subject experienced urinate every half hour. On 15-MAR-2021, the subject experienced "seeing things as a third person" like shes watching it. On 15-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was on fire on 15-MAR-2021, and had not recovered from kind of drunk feeling, bad headache, whole body aching, urinate every half hour, and "seeing things as a third person" like shes watching it. This report was non-serious.
Started going into own little world-spaced out, flapped like autistic kids. Developmental ? in every area.
SHE HAS URTICARIA ,RASH AND HIVES IN ALL THE BODY. ALSO AN ITCHING SENSATION.
Pt reports heart palpitations, racing heart , and pounding heart even when at rest. Shortness of breath and dizeness
RASH ALL OVER BODY. PT TAKING ZYRTEC 2 TABS EVERY 12  HOURS
Lost hearing in her right ear due to neuronitis possibly from live virus administration to nasal mucosa. 2/23/06 - medical record reviewed. Pt c/o R ear pain on 2/14/05 followed by dizziness and recurrent pain after treatment. On 3/4/05 pt was diagnosed with OM chronic mucosanguineous R ear and restarted on Biaxin and Duratuss. On 3/15/05, the patient was diagnosed with otitis media nonsuppurative serous after fluid was shown behind TM on audiogram. It was recommended that patient not receive further FluMist vaccines. An aeromedical summary dated 11/4/05 stated diagnosis as sensorineural hearing loss caused from FluMist vaccination. 03/31/2010 Follow-up: Permanent sensorinerial hearing loss most likely secondary to viral neuronitis (moderate to severe hearing loss).
Pediatric dose given to adult; Pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number A9349) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Pediatric dose given to adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The reporter reported that one of their employees gave another of their employees (patient) a pediatric dose of Engerix B, instead of an adult dose The reporter consented to follow up. A pediatric dose of Engerix B was administered instead of an adult dose which led to underdose and adult use of child product.
About 20 minutes after right cheek started twitching intermittently then became more frequent.; Right cheek feels numb; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, shellfish allergy, penicillin allergy and angiotensin-converting enzyme (ACE) inhibitors allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included BYSTOLIC, CLARITIN and BENICAR, all for unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination. the patient had not been tested for COVID-19. On 22Mar2021, about 20 minutes after, the patient's right cheek started twitching intermittently then became more frequent and about an hour later, the patient's right cheek felt numb. It was unknown if patient receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of facial twitching and numbness facial were unknown.  No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 4 vaccines Pfizer 3/10/21 lot# EN6207;  Pfizer 3/31/21 lot# ER8734;  Pfizer 11/18/21 lot# FH8030;  Pfizer 4/15/22 lot# FM9992
Pfizer-BioNTech COVID-19 Vaccine EUA. (booster shot).  Side effects: Tiredness, chills, fever, feeling unwell, decreased appetite.  Fever began about 9PM (12 hours after injection) and continued to increase for about 4 hours at which time it "broke".  When the fever broke the chills stopped.  Tiredness and decreased appetite continued for 37 hours during which time I slept almost continuously.  Thereafter, during a period of 3 days my appetite returned and I began to feel better.  I seem to be fine now
Left armpit lymph node pain and swelling 12 hours after the vaccine. Heat/cold doesn't improve. I have taken various pain medications (Tylenol, Ibuprofen) with no help. The pain is not as severe as it was 24 - 72 hours after the vaccine, but it still is painful and swollen.  Lymph nodes in groin swollen - no idea if it is related.   I called the clinic where I had the initial vaccine and they said call my doctor. My doctor said to call the walk-in clinic. The walk-in clinic said to go to the ER (and I won't go unless it is life or death - no need to take room there), and I called Moderna - no response.
achy; tired; chills; pounding head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (tired), CHILLS (chills) and HEADACHE (pounding head ache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), FATIGUE (tired), CHILLS (chills) and HEADACHE (pounding head ache). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN (achy) and FATIGUE (tired) outcome was unknown and CHILLS (chills) and HEADACHE (pounding head ache) had resolved.            No concomitant medications were reported   This case was linked to MOD-2021-366207 (Patient Link).
My trunk area starting itching. I developed a fine rash on chest/ abdominal area. A few hive like weals appeared on abdominal area. No other symptoms. I took Benadryl 50 mg . After a while itching subsided.  No further issues.