chrisvoncsefalvay/vaers-outcomes huggingface dataset:
infection was cellulitis at the site of injection; swelling at the injection site / shelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date 25th May 2022) for prophylaxis.   On 8th October 2020, the patient received the 1st dose of Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced injection site cellulitis and injection site swelling. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the injection site cellulitis and injection site swelling were unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced swelling at the injection site.  The patient visited their doctor where it was diagnosed as a possible cellulitis infection.  The patient was prescribed antibiotics for the infection.  After transfer of pharmacist from first line specialist, second line specialist further clarified with pharmacist that the reported infection was cellulitis at the site of injection. No further details were provided. The reporter consented to follow up. The case US2020206883 was deleted and all the information was merged into the case US2020206879.
Site: Pain at Injection Site-Medium, Additional Details: called to complain about pain that persisted from the shoulder down to the area of where the vaccine was given on 7/10/21.   She said the pain did not occur until the Wednesday after the vaccine was given which was on 7/14/21.  She is able to raise her arm and perform regular activities but she says it does hurt.
No additional adverse effects; improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided. On 13-FEB-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), one dose (lot number S030208, expiration date 25-MAR-2021) (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. No adverse events were reported. According to the reporter, the temperature excursion was -9 to 8/-4 degrees Celsius for a time frame of 20 minutes, without any previous temperature excursion. Digital data logger was involved.
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.   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 case was reported by patient. The age at vaccination was not reported. The patient stated that the he/she had every vaccine for shingles still experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
lips swelling; ankles swelling; still hasn't gotten his second shot 6 months after the first; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (lips swelling), JOINT SWELLING (ankles swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and BIMATOPROST (LUMIGAN) for an unknown indication.    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 LIP SWELLING (lips swelling), JOINT SWELLING (ankles swelling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first). At the time of the report, LIP SWELLING (lips swelling) and JOINT SWELLING (ankles swelling) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (still hasn't gotten his second shot 6 months after the first) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. (Patient herself- A healthcare worker) via other company (Merck). This case involves an unknown age female patient who accidently received vaccine PENTACEL in her eye. The patient's past medical history and concomitant medication were not provided. On 17-Sep-2018, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine lot number (Batch numbers: HIB: C5573AA and DtaP: C5427BA) expiry date: 13-Oct-2019) reported. It was a case of actual medication error due to Occupational exposure to product and exposure via eye contact. No adverse event 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 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. Documents held by sender: none.
While training a student, the student administered a vaccine to a couple (husband and wife). After administering the vaccine the student completed the vaccine card for the couple. The first dose on the vaccine card stated "Pfizer vaccine" given on 02/10/2021, and the student told them they would be receiving the second dose of Pfizer vaccine, they agreed. The consent form that was completed showed they were there for the second dose. After vaccines were administered, when entering vaccines into computer, it was noted that their first vaccine was Moderna. Meaning, they received Moderna as the first vaccine and they received Pfizer as the second dose.
Initial site soreness and two days of flu like symptoms, mild headache, muscle soreness/body achs, fatigue, after second dose.  Fatigue has persisted to this date
Appendicitis beginning 4/14/21, leading to surgery (appendectomy) 4/15/21
The following symtoms occurred within a few minutes after receiving the vaccine as I sat in the waiting room:  1. difficultly breathing  2. fast heartbeat  3. brain fog/dizziness.   These symptoms went away within approximately 5 minutes. The next morning I woke with a slight headache which didn't last very long. I had significant discomfort in the left arm at the injection site.  It felt like someone had inserted a balloon in the muscle.  It hurt to raise my arm to 90 degrees and above my head.  I became less aware of it about 9:00 pm the following night.  I called my doctor to report the side effects and it was recommended that I take 2 extra strength tylenol.  I still feel some discomfort at the injection site.
Two to 3 days (12/20-12/21) after her immunization, she started experiencing an achy pain in her arm. It spread from her upper arm to elbow to wrist. There was redness and some warmth in the arm, but no hardness. On 12/26, her arm got worse and she went to see her PCP. He denied infection and suspected a blood clot. She had a CT scan done which concluded it was not a blood clot. No other workup was done regarding the issue. Her symptoms later improved even though her hand was still swollen.
I started to feel like I had a Sinus infection, and I was due to get surgery, so I got a COVID 19 test, and it was positive. About three days after my symptoms started, I lost my sense of taste and smell. It was two weeks before it returned. It has been three weeks and it is still not 100%. I had no fever and no respiratory problems.  I had fatigue for a period of time and a little brain fog, but I was not as bad as I had expected. My Sinus congestion was the main symptoms with a headache. I stated to recover slowly after two weeks, and I am still a little fatigued after almost one month. I was not prescribed any medication.
Chronic eczema on scalp 4 months post vax (DTP 1). Also: projectile vomiting, "gags, regurgitates food" in chart at 9 months after DTP 1/2/3. Seborrhea/eczema on scalp and face. 10/28/92 MMR 1/Hib 4 above mentioned in chart 11/17/1992. Bloody diarrhea  for 7 days after DTP 4, administered 1/27/1993 (18 months old) .
Pt. received vaccines 2/1 430 pm. 2/2 8:15 AM mom reported child feeling achy all over. Pt had gone to school, no c/o arms except soreness. No fever. After school arms very sore with some redness/swelling - lime size. Advised Ibuprofen and circling swollen area. 2/3 AM swelling whole shoulder, axilla. Treated with KEFLEX. 2/4 2AM to ER for increased swelling and pain. ? cellulitis - IV CEFTIN - home with PO. 2/4 - on CEFTIN PO.
She described the reaction as hives, welts, and rashes; She described the reaction as hives, welts, and rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE 1, SINGLE), for Immunization. The following information was reported: URTICARIA (non-serious), RASH (non-serious), outcome "not recovered" and all described as "She described the reaction as hives, welts, and rashes". The events "she described the reaction as hives, welts, and rashes" required emergency room visit. Additional information included: The patient received the Prevnar 13 injection on 25Jul2022 in left arm. Since the injection she had been having a reaction on the left hand side of her body for more than 3 weeks. She has been to her primary care doctor, endocrinologist, and the ER. She described the reaction as hives, welts, and rashes. She would like to know if there is any information on this type of reaction and also like to report her reaction. She states that she believes she has had the PCV23 vaccine as well. The patient confirmed the hives, welts, and rashes are all ongoing and persisting, no change. The patient was not admitted to the hospital, just went to the emergency room on 07Aug2022. Prevnar 13: Had 1 dose of Prevnar 13 several years prior to caller's 2nd dose of Prevnar 13. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Broke out in pox-like lesions about 12 days after vaccines given. Resolving 08/16/04.
Red, swelling of eye, itching, burning pain all over face. Puffiness under left eye corner of left eye bloodshot. Has had shingles 3 times on this eye.
This spontaneous report was received from an administrator refers to an unspecified number patients of unknown demographics. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date the patients were vaccinated with improperly stored VARIVAX injection (dosing regimen unspecified) (lot M027885, expiry 30-JUN-2018) (dose, route and frequency unspecified) for prophylaxis. Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 7.7 F, Time frame: 24 hours, there were no previous temperature excursions. Was this a call because of a data logger was reported as no. No adverse effects were reported. No further information was provided. Additional information has been requested.
Stomach pain in right quadrant; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 27Jan2021 17:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stomach pain in right quadrant on 28Jan2021 with outcome of not recovered. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information of Lot/batch number has been requested.
Dizziness fatigue Narrative:  BP @ 1329; 142/92, HR 73. BP @ 1343; 130/91 HR 68
CONTACTED PARENTS, PARENTS WERE INFORMED OF ISSUE AND GIVEN THE OPTION TO REVACCINATE THEIR CHILD, THEY WERE ALSO CONSULTED TO CONTACT THEIR PEDIATRICIAN
had a serious allergic reaction to her first COVID 19 shot; passed out while driving her car; On the way home she started to feel sick; She had a small accident, hitting a street sign; The next day she started having respiratory symptoms and spent the day in the ER because she was having difficulty breathing.; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A female patient of an unspecified age received her fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a serious allergic reaction to her first COVID 19 shot. She waited after receiving the shot for 15 mins and felt fine. On the way home, she started to feel sick and passed out while driving her car. She had a small accident, hitting a street sign. The next day she started having respiratory symptoms and spent the day in the ER because she was having difficulty breathing. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Slight pain at the injection site; but mostly a large egg shaped hive that itched--that went away two days later
On 5th day p/vax pt exp flu sx & chest pains; rt side felt paralyzed; diarrhea sx started leaving & was able to go to MD 3 days later;
pt recvd vax & had a convuls 1 wk p/clinic visit 23AUG94; aunt feels that the multiple immun were the cause of pt's convuls; pt taken to hosp ER for rx;
Well in mid March I was diagnosed randomly with pre-eclampsia. Then later on I was admitted to the hospital after having high BP and I was put on magnesium and labetalol. I delivered my daughter on March 28, 2021. I also tested positive for Covid-19 and then an antibody test as well. I was unable to see my daughter in the NICU due to being positive for the COVID, but luckily my daughter tested negative. So I have never been pregnant before, and my daughter was supposed to be due on May 6th 2021. My daughter's birth weight was 3lbs and 3 ounces. I was discharged from the hospital on March 30th 2021. I was sent home with BP medication as well and that I was on for about four weeks, and it is nifedipine (60MG 1x daily for two weeks and then 30MG 1x daily for two weeks). I have also seen my OBGYN two weeks post giving birth and another appointment 6 weeks post birth as well. Also, just to say, I had no COVID symptoms when I tested positive for COVID. Like I said, my daughter tested negative but also, my mother was in the hospital room with me and all that, and my mother tested negative as well.
patient received a 0.05 ml invalid dose of Adacel ,No AE; Adacel was administered after being exposed to 30 Farenheit, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  The case is linked to the cases 2020SA209621 and 2020SA210303 (same reporter).  This case involves a 33 years old female patient who received a 0.05 mL invalid dose of  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiration date were not reported), after being exposed to 30 Fahrenheit via unknown route in the right deltoid as prophylactic vaccination on 09-Aug-2020.  Medical history, medical treatment and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  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 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.  There will be no information on the batch number for this case.
PATIENT HAD REDNESS AND HARDENING OF VACCINE SITE (LEG) AND BEGAN TO SHOW POX SPOTS ON BODY.
I experienced severe vertigo (the room seemed to be spinning) when I first got up from bed the morning after taking the first dose of VIVOTIF. The vertigo lasted about 2 or 3 minutes. I have experienced nothing that severe since, but for the following 4 days have experienced brief, moderate dizziness most of the time after getting up or lying down.
This spontaneous report was received from the patient's mother, concerning a 2 year old female patient. The patient did not have any medical history to report. Her concurrent conditions included allergy to dairy and egg. The patient did not have any concomitant medications to report. On 12-DEC-1997, the patient was vaccinated with the first dose of M-M-R II subcutaneously for prophylaxis lot #0015E (strength, dose, frequency and expiration date were not reported). On the same date, 3 hours after receiving the vaccination with M-M-R II, the patient began to experiencing a severe reaction including joint swelling, fatigue and generalized weakness. The patient sought for medical attention and was treated with prednisolone sodium phosphate (PEDIAPRED) liquid and a 6 day steroid regimen. On an unknown date, the patient recovered from joint swelling. On an unknown date in March 2001, the patient received a second "graduated dose style" of M-M-R II subcutaneously for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). The patient did not have any reaction following this administration. On 06-JUL-2018, when the patient was 22 year old, the patient had a measles titer test performed and it was failed, there was no immunity. On an unknown date, approximately in 2018, the patient died. It was unknown if an autopsy was performed. At the time of reporting, the outcome of fatigue, generalized weakness, measles titer failed and no immunity was unknown. The causal relationship between the vaccination with M-M-R II and the events was not provided by the reporter.; Reported Cause(s) of Death: Did the patient died: yes.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 09-JAN-2013 had administered dose of GARDASIL (lot # H011350 expiration date 21-FEB-2015) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the report from the same source. Additional information is not expected.
sick/felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick/felt sick) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (sick/felt sick). At the time of the report, MALAISE (sick/felt sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Client received 2 flu vaccines on 10/6/10. Received High Dose in one arm and regular flu vaccine in other arm. 2nd flu was given by mistake - PNEUMOVAX was to be given. Monitored client 10/6/10. She has scheduled appt. with MD 10/6/10 PM. Followed up with client daily. She has no adverse events.
Vaccine received 11/13 on 11/14 developed rash on chest, abdomen, neck, shoulders, arms.
mild soreness of jaw-generalized weakness had a bad reaction in 1976 (swine flu) pt jaw closed @ that time; no permanent disability;
Ringing in ears. Started with a shrill whistle in my left ear. Now is constant and debilitating in both ears.
injection site left shoulder pain - a lot redness moving down and around arm, swelling in and around injection site, very tender to the touch
got the shot. She 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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 case details were reported as follows: The reporter was patient's family member. The age at vaccination was not reported. The patient got the shot and she still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.