chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of nerve pain in a 71-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). Co-suspect products included HAVRIX (batch number 4H37Y, expiry date 8th November 2020). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and HAVRIX. On 14th May 2018, less than a day after receiving SHINGRIX and HAVRIX, the patient experienced injection site swelling (serious criteria other: As per reporter), injection site erythema (serious criteria other: As per reporter) and injection site pain (serious criteria other: As per reporter). In May 2018, the patient experienced nerve pain (serious criteria other: As per reporter). The patient was treated with TYLENOL and prednisone. On an unknown date, the outcome of the nerve pain was not recovered/not resolved and the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the nerve pain, injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX and HAVRIX. Additional details were provided as follows: The case was reported by the Medical Assistant. The patient was administered SHINGRIX and HAVRIX in the right arm. The patient reported that her arm was swollen, red and sore at the injection site and that reaction started later that same day and it was resolved within 3 days. Less than a week after receiving vaccination, the patient also experienced a nerve pain in her hands and fingers as well as a spot that when she touched it, it radiates and feels like a lateral line was going down the arm where she received the vaccine. This had not been resolved. The patient called the doctor's office and the doctor recommended TYLENOL, heating pad, and Prednisone 40mg daily for 7 days. The reporter stated the patient would not get the 2nd dose because of this reaction. The patient would follow up with the doctor. The batch number of the HAVRIX was reported as 4A37Y, however it was changed to 4H37Y as per latest sales data sheet.
1st dose years ago, 2nd dose wasn´t administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. Till the time of reporting the patient had not received their 2nd dose, which led to incomplete course of vaccination. The pharmacist reported that a patient being vaccinated with first dose of Shingrix two years ago from the day of reporting and the 2nd dose was never administered. The pharmacist did not had more information regarding 1st dose. The patient received the 1st dose and then moved to another city. The reporter consented to follow up.
Patient stated that 2 days after receiving vaccine she is having severe pain in her elbow. She did state that she has a chronic intermittent mild pain in her elbow. She is concerned the vaccination agitated the elbow condition, because the pain is very severe. I advised patient to contact her doctor for further evaluation.
Pt recvd vax 17JUL92 & became febrile 17JUL92 & vomiting x 24 hrs; fever persisted 4 days;
Day one had a fever up to 102. Day 9 had greater than 3 events in one day of paralysis of the right leg leading to collapsing mid run/walk. Went to ER. No findings noted.
expired dose of kinrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number pp9l5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Health care professional reported dose of kinrix was administered to a patient which was already expired on 16th October 2021. The reporter consented to follow up.
fever of 101.5F; chills/shivering; Body aches; headache (felt like 3 trucks had collided and exploded); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.5F), CHILLS (chills/shivering), MYALGIA (Body aches) and HEADACHE (headache (felt like 3 trucks had collided and exploded)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 101.5F), CHILLS (chills/shivering), MYALGIA (Body aches) and HEADACHE (headache (felt like 3 trucks had collided and exploded)). At the time of the report, PYREXIA (fever of 101.5F), CHILLS (chills/shivering), MYALGIA (Body aches) and HEADACHE (headache (felt like 3 trucks had collided and exploded)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Angioedema being treated with steroids Pepcid and benedryl. Patient Stable
pt devel severe erythema & swelling @ the inject site w/in 48 hrs of receiving Tetanus Toxoid Adsorbed; pt was treated w/Cephalexin for adverse event;
102 fever. 14 hrs after shot . For 24 hrs  Rash appearing post shot  aporoximately 4 days later -groin area and upper right hip. Continued to present it self interior arms soft skin  then back of legs. Fading as of 04-20-2021  in the. Sequential order of  the rash presenting itself Prior to rash extreme sensitivity to touch on right side hip. Peeling occurred after 1st shot on lower legs.  Benedryl seemed to help
MOC reported pt recv vax 17SEP93 & 3hr later devel a fever of 106 & became unconscious;pt was taken to ER & mom stated that now has multiple developmental delays;
patient self reported a fever of 107 taken with a temporal thermometer at 1700 the day of the vaccination. The patient used Tylenol a couple of times since the elevated fever. His fever initially reduced to below 102; he has not taken it recently and his temperature has been reduced to between 100.9 and 103.
40C temperature, chills, swollen upper arm, deep red upper arm skin, painful triceps, excess fluid around elbow and upper arm, inability to bend or use arm. Fever/chills subsided 8/31/2012 around 3:30 AM. Redness, pain, edema progressively decreased into      09/03/2012. No fever or edema treatment.
Patient reported she had some difficulty breathing and her throat was hoarse and raw about an hour after she received the vaccine.  When asked if she sought medical attention she replied, "No, I just had my family keep an eye on me".
She tested positive for COVID-19 on January 11, 2023.  She had a fever up to 102 along with a productive cough and runny nose.  Symptoms lasted for about 5 days.  She still has a productive cough, but only at nighttime.
C/o of nausea and dizziness. Stated she did not eat this am and takes metformin daily for pcos. States she sometimes feels nauseous when she doesn?t eat. Has never taken metformin on empty stomach
2 days after vaccine-woke up with low grade fever 99.  Left knee and thigh (lower) swollen sore to move. Pt flew to California saw MD-blood work showed positive Lyme disease. Started on Doxycycline and is going to ID MD.
Noticed red patch approx. 2 inches lower than injection site on arm and about the size of 3 quarters (around 10 am 12/22). Later (about 4 pm same day) still saw it and felt it was warm to the touch and swollen. Today (12/23 about 11:30 am) swelling is still present, redness and size is going down, and the warmth is slowly going away but still present.
Patient's wife stated that the patient felt very ill the night of getting the vaccine. His arm has been very red and sore. He is having to wear an ice bandage.
No additional AE reported.; a patient was administered an expired dose of MMR II.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-FEB-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot # S004118, expiration date: 11-FEB-2021 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis.  There was no previous temperature excursions. No additional adverse event was reported.
Patient was seen 1-10-2022 for eyerolling that began 4 days after this dose. The movement lasts < 1 minute and frequency has increased to 30x per day. It has started to cause eye pain.
Administered 10:40 am, by 2 pm pt screaming, left thigh swelled to 3 x normal size, redness, tender, crying. Mom gave acetaminophen, cool compress to area, swabbed area with iodine. By 5 pm only swelling remained - for a fe days.
This represents a re-challenge reaction, similar cascade of neurologic and neuropsychiatric difficulties following Td and Hepatitis B-2 injections in childhood. 1. GERD, significant, requiring treatment with gaba-nergic Baclofen, within days. 2. Major Depression symptoms over next two weeks - medication initiated. 3. Obsessive Compulsive symptoms marked especially by morbid indecision. 4. Aseptic Meningitis, possibly Drug-Induced, requiring hospitalization, onset about 4.5 months post-injection, hospitalization. 5. Worsening of neuropsychiatric symptoms ultimately resulted in suicidal ideation and first-ever psychiatric hospitalization for same
severe ecezma outbreak occurred all over my body; immune system has not returned to normal yet; I still have a severe rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 at 15:45 as dose 2, single (Lot number: EW0164) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer/AMIRAC, prev dose brand unknown=False, prev dose lot number=EW0150 , prev dose lot unknown=False, prev dose administration date=01Apr2021, prev dose administration time=03:45 PM , prev dose dose number=1 , prev dose vaccine  location=Left arm, SEVERE ecezma outbreak occurred all over my body one week after first dose), administration date: 01Apr2021, when the patient was 51-year-old, for COVID-19 Immunization, reaction(s): "SEVERE ecezma outbreak occurred". The following information was reported: RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "I still have a severe rash"; IMMUNE SYSTEM DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "immune system has not returned to normal yet"; ECZEMA (non-serious) with onset Apr2021, outcome "not recovered", described as "severe ecezma outbreak occurred all over my body". The events "severe ecezma outbreak occurred all over my body", "immune system has not returned to normal yet" and "i still have a severe rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, immune system disorder, rash.  Additional Information: Vaccination type facility was other. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had  been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are needed. No further information is expected.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A female patient in her 80's received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed), for Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02May2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive.  Clinical course: Reporter scheduled for second booster of pfizer Covid 19 today however they spent the whole day yesterday with their Son. the son tested negative for Covid previously however he tested positive Today. Reporter would like to know if they should receive the second booster dose today given the fact that they have been in close proximity with a person who tested positive for Covid. The reporter and his wife have not yet tested for Covid infection. Patient tested positive today, 02May2022 and has appointment for the second booster of Pfizer Covid-19 later today. Clarification of what patient tested positive for not provided as caller unwilling to provide any further information for this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200649519 same reporter/drug/AE with different patient
DOSE INJECTED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS/VACCINE VIAL WAS PUNCTURED YESTERDAY AND LEFT  OVER NIGHT IN THE FRIDGE; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a 23 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced dose injected outside of recommended storage conditions/vaccine vial was punctured yesterday and left over night in the fridge. On 03-JUN-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose injected outside of recommended storage conditions/vaccine vial was punctured yesterday and left over night in the fridge and poor quality product administered was not reported. This report was non-serious.
Per pt. she had a bad swelling and pain with redness and warm to touch all over (R) upper arm the ff. day after vaccine. She went to ER, diagnosed with cellulitis. Tx with KEFLEX and SEPTRA. Today (1/4/10), swelling subsided, c/o only minimal pain.
Patient received Janssen COVID vaccine on 4/6/21. On 12/30/21, patient tested positive for COVID. On 1/5/22, patient admitted to our facility with acute hypoxic respiratory failure secondary to COVID-19 pneumonia on high flow. Patient transferred out of facility to med/surg unit today (1/11/22) and currently still hospitalized.
Although the child was fully vaccinated, the child tested positive for Bordetella Pertussis by PCR on 10-24-2022
This patient had a very inflammed red arm, body ache, headache, and nausea.
over 6 months since the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2SP, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019).   On 25th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 25th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was a pharmacy technician. The age at vaccination was not reported. The patient received 2nd dose intramuscularly into her left deltoid later than the recommended interval, which led to drug dose administration interval too long. The reporter inquired if a patient needed to restart the Shingrix series if it had been over 6 months since the 1st dose. The reporter was not asked for consent to contact health care professional because the patient was not available to speak to.  The reporter consented to follow up.
Patient received PCV23. Went to check out. Apprx 2-5 minutes after injection patient c/o feeling very hot, dizzy, fatigue, "funny", with upper back pain and spasms. BP became elevated.
face flashed. Accelerated heart rate. At 8pm went to bed, at 10pm walked up with chills, fever and body aches. At midnight head ache continue, body aches, chill till 4am. By 5am all symptoms were gone but head ache remained. At 6am took EXCEDRIN by 7am head ache subsided. During the night had a full bladder; had to empty three times. Urine had an unusual medicine smell. all symptoms were away by 8am next morning
SIGNIFICANT SIDE EFFECTS; A spontaneous report was received from a Consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events significant side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number)  for prophylaxis of COVID-19 infection.   on an unknown date, patient experienced significant side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of event, significant side effects was not reported.
Tired and fatigued for 2 days.  Minor joint and muscle ache. Headaches
Information has been received from a physician concerning a 6 year old patient who on 18-JUN-2007 (also reported as 19-JUN-2007) was vaccinated with a second subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot #656692/0457U). Secondary suspect vaccine administered on the same day included Havrix administered in the same arm. On 19-JUN-2007, the patient developed a rash that was red and hard around the injection site and had hives. The patient was treated with cold compresses and Benadryl (unspecified manufacturer). No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
pt recv vax 15CT96 pt devel GI sx, nausea & diarrhea later that evening;the next had h/a & itching around the collar & neck;2 days later had hive devel on forearm in morning (less than 48hr p/dose given);
Cough bamlanivimab 700 mg, etesevimab 1,400 mg in sodium chloride 0.9 % 100 mL infusion  Admin Date  04/23/2021  13:08 Action  New Bag Dose  700 mg Rate  310 mL/hr Route  intravenous Administered By  RN
Approx 8 hrs after FLUCELVAX injection pt experienced right lower eyelid area swollen and puffy - she took BENADRYL and over a few hours swelling went down.
I had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose; This is a spontaneous report from a contactable Other HCP (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 1284), via an unspecified route of administration in left arm on 12Jan2021 15:15 at second single dose for COVID-19 immunization. The patient medical history was not reported. No COVID prior vaccination. No known allergies. Concomitant medication included sertraline. No other vaccine received in four weeks. The patient previously tool first dose BNT162B2 (Lot number: EL 1284) on 22Dec2020 03:30PM in left arm for COVID-19 immunization. The patient had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose. Adverse event start date/time: 12Jan2021 10:15 PM. No treatment received for AE. No COVID tested post vaccination. Outcome of the event was recovered in Jan2021.
Urticaria within 1 hours of vaccine. Treated with Benadryl.
Body ache's, chills and low grade fever started approximately 11 hrs. after the shot.  Symptoms lasted approximately 18hrs and felt fine after that.  Took Advil and Tylenol.
Symptoms: SIRVA: upper shoulder numbing pain that got progressively worst and turned into sharp pain for 2-3 weeks after the first shot. Having to alter lifestyle to take care of the shoulder.
Pregnancy is normal no problems, EDD is 07/11/2018. On 6/22 vision was blocked by sparkles in eyes like bright lights that float accompanied by lightheadedness. Those symptoms continued until 6/23 at 5:00pm when symptoms of vomiting, diarrhea, contractions and body pain were added to the blurry vision and dizziness. Symptoms of vomiting/diarrhea subsided at 10:30pm on 6/23 and contractions stopped at 11:40 pm 6/23.
Fever, chills, cough. Officially tested positive on 01-06-2021. Two days after receiving vaccine.
This case was reported by a consumer via call center representative and described the occurrence of influenza in a 18-year-old female patient who received Influenza vaccine. The patient's past medical history included influenza (experienced last year, before receiving the vaccine). Previously administered products included Influenza vaccine with an associated reaction of influenza (Caller reports that at least once, maybe twice, her daughter had influenza after receiving the influenza vaccination. She does not know what brand her daughter received that/those year(s), or what year(s) this occurred.). Concomitant products included ZYRTEC. On an unknown date, the patient received Influenza vaccine (intramuscular). On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced influenza and possible vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the Influenza was recovered/resolved and the outcome of the possible vaccination failure was unknown. The reporter considered the influenza to be unrelated to Influenza vaccine. It was unknown if the reporter considered the possible vaccination failure to be related to Influenza vaccine. Additional details: This case was reported by patient's mother. This case was linked to US2014GSK011257 as it refers to the same patient.