chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills 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 was selected as adult as per vaccine indication. The healthcare professional stated that, another pharmacist had a patient who reported chills after receiving Shingrix. No other details were provided by the reporter.
After vaccine administered, patient had intense itching. This happened within 1 hr of administration. Rash was not discovered until morning of 10/23/2013. Rash/itching treated with Hydrocortisone 1%,  patient still recovering, but better today.
09/10/2022 I received my Covid-19 vaccine. On 03/06/2023 I noticed I had a sprained neck injury. I went to the doctor on 03/08/2023 and was prescribed muscle relaxers.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 64-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        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 was not reported by the reporter.
This spontaneous report as received from a 83 year old male patient regarding himself. The patient has high blood pressure and heart condition. On an unknown date in 2013 (reported as two years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported). Concomitant therapies included aspirin, unspecified heart and high blood pressure medications. On 13-NOV-2014 (reported as 1 week ago), the patient noticed that he had some itching and cluster of pimples. On an unknown date in NOV-2014, the patient was in pain. Since the patient was in pain and itching he applied some ointment. There was no lab tests performed. The outcome of the events were unknown. The patient did not seek medical attention. Additional information has been requested.
over 42 days. 1st dose 08/15/2021, 2nd dose 09/20/21
Possible adverse reaction to the Moderna vacccine; Episodic recurrent tachycardia; Hypertension; Palpitations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Possible adverse reaction to the Moderna vacccine), TACHYCARDIA (Episodic recurrent tachycardia), HYPERTENSION (Hypertension) and PALPITATIONS (Palpitations) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccine.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ADVERSE EVENT (Possible adverse reaction to the Moderna vacccine). On an unknown date, the patient experienced TACHYCARDIA (Episodic recurrent tachycardia), HYPERTENSION (Hypertension) and PALPITATIONS (Palpitations). At the time of the report, ADVERSE EVENT (Possible adverse reaction to the Moderna vacccine), TACHYCARDIA (Episodic recurrent tachycardia), HYPERTENSION (Hypertension) and PALPITATIONS (Palpitations) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information and concomitant medications were reported.   Reporter did not allow further contact
Had Varivax vaccine 03/06/02, Dev Varicella 08/30/02
severe leg and hip pain; severe leg and hip pain; painful to walk; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Feb2021, the patient developed severe leg and hip pain, making it painful to walk. The patient asked if these were from the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
One week after 2nd dose patient developed 1 1/2"x 3/4" welts on her cheekbones with redness to the tissue.  She states it felt pliamble to the touch, thicker than fluid.  Her dermatologist,  saw her and she was treated with a steroid injection,  in the left welt area under her right eye, unsure of name of medication she received.  The dermatologist  told her today during her visit that her reaction was due to her covid vaccine (Pfizer).  Patient had fillers done 5 years ago (Juvederm).  The smaller welt on the left side cheekbone area has gone down and is barely noticeable now so she did not get a steriod injection in that area.  She is schedule to return to see her dermatologist in 6 weeks.
Consistent mild chest pain.  Random instances of persistent gag reflex, no associated nausea. Happens 5 or 6 times in a row, barely avoid vomiting. Bleeding of gums, severe, while brushing teeth.
After getting vaccinated , pt sat in the waiting room for 15 minutes. While sitting he fainted and another customer caught a hold of him. I was called out and I see the boy on the floor . I told him to sit still and rest and not to do anything. I went back in pharmacy to call manager to see if we can get some water for him. I also had someone page mom because mom went shopping. When I went back out to see the boy, his mom was there and he was drinking some water. I came out to talk to mom. while I was there, the boy started to shake and complained of chill. He look pale, so, I went and called 911. They transfer me to the fire department. They said to have him stay where he is and not have anything to eat or drink just incase her may throw up.I told mom.  After that , I went about doing my things . Then emergency came . Then they all left. About 7 pm that day I called mom for follow up and she said he was doing ok.
Neck tightness, left and right trapezius tightness and inhibiting the movements. Took 2 tabs of Naproxen 220 mg.
upper arm numb and felt heavy immediately after administration and for a couple days after administation-no general symptoms only localized to upper arm
There has been no adverse event as of this forms completion. However, the risk for significant adverse event warrants the occurrence documentation. My office contacted the manufacturer - Merck - employee there forwarded me to the Medical Team Rep -with their National Service Center. She in turn forwarded me to employee at Global Medical Dept for further guidance and care recommendations for the infant in general terms. The child's mother was then contacted around 1245pm.
Despite rx of vacyclovir of 1g daily as a preventative, rapid shingles eruption, size larger than half dollar coin within hour of first sign of shingles on 4.3.21. Began active shingles rx, of 1g of vacyclovir 3/day.  As of 4.10.21, still recovering.
Noted 04/27/05 Nickel size red area at immunization/injection site on right leg.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored ZOSTAVAX (lot # L021609, expiration date: 10-SEP-2016; lot # L035284, expiration date: 15-DEC-2016; lot # L029484, expiration date: 06-NOV-2016; dose and route were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had Moderna, both doses. I was due for the booster and got Pfizer. Within a week, I noticed my scalp turning red in a dime-sized area. No injury, no rash or cuts. Just reddened. It appeared to be missing a little bit of hair in the area. Over time all the hair in that dime-sized area fell out, as well as in another much smaller area adjacent to that one. I was diagnosed with alopecia areata shortly after. I have never had problems with my hair until after the Pfizer vaccine.
severe diarrhea 2 days p/vax w/no fever; no fussiness; knot in lt parotid gland that involved lt side of face & neck; prev shots had no knots @ site of inject but this time both inject sites were red & hard x 3 days;
This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Hepatitis B vaccine for prophylaxis. On an unspecified date the subject received primary course and booster dose of Hepatitis B vaccine (unknown manufacturer). At an unspecified time after vaccination with a complete series of Hepatitis B vaccine, the subject experienced not responding to therapy. The surface antibody titers were negative. A booster dose of hepatitis B was given and the titers are still negative. It is unknown when the titers were taken. Medical attention was required at the physician's office. At the time of reporting the outcome of the events was unspecified.
devel hives 3 days p/inj, persisted for over a week; pt also had a fainting spell 16 days later;
fever 103.2 @ office reported higher @ home); irritability & crying x 12 hr;
had the vaccine still got shingles/Suspected vaccination failure; Shingles; 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.   The patient's past medical history included cold sores (had cold sores all his/her life).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she never had chicken pox but had cold sores all his/her life. The patient got Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
pt recvd vax 28DEC94 & 3JAN95 devel diffuse arthralgia & fever 101.5-seen by MD;9JAN95 dx w/bronchitis sx consisting of yellow sputum & cough;trouble using hands d/t inflamed joints;cont exp migratory arthralgias & myalgias;ANA +;urticaria
2 dose of Havrix after one month of the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 44-year-old female patient who received HAV (Havrix 1440) (batch number unknown, expiry date 20th May 2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440).   On 11th November 2021, the patient received the 2nd dose of Havrix 1440. On 11th November 2021, unknown after receiving Havrix 1440 and an unknown time after receiving HAVRIX 1440, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The reporter consented to follow up. Additional Supportive Information: The reporter reported that ,a patient been inadvertently given the 2 dose of Havrix after one month of the first dose, which led to shortening of vaccination schedule.
Pt developed shortness of breath, wheezing & flushing within minutes. He received EPIPEN, Prednisone, Albuterol & BENADRYL & was transported by ambulance to the ED. He developed petechiae on upper body.
Adult patient inadvertently received incorrect vaccine on 10/1/08. Patient received pediatric Dtap. Patient stated he had no adverse effects from the vaccine.
Day 4 through day 9 after the vaccine I developed hives all over my body, fatigue and both wrist had pain.  I am pregnant so I used hydrocortosone cream, zyrtec and benedryl to help with the hives and consulted with an allergist who  stated he will prescribe steroids if they symptoms persisted and he was concern that I had serum sickness because of the joint pain and hives Estimated delivery date 6/2021.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates since 13-JUL-2015 the patients were administered with PEDVAXHIB, lot# K025002 with expiration date of 20-JUL-2017, (strength, dose, route and lot number unspecified), which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache. Additional information: Treatment included paracetamol (TYLENOL) (regular Tylenol).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1. Red swelling induration 2" X 1" noted on right thigh.  2. Warm compress and observation. Right thigh lateral side red and swelling around DTap injection site, it is about 5 X 6cm with mild tenderness. Warm compress and observation
The patient called at 4:45 pm to tell us about symptoms he was experiencing after receiving his covid vaccine today. He said he had arm pain from his elbow to his shoulder that was  a 7 out of 10. He reported being dizzy and nauseous. He said he had a low-grade fever and most importantly,  he was disoriented. He said that these symptoms started to appear about 45 minutes after receiving the vaccine.
Patient was administered expired IPOL (On: 13-Mar-2021) vaccine with no reported AE.; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information  (Reference number- 00544725) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 2-month-old male patient who administered expired IPV (VERO) [IPOL] vaccine on 01-Apr-2021 [Expired product administered].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 01-Apr-2021, the patient received a dose of suspect IPV (VERO) [lot R1B252M and expiry date: 13-Mar-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used [Latency: on the same day].  It was reported that, the caller would like to know if the patient must be revaccinated and if there would be any adverse effects. The caller stated that a patient was administered IPOL today, 01-Apr-2021, less than 1 hour ago.   Details of laboratory data not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
severe upper arm & shoulder pain bilateral brachial plexitus; hyperasthesia; swelling of fingers & ankles; triceps atrophy; weight loss, rash, flushing, sweating; weakness, neck pain; pain & numbness in lt leg;
Patient reported small bumps/hives on both wrists after 5 minutes of immunization. About another 5 minutes later patient stated her tongue was started to swell, at which point a dose of epinephrine 0.3 mg was administered into upper right thigh and 911 was called. About 5 minutes later 911 instructed us to administer second dose of epinephrine as she was unable to speak to us. She remained upright and alert until the paramedics arrived and took her to the hospital. Total time in the pharmacy area after reaction occurred was approximately 20 minutes until paramedics arrived.
following immun, pt felt horrible all over, took tylenol and devel no systematic sx. arm was very red and swollen.
This spontaneous report as received from registered nurse refers to a 50 year old female patient. On 25-MAR-2011 the patient received a dose of VARIVAX (Merck) (Lot #0747Z, exp. date unspecified, 0.5ml dose, subcutaneous route). Concomitant therapy was not reported. On 24-FEB-2014 the patient had a low titer of 0.91. The patient sought unspecified medical attention and received a booster of VARIVAX (Merck) on 05-MAR-2014 (Lot # J006161, exp date 20-MAY-2015). The patient's outcome was unknown. Additional information has been requested.
Explosive diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhoea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM OXIDE, VITAMIN D NOS, LEVOTHYROXINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced DIARRHOEA (Explosive diarrhoea). At the time of the report, DIARRHOEA (Explosive diarrhoea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
This is a spontaneous case, initially received from other health professional (nurse) on 29-Oct-2018, concerning a 03-year-old, male child patient. The patient did not have any medical history. The patient did not receive any concomitant medications. On 29-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, batch number: 252679 and expiry date: 30-Jun-2019). The patient's mother and the pediatrician were notified. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Child given sanofi pastuer fluzone immunization on 10/10/08 at pharmacy.  Presents to our office with redness, warm to touch and hives on 10/13/08.
Daughers arm swollen and hard at shot site for 1 week.  Redness.
about 4 hrs after  vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas,  No diarrhea but soft stools. today headache, and fatigue
The patient reports the evening of vaccination she had redness around the injection site - the redness spread over the next couple days, and was uncomfortable, also reports fever and nausea. Today, 8/29, some redness remained and went to see her physician at 2:15pm. Patient came here to pharmacy at approximately 6pm this evening to report the incident.
Mother called and reports it to use on hives and itching from head to toe, as of yesterday hives was better and almost gone today.
Patient's husband reported patient having pain, soreness at site of injection, headache, muscle aches, and fatigue and gotten worse so he took patient to emergency room. Both patient's Dr. and hospital doctors agreed and told patient that she had an adverse reaction to the second SHINGRIX vaccine shot. The first dose given 2 months prior she did not have this significant reaction just arm swelling and pain for few days. Patient was treated for adverse reaction in emergency room. Patient said she had chills, headache, every bones in her body hurts, hot/cold, shaking, sweating.  The following day on 2/14/19 she went to emergency room for few hours and was discharged.
FEVER FOR 2 DAYS. DELUSIONS 1ST NIGHT. NIGHT SWEATS FOR 2 NIGHTS
My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction.  Approximately 20-25 minutes after the shot, while driving home, I  felt dizzy and light-headed.  By the evening, I had a fever, chills, headache, body aches, pain in my left arm (shoulder, elbow down to my wrist); nausea and vomiting.  Condition lasted Tuesday evening and throughout Wednesday.  By Wednesday evening I felt a little better and by Thursday afternoon, most of the symptons had dissipated
Pt had moderate bleeding at injection site. A 23 gauge needle was used.  Pt is not on any blood thinners. Initially no bleeding after removing needle and then after a few seconds, bleed through band-aid and immediately placed pressure to clot.