chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via 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 age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt 1/6
This is a spontaneous report from a contactable Medical Assistant who called on behalf of doctor. A 52-year-old female patient received PREVNAR 13 (Lot # L62075, Expiry date 31Dec2016, NDC # 0005-1971-01) via an unspecified route of administration at 0.5 ml single at right deltoid on 10Oct2015. Medical history included diabetes mellitus taking Metoprolol 25 mg, one tab by mouth, gastrooesophageal reflux disease taken omeprazole, hyperlipidaemia taking Pravastatin 20 mg. Concomitant medication included metoprolol 25 mg, one tab by mouth for diabetes, pravastatin 20 mg for hyperlipidaemia, omeprazole 40 for GERD. On an unspecified date in Oct 2015 the patient experienced cellulitis, sore arm, arm was painful to the touch, fever on and off and right deltoid that was warm to the touch. The outcome of the events was unknown. She saw her doctor who recommended that she was due on PREVNAR 13 vaccine and she was due as well for the Tdap vaccine to bring her up to date on her immunization. She went back to their office on 15Oct2015 complaining about the sore arm, her arm was painful to the touch, fever on and off and the right deltoid that was warm to the touch. The patient was taking over the counter TYLENOL 500 mg for her fever, she had been given KEFLEX 500 mg, one tab by mouth 4 times a day and instructions on how to care cellulitis. Causality: Medical Assistant mentioned that the doctor believes that the patient had cellulitis from PREVNAR 13.
SEP 10, around injection site - hot, swollen, pain. SEP 11 hot, swollen, pain, during the day developed discoloration/rash 8x9" above and below inj. site to within 2 1/2" above bend of elbow at emergency room before midnight. SEP 12 examined, took Cetirizine and SINGULAIR and ALEVE during this time.
Following administration of Td, pt devel generalized body aches, t101, swollen arm;
This spontaneous report was received from a nurse and refers to a 5 year old male patient. The patient had no relevant medical history and no concomitant medications. On 28-NOV-2016, the patient was vaccinated with 0.5 ml dose of PROQUAD subcutaneously, lot # M022402, expiration date 01-NOV-2017, administered for a routine health care, which underwent a temperature excursion. To the best of the nurse's knowledge, the patient did not experience an adverse reaction and no treatment was provided. There was no relevant laboratory data. At the time of this report it was unknown if the patient continued to receive PROQUAD. Additional information has been requested. Sender's Comments: US-009507513-1612USA000174: US-009507513-1612USA000174.
PATIENT REPORTED TO WALK IN CLINIC WITH RED ITCHY ARM. AT THE SITE OF THE FLU SHOT. WALK IN CLINIC CALLED TO REPORT TO US AND PATIENT WAS ADVISED TO TAKE RANITADINE AND LORATADINE.
Patient with fever, irritability and crying for 4 days after vaccination. Patient returned solid and slept poorly for 5 nights. Per parents, patient didn't wish to be touched - would make her more fussy/irritable.
Patient reported severe entire body aches, fever, chills, and dizziness after receiving the Janssen vaccine. He had difficulty standing due to dizziness, headache, weakness, shortness of breath, and loss of appetite the following morning. He was seen by a medical provider on 12/18/21, and had 99.8 temp, pulse 103-118, and BP 78/46 right arm and 85/53 left arm. Patient received 1 liter of normal saline via IV and Ketorolac injection. He was observed overnight and received Boost Plus and Ibuprofen as needed. The following day, he felt better, ate breakfast, and had stable vitals.
Swelling of left leg where immunizations were given. Pt's mom instructed to give ibuprofen & ice the site of swelling.
she knows her friend received COVID after the booster dose; she knows her friend received COVID after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported as no additional vaccines administered on same date of the pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she knows her friend received COVID after the booster dose". Clinical course was reported as, reporter states her friend (patient) was 39 years old when she received the booster dose of COVID-19 Vaccine and is now 40 years old or was 40 years old when she received the booster and is 41 years old now. She states after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle. She states after her friend's booster dose of the COVID-19 Vaccine almost a year ago, her friend was suffering from horrible long strong cycles and visited physician office multiple times. Her friend believed the first 2 were preventing COVID but did not and states her friend felt coerced to receive the booster so that she would be able to fly. She knows her friend received COVID after the booster dose but she states her friend might have gotten COVID after the first 2 doses as well. Also reports she has a lot of friends who were pregnant. She states the friends took the Pfizer COVID-19 vaccine and got problems after the COVID-19 vaccine. She states serious issues with menstrual cycles and lost there babies. Agent reports the caller is pregnant. Reporter wants to know if the vaccine is safe to take for women. Agent reports the caller is quite afraid. The reporter confirms details provided by transfer agent. She states the previous agent already read her a long list of potential side effects. She thinks she is okay to do a report but states she is calling today as she was concerned for herself.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8-10 hours after vaccine she noticed a rash on both hands-left worse than right. No other problems.
arm sore, raised welts, hot, tender, painful to touch affected range of motion underneath arm pit in front of arm pit under arm opposite of inj site;
September 7 mid-morning I started having a runny nose but it wasn't really bad and I didn't pay much attention to it. September 8 it was a little more and I did a home covid test and it was negative, but on September 9 I did another home test and it was positive, so I went to the Doctor and did a PCR and it was positive so I received monoclonal antibodies. Symptom wise, it was like a minor head cold but on day 3 it felt like someone wrapped a chain around my chest, but after the antibody shot within 3 days it was all gone. It didn't go into my chest at all. Within a week I tested negative again and was back to normal. I was down in bed during it for at least a day and a half.
TREMBLING OF RIGHT ARM; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021 22:00, the subject experienced trembling of right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trembling of right arm. This report was non-serious.
Joint pain and stiffness. Have used over the counter arthritis rubs and ointments. I had I stiff/ trigger finger before vaccine now all my finger hurt and most are stiff and click. My shoulders, elbows, knees, ankles and toes are hurting, stiff and clicking. I don?t know if this condition is permanent, but I am still dealing with it.
Raised red rash over arms and legs. Not too itchy, but sensitive to hot water. Started on thigh, and has now spread to calves and arms. Worse on left side, which is side I got shot on.
2x2cm induration red nodule lt deltoid area-not red or tender;parent & nurse observed that pt jerked arm when inj was given, likely resulting in a unavoidable SC inj of some of the vax
Headache, Myalgia, Fever,  FATIGUE, LEFT ARM SORENESS Narrative:    Other Relevant History:
Pfizer-BioNTech COVID-19 Vaccine EUA - injection site pain & swelling & redness, tiredness, monster of a headache, chills but no fever, another red, itchy,  blotchy, painful  area, about the size of a man's wallet, just below injections site (but, not connected to injection site redness).
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with VARIVAX (Merck) injection (lot number and expiry date unknown) (Dose 0.5 ml, frequency unknown) subcutaneously for an unknown indication which on an unknown date had undergone a temperature excursion (details unspecified). No adverse events were reported. No product quality issue was reported. The action taken with the VARIVAX (Merck) therapy and the outcome of the events was unknown. Follow up information has been received on 9-DEC-2014. The reporter provided the lot numbers. This case includes Lot number # K00294, expiration date: 26-FEB-2016 and doses to be returned 20. This case is linked to the case 1412USA008275 and 1411USA011908 (same reporter link). Additional information has been requested.
Two days after getting the vaccine, had a minor car accident.  Knew there was no injury, and continued driving.  Within the next hour, began to feel muscle or neck soreness, but assumed this to be psychosomatic.  Over the next few days, experienced other symptoms, including difficulty sleeping and a bad cough that sounded like phlegm in the lungs.  Now believe that either (a) at the time of getting the vaccine, was already infected with something that caused all the symptoms, including muscle soreness, cough, etc., and may have contributed to the car accidents, or (b) side effects of the vaccine caused all the symptoms, including muscle soreness, cough, etc., and may have contributed to the car accident.  (Neither the car accident nor a psychosomatic reaction to it could cause phlegm or the cough, which is indicative of a real medical cause.) In previous years, received the intramuscular flu vaccine without any problems.  This year, received the intradermal vaccine for the first time ever.  If the intradermal vaccine causes side effects in patients that don't have the same reaction to the intramuscular version, this should be added to the informed consent disclosures. I have read that the onset of flu can cause accidents.  I don't know if that is true of the vaccine.  If vaccine side effects can cause car accidents, then vaccine administration should, ideally, occur on a day that will result in the onset of possible side effects being on a day when patient is not driving.  This precaution was not taken.
I started to have pain and skin sensitivity along sciatic nerve on my left side on 4/12, 10 days after receiving first COVID vaccine. 3 days later a rash started to develop in the same area. The rash continued to spread along back of left leg onto bottom of my left foot over the next week, accompanied by pain, sensitivity and itchiness. All symptoms subsided and resolved within about 6 weeks from onset.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Nov-2020 and the estimated date of delivery was 03-Sep-2021. On 31-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  Patient wants to be a part of pregnancy registry.
The tingling started in my fingertips, numbness. On Saturday started felt tingling and tightness on my face. As time progressed, I felt the tingling on my arm near my wrist no weakness. Once the tingling would start nothing would alleviate it and still able to grasp things, walking. I went to urgent care on November 3, 2021, got lab work to rule out electrolytes imbalances, Vit D deficiency and magnesium levels were fine. As of the weekend my symptoms have continued, started to feel tingling in my buttocks. I went to ER on November 7, 2021, did CT scan of my head to follow up with Neurologist.
Gave child undiluted Pfizer vaccine for 5 to 11-year-old.
Patient developed petechia, oral ulcers and platelet count of 1. Suspected ITP secondary to Pfizer COVID-19 vaccine 12 and over.
PATIENT CAME 5/19 FOR ADACEL VACCINE BUT PHARMACIST GAVE PATIENT 3RD DOSE OF MODERNA COVID 19 SHOT. PATIENT RECEIVED 2 DOSE OF MODERNA COVID 19 SHOT IN APRIL
redness around inj site size of softball a little raised, itched a little;took Ibuprofen per instruction;
Swollen 2" out (RA) redness in a circle.  (Varicella shot), T-Dap (Adacel) area bottom, top 1".
Swelling and erythema around site of injection measuring 17 x 12.5 cm. Pain at site. No respiratory symptoms, no shortness of breath. Treat with ice, ibuprofen, BENADRYL.
Moderna Covid 19 vaccine dose 1 -12/29/2020 Positive pregnancy test 1/28/2021 (approximately day 14 gestation) Moderna Covid 19 vaccine dose 2-1/28/2021  12 week nuchal translucency test Maternal fetal medicine doctor diagnosed giant omphalocele (3/23/2021). Follow up visit at 14 weeks (4/6/2021) confirmed giant omphalocele as well as large Ventral septal defect, and spinal abnormalities; diagnosis of Pentalogy of Cantrell; pregnancy terminated
right after shot, pain in arm, couldn't lift arm, as of today 12/1/2010 still have pain in arm, hurts to lift above my head, hurts to carry things, feel twitching at times, goes from my shoulder to elbow in the front part of my arm
Vaccine administration error. Patient given a third dose of MMRV.  MMRV 06-20-2023 MMRV 05-11-2023 varicella 04-09-2019 MMR       04-09-2019
The first two days I was like really tired but now I don't have no smell or no taste; The first two days I was like really tired but now I don't have no smell or no taste; The first two days I was like really tired but now I don't have no smell or no taste; It's like I was sneezing like my nose was like kind of run; It's like I was sneezing like my nose was like kind of run; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, UPC, NDC number and Expiry date: unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination was 57 years) as dose 1, single for COVID-19 immunisation. Medical history included diabetes and blood pressure high; both were from an unknown date and unknown if ongoing; cholesterol was a little high and pain management in Feb2021. Concomitant medication included Rosuvastatin (tablet) at once a day; Oxycodone; Lisinopril (tablet) at once a day via orally, all were taken for an unspecified indication, start and stop date were not reported. The patient stated as, I was calling, I got my first Pfizer vaccine shot Saturday and on an unspecified date in Mar2021, all of a sudden I don't have no smell or no taste. The first two days I was like really tired but now I don't have no smell or no taste and I am just wondering it's like I was sneezing like my nose was like kind of run but I got up yesterday with no smell or taste then I am just wondering if that is a side effect. The patient had a lab test before, because patient was on pain management and cholesterol was a little high. It was last month sometime, patient don't remember the date, it was last month, and patient was not sure. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
High fever (104),  muscle aches/joint pain, chills, pain I left armpit. Treated with Tylenol. Fever lasted around 30 hours. Aches and pain under an still ongoing.
Headache, Tiredness, spontaneous bruises on skin, Bleeding gums, High blood pressure, Dizziness.
Itchy/burning rash formed on both wrists and back of hands. Symptoms started easing  on their own about an hour after they started. Diphenhydramine 25mg was taken a couple hours after the event started and seemed to help reduce the symptoms further and cleared them up. No re-emerging of symptoms have occurred since.
Acute necrotizing Pancreatitis; hospitalized on 10/5/2021-10/16/2021.
patient received first dose of the pfizer vaccine at 1220. patient was in our observation area and complained of nausea and shakiness to the RN. patient escorted to our clinical area for monitoring  and vital signs obtained. patient had been hospitalized in 2/01/2021 for Covid. patient does have allergies to shellfish, nuts, morphine and and anti nausea medications. patient has not other medical conditions noted. patient sister was at bedside with pt.  pt recieved 50 mg im benadryl at 1306 called ems at 1315, unit responded at 1318. patient taken to hopsitl by EMS unit
Given 2.5mg IM Benadryl L arm secondary to vaccine, mild discomfort throat/neck area. some soreness and plushing.
incredibly dizzy; crystals in middle ear; nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (incredibly dizzy), MIDDLE EAR DISORDER (crystals in middle ear) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced DIZZINESS (incredibly dizzy), MIDDLE EAR DISORDER (crystals in middle ear) and NAUSEA (nausea). At the time of the report, DIZZINESS (incredibly dizzy), MIDDLE EAR DISORDER (crystals in middle ear) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: Added nausea as an event and outcome was unknown.
she felt extreme pressure when she breathed, like an elephant sitting on her chest; Extreme chest pain/chest pain was not like a heart attack, but she felt a lot of pressure and weight when she was breathing in; heart rate went up (from 89 to 99); Pains; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on the left arm on 24Jan2021 09:22 at a single dose for COVID-19 immunization. Medical history included degenerative disc disease (first disc came out) from 2007, chronic fibromyalgia from 2005, rheumatoid arthritis from 2000 (went into remission for a few years; while in remission, she was diagnosed with fibromyalgia), vertigo (diagnosed when she was 24 years old; bout of vertigo about twice a year; last year, 2020, was the worst bout of vertigo she ever had), allergy to shellfish (hives, itching, welts), sulfa (anaphylactic reaction), and mostly pain related issues. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient wanted to know if she should get the second dose of the COVID vaccine knowing that she had a reaction to the first dose. She had a reaction which she believed was from the vaccine she received. She felt something immediately but did not concern herself with it, was kept for 30 minutes for observation. Her heart rate went up (from 89 to 99) and then her heart rate came back down. She said after the 30 minutes had gone by, she felt better. On 25Jan2021 and 26Jan2021, she felt extreme pressure when she breathed, like an elephant sitting on her chest which lasted all day. Patient woke up the next morning and pains were still there. It was also reported that the patient had extreme chest pain on 25Jan2021. She said that the chest pain was not like a heart attack, but she felt a lot of pressure and weight when she was breathing in. By the time she went to bed in the night of 25Jan2021 night, she felt fine. When she got up the next day, Tuesday, 26Jan2021, and started moving around, the chest pain came back. When she woke up on Wednesday, 27Jan2021, everything was all gone. Patient is scheduled for her second COVID-19 vaccine shot on 14Feb2021. The events did not require a visit to emergency room or physician office. The patient recovered from the chest pain on 26Jan2021, from heart rate went up on 24Jan2021, and from the other events in Jan2021.