chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccination 9/20/11. Reported redness on arm 9/21/11 stated there was a hard nodule at injection site, the arm was red onto the elbow and hot to touch. The patient reported 9/23/11 that she was flushed & had a headache. Was going to physician at 2pm. At this time, 9/23/11, the patient reported taking an expired prescription of Prednisone 20mg 1/2 tablet at 4pm then a full tablet at 7pm on 9/22/11. Otherwise only Aspirin & TYLENOL.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with hydrocortisone and BENADRYL. On an unknown date, the outcome of the injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX subcutaneously rather than intramuscularly, which led to inappropriate route of vaccination. The patient experienced a coffee cup sized localized redness and swelling reaction at the site of the SHINGRIX administration. The route, dose and frequency of treatment drugs BENADRYL and Hydrocortisone were unknown. The patient was also told to apply ice to the affected area. The reporter agreed to have follow up contact. This case was linked with the case US2018GSK126432, reported by the same reporter.
hearing loss in left ear; All the other symptoms too; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced hearing loss in the left ear.  The patient's medical history and concomitant product were not reported                                                                                                   On 12 Feb 2021 date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On 12 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.    On 12 Mar 2021, patient had experienced other symptoms too but did not elaborate the same.  On 15 Mar 2021 patient started noticing hearing loss in his left ear. The patient had not treated his ear loss.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
pt admitted 11/2/21 with COVID (tested positive on 10/29) s/p receiving 2 doses Pfizer on 3/5/21 & 3/26/21
Information has been received from a health professional concerning a patient who on an unspecified date, was vaccinated with a first dose of VARVIVAX (Merck). It was indicated that the patient developed a local reaction after receiving VARIVAX (Merck). The reaction was described as approximately a 4 inch swelling in diameter at the injection site. It was not specified if the patient was seen by the physician, or called the office. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information has been requested. This is one of two cases from the same source.
Topical reaction at injection site, warm, itching, back of right arm is red. Advised to take BENADRYL as directed.
Red rash on face, legs, arms, trunk, about 3 hours after immunizations.  Had increased temp - 101.3 Ax.  Fever x 3 days.
Patient was seen on 2 Dec 2011 for redness on R thigh with pain and swelling. Vital Signs P105, Resp 16, Temp 98.6, O2 100% room air, Weight 17Kg, pain 3-4/10. Pt given Keflex 250mg.
Vaccine given 2-5-02. On 2-20-02, seen for red swollen site. 1-15 cm knot with erythema at injection site.
Right lateral thigh with maculopapular red rash in anular pattern, 3 cm circumference. 5 distinct papules, one beginning to become vesicle.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration, on an unspecified date, as single dose. The patient's medical history and concomitant medications were not reported. The patient experienced allergy on an unspecified date with outcome of unknown. Clinical details were as follows: the patient was immunized fifteen years ago (date unspecified), with PREVNAR. He had an adverse reaction. He was instructed to avoid any further immunizations. He now wants to travel extensively internationally and the physicians would like to track down the ingredients of the PREVNAR to help identify the allergy. The outcome of allergy was unknown. Follow-up (10JUN2016): Follow-up attempts are completed. No further information is expected.
red pigmented lesion ,first started at the injection arm( left arm); red pigmented lesion spread to the legs; red pigmented lesion spread to the other arm(right arm); This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)). At the time of the report, SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow Up Appended. Added batch number. Patient route of administration updated. On 30-Jun-2021: Follow up received and contains No New Information.
This spontaneous report as received from the patient's mother referring to her son, a 2 month old male patient. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine live oral (Opv), poliovirus vaccine inactivated (Ipv), hib conj vaccine (unspecified) (HIB) and Hepatitis B Vaccine (Recombinant) (manufacturer unknown); all given on 10-APR-2017. On 10-APR-2017, the patient was vaccinated with GARDASIL 9, (dose,lot # and expiration date were not reported) intramuscularly for prophylaxis by accident. The physician, mistakenly gave the patient GARDASIL 9 thinking it was the pneumococcal conj vaccine (unspecified) (PCV) instead. It was also reported that the pneumococcal conj vaccine (unspecified) (PCV) was administered on the same date. Additional information has been requested.
Type 1 Diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 2, 0.2 ml single (Lot number: FL0007) at the age of 7 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, lot FL0007), administration date: 27Dec2021, when the patient was 7-year-old, for Covid-19 immunization. The following information was reported: TYPE 1 DIABETES MELLITUS (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "Type 1 Diabetes". The event "type 1 diabetes" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: more tests: (2022) diagnosed with type 1 diabetes; other tests: (2022) Negative; SARS-CoV-2 test: (2022) Negative; (2022) Negative; Viral test: (2022) Negative; Weight: (2022) losing, notes: but not rapidly. Therapeutic measures were taken as a result of type 1 diabetes mellitus.   Clinical Course-Caller was asking about the vaccine if it can be a cause of Type 1 Diabetes. Caller mentioned that right after his sons second vaccination, they were slowly noticing symptoms. They went to the doctor every now and then and even had his son for viral testing but he tested negative. Now, the doctor recommended his son for glucose, more energy, and exercise. However, after 6 months, the symptoms have been increasing more and more. His son became weak with type 1 diabetes. Caller was looking for additional resources about the vaccine and type 1 diabetes for his son. Caller stated the strange thing genetically it has to do with genes and viruses and it was not until after the 2nd dose. Caller stated that after the diagnoses they learned more about its symptoms and how it develops. Caller stated it continued and they started seeing more and more symptoms a month ago and they took him to the ER and learned he is Type 1 diabetic. Caller relays he was having more urination than normal, his body, they were especially able to notice his symptoms but not highly. Stated he was getting little breathing issues and more pee than usual and was losing weight but not rapidly. Stated over 2-3 months as time was going on they saw more and more impact and based on what the doctor said he was negative for COVID and fever and other things and they could not figure out what was taking place. Stated a week ago he was diagnosed, and they did not had family history of Type 1 diabetes and he does not see anything else to be considered there. States he was in the hospital around 19Jun2022 and was discharged home in 3 days and was doing well. Caller also wanted to learn as he has one more kid and does not want him vaccinated, he wanted to learn was there any other instances reported or anything like that. Stated to benefit or support him. Asking if there was a helpline to report adverse events.
red itchy splotches on face, dizzy & nauseated secondary p/vax;arm hurt all the way down; a little tightness in chest;MD evaluated stated not true hives, gave antihistamines x 3 days;
Patient felt swelling and heat under applied bandaid. I asked if she was experiencing any shortness of breath or swelling of lips or tongue and she said no. I advised her to take BENADRYL for the pain and Acetaminophen or Ibuprofen for any pain or heat and to watch for any worsening of symptoms. By next morning her arm was swollen down to her elbow. She said still no shortness of breath or swelling of lips or tongue, but I advised her to keep taking BENADRYL and to see her doctor. On Monday, she said most of the swelling was gone and the heat/redness was getting better but I still recommended she see her doctor. She did finally go and the doctor told her to Take BENADRYL 4 times a day. I saw the patient on Monday, October 10th, her swelling was all gone, her arm had returned to normal size and she said she had no lingering effects.
I've been unwell; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I've been unwell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (I've been unwell). At the time of the report, MALAISE (I've been unwell) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.
Has had sharp back / pain / not resolved; Right leg pain / not resolved; This case was reported by a consumer and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 6th November 2020, refer case US2021032748).   On 25th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced back pain and leg pain. On an unknown date, the outcome of the back pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the back pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had sharp back and right leg pain.  It had not resolved and would follow up with HCP.  The reporter could not find HCP contact information during call, it was not obtained for that reason. The reporter did not consent to followup.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021032748:Same reporter.
Pt given TD and Twinrix on 04/02/2002. Returned on 04/03/2002 given IPV, typhoid and yellow fever. Some urticaria on morning of 04/04/2002. The pt returned to the office on 04/05/2002 and was given injection of steroid packs and lelestone.
Patient was admitted 9/6/06 and received pneumococcal vaccine in right arm IM.  Patient developed a cellulitis below the level of injection.  Area has been circled by attending physician and is being observed.  Lot number was reported on vaccine sheet as T122106 which may not be correct.  Patient was started on Nafcillin IV 2gm every 4 hours with little improvement.  Patient was started on VANCOMYCIN IV 1 gm every 18 hours and discharged on BACTRIM DS 1 tab by mouth twice a day for 7 days.
I administered four shots to patient at about 3:00pm on 10/10/17. The first three (MCV, Tdap and Flu) went well. I administered MCV and Tdap to into the left arm and Flu and HPV into the right arm. Right after administering the fourth shot (HPV/Gardasil 9) the pt fainted, falling backwards. I caught the pt and laid her down on the exam bed as she was sitting on the bed during shot administration. I called code blue immediately, followed by Dr. calling code blue into the hallway. The pt woke up almost immediately after falling backwards. She tried to sit up but I instructed her to stay laying. I used my pulse ox to find that pt's oxygen was 98 and her pulse was 70. She was coherent, knew where she was and what she was doing. I asked nurse, who had responded to the code blue to retrieve a cold pack and she did so. I placed the cold pack under the pt's neck. Dr. advised the other medical assistants that everything was under control and they could go back to work. Dr. and I stayed with patient for 10 minutes, monitoring her pulse and oxygen and making sure she was doing okay. Dr. and I checked on the pt two more times in five minute intervals. We gave the pt juice. After twenty minutes the pt was feeling fine and pulse was checked at 78 and oxygen saturation still at 98%. We instructed the pt to slowly stand up . She did so and was feeling fine so Dr. discharged the pt. Dr. instructed the pt to take it slow and have something to eat when she got home.
Intense pain radiating from the site of injection, through shoulder into neck and down arm to hand. Tingling in arm and hand of injection. Stiff neck
second Covid shot on 01Apr2021 and it made her feel crummy; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as DOSE 2, SINGLE for covid-19 immunisation (immunocompromised and was called by withheld institute to get the third shot); ocrelizumab (OCREVUS), route of administration, start and stop date, batch/lot number and dose were not reported for multiple sclerosis. Medical history included Immunocompromised, multiple sclerosis, rare autoimmune vasculitis; It was reported that patient was immunocompromised and had Multiple sclerosis and a rare auto immune vasculitis prior to getting any Covid shots. States 14 years ago was diagnosed with multiple sclerosis and having been on a number of medicines since then, immunosuppressant drugs by Genzyme, Sanofi, Biogem, but she has tried all the MS drugs, pysabri, Capaxone, Betaseron 1A shot, and then provides for the rare autoimmune vasculitis she takes 2 medicines at a time, Rituxan and Cytoxan. The Rituxan is every 6 months and Cytoxan was monthly, plus a truck load of IV corticosteroids, but she does not know how much, but it was a lot; Reported that she was on a new drug for her multiple sclerosis called Ocrevus, it's a form of Rituxan, but it's like 4-6 times stronger than that. One of the warnings on the bottle is for skin infections and lower respiratory infections. That you are more at risk for skin infections, so it's a perfect storm. Like maybe a critter got in there and made her life miserable and caused this skin infection. This medication certainly makes you immunocompromised and her blood work recently showed she is low on immunoglobulins. Wonders if the skin infection could have come from this new medication or shot. Mentions she is also taking 5 days a month of IVIG therapy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6204), on 10Mar2021 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced first Covid shot on 10Mar2021 and it was not as bad as the second one. No other vaccines given that day and none 4 weeks prior. No problems with vaccines in past. No history of previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations (within 4 weeks). On an unspecified date in 2021, the patient experienced second covid shot on 01Apr2021 and it made her feel crummy. The action taken in response to the event(s) for ocrelizumab was unknown. The outcome of event was unknown.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
One week post vax the pt experienced fatigue, swollen lymph nodes, and a raised maculopapular rash on her extremities. The pt sought unspecified medical attention. Additional information has been requested.
Started to have redness on her body about 10 different places and got bigger and more itching on those spots every day. Pt complained her throat was kind of tight. The painful sensation on injection site got better with time though. Pt did not do anything and did not call the pharmacy and doctor at all. Pt finally called me on Wednesday night. She is contacting Dr. for treatment for further discussion.
felt weird; A large(3x4 inches), warm, red, itchy area developed lower on my arm(more inside just above the elbow)/the area is still slightly itchy, and just a little visible; A large(3x4 inches), warm, red, itchy area developed lower on my arm(more inside just above the elbow)/the area is still slightly itchy, and just a little visible; warm, red, itchy area; tightening in the chest which moved up to the neck started happening; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Ewd62), via an unspecified route of administration, administered in Arm Left on 17Apr2021 17:00 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 64 years). The patient medical history included reflux, Blood Pressure and Allergies all from an unknown date and unknown if ongoing. Concomitant medications (Other medications in two weeks) included Lisinopril 10mg, Esomeprazole 40mg, (CLARITIN (loratadine) and Vita all taken for an unspecified indication, start and stop date were not reported. It was reported that, the patient was not a pregnant at the time of vaccination. She did not receive any other vaccine in four weeks prior COVID vaccination. She was not diagnosed with COVID prior vaccination and was not tested with COVID post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Er8730), via an unspecified route of administration, administered in Arm Left on 27Mar2021 16:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 64 years) and experienced normal side effects like sleepy, 2 waves of nausea, chills, feeling out of it, arm ache and soreness for 2 days. On 17Apr2021, 35-40 minutes after receiving the shot while driving home, the patient experienced a tightening in the chest which moved up to the neck started happening. On 18Apr2021, the next day, the patient experienced she felt weird, and had a less severe feeling of the tightening in the chest and neck area, but still there, a large (3x4 inches), warm, red, itchy area developed lower on her arm (more inside just above the elbow) and expanded in size the next day. It expanded a little more and is slowly going away. On 23Apr2021, 6 days later, the patient experienced the area is still slightly itchy, and just a little visible. She called the family physician on 26Apr2021 morning to let them know about the reaction and they had her send a photo. Her physician wants her to see an allergist about the possibility of having to skip a booster shot because of the reaction. The patient has visited physician office as a result of events. Therapeutic measures were taken as a result of events include Benadryl. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.