chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9W0168) via an unspecified route of administration in the right arm on 11Jun2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included inflamed sinuses/allergies, childhood asthma and mild seasonal allergies, and cold (bronchitis) almost once a year (few days to a week) during winter which resulted in runny nose, nasal congestion, cough and mild infection (yellow/green phlegm). The patient was allergic to theophylline (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN) 10 mg, from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 19May2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 17Jul2021, the patient experienced inflamed sinuses or allergies, sinus infection, severe drainage, congestive cough and shortness of breath. The patient had reported that he had mild seasonal allergies in the past, to include childhood asthma and a cold (bronchitis) almost once a year (few days to a week) in the winter, both resulted in runny nose and in the winter, congestion, cough, mild infection (yellow/green phlegm) and sinuses/allergies, which had been in over 20 years, with severe drainage, followed by congestive cough and shortness of breath. This year has been by far the worst as it inflamed on the weekends due to yard work (allergies), subsided over a couple of days, and inflamed the next weekend. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with OTC medication, pseudoephedrine hydrochloride (SUDAFED) and cetrizine hydrochloride (ZYRTEC); from unknown dates and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 13Sep2021 and the result was negative. The clinical outcome of the events inflamed sinuses or allergies, sinus infection, this year has by far, been the worst of her sinuses/allergies have been in over 20 years, severe drainage, congestive cough and shortness of breath was unknown at the time of report.
Mild allergic reaction; General swelling of the whole body and pronounced swelling of the feet, particularly the left foot.; This is a spontaneous report from a contactable consumer or other non-health care professional (parents). A 16-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 16-years), administered in arm left on 14Apr2021 at 15:00 as dose 2, single for COVID-19 immunization. Medical history included depression, anxiety from an unknown date and unknown if ongoing. Concomitant medications included melatonin (MELATONIN), mirtazapine (MIRTAZAPINE), fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 24Mar2021 at 14:00 as dose 1, single for COVID-19 immunization. The patient previously took epinephrine and diphenhydramine for known allergies of history of stress induced allergic reactions. The patient did not receive any other vaccine in four weeks. The facility type vaccine was reported as other. The patient was not tested for covid post vaccination. It was unknown if patient had covid prior vaccination. On 14Apr2021 at 17:00, the patient experienced mild allergic reaction, general swelling of the whole body and pronounced swelling of the feet, particularly the left foot. The treatment was received for the adverse events with diphenhydramine. Treated with repeated doses of benadryl(diphenhydramine) which seemed effective in stopping the progression of the swelling. Swelling eventually receded over the following 4 days. The clinical outcome of the event mild allergic reaction was reported as unknown while for the event general swelling of the whole body and pronounced swelling of the feet, particularly the left foot was reported as recovering.  No follow up attempts are Possible. Information about lot/batch number cannot be obtained  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Both arms became numb and heavy.  It was difficult to use them.  I felt a deep pain in both arms.  This resolved after about 30 minutes but has recently started again to a lesser degree but the arms feel weak.  I am unsure as to whether I have recovered from the adverse event, because it seems to be happening again which is why I decided to report the event.  So I would describe it as a sudden numbing pain and weakness in both arms making it difficult to use the arms.
This spontaneous report was received from a physician via Pfizer (#2019103793) refers to a patient of unknown age and gender. Patient's medical history, concurrent disease and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number, expiry date was not provided) for prophylaxis. On an unknown date, the patient experienced superinfection (super infection). The outcome of event was unknown. The reporter considered that event superinfection to be related to therapy with ZOSTAVAX. This is 1 of 3 reports received from the same source. Sender's Comments: US-009507513-1903USA006919.
sore throat, headache, increase in shortness of breath, fatigue and side pain over last 5 days. took home test and +covid 4 days ago.hasn't used his resuce inhaler, felt didn't need it.. starting 12/29/21
Generalized varicella adverse reaction.  Smallpox vaccine 13 days ago L arm.  This am woke up with red bumps on L arm, upper back, lymph nodes in axilla swollen.
fever for 3 days, chills  nauseau off and on for 6 days severe pressure headache 8 days  injection site pain 7 days (still can't sleep on my arm)  very tired, sleeping 12 hours a night with a nap during the day 8 days
Injection area hurt, flu like symptoms started-tired, ache and pain throughout body, by 6:00 PM fever, cold, sweating, extreme ache and pain in body, fever 102+, extreme sweating, pain throughout night - very difficult to sleep (missed worked), by 10:00 PM on 06/17/2010 symptoms lessen and getting better but still have body pain, injection area painful, tired and fever.
Vaccine breakthrough, asymptomatic. 9/28   Inpatient admit 9/28 to present,
This spontaneous report was received from a pharmacist via a company representative referring to a three to four unspecified patients of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 25/0.5 ml (dose number, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient's whole arm became swollen, they couldn't felt their fingers and they couldn't move their fingers. The outcome of peripheral swelling, movement disorder and feeling abnormal was reported as recovered. No product quality complaint was involved. The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.
Pt has a mild rash that covers the injection site and large parts of the chest. Pt advised to take allergy medications
I broke out in hives over my entire body with an hour of my vaccine. I had to take Benadryl, Pepcid AC, Xyzal. It started on stomach, back, ankles and would shift to hands, arms, head. It would move to different locations and was itchy. It took a few days to clear up. I went to My NP the next day March 17th. I saw the doctor on March 18th, and she told me to continue what I was doing, and she asked me to follow-up She advised me against doing the second vaccine. She contacted me about a study and then advised me to do my second shot October 6th. I went to the allergist March 18th. Doctor told me not to take anything prior to my second. I was skin tested for allergies before getting second shot. She told me to call the Hospital to have my second shot there just in case. They gave me 10% and waited 20 mins, then 30%, and the remaining 60% an hour later.
sick; is not feeling well; nauseated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Aug2021 13:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid problem" (unspecified if ongoing), notes: she takes medication; "Diabetic" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 04Sep2021, outcome "not recovered", described as "nauseated"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown", described as "is not feeling well".  Additional information: Caller was a consumer who received the first dose of the Pfizer BioNtech COVID-19 vaccine on 04Aug2021. Anatomical Location of Administration of Pfizer vaccine: right upper arm. Caller said she felt nauseated and that she can express how sick she is, which started on Sunday. Caller wants to know if it is a side effect with the vaccine. Caller was not able to receive second dose since she is not feeling well. NDC number of Covid vaccine: Unknown. Reason for no lot number: of Covid vaccine: Other: caller does not have her card with her. Expiry Date of Covid vaccine: Unknown. Other Products: No. Additional Information for Other Conditions: states she takes medication. Medical History: Caller states she has mental health medication she is on also. Vaccination Facility Type: Pharmacy. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect: 1st dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to Emergency Room/Physician Office: No. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Investigation: States she called for something for nausea and the nurse is supposed to get back to her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Slight soreness after receiving the vaccine), FEELING ABNORMAL (feeling like "a little something was brewing in my body), FATIGUE (fatigue) and LYMPHADENOPATHY (Supraclavicular lymph node swollen and hard) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Postmenopausal symptoms. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Slight soreness after receiving the vaccine). On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (Supraclavicular lymph node swollen and hard). On an unknown date, the patient experienced FEELING ABNORMAL (feeling like "a little something was brewing in my body) and FATIGUE (fatigue). On 14-Jan-2021, PAIN IN EXTREMITY (Slight soreness after receiving the vaccine) had resolved. At the time of the report, FEELING ABNORMAL (feeling like "a little something was brewing in my body), FATIGUE (fatigue) and LYMPHADENOPATHY (Supraclavicular lymph node swollen and hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided.
Severe cramping pains in the left  calf that woke my up from sleep. I had difficulty moving my leg. I am assuming it was about 2 AM and it kept me up for at leas 20 minutes. However I did not look at the clock. I am an internist. I have not reported this to my PCP's office of to employee health yet as it is the weekend. It did not recur so far and I hope it does not
This spontaneous report as received from a physician refers to a 13 years old female patient with a drug reaction (rash) to ZITHROMAX. On 25-JUL-2013 the patient was vaccinated with a dose of GARDASIL (lot#, dose and route not provided). Concomitant medications were not reported. On 25-JUL-2013, the patient developed dizziness "within minutes" of receiving the dose of GARDASIL. The patient was asked to lie down in the physician's office, and while she was lying down, she developed a rash on her chest. The physician did not provide any further description of the patient's rash except to clarify that the patient appeared to be having an allergic reaction to the GARDASIL dose. The patient received an unspecified dose of BENADRYL, and after an unspecified period of time, the patient recovered and was released from the physician's practice to go home. The patient did not experience any further adverse effects. The patient had a family history of an allergy to Penicillin which manifested as a rash. No lab diagnostics studies were performed. The outcome of the event was recovered on 25-JUL-2013. Additional information has been requested.
Shortly p/receipt of shot pt noted severe pain swelling in lt arm, elbow, fingers; pain then appeared in other extremities rt arm/hand lt ankle; pain was constant & shooting pains w/grip of hand; had to get wrist braces;
high fever of more than 104; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever of more than 104), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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. On an unknown date, the patient experienced PYREXIA (high fever of more than 104), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PYREXIA (high fever of more than 104), CHILLS (Chills) and MYALGIA (Body aches) had resolved.       Concomitant medications were not reported.  The patient reported receiving the second shot one month after the first, and experienced a high fever with chills and body aches that were worse than the first. It took about 3 days to resolve.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-008430 (Patient Link).
diarrhea; gas; Intestinal issues; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FLATULENCE (gas) and ABDOMINAL PAIN LOWER (Intestinal issues) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced DIARRHOEA (diarrhea), FLATULENCE (gas) and ABDOMINAL PAIN LOWER (Intestinal issues). On 01-Mar-2021, DIARRHOEA (diarrhea), FLATULENCE (gas) and ABDOMINAL PAIN LOWER (Intestinal issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include bismuth subsalicylate.
hives started maybe a month after injection. Never had hives in my life.  No changes in home, no food changes.  Started just on hands and over the course of a month or so increased from head to toe.  Went to allergist who recommended taking steroid and daily antihistamine.  At first it stopped the breakout then after steroid was complete, hives started again, but not as bad as first outbreak.  Increasing to fexofenadine hydrochloride every 12 hours to see if that improves symptoms.  I understand I may never know if this is the cause of my chronic urticaria, but I feel it is important to note it happened after the vaccine and no other notable changes have occurred since the hives started.
Pt reported noticing in left arm around 10:00 pm on the evening of her vaccination.  She continued to have pain and about 2 weeks after initial COVID vaccine she reported that it began to get worse.  She reports that it aches all the time and that it throbs at night and the pain is so bad it keeps her awake at night.  She reports with certain movement the pain is much worse.
What is being called "COVID arm" , original injection very mild pain, at injection site, slight redness, faded one week out. Evening of the eighth day, injection site became swollen, slightly itchy, raised red rash-lie appearance (worse appearance than original symptoms). Very mild symptoms but very visible, still present morning of tenth day.
syncopal episode with bradycardia and hypotension, treated with IV atropine 1 mg and 1 L NS IVF.  transported to an emergency department
patient got flu shot had flu for three day; Initial information regarding an unsolicited valid non-serious case was received from a consumer via social media and transmitted to Sanofi on 12-Dec-2020.  This case involved patient with unknown demographics who got flu shot had flu for three day (Influenza), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history and concomitant medications were unknown.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown), after administration of INFLUENZA VACCINE, the patient got flu shot had flu for three day (influenza).  Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown.  There would be no information available on batch number for this case.
tested positive for covid on 02Mar2021/lingering symptom of a smell issue; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection,Lot number and Expiry date:Unknown), dose 1 via an unspecified route of administration on 28Feb2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient was tested positive for covid and on an unspecified date patient experienced lingering symptom of a smell issue. The patient was scheduled to receive the 2nd dose of the vaccine 21Mar2021. The patient treating doctor said he should wait 90 days before getting the 2nd shot as his antibodies are already high. The doctor was concerned about the side effects. The outcome of the event tested positive for covid on 02Mar2021/lingering symptom of a smell issue was unknown.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
WE ADMINISTERED COVID BOOSTER DOSE ON 12/10/21. WHEN WE WENT TO RECORD IN system, PT ALREADY HAVE 4 SHOTS DOCUMENTED. OUR PHARMACY ADMINISTERED THE 1ST AND 2ND DOSE WHICH MATCHED THE VACCINE CARD THE PATIENT HAD. THE 3RD AND 4TH DOSE FROM ANOTHER LOCATION WERE NOT MENTIONED AT THE TIME OF VACCINATION. SO INSTEAD OF BOOSTER BEING A 3RD DOSE FOR THE PATIENT, IT WAS THEIR 5TH.
Immediate limpness w/out color change or sz; spontaneous recovery w/in less than 1-2min; Had subsequent dose same vax on 1JUL91 w/out event;
Unusual soft tissue edema.; Also had swelling following the second injection (3x3x8cm)/a persistent fullness in both axilla; This is a spontaneous report from a contactable physician, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 11Feb2021 at 12:00 PM (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included osteopenia and COVID-19. Concomitant medications included bisoprolol fumarate (ZEBETA) taken from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 11Jan2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and experienced a significant swelling in the left axilla (4cmx3cmx14cm) which improved by 50 percent following the first injection. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient experienced swelling following the second injection (3x3x8cm) on 11Feb2021 in the left axilla which had improved but was not back to normal. The patient reported that it felt more like an unusual soft tissue edema on 15Apr2021. This did not appear to be lymphadenopathy or lymphedema as there were no palpable nodes or swelling of the hands or arms. The patient had no pain, fever or redness or sign of infection and just felt a persistent fullness in both axillae. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with five physical therapy sessions on unknown dates. On 15Apr2021, the patient underwent an ultrasound of both axillae and it was observed that there was a small node on the left axilla (3-4mm and normal architecture) but otherwise normal and the right side was normal (no fluid collections identified bilaterally). The clinical outcome of the events swelling following the second injection (3x3x8cm), a persistent fullness in both axilla and soft tissue edema was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse concerning a female who on 03-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 03-DEC-2007, the patient experienced arm pain, myalgia with full range of motion and trouble sleeping,and subsequently, visited an emergency room. It was unknown if the patient was hospitalized. The patient was treated with TYLENOL and naproxen without relief. At the time of this report, the patient was not recovered. Additional information has been requested.
Pt had mild to moderate case of chicken pox, had vaccine on 11/12/1999.