chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec'd Swine flu vaccine; Upper respiratory infection, given 3 courses of antibiotics with no improvement, then my voice became hoarse   sounding that lead to shortness of breath with talking. Now I sound like I was deaf and learned to talk as an adult. I was medically retired as a RN and I am now on Social security disability.
Right arm, swelling, reddened, site hot, redness, redness moved down right arm, trouble breathing took to ER late Friday evening, ER personnel instructed clients mother to give Benadryl according to package insert.
Expired booster dose given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose given). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Arm was sore; Fever every day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and PYREXIA (Fever every day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever every day). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and PYREXIA (Fever every day) outcome was unknown. Not Provided          Treatment details not reported.
Reported on 01/06/21 at 2:00am felt nauseated. By  8:00 felt feverish, temperature was 99.0 F.  By 10:00 am symptoms had not resolved.  Went to  ER for evaluation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 at 14:15 as dose 4 (booster), single (Lot number: Fj4991) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: Other medical history: Afib; "Hay fever" (unspecified if ongoing), notes: Known allergies: Hay fever. I use Flonase daily. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: COVID 19 Treatment, Brand was Paxlavoid, Treatment start date was 09Jun2022 to 14Jun2022. other medication in 2weeks product: Xarelto, Atorvastatin and Flonase. Adverse event was Sluggish for a few days. Nose runny. Post nasal drip with throat clearing cough. Known allergies was Hay fever. patient use Flonase daily. Other medical history was Afib.
Suspected myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: MYOCARDITIS (medically significant), outcome "unknown", described as "Suspected myocarditis".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Client stated that she had migraine with nausea, hallucinations, swollen lymph nodes on left side and severe back pain.  She started that the pain also affected with ear-ache/sore throat type symptoms.   She stated that she still has severe back pain, which is debilitating, but has improved.
Information has been received from a physician concerning an 8 week old female who was vaccinated with first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Four days after the vaccination the patient experienced vomiting and diarrhea.  It was reported that the patient recovered seven days after the vaccination.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided. Additional information has been requested. 04/04/2010 Follow-up information from a physician indicated that on 01-SEP-2006 the patient experienced vomiting and diarrhea. The patient had a follow-up visit. An ultrasound was done to rule out pyloric stenosis secondary to vomiting and it was normal. The physician reported that the patient continued experiencing vomiting and diarrhea for 12 days from the vaccination. It was reported that the patient recovered on 11-SEP-2006. Additional information is not expected.
Pt arrives to the ED with shortness of breath and 4 days of diarrhea.  Pt has a history of DM type 2 and obstructive sleep apnea.  Pt was found to have acute hypoxic respiratory failure in the presence of COVID-19.
no reported side effects.; an expired dose of PROQUAD was administered to a patient; Subcutaneous injection formulation administered by other route; This spontaneous report was received from an office administrator referring to a 4-year-old unknown gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 27-JUL-2022, the patient was vaccinated with an expired dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) 0.5 mL x1 dose, lot #U002535, expiration date: 24-JUL-2022, intramuscularly (IM) for prophylaxis (strength was not provided) (incorrect route of product administration, expired product administered) which was reconstituted with sterile diluent (MERCK STERILE DILUENT) IM (lot # T029528, expiration date: 14-APR-2023) (dose, frequency, strength, formulation was not provided) which was not expired.  Reporter confirmed that the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had no temperature excursions. There was no adverse event reported and reported side effects (no adverse event).
Systemic: sudden sensorineural hearing loss-Severe, Systemic: Tinnitus-Severe
6 days after the injection, area of shot began to itch during overnight hours.  next morning the area was tender and slightly red and felt swollen.  on day 8, approximately 30 hours after the initial itching- the site is a little more red, rather sore and a bit swollen.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a male patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and general body pain. On an unknown date, the outcome of the swelling arm and general body pain were unknown. It was unknown if the reporter considered the swelling arm and general body pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported adverse event for herself and her husband. The age at vaccination was not reported. The patient wanted to know if her reaction was common with SHINGRIX, and how long should she wait before getting the flu shot. The patient experienced swollen arm and body pain. The caller was driving, therefore very limited data was provided. This case has been linked with US2018172538, reported by the same reporter.
Information has been received from a physician concerning a 4 year old female with no medical history or allergies, who on 4/26/05 was vaccinated into the right leg with a dose of hepatitis A virus vaccine inactivated (lot # 648885/0157P). Suspect concomitant medication given into the right anterior thigh included a dose of MMR (lot # 647861/0851P). Other concomitant therapy given in the left leg included a dose of poliovirus vaccine inactivated and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. There was no illness at the time of vaccination. On 4/27/05, the patient developed right leg redness, swelling, and her leg was also slightly tender and hot. The patient was diagnosed with cellulitis. The physician stated that the patient's reaction was not a typical reaction and that the cellulitis was probably related to either the dose of hepatitis A virus vaccine inactivated or the dose of MMR. The physician confirmed that the patient required medical treatment with oral antibiotics in order to prevent a more serious outcome. No diagnostic laboratory tests were performed. The physician had seen the patient since she was treated and she has fully recovered. No product quality complaint was involved. Cellulitis was considered to be an other important medical event (OMIC). No further information is expected.
This case was reported by a consumer via other manufacturer and described the occurrence of fever in a elderly male patient who received SHINGRIX for prophylaxis. Concomitant products included propranolol hydrochloride (Propranolol), acetylsalicylic acid (Aspirin), tamsulosin hydrochloride (Tamsulosin), finasteride, rosuvastatin calcium (Rosuvastatin) and pregabalin (Lyrica). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, weight loss and dizziness. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the weight loss and dizziness were unknown.  It was unknown if the reporter considered the fever, weight loss and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not know the date of the SHINGRIX vaccine administration. The patient called to report an untoward reaction to the SHINGRIX and stated that, he was put down in bed for 3 weeks and he finally went to the emergency room. The patient was released on the same day. The patient had fever for 13 days, lost 20 pounds, and was also very dizzy. The patient refused 2nd shot of SHINGRIX.
Adverse symptoms:  bilateral lower leg / ankle swelling.  Pt said that she experiences bilateral leg swelling after  immunizations.
Dizziness in waves.  Not dizzy, then a sudden burst of dizziness and feeling faint for several minutes, then feeling not dizzy. Feverish, chills. Dizziness got worst on the second day after vaccine injection. For item 21, I?m  still on the second day and very dizzy. Considering going to the doctor since dizziness is not listed as a symptom
No adverse event; Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose).    Concomitant medication not reported.   Treatment medication not reported.
7/20/22 Started feeling sick. 7/22 cold symptoms 7/27 medical clinic vist diagnosed Acute bronchitis or mild pneumonia 8/1 back to clinic with same diagnosis trouble breathing lathargy all around very ill 8/3 ER visit cognative issues dehydration mobility issues lactic acidosis symptoms and high LAC bloodwork 8/4 sever impairment with cognative ability. death by suicide 8/4
Developed severe shoulder pain at site of injection (right arm) with severely limited range of motion, and intense pain on movement.
Pain on both arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on both arms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CYANOCOBALAMIN (VIT B12) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on both arms). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain on both arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include: hydrating drinks, eating bland diet   This case was linked to US-MODERNATX, INC.-MOD-2021-114516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114516:dose 2
Fever above 38 degrees C; Pain during the night; Headache; Swollen injection site; Pain and bodyaches while breathing; Pain and bodyaches while breathing; This is a spontaneous report from a contactable consumer. A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. It was unknown whether prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 04:00, the patient experienced fever above 38 degrees Centigrade, pain during the night, headache, swollen injection site and pain and body aches while breathing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the events. It was unknown whether since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever, pain during the night, headache, swollen injection site and pain and body aches while breathing were resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
COVID Arm- swelling on top half of left arm, although present on the front portion of my arm (at injection site), above the elbow. Warm to touch; swollen; red. Swelling and warmth noted through long sleeve shirt for about 48 hours.
pt recv vax 5JUN97 & JUN97 pt devel chickenpox consisting of approx 12 vesicles on face, back, & chest;
This spontaneous report has been received from a registered nurse and concerns a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored (temperature: 48 F, time frame: less than 30 minutes) GARDASIL 9 lot # L016429, expiry date 09-AUG-2017 (dose, strength, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
01/22/22 presents to EC ED for "chest pain, SOB, and lightheadedness". PMHx of "hypertension, hyperlipidemia CKD, and BPH"
4/3/2021:   Adverse events: soreness at injection site, tiredness in the afternoon Treatment: none  4/4/2021:   Adverse events: soreness at injection site, tiredness.  After approx. 12 pm, experienced general muscle aches in back, shoulders, and arms, chills, slight fever (~99.8); "covid arm" - swelling, redness, warm to touch skin surface, and itchy at injection site (approx. 4 x 4 inches around injection site area) Treatment:  single dose of Tylenol 500 mg Outcomes; all symptoms subsided after Tylenol.  Similar symptoms returned but milder in severity approx. 5 hours after taking Tylenol.  Did not take any subsequent doses of Tylenol.  4/3/2021:  "covid arm" - swelling, redness, warm to touch skin surface, and itchy at injection site (approx. 4 x 4 inches around injection site area) Treatment: none
Pt noticed bruising and redness on the same arm where she received the vaccine. Bruising was approximate 1.5 inches x 3 inches. Rash was approximately 8 x 6 inches that extends to her elbow.
Sudden onset itchy red raised rash legs and arms.  Slight relief with topical steroids.  Oral prednisone taper with gradual resolution.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiry date, dose, route unspecified (interchange of vaccine products). No adverse effect reported.
Small red splotches began showing up all over body two days post vaccine. Two days later red spots began to become larger, raised, and red. Also, sore to the touch and some itched. Two days later the spots are now filled with puss, and some have clear fluid in them. Majority of the spots are on lower abdomen, back, buttocks, arms, and legs.
dry mouth, so she got up in the middle of the night; little sore in the injection site; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth, so she got up in the middle of the night) and INJECTION SITE PAIN (little sore in the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-2A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Diabetes.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DRY MOUTH (dry mouth, so she got up in the middle of the night) and INJECTION SITE PAIN (little sore in the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER PLUS [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, DRY MOUTH (dry mouth, so she got up in the middle of the night) and INJECTION SITE PAIN (little sore in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-013713 (Patient Link).
2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM
DISCHARGE DIAGNOSES 1. AKI with nontraumatic rhabdomyolysis 2. Anion gap metabolic acidosis likely secondary to above, resolved 3. COVID-19 infection without evidence of hypoxia or PNA   HOSPITAL COURSE   39 y.o. male with history of HSP presenting with nausea, vomiting and recent Covid 19 sick contact with brother. He was vaccinated, has not received booster.  Patient reports 3 days of nausea and significant amounts of vomiting.  He has not eaten well over the last 4 days has been unable to keep fluids down.  He is also noted fever, chills, sore throat, body ache, headache and cough.  After he developed significant amounts of vomiting he reports having abdominal pain and felt lightheaded and dizzy falling to the side in the bathroom and striking his back against the sink.  For his abdominal his back pain he has been taking significant amounts of Advil prior to this admission   AKI with nontraumatic rhabdomyolysis Anion gap metabolic acidosis likely secondary to above, resolved COVID-19 infection without evidence of hypoxia or PNA   Patient was admitted with nausea and vomiting found to have AKI likely prerenal from GI losses also in the setting of NSAID use which rapidly resolved with discontinuing NSAIDs and IV fluid resuscitation.  He was also noted to have nontraumatic rhabdomyolysis also with improvement in IV fluid hydration and his CK level had plateaued and down trended on the day of discharge.  Also in the setting of his above diagnoses he was diagnosed with COVID-19 infection and there is no evidence of hypoxia no pneumonia on his chest x-ray.  He was given antiemetics and was tolerating oral intake.  He was hemodynamically stable, afebrile and ambulatory prior to discharge.  He will be able to maintain oral hydration and recommend he follow-up with primary care to ensure that his labs have normalized over the next 1 to 2 weeks.  We will continue supportive symptomatic care for his COVID-19 infection and recommend he avoid NSAIDs for now.  All questions were answered and concerns were addressed prior to discharge.  He verbalized understanding and was in agreement with the discharge plan prior to discharge
Next day after getting the shot, I had sore muscles & became very sick at stomah for half day
No additional adverse events; an expired adult dose of VAQTA was administered today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 26-AUG-2021, the patient was vaccinated with an expired adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # T033517, expiration date 11-JUL-2021, 1 dosage form) for prophylaxis (expired product administered). The dose was properly stored up through administration. No adverse event was reported.