chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLISTERS AT INJECTION SITE; INJECTION SITE ITCHINESS; LOW PLATELET COUNT; PREMATURE VENTRICULAR CONTRACTIONS; MIGRAINE; SWOLLEN ARM; FEELING HOT AT THE INJECTION SITE; CHILLS; FEELING TIRED; REDNESS AT INJECTION SITE; FEELING FEVERISH; FEELING NAUSEOUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 145 kilograms, and height was 60 inches. The patient's past medical history included history of four heart attacks, thrombocytopenia, and colon cancer, and concurrent conditions included smoker, and food allergy, and other pre-existing medical conditions included patient is allergic to bees, honey, sulfa, cephalosporins, moderna vaccine, fish, seafood. patient tends to run at 142,000 which was the result when a test was done in march. she stated that previously she did get the moderna vaccine at the end of april and had an anaphylactic reaction. The patient experienced drug allergy when treated with cefaclor, erythromycin, cefalexin, nitrofurantoin, penicillin nos, and azithromycin. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Heartbeats irregular (NR: not provided) not reported, and Platelet count (NR: not provided) 94, 000. On 21-MAY-2021, the subject experienced swollen arm. On 21-MAY-2021, the subject experienced feeling hot at the injection site. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced feeling tired. On 21-MAY-2021, the subject experienced redness at injection site. On 21-MAY-2021, the subject experienced feeling feverish. On 21-MAY-2021, the subject experienced feeling nauseous. On 23-MAY-2021, the subject experienced low platelet count. On 23-MAY-2021, the subject experienced premature ventricular contractions. On 23-MAY-2021, the subject experienced migraine. On 24-MAY-2021, the subject experienced blisters at injection site. On 24-MAY-2021, the subject experienced injection site itchiness. Laboratory data (dates unspecified) included: Fibrin D dimer normal (NR: not provided) 0.5. The action taken with covid-19 vaccine  was not applicable. The patient recovered from premature ventricular contractions, and migraine on 24-MAY-2021, chills, and feeling nauseous on 22-MAY-2021, and feeling tired, and feeling feverish on 23-MAY-2021, and had not recovered from low platelet count, swollen arm, redness at injection site, feeling hot at the injection site, blisters at injection site, and injection site itchiness. This report was non-serious.
First vaccine: headache; First Dose: pain in her arm; had shingles by that time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 (Lot number: EL9266) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart surgery she had three bypasses" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "Arthritis" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "Diabetes" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "thyroid" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "Blood cholesterol" (unspecified if ongoing), notes: The caller had heart surgery she had three bypasses, arthritis, diabetes, thyroid, and cholesterol.; "for her heart" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; METFORMIN taken for diabetes mellitus; ATORVASTATIN taken for blood cholesterol abnormal; GLIPIZIDE XL taken for diabetes mellitus; GABAPENTIN taken for arthritis. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "First vaccine: headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "First Dose: pain in her arm"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "had shingles by that time".  Additional information: No investigation assessment was done. The caller got the first vaccine and she had a headache and pain in her arm and it was fine because it then went away. The caller got the first shot of the Pfizer COVID 19 vaccine on 23Feb2021 clinic. When the caller got the first one she had a headache. The caller felt like her head was going to explode because she just had shingles by that time. The caller got her vaccines at (Hospital withheld). The caller provides informatiom from her vaccination card. Everyone was saying that senior people have to get the vaccine and there were a lot of announcements. It was a law and 4 of the caller's brothers died of COVID. The caller took the same medications that she took for many years. The caller also takes another medication but she did not know the name of it. The caller did not have allergies to medications and has no records for allergies. The caller's doctor has this information. The caller wanted treatment.  No follow-up attempts are possible. No further information is expected.
Tenderness, redness, swollen Left arm at injection site. Mild fever, lasted 5 days.
After receiving both vaccinations on 7/14/16. ZOSTAVAX arm had very raised red lengthwise patch up and down back of arm. Then 1 wk later PREVNAR arm began to swell 5" diameter swelling red itchy around arm in a band fashion around arm.
Site red and swollen. Site initally red, warm and raised to the touch. member asymptomatic and voices no complaints. cardio respiratory unremarkable. vitals 129/84 bp72 rr16 spo2 99%. member advised to seark immediate care for any concerning syptoms that may arise approximatly 4 days out from recieving vaccination.
Patient was administered the bivalent injection and should have received the primary series, he had not received the primary series before the bivalent was given. No adverse events occurred and we didn't find out about the mistake until patient was taken to Health Department to receive second dose.
I had a low-grade temperature for about a day after receiving the vaccine.  I had an optical migraine in my left eye. My vision is impaired for half of the vision with light sparkles. I have had 11 migraines since then.  With two of them, I had a headache as well. As of now, I am not on any medications. I try to distract myself when I know I am having a migraine.
TRANSIENT HYPOTENSION CARDIOGENIC SHOCK 12/20/2022,  12/15/2022,  1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A couple days after my  shot, I developed a 'knot' or bump at the injection site.  It continue to swell and when I went to the doctor, it was about the size of a baseball sticking out of my arm.  They weren't sure what it was but prescribed me something in case it was infected.  I'm sorry but I don't remember what the rx was.  They also outline the swelling with a sharpie to see if it continued to grow.  It got slightly bigger but then started to recede.  After another week, it was back to normal.
Initial misuse report received from a healthcare professional on 16 April 2013. A 4-year-old patient had received ADACEL vaccine as a fifth dose in of DTaP series. No adverse event was reported. List of documents held by sender: none.
Night of  1st vaccine had numbness in mouth & tongue Day after vaccine fever, malaise, back pain, hand pain 2 days after vaccine painful lump on collarbone on shot side 3 days after vaccine soreness in armpit on shot side  All events subsided by day 4 except lump on collarbone which was then painless Lump on collarbone still there as of today 10/4/21
Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Contains Vaccination facility information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old femal) for mRNA-1273 (lot number 046A21A) with no associated AEs reported.
Severe headache that lasted two days, swelling on the right side of face, heart palpitating, couldn't walk without assistance, nausea, metal taste in mouth, loss of appetite,  arm swollen at injection sight, fever, entire body in pain, slight cough and congestion, tiredness, fluttering in chest
A few minutes after receiving the vaccine, the patient fainted.  The mother caught her son in her arms and we were both able to lay him on the floor safely without hitting his head.  He came to within a few seconds.  He remained in the pharmacy area for approximately 20 more minutes for observation.  He was feeling back to normal before leaving.
varicella lesions 3DEC97, pt recv vax 25JUL95;
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 18-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 336 and 804 hours respectively. The lowest recorded temperature was -3 (-3 Celsius degrees). The highest recorded temperatures was 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
10/21 0830 - Adacel Tdap administered L deltoid;  10/24 1200 - Recipient reported to Employee Health from home and described a small localized reposonse, with redness; 10/27 0830 - Recipient reported to Employee Health from home that she was febrile, her injection site was increasing redness and swelling, and a hard knot at center, also tender to touch; 10/28 0930 - Employee in to see Employee Health RN.  Erythema approximately 3" in diameter, with a more redenned area at the center with a palpable knot at center.  Still febrile.  Referred to the Emergency Department.  10/28 - She was seen in the ED. Differential included cellulitis, small hematoma, abcess or vigorous response to the Tdap vaccine.
swelling/big lump first injection site; little red second injection site; hurting first injection site; itching first injection site; red inflamed first injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that: A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EM9810 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm left on 11Feb2021 09:15 AM (age at vaccination was 60-year-old) as dose 2, single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis (Hashimoto's disease) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) dosage 100mg, take once daily by mouth taken for autoimmune thyroiditis (Hashimoto's disease) from an unspecified start date and ongoing from four years. The patient previously received the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9262 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 21Jan2021 1415PM (age at vaccination was 60-year-old) as dose 1, single dose for covid-19 immunisation. On 31Jan2021 she reported a weird rash 10 days after the first dose and it went away on 02Feb2021 and she was fine. Duration of reaction/event was 2 days. She received second dose on 11Feb2021. After the second dose, she reported having swelling, redness, painful itching and a big lump that was inflamed at the site of her first injection. She stated it seemed kind of strange. The second injection was an inch and a half away from the first injection, but this occurred at the site of her first injection. She stated last night it was a big knot and today it's kind of dissipated. She stated it doesn't seem to be getting any worse and she had no other symptoms except that she woke up feeling like she had a bad hangover. She was asked if this side effect is normal. Adds it was like a red box under the injection site. Then last night her arm at the first injection site was hurting and itching; and she noticed a big lump right where she got the first injection below the second one. Adds the second one is a little red, but the first injection site has a lump about 2 inches by 2 inches and it is red and inflamed. States the lump feels a little better when she ices it and now it seems like it is a little less hard maybe going down. She was asking, is this normal or expected. on 11Feb2021 patient experienced swelling/big lump first injection site, little red second injection site, hurting first injection site, itching first injection site, red inflamed first injection site. Outcome of the events swelling/big lump first injection site, hurting first injection site was recovering, red inflamed first injection site, little red second injection site was not recovered, and rest of the event was recovered 11Feb2021.  Follow-up attempts are completed. No further information is expected.
On 2/16/00 an MMR was given to this new employee. The pt felt ill that evening, he developed body aches, fever, and was seen in the ER. 2/17/00 was seen by MD. On 3/8/00 he developed a rash, fever and experienced an elevated LFT. The pt was admitted to the hospital 3/12/00, was dismissed on 3/18/00 and again admitted on 3/30/00.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION, start date: Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
91 year old female patient received expired dose of FLUZONE HD vaccine with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional via Medical Information (Reference number- 00829577).  This case involves a 91 year old female patient who received expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA and expiry date: 30-Jun-2021) (Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is. There were no adverse reactions, treatment or ER (emergency room) visits reported post administration".  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.
2 days after first inj. developed cold sore upper lip treated normally and went away after week or so. 3 days after second dose another sore on bottom lip felt and looked like a burn, used vaseline and better after week and a half. 3 days after second dose extreme tinnitus started in left ear, 4 th. day hearing loss in left ear, stuffy plugged feeling, no pain. Continues to this day. Also feeling fatiqued.
Headache; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via unspecified route of administration in the left arm on 17Mar2021 at 01:00 pm (at the age of 47-years-old) as a single dose for Covid-19 immunisation. The patients medical history was not reported. Concomitant medication was reported are Zyrtec (MANUFACTURER UNKNOWN), Wellbutrin (MANUFACTURER UNKNOWN), Magnesium (MANUFACTURER UNKNOWN), Turmeric (MANUFACTURER UNKNOWN), Biotin (MANUFACTURER UNKNOWN) which are taken within two weeks of vaccination. Patient was allergic to macrolides. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 17Mar2021, patient experienced headache. The clinical outcome of headache was reported as recovered.  No follow-up attempts are needed. No further information is expected.
PT received Pfizer Covid 19 vaccine 7 days prior to scheduled 2nd dose date during a traveling evolution by clinic team. No treatment and no adverse reactions were reported at the time. First does of Pfizer Covid 19 vaccine was received 3/9/21 with no reported adverse reactions.
Patient has a rash at the site of injection. She does not have itching or pain - just a slight rash. She will call her MD if it gets worse or doesn't go away.
pregnant; miscarried; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (prolonged hospitalization, medically significant), outcome "unknown", described as "pregnant"; ABORTION SPONTANEOUS (prolonged hospitalization, medically significant), outcome "unknown", described as "miscarried". Patient miscarried after her Pfizer vaccine (1st shot). Patient thought that was the reason why. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Congenital anomaly or birth defect. The events "pregnant" and "miscarried" required physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sensation of cold, circulation issues in extremities, Severe shakes, Chills, fever: 100.4 at highest, fatigue, muscle aches, abdominal pain. as of now, 15 hours later after incident started at 3:15 am, still low fever of 99.4 ad feel like crud, like have a flu.
Discomfort at injection site; Injection Site Redness; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema and injection site discomfort. On an unknown date, the outcome of the injection site erythema and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema and injection site discomfort to be related to FluLaval Quadrivalent.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness and discomfort at injection site. The reporter consented to follow up. This is 1 of the 5 linked cases reported by the same reporter.
redness at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The day after receiving the vaccine, the patient developed redness and swelling at the injection site. The reporter did not provide any additional information. The reporter consented to follow up.