chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain and discomfort in the arm; tiredness; fogginess in her mind; i cannot sleep; heart palpitations; feeling that something is dislodged from my left  breast/sensation of dislode in her left breast; breast pain; pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator; This is a spontaneous report from a contactable 64-year-old female consumer and other health care professional reported that. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 7:00 PM (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation.  Medical history included diverticulum. patient received other medications within 2 weeks of vaccination were multiple vitamins and melatonin. Patient was not pregnant at the time of vaccination. Patient was not received treatment for the adverse event. Patient was not Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to Penicilline. Caller got the first dose of the Pfizer COVID-19 vaccine on 03Mar2021. After getting vaccinated, she developed pain and discomfort in the arm in which she thought it was normal. Two days after vaccination, on 05Mar2021, the pain increased and it extended to her underarm, her left breast, her neck, and her back. She said the pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator. She also has a sensation of dislode in her left breast. She mentioned that was vaccinated in her left arm. She said that she didn't have fever, but she experienced a little bit of tiredness and also fogginess in her mind. She said her main concern is the pain in her arm that extends to her breast and underarm. She wanted to know if this is a reported adverse event with the Pfizer COVID-19 vaccine. First only pain & discomfort in the arm, but 2 days, after the pain increased and extended underarm, axil and is particularly SUPER-ACUTE in the left breast, to the point that i cannot sleep. Also have heart palpitations, difficulty raising the arm, plus the feeling that something is dislodged from my left breast. The horizontal position in bed is the worst for the breast pain. For the record I have never had any pain in the armas & breasts before I received the Pfizer vaccine on March 3rd. I am very concern. I am scheduled to revive the 2nd. shot in Mach 26th. but before I need to get an explanation of my side effects, how dangerous they are, what to expect, and the assurance that I can safely receive the second dose of Pfizer Covid-19 vaccine. Outcome of the events were not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289248 Pfizer
1ml was given instead of 0.5ml.  Patient was monitored for 30 minutes after vaccination and no side effects occurred.  Will call to follow-up with the patient daily for 2 days.
4 trips to urgent care Diagnosed with RSV Tubes in both ears Now I?m wearing hearing aides praying my hearing might be restored.
1 red round mark noted on right front thigh, 1 red round mark noted on left lateral thigh, 3 red round mark noted on posterior back. Encouraged to follow up with PMD or take child to ER.
Taking anti-inflammatory daily; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient was taking anti-inflammatory daily on an unspecified date. The patient did received the treatment. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
1st seizure as riding home from H1N1 shot she had further seizures 4 and 5 days later ZONISAMIDE began seizure brief complex partial.
I started getting stuffed up and generalized ache. Stuffiness in my head and a headache. I tested positive for Covid 10/16/21, I felt like I had a cold and didn't think anything of it. The next morning I felt really sick and called my doctor and they had me get Covid tested. Right away I got an infusion because the next day I had no taste or smell. The smell issues continues, my smell is very diminished. Also the taste is weird, I've never been able to eat spicy food but now I can eat a whole jalapeno pepper. The most annoying symptom is the sinus issues, I feel stuffed up all the time with a lot pressure.
He developed Shingles on his left scalp, left eye, and left ear. He had pain in his eye and headaches. He was given valacyclovir HCL and methylprednisolone. He has completed both of the prescriptions. He still has blisters, but the symptoms have improved.
complained of feeling light headed 20 minutes after vaccination.  BP- 210/86, p-67  Repeat BP- 10:16- 197/86,   Monitored in Triage area,  repeat BP 10:30- 220/86, p-67,  and manual BP- 224/85.  Evaluated by Dr and patient instructed to take Lisinopril 20 mg tab now,  and to call her primary MD for appointment in morning.
Erythema 13cmx5cm on R upper arm surrounding injection site no itching no respiratory symptoms.
SICK FOR A WEEK; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal), via nasal route, on an unknown date.     On an unknown date, the patient experienced sick for a week (preferred term: Malaise).     It is unknown if any action was taken with Flumist (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.
Chest feels slightly tight; Pain from shot site all the way down arm; Really tired; muscle aches; pains; This is a spontaneous report from a contactable consumer (patient). A non pregnant 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 15:30(at the age of 24-years-old) at dose 1, single for covid-19 immunization. Patient had known allergies to Sulfa, tree nuts, coconut, blueberries, etc. The patient's concomitant medications were not reported. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced pain from shot site all the way down arm  and was really tired with muscle aches and pains; chest felt slightly tight on 04Mar2021 15:45. No treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Large local reaction within 2 hrs of admin. of PNEUMOVAX. Fever of 103 degrees, throat fullness, persistent pain for 3 wks.
In May 2021 I started experiencing more bruising and breaking of the skin.  In June 2021 I noticed my skin started to "peel" off in 3 areas and created a wound on my leg, foot, and toe.  I treated the wounds with Neosporin and bandaids.  The smaller ones healed after a couple weeks, but the larger one on my leg continued to fester and go through different stages of healing.  After over a month I went to my primary care Dr.  He first treated me for a bacteria infection with antibiotics and cream.  During this time I am still bruising very easily or noticing new bruises that I don't remember any incident associated with it.  I also have more wounds that come just from scratching my skin in a normal manner.  After 10 days and no change and I went back to get checked out again.  This time the Dr. treated me for fungal infection with antibiotics and topical cream. With this route and now 2+ months after the initial wound, the larger wound did close up but it is still not gone.  It's raised and a different pigment.  I am still bruising more and still getting smaller wounds all over my body just with minimal pressure from scratching and those wounds are also very slow to heal.  I went back to the Dr and got full blood work done.  All my blood work did not indicate any issues.
During the post-vaccination observation, patient started to feel weak and turn pale. Our pharmacy brought patient back to the pharmacist in the immunization.  She began to experience the anaphylactic reaction and a dose of Epipen 0.3mg was given to patient by the pharmacist. The pharmacist called 911 and after a few minutes patient started to feel better and and skin turned back to normal. Pharmacist continued to observed patient until paramedic team arrived.
Discomfort / pain chest area by heart Fluttering and heart racing  Major heart acceleration with caffeine (coffee)
Diarrhea, watery not associated with vomiting. He had low grade fever, slightly decreased appetite. Activity unchanged. Voiding well. He had 4-5 large watery and 3-4 moderate amount of mushy stools. Physical exam today showed a happy, smiling and cooing baby, temp. of 100.4 (R) Weight=12# 15oz (weight yesterday=13#), moist mucous membranes. Rest of P E unremarkable. Mom Started feeling sick yesterday and today she is having diarrhea also. Rx: Continue breastfeeding.
This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient requested a flu shot today but was given Moderna booster shot (0.5ml) instead by an intern.  He had 2 doses of Pfizer already and it had been 6 months after his 2nd dose.
very sick for the last 4 days; sure feels like the flu; Initial information received on 15-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an Adult and unknown gender patient who was very sick for the last 4 days and sure felt like the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, form, lot number and expiry date) via subcutaneous route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed very sick for the last 4 days (illness) and sure feels like the flu (influenza like illness) (unknown latency) following the administration of influenza vaccine.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events (sure feels like the flu, very sick for the last 4 days).  At time of reporting, the outcome was Unknown for the event sure feels like the flu and was Unknown for the event very sick for the last 4 days.
This case was reported by a healthcare professional and described the occurrence of arm burning in an adult male subject who was vaccinated with ENGERIX B. There were no concurrent medications. In July 2008 the subject received unspecified dose of ENEGERIX B in the left arm. At unspecified time after vaccination with ENGERIX B, the subject experienced burning and stinging in the left arm. At the time of reporting the outcome of the events was unspecified.
My arm began itching and I had a hard knot and red area where the injection took place. It began 9 days after the vaccine was administered. It lasted about 3 days. It still itches occasionally.
Crohns disease flare up; This spontaneous case was reported by a physician and describes the occurrence of CROHN'S DISEASE (Crohns disease flare up) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a day. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease flare up) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohns disease flare up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: inconclusive (Inconclusive) reports not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided. Action taken with mRNA 1273 in response to event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, flares are inherent to the nature of the underlying Crohn's disease.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, flares are inherent to the nature of the underlying Crohn's disease.
Paresthesia face, neck, chest x 1 D. BENADRYL 50 mg PO.
A consumer report has been received. The report concerns a 1 year old, Female consumer, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that patient under age of two had received FLUMIST quadrivalent which started on 12-Dec-2014. The outcome of the event of administered FLUMIST quadrivalent to under 2 yo was unknown. The report was considered to be non-serious.
Admitted for COVID-19 infection, COPD exacerbation; tx w/O2, abx, steroids; pt had epsidoe of code blue 1/16. d/t multiple readmissions and extensive medical problems, family expressed goals to keep pt comfortable and pt dc'd to IP hospice.
pt recvd 2nd dose of vax & exp recurrence of flu-like sx; No further details were provided
Stopped menstruating for a couple of months; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "Stopped menstruating for a couple of months".  Additional information: The PA reports that the daughter of one of his patients stopped menstruating for a couple of months after receiving the Pfizer COVID vaccine. Subject stopped menstruating for a few months after receiving the Pfizer COVID vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 0347pm patient received COVID19 vaccine. At 0407pm she developed facial flushing At 0420pm she developed throat itching/tingling. At 0424 she recieved 10mg of zyrtec (she states she cannot tolerate benadryl). Very shortly after her flushing, throat tingling symptoms completely resolved. She did have some right hand tingling that still persisted, but she attributed to the way she was sitting. 170/100, P80, O2 97%. Repeat BP 15 minutes later was 146 / 98. PLEASE NOTE: patient had flushing from the first vaccine, but was instructed by her immunologist that she could receive it.  She was now advised to go to the ER for further eval but she refused and signed a refusal form. She understands the risks of not going.
Friday evening my arm became warm and it was itching by Saturday AM with a large red rash about the size of the palm of my hand.
stress out the autoimmune system; inflammation in my eyes; inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history included: "auto immune disorder" (unspecified if ongoing), notes: I do have an auto immune disorder already I'm celiac person.; "celiac person" (unspecified if ongoing), notes: I do have an auto immune disorder already I'm celiac person. The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "stress out the autoimmune system"; EYE INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation in my eyes"; INFLAMMATION (non-serious), outcome "not recovered".  Clinical course: Caller was a patient that states the following: "I've reached out to Pfizer before, and you guys have sent me some forms to fill out because of the COVID vaccine and some of the terminology I just don't know what it was. I really need to sit down to review it again. The reason I was reaching out this time was that I want to know if you guys have learned any more about how the COVID vaccine could stress out the autoimmune system and we can have some inflammation as a result of that.  I have some inflammation in my eyes to come down. I'm seeing a specialist." I need information for both [Pfizer monovalent and bivalent vaccines] because my first reaction was from the initial vaccine and then I had reactions to the booster also. I do have an auto immune disorder already I'm celiac person so you know I had other things go on but mainly the thing I can't seem to, I guess I'm having a hard time figuring out was this inflammation and the only thing that can come down to is that it might be a reaction to the COVID vaccine. I was just curious about what you guys are finding out about that and if other people are having the same reaction and if they are going down and see if they can get it resolved, you know what I'm saying, I'm not upset about it, I'm just trying to figure it out. You know what you might already have my information because I called in before I don't know if I can pull it up because I'm in my car and I don't have the vaccine information with me to give you exact dates, I did give it before.
Mother of patient specifies that she took her daughter to the pediatrician because she had inflammation on the arm and cellulitis developed.  She was given antibiotics, anti-inflammatory medications and instructions to go to the ER if there is no improvement.
Patient had brief loss of consciousness when standing from mothers lap. She was out only 5-15 seconds. Neurologically intact. Clammy skin, crying, when asked where did she hurt she pointed to injection sites each time. Mother stated she thinks she hit her head. Hairband removed and scalp inspected, no redness or swelling. Denies head pain. Initial Heart rate 118 at 2:15 and repeat heart rate at 2:36 106. She was given water and able to swallow. She ate lollipop and responded to verbal commands. Stopped crying. Walked to car by herself accompanied by mother and this nurse. Mother given nurse cell #, office # and email for f/u and stated it was okay for nurse to call and check on her later today.
13 min to 60 mins after the injection she develop mild left lower facial numbness.  Gradually decreasing  until today 3/10/21 when she told Propranolol and symptoms worsen.  No motor weakness.
The patient had a 50 cent size area of erythema and edema at the site of injection within minutes of injection. No systemic symptoms.
pt recvd vax & devel redness & swelling of right arm deltoid; pt had disccomfort of right upper arm; redness, swelling & sensitivity to touch remain present;
See attached visit note. Stimulated lasted 20 min. Pt presents with apneic spells. Initial eval or follow-up. The patient presents for new evaluation of a possible seizure disorder. Witnessed seizure activity is described as unresponsive staring. The duration of the last (most recent) seizure was approximately 10 to 15 minutes. This occurred at 9 pm last night. She became very limp and pale and her breathing was very shallow. She was unresponsive and lips became cyanotic.
Sick; Run fever; Fatigue; Arm was swollen; Arm had heat; I still can't lift my arm; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness, fever, fatigue, swelling arm, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the sickness, fever, fatigue, swelling arm and extremities hot feeling of were unknown and the outcome of the mobility decreased was not recovered/not resolved.   The reporter considered the sickness, fever, fatigue, swelling arm, extremities hot feeling of and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the shingle vaccine made him/her sick, run fever, fatigue, arm was swollen and had heat. The patient stated that 2 weeks after receiving Shingles vaccine he/she still cannot lift his/her arm and the patient stated that they wanted him/her to receive a second dose. Additional supportive information: Follow-up would not possible, as no contact details were available.
rash on trunk & face;non on arms or legs;much crying & fussing;no inc temp;8APR97 mom phone again states first rash went away & now has broken out w/some rash rxn only more sever-red is more intense; rash has more papules & painful
All symptoms are for the second dose. Fever and chill 16-18 hours after the vaccine, which subsided quickly.  Swollen lymph nodes at the armpit of the arm injected with the vaccine 24 hours after the vaccine, still ongoing. Severely swollen tonsils, still ongoing.
Painful, redness, elevated - patient went to md and was diagonsed as having cellulitis.
PATIENT HAD LARGE INFLAMMED CIRCLE ON ARM WHERE VACCINE WAS ADMINISTERED. PATIENT DESCRIBED IT AS A HARD BUMP AND ITCHY. PATIENT WENT TO EMERGENCY DEPARTMENT AND PRESCRIPTIONS FOR TREATMENT.
small papular erythematous rash along leg where Varivax was provided (right leg)
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K021881 with expiration date of 30-JUL-2016, lot # L003188 with expiration date of 06-JUL-2016, dose, strength and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.