chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got sick with bronchitis; got sick with Flu; coughing; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: PFEN6207, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in left arm on 18Mar2021 at 11:30 hours as dose 1, single (at the age of 72-year-old) for COVID-19 immunisation. Medical history included cancer unspecified, blood pressure (both from unknown date to unknown if ongoing) and ongoing diabetes. Patient concomitant medication included patient was taking a cancer pill and sees a cancer doctor, sugar pill and blood pressure pill. Patient had no previous immunization with the Pfizer vaccine considered as suspect. Patient had no additional vaccines administered on same date of the Pfizer Suspect. Patient had no prior vaccinations (within 4 weeks). On an unspecified date of 2021, patient got sick with bronchitis and got sick with flu. Patient was nervous with everything. On an unspecified date of 2021, patient was coughing already, and got checked out and patient was okay. Patient added that her house has electric, and no heater and the snow came in and it was cold. Patient used to be 5 foot 6 inches, but now was 5 foot 5 inches. Patient weighs less than 180 pounds, as she put herself on diet. Patient could not get the second dose, missed the second dose. Patient added that she was not that bright and was slow. Patient was in the emergency room and had bronchitis. Patient had no emergency room and physician office visit for the events. Patient had no relevant tests for all the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for Displaced intertrochanteric fracture of left femur within 6 weeks of receiving COVID vaccination.
Huge rash  over the upper part of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Huge rash  over the upper part of the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.  Concomitant products included ATORVASTATIN, LORATADINE and TENOXICAM (SORAL).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Huge rash  over the upper part of the arm). At the time of the report, VACCINATION SITE RASH (Huge rash  over the upper part of the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       having a reaction is a event is not resolved
Extreme fatigue, chest and nasal congestion - started morning 7/4, worse today 7/5.
Fever, headache, nausea, chills, fatigue, inability to speak quickly or clearly, loss of appetite, back pain, joint paint, injection site pain - 18 hours - no treatment
Immediate redness and swelling at injection site. Ice applied after reaction viewed by provider. Swelling and redness resolved within 20 minutes.
My adverse event started 1 month after receiving my 4th Pfizer Bivalent Booster on 03/18/2023 in the afternoon. I had a fever, slight nasal congestion and sore throat. It lasted for 6 days with high fever. I took a home COVID-19 test on 03/20/2023 which was negative.  I went to the urgent care on 03/24/2023, they did a PCR test which was negative for COVID-19. They said that I had the fever for too long that I wasn't eligible for any medication. My son got sick after 1 day and tested for positive for 2 virus which are Human Enterovirus and Human Rhinovirus. My son was admitted to the hospital so I stayed with him there.  I had vomiting and had the same symptoms my son had so they gave me Pedialyte to help with vomiting. I wasn't admitted at the hospital it was my son.  As of today I am still have recovering.
Feels like there is pressure up underneath my arm that too and it is coming back on my shoulder blades; left arm went kind of numb and tingly well and it is sore/ Fingers are going numb; left arm went kind of numb and tingly well and it is sore/My arm was like tingling; left arm went kind of numb and tingly well and it is sore/My arm got real sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 26Jul2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Feels like there is pressure up underneath my arm that too and it is coming back on my shoulder blades"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "left arm went kind of numb and tingly well and it is sore/ Fingers are going numb"; PARAESTHESIA (non-serious), outcome "recovered", described as "left arm went kind of numb and tingly well and it is sore/My arm was like tingling"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "left arm went kind of numb and tingly well and it is sore/My arm got real sore".  Additional info: He states here it was a week and a day later and he had pressure under his armpit and he had tingling arm and fingers still on the injection arm and wants to know if that was normal. He states he did call his doctors and they stated that there was really nothing they can do. Doctors said to wait it out for a little while. He states that it kind of went down the side of his arm and then a couple days later it went towards his back or his shoulder blade. He states that had all dissipated but he still had pressure up underneath his arm pit by his joints. He states that he also had numbness in his wrist that feels like carpel tunnel and states his fingers are numb in the middle. He states that was the only thing that was left and it was aggravating, he guesses. Consumer stated, "I had my Pfizer vaccine, my first shot, a week ago, this was past Monday which would have been July, I do not know. When I first got it, like the next day my arm was like tingling and stuff. It got real sore and then tingling started going up and down my whole arm and it was coming back, into my back. when I first got it I had a bunch of tingling and stuff in my arm which I thought was normal and my arm got real sore with that and then it all had gone away. But now my fingers are going numb like I have got still in my 'wrist' and it was still there like I got Carpal tunnel. But I never had that before. Patient stated, I am not going to get my second shot because of my job and I cannot risk having the 'no feeling in my fingers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Post herpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 05-JUN-2012, pt was inoculated with zoster vaccine live (ZOSTAVAX) by unknown route, as prescribed and/or administered by a pharmacist at a local pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, she was treated by a physician for shingles (herpes zoster) and post herpetic neuralgia. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medication, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  At reporting time, pt was not recovered from herpes zoster and post herpetic neuralgia and it was considered to be related to zoster vaccine live (ZOSTAVAX).
3wk post vax 1AUG97 parent reported sunken in arm on lt upper arm indicated it was the spot where hep B inj given on 11JUL97;pt saw MD 1AUG97;MD indicated concave area appears to be fatty tissue loss poss r/t hep b;arm tired;not sleeping;
Pt. received a Varicella vaccine on 05/13/08. Pt. complained about reddness and swelling at the site on the morning of 05/14/08.  The patient returned to the health dept. for recommendations. The swelling is about the size of a silver dollar. No other symptoms. Will monitor the next couple of days.  Pt. advised to see PCP if site worsens.
No adverse event; Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) 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 WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.).    No concomitant medications was reported. Suspect product dosage text was reported as unknown. It was reported that 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation. Doses were administered on 21-APR-2023 and 28-APR-2023. Each was administered as a second dose in the series. Patients ranged from 10m-5y old.  No treatment drug details was reported. This case contains information of 1st out of 4 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723265, US-MODERNATX, INC.-MOD-2023-723266, US-MODERNATX, INC.-MOD-2023-723267 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723266:Patient 3 US-MODERNATX, INC.-MOD-2023-723265:Patient 2 US-MODERNATX, INC.-MOD-2023-723267:Patient 4
severe diarrhea with abdominal pain that started a few to several hours after vaccination. Symptoms self resolved within 2 days
2MAR92 pt recvd Engerix-B & immed became lightheaded which came & went w/in 12 hrs & had a little rash in back; 3 hrs p/receiving Engerix-B devel sl rash on back, lightheadedness & vertigo; resolved w/o tx;
Developed a small rash a few hours after the vaccine at the injection site with significant swelling. Area was also very hot to the touch.  Over the next 3 weeks, the rash grew in size. At its largest, it was about 5 inches in diameter. The swelling went down after about 2 weeks. 4 weeks later- the swelling is gone, the rash is mostly faded (looks like a very light bruise now), and the area is still slightly warm to the touch.
FIRST DOSE: slight pain at injection site, fatigue, flu-like symptoms and general malaise lasting over a week. Leg pain may have been due to muscular pain from vaccine. Unsure.  SECOND DOSE: pain at site day of, headache day after, low grade fever, some chills, sore throat and earache, body aches, fatigue and unwell feeling. Still on day 2 at time of this report.
I had no adverse events until a couple of weeks after the vaccine around middle of June 2021. I started to noticed I had trouble remembering things and drawing a blank when trying to think. This brain fog happens throughout the day. I notice I can not find the words to explain things and it takes much longer to process thought and get the word out. I did consult with my doctor and she recommended exercise to lower stress. I did do bloodwork which came back normal.
No other adverse events reported; Caller reports that doses of improperly stored vaccines were administered to patients. Additional adverse events 02189036, 02189037, 02189038, 02189039 and 02189040 were filed. No further information provided. No other adverse events reported. No pro; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medication was not provided.  On 15-JUN-2022, the patient was vaccinated with the first dose of improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742084, expiration date 05-OCT-2022, orally, for prophylaxis (Incorrect product storage). Temperature was 47.17F, time frame 15 minutes. There was not previous temperature excursion. No other adverse events reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2206USA006096:02189036 US-009507513-2206USA006272:02189037 US-009507513-2206USA006061:02189038 US-009507513-2206USA006141:02189039 US-009507513-2206USA006019  :02189040
Information has been received from a physician concerning a 9 year old patient who on 07/09/1997 was vaccinated with a dose of varicella virus vaccine live. On 06/22/2004, the pt presented with chickenpox. The pt had a severe breakout with lesions covering the entire body including the genital area. Unspecified medical attention was sought. No product quality complaint was involved. It was also noted that the pt's grandmother has a case of shingles. The physician also reported that he had another case that was not related to this case in any way concerning a 4 year old child who had a very mild breakthrough case of chickenpox last week (vaccination hx unknown). Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot # N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: 1801USA002808: 1806USA010177: 1806USA010178: 1806USA010179: 1806USA010180: 1806USA010176: 1806USA010181: 1806USA010174: 1806USA010173: 1806USA010171.
Fever, chill, body aches, red swollen itchy upper arm where shot was given.Symptons lasted 72 hours. Arm still red/sore 4 days later.
Swollen painful lymph node above right collar bone. Painful lymph nodes in right armpit, right breast, right side of neck, and right side of face-front and back area of ear.
A few days post vax, the pt developed bruising at the injection site. On 12/16/99, the pt recevied the second dose of Hep b vaccine and bruised again. She did not seek medical attention. No further information is available.
Noted areas of redness on legs; 2 areas on inner left thigh and 1 area on inner right lower leg.  All areas approximately 1 cm, round, slightly raised, scaly.  No itching, no drainage.  Areas not tender.  5-11-2007 update received:  Patient reports his spots have completely disappeared.
Sudden heavy menstruation post-menopause of dark black blood. Bleeding on and off from 5/13/2021-06/12/2021. Two-day breakthrough on July 20 and 21, 2021
This spontaneous case was reported by a nurse and describes the occurrence of CRYING (Moderna Covid-19 shot 3 days ago and he has been crying non stop for 3 days) and STOMATITIS (sores in his mouth after his Moderna Covid-19 vaccine.) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced CRYING (Moderna Covid-19 shot 3 days ago and he has been crying non stop for 3 days) and STOMATITIS (sores in his mouth after his Moderna Covid-19 vaccine.). At the time of the report, CRYING (Moderna Covid-19 shot 3 days ago and he has been crying non stop for 3 days) and STOMATITIS (sores in his mouth after his Moderna Covid-19 vaccine.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's age was reported as 2 years 9 months. No concomitant medication information was provided. No treatment information was provided.
I developed a rash across my chest around 6 hours after my shot and it is still there.
Day of vaccine blood sugar levels rose to 400 but was fine when corrected with insulin. The next day, 07/10/2013 experienced extreme drowsiness and when woke up around 3:00 pm was dizzy and felt like I was about to faint when walking, standing up, and sitting upright. Went to emergency room around 4:00pm and was told that I was experiencing a side effect of the Cervarix vaccine and that it could last for up to 72 hours, but if the problem persists that I would need to be rushed back to the hospital. They treated me for vertigo with meclizine for motion sickness and reglan(?) for nausea.
Information has been received from a consumer concerning her son who in November 2009, was vaccinated with a dose of MUMPSVAX (lot number not provided). After vaccination, the patient experienced high fever and rash and was hospitalized. On an unspecified date, the patient recovered from high fever and rash on an unspecified therapy. Additional information has been requested.
WATERY EYES, SINUS DRAINAGE, SCRATCHY THROAT, NECK ACHE, MILD HEADACHE.
This spontaneous report was received from a registered nurse regarding multiple, unspecified patients of unknown demographics. There was no information about concurrent condition. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # L013546, expiration date- 17-JUL-2016, lot # L016283, expiration date- 07-AUG-2016 and lot # L016284, expiration date- 07-AUG-2016 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
On 12pm on 7/10/2021, I began feeling like my autoinflammatory disease,  Familial Mediterranean Fever, was beginning to flare. I took 2 tablets of 500mg acetaminophen, to lower the fever. The fever kept climbing. The fever rose to 102.5°F, and, at 6pm, on 7/10/2021, I took 2 motrin tablets (200mg each).  At 8pm, I took 1.2mg of colchicine, to help stop the flare. I had an intense migraine and terrible body aches, particularly painful in my limbs. Also, I felt pleurisy  starting on the left side of my chest, as well as peritonitis starting on the left side of my abdomen. These are all symptoms which I have experienced before with my Familial Mediterranean Fever, during flares. Incidentally, during a typical flare, I do not usually experience them all at once, as I did after the J&J vaccine.  The fever subsided between Monday evening 7/12/2021 and Tuesday morning, 7/13/2021. The body aches and the peritonitis discomfort remained, after the fever disappeared.  On 7/19/2021, the flare returned, with body aches, 101°F fever, peritonitis, and pleurisy. Colchicine does not seem to be working to control the FMF flare.
Information has been received from a registered nurse concerning a 66 year old male patient with no pertinent medical history and no drug reactions/allergies who on 12-JUN-2012, was vaccinated with a dose of ZOSTAVAX (lot# 672608/1715AA, exp date: 02-FEB-2013). No other co-suspects were reported. Concomitant medications included AMBIEN, FLEXERIL, baby aspirin and multivitamins. The nurse reported that the patient developed chickenpox after receiving ZOSTAVAX. The patient came down with rashes about 3-4 days ago "approximately on 28-JUN-2012" and they were described as "3-4 eruptions, fluid-filled, blistered, itch lesions on his legs and moving up his body". The patient did not receive any treatment for chickenpox. There was no lab diagnostic performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention at physician's office. The relatedness for chickenpox is unknown for ZOSTAVAX. Additional information has been requested.
day after injection (1/5) extreme fatigue, worst of it was 1/5 but symptoms lingered for several day with significant improvement after day 2 and smaller amounts of improvement in following days.  Also, day after injection (1/5) had pain at injection sight that lasted 4 days,.  On day 7, I had swelling and redness at injection site that was circular and was about 3 inches high, 3 inches wide with no noticable pain only slight discomfort, redness and swelling has not subsided at time of this entry
On 03/19/19 patient with a red papule with a small induration in her right posterior arm. Mother denied fever, pain and tenderness.