chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed subcutaneous hypersensitivity/Covid arm- delayed; lump on my pinky joint; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymph node dissection (Lymph node removed in the second arm.(right or left not specified).).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up attached on 08 Feb 2021 and contains information
No additional AE; Patient was administered an Expired PNEUMOVAX 23; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-AUG-2021 at 14:00, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) lot # S029542, expiration date 10-JUN-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). There was no additional adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
1 day p/vax pt devel a nodule & a bruise @ the site of vax;pt recovered;this is 1 of 2 pt from this site to devel an inj site nodule p/vax lot# 431966;
I've gotten through the worst symptoms with the second Varicella Vaccine, I hope. Had pretty intense stomach cramps and diarrhea for an hour around 4am on Friday night after getting the vaccine, and it was swollen to about 3 inches across and bubbling about one inch across by the time I went to bed that night (so much faster than last time). I took BENADRYL every night and day until Monday, and used the hydrocortisone right away and both seemed to help. It was swollen (hard, hot, itchy/burning/sore) all day Saturday and Sunday, though improving a little Sunday, but not intolerable. My left arm was very achy all day Saturday though, like get from a fever, from my Trapezius down through my inner elbow and into my finger joints, and seemed better the less I used it. Saturday night for about an hour the pain was really intense, deep and aching in my muscles and joints of my left arm, and that was pretty intolerable. Maybe a 7 out of 10? I was thinking I could probably handle it for about two hours and then would need to go to urgent care if it didn't get better. But I took Ibuprofen (which I then read you're not supposed to take with Varicella, so I got TYLENOL) and had a massage therapist friend work on my arm for about twenty minutes (that was handy) and it subsided almost completely. Today and yesterday the muscle ache is gone and the swelling is way down, but the center is still red, bubbly, and quite itchy. I expect that will go away over the next few days.
my fingers are little numb/2 or 3 of my fingers are numb/3 of my fingers are going numb; arm is sore; arm is hurt/pain in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiration date unknown), via an unspecified route of administration in left Arm on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date patient that i had my Pfizer vaccine the second dose, my arm is sore and my fingers are little numb and my arm is hurt from the Pfizer vaccine and my fingers are like numb." Consumer stated, "2 or 3 of my fingers are numb." Consumer stated that "My left arm I got the COVID vaccine twice but now my arm is painful 24 hours a day and it has been 2 weeks and 3 of my fingers are going numb." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 4 pm that afternoon I felt like I had the flu, I got really cold. At 6pm I had a 103 fever. I was completely immobile for 3 days. I started having low-grade fever and severe leg pain for about a week, Went to ER for dehydration. Ruled out blood clots. We back to ER a week later, couldn't find anything wrong. About a month later I still feel off,  Dr. diagnosed me with spinal cord inflammation,
administration of an expired dose / on the same day of the report. It was meant a first dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HBV (Engerix B) (batch number AN3NC, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 18th June 2021, patient received 1st dose of Engerix B, which was expired on 3rd June 2021. No further events were reported.  The Health care professional agreed to follow up. The reporter consented to follow up.
developed painful genital aphthous ulcers.; developed painful genital aphthous ulcers.; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FC3183) intramuscular on 03Sep2021 (age at vaccination: 15-year-old) as dose 2, single for covid-19 immunization. In the Physician Office Visit. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: 088d21a), intramuscular on 13Aug2021 as a single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 05Sep2021, patient experienced developed painful genital aphthous ulcers. Topical Lidocaine, Topical Clobetasol, antibiotics were taken as a result of developed painful genital aphthous ulcers.The outcome was recovering  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional and a  nurse concerning a 46 year old male who on 5/25/05 was vaccinated with hepatitis A virus vaccine inactivated (lot # 648685/1115P), 0.5ml, IM. Concomitant therapy included diphtheria toxoid (+) tetanus toxoid on 5/25/05. On 6/7/05, the patient developed nausea and vomiting. He then went to two countries overseas in June 2005 and later developed jaundice. He was seen in the emergency room last week (July 2005) and treated with IV fluids. On 7/11/05, he was seen in the office and diagnosed with acute hepatitis. It was reported that the patient would be hydrated in the office with IV fluids and monitored. The nurse reported that the patient was seen in the office on 7/14/05. She reported that all labs were currently pending and he had been referred to a gastroenterologist. The patient was not hospitalized but had been treated with IV fluids. He was now instructed to increase his fluid intake. As of 7/14/05, the patient was still jaundiced and had not yet recovered from the hepatitis. His condition was reported as, "fair" and he was slowly progressing. She also reported that the patient had no past medical history and had been healthy up until now. The nurse reported that they were unsure if the hepatitis was related to the vaccination or his trip overseas. She said they expect to know more after the labs come back and he sees the gastroenterologist. She had no information on the gastroenterologist the patient was to follow up with. The nurse confirmed that had the patient not been treated appropriately with IV fluids, a more serious outcome could have occurred such as hospitalization. The reporter considered the acute hepatitis to be an other important medical event (OMIC). Additional information has been requested.
Pt woke up 8/8/15 at 2 AM with pain, redness and swelling in her (L) deltoid. She had a fever of 102 degrees and was dizzy and having hallucinations. Her arm was swollen the size of a baseball. She states that by Saturday evening her fever was gone and she was feeling better.
I have muscle spasms in my upper and lower arm and the pain radiated into my hands. I had tingling in fingers numbness in my thumbs. It was just extreme pain anytime I moved my arms and even let it hand independently. The pain is still there just not as intense.
about 4:30pm pt noticed nose felt like it was closing a bit, throat was a little scratchy and it felt sore to swallow and slight dizziness. onset of symptoms were about 1/2 hour after vaccination. patient did not want to take diphenhydramine as it makes her heart race, so we offered her cetirazine 10mg which she took around 5:30pm. Patient and companion decided to go to car to wait, but I asked her to call back by 6pm or I would call her before we closed. Patient reported during that time period that her symptoms were improving and then again at 6pm that she was feeling better. I instructed her to call 911 if symptoms deteriorated again in the evening or it felt like she was having more trouble breathing later on.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PVCs" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient did not take other medication in 2 weeks. Patient took Paxlovid Antiviral COVID 19 Treatment from 12Jul2022 to 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
slight fever; malaise; headache; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, on an unspecified date patient experienced malaise, headache, slight fever developed from the afternoon of the day after the 2nd dose vaccination day. The outcome of all events was resolved on the next day (unspecified date).  No follow-up attempts are needed. No further information is expected.
2nd dose of unk flu vaccine given at a shorter interval from first; sore arm after 2nd shot; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 7-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 3rd November 2021, the patient received the 2nd dose of Influenza vaccine Quadrivalent 2021-2022 season. On 3rd November 2021, unknown after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced drug dose administration interval too short. In November 2021, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The age at vaccination was not reported but it could be 6 or 7 years. The patient was given dose 1 of fluarix on 13th October 2021 and was scheduled to receive a 2nd dose on 10th November 2021 by the facility. On 3rd November 2021, the patient was administered  another dose of flu vaccine at school, which led to shortening of vaccination schedule. The patient also had a sore arm after school shot. The patient's vaccination history was not known. The reporter consented to follow up.
Pain under armpit; This case was reported by a nurse and described the occurrence of axillary pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles last October presented with severe pain under armpit and got rash upper left back). Previously administered products included antiviral and prednisone.   On 25th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was anxious to get the Shingrix vaccine to lessen the chance of ever get Shingles.  The patient received Shingrix and experienced the pain under my armpit. For tolerances of 2nd dose, refer case US2019AMR190710, reported by same reporter for the same patient.
Passed out; Fell from bed; Low systolic blood pressure at 54mmhg; Arm soreness; Felt sick; Diarrhea; Something was cooking in lung; Productive coughs; Vomiting; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), ILLNESS (Felt sick), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening), FALL (Fell from bed) (seriousness criterion life threatening) and HYPOTENSION (Low systolic blood pressure at 54mmhg) (seriousness criterion life threatening). On 21-Apr-2021, PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved, ILLNESS (Felt sick) outcome was unknown. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood pressure systolic: 54 mmHg (Low) Low systolic blood pressure at 54mmhg.         Physician treated him with fludrocortisone until he felt better for five days.; Sender'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.
Saturday 9/2/21 patient came to receive 2nd dose of vaccine and did not have an appointment and forgot his vaccine card. Patient requested pfizer but system showed that patient received Moderna 1st dose at his last visit. This was explained to patient and he insisted he received Pfizer. Patient was again informed by the nurse that he cannot receive the Pfizer vaccine today as the system shows he received Moderna and there is no way to verify with his card what he received. Patient decided to receive the Moderna vaccine and signed the 2nd dose consent form. Today 9/9/21 patient returned with the original card which states he received Pfizer for his first dose. I had the nurse practitioner educate him on both vaccines and CDC guidance on potential mixing of mRNA vaccines. She took his vitals and glucose which all came back normal as well. NP advised if he has any additional side effects to consult his PCP. Vaers report completed as well.
Patient called pharmacy 09/12/2021 in the afternoon stating that she wanted to report an adverse event.  She stated that on Friday night she experienced chills so cold it felt like she was in a freezer. She also stated that she felt she had seizure-like contractions, arms were jerking, and has pink plaque on both arms and they are itchy.  She did not go to the hospital.  She had been taking benadryl and using a heating pad to soothe herself.  She said that she will reach out to her doctor tomorrow.
Patient developed profound lip swelling, tongue swelling, and diffuse urticara. Intermittent wheeze. Improved with administration of Benadryl within 15 minutes.  12/10/09 MR received for DOS 11/23/09. DX: Anaphylaxis. Pt presented to clinic with lip swelling, urticaria, intermittent wheeze, tx: Benadryl.  No other new episodes. To check for egg allergy.
1 hr after MMR & Hib, slight rash where immunization was given-started breaking out more. next am was completely covered with hives-Benadryl helped for few hours lasted for 3 days. She had been on antibiotics but mom did not discontinue them-3 days later hives with itching finally went away. Still taking antibiotics.
Extreme dizziness all night long. I felt like I was drunk. Even my vision was affected. I felt like the room was spinning. The dizziness lasted until mid-morning the following. I all was so bad it actually scared me. I have never had such an extreme reaction to a flu shot.
onset of shaking (poss-chilling), t103 R w/in 1 hrs p/vax; pt seen by MD 5NOV92 because of t104 R;
Right after vaccination, I had a tingly feeling that went down to my arm to my finger tips on my left side where the vaccine was given. Within an hour or so I lost all feeling in my hand that lasted 2-3 days. Then I started having pain that radiated to my shoulder. I seen my doctor and was prescribed muscle relaxer. I was sent to physical therapy 3-4 months that lasted. I had my 2nd dose 4/17/2021 Moderna lot number 039A21A and the same issued happened. I still have issues with this. I seen a neurologist that told me that it could be a life long effect.
Breakthrough case admission after 2 vaccines Moderna 3/4/21 Lot# 030A21A;  Moderna 4/5/21 Lot# 025B21A
Achiness, fever, severe chills/teeth chattering, rapid heartbeat, nausea, vomiting, restlessness
Information has been received from a licensed practical nurse concerning one pt out of a total of four (previously reported as three) who was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt experienced an injection site reaction with swollen arm, fever, heat and difficulty using the arm. This pt also experienced nausea, vomiting, pain radiation down the arm and is in bed. Follow up information from the practical nurse indicated that on the second day after vaccination, the pt has arm pain, was just not feeling well, and had flu like symptoms. The pt was instructed to ice the arm and use Tylenol for discomfort. On day 3 after vaccination, the pts daughter (who is a dentist) called the physicians office and stated that her mother had a fever of 103, was nauseous, dizzy and could not get out of bed. the daughter described the pts arm as red, painful and swollen to elbow, looking like cellulitis. The pt visited the physicians office and required an IM injection of Celestone in the opposite arm to prevent serious complications. On day 4 after vaccination, the pt phone the physicians office stating that she was feeling better. The licensed practical nurse stated that the pt was not hospitalized, the events were not disabling or life threatening. Arm pain, just not feeling well, flu like symptoms, fever of 103, nauseous, dizzy, could not get out of bed, arm red, and swollen to elbow, looking like cellulitis were considered other important medical events (OMIC). Additional information has been requested.