chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 minutes after the injection I had an intense allergic/anaphylactic reaction.  I was watched and treated on site by EMS for 2 hours with Benadryl, oxygen and rest.  We did not use epi because I was still able to breath (minus some wheezing, coughing, hoarseness and lung irritation).  I felt the reaction hit when I started seeing green spots and my vitals dramatically increased (BP 181/111, HR 142 and weak).  I then experienced the following symptoms: rash/hives on neck and chest, fatigue and weakness, dizzy and lightheaded and needed wheelchair for moving around, chills and shaking, blurry vision, nausea, stomach pain, headache, chest pain and increased urination.  I also had elevated glucose (147).  During those two hours my vitals decreased a little, but the rest of my symptoms persisted.  I was not getting better and my vitals started to increase again at the two hour mark so EMS called an ambulance and transported me to hospital.  I was treated with solumedrol and observed for several hours.  The meds helped enough to send me home.  (I did have to continue taking Benadryl at home that night and the next day because I continued to have an allergic response). I also had severe injection site pain and bruising.
Patient reported having sxs 2 hours after receiving vaccination. Reported following: difficulty breathing, cough, fever, headache, increased heart rate and blood pressure. Received IM-H1N1 vaccine. F/U with physician/provider 11/4/09 and 11/5/09. Seen by healthcare provider for f/u.
expired dose of ActHib was administered, no AE; Initial information received on 18-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves an unknown demographic patient who was vaccinated with a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] vaccine (third dose in series, lot UJ121AAE and expiry date was 05-May-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 18-May-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It is an actual medication error case due to expired vaccine used as it was reported that an expired dose of ActHib was administered to a unknown demographic patient.  At the time of this report, no adverse event was 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.
Large (3 1/2x3inches) raised red swollen red area surrounding injection site.
muscle aches; fatigue; fever; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number D7797, expiry date 9th July 2021) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th May 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling. On 22nd May 2019, the patient experienced fever. On 29th May 2019, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the fever, muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, fever, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The Shingrix  batch number was reported as 07297, however based on a batch number review, the batch number was corrected to D7797. The pharmacist reported that a patient had swelling at the injection site after receiving the first dose of Shingrix which started the same day and then resolved.  Five days after vaccination the patient experienced a fever. On 29th May 2019, 12 days after vaccination the patient experienced muscle pain and fatigue. The reporter had consented to follow up.  The onset date of fever was reported as 22nd May 2019 in core and source document. But in narrative it was reported that the patient experienced a fever on last night on 29th May 2019. The onset date of fever was captured as per core and source document.
developed a raised palpable bump on arm (no hives, itchiness swelling, SOB, difficulty breathing) iced area in clinic and gave ice pack to take home with her, gave 10mg zyrtec by mouth and 20mg pepcid by mouth at clinic. patient left on her own, feeling fine
Pt developed generalized vesicular, varicella rash over head, neck, trunk and arms, 2-3 days following varicella vaccination. No fever, but had 3-4 days of malaise and decreased appetite. Lesions would pop and crust over in typical chicken-pox fashion with lesions in multiple stages of healing.
loss of mobility; shoulder pain; excruciating pain, progressive; soft tissue cyst, surgically removed, metallic appearance; Numbness; nerve pain; tingling; did not come for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of immobile in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination. On an unknown date, the outcome of the immobile, shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immobile, shoulder pain, pain, cyst, numbness, nerve pain and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment:  The patient did not have a good experience after first dose complained of shoulder pain.  Later a notice was sent to reporter which stated that the patient developed an excruciating pain with soft tissue cyst which was surgically removed. MRI (Magnetic resonance imaging)/X-ray showed cyst was noticeable with metallic appearance.  The progressive pain after failed consecutive treatment.  The patient also had numbness, nerve pain, tingling and loss of mobility. The patient did not come for the 2nd dose in spite of the pharmacist reminding the patient.  The vaccine administration facility was the same as primary reporter.  VAERS details were reported for 1st dose. No other information of patient or vaccine was available. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-JAN-2013, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 06-MAY-2014, the patient was treated by a physician, for the onset of a rash, which was diagnosed as herpes zoster or shingles. On or about 06-JUL-2016, the patient sought subsequent treatment from another physician for the continuance persistent strain of shingles, or severe herpes zoster. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Patient experienced nausea; hot and cold flashes; had a red, swollen and hard arm at injection site. MD office directed to take 2 extra strength TYLENOL.
Was vaccinated against my will, and I am having an adverse event. Woke up the next day, while in hospital, face felt swollen, looked at my hands, they were huge. I looked in mirror and i could barely open my eyes, and i asked nurses, they stated that I was fine and to go back to bed.  I kept saying I need to see a doctor and the nurses kept saying no. Everyday all day, I kept saying I need help. The doctor came in and said that it looked like I had rhumatoid Arthritis. I started itching all over, and burning. All over my torso and back and then all over my body. I ended getting welps all over my face, around my mouth and scalp. Nothing was given for relief. Pt stop taking drugs doctors were given. I did not agree with giving the vaccination. Expiration date is 5/31/2022
Skin rash, welts itchy raised. Same arm as injection (right arm). Stomach discomfort, abdominal discomfort. some diarrhea, headache, no temperature recorded (97). Skin rash, welts spreading to other parts of inside of arm as of 4:47 PM 09/26/2013. Called Pharmacy they gave this website.
weak, fever, chills, shaky, achy, sore throat, pain at injection site..... aspirin
Patient immediately felt "itchy" and warm after injection, we had her sitting in a chair and she expressed feeling warm and showed us redness in her upper chest area. Patient wanted to scratch her chest and neck area from the feeling, she stated it was very warm in the room and didn't like the sweating. She was given two Diphenhydramine HCL 25 mg capsules, and water. She used a wet paper towel to cool her neck and face she sat in chair until 2:15 pm then left on her own.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2015, an unspecified number of patients might have been vaccinated with a dose of improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (route of administration, doses, dose number not reported). RECOMBIVAX HB was improperly exposed to temperatures of 90F for 24 hours on 28-MAY-2015 and 91F for 24 hours on 29-MAY-2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax;crying & hives;eyes rolled back, not breathing for 30 secs;to hosp for eval;pt kept for 3 hrs;probable szs from DTP vax;
Patient is having severe discomfort in the arm where shot was administered. Described as arthralgia, cannot move arm properly. Had an MRI done today. No results known yet.
This is a spontaneous report from contactable pharmacist via Pfizer sales representative. This Pharmacist reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness, swollen and feels warm at the injection site after pneumococcal 13-valent conjugate vaccine administration on an unspecified date. Outcome of the events was recovered. Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018424190 same reporter/event/drug, different patients; US-PFIZER INC-2018424203 same reporter/event/drug, different patients.
shots and I still break out with 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patent. The age at vaccination was not reported. The reported stated that, he/she had the 2 Shingles shots and still broke out with shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting.
blood pressure high; swelling right hand; severe numbness on right hand,severe numbness on left hand; delayed hypersensitivity reaction; Hypersensitivity reaction; Body rash,rash over arms,rash over foots; rash progressed into large red patches; rash large and red patches over wrists; tingle right hand/like electric shooting on hands; A spontaneous report was received from a Healthcare Professional who is also a Consumer and a 65-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced elevated blood pressure,  hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity .  The patient's medical history was not provided but she reported she does not suffer of chronic hypertension. Concomitant medications reported were cholesterol medicine (Lipitor), levothyroxine, calcium, vitamin D, multivitamin, magnesium for drug use for unknown indication.  On 24-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced a delayed hypersensitivity reaction with body rash, rash over arms, rash over foots, rash over hips, rash over chest, rash very itchy, rash progressed into large red patches, large and red rash patches over wrists, tingling right hand, swelling right hand, severe numbness on right hand, severe numbness on left hand, like electric shooting on hands. On 04-FEB-2021, the patient experienced the blood pressure high without being hypertensive before.  From 04-FEB-2021 to 05-FEB-2021, treatment included Benadryl and Oral Prednisone, which solved the rash.   Additiona treatment was reported to start on 11-FEB-2021 and included Oral Prednisone and Gabapentin..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events elevated blood pressure,  hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a pharmacist and described the occurrence of medication errors in approximately 20 subjects and possibly 200 residents and employees at a long term care facility. Two of the subjects seen at the facility following th medication errors were female subjects of unspecified age who were vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. This subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received Fluarix at 0.5 ml, subcutaneously in an unknown deltoid. This was considered to be a medication error, as the Fluarix should have been injected intramuscularly. At an unspecified time after vaccination with Fluarix, the subject experienced injection site pain and discomfort. Tylenol was given for pain. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with Fluarix.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced vomiting and a three day prodrome before breaking out with lesions. The pt was diagnosed by a physician with chickenpox. The pt had more than 20 lesions. Follow up data states the patient had a low-grade fever. It was noted the patient did well clinically. Additional information has been requested.
Unknown if this is an adverse event due to vaccination. Patient reports rectal rash and discharge post vaccination with Shingrix. Initial episode occurred in December after vaccination on 11/20/2019 for Shingrix. Seen by this provider in clinic on 12/31/2019 and then patient reports symptoms recurred after second Shingrix vaccination on 1/29/2020.   Patient denies having these symptoms prior to vaccination.
Information has been received from a physician concerning a female patient with an "autoimmune disease" who on an unspecified date was vaccinated with MMR II. Subsequently, "last winter" in approximately 2007 the patient developed mumps after receiving the vaccination. Medical attention was sought. The patient was seen by the physician. It was unspecified if lab studies were performed. At the time of report the patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information has been received from a registered nurse and medical records dated 20-FEB-2008 concerning a 14 year old white female patient with colitis ulcerative who on 05-JAN-1998 was vaccinated S.Q. with a second dose of MMR II (lot # 622896/0740E). In February 2008, the patient developed acute mumps parotitis. Medical attention was sought. On 20-FEB-2008 the patient had lab studies performed which revealed the following abnormal results: albumin 3.3 L (3.4-5.0 G/DL), MCHC 32.8 L (33.4-35.9 G/DL), RDW 17.0 H (11.5-14.5 %), metamyelocyte 1 H (0 %), atypical lymph 6 H (0-5 %), sed rate 44 H (0-20 MM/HR), mononucleosis test positive (negative), mumps viral AB 4.70 (>= 1.10 positive: IgG antibody to mumps detected which may indicate current or previous exposure/immunization to mumps), mumps IgM antibody 4.74 (greater than 1.20 index: positive). At the time of the report, the patient recovered on an unspecified date. Follow-up information was received from a medical assistant (M.A.) in the physician's office via phone call. The M.A. confirmed that the patient was not hospitalized from 20-FEB-2008 to 25-FEB-2008. Additional information is not expected.
2JUN95 cellulitis rt upper arm dx by MD; rx Keflex 500mg BID x 10 days;
Information has been received concerning a female who was vaccinated with the second dose of Gardasil.  Subsequently, the patient experienced dizziness, fatigue and tiredness.  The patient did not have any AE after the first dose.  It was unknown whether medical attention was sought.  The patient's dizziness and fatigue persisted.  No product quality complaint was involved.  Additional information is not expected.
Severe rash on my face, my thighs (front and back), breasts, nipples, arms and under arms, stomach, back
4MAY93 430PM pt noted to have shaking of body, eyes rolled back drooled; lasted 3 mins;
fatigue; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and ARTHRALGIA (achy joints) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 FATIGUE (fatigue) and ARTHRALGIA (achy joints). At the time of the report, FATIGUE (fatigue) and ARTHRALGIA (achy joints) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-JUL-2021 contains non-significant information.
She had just had her 2nd PEDIARIX one week earlier on 10/2/18 and was in for HIBERIX and PREVNAR but also incorrectly got a PEDIARIX. I told mom of error. Followed up. She had mild fever -felt warm on and off and a little cranky, on and off for a day, But then did well and fine since.
7pm: J&J shot at Rite Aid 4/6/2021 11pm-4am  sleep 4am-7am  sleep off and on, slight chills,sore throat,body aches 7am-9am sleep 9am awoke feeling terrific 12pm in bed with aches, chills, no appetite, low temp felt better 9pm 4/7/20121
Telephone call from mom on 8/19/03. Stated her son started to have a lump or knot at site of injection on right arm. His sister (twin) also had same reaction.
patient stated when she got the shot she felt like it was an electric shot, arm sore and still hurts and hard to use
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored GARDASIL, inj (lot# and expiration date not provided) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
So, I had a rapid heartbeat that was not regular, this sounds like I'm having extra heart beats. I have not seen doctor yet but, an appointment was made.
5/10/22  I seemed to tire very easily.  I would have to rest frequently. I have never recovered from that. I have not gotten my full energy back. I mentioned it to my doctor who did not seem real concerned.
3.5 hours s/p injection #2 patient arrived back at Vaccine clinic with complaint of acute onset of severe fatigue and dizziness.   Patient VS- 148/86, 78, 18, 99% Patient driven home by family member after calling the nurse on call line and co-worker health Patient to follow up with Co-worker Health in the AM
Patient received a 2nd dose of undiluted pfizer covid vaccine (0.3ml). The patient was observed for full 15 minutes after administration and followed up 45 minutes after administration. No adverse drug reaction was noticed.
6 months: dizziness, weakness, lightheadedness, fainting, fast heartrate, fatigue, migraine, nausea, vomiting
Information has been received from a parent's consumer regarding to 8 years old male patient with autism. On 05-OCT-2012, the patient was vaccinated with dose 1 GARDASIL. No other co-suspects were reported. No concomitant medications were reported. Past drug therapy included hepatitis A virus vaccine (unspecified). On 05-OCT-2012, the patient had an appointment with his pediatrician to receive the second series of Hepatitis A Vaccine. However the pediatrician's office mistakenly administered the GARDASIL. At the time of the report, the outcome of pediatrician's office mistakenly administered the GARDASIL was unknown. Additional information has been requested.
Neck stiffness  Chest tightness  Right arm pain Pale  Upper back pain  Fatigue  Nausea
Large area of redness and swelling of thigh 7" x 4" two days after injection.