chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after second dose I developed shingles.  Within a month following the second dose I noticed that my (pre-existing) tinnitus had worsened by  approximately 50%  Shingles resolved on it's own within 4 weeks.  Worsened tinnitus continues to this day.
Case number PHEH2012US014308 is an initial spontaneous report received from a pharmacist on 16 Jul 2012: This report refers to a male patient of unknown age group. He was vaccinated with MENVEO (batch number: A10047) subcutaneously on 15 Jul 2012. No other adverse reaction was reported following this administration error.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with live ZOSTAVAX (dose, route and lot# were unknown) on an unknown date and after an unspecified time period developed a rash. No other co-suspects were reported. No concomitant medications were reported. The outcome of rash is unknown. The relatedness for rash is unknown for live ZOSTAVAX. The patient had sought unspecified medical attention. Additional information is not expected.
Swollen lymph node on right side of neck the morning after receiving the vaccine. Telehealth appt with PCM who prescribed 800mg ibuprofen.  Took 200mg motrin for swelling because i have not had the chance to pick up prescription. The following day, swollen lymph node continued and broke out in hives approx at 1300. Went to emergency room and was given an oral steroid (dekadone?). Prescribed prednisone, claritin, and Benadryl.  Have taken 1 claritin a day. Hives have disappeared within 5 hrs of oral steroid. Swollen lymph node persists and has enlarged. Painful  and swollen past the jaw line.  Will return to ER today for pain and continued swelling as directed by ER.
5x5cm erythema L arm. DTaP and MMR given on that arm on 8/16/02.
Achy joints; Fatigue; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female 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 05Apr2021 at 16:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously received SULFONAMIDE on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN)10 mg, spironolactone (MANUFACTURER UNKNOWN) 50 mg for an unknown indication, from an unknown date and unknown if ongoing.  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 vaccination. On 08Apr2021 at 08:00, the patient experienced achy joints, fatigue, headache and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. Achy joints, fatigue and headache lasted for 2 days but diarrhea continued on 5th day also. Other symptoms subsided. The clinical outcome of the events achy joints, fatigue  was resolved on an unknown date in Apr2021while the clinical outcome of the event headache was resolved on 10Apr2021. The clinical outcome of the event diarrhea was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
pt recv vax 31OCT96 & 3NOV96 pt exp dizziness;has no hx of an egg or chicken allergy;
Patient's Mom reported on 3/29/17 9:00 pm. his left arm with redness and swelling. No pain, fever, rash or N and V. 3/30/17 arm better, less red and less swollen. Patient went to school. 3/31/17 she brought patient to HU states arm better today, less red and swollen. It is warm to the touch. Reviewed VIS on each vaccine given with patient's Mom. I asked if she had read her VIS that was given to her prior to patient getting his vaccinations on 03/29/17. She states she read parts of them, but not all. I read and showed to her on each VIS; DTaP, Mild problems (common) were redness or swelling, soreness or tenderness where shot was given. Also sometimes with the 4th or 5th dose of DTaP, swelling of the entire arm or leg in which shot was given, lasting 1-7 days. VIS; varicella, Mild problems were soreness or swelling where shot was given, fever and rash up to a month after vaccination. VIS; MMR, Mild problems were fever, mild rash, swelling of glands in the cheeks or neck. I told her she could give patient, TYLENOL following manufacturer's directions for his age and weight, available at any pharmacy, if needed. Also told her she could apply a clean, cool, wet washcloth over the sore area for comfort. I gave her names and phone numbers of walk in clinics in the area, if needed and told her to keep a watch on it today. If his arm dose start to get worse, to go to one of the walk in clinics or to the ER. She verbalized she understood and she stated she felt better about his arm and it was better than yesterday.
weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet
A non-serious report of expired dose of vaccine administered has been received from a nurse concerning a nine-year-old female patient. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Jan-2008. The FluMist had expired on 10-Jan-2008. The reporter indicated that no adverse events have occurred since the time of the report. The patient did not experienced a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. 29-Jan-2008: Follow up information obtained and incorporated in above narrative: clinical outcome.
This spontaneous report as received from a consumer refers to herself: a female patient of unknown age. The patient's doctor was suspecting she might have contracted lyme disease. Concomitant therapy included an unspecified antibiotic. There was no medical history reported. On an unknown date, the patient was vaccinated with first dose of ZOSTAVAX (route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced dizziness and nausea. The patient sought unspecified medical attention. The outcome of dizziness and nausea was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as the reporter did not give any contact data.
Bella Palsy about 5 days after the booster shot. I had an immediate strong reaction following my booster injection on 12/8. Symptoms of fatigue, body aches, headaches and more lasted until 12/11. Then on 12/13 I noticed that my tongue had reduced taste?felt like I had burned it with hot liquid. Then on 12/14 the right side of my face went numb and I went to ER and was diagnosed with Bell?s Palsy.
Information has been received from a registered nurse concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not provided. The patient received a dose of GARDASIL (confirmed Lot# K008931 and exp. 04-MAR-2017, dose and route unknown) on 26-FEB-2015, the patient received a dose of GARDASIL 9 (confirmed Lot# K026247 and exp. 29-JAN-2017, dose and route unknown) on 09-JUL-2015 and then the patient received another dose of GARDASIL 9 (confirmed Lot# L000610 and exp. 31-JAN-2017, dose and route unknown) on 11-AUG-2015; this was outside the recommendations per the GARDASIL and GARDASIL 9 prescribing information. No adverse effects reported. Additional information has been requested.
pt became very fatigued and has bouts of confusion.  She has episodes where she doesnt know where she is or who she is with.  She has had one episode that she didnt know who she was that lasted a few seconds.  Most episodes last a couple of minutes.  Her parents took her to Hospital ER i.  They did an EKG and electrolytes- lab work.  Test were normal.  She was released to FU w/ PCP and Neurologist.  She is scheduled to see a Neurologist today 4/13/2021 and is scheduled to have an EEG tomorrow on 4/14/2021.  She has an appt to see her PCP on 4/14/2021.
Patient reported fever, chills, diarrhea, and a sore arm after receiving vaccinations. On Saturday 10/20 patient reported to pharmacy. He stated the fever, chills, and diarrhea had subsided. Pt had diffuse, red, swollen area on his right bicep. On 10/21 patient reported that redness/swelling had started to go down. On 10/22 patient reported redness/swelling had improved, but a quarter-sized "knot" had formed on his right bicep that he first observed on 10/20 or 10/21. On 10/23 patient reported all symptoms had resolved except for the quarter-sized knot on his right bicep. He presented to the pharmacy on 10/23. A red, quarter-sized bump was observed between the right deltoid and right bicep. Per the immunizing pharmacist, location did not appear to be at the exact injection site. He denied ever having a reaction like this before. Over the next several days, patient reported bump remained the same size and color (red). By 10/29 the bump remained the same. The patient plans to request an appointment with his doctor's office if bump does not resolve by 10/31 or 11/1. Patient reported he called his doctor regarding the bump on 10/25 and 10/26 and the doctor's office told him to monitor the bump and request an appointment if it does not improve.
patient given bivalent vaccine for first dose in series instead of monovalent in error.  No adverse symptoms
lower left eyelid erythema; sty on left eyelid; herpetic eye infection; acute herpetic eruption; swelling and redness on the nose; redness on nose; pimple; Headache; This case was reported by a physician via call center representative and described the occurrence of herpes ophthalmic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number AH992, expiry date 18th March 2022) and (batch number 9H524, expiry date 22nd October 2021) for prophylaxis.   The patient's past medical history included hypothyroidism, gastroesophageal reflux disease and gastritis. Concurrent medical conditions included lipids abnormal. Concomitant products included thyroxine sodium (Levothyroxine) and denosumab (Prolia).   On 31st December 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the dose was an unknown dose (.5 ml daily). On 31st December 2019, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir and Erythromycine, the patient experienced headache. On 4th January 2020, the patient experienced herpes virus infection, swelling, erythema and pimples. On 6th January 2020, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and stye. On 9th January 2020, the patient experienced erythema eyelid. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and erythromycin (Erythromycine). On an unknown date, the outcome of the herpes ophthalmic, herpes virus infection, swelling, erythema, pimples, stye and erythema eyelid were recovering/resolving and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the herpes ophthalmic, herpes virus infection, headache, swelling, erythema, pimples, stye and erythema eyelid to be related to Shingrix.  Additional details were provided as follows: The patient developed an acute herpetic eruption after receipt of her first dose of Shingrix.   The patient had a minimal headache for 24 hours after receving Shingrix. On 4th January 2020 had some redness and swelling on her nose with a pimple.  On 6th January 2020 she got a sty on her lower left eyelid and her eye felt funny.  She went to the eye doctor on 9th January 2020 and was diagnosed with a herpetic eye infection.  She was started on valacyclovir and erythromycin ointment with some improvement noted. The reporter consented to follow up.  The physician said the patient was a small part of the phase 3 trials for Shingrix and he had 7 more doses of Shingrix from the box this patient received her dose from if GSK want to test them.
No reaction until day 8.  There is injection site redness, swelling, discomfort and itching.  Area is warm to touch.
Patient states face was red where her mush was on the evening of these 2 vaccines. The next day chest and arms were red and blotch. No itchiness, not raised, not hot. No breathing problems - injection sites not red, warmer inflamed.
Pfizer COVID vac #1 given 03/03/2021, lot #EN6201; Pfizer vac #2 given 03/24/2021, lot #EN6208; pt admitted to hospital for SOB, fever, cough, diarrhea, O2 on RA low 80s%; pt states he had a positive COVID test today 1/24/22 in PCP's office and came to hospital; treated with dexamethasone, remdesivir; had acute thrombotic event; thrombectomy; pt required intubation; condition worsened; pt transitioned to comfort care and passed away in the hospital
She felt cold, pain in shoulder hip and knee joints and joints of hand, felt nauseous around 1 am. Felt tired. When she called around 9:30 am she was feeling better.
Took H1N1 vaccine because I was pregnant. The baby's heart beat was heard on 11/03/09. On 11/10/09 the heart had stopped beating. Baby was miscarried by induced labor on 11/18/09.
Tinnitus: loud static with occasional ringing. Static 24/7. Louder at night. Is subsiding but still there.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# L037561, expiry date 29-SEP-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the vaccine was exposed to a temperature of 7.5 degrees Fahrenheit for a total period of 14 hours (date unspecified). There was no previous temperature excursion or product quality complaint involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a currently 60 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-APR-2015 the patient was vaccinated with ZOSTAVAX lot # K018171, expiry date: 23-OCT-2015 (route of administration was not reported). The pharmacist reported that the patient came by the pharmacy on unknown date (reported as "recently") and reported that his potassium levels have been altered since an unspecified date following the vaccination. Unspecified potassium level test was performed and no treatment was given to the patient for the event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
No adverse effects; received expired dose of M-M-R II on 06-MAY-2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were unknown. Patient's concomitant medications included sterile diluent. On 06-MAY-2019, the patient was vaccinated with an expired doe of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (rHA)) (lot # N013866, expiration date: 04-MAY-2019 (strength, dose, dose number and anatomical location were unknown) via subcutaneously for prophylaxis (expired product administered). The lot number and expiration dates were not known for the properly stored sterile diluent, which was used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse effects (no adverse event) were reported. No product quality complaint was involved.   This is one of the two reports from the same reporter.
FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.  Version created to amend previously reported information on 23-MAR-2021. Upon review, the following information was amended: Reporter type in tab and narrative, medically confirm tab  and due diligence corrected.
10/17/2022 in the evening when I was going to bed, my injection site was sore. And I took Tylenol. 10/18/2022- My arm was still sore. I took more Tylenol. Throughout the day, I felt achy, and I had general malaise. That evening I took more Tylenol. 10/19/2022 - I had soreness around the injection site. My arm was swollen. And I took more Tylenol. I went to see the nurse at the school I work, and she advised me to take Tylenol. I put an ice pack on it that evening. 10/20/2022- I had a headache, still swelling around the injection site. I took Tylenol this morning. It is still sore to the touch, and it is slightly red.
24 hours post vax, the pt experienced cellulitis with a 3 " diameter axillary lymphangitis, and adenopaty. There was red streaking down the affected arm.
This case was reported by a consumer and described the occurrence of weakness in extremity in a female patient who received dTpa vaccine. On 11th March 2015, the patient received dTpa vaccine. On 11th March 2015, less than a day after receiving dTpa vaccine, the patient experienced chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain and nocturnal awakening. On 12th March 2015, the patient experienced weakness in extremity and tiredness. In March 2015, the patient experienced weight bearing difficulty. The patient was treated with Ice Pack (Nos), heat therapy, MOTRIN, Acupuncture and TYLENOL. On an unknown date, the outcome of the weakness in extremity, tiredness and weight bearing difficulty were not recovered/not resolved and the outcome of the chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain and nocturnal awakening were unknown. It was unknown if the reporter considered the weakness in extremity, chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain, nocturnal awakening, tiredness and weight bearing difficulty to be related to dTpa vaccine. Additional information: The patient received a dose of TDAP on 11 March 2015 at about 5 p.m. She developed chills, redness and pain around the injection site. She also developed pain and body aches. It was very painful when she received the shot. By 8:30-9 p.m. her legs were achy. She was up for 2-3 hours during the night because of this. The next morning, she had achy and weak legs. She went to work for only the morning and then came home and slept until 9 p.m. got up for a few minutes and went back to bed. She was down all weekend. She had weakness in arms the first 2-3 weeks. It was heavy to pick up her purse, lunch, gallon of milk, etc. She have continued to have the same achy, very weak legs through the present. It has affected the patient during her daily living and work. She told her doctor about it about a month ago and he said it would probably just have to run its course. Nothing helps. She tried ice, heat, MOTRIN, elevation, acupuncture, chiropractic and TYLENOL.
1/28/2022- Presented to ER, due worsening SOB and productive cough x 2 weeks. Covid + test on 1/20/2022. Admit acute hypoxic respiratory failure secondary to COPD exacerbation with underlying Covid positive status with Acute. Afebrile, P-124 and BP-175/81. EKG- A-Fib with RVR. ABG-7.4/33.1/78/21.2/-2.5  on 2L via NC.WBC-14. Chest CT-No evidence of acute pulmonary disease. Left lower lobe acute nonocclusive embolus. Started on IV diltiazem, Solu-medrol, Remdesivir, ceftriaxone, Lovenox and doxycycline.  1/30/3033- Dilitaxzem changed to PO. Exertional SOB continues. BP-116/66 ans Spo2 96% on 2L.  2/1/2022- D/C remdesivir and IV ceftriaxone. Currently tolerating RA.  2/3/2022- Continue doxycycline, eliquis and dilitazem. WBC-10.9. Afebrile, BP-181/76 and P-78. Spo2 98% on RA. Discharge to home
Administered in LUE; developed painful swelling with heat and erythema from shoulder to wrist.  Circumference of arm ~tripled.  No hives or pruritus.
wants to sleep; she feel week and not strong at all; urine all night long and is wetting herself; she feels fatigued and tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wants to sleep), ASTHENIA (she feel week and not strong at all), NOCTURIA (urine all night long and is wetting herself) and FATIGUE (she feels fatigued and tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Cholesterol. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (wants to sleep), ASTHENIA (she feel week and not strong at all), NOCTURIA (urine all night long and is wetting herself) and FATIGUE (she feels fatigued and tired). At the time of the report, SOMNOLENCE (wants to sleep), ASTHENIA (she feel week and not strong at all), NOCTURIA (urine all night long and is wetting herself) and FATIGUE (she feels fatigued and tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included Sebreval the pill in the inhaler, nebulizer drops, blood pressure pill and cholesterol  pill.  The patient did not receive any treatment medications.
Patient approached Observation RN (3rd Floor stadium location) that her "heart was racing". Patient informed RN at 12:55pm, the injection was administered at 12:08pm in the left deltoid. Paramedic notified and vitals were taken: BP 117/75, HR 88, SpO2 98% on RA, RR 16. Patient denied lip or tongue swelling, difficulty swallowing, SOB, or chest pain. Patient stated she has history of anxiety, CAD, and LBB.   Patient signed ambulance waiver declining transport to the emergency room. Patient left observation area at 13:18 on her own without the need for assistance.