chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose received: 3; Injection site hurt for 2 days; Bones ached for approximately 2 days; Flu like symptoms severe enough to miss work 2 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is a Pfizer colleague.  An adult male patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical site: unspecified, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown, Anatomical site: unspecified, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Injection site hurt for 2 days"; BONE PAIN (non-serious), outcome "recovering", described as "Bones ached for approximately 2 days"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovering", described as "Flu like symptoms severe enough to miss work 2 days". It was unknown whether any therapeutic measures were taken as a result of the events vaccination site pain, bone pain and influenza like illness.  Additional Information: Employee reporting for a friend (patient). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
delayed cutaneous hypersensitivity reaction,5 x 7 inches, discomfort, mild itch and redness not bothering me
Monday 7/26/2021 day one I had woken up with pain at injection site, and felt a little warm. I went to work like normal and at approximately 0830am I started to feel very sweaty and my stomach was hurting. I started to experience extreme nausea and vomiting with diarrhea for almost 30 minutes straight. About a hour after this is started to experience  a sensation that my heart was racing. I did send a message through my chart At this point to see if this was a commonly reported effect.Later that evening when I got home I started to run a small fever of 99 and laid down. Day two 7/27/21 I was already schedule off of work so I slept most of the day as I was feeling very fatigued and my stomach was hurting. My vomiting had stopped but I did start to run a higher fever of 102 and around mid afternoon I had woken up feeling short of breath and weak. So I slept most of the day. Day three 7/28 I would say this was when it got progressively worst. I was at work and I started to notice my heart rate was very high and I had a very tight feeling in my sternum and it was difficult to take a breath in. At this point I called my primary doctors office to let them know what was happening and that I was  concerned that this was similar to when I had pericarditis earlier in the Year. They said with my cardiac history it was best I came in and got observed. When I got to the Doctors around 2pm she had listen and took vitals. She did perform a ECG which she said was abnormal. She ( NP of my primary doctor) suggested that I need to reach out to my cardiologist at this point and possibly get a echo. She did order a stat chest X-ray which was negative that same day since I was having SHortness of breath. At this point I called my cardiologist and explained the situation. I also called and reported this to my employee health because this was a work related issue as it was mandated from my employer. I was directed at that point from employee health that this would be work related injury and needed to get the echocardiogram. Day 4 the pain was at its worst!  Extreme chest pain and very sob
The patient had mentioned a fear of needles before the encounter. The patient was dehydrated and mentioned after that they had not drank much or eaten anything the morning of the incident. The patient was sitting when receiving the vaccine and after 5-10 minutes the patient lost color and passed out. The patient was making a slight choking sound so the pharmacist and I positioned him in the supine position on the floor. After a couple of minutes, the patient regained consciousness and started shivvering.  After about 10 minutes passed of the patient laying on the ground, we sat him up against a wall and then stood the patient up. The patient then walked around the store with me and said he felt 100% and left the store.
Myasthenia Gravis; in his 60's, received a complete series of Bexsero in 2020; This serious case was reported by a other health professional via call center representative and described the occurrence of myasthenia gravis in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero. On an unknown date, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced myasthenia gravis (Verbatim: Myasthenia Gravis) (serious criteria GSK medically significant) and inappropriate age at vaccine administration (Verbatim: in his 60's, received a complete series of Bexsero in 2020). The outcome of the myasthenia gravis was not reported and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the myasthenia gravis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the myasthenia gravis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-JUN-2023 A study coordinator called in stating a patient, in his 60's, received a complete series of Bexsero in 2020 and one dose of a series of Bexsero in 2016.  The patient was now enrolled in a Myasthenia Gravis study, since 2018, that may or may not be requiring the patient receive a Bexsero booster.  Study coordinator was asking if the patient needs to get another booster dose or full series of Bexsero.  If so, will the dosing need to be adjusted due to the fact that the patient is enrolled in the Myasthenia Gravis study? The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received complete series of Bexsero at an inappropriate age (in his 60's), which led to inappropriate age at vaccine administration.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 07-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L013824, expiry date: 21-APR-2017) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
First & second days:  arm swollen and discolored, fussiness.  Third day: fussy, lethargic, vomiting, diarrhea.
VOMITING; CHILLS; FEVER; NAUSEA; SWEATING; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.7 F, 101.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 07-APR-2021 and the outcome of chills, nausea, vomiting and sweating was not reported. This report was non-serious.
PATIENT GIVEN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 06-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported.  On 06-OCT-2022, the patient experienced patient given expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient given expired vaccine was not reported. This report was non-serious.
This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received a dose of VAQTA (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 times for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports from the same source. Additional information has been requested.
Within a couple hours of receiving the vaccine I experienced tenderness at the site of the injection. As the day wore on, I also experienced widespread muscle and joint pain as well as a severe headache. Additionally, overnight, while trying to sleep, I experienced calf and foot muscle cramps about 8 times.
Pain up and down the arm in which the vaccination was administered. Took place 1 day following vaccination and then stopped; This is a spontaneous report from a non-contactable consumer (patient herself).  A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Mar2021 (Age at vaccination was 70-years-old) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain up and down the arm in which the vaccination was administered. which took place 1 day following vaccination and then stopped on 04 Mar2021. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Increase in level of tinnittus leading to diagnosed hearing loss in early December.  The healing loss was of sudden onset shortly after the vaccine booster.  Loss was only in one ear(left)
Patient experienced a near syncopal episode within 5 minutes of receiving the vaccine. She was seated in the Observation area and raised her arm indicating she needed help. The RN responded immediately. I was summoned over and was able to move patient to a table in the back of the room. She was complaining of "Stars: in her vision and not feeling well. First set of vitals were completed at 14:27 BP 116/91, P 100, O2 Sat 97%. Patient is a student. She ate a granola (Nature Made fruit and nut) bar that she has in her pocket. She remained with us for just over an hour , during which time she complained of a fast heart rate, mild nausea and "stars" at the edges of her vision. During the hour she drank over 16 oz of apple juice. She called parents friends to come pick her up and deliver her to her dorm on campus. Last vitals taken at 15:35 110/78 P 104, O2 Sat 99%
1 day after the vaccine he had a low grade fever... 1 week later he had a seizure and then multiple ones in the ER...
persistant fever poorly responsive to APAP w/apparent bad pain per mom; later developed flaccid paralysis of limbs adm to hosp 3DEC94;
11 weeks pregnant at time of first vaccine. Next day had swollen glands under jaw and sore throat that lasted for 4-5 days. These exact symptoms came back exactly 2 weeks later, but more swollen lymph nodes. Some ON my jaw, on the side of my neck and under my jaw. Worse sore throat. Went away after a few days. Second shot was just a mild headache for 12 hrs
Low grade fever; Body ache; Chills; Muscle soreness; Extreme tiredness; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 16Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Mar2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 15:00, 6 hours after the vaccination, the patient experienced extreme tiredness. On 17Apr2021, 18 hours after the vaccination, the patient experienced low grade fever, body ache, chills and muscle soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme tiredness, low grade fever, body ache, chills and muscle soreness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Beginning about 12hrs after injection, and for next 12hrs, headache, nauseous, body ached all over, extremely tired and stayed in bed for those 12hours except for trips to bathroom, and to get ibuprofen(2) half way through the 12-miserable-hours. This was unusual because I've never before had an adverse reaction to any vaccination (including the "old" shingles vaccine, and years of influenza, etc).
Ten minutes after I got the vaccine, I started noticing a weird tingling feeling on the left side of my neck. Soon after, I had neck pain on that left side and stiffness. The first couple nights after the vaccine, i couldn't sleep on that side and it was very painful. As time passed, it would start to feel better, then about eight days later, the pain came back. About twelve days later, the pain went away, and then it came back. By the end of June, the symptoms were worse, constant neck soreness, stiffness, numbness and pain on the left side of my neck. It interfered with my ability to do my job and I often found myself using my right arm instead of my left and work slowly. The doctor took an xray and said I had deterioration on the c5 and c6 vertebrae. I started physical therapy on August 14th. I am still in pain and working through it.
Fever, chills, aches in joints. Headache, sinus head ache, stiffness neck and shoulders. Symptoms persisting 20 hours beyond shot.
swelling and bruising on her arm where she got the injection; bruising on her arm where she got the injection; itching on the same arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced swelling arm, bruising of arm and pruritus. On an unknown date, the outcome of the swelling arm was recovered/resolved and the outcome of the bruising of arm and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, bruising of arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the shingrix vaccine.  The patient stated that initially she had swelling and bruising on her arm where she got the injection.  The patient did not specify which arm. She said, this week she had intermittent itching on the same arm. The patient did not want to provide any demographic information, nor any further details about the adverse.  She disconnected the call before able to ask about health information or consent. The reporter did not consent to follow up
pt recvd vax 10AM 18APR95 mom called mid afternoon to report that pt would not stand or walk on leg (rt); mom reassured; mom called again reporting pts temp reached 102 @ 10PM & dark red streaks on lt side of body from shoulder to waist;
Shortness of breath, dyspnea on minimal effort (walking short distance, showers) tiredness, weakness, headache.
This spontaneous report as received from a physician via company representative refers to a 2 year old male patient. Patient had no previous medical history. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX injection (dose number, dose unit, route, lot # and expiry date unknown). No concomitant medications were reported. ON an unknown date the patient experienced mild to moderate chicken pox under the fee, on the ands and truck of his body after received (Oka/Merck) VARIVAX. On an unknown date, patient visited office for medical attention. On an unknown date patient recovered from the event. The outcome of mild to moderate chicken pox under the feet, on the hands and trunk of his body was reported as recovered/resolved. The reporter did not provide the causality of (Oka/Merck) VARIVAX. to mild to moderate chicken pox under the fee, on the hands and truck of his body. No further AE information provided.  Additional information has been requested.
Itching, swelling, skin warmth - No systemic symptoms 9cm x 5cm patch on R tricep - Warm and indurated. Dx: Cellulitis Tx: SEPTRA DS 1 tablet by mouth every 12 hrs for 7 days.
suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In August 2018, the patient received the 2nd dose of Shingrix. In May 2019, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient still ended up getting Shingles on the reporting weekend.  At the time of reporting, the patient was being treated with Valacyclovir. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation were unknown at the time of reporting.
Ringing in ears (tinnitus) No treatment Still ringing after dose 2 of Pfizer Covid 19 vaccine Have been told there is no treatment, no cure for tinnitus.
This spontaneous report was received from an office manager, referring to a 18 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 03-MAR-2018, the patient was vaccinated with one pediatric dose of VAQTA, (strength: 25/0.5), for prophylaxis (frequency, route of administration, lot number and expiration date were not reported). On 05-SEP-2018, the patient at 19 years old received a second pediatric dose of VAQTA, 0.5 (units not provided) for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported). No adverse events were reported.
Unknown adverse events; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 4 months after receiving Boostrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the physicians from the pediatric unit reported adverse reactions to a specific lot number for the product. The reporter consented to follow up. This case has been linked with cases US2019145738, US2019145742, reported by the same reporter.
Tested positive for COVID on 07-29-2021 has very mild symptoms congestion and headache.
Developed rash (hives) on the face/neck around 4 PM on 6/13; advised oral Benadryl. Rash progressively increased in size/number. Spread to arm, hands, leg, feet, thigh. Swelling and redness noted on dorsum of hands and feet; discrete rounded raised patch with central pallor. Different sizes in 24 hours.  Medical record 06/29/05 states erythema multiforma and allergic reaction.
Shortly after my blood pressure rose up to 100/100 and higher, up to 190/110. It is not uncommon during stressful situations. Vaccination just made it sky rocket. Saw Dr and started protocol and back on Lisinopril. Both of these helped keep blood pressure normal. Started me on some natural antiviral to help before my next booster.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 20-year-old female patient who received BEXSERO (batch number 16E601, expiry date unknown) for prophylaxis. Concomitant products included BEXSERO. On 13th July 2018, the patient received the 2nd dose of BEXSERO. In July 2018, less than a week after receiving BEXSERO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by an office staff. On 12th June 2018, the patient received the 1st dose of BEXSERO (batch number 16D601) and experienced pain and swelling at injection site (refer case US2018GSK130899). The patient received 2nd dose of BEXSERO on the left arm and experienced same adverse events. The reporter agreed to be contacted for follow up.
The morning after my shot, I woke up with a multitude of cold sores, and inside my mouth too. I have had cold sores before, but never in my mouth. There were a number of them along my gum line. This is a first for me.