chrisvoncsefalvay/vaers-outcomes huggingface dataset:
February 10, 2021 left ear was having tinnitus. Went to general practitioner a month later and the prescribed Zertec and Phlonaise for the pressure in your ear, looked at ear an stated it was bulging but not infected said that you had pressure in the ear. Six weeks later for a visit still had tertius and pressure and was referred to the audiologist. Audiologist a full evaluation no hearing loss in either ear but Asymmetrical pressure with left ear having a lot of pressure. Then was referred to ENT end of June. She did a scope from note to ear and also notice pressure in left ear and was referred to Gastroenterologist. 08/15/2021 order an MRI of brain to look at Choclear nerver have brain MRI normal.
Severe pain, fever, increased heart rate feeling ill. In the hospital now. On antibiotics. Undergoing hyperbaric oxygen therapy 90 minutes a day. It is very painful!
Patient received the Moderna brand of the COVID19 vaccination (instead of the Pfizer, which is the brand the patient initially received in Jan/Feb 2021).   No adverse events or other symptoms were reported.
Patient developed breakthrough COVID-19 requiring hospitalization.  This patient received the first dose of the Pfizer 2-dose series on 1/25/2021, and has yet to receive her second dose.
Bilateral eyelid swelling staring 12 hours after vaccine and lasting about 30 hours.; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: ACE inhibitors" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; HYDROCHLOROTHIAZIDE; ATORVASTATIN; VIT D [VITAMIN D NOS]. Past drug history included: Macrobid, reaction(s): "known allergies: macrobid"; Inapsine, reaction(s): "known allergies: inapsine". Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 03Oct2023 at 02:30, outcome "recovered" (04Oct2023 at 08:30), described as "Bilateral eyelid swelling staring 12 hours after vaccine and lasting about 30 hours.". The events "bilateral eyelid swelling staring 12 hours after vaccine and lasting about 30 hours." required physician office visit. Therapeutic measures were not taken as a result of swelling of eyelid.  Additional information: The patient did not have COVID prior to vaccination and was not COVID tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Client developed tingling of her lips 10-15 minutes after receiving the vaccine.  Within 10 minutes of receiving Benadryl 50 mg p.o., the itchiness disappeared.
Severe chills/trembling which I could barely control and then for only a minute of so. Felt very cold and could not get warm. I began to feel better within an hour or less.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored ROTATEQ (dose, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002966: US-009507513-1709USA007015: US-009507513-1709USA007017: US-009507513-1709USA007018: US-009507513-1709USA007019.
1/18/22 pt had a positive COVID test; 2/8 - 2/17/22 pt in hospital for COVID; dc'd to home on O2; 2/21/22 pt to ED with worsening SOB; transferred to another hospital; developed worsening respiratory failure; Vapotherm dependent; pneumothorax; CT placed; CT became dislodged and pt's respiratory status worsened; CT reinserted and pt transferred to another hospital; arrived on Vapotherm; eventually required intubation; pt okay with short time frame for intubation; does not want CPR or tracheostomy; placed on steroids; condition worsened; pt transitioned to comfort measures; was extubated and passed away in the hospital
Pain at injection site. Dizziness after shot. Fever 8 hours later. Slight headache.
On 8/3/00, mom noted red, swollen, painful and warm area over left anterior thigh at injection site. Pt was started on Keflex, worsened for the next 24 hours and then all symptoms resolved. Had a slight fever (101F). Now doing well as of 8/7/00.
Information has been received from a RN concerning a 14 month old Hispanic female who was vaccinated in the right thigh with a third dose of Comvax on 05-DEC-2000. It was reported that the adverse reactions started 2 days after the injections, the pt's mother noticed a lump. On 07-DEC-2000, the reaction was 1.5 inches long induration by 1/2 inch wide. It was reported that the mother contacted the doctor one week after vaccination. On 08-JAN-2001 the pt was vaccinated with a fourth dose of Comvax in the left thigh. On 10-JAN-2001 the pt developed an induration 1/2 inch by 1/2 inch and fever of 100.8. It was reported that no pain at the site of injection was noted for either episode at the time of examination. the pt's outcome was reported as unknown. It was reported that 4 other pts had a similar reaction after exposure to Comvax. Additional information has been requested.
Painful ebow/lower arm swollen; cramping in finger; redness of elbow; swollen elbow; Pain in elbow; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of intestinal obstruction (1st dose receive on 2nd October 2019, kindly refer case US2019205765). Concomitant products included cyanocobalamin (Vitamin B12).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 11th November 2019, 5 days after receiving Shingrix, the patient experienced erythema of extremities, swelling of elbows and pain in elbow. On 12th November 2019, the patient experienced hand swelling and finger cramps. In November 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the erythema of extremities, swelling of elbows, pain in elbow, hand swelling, finger cramps and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling of elbows, pain in elbow, hand swelling and finger cramps to be related to Shingrix.  Additional details were provided as follows: The patient received injection on an unknown arm. On 6th November 2019, the patient received 2nd dose of Shingrix, which was earlier than the recommended schedule, which led to drug dose administration interval too short. The day before reporting, the patient woke up and her right elbow was swollen, painful and red an she went to he doctor. The doctor recommended to apply ice and a wrap the elbow. On the day of reporting, that morning the patient stated that when she woke up, her right hand and lower right arm were swollen and she developed cramping in the fingers of her right hand. Emergency room visit was required. The reporter did not consent to follow-up.
10/1 12AM&1am Awake/No specific complaints       3AM Vomiting/pain in arms,legs,joints/fever 10/1 Fever 104 AM/102PM  No vomiting in PM      Tylenol/Motrin for fever 10/2 No fever by PM/ Pain in ear PM(Has tubes) 10/3 Pain in ear and joints continues/Lethargic 10/4 Appt with family doctor.  Follow up on 10/31/2003: "Vaccine recipient did recover from the adverse event."
Patient presented with headache and lightheadedness at the 15th minute of observation. Physician notified of adverse reaction. Vitals taken (BP, HR, SpO2, Temperature). Patient was afebrile and SpO2 within normal limits. Patient's BP was 98/60 and HR 65. Patient evaluated by Physician. Physician noted erythematous papular rash on left arm 5 inches below injection site. The rash was not warm to touch. Immunization injection site had no erythema, tenderness to palpation/touch, or rash.  Physician advised patient to eat few salty chips and drink a glass of water.  Physician rechecked BP 5 minutes later. MD obtained the following vitals: 102/68 with HR 65. Patient was observed for an additional 15 minutes for a total of 30 minutes. At the end of the 30 minute observation period, vitals were rechecked by the MA. The MA obtained the following vitals: 106/70 with HR 66. At the end of observation period, patient stated lightheadedness has resolved. Patient stated headache was still present, but subsided.
Headache for 3 days straight after 2nd dose. Very heavy bleeding during period - very intense pre-menstral symptoms including - mood swings for a week and cramps like I?m in labor before period arrives.
Patient states her left middle finger turned black/purple. Patient saw her primary doctor. No treatment needed.
Headache, Arthralgia & Diarrhea Narrative: Injection site discomfort for 2 days, Joint pain x 4 days Day 2-Diarrhea Headache x 3 days
1st dose in series on 03-18-2021; 2nd dose in series on 04-08-2021  2 days after 2nd dose, he developed severe pain in both legs.  He was taken to the hospital where clots were diagnosed in both legs and groin area.  A previously undiagnosed lung nodule was found and he was given a cancer diagnosis.  He was discharged home on apixaban (Eliquis) and comfort measures 2 days after admission.  Over the following weeks, he had a permanent lung drain placed.  He died on May 5th or 6th at home.  No autopsy performed.
Started developing what they are calling COVID arm about a week after getting the vaccine. The rash has now grown to about four inches in diameter right around the injection site.
The patient called us at 3:15pm on 1/25/20 and said that his right arm (Pneumovax 23 given) started swelling in the evening  of 1/23 and it was very painful . He also had a fever on 1/23 and 1/24. He took Tylenol on 1/23 ,  1/24 & 1/25. He no longer has a fever and the arm is less painful on 1/25.
Redness & "egg-size" knot noted to left upper thigh evening of injections, increase size of knot and area of redness with heat to touch X 2 days, warm baths with relief. Started oral Benadryl 01/16 with change; Keflex started 01/17 am 01/25 mother states much improved
Tired; Achy; Runny nose; Cough; 98.3 Fever; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the arm left on 31Mar2021 at 12:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, metabolic syndrome, hyperlipidaemia and coronary disease. Concomitant medications included acetylsalicylic acid (ASPIRIN), metoprolol succinate (METOPROLOL), losartan potassium (LOSARTAN), atorvastatin calcium (ATOR) and multi vitamin. The patient had no known allergies to medications, food, or other products. 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 31Mar2021 at 22:00 the patient felt tired, achy, runny nose, cough, fever of 98.3, headache and sore arm. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tired, achy, runny nose, cough, fever of 98.3, headache and sore arm was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Area of injection site started to hurt about 15 min after vaccine administration.  12/17/22, later in the evening noticed bruising around the injection site area.  Skin appears slightly broken where needle entered arm/injection site.  Patient reported to pharmacy in person 12/18/22 at 2:30 pm.  Observed bruise that was approximately 1.5 to 2 inches in diameter, pale blue bruising/discoloration, with darker/more purple areas that radiated out from injection site.  No swelling or inflammation.  Skin slightly broken where needle entered arm.  Patient said that she felt normal.  Denies fever, denies body aches.  Patient did state that it was healing and improved from how it looked the previous day.  Recommended to call her primary care physician on Monday 12/19/22 and to keep an eye on it.  Advised to visit physician if symptoms worsened.
Moderna 4/1/21, 5/1/21, 11/24/21. Positive on 9/4/22
patient received moderna covid 19 vaccine and then had chest pain. Blood pressure was elevated 171/92 HR 69 and pt has hx of HTN and has pacemaker. 911 was called, patient refused transport to ED and stated chest pain had resolved by 0916 and patient left at 0925.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient's pap smear came out positive. Medical attention was sought. Her outcome was unknown. Additional information has been requested.
health has been getting worse; have pains in her chest and back; have pains in her chest and back; making it difficult to move, breathe and cough; making it difficult to move, breathe and cough; coughing; coughing up bloody phlegm; constant waves of fever; cold chills; swollen lymph nodes; earache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09May2021 09:30 (Lot Number: EURO182) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that for the last 6 days her health has been getting worse, she have pains in her chest and back, making it difficult to move, breathe and cough. She's coughing up bloody phlegm and go through constant waves of fever and cold chills. She have swollen lymph nodes right side with a terrible earache. The events started on 11May2021 08:00. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.
Front of my neck became very itchy. Shortly after it was red with some blotches. Because I had seen the doctor, not my primary but a different one, had given me some cream for this when it happened with my 3rd booster. I had left over so I used it for my 4th and after 2 days it went away.  It was triamcinolone acetonide cream. The doctor for the 3rd booster did not know I had taken the vaccine when he prescribed me this cream.
Patient did not have an adverse reaction but vaccine was given too soon after 2nd Covid-19 vaccine; was given 1 month after 2nd vaccine dose.
Incredibly bad period cramps and lower back pain,  starting 1 day before start of menstrual cycle and lasting until day 2 of the cycle.  I normally experience very mild cramping fon Day 1 and nothing else.  Treatment consisted of Ibuprofen every 4 hours and application of heat.  Symptoms were debilitating even with treatment for 2 of the 3 days they persisted.
Pink Red macular papular rash with a few tiny pustules. Abdomen- 30 lesions most likely modified, mild varicella. Benadryl and Aveeno Baths.
Pt states she had itchy rash similar to shingles & pain starting about 10 minutes after she received vaccine.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
A report was received from a health professional on 10/11/2001, concerning a pt of unknown demography who developed multiple sclerosis and neurological symptoms which were disabling/incapacitating, shortly after receiving the Fluvirin vaccine on 10/21/1996. On 10/21/1996, the pt developed multiple sclerosis and neurological symptoms, shortly after receiving the Fluvirin vaccine. The pt has not received any flu vaccinations since 1996. The pt had not recovered at time of report. The reporter has assessed the relationship of study medication to the events as unknown.
Has felt run down and not right since second shot on 4/22/2021, then started with TIA like symptoms 6/2/2021, and found to be bacteremic.
Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing); "found tumors" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Covid shots made her sick.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a healthcare professional via Pfizer (case # 2016382414) referring to a female patient of unknown age. The patient's medical history included fibromyalgia, chronic fatigue/malaise, mild hypertension, anxiety, asthma (mild), high cholesterol, migraines/stress headaches, lower lumbar spine (LS) pain, sleep apnea, hysterectomy, biopsy breast, cervical spinal fusion, carpal runnel release, radial tunnel release, lumbar vertebral fracture L1, ischemic colitis, spinal cord stimulator (SCS) implant. The patient's historical drug included cortisone. On unknown date in January 2012 the patient was vaccinated with PNEUMOVAX 23. On an unknown date the patient was allergy to the vaccine. The outcome was unknown. This is one of several reports received from the same reporter concerning the same patient. Additional information has been requested.
When I lay down I feel it dully; Pain in back; Felt like a stab in my back; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (When I lay down I feel it dully), BACK PAIN (Pain in back) and MUSCULOSKELETAL DISCOMFORT (Felt like a stab in my back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pleural infection (The patient felt like a stab in back once in her 30s, and that was a pleural infection).    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (When I lay down I feel it dully), BACK PAIN (Pain in back) and MUSCULOSKELETAL DISCOMFORT (Felt like a stab in my back). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (When I lay down I feel it dully), BACK PAIN (Pain in back) and MUSCULOSKELETAL DISCOMFORT (Felt like a stab in my back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Normal.         No concomitant medications were provided.  The patient had 2 primary series doses and 2 boosters. After the second booster patient had pain in back. She had a heart monitor. It felt like a stab in her back. Patient had that once in her 30s, and that was a pleural infection. She took aspirin the next couple days. When she laid down she felt it dully. It had never gone away. Mentioned it to her heart doctor and primary doctor. Asked for an Xray, but they said the Xray was normal. They were not able to tell her the cause of her symtpoms.   Reporter did not allow further contact
Patient inadvertently received vaccine after published expiration date. Moderna company analyzed lot 031L20A and advised vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Symptoms: Swollen arm for 1 week couldn't move, back pain, unusual urine smell (chlorine like), hair loss, white discharge, flu like symptoms with vomiting, fever, soft stool, not feeling good at all. Presented to office 9/18/07, has had 2 HPV vaccines and feels her illness is from vaccines
Soreness & numbness in vaccinated arm at injection site. Patient said "arm falling asleep".
?Covid arm?. Injection site and about 1.5 inch around red and swollen hot and painful to touch   Similar reaction to what I get with bug bites but a bit milder