chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; swollen arm; skin warm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and SKIN WARM (skin warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and SKIN WARM (skin warm). At the time of the report, PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and SKIN WARM (skin warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided. concomitant drugs were not provided
Lg reddened welt to (L) arm; Sm reddened welt to (R) arm.
No additional AEs; expired dose of VAQTA was administered; the vaccine had been involved in a previous temperature excursion; This spontaneous report has been received from a licensed practical nurse (LPN) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 14-FEB-2023, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) vial 50 (units not provided) (1 milliliter, lot # U013476 has been verified to be valid, expiration date was reported and established as 06-FEB-2023 upon internal validation) intramuscularly for prophylaxis (expired product administered). It was also reported the vaccine had been involved in a previous temperature excursion (product storage error). The maximum storage temperature of the vaccine was 49.82 degrees Fahrenheit for a total time frame of 1 hour 30 minutes. No other information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Initial local site reaction, ie induration and erythema in circular pattern around the site of injection of H1N1 (right shoulder). With progression to scaling, papular, erythematous rash in same circular pattern (measured 5.5 x 5.0 cm diameter) around the site of injection.
My both hips started hurting approximately 24-48 hrs after vaccine.  I have had pain , sharp and dull, in both my hips when I walk, and they feel stiff too.  I have had to take Motrin ever since. I started taking glucosamine with joint shield ever since with some relief.
This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender. Medical history and current condition of the patient were not reported. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ oral (lot#, expiry date, dose unspecified). Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from same source. Additional information has been requested.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
She got her vaccine, she woke up on Saturday with a little soreness and a small about .50 light pink area.  Over the next days it started spreading faster and faster where she took pictures every day of how big it was.  It got as big as a softball, red, hot and hard as a rock underneath.  The night before, on 11/20/23 she was sleeping and at 2:00 AM it was having spasms just where the shot had been.  This lasted for about 15-20 minutes, she tried to move her arm around and the spasm finally stopped.  The red spot is still very big, the hard ball is still rock hard, but inside it is now the size of a baseball.  Her underarm on that side is about 104 degrees compared to the other underarm.  She did contact her doctor when she first got it, and was not too concerned about it.  It was hurting a lot and took 2 Tylenol and slowed it down a little bit.  It is very painful to lay on or touch, and this continues.  She has never had a reaction to any vaccines, and gets all of her vaccines that she is supposed to get.    She had a COVID vaccine a few weeks ago and she it there is still a lump on it, and still sore to touch in that area as well.    She had the flu last year and was in the hospital.
within 24 hours, chest pain, pleuritic, Troponin I0486, cardiac MRI with LGE and abnormal T1 (1100 msec)
After first shot, migraines began and persisted; still suffering from daily migraines and headaches (I had not had a migraine in 5 years prior to the vaccine)  I have begun losing my hair in large patches on the back of my head. My endocrinologist, after looking at my blood work, has determined that this may have been an autoimmune response from the vaccine and that I am likely suffering from alopecia.
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu seasonal TIV (intramuscular) .5 ml on 6th November 2014. Concurrent medical conditions included thyroid function decreased. Concomitant products included Prenatal Vitamins and SYNTHROID. The subject's estimated date of delivery was 25th March 2015. The subject received Flu seasonal TIV at week 20 of the pregnancy and during the second trimester of pregnancy. On 6th November 2014, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. The investigator considered the vaccine exposure during pregnancy to be unrelated to Flu seasonal TIV. Additional details: No adverse events reported, the reporter was seeking to provide information for pregnancy registry. LMP was unknown.
Chills; low grade fever; extreme fatigue; headache; newmuscle pain; joint pain; weakness; This is a spontaneous report from a non-contactable other HCP(patient). A 26-years-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686), via an unspecified route of administration at Arm Left on an unknown date at single dose for COVID-19 immunization.  The medical history included Asthma, eczema, Sulfonamides allergy , cephalosporins allergy, penicillin allergy. The concomitant medications were montelukast, sertraline. The patient previously took azithromycin and experienced allergy. The Historical Vaccine was first dose BNT162B2 for COVID-19 immunization. The patient experienced Chills, low grade fever, extreme fatigue, headache, new muscle pain, joint pain and weakness on an unknown date. The symptoms occurred 8 hours after receiving injection. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
temp 102deg on 8/21/08 - then broke put with (+) multi erythema papules and pustules.
Patient reported nausea and dizziness following the 15 minutes observation period. Patient was advised to sit. She denied any shortness of breath. She stated that she did not eat anything that morning. Juice and crackers were provided to the patient. Vital signs were all within normal limits. Patient reported improvement after hydration and snacks.
she felt chills; feeling of tiredness; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller wants to check if she can have other vaccines for the 2nd dose instead of Pfizer since she got Pfizer for the first dose. She wants to know also why people are getting blood clots with other vaccines. She said she felt chills and a feeling of tiredness. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I experienced severe fatigue and muscle fatigue, joint pain in shoulder, fingers, knees toes all on the injection side of my body. Also, numbness and tingling in arm and leg, kidney problems, brain fog, and severe sore throat with gum and tongue pain.
seen 7 days p/vax rash on trunk & arms fine raised rash; No resp; no treatment; t99.0; pulse 124; resp 28;
Systemic: CLAIMS SHE HAD A BITTER METALLIC TASTE IN HER MOUTH, AND A LITTLE BIT OF SWELLING UNDERNEATH HER TONGUE AFTER 15 MINUTES. -Mild, Additional Details: After she reported her symptoms, I had her sit and wait an additional 10-15 minutes to monitor her symptoms to check for severity. She said she was feeling fine other than the symptoms described above, and did not claim any worsening of symptoms. I did advise her to take benadryl if swelling persists and inform MD or report to the emergency room if it gets worse. She left on her own accord as I was typing this report without letting me checking her status one last time and clearing her to leave.
my arm still hurts and just after getting the shot i got corona; my arm still hurts and just after getting the shot i got corona; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced my arm still hurts and just after getting the shot i got corona and my arm still hurts and just after getting the shot i got corona while receiving vaccine Influenza Vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious my arm still hurts and just after getting the shot i got corona (vaccination site pain) (unknown latency) following the administration of Influenza Vaccine. On an unknown date the patient developed a non-serious my arm still hurts and just after getting the shot i got corona (covid-19) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (my arm still hurts and just after getting the shot i got corona, my arm still hurts and just after getting the shot i got corona).  At time of reporting, the outcome was Unknown for the event my arm still hurts and just after getting the shot i got corona and was Unknown for the event my arm still hurts and just after getting the shot i got corona.
1616  states she is itching on her left arm at vaccine site. Area red about 3" in diameter. Flat red area, no hives. Denies throat itching or mouth.  Denies lightheadedness. Ambulated to private observation area. Had patient remove mask. Cheeks flushed, not itching. States she takes Benadryl all the time and does not get drowsy. Gave Benadryl 25 mg tablet by mouth. Drinking water without difficulty swallowing. States she felt a "flush" throughout directly after vaccine administration. States she has had a lot of allergic reactions in the past and takes allergy shots. States her allergist okay'd her to get the vaccine.  BP is 142/110 via electronic BP machine. HR 82  Continue to observe. Pt. drinking water  1618 recheck BP manually per auscultation and is 134/108 States she does have anxiety. Does not take meds for it.  1642 recheck BP manually per auscultation and is 138/86  HR 64 O2 sat 99% on room air.  1643 States itching gone. Redness appears to be lightening in color. No resp. distress, tongue not swollen. no throat itching. Denies lightheadedness. Gait steady. Left ambulatory to POV
Fever, eyes watered, bloodshot and yellow custard stuff ran out of them. One eye turned in and my eyes did not look the same direction with severe photophobia. Nose plugged, sneezing, hoarse. Nose and bottom lip swelled. Joints and muscles ached. Ran fever Thursday, Friday and Saturday.
Patient received the vaccine at 1:17 pm, felt fine after administration. per our usual protocol, we asked pt to wait around pharmacy for 15 minutes. She did so then left. Around 1:50pm, pt came back to pharmacy and informed tech that her face was starting to feel "tingly". Tech informed pharmacist and pharmacist gave patient one dose of Benadryl. Blood pressure was also checked. Initially it was 140/83, pt states her blood pressure is usually normal even though it is not checked regularly. After a few minutes, blood pressure is checked again and it is 136/82. Patient states as time passes she feels the tingling on her face diminishing. Husband was with her, although they drove separate, I recommended she drive with him so that she is not drowsy from the dose of Benadryl she took. Patient wanted to go home and asked patient if she needed EMS to be called, patient declined. Counseled patient to be cautious of a more emergency type reaction such as throat, lip or mouth swelling. Patient felt comfortable enough to leave.   Pharmacist called patient at 8pm to check in with her. She said the tingling feeling in her face went away shortly after she left the pharmacy.
At 7:30am on September 1, 2021, I started feeling my heartbeat faster, felt dizzy and lightheaded. The ER doctor said that my pulse became normal but my blood pressure has remained high since then. My blood pressure is normally 120/70 prior to the shot. After the shot, it has been 160/98-140/100.
A non-serious spontaneous report of some H1N1 LAIV got into three year old's eye was received from a registered nurse/healthcare professional concerning a 36-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Nov-2009, the nurse accidentally squirted some of H1N1, Intranasal into the three-year-old's eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Boostrix and Menveo administered on 08Aug and 16Aug; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENVEO and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 16th August 2022, the patient received the 2nd dose of Menveo, the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 16th August 2022, unknown after receiving Menveo, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date- 17-Aug-2022 Reporter's comment: The nurse reported a patient received a dose of Boostrix and Menveo. The nurse inadvertently administered Boostrix and Menveo again. The reporter consented to follow up. Additional Supportive Information: The nurse inadvertently administered Boostrix and Menveo again, which led to extra dose administered.
Headache; fingers on left hand were numb; very intense pain in left arm; unable to move arm for 2 days.  Symptoms lasted 3 days- the 4th day was much better but still had lingering s/s- resolved by day 5.
eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is an MD received the COVID vaccine on 21Dec2020. She quickly developed rhinitis, cough, and congestion which have persisted. Her eosinophil count is 12.2%. She received a Medrol pack, but it did not relieve her symptoms. She has delayed her second injection for now. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 21-JUL-2015, 24-JUL-2015, 28-JUL-2015, 29-JUL-2015, 03-SEP-2015, 10-SEP-2015, 14-SEP-2015, 28-SEP-2015, 29-SEP-2015, 01-OCT-2015, 02-OCT-2015, 05-OCT-2015, 07-OCT-2015, 12-OCT-2015, 20-OCT-2015 and 21-OCT-2015, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # K010755, expiry date: 19-MAY-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. There were no medical history nor concurrent conditions reported for the patients. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of a VARIVAX (Merck) lot # J014152 and expiration date 07-NOV-2015 (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. Thiss is one of several cases from the same reporter. Additional information has been requested.
Case number PHEH2012US016020 is an initial spontaneous report received from a nurse on 13 Aug 2012: This report refers to three-year-old male patient. He was vaccinated with MENVEO (batch number: M11053) intramuscularly on 13 Aug 2012. The nurse reported that MENVEO was administered to patient in error. No adverse event was reported following vaccination. No other information was available.
Chills; malaise; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263802 Same reporter and drug, similar events, different patient.
swelling; extreme itchiness; soreness; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PRURITUS (extreme itchiness), PAIN (soreness) and ERYTHEMA (redness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING (swelling), PRURITUS (extreme itchiness), PAIN (soreness) and ERYTHEMA (redness). The patient was treated with CORTISONE at an unspecified dose and frequency. On 02-Mar-2021, PAIN (soreness) had resolved. At the time of the report, SWELLING (swelling), PRURITUS (extreme itchiness) and ERYTHEMA (redness) outcome was unknown.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Severe H/A, Severe tingling of all extremities, Severe body aches, fever -Mother reported S/S to office 7-22-2016.
Rash (hives) on arm.  Weakness, upset stomach, chills.  Unable to raise arm for 3 days.  General feeling of ill health (lost 2 days of work) pain.
Headache, Myalgia, Arthralgia, CoughWheeze, Injection site discomfort Narrative:
Information has been received from a pharmacist concerning a 61 year old male patient who on 22-NOV-2010 was vaccinated subcutaneously with a 0.65ml dose into the left arm of ZOSTAVAX (Merck) (Lot # 664670/0151Z, expiration date 28-OCT-2011). It was reported that on an unspecified date, the patient developed a rash, redness and swelling on his left arm at the injection site after receiving ZOSTAVAX (Merck). On 24-NOV-2010, the patient was evaluated at an unspecified emergency room and released. The patient was diagnosed with cellulitis and treated with KEFLEX. At the time of the report, the patient was recovering. The pharmacist reported that early this month an adverse experience from a different pharmacist at the same pharmacy was reported (WAES 1011USA01255). The pharmacist requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
31 week pregnant pt admitted on 9/17/21 with soa, tachycardia and chest pain . Diagnosed with covid pneumonia and had been fully vaccinated. Delivered viable infant at 38 weeks gestation.
Blackout around 11 pm, came to on the floor , cold sweats, nausea, almost threw up. Chest pains (maybe unrelated)