chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm turned fire red from shoulder to elbow; Itchiness on back, shoulders and top of chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA and PRURITUS in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-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 ERYTHEMA and PRURITUS. At the time of the report, ERYTHEMA and PRURITUS outcome was unknown.            The patient called to report that they received their 2nd dose of the Moderna vaccine, and their right arm turned fire red from shoulder down to their elbow. The patient also had itchiness on their back, shoulders and top of chest.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Patient developed generalized urticaria, nausea/vomiting 10 seconds after vaccine injection. Had difficulty swallowing after that with a feeling of airway closing. On exam, she maintained a normal, patent airway - no epinephrine was given as a result. She did receive IV Benadryl and IV Solumedrol and was transported to the hospital via ambulance. Initial vital signs were as follows: BP 130/89, HR 110, RR 16, SpO2 99%. Advised she should not get second dose of the vaccine given severity of reaction.
Flu symptoms after 1st capsule: fever, aches, diarrheah.
Post vax, of my 1st Lymerix shot, I experienced significant redness and swelling at the injection site which lasted about 3 days. More importantly, I began to experience joint stiffness and pain in my hands, shortly thereafter. Prior to the shot, I had not had any such problems. I assumed the stiffness was temporary and therefore, had the 2nd shot on 6/11/99. The joint stiffness, inflammation and pain in my hands continued to increase. Eventually, I was referred to a rheumatologist who thinks I have some type of rheumatoid arthritis (even though the symptoms only began days after the 1st Lymerix shot) and started me on NSAIDS. The NSAIDS caused a rise in my blood pressure to the point that I had to start taking medication for that, too. I know that the Lymerix triggered some type of auto-immune reaction!
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment of COVID-19 from 01Jun2022 to 03Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
As soon as I got the vaccine I was dizzy. I sat down where they had us wait and the dizziness wouldn't go away. Became difficult to swallow - felt like a lump in my throat. More difficult to breathe then normal. Vitals taken. BP taken. Feeling like I had an epidural. Legs had a sensation like they were going numb and then they went numb. Benadryl injection given. Legs felt like they fell asleep. Waited and within second 30 min timeframe I was feeling a lot better so I left. 2:30 in the morning, my legs were asleep again and the lump came back in my throat and took Benadryl and it went away and I felt fine. I went to work the next day. At 7:00 that evening felt chilled and it came and went. I came up and took more Benadryl and rested.I went to work the next day and I sent a message to my Primary Care DR. - but leg was fine and the lump in throat wasn't there. On Saturday morning - after 10 days - had a headache that would not go away  (Very severe headache)- took Tylenol 1000 mg it didn't work. It was very bad Saturday night I took another Tylenol 1000 and Sunday morning it - headache still wasn't gone. Leg was numb again. This time the leg  numbness was worse than ever had felt. Left axilla - there was a lump/nodule and it was painful. Tried TeleHealth Med and they recommended I go to ER but I didn't feel good enough to do it. Dr.  I reached out to her and she took the history and she prescribed Prednisone; but wanted me to do a COVID test and Urine sample to see how I was doing before I took the medication so I did it next the day. Urine sample was clean. Prednisone 60 for four days 40 for four days and 20 for four days - On day Prednisone my legs feel fine, but the headache just lingers. On day two of Prednisone she told me to stop the Benadryl. Three days after Prednisone the lump under axilla resolved. I am taking coffee. Headache is still there but not as severe.
Member received tetanus vaccination to left arm on Mar. 18, 2006. Developed localized swelling and erythema to area. Never had similar reaction before. Member now reports small firm nodule to region of previous vaccinations.
Patient came in to receive his 3rd( Booster) Moderna vaccine. Patients covid vaccine card showed 2 Moderna doses (1st dose 5-8-21, 2nd dose 10-11-21). Upon documenting it was noted patient received Janssen (3-6-21) from other source which patient didn't mention at time of confirming 3rd dose visit. Vaccine history not linked with our system.  Patient is now vaccinated with 3 doses Moderna and Janssen his initial vaccination. Patient waited 30 mins. No concerns or questions nor ADR's noted at time of patients departure. follow up will be next day.
Sore arm; Fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and TACHYCARDIA (Fast heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination.     Concurrent medical conditions included Tetanus (allergic to tetanus shot). Concomitant products included PREDNISONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and TACHYCARDIA (Fast heart beat). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm) and TACHYCARDIA (Fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-076537 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021. No new information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076537:Dose 2
NUMBNESS IN THE ARM AND WHOLE BODY; DIFFICULTY IN BREATHING; CHEST PAIN; FELT LIKE COULDN'T MOVE BODY; COULDN'T MOVE HAND; PRESSURE IN CHEST; SHARP PAIN; This spontaneous report received from a patient via a company representative concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medical history, no known allergies to medications and not taking any medications regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry date: unknown) dose was not reported,1 total, administered in on an unspecified date in JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JUN-2021, after 20-25 minutes of vaccination, the patient experienced difficulty in breathing, numbness, chest pain and felt like he could not move his body. All these events were subsided within 15-20 minutes. On 29-Jun-2021, patient experienced the events again. The patient experienced the numbness in whole body then numbness subsided to the arm. The patient was not able to move his hand and experienced the numbness in his hand. The patient experienced sharp pain. On 29-Jun-2021, the patient was admitted to the hospital. It was reported that by the time of patient admitted to the hospital, sharp pain was slightly improved but still felt numbness. The patient also experienced the pressure on chest and the numbness was improved. The number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sharp pain and numbness in the arm and whole body, and the outcome of felt like could not move body, difficulty in breathing, chest pain, pressure in chest and could not move hand was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210703857-Covid-19 vaccine ad26.cov2.s- Numbness in the arm and whole body, difficulty in breathing, chest pain, felt like couldn't move body, couldn't move hand, pressure in chest, sharp pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Respiratory disorder; muscle aches; feeling like death; This is a follow up spontaneous report received from a non-contactable consumer or other non-HCP via Company Representative. A 40-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient experienced respiratory disorder, muscle aches and feeling like death, as she stated after second dose of Covid vaccine. Event took place after use of product. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunization. Medical history included autism, multiple severe allergies, penicillin allergy and pecans (food) allergy. Concomitant medications included levocabastine hydrochloride (ZYRTEC), cyproheptadine (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR) for an unknow indication since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 15:45, the patient experienced itchy rash on chest and back. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with Benadryl and multiple doses steroid cream started from an unknown date. The clinical outcome of the event itchy rash on chest and back was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Mononucleosis Flare up; Mononucleosis Flare up; This is a spontaneous report from contactable consumers (primary reporter was the patient). A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiry date unknown), via an unspecified route of administration administered in arm left on 10Aug2021 as dose 2, single for covid-19 immunisation. Medical history included autism, mononucleosis, and allergies. There was no other medication (concomitant medications) in two weeks. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered in the left arm on 20Jul2021 for covid-19 immunisation at the age of 16-years-old. There were no other vaccines received in four weeks. The patient had no covid-19 prior vaccination. The patient was not pregnant at the time of event and time of vaccination. The patient experienced mononucleosis flare up on Aug2021 caused by the vaccine after the 2nd dose which was administered at same location on 10Aug2021. By 23Aug2021 symptoms of flare up of prior mono diagnosis flared up and continued to this day 02Sep2021. Negative covid-19 tests post-vaccination included rapid test (reported type nasal swab) on 01Sep2021 and; PCR test (reported type nasal swab) on 29Aug2021. The patient missed school and still ongoing. It was further reported that the patient was allowed to receive the vaccine at age 16 without her parent's permission and; now was extremely ill from prior mono diagnosis. The patient was autistic and should not have been allowed to take the vaccine without parental permission. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care - 3 Telehealth visits and one urgent care visit. Seriousness criterion was reported as disability or permanent damage. The patient has received treatment for the event and reported as "symptoms treatment for mononucleosis". The patient had not recovered from the event. Seriousness criterion was reported as disability or permanent damage.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
The patient was given double IPV by receiving Ipol and Pediarix, no AE; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4-years-old patient who received double dose of IPV (Inactivated Polio Vaccine) by receiving IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] (extra dose administered).  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant vaccinations included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) on 04-Sep-2020 for prophylactic vaccination. On 04-Sep-2020, the patient received a fourth dose of 0.5 mL (frequency: once) of suspect IPV (VERO) (lot number: P1F49, expiry date: 30-Nov-2020, strength: standard  via an intramuscular route in right leg) and a dose of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (lot number and other dosing and administration details not reported) for prophylactic vaccination (extra dose administered).  It was an actual medication error case due to extra dose administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient experienced prolonged itching, swelling, and hives post Pfizer COVID vaccination. Please see next page for detail.
S/O Note Written by person @ 29 Jan 2019 1502 EST Chief complaint, The Chief Complaint is: Vaccinia reaction. 27 yo Male s/p smallpox vaccination (14JAN2019), ER visit 25 JAN 2019 for erythema of vaccine site and small erythematous papules/pustules of the trunk. Was referred for re-evaluation by ID and Dermatology, he is otherwise well. Was diagnosed with non viral pustulosis/ID reaction to the vaccinia vaccine.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that a approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 4 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 4 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient received MMR at the right leg, developed redness, swelling, induration and pain within 8 hours of administration.
Patient complains of severe headache on 11-20-09 at 4:00 am with throbbing pain in head and sensitive to light. Patient states OTC TYLENOL or MOTRIN would not stop pain. Headache lasted 5 1/2 hours. Pt has appt with clinic 11-25-09 at 9:00 am for evaluation. C/O headache  4 hrs/day after FLUMIST given.
Vaccinated 3/28/03, follow up visit 4/4/03 (day seven) mild erythema with major response. Patient related day 8 erythema increased approximately 6" distally from site with warmth and tenderness, arthralgias and fever-low grade. Symptoms persisted on 4/6 and 4/7. Seen 4/8 with erythema approximately 5cm surrounding SP site; skin warm/tender. Vaccine site umbilicaled and swollen. No lymphoma. 4/11/03 Cellulitis results after 5 day on Tequin.
Patient vaccinated at on 9/26/10 vaccination - influenza in left deltoid - very edge of muscle. Rash on arm developed on 09/27/10, within 24 hours of vaccine. Looks like mild cellulitis. Consulted pt to use OTC - hydrocortisone cream and if not getting better in 2 days to contact MD. Arm also hurts - use apap and cold compress.
COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Moderna / dose #5 Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EK4176), on 12Feb2021 as dose 2, single (Lot number: EM9809) and on 11Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 60 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 066A21A) and on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: macrodantin, reaction(s): "Drug Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Moderna / dose #5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Two negative daily tests and then a positive; Negative, notes: Two negative daily tests and then a positive; Positive, notes: Two negative daily tests and then a positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
body aches, joint aches, low grade fever 100.7, sore throat, headache, I took no meds for the symptoms, these lasted about 12 hours, gradually symptoms went away
Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath, increased Heartrate, pulse ox fell to 88-93-Normal 95%, orthostatic hypotension
Redness of 2x3 in the injection site; Itching at injection site; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed itching on the vaccination site (Vaccination site pruritic) and redness of 2x3 in the injection site (Vaccination site erythema).   The patient's medical history was not provided. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 31-Dec-2020 for prophylaxis of COVID-19 infection.    On 07-Jan-2021, a healthcare professional reported having itching at the vaccination site that lasted a couple of hours.    On 08-Jan-2021, she reported waking up with redness at the injection site that measured 2x3.    Treatment information was not provided   Action taken with mRNA-1273 in response to the events was not provided.    The event, itching on the vaccination site, was considered resolved on 07-Jan-2021. The event redness of 2x3 in the injection site, was considered unknown.    The reporter did not provide an assessment of the events, itching on the vaccination site and redness of 2x3 in the injection site.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
small local rash 1 and 1/2 weeks after, resolved in a few days