chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of generalized erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT (batch number GY29L, expiry date 29th June 2019) for prophylaxis. Previously administered products included SHINGRIX (1st dose 0.5 ml via intramuscular route was received on 29th June 2018). On 22nd October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 30th October 2018, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In October 2018, less than a month after receiving SHINGRIX and less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced generalized erythema, pruritus and raised rash. The patient was treated with prednisone, BENADRYL and Calamine Lotion. On an unknown date, the outcome of the generalized erythema, pruritus and raised rash were unknown. It was unknown if the reporter considered the generalized erythema, pruritus and raised rash to be related to SHINGRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that she received the SHINGRIX vaccine in the left arm. At 10:00 AM Tuesday, the patient received the FLUARIX QUADRIVALENT vaccine in the left arm. The patient reported that during the evening she felt itchy, but it did not bother her. The reporter did not recall where the itchiness was occurring on her body. On 31st October 2018 the next day at 6:00 AM, the patient was eating breakfast and noticed that her inner forearm was getting red and the redness started moving up her arm. The patient went for a walk and when she got back, she noted that the trunk of her body, legs, and arms were red, too. The redness turns to bumps, resolves, and then cycles back to redness and bumps again and her face was very red, too. The patient went to her physician the day before reporting and was prescribed with treatment. In the morning on the reporting date, the patient reported it was not as bad, but notes that her shins are red, too. The patient commented that may be having both vaccinations could possibly have caused this. No more additional information was obtained. The reporter gave permission for her physician to be contacted.
My Left hand became numb with intense tingling and cold.  Then my middle finger turned completely white from the middle knuckle to the tip.  It felt like it had no circulation and appeared as if it were dead or made of wax for about 8 minutes.  There is still mild tingling of my left hand the next day but the color has returned to normal.
Swelling, itching at vaccine site. Mild headache for a couple of days. Woke up about 36 hours after feeling fatigued. But sometime after that, either on 5/7 or 5/8, I started having leg pain in my left upper thigh, just below buttock. Some cramping in calves at night over the weekend. The upper leg pain has been pretty uncomfortable, but it doesn't appear red or swollen and I don't appear to have any other symptoms. I'm not planning to seek medical treatment unless something else happens. And, it could be completely unrelated! I'm only reporting it to contribute to the overall scientific information.
Initial unsolicited report received from a consumer via partner company (Pfizer) (manufacturer report number- 2016056934) on 09 February 2016. This case involves 4-year-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Dtap) (batch number, route and site of administration not reported) eight year ago on an unspecified date. The patient's medical history includes allergy to nuts and asthma and concomitant medications were not reported. On an unspecified date (eight years ago), following the vaccination, the patient had experienced allergy to vaccine, thrush and was not good. The patient's breathing was bad. Laboratory data and corrective treatment were not reported. The outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event terrible allergy, bad breathing, and thrush. List of documents held by sender: none. This is a poorly documented case. Further information on time to onset, vaccination details, medical history, allergy testings to identify the culprit allergen, etc. will be required to complete the assessment. Based on the information available, a role of the vaccine cannot be assessed.
Within two minutes of being injected, I had a flush sensation throughout my body and became very nauseous, faint and got a headache. The symptoms persisted for 30 minutes so the pharmacist called an ambulance to the store.  The paramedics checked my vital signs which were stable but recommended that I go to the nearest hospital for further examination and treatment.
Cellulitis distal to injection site but on upper arm, started Saturday AM, small redness developed Sunday into cellulitis.
02/09/2015 Addendum status: Completed. Patient calling back to state that when he saw PCP on Wednesday he got a PNU shot in his L arm, states it was a booster shot, patient states that his arm is slightly swollen, red and itching, patient states that it started swelling up. About two 2 days after, states the swelling is not to bad, but the redness and itching is about the size of a small cantaloupe. States he has not ever had a reaction before, he does not c/o of swelling in the mouth, tongue, or any SOB. He is not taking any OTC meds for this. Will forward to PCP to review. Can he come in to nurse clinic to show us the area so we can document if this looks like reaction to PREVNAR 13 shot he got last week? Called patient, he will come to clinic today at 1PM. I saw him briefly in nurse clinic left upper arm has area approx 4-5 inches in widest diameter about the injection from PREVNAR shot last week, center of this area w/induration and midly warm to touch on my review of chart, there is an order in note to administer PREVNAR 13 shot and patient acknowledges it was givwn but i do not see the vaccine status in cprs/will notify lpn.
Information has been received from a licensed practical nurse concerning her 4 year old granddaughter who on 21Feb04 was vaccinated with a dose of varicella virus vaccine live. On 01Mar04 the reporter noticed a small red, raised area about the size of a quarter near the site of the injection. The child had not been seen by a physician. There was no product quality complaint. Additional information has been requested.
Patient thinks that he had a reaction to second dose of Shingrix vaccine, that manifested about a week after the injection. States he had chills, muscle aches all over for a few days, and night sweats. Does not think he had a fever.  Remembers getting a milder version of this about a week after receiving the first dose of Shingrix.
symptoms: pale, shaky, palpitations, signs: heart rate to 120s, oxygen sat 99 time course: improved and asymptomatic after 10 mins; observed in the office for 30 mins, no recurrence of symptoms after she left the office
Varicella vaccine given 02/16/10. On 02/27/10 dev rash starting on neck & spreading to trunk, UE/LE, scalp, face. Appearance & pattern consistent with varicella.
discussed vaccine with parent and patient and they wanted the jj vaccine due to almost being 18 and being over 250 pounds no sickness resulted
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 15-APR-2016, orally, which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 168 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
1/14 in evening developed "twitching" resolved, then developed vomiting/diarrhea requiring hospitalization for IVF due to dehydration.
Cant lift arm at all; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Cant lift arm at all) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Cant lift arm at all). At the time of the report, LIMB DISCOMFORT (Cant lift arm at all) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment details reported.
Very high fever developed within hours of vaccine, no previous sign of illness, no other symptoms developed other than fever.  Highest recorded temp 105.5, fever lasted 4 days.
About 24 hours after vaccines developed fever to 103, fatigue, and sore neck. Seen in ER, MD noted red throat without meningismus. Was discharged on fever control.
Dizziness, Myalgia, Fever, hot, sweating, chills Narrative:
I am pregnant and due Dec 23, 2018. I received the flu shot at my OBGYN yesterday. This morning I woke up at 6 AM feeling week and sick with my left arm where the shot was given significantly sore. I rallied and got ready and went to work despite feeling very ill and extremely thirsty.  I drank two bottles of water. At 11 AM I decided I didn't feel well enough to stay and would go home. As I got to the car I had uncontrollable explosive diarrhea. I have had it two additional times in the next three hours. I am resting now but extremely nauseated and feel lightheaded and not well at all. My stomach is still very upset.
After receiving the first dose on February 12, 2021 I noticed more fatigue. I had labs on February 15th. My tacrilimus increased slightly and my CMV viral load increased. After the 2nd dose on March 12, 2021, the fatigue was slightly worse. When labs were done again on March 15th, the tacilimus increased again and Dr reduced the dosage.The CMV increased more. There were no changes to the anti-viral med. Dr was also notified but have not heard back from her.
I have been sick all night; I got 101 fever; Chilliness; Hoarseness; Ache all over; Joints are aching; Coughing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (Solution for injection, Batch/lot number: unknown) via an unspecified route of administration administered in left arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alprazolam. The patient got first Covid shot yesterday as her doctor told her to go ahead and get it. She asked what kind of side effects it has and he said you would probably get sore arm and I was okay. So, she went and got it yesterday and about 8 o'clock. She have been sick all night. She had a fever, chilliness, little hoarseness and ache all over. She didn't have before the Covid-19 shot. She went in there and now got 101 fever, coughing, joints were aching. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I rec'd a flu shot the afternoon of the 17th. By the afternoon of the 19th I was feeling flu symptoms and I became really sick over the next few days. It has been 8 days and I am just now feeling a little better. I missed 3 days of work. My arm bled a lot when the technician injected me and the bruise was very dark.
Information has been received from a RN concerning an adult female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently, the pt developed an injection site reaction that included pain, swelling, redness and warmth. Unspecified medical attention was sought. The pt was treated with prednisone. The pt has reported improvements in her symptoms. A product quality complaint was not involved. The reporter also mentioned another female pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N) (WAES#0404USA01267).  Additional information has been requested.
Seizure-like activity for approximately five minutes, witnessed by grandparents. Patient drowsy but oriented after episode.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 1, single (Lot number: ER8735), in left arm, on 05May2021 at 12:00 as dose 2, single (Lot number: ER8735), in right arm and on 01Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 301358A) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 17Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: Covid symptoms and positive rapid antigen test on 17Apr2022; (24Apr2022) Negative, notes: Negative rapid antigen test on 24Apr2022 (Day 8); (29Apr2022) Negative, notes: Symptoms returned on 29Apr202 (Day 13) along with positive rapid antigen test; (01May2022) Positive, notes: Still testing positive as of 01May2022 (Day 15). Therapeutic measures were taken as a result of covid-19.   Clinical course: Covid symptoms and positive rapid antigen test on 17Apr2022. Symptoms quickly improved and resolved. Negative rapid antigen test on 24Apr2022 (Day 8). Symptoms returned on 29Apr2022 (Day 13) along with positive rapid antigen test. Still testing positive as of 01May2022 (Day 15). Patient did not have known allergies. Patient did not received other medication in 2weeks. For treatment of covid-19 patient also received Paxlovid (from 17-Apr-2022 to 21-Apr-2022).  No follow-up attempts are possible. No further information is expected.
1-2 hours after admin of Flu shot, itching and rash to left arm, face, neck and back. Raised red rash.
gets minor leg issues and circulation issues but no clots/every time he gets the vaccine less than two weeks later he gets indentations on both legs; when he gets the vaccine he would get a headache, no fever, chills, and really tired.; when he gets the vaccine he would get a headache, no fever, chills, and really tired.; when he gets the vaccine he would get a headache, no fever, chills, and really tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "when he gets the vaccine he would get a headache, no fever, chills, and really tired", "when he gets the vaccine he would get a headache, no fever, chills, and really tired", "when he gets the vaccine he would get a headache, no fever, chills, and really tired", "minor leg issues and circulation issues but no clots". The following information was reported: SKIN INDENTATION (non-serious), outcome "unknown", described as "gets minor leg issues and circulation issues but no clots/every time he gets the vaccine less than two weeks later he gets indentations on both legs"; HEADACHE (non-serious), CHILLS (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "when he gets the vaccine he would get a headache, no fever, chills, and really tired.". Relevant laboratory tests and procedures are available in the appropriate section.  Caller stated he has had 2 Pfizer covid 19 vaccines and 2 Pfizer covid 19 booster shots noting that he had the last vaccine in November and the 2nd booster dose this past Friday, 29Jul2022. Caller stated he has had 4 vaccines in less than 2 years. Caller stated every single time he gets the vaccine he has the same side effects and in a couple of days he is back to normal. Caller asked can the vaccine affect the kidneys and the heart. Caller asked what the long term are effects on his body and the short-term effects. Caller stated he gets minor leg issues and circulation issues but no clots. Caller stated every time he gets the vaccine less than two weeks later, he gets indentations on both legs, and it comes and goes throughout the day and goes away in a month. Caller stated his HCP does not know what it could be. Caller reported that when he gets the vaccine he would get a headache, no fever, chills, and really tired. Caller stated he was so tired from the vaccine saying it was intense, unbelievable and something else. Caller stated it knocked him for a loop. Caller asked if the fact that he is having this reaction is positive that the vaccine is working. Caller stated this is very stressful putting this medication in to his body. Caller stated she was fine before the vaccine  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash, swelling and itchy area surrounding the injection site. Used benadryl cream nightly to curb itchiness.
Chronic Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Chronic Fatigue). At the time of the report, FATIGUE (Chronic Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided.  No Treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant FU- DOB, email address and first dose vaccination date added
Shortness of breath, stabbing/burning chest pain, tachycardia of 150+, hypertension, fever, back aches. Treatment in ED with NSAIDs.
Return of migraine (from 11/12 that had just resolved) around 3 am 11/15. I was taking torodol 3 xs daily 11/12-11/14. My doctor called in 500 mg Nabumatone for 7 days for the migraine.  As of Wednesday evening my head feels fine. Full body muscle aches and pain and nausea and chills (started 11/14 in the evening). Unable to lift or move right arm  without severe pain, until Wednesday 11/17. Immediate pain upon injection (I am not afraid of needles or vaccines and I had my flu shot 2 weeks ago, in the same arm, and didn't feel a thing). Tuesday 11/16 the dizziness started in late afternoon and I actually fell over and landed flat on the floor because I lost my balance. I was still dealing with dizzyiness Wednesday morning 11/17, It seems to have resolved Wednesday evening.  I missed work Monday and Tuesday.
approx 4hr p/vax pt awoke crying;pt cried persistently that evening, fever of 104.3 R;pt given APAP q 4hr;local rxn @ inj site w/erythema & swelling;Did not contact MD;
Upper arm redness from the elbow to just above the vaccination site, itching enough to cause scratching, red area is warm-to-touch and warmer than the skin around it, slight pain at the injection site --- symptoms were on and off in the days after the injection, then got a bit more severe on May 5, 2021, nearly a week after the second injection.
Symptoms that were present and lasted for 9 hours: Severe chills, severe back pain, bad headache, hot/cold sensations, sweating, hallucinations  Symptoms that were present for lasted for 24 hours: Headache, fatigue
I developed a small itchy bump on the left hand side of my torso which spread across the majority of my left torso over the next two days. So VERY itchy and on 12/13 I contacted my Dr. who said to contact pharmacist so they could make a note of it in their records. He recommended Benadryl and cortisone cream. I used them twice a day with little to no improvement and went to an urgent care center on 12/17. The Dr. identified the rash as shingles then administered a steroid injection and prescribed two medications, Valtrex and Prednisone.
Local about 1 inch diameter indurated reaction which mom reports was twice that size 1 day ago. 02/11/2010 Information has been received from a nurse practicioner and a registered nurse concerning an 8-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 27-FEB-2007 at 15:50 pm was vaccinated subcutaneously in the left arm with second dose of VARIVAX (lot# 656079/1106F). It was reported that he was vaccinated at her well child check-u. on 28-FEB-2007 the patient returned to the office with an 8 x 5 cm swollen, hard, red, hot area at the injection stie. The patient's mother reported a decrease in swelling without treatment. It was reported that hte patient recovered as of 13-MAR-2007. The records of testing prior to release of the lot in question have been rechecked and found to be sastifactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-AUG-2015, the patient was vaccinated with improperly stored PROQUAD with lot number: L007230, expiry date 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Experience a rash on both arms (lower portion of arm) Sunday May 23, , rash was hot, red. Monday May 24, no rash during the day, later that night, it came back, next moring it was gone, following day rash is back on arms and belly.  Went away by thursday.  Saw doctor on Friday, no signs of rash. was prescribed something for the itch, but didn't need. Rash didnot come back.
This case was reported by a other health professional via call center representative and described the occurrence of uvula swelling in a 71-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced uvula swelling. On an unknown date, the outcome of the uvula swelling was recovered/resolved. It was unknown if the reporter considered the uvula swelling to be related to Shingrix. Additional details were provided as follows: The patient experienced swollen uvula within a day after receiving Shingrix. Symptoms resolved one to two days after onset. The reporter declined to provide more information.
pt was given an expired moderna bivalent lot ...vaccine lot expired 06/01/23 and  was given 06/16/23