chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching after Shingrix,; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergy to Erythromycin, refer case US2021AMR196343).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient just had first dose of Shingrix injection and at the time of reporting had itching over a portion of body.  The patient asked if Shingrix could be causing the itching. The patient further stated that the patient was allergic to Erythromycin.  The patient also asked if an allergy to Erythromycin would cause a reaction from the Shingrix vaccine. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196343:same patient
Had shot at 1:15 Tuesday- woke up Wednesday with total body aches and fever of 3 degrees above my normal.  Headache and chills all day.  Took Tylenol twice Wednesday and by bedtime fever down to normal. Next morning - woke up and felt 70% better- fever returned but aches were gone.  Still just rested all day.  Now Friday and feel much better.
This is a spontaneous report from a Pfizer Sponsored Program by a contactable physician. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose in her Gluteus Medius Left in Mar2019 for immunisation. Medical history none. There were no concomitant medications. The patient previously took SHINGRIX for immunisation. In Mar2019, the patient experienced cellulitis with outcome of unknown, possible shingles with outcome of unknown, induration and swelling at the injection site with outcome of unknown, erythema in a separate area from the injection site in the inguinal fold with outcome of recovered, they were a bit painful and about 3inches/1inch with outcome of unknown, 2 areas of redness with outcome of recovering, itchy with outcome of unknown, malaise, tired, maybe myalgia and low grade fever with outcome of recovered. Therapeutic measures were taken as a result of cellulitis, possible shingles, erythema in a separate area from the injection site in the inguinal fold, 2 areas of redness, itchy. No hospitalization occurred. The events were described as follows: 40 hours after receiving the vaccine the patient experienced "induration and swelling at the injection site, which became quite big 5-7 in across". There was also erythema in a separate area from the injection site in the inguinal fold, which had 2 areas of redness and they were a bit painful and about 3 inches/1inch. The patient went to the ER, it was thought to be Cellulitis or Shingles. She was prescribed Prednisone, VALTREX and Clindamycin. Two days after starting her prescribed medications she stopped taking them it appeared to be better. After 24 hrs the erythema located in the inguinal fold was gone and the site of injection had "less redness and decreased in size". Since the medications were stopped the patient had 2 additional regions of redness that were "non-tender but itchy and was using hydrocortisone". The patient also had systemic reactions 40 hours after the vaccine, such as "malaise, tired, maybe myalgia and low grade fever" which resolved 24 hours later. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Slightly raised rash beneath both arms, extending across stomach was noticed approximately 48 hrs after injection. Raised red mark also noticed around injection site on left arm. No pain, itching or discomfort associated with either mark on arm or rash.  Rashes have faded but not disappeared at present time, approx. 24 hours after first observed.
Celiac disease; Mild case of shingles on the left side; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL46202), via an unspecified route of administration, administered in right arm on 03Mar2021 12:00 (at the age of 68 years old) as 2nd dose, single for COVID-19 immunization. Medical history included mild high blood pressure, and known allergies to sulfa and gluten, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included lisinopril taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267) in Feb2021 at 12:00 PM, administered in Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had a mild case of shingles on the left side about 20Mar2021. Her doctor saw it and said it was definitely shingles. She has no other health problems except celiac disease on 20Mar2021. No treatment was received for the events. The outcome of the events was recovered with sequelae.
Initial unsolicited report received from a nurse on 12 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, one week following the vaccination, the patient had developed circular, red, warm area, the area was tender. It was reported that the redness, warmth and tenderness were progressively worsening. Laboratory data and corrective treatment were not reported. The patient was not recovered from the event. Follow up information received from nurse on 30 November 2015. The patient was vaccinated with a dose of FLUZONE HIGH DOSE (batch number: UI442AA, expiry date: 06 April 2016) in left deltoid on 21 September 2015. List of documents held by sender: none.
Pt. had a 3cm x 3cm soft tissue swelling of left upper arm area felt warm to the touch, no fever noted by patient some pain & discomfort noted in (L) arm pt advised on therapeutic modalities for symptom relief.
Pt received her first dose of the Moderna COVID-19 vaccine and within minutes c/o feeling dizzy. EMS was on site and evaluated the pt. Pt's HR was up to 137 though pt reported feeling better, just anxious. Pt denied headache, chest pain, shortness of breath. Pt signed a refusal for transport to the hospital with EMS.  Pt waited an addition 15 minutes in clinic for a total of 30 minutes and by the time she left she reported feeling much better. Pt was advised by RN to call her PCP to discuss prior to her second vaccine. Pt verbalized understanding and agreed to the POC.
This case was reported by a healthcare professional and described the occurrence of intermittent pruritus in an adult male subject aged 30-40 years old who was vaccinated with BOOSTRIX. On an unspecified date the subject received 1st dose of BOOSTRIX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced mild intermittent pruritus (no redness) on different areas of his body every 3 days. The subject was treated with Benadryl when the event first occurred with temporary relief, but was no longer taking it at the time of reporting. At the time of reporting the outcome of the event was unspecified.
Patient experienced a bumpy and swollen tongue, "raw" throat, arm tingle, cold sweats, "ant crawling itching", and heart palpitations
itching, hives on chest, flushed cheeks, thickness feeling in throat that began about 1.5 hrs after receiving second vaccination - relieved by 50mg of Benadryl.  Itching persisted and controlled with Benadryl 25mg every 4-6  hours for the following two days.  So far today, I have not taken any Benadryl, but am still feeling slightly itchy.
multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was prescribed zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider and vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions by a pharmacist. On an unknown date, the pt suffered multiple outbreaks of herpes zoster as a result of the zoster vaccine live(ZOSTAVAX) vaccine.The outcome of herpes zoster was unknown.
I had a delayed hypersensitivity reaction around the injection site. It was a raised welt that was circular measuring about 3 inches by 3 inches that feels very itchy and hot to the touch.
Left arm pain, swelling and swollen glands day of immunization.  Left arm pain and limited mobility ongoing . (3 months now.)
17 y/o female received 1st dose of Pfizer and was sitting in the observation area. She had a witnessed syncopal episode, lasting approx. 45-60 secs.  When pt. regained consciousness she was placed in a wheelchair and moved to a private area. VSS at that time. Pt. was given some water to sip on and stated she was feeling better. Pt. denied any other complaints at that time. Pt. denied any PMH/ Meds./Allergies. Pt?s grandmother is with her and states pt. appears to be back to baseline. Approx. 30mins. after syncopal episode, pt. stated ?my heart is racing and my throat feels dry?. VS reevaulated, pt?s HR was 122,  BP 130/66. Pt. stated she wanted to go to the ER. She was t/p BLS to ER. See PCR for further.
Pt seen in ED on 1/20 with increasing chest pain - pain in the mid chest, worse with breathing and limited ability to bend over and lay flat.. Troponin negative x2, ProBNP 42.4. Slightly elevated WBC at 11.96 and PTT at 36.7. PT/INR ok at 11 and 1. CT of the chest demonstrates no PE or pericardial effusion. ECG with no significant changes. Pt given ASA 324 mg and Norco 7.25/325 x1 in ED. D/C with Ibuprofen 800 mg TID for pericarditis. Covid test on 1/21 was negative. Pain improved as of 1/26. Per cardiologist review on 1/22 patient with elevated CRP (1.522) suggestive of pericarditis as cause.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' concurrent condition and medical history were not provided. On 25-MAR-2016 the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # L019125, exp.: 27-MAY-2017) (dose, route and site of administration not reported). Concomitant medication was not mentioned. The vaccine was stored at 12F for a time frame of 20 minutes daily for 140 days (incorrect product storage). The call was a result of a data logger. There was no previous temperature excursion reported. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
hives, swelling of face and throat, difficulty breathing, fast heartbeat and weakness and swelling and weakness of left arm
rheumatoid arthritis; Both of his hands were swollen; face is swollen; pain was 3 to 4 from a scale of 1-10; This is a spontaneous report from a contactable consumer reported for her husband that a male patient of an unspecified age (reported as 71, no unit) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Patient received both doses of the vaccine with the last one on 12Feb2021, he was 70 (no unit) when he had the shot. His wife stated his doctors were a bit flabbergasted at his symptoms and the test had not given any indication of where he should go next. He is having some issues that look like rheumatoid arthritis and he has had several tests from emergency and a primary care provider. At first, they said there was not an indication of rheumatoid arthritis and then it said it was questionable as to "ANA." Both of his hands were swollen. Initially it was little and it got to be huge. His pain was 3 to 4 from a scale of 1-10. They gave prednisone and his hands went down and then several days later they were swollen again. He had prednisone again and then it went up again. He woke up and his face was swollen. The doctors were saying cold compresses. They looked at rheumatoid arthritis positive tests online and found that one way to be positive is due to a vaccine. She wanted to know if there is any help they can be referred to or any information on this. The wife stated she has already spoke with 3 people and reported this to all 3 agents. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swollen lymph node. Swollen armpit/very painful. No rashes/no redness. MD prescribed antibiotic 9/18/14. Pain/hurts x3 days.
PALPATATIONS, FELT FLUSH WITHIN 13 MINS OF RECIEVING.  BLOOD PRESSURE ELEVATED FOR THIS PATIENT, CAME BACK DOWN TO NORMAL FOR HER WITHIN 15 MINS
injection site pain, tiredness, headache, muscle pain, chills, injection site redness/rash/itching, nausea, swollen lymph nodes (armpits/throat), inside of mouth cheeks/throat very sore, hard to breath, sharp/achy chest pain - sort like bronchitis without the phlegm, potentially high blood pressure but I have no way of measuring it. Have been taking benadryl 2 pills every 4-6 hours since around 15 minutes after dose one, took aleve since yesterday (April 5 2021). As of present (April 6 2021) still experiencing all of the above and feel unwell
Patient received Moderna Vaccine # 1 on 2/19/2021. On Sunday 2/21/2021 at 9am patient noted both lower extremities covered in hives, and both ears were red and swollen.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown gender and age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, route, lot/batch number and expiration date were not reported). On an unknown date, after receiving PNEUMOVAX 23, the patient developed cellulitis at the injection site and was hospitalized (date unspecified). No product quality complaint (PQC) involved. The outcome of cellulitis at the injection site was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of the several reports from the same source. Additional information has been requested.
Patient had PREVNAR 13 1 year ago with no reaction. Came back after year to get PNEUMOVAX 23. Came back to pharmacy 2 days later left arm from deltoid muscle area all the way past elbow was red and swollen. Patient was advised by her doctor's office to take benadryl and if not better after 24 hours to seek treatment.
This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of MMR II injection (lot # K016153 with expiration date 24-SEP-2016, albumin status RHA (recombinant human albumin), lot # K024038 with expiration date 26-NOV-2016, albumin status RHA, lot# L001336 with expiration date 13-JAN-2017, albumin status RHA and lot# L007577 with expiration date 05-MAR-2017 albumin status RHA: dose, frequency and route were not provided. No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On sixth day, began vomiting, headache, chills.  Unable to keep food or water down for 4 days.  Had 2 Liters IV fluids in ER on March 24, but remained ill for 2 more days.
Acute respiratory failure requiring 6 L by mask.   Only into this 2 to 3 days positive COVID.  History of prior COVID immunization.     Patient was shifted over to BiPAP   He was last on 19/10 70% FIO2 and then shifted back to high flow to go to CT PE for d-dimer elevated.  Admitted.
Fever, max 100.5; redness, induration 2 cm x 2 cm.
I woke up with intense headache several times. I also had upset stomach, mental fogginess, and fatigue. The very next day I started having nasal congestion and sneezing. So, I took an at home test which came back positive. I started isolating for 5 days and got plenty of rest. I had a virtual doctor's appointment. My doctor told me to take EXCEDRIN after giving her all my symptoms and drink plenty of fluid. I ask were there any downside to taking PAXLOVID and she said that most people have returning symptoms, so I just took over the counter. By the 3rd day I started coughing bad and had chest tightening. The next day I started having a sore throat which I took HALLS for and all the other symptoms (headache, upset stomach, and body aches) had started to resolve. By Friday I only had congestion, fatigue, and some couching at night until maybe Tuesday. On July 7th was the day I tested negative.
second dose of the vaccine my symptoms are much worse and lasting much longer; Sick with vomiting; Sick with vomiting; Really Nauseous; headache; Bad chills; Chills and fever; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8732), via an unspecified route on 26Mar2021 at 13:00 (at the age of 59-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199), via an unspecified route on 05Mar2021 (at the age of 59-years) as dose 1, single in the right arm for covid-19 immunisation and experienced headache, nausea. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced really nauseous, headache, bad chills and fever, sick with vomiting. Patient states she is still feeling really nauseous and headachy. Caller was prone to migraines, states usually with her migraines, an Aspirin product was the only that that helps her. Caller would like to knew if it was safe to take Aspirin products, she thought it was not safe to take after the vaccine. She also states typically 24- 48 hours is when you are supposed to start feeling better after receiving the Pfizer Covid 19 Vaccine, caller just wondered how much longer until she started feeling better. Patient nausea began at 10pm the same day she received the vaccine. States she received the Pfizer Covid 19 vaccine at 1300 and 45 minutes later she got bad chills and went to bed and had chills and fever and nausea all night. The chills and fever are not ongoing. The chills and fever broke by morning. The nausea and headache came Saturday and remain, the nausea and headache were worse yesterday, which was two days after. She actually got sick twice last night. Caller clarifies this was sick with vomiting. Caller thought she would wake up feeling better today and really had not. Patient stated "After getting the first dose of the vaccine my symptoms were really mild lasting 7 - 8 hours. After getting the second dose of the vaccine my symptoms are much worse and lasting much longer." They are going past the 24 - 48 hour mark." Patient did not visited to Emergency room or Physician office. Patient reports she was taking Tylenol. The outcome of events was bad chills and fever was resolved on unspecified route of 2021, headache, really nauseous was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
After receiving the vaccination, patient presented to pharmacy counter stating her "tongue is itchy".  We had her sit down and went over if she was experiencing any other symptoms. Patient stated No to the following:  shortness of breath, dizziness, difficulty breathing, hives.  Patient was feeling well otherwise and agreed to sit for a while longer at pharmacy.  Upon discussion, she stated she did have a reaction following the 1st dose (itchy and hives) however this was several days after and her doctor believes this was related to a change in haircare product.  After sitting for a few more minutes, patient was ready to go home even though he symptoms had not improved.....however nothing was worsening either.  She was advised to go home and take diphenhydramine and monitor closely.   After a follow-up phone call 24 hours later, patient said she was feeling better with the tongue itchiness, but now is experiencing more common side effects of headache and body aches.
This spontaneous report was received from a physician and refers to a 15-year-old male patient. The patient's concurrent condition included environmental allergy and fatigue. His medical history included nasal congestion. Historical medications included MOTRIN PM for allergy and MOTRIN IB SINUS for nasal congestion. The patient had several FLUZONE vaccinations in past flu seasons. The patient did not take any concomitant medications. On 11-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot# R003245, expiration date: 16-NOV-2020 and with FLUZONE lot# UT6258NA, both into left arm (doses and routes of administration were not provided). On the same day, the patient experienced syncope after receiving the vaccinations. No drug treatment prescription was required for the event. The outcome of syncope was reported as recovered on an unknown date in 2018. The relatedness between the events and GARDASIL 9 was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1809USA005320.
Autoinnoculation site, about 2cm away from primary smallpox vaccination site - likely secondary to tape reaction.
Felt woozy 5 minutes after vaccine, but that seemed to subside within an hour. For 3 days felt exhaustion/chills. It has been 10 days and still feeling  off. Dizziness and continued brain fog makes it hard to concentrate.
High Fever - 99 to 101 °F: lasted for day and half. Intense Pressure in head and Headache: Tylenol, and ice pack had little to no effect on it. Same time schedule as other symptoms. Slight stomach sensitivity: same time schedule as other symptoms.
This medically confirmed spontaneous report (initial receipt 17-Oct-2013) concerns a female patient with a history of allergy to VALTREX. The patient had no pertinent medical history or concomitant medication. On an unreported date (2 years ago), the patient received influenza (batch and manufacturer not reported). On an unreported date (2 years ago) the patient broke out in hives and her face was swollen. She became dehydrated. She visited a healthcare centre but was not admitted to hospital. She was treated with BENADRYL and IV fluids. Outcome was reported as recovered.