chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given on 11/19/18 at school flu clinic. Mom states child's arm became red and swollen, took to walk in clinic on Wednesday 11/21/18 and was diagnosed with cellulitis/bacterial infection and given antibiotics. Spoke with mom today, child has finished medication and is no longer symptomatic and is doing well.
Pt did not respond when trying to wake her the AM of 2/18/00. Pt was cold, clammy, shallow breathing, eyes rolled back into head, lethargic. Dx: Obtunded & admitted to ER. Given IV & glucose solution. Blood sugar was 38 & keytones high. FU received notes that pt "has been recently dxed with ketotic hypoglycemia - this appears to be the cause of the events in question." Annual follow-up states the pt was hypoglycemic and it does not appear that the reaction was due to the vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced slight injection site pain after receiving 1st dose of SHINGRIX. For tolerance to 2nd dose refer linked case US2018GSK162343, for same patient.
BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS FOR ARM AND CHEST.
It is believed by the on call doctor that the DTaP (unsure of which DTaP was received) was the vaccine given in the right thigh which is where the reaction site is. Vaccine given Friday morning, but Saturday evening, right thigh was red, raised, and warm to the touch, as well as itchy. A circle was drawn around the site. By Sunday evening, the site had gotten bigger and more itchy. Does not seem to cause any pain and no other adverse reactions to report. Doctor said to give MOTRIN and call if anything else changes.
Case previously recorded as MA2009-4375. Initial case report received from a health care professional, via Novartis Medical Communication on 12 NOV 2009. A 2 year-old female patient was vaccinated with 0.5 ml of FLUVIRIN (batch no. 102041P, expiration date 31 MAR 2010) i.m. on 11 NOV 2009, an off-label indication. No adverse event was reported. Agency reference no.: NA09-008119.
migraine; Vomiting; low grade fever and headache; headache; chills; light sensitivity; This is a spontaneous report from a contactable Nurse (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 18Dec2020 around 07:45 at single dose for COVID-19 immunization. Anatomical location of administration provided as left upper arm; deltoid. Medical history included migraines (Hasn't had one in a while). There were no concomitant medications. There were no prior vaccinations within 4 weeks. The patient previously took FLU VACCINE and had a low grade fever. The patient experienced low grade fever and chills on 19Dec2020, Headache with Light sensitivity: Woke up in the night with the headache after going to bed on Saturday, 19Dec2020. The patient has been vomiting off and on since Sunday, 20Dec2020. Caller stated she got the vaccine on Friday the 18Dec2020 and now has a low grade fever and headache and asked if she can take Tylenol or Ibuprofen for her symptoms. She also asked if she is allowed to take these before her next dose. Caller asked since she was experiencing symptoms with first dose is it likely she will experience them for second dose or it would be worse. Specifically, it was reported that late Saturday, the patient started running a fever and chills between 4PM and 5PM on 19Dec2020. She knew it was a potential side effect and minor. Got a headache since then and with light sensitivity. She wasn't sure what she could do to break it. Turned into a migraine on an unspecified date and has had vomiting. Vomiting occurs with her migraines, but hasn't had a migraine in a long time. The patient wasn't sure if she could take Ibuprofen or Tylenol with the vaccine. The light fever and chills is listed on the potential side effects she received. She can't focus with the headache she has. Called in to work. The patient knew COVID Vaccine could cause headaches. Think the headache started and ballooned into a migraine. Has been vomiting off and on since Sunday, 20Dec2020. Thinks the vomiting is from the headache and not the vaccine. Not due for next dose of COVID Vaccine until 08Jan2021. Wants to know if she is likely to experience the same symptoms with the second dose. Or if the symptoms will worsen. The outcome of the events was unknown. The seriousness provided as between not serious and medically significant. The causality assessment for events fever and chills, headache with light sensitivity with suspect vaccine provided as Related by Primary Source Reporter via Method of assessment Global Introspection.
The day after receiving the Shingrix vaccine, symptoms of shingles in my right eye began to appear.    Within less than a week Dr diagnosed it as shingles.   She prescribed Valacyclovir,  Prednisolone Ac 1% Eye Drop, Gabapentin, Ibuprofen, Acetaminophen. The incredibly intense pain lasted 6 weeks.
Patient received Pfizer vaccine on 3/18/21. Approximately 15 minutes after administration he fainted. Aid was rendered and he recovered quickly. Vitals were checked, and ice pack given. 911 was called and patient left with paramedics.
I received the vaccine at 2:00 Tuesday Oct 12th. That evening I felt so weak and my heart seemed to be beating hard.  When I tried to get up at about 5AM the next morning I was so dizzy, I actually fell back into the bed.  I was not able to walk for about one hour.  After about 5 hours I was over it, but still quite worn out and extremely weak.   I knew right away it had to be a reaction to the flu shot.  I called the Health Dept on Thurs of that week but they were giving out shots and did not have anyone to man the phones, I was suppose to leave a message.  I did not.
DIZZY, SEVERE HEADACHE, MUSCLE ACHES, FEVER, INJECTION SITE SWOLLEN APPROX 4 IN IN DIAMETER. EXACTLY ONE WEEK LATER SWELLING IN ARM REAPPEARED.
p/2nd dose of Hep B vax pt exp an inflamed area around site which was about 5 inches in size;
severely sick for 6 weeks; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got severely sick for 6-weeks (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient got severely sick for 6-weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Approx 10 days after shot  - severe pain in muscle part of arm, neck gland protruding , swelled, neck pain going all way to ear- previous to this time  could not lift arm above waist- not concerned at first but kept getting worse and extending to neck, shoulder,  upper arm.  Some swelling  in hand as well numbness - fullness feeling in inside of arm especially at bend and hard lump in muscle of arm. I had this w first shot, filled report, met w 3 doctors, each prescribed  different rememdoes.  First time went to UC - prescription for steroids & ice. Family dr back from seminar visit - said should never have prescribed steroids  -- prescribed heat, topical cream.  2nd shot effects mush later showing - this time dr prescribed xtra strength Tylenol,  ot ibuprofen.  Do not want to talk meds, want to know why this is happening. Since last major surgery, 2019, after 2 others in 6 years, only take low dose aspirin & vitamins pills.
Initial unsolicited misuse case received from a non-healthcare professional (Social media) on 19 March 2016. Case was linked to 2016SA068811 (same reporter, vaccine and source). This case involves a 30 years old female patient who was vaccinated with a dose of Flu Vaccine (batch number, expiry date and route of administration were not reported) in hand (poked it) instead of TUBERSOL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Hours later I was informed that they had somehow mixed up the vials throughout the day and the nurse had injected me with the influenza instead of TB under my skin. Patient medical history and concomitant medications were not reported. It was reported that patient had taken TB tests before but stated that experience with her nurse on the day of vaccination was unusual. On an unspecified date, after vaccination patient experienced injection site swelling which began to welt up. It was a case of wrong vaccine administered and wrong route of administration. Lab tests and corrective treatments were not reported. Outcome of the events were not reported. Documents held by sender: none.
Accidentally administered 4th dose of Pfizer when patient was not immunocompromised per current guidelines
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed fever and experienced chills and achiness after receiving vaccination. On approximately 24-JUN-2008, "within the last ten days" the patient was seen by emergency room physician. The outcome was unknown. Additional information has been requested.
The injection site was swollen, I had a fever, body aches, joint aches, and fatigue. This lasted for about 5 days. I was prescribed a cough suppressant and antibiotics. I am feeling much better now. My voice is still giving out and I still have some congestion, but I am much better.
The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date; No adverse event; Bivalent Moderna vaccine was administered after date of expiry to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  No treatment medication was provided.  This case contains information for the 19th out of 19 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Slightly edematous arm - warm to touch at injection site. Cold packs to arm x 20 minutes, then off. OTC Advil for discomfort - follow up with PMD.
Patient received vaccine beyond 30 days  on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days  on the fridge) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days  on the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days  on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Second dose and first dose details were not reported Expired doses of the Moderna vaccine was administered to 25 patients. The vials were in refrigerator for over 30 days. Number of doses per vials on 27-Sep-2021 1 vials of 14 doses and on 29-Sep-2021, 1 vial, 11 doses. Date the vial was initially stored in the refrigerator is on 24-Aug-2021. Dates of administration of vaccine on 27-Sep-2021 and 29-Sep-2021.   This case was linked to MOD-2021-338604 (Patient Link).
booster was different from the lot number with a combination of 2 letters and 4 numbers; very very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Sep2021 (Lot number: 30135BA, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "very very sick"; PRODUCT LOT NUMBER ISSUE (non-serious) with onset 28Sep2021, outcome "unknown", described as "booster was different from the lot number with a combination of 2 letters and 4 numbers".  Additional information: Caller was a consumer who received her booster dose of the Pfizer Biontech COVID19 vaccine on 28Sep2021. Caller said the lot number for her booster was different from the lot number with a combination of 2 letters and 4 numbers. Caller said the pharmacy was now giving the vaccine with lot number of 2 letters and 4 numbers. Caller said that she had a "very strong reaction" and was "very very sick" with the booster with different lot number and did not have a problem with her first two doses. Caller provided the lot number of 30135BA. Caller wants to know if the vaccine was indeed a Pfizer Biontech COVID19 vaccine and why does it have a different lot number. She said her question was she got a dose that has very different LOT number than all the LOT numbers being given including the ones they are giving now. She said it was a very different LOT, and she didn't have a problem with her first two doses and knows no one who got a dose a LOT other than with the two letter then four numbers combination. She said the combination of the fact that she had a very strong reaction to the booster and the fact the LOT was so different, makes her wonder if something was mislabeled as COVID-19 vaccine, she was the only person she knows who got that LOT, and she had such a strong reaction after it. She said no one can tell her why the LOT number for that dose was so different. She said the pharmacy was back to giving the LOTs with two letters and four numbers. She said her LOT for the booster dose was 30135BA, and no one can tell her why it was so different. She said she had such a bad reaction to it, she wants to talk to someone who can tell her why the LOT number was so different.  No follow-up attempts are possible. No further information is expected.
Pt. received her MMRV on her left thigh on 09/05/2006, given by nurse and by 5-6 weeks later developed a case of Herpes Zoster large lesion at the area where the vaccine was administered and was seen by a local dermatologist that tested the lessions and was positive for Tzanck smear and treated it with zovirax and resolved it. Mother denies any previous history of varicella infection. I became her doctor on 11/16/06 and you can still see the large area affected already healed on her left external upper thigh region. pt. is asymptomatic. parents are not upset about it as far as i can tell, but i felt that you might need to know this incident for research purposes benefits. I have not heard of this happening before.So, I thought it would be a good idea to transmit this information to your agency.
I get sick every time; Initial information regarding this unsolicited valid non-serious social media case received from a consumer on 16-Dec-2020.  This case involved a patient who get sick every time, after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, the patient get sick every time (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was get sick every time.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
PATIENT RECEIVED VACCINES ON 11/23/21, TODAY ON 11/24/21 AT AROUND 5:00 PM PT CALLED AND STATED AT AROUND 6:45 PM, SHE EXPERIENCING SHAKING, NO FEVER, DIARRHEA, VOMITTING AND ITCHING ON NECK AND FACE, DIZZINESS AND FELLING WEAK AND SHE EXPERIENCE THIS UNTIL 4:00 AM.  SHE IS STILL TIRED AND WEAK NOW BUT FEELING A BIT BETTER.
Extreme headache, body ache, arm sore, my mouth has a metallic taste and can not taste salt.
2OCT91 pt had t99.2 ax w/runny nose & cough; 3OCT91 temp went to 102 ax, runny nose continued; Seen by MD who started on ATB & told mom pt was reacting because had 2 many shots & ear problems;
Severe abdominal pain and diarrhea accompanied by Lower gastrointestinal  bleeding resulting in drop of hemoglobin almost 3 grams. Treatment and tests at Presbyterian, University of Pennsylvania  Emergency Department 1/19/2021. Discharged to home after 12 hours. Back to normal bowel function on 1/29/21
pt had a positive COVID test on 9/28/21; 2 days later pt passed away in the nursing and rehab center; per death certificate, COVID 19 was a condition contributing to death
This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 37-year-old female patient who received INFANRIX (batch number 9D7CM, expiry date 27th February 2017). On 21st January 2015, the patient received INFANRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: INFANRIX mistakenly administered to a 37 year old female instead of Tdap.
A report received from a nurse on October 02, 2001, concerning a 35 year old female patient who experienced redness, itching and swelling at the injection site on September 22, 2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on September 21, 2001. The patient was treated with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assessed the relationship of study medication ot the event probable. See PJP-2002-00295 and PJP-2001-00299.
A few minutes after patient has the flu shot he passed out. His dad caught him and layed him down. He came to immediately. We sat him in a chair for a little while so he can rest.
Pt developed pain, then erythema at the injection site.  This was followed by a fever 2 days later.  Size of Erythema was not observed by me but described as "upper arm." She was seen in ER 10/02/2011 and hospitalized for Cellulitis vs Vaccine Reaction.  Treated with antibiotics and supportive care. Discharged 10/04/2011.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old infant patient of unknown gender. On 17-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effect were reported. This is the one of several reports received from the same reporter. Additional information is not expected.