chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Is itching a common adverse reaction to Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had itching. The reporter asked was itching a common adverse reaction to Shingrix.
Extreme fatigue, Urticaria all over body, benadryl and prednisone taper
Vaers being submitted per work policy due to getting booster too early.  we gave bivalent booster on 4/1/2023, pharmacy 9/7/2022 then we did again on 11/23/2022.
The patient said she may be having a reaction to the Shingrix vaccine that she received 5 days ago. When she woke up this morning, her right arm was itchy, red and warm. There was a 5 inch round/circle area of redness that began 2 inches below where the vaccine was given. She said that it might be a bug bite, but wasnt sure so she went to the dr today. The dr prescribed prednisone and told her to take benadryl otc. She said the redness had already gone down from this morning and she was getting her rx filled while she talked to me. I told her to let me know if it got worse and that I would make a report about her symptoms in our system. She said she was going to buy some bug spray to spray her room in case it was a bug bite.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ per oral, for prophylaxis (dose, lot #, and expiration date were not reported). It was stated that the vaccine was exposed to a temperature between 32 and 35 Fahrenheit degrees (°F) with a time frame of 9 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. No adverse effects were reported.  A product quality complaint was not involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010803: US-009507513-1705USA001583: US-009507513-1705USA001584:
Pt was admitted on 9/21 and had a COVID swab done on 9/23 that was negative prior to surgery for a right hip periprosthetic femur fracture.  Prior to skilled nursing home placement, pt had a repeat COVID swab completed on 9/28 that was positive.
This is a spontaneous report received from a contactable other HCP, who reported similar events for 3 patients. This report is for 2nd patient. An adult patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient had increased hepatic enzymes (elevated liver enzymes), onset May 10, 2021, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
pain in injection site X 1 day then on 1/11/21 developed  bruise to ventral aspect of left arm/injection site Narrative:
Nausea; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER2613) via unspecified route of administration in the left arm on 20Mar2021 at 03:45 PM (at the age of 27-years-old) as a single dose for Covid-19 immunisation. Medical history included anxiety from an unknown date. Concomitant medication included citalopram  30mg/day (MANUFACTURER UNKNOWN) and  norethindrone acetate and ethinyl estradiol(HAILEY)1.5/30 for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since the vaccination. On 21Mar2021, the patient experienced nausea, fatigue and brain fog. Therapeutic measures  were not taken for the reported event. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the nausea, fatigue and brain fog was recovering.   No follow-up attempts are needed. No further information is expected.
She was exposed at school, that's where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic; Loss of smell; Loss of taste; Fatigue; Cousin began to have COVID symptoms the same date as her aunt, 27Jan2021; This is a spontaneous report from a non-contactable consumer or other non hcp. This is report 2 of 2 for caller's cousin. The report is cross referenced to report ID: 91UGN7DB (patient: caller's aunt). A 34-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL3246; Expiration Date: unknown), dose 1 intramuscularly on 22Jan2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's cousin began to have covid symptoms the same date as her aunt, on 27Jan2021, she was exposed at school, that's where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic (exposure to sars-cov-2) on an unspecified date. The caller confirms her cousin began to have COVID symptoms the same date as her aunt, 27Jan2021. Her cousin was vaccinated the same date with the same Lot number and doesn't know if her cousin was tested. After doing exposure tracing, it was discovered she was exposed at school, that's where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic. The patient experienced loss of smell, loss of taste, fatigue on 27Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 05-JAN-2017, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml, once, lot # M016233, expiration date: 31-MAR-2018 (strength, route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was 45 F for a time frame of 15 hours and 30 minutes.  There were no previous temperature excursions. The call was not because of a data logger. Additional information has been requested.
sudden onset of Shaking chills, fever 102.7 oral, body aches, feeling of malaise. Tylenol and motrin taken for fever and pain; started wed 12/29/21 w low grade temp and bodyaches; woke in the night soaking wet; then two days later (12/31/2021) developed sudden onset of above symptoms; sent to ED at advice from doctor.  at ED-Covid swab done and negative, blood drawn, found to have a high white blood cell count, given IV fluids; treated for early pneumonia-given prescription for antibiotics,  1/2/22 developed leg infection (cellulitis), given a shot of antibiotics by PCP, started on second antibiotic
Immediately there was redness at the injection site and warmth.  The tenderness/pain and elevation with firmness began on 6/10/14.  The redness also expanded to the size of a quarter in diameter, at the injection site.  The firmness is hard like a marble, and elevated about 1-2cm above the skin. The firmness is still present as of today, 6/16/2014 and hasn't resolved. The redness is also still present, but has diminished in size by 70%.
Left arm is still very sore, almost 6 months later. Feels bruised, and when I lift arm while picking up kids, during exercise or while driving, it always has a dull ach/soreness. Some times are worse than others, massage or heat is not making it feel better. I have called and reported it to the facility who gave me the shot and my primary doctor as well.
this type of reaction was not exactly anaphylactic even though they were considering it as such; heart racing/heart was racing; eyes swollen shut/eyes swelled shut; red arms/arms turned bright red; itchiness; This is a spontaneous report from a contactable physician (patient's father, a dermatologist) via Medical Information team the Pfizer-sponsored program, Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date, 1.5 weeks prior reporting (batch/lot number and expiration date were not reported) as the 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date within an hour after vaccination, the patient had "red arms, heart racing, itchiness, and her eyes swollen shut." She was given diphenhydramine (BENADRYL), and was advised not to get the second shot. The reporter was seeking recommendation on how to proceed; if the patient could take another COVID-19 vaccine instead to complete the vaccination series. It was further reported that the patient had a Pfizer COVID shot a week and half prior reporting and she had a reaction to it, which included "arms turned bright red, heart was racing, and eyes swelled shut" on an unspecified date. They gave her a shot of Benadryl, and then she drove home. She had no problem after that.  She had no trouble breathing. They told her not to get the second shot. So the reporter went and looked for more information and saw on one website that she could go ahead and get the Johnson and Johnson vaccine or just stick with the one Pfizer shot. The reporter was wondering what was the current recommendation for this and wanted to clarify. The reporter stated that this type of reaction was not exactly anaphylactic even though they were considering it as such. The patient recovered from all the events on an unspecified date.  Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction  and other reported events.  There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.
Patient called to report redness around the needle stick on her arm, which was warm to the touch and was causing her discomfort.
had inc temp 102-103.5 off & on from Friday noc, until Sunday noc, also had dec appetite & fluid intake
Patient stated 1.5 hours after receiving vaccine she felt back spasms, pain in back and neck, she could not move, felt like seizures.
Patient was brought into have a well child and immunizations completed. In the process of drawing up immunizations other nurse offered to help. When I informed her that I needed the PCV serum the PPV was brought out and drawn up. Instead of double checking the serum the immunizations were administered.
Subsequent to receiving vax, the pt developed a fever of 104F, irritability and lethargy. The pt was seen in an ER where 2 full septic work-ups were performed. The pt was not hospitalized. On an unspecified date, the pt recovered. No further information is available.
pt devel t101 12hr p/vax & local 3mm erythema & large induration @ inj site (9x8);pt had significant leg tenderness, fever & refusal to walk on lt leg;rxn sorsened over the next 24-48hr where it covered nearly 90% anterior portion lt thigh
On November 20, 2001, this employee received the flu vaccine. On December 19, 2001 he was diagnosed with GBS. He was hopsitalized for one week and is recuperating at home. His completed recovery may take three months.
Besides the normal arm ache, slight headache and some tiredness, the following day after receiving the Covid Vaccine, my menstruation cycle began. I was due for my menstruation cycle but when it came, I began to bleed heavily. This is not a norm for me - my periods are usually light with spotting at the beginning of my cycle. It was so heavy when it began on Friday that I bled through my pants. For the rest of the day, Saturday and the beginning of Sunday my blood flow was very heavy and I was constantly changing pads. I was going to contact my GYN doctor but then my flow slowed down later in the day Sunday thankfully. I just wanted to let your office know just in case other woman are reporting the same issue. Thank you.
Red, raised rash from elbow to shoulder that started at injection site and spread. Rash resolved slowly over 5 days and is now the size of a quarter. No treatment administered. Patient has felt very "run down."
hives; cold; bumps that are spreading; very very sleepy; horrible experience; itching; bumps that are spreading; fever; rashy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), NASOPHARYNGITIS (cold), SKIN MASS (bumps that are spreading), SOMNOLENCE (very very sleepy) and MOOD ALTERED (horrible experience) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CHOLESTEROL, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), GARLIC [ALLIUM SATIVUM] and IRON for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), NASOPHARYNGITIS (cold), SKIN MASS (bumps that are spreading), SOMNOLENCE (very very sleepy), MOOD ALTERED (horrible experience), PRURITUS (itching), MASS (bumps that are spreading), PYREXIA (fever) and RASH (rashy). At the time of the report, URTICARIA (hives), NASOPHARYNGITIS (cold), SKIN MASS (bumps that are spreading), SOMNOLENCE (very very sleepy), MOOD ALTERED (horrible experience), PRURITUS (itching), MASS (bumps that are spreading), PYREXIA (fever) and RASH (rashy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported. Concomitant medications includes hormone medications.
Pt received IZ on 2/18/2009, mother phoned 2/19/2009 fever 104 advised ER.
This case was reported by a physician and described the occurrence of injection site reaction in a patient who received KINRIX (batch number 74G79, expiry date unknown). On an unknown date, the patient received KINRIX (intramuscular). On an unknown date, unknown after receiving KINRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: This case was previously reported to manufacturer. The age at vaccination was not reported. The patient did not received any other vaccinations 4 weeks prior to the date. The patient did not had illness at the time of vaccination. The patient had no preexisting physician diagnosed allergies, birth defects and medical conditions. The patient experience severe local reaction.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727) via an unspecified route of administration on left arm on 18Mar2021 at 07:00 as a single dose (at the age of 53-year-old) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration on left arm on 28Feb2021 at 15:30 as a single dose for COVID-19 immunisation. The patient reported no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested positive for COVID-19. On 20Mar2021 at 12:00, the patient experienced swollen lymph nodes on injection arm and on 21Mar2021, the patient experienced lower back pain. No treatment was received for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph node and lower back pain was recovered.   No follow-up attempts are needed. No further information is expected.
SEVERE ITCHING NOT RELIEVED WITH BENADRYL, ZYTEC PILLS, HYDROCORTISONE CREAM, PREDNISONE IM X 1.
6/10/21 Was given 1st COVID vaccine. 6/11 was seen in office for c/o fever, nausea, body aches, GI complaints and increased heart rate. Admitted to hospital with leukocytosis and abd. pain. She was discharged after 48 hours. Repeat bloodwork showed improved CRP and BNP. diagnosis was: "Inflammatory response to COVID vaccine."
hives devel around inj site of vax 1 day p/vax;hives over knee & neck & legs devel next day;
Information has been received from a consumer concerning her 12 month old son who on 21-AUG-2002 was vaccinated with an only first dose of MMR II (Lot # 641020/1483L). Concomitant therapy included VARIVAX. On 22-AUG-2002, the next day, the patient had fever of 104 degrees and cranky behavior. On 27-AUG-2002, the patient started throwing up with diarrhea whole week and next week diarrhea changed to large chunk tissue coming out from his stool. On 28-AUG-2002, the patient was hospitalized and stayed there for 3 days; the patient was diagnosed with viral colitis of unknown origin. A week later, the patient was diagnosed with autism, chronic pain and autoimmune response, which were ongoing at the time of reporting. Upon internal review, autism was considered to be an other important medical event. No further information is available.
No adverse effects reported; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about pertinent medical history, drug reactions or allergies was not provided.           On 31-OCT-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017251, expiration date 01-DEC-2020, dosage detail, route and strength were not reported) for prophylaxis. The sterile diluent (lot # S015238, expiration date 08-MAR-2022) used to reconstitute the vaccine was properly stored. Administered doses of vaccine experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (also reported as 7.4 Fahrenheit degrees) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6206, via an unspecified route of administration, administered in left arm on 15Mar2021 10:30 as single dose for Covid-19 immunisation. Medical history included folate deficiency and allergies to sulfa. There were no concomitant medications. After the first dose on 15Mar2021, the patient had vaginal bleeding/blood clots at mid-cycle. No treatment information was provided. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association reported events causal relationship with BNT162B2 cannot be excluded. Case to be re-assessed upon receipt of new information.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Pt states vaccine hurt upon administration. Had a what she believes is a seizure about midnight-same night as Admin Date. Body was jerky-lasted 20 minutes-tapered off and stopped. No problems since then.
The patient has a history of endometrial cancer and chemotherapy-induced peripheral neuropathy. She was brought to the ED by EMS on 9/24/23 for evaluation after sustaining two falls that day. Additionally, she reported she was exposed to someone who tested positive for COVID, and reported a fever of 100.1 F, cough, weakness, and congestion. A COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 9/24/23 - 9/27/23. The patient was placed on supplemental O2 during admission, however was able to wean to room air. During admission, dexamethasone therapy was initiated with noted hypoxia of 88%. Discharge diagnosis included acute hypoxic respiratory failure secondary to acute COVID-19 infection, among other diagnoses.  Of note, the patient was received three doses of the COVID-19 vaccine - Jansseen COVID vaccine on 3/14/2021; Pfizer Monovalent COVID vaccine on 11/5/2021; and Pfizer Bivalent COVID vaccine on 9/26/22.
Dizziness, tunnel vision, chills, low grade fever, light nausea, lethargy