chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient ready got the boosters,but the doctor says she didn't have the immune and to restart the 4 dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (159558).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "The patient ready got the boosters, but the doctor says she didn't have the immune and to restart the 4 dose".  Additional information: Caller was a pharmacist who mentioned that a patient called her saying that her oncology doctor wants to restart her series of Covid 19 vaccines and she was not sure if it was okay, she was wondering for some advice.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a male patient who on 20-Jun-2003 and 15-Mar-2007 was vaccinated with a first and second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported that approximately one year after the first vaccine, in 2004, the patient developed a mild case of chickenpox. The patient received the second vaccine and on 07-May-2007 the patient again experienced a mild case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. The patient's brother had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES number 0705USA05299). Additional information has been requested.
Sore arm at injection site, sleepiness for about 4 hours in the afternoon following the vaccine tested positive for Covid on 10/6/22
12 year old patient was given the Pfizer covid-19 vaccine for 5-11 year olds
THE PATIENT RECEIVED THE FLU VACCINE  (FLUAD) TWICE. THE FIRST TIME ON 9/16/21 AND SECOND TIME 10/01/2021. PATIENT DID NOT REPORT ANY ADVERSE EVENTS AFTER THE SECOND VACCINE
13days after vaccination my right arm developed a huge red rash warm to the touch downward from the injection site for about 5 inches
Information has been received from a registered nurse referring to multiple unknown patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unknown dates in "November 2016", the patients were administered improperly stored vaccine products (dose, route) for prophylaxis (also reported as "these vaccines have not been administered to any patients"). The products was VAQTA (lot # L017757, expiration date 08-APR-2018 was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes, lot # M022531, expiration date 23-FEB-2018, some was stored in the temperature of between 32 and 36 degrees Fahrenheit for 780 minutes, other was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes, lot # M036459, expiration date 18-JAN-2018, some was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes, other was stored in the temperature of between 32 and 36 degrees Fahrenheit for 780 minutes, lot # M027879, expiration date 24-JAN-2018 was stored in the temperature of between 32 and 36 degrees Fahrenheit for 1612 minutes, in the temperature of 47 degrees Fahrenheit for 25 minutes and in 48 degrees Fahrenheit for 20 minutes;   No adverse effect was reported. The report involved a "data logger".  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA000989:
Right arm swelling down to the dorsum of hand, distal to site of Immunization Tylenol and Benadryl.
I took both doses of the pfizer vaccine and noticed that my thumb joints and my right wrist started to hurt. It hasn't resolved and it seems to not be getting any better
pt recvd vax & w/in 15-20 mins p/vax exp a sl tingling all over body,& sl weakness;pt was monitored in MD office & all sx resolved;no further details available;
Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours
Patient with a recent complex medical history of an MVA in October 2021 with multiple orthopedic injuries to the right tibia, left femur, left tibia, left humerus requiring multiple surgeries who presents to the ED with request for rehab stay as she is unable to care for herself at home. Currently admitted (4/1/2022). ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Post herpetic neuralgia; other zoster-related conditions; Information has been received regarding a case in litigation from a lawyer referring to a currently 71 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-MAY-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a health department for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: postherpetic neuralgia and other zoster-related conditions. The outcome of the events was unknown.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; RASH; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. The patient previously received Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced rash following administration of Moderna covid-19 vaccine (elasomeran) (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  The Patient was revaccinated with different covid-19 vaccine. On an unspecified date, the patient experienced rash for each 10 to 12 days after the shot (dose number in series 2) (dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date, the patient experienced rash following administration of Moderna covid-19 vaccine (elasomeran) (dose number in series 3). The patient got a minor, then a moderate, and a severe rash for each dose and was given a cortisone injection that lasted 5-6 weeks. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from rash, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sever joint pain and swelling in my finger joints, wrists, elbows, shoulders, knees, ankles, and toes. It is very difficult to walk up and down stairs now and do many household chores. The pain is non-stop all day, 24 hours a day. It has been going on every day and night since about a week after I got the booster shot.
Swollen lymph nodes in her armpits, groin, and neck area/Supraclavicular swelling; Lungs were hyperinflated; Painful lymph nodes in her armpits, groin, and neck area; Itching; Achiness all over; Exhausted; Feeling crummy; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 13th February 2022, 1 days after receiving Shingrix, the patient experienced feeling bad and injection site pain. On 19th February 2022, the patient experienced pruritus, general body pain and exhaustion. On 1st March 2022, the patient experienced enlargement of lymph nodes, lung hyperinflation and lymph node pain. On 14th February 2022, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the enlargement of lymph nodes, pruritus, general body pain, exhaustion, lung hyperinflation and lymph node pain were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   The reporter considered the enlargement of lymph nodes, feeling bad, pruritus, general body pain, exhaustion, lung hyperinflation and lymph node pain to be possibly related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details reported were as follows: The patient self-reported this case. The patient received Shingrix into her right arm at her pharmacy. The reporter could not provide the lot or expiration date of the vaccine  The day after receiving the vaccine, patient feeling crummy and had pain at the injection site. After 1 day patient felt better, but then one week later on 19th February 2022, the pain in her arm at the injection site, transitioned into an itching that was not resolved. On 19th February 2022, 7 days after vaccination, the patient also began to feel achiness all over and exhausted.  The reporter stated that, she had been to her general practitioner, a pulmonologist, and an ENT for her symptoms. The patient had a chest x-ray and CT scan of her lungs which showed they were hyperinflated. Around 1st March 2022, ten days after the exhaustion began, the reporter stated patient been to had painful, swollen lymph nodes in her armpits, groin, and neck area and was diagnosed with supraclavicular swelling which was unresolved. The reporter's ENT had ordered a MRI. The reported stated that she feels these event could all potentially be due to the Shingrix vaccine she received. The reporter did not give consented to contact her HCP but stated s, herself, would like a call from the safety department to discuss. GSK note- there is descripancy in the reported onset date of painful, swollen lymph nodes as in structured field date is mentioned as 1st Mar 2022 and in narrative it is 10th March 2022. The onset date for these events captured as per structured field.
Hives: pt now remembers he had this same reaction to the injection years ago, not as bad.
Began developing symptoms of dermatographia - I started getting intense itching all over my body 12 days after my Moderna booster shot. The itchy areas I scratch turn red and splotchy, have raised rashes, and burns. I have been taking antihistamines daily to manage the symptoms, but the symptoms are not improving and are in fact getting worse. I'm currently on day 10 of these symptoms.
I received the Pneumovax 23 shot at 8:30 am. By afternoon I was so ill I knew I would not be able to work the following day. I had fever, body aches, cough, difficulty breathing, headache, nasal congestion, runny nose, sneezing and unusual tiredness. On Friday, 6/7/19, I went to urgent care and was diagnosed with pneumonia. I was prescribed benzonatate, doxycycline, and cough syrup. I missed five days of work. On Monday, 6/10/19, I was seen by Dr. of Primary Care. They took a chest x-ray and the results were clear of pneumonia. The doctor indicated that I may have bronchitis, not pneumonia. Regardless of the label, I was exceptionally ill.
This case was reported by a other health professional via patient support programs and described the occurrence of fainting in a 11-year-old male patient who received BOOSTRIX (batch number 9PD92, expiry date unknown) for prophylaxis. Co-suspect products included MENVEO (batch number A17074, expiry date unknown) for prophylaxis. On 20th August 2018, the patient received the 1st dose of BOOSTRIX and the 1st dose of MENVEO. On 20th August 2018, less than a day after receiving BOOSTRIX and MENVEO, the patient experienced fainting. On 20th August 2018, the outcome of the fainting was recovered/resolved. The reporter considered the fainting to be probably related to BOOSTRIX and MENVEO. Additional details were provided as follows:  This case was received from other health professional via the vaccine patient assistant program. The patient fainted for approximately 5- 10 seconds following the administration of BOOSTRIX and MENVEO. The reporter was unsure which vaccine caused the reaction. The events did not require surgical medical intervention. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. The health care professional did not consider the event as life threatening event. The health care professional did not consider the events to result in persistent or significant disability or incapacity. The event did not resulted in congenital anomaly or birth defect. This case has been linked with case US2018GSK152212, reported by same reporter.
she is having itchiness on her body.; This is spontaneous report from a Pfizer sponsored program Covax  Support. A contactable consumer (Patient) reported herself that a female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced itchiness on her body in Mar2021.  She was asking if she can take Benadryl. The outcome was unknown.  Information on the lot/batch number has been requested.
Warm to the Touch Injection Site Left Arm; Skin Reaction (Nothing visible) on Stomach and Legs; Burning Sensation on Stomach and Legs; COVID Arm (Left Arm); fatigue; Aching body; Flu Like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms), SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs), SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs), PAIN (Aching body) and VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms), PAIN (Aching body) and FATIGUE (fatigue). On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm (Left Arm)). On 29-Mar-2021, the patient experienced SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs) and SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm). On 26-Mar-2021, INFLUENZA LIKE ILLNESS (Flu Like symptoms), PAIN (Aching body) and FATIGUE (fatigue) had resolved. On 03-Apr-2021, VACCINATION SITE WARMTH (Warm to the Touch Injection Site Left Arm) and VACCINATION SITE REACTION (COVID Arm (Left Arm)) had resolved. At the time of the report, SKIN REACTION (Skin Reaction (Nothing visible) on Stomach and Legs) and SKIN BURNING SENSATION (Burning Sensation on Stomach and Legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
I experienced a shingles outbreak, with pain from the top of my leg to my heel, it was a large round rash that itched badly but did not break the skin. The rash moved to my right side all the way down to my heel with painful nerve pain. These symptoms lasted for 10 days. I had received the shingles vaccine in 10/2020. The same shingles outbreak returned with dose 3 and the shingles were on my eye this time. I have not had any recurrent outbreaks since then.
Patient with PMH AML, s/p stem cell transplant x2, history of GVHD including lung - baseline oxygen supp of 3L at home, previous pulmonary embolism in past. Received Pfizer vaccine on 2/15 and presented to our emergency center with  new onset chest pain across anterior chest wall, more severe than usual, and shortness of breath, not improved by inhalers. Admitted to hospital.
Patient was sitting in the waiting area for 15 minutes after her immunization. During this time she passed out and her mom caught her before she slid into the floor. She was given a sprite to drink and was fanned to cool her off. She was clammy and pale. She started to pass our again and was placed in the floor with her legs elevated. She began feeling better and was taken to her mother's vehicle in the store's wheelchair. Mother will continue to monitor at home.
At around 9am, my husband started shaking and reported he was very cold. The shaking was spontaneous and I covered him with electric blanket and within 30 minutes the shaking stopped and he was no longer cold
Full body hives and rash developed that required me to seek urgent care 5 times in the span of a week, and required a high dose of antihistamines and prednisone to manage symptoms.  Nearly one month later, still dealing with suppressing the extremely itchy hives although not as bad as before.
Narrative:  70yo male with a history of acute myeloid leukemia, myelodysplastic/myeloproliferative disease, HLD, diabetes mellitus, and HTN. Died on 06/16/2021 in a hospice care facility. Patient received covid vaccinations on 01/08/21 and 02/05/21. Appears patient died from complications of AML and death does not appear to be related to the covid vaccinations.
hx always fussy-day of shot cried on & off screamed for 24 hrs, leg sore & red, won't take bottle; wasn't goint to get more shot;
Injection site has a bruise around it. Below the injection site is a large, hot, red, tender area. It's swollen to the size of an egg over the course of the day.
Vaccine Exposure Via Breast Milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine Exposure Via Breast Milk) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AZIA) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Gestational Diabetes.  The mother's past medical history included Gestational diabetes. Concurrent medical conditions included Latex allergy.    MEDICAL HISTORY (Patient): No medical history was provided by the reporter.  Concomitant product exposures included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and MAGNESIUM OXIDE for an unknown indication.    On 02-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on 04-Sep-2020 and the estimated date of delivery was 11-Jun-2021. On 02-Mar-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine Exposure Via Breast Milk). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The vaginal delivery occurred on 04-Jun-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. On 02-Mar-2021, EXPOSURE VIA BREAST MILK (Vaccine Exposure Via Breast Milk) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   The mother taken Red Raspberry Leaf Tea (2x daily) and 1 shot Apple Cider vinegar( 1x daily) at the time of conception and during pregnancy.  Upon internal review on 03-Nov-2021, fetal outcome captured as delivered NOS   This case was linked to MOD-2021-032275, MOD-2021-032276 (Parent-Child Link).   See case MOD-2021-032276,MOD-2021-032275 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Non-Significant Follow up-Email attached
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 20-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route of administration were not provided) (lot # H016765 (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient developed fatigue, malaise, abdomen pain, and diarrhea starting 12 hours after getting vaccine.
The patient received the same two vaccines at well care last year, she didn't not need the additional doses. Vaccines did not show in the patients EMR, visit was made in a time frame where we were switching  EMR's and lot all information migrated over.
Ringing in ears. Constant and getting louder. Cricket sound. Driving me nuts.  Swollen lymph nodes in neck. Slowly improving.
a bad panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "immune issues" (unspecified if ongoing), notes: immune issues; "brain surgery" (unspecified if ongoing), notes: brain surgery; "bad anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious), outcome "unknown", described as "a bad panic attack". The event "a bad panic attack" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of panic attack.  Additional information: The reporter's contact information available to you or a sub-contracted party was provided. The patient identifiers were not provided, it is unknown if the reporter had a specific patient in mind. The reporter had a family member who got their 1st dose of the Covid vaccine and they had anaphylactic shock which later was determined by the emergency room that it was a panic attack. Her family member had tightness in the chest and difficulty breathing. Now they had a hard time getting their second dose because of what happened. She stated that this family had a history of brain surgery and COPD so it's important that they get their second dose since the emergency room declared it a panic attack.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.