chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Completed treatment for tongue cancer in Jan2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL. Vaccination history included: BNT162b2 (DOSE 2, SINGLE,Vaccine brand: Pfizer / BioNTech,, Vaccine lot number: EL1283,), administration date: 11Jan2021, when the patient was 45-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Vaccine brand: Pfizer / BioNTech,, Vaccine lot number: EH9899), administration date: 20Dec2020, when the patient was 45-year-old, for Covid-19 immunization. The following information was reported: TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED (medically significant) with onset Jan2022, outcome "unknown", described as "Completed treatment for tongue cancer in Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: post-treatment rapid testing negative; Positive, notes: symptoms recurred on Day 11 and RAT positive. Therapeutic measures were taken as a result of tongue neoplasm malignant stage unspecified.  Clinical information: Reported as, patient received BNT162b2, on 30Mar2022 as dose 4 (booster), single (Lot number: FL9729) and received BNT162b2 on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694). Completed treatment for tongue cancer in January 2022 (radiation/chemotherapy). No Known allergies.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported event and the suspect drug cannot be excluded. 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
No adverse event. The only issue of concern is that, the patient was less than the 18 years threshold  to qualify for the above vaccine.
hiccups; This is a spontaneous report from a contactable nurse (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hiccups on an unspecified date. When asked for the treatment, nurse stated, that they have been doing all the usual hiccup kind of stuff, Tums, Gas-X, and sipping on ice. Outcome of the event was unknown.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route of administration were not reported), that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
Pruritic truncal eruption/Hives on abdomen extending around to the sides and back. Extremely itchy.
On April 21st, 2021, 7 days after receiving the 1st dose of the Moderna vaccine, I was hospitalized with severe muscle weakness/stiffness, joint pain and loss of fine motor skills.  There was also Myoclonus episodes that started at the same time.  I was hospitalized for 3 days and when released I started PT to try to regain some of the mobility that was lost through this occurrence and continued up through the 2nd dose. On May 21st, 9 days after receiving the 2nd dose of the Moderna vaccine I started encountering more severe and debilitating symptoms.  I was again hospitalized, via ambulance from my home on Tuesday May 25th from complete leg failure and a severe Myoclonus episode and remained there until Saturday May 29th when I was transferred via ambulance to Inpatient Rehabilitation Center where I stayed until June 9th.  While there I received intensive PT/OT and Speech Therapy.  As mentioned, the symptoms were much more severe that I was wheelchair bound with very limited ability to use a walker.  Upon release, I have continued at our local Outpatient facility  where I am still receiving PT/OT and Speech.  Speech has since completed on August 2nd, 2021.  I am currently using a walker, cane and sometimes a wheelchair and I am NOT cleared to resume driving.  There is NO timetable currently on when I will be cleared to drive. Through the intensive testing performed and described in section 19 of this form, I have been diagnosed with Demyelinating Polyneuropathy or CIDP.  I have commenced IVIG infusion treatments, on August 9th, 2021, to hopefully reverse the damage caused by the vaccine and to get my life back!!
asthma; This spontaneous report was received from a pharmacist, referring to a 55-year-old female patient. The patient's pertinent medical history included asthma and pneumonia. Information regarding the patient's drug reactions/allergies and concomitant medication was not provided.  In approximately 2015 (also reported as at the age of 49 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced asthma. It was unknown if the asthma was diagnosed before or after pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of asthma was unknown.  The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Left arm is having a lot of pain/pain is below the vaccine part/above the joint; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm is having a lot of pain/pain is below the vaccine part/above the joint) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 013F21A, 030A21A and 011AZ1A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in October 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Diabetes (Start Date: 25 years ago) and Blood pressure high. Concomitant products included INSULIN GLARGINE (TOUJEO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Left arm is having a lot of pain/pain is below the vaccine part/above the joint). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; MELOXICAM for Pain, at a dose of 15 milligram once a day and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Left arm is having a lot of pain/pain is below the vaccine part/above the joint) had not resolved.            Patient saw a doctor, who told him to do exercises and put ice.  The patient states he took Motrin the first couple of days, but was told to stop because it could bump his blood pressure up. He was prescribed a pain killer called meloxicam 15 mg to be taken one table once a day. He has been taking it every day. He is also using Voltaren topically. Symptoms are ongoing as same.   This case was linked to MOD-2022-570131 (Patient Link).
Moderna COVID-19 Vaccine EUA First 72 hours after vaccine:  extreme fatigue, sore throat, muscle aches, slight congestion, head aches - These adverse side effects are no longer being experienced.  1 week and 2 days after vaccine: left arm deltoid muscle stiff, red/irritated, itchy - These adverse side effects just started and are still being experienced
PATIENT called the pharmacy and reported that she woke up this morning with a rash and knot at the injection site. She did not have a reaction in the past or on Tuesday when she received her vaccine.
This spontaneous report as received from a Certified Medical Assistant (C.M.A.), refers to a 17 year old male patient. No pertinent medical history or drug reactions/allergies were provided. On 29-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) INJ (Lot number J010159; expiration date 23-FEB-2015), 0.5 ml, subcutaneously, in the right deltoid region. On the same day, during the same office visit, the patient was vaccinated with a dose of VARIVAX (Merck) INJ (Lot number J003541; expiration date 25-MAR-2015), subcutaneously, in the left deltoid region. No concomitant therapies were reported. The C.M.A. had initially reported that the two doses were administered in the deltoid muscle, and when informed that the route of administration for these two products was subcutaneous, she confirmed that the doses were administered subcutaneously. She stated that the patient stated that he "felt fine," and she did not observe any adverse effects. Additional information has been requested.
Reduced oxygen level; Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm; tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back; No appetite; Could not sleep; Speech problem; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Reduced oxygen level) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic pain. Concurrent medical conditions included Cancer and Speech disorder. Concomitant products included INSULIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOXIA (Reduced oxygen level) (seriousness criterion medically significant), BURNING SENSATION (Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm), PARAESTHESIA (tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back), DECREASED APPETITE (No appetite), INSOMNIA (Could not sleep) and SPEECH DISORDER (Speech problem). At the time of the report, HYPOXIA (Reduced oxygen level), BURNING SENSATION (Burning sensation in face, burning sensation in back, burning sensation in chest area, burning sensation in arm), PARAESTHESIA (tingling sensation in arm, singling sensation in face, tingling sensation in chest area, tingling sensation in back), DECREASED APPETITE (No appetite), INSOMNIA (Could not sleep) and SPEECH DISORDER (Speech problem) outcome was unknown.            Patient has not taken anything for treatment.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
"Moderna COVID-19 Vaccine EUA"  Vaccine administered to wrong age patient. No known allergies or medical conditions. Nurse who administered vaccine did not know vaccine not approved for anyone under the age of 18.
11 x 11 cm area of blanchable erythema. Pruritus, mild tenderness. No inc. warmth. Tx: BENADRYL. If worse over weekend start KEFLEX.
The first dose of the vaccine was fine.  Just felt a little ill.  The second dose was terrible.  I woke up the next day and felt like there was a block of concrete in my arm and shoulder.  I couldn't move it at all.  I had flu-like symptoms for about 5 days, which resolved on its own with no issue.  The arm and shoulder, on the other hand, did not resolve.  I had very little range of motion, painful shooting pains when the arm and shoulder were used, and there was swelling.  I could not get dressed, wash or brush my hair, cook or clean, lift anything or complete even the most simple tasks at work.  Driving was very difficult.  Sleeping was nearly impossible. After 4 months and deciding that my arm and should were not going to get better on their own, I went to my PCP where I was told I had bicep tendonitis and adhesive capsulitis (frozen shoulder).  My PCP thought it was caused by the vaccine being injected into the joint in the shoulder rather than the muscle.  She provided me with pain medication and I was referred to an orthopedist.  Dr did a thorough examination, took ex-rays, gave me a cortisone injection, and sent me to physical therapy.  He didn't know if the issue was caused by giving the vaccine in an incorrect location or if it was just my body's reaction to the vaccine.  After several weeks of physical therapy and very little improvement, I had shoulder manipulation surgery and another injection of cortisone.  I was provided with pain medication and I had physical therapy every day for another two weeks.  I'm at about 90% mobility now.  It is extremely unlikely I'll ever be back to 100%.  I can perform most day-to-day tasks with little to no pain.  I continue with daily physical therapy exercises at home.  My pocket book is still hurting.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006064:
Reporting on behalf of facility. Report per Information Brief dated 9/9/2022. Monovalent COVID vaccine administered as booster after FDA authorization. Two patients were given Moderna monovalent COVID vaccine after FDA authorization of bivalent booster. Dates 9/2/2022 and 9/6/2022. Delay and confusion regarding vaccine information brief. Since that time, bivalent boosters received and provider/staff education provided. Please let me know if you have any additional questions. Thank you.
Client called on 11/22/2004 requesting to know the type of vaccine administered to her on 11/19/04. Client reports that she developed a rash covering her entire body following administration of vaccine. Instructed client to see family physician client reports that she is going to contact family physician. 11/29/04 TC: pt reports that she is taking prednisone, saw physician and rash is resolving.
Child cried screaming episode for 3.5 hrs; Temp 100 w/APAP for 24 hrs;
Immediately after pt received vaccine, became unresponsive - unconscious. Pt was breathing and had steady pulse. Nurse used ammonia inhalant, pt responded to. Pt feel were elevated. Pt remained very drowsy but oriented. Pt was transported to ER for evaluation and released within 1 hour with dx of vasovagal response to vaccinations.
Extreme swelling at site of filler (Restylane) injection - jawline.  Pain, discomfort.  Lasted one week, currently taking Methylprednisolone 4 mg Dospak 21S to reduce swelling.  Area of injection became hard to the touch and spread across jawline.
This spontaneous report was received from a nurse and refers to a currently 22 year old female patient. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On unspecified dates since 30-NOV-1993, the patient was vaccinated with two three dose series of RECOMBIVAX HB (intramuscular, exact dose, lot #, expiration date and anatomical location were not reported). On 21-DEC-2015, the patient had a "susceptible titers" drawn and because of that, she had the series of RECOMBIVAX HB repeated. During the patient's second series, on 13-JUL-2016, she received 0.5 ml of RECOMBIVAX HB in the right deltoid (unspecified which dose in the series, lot # M003658, expiration date 02-JUN-2018). The nurse reported that afterwards, on 22-JUL-2016, the patient sought medical attention at an unspecified physician's office for hives on her back and arm with no throat tightness or fever reported. The nurse reported that the patient was taking BENADRYL for treatment of the hives. The outcome of hives on back and arms and "susceptible titers" was reported as not recovered. Additional information has been requested.
small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number ENG201) via an unspecified route of administration on 19Feb2021 at 16:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) from an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. On the first day (also reported as 12Feb2021) at 18:00, the patient experienced burning sensation on the inner left arm. On the second day, the patient experienced small rashes on the inner left arm but different spots from the first day. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcome of burning sensation on the inner left arm and small rashes on the inner left arm were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
July 3, 2002 NOTES ABOUT PT Client called on Wed July 2nd stating she was having a reaction to shots she received last week.  She received Td and HepB on Wed June 26 and MMR on Thursday June 27.  Complaint of fevers and sweats at night. Scalp itchy. And "baseball size welt" on the arm where tetanus was given.  States that area has been sore since the shots but swelling started on Tuesday night. (last night).  Fevers started on Monday night.  The welt is "hard and puffy."  Recommended that she see her dr.  States she cannot get to her doctor today.  I recommended she go to clinic and gave her their location and phone number.  Addendum: July 5, 2002 Message left on voicemail on Wednesday July 3, 2002. 6pm. Pt went to clinic.  They gave her antibiotics and told her it may be a secondary infection from the tetanus shot.  She said there was a ring around the red area and they told her to come back if the ring got any bigger.  She stated she will continue to take the antibiotics and call if any thing changes.  Spoke to pt's mother today and she said the red area had decreased significantly by July 4. (approx. 24 hours after antibiotics started.) Unknown how many previous doses of DTAP pt had. Last dose was for kindergarten entry.  Regarding adverse advent in sister, unknown age other than she was not in school yet. Did not receive any more DTP or DT vaccines according to mother.
LIGHT-HEADED; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 300 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced light-headed, and nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light-headed and nausea was not reported. This report was non-serious.
The shingrix vaccine was administered manufacturer GlaxoSmithKline  Body ache, headache, fever of 101.6 on Sept 18, shivering
No adverse effects reported; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.     On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally,  lot # S009940, expiration date 04-OCT-2020 (strength and dose were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of 34.1 degree fahrenheit during 4 hours and and 33 minutes on 13-AUG-2019 and 14-AUG-2019. There was a previous temperature excursion of 34.7 degree fahrenheit during 3 hours and 2 minutes.  It was reported that digital data logger was involved. No adverse effects were reported.
had a sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: EM9810) at the age of 74 years as dose 2, single and administration date 09Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "had a sore arm".