chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the shot (05/22/2021), I felt like I had Covid again - chills that I could not get rid of even by sitting in front of a heater, fever that spiked to 102°, body aches, difficulty catching my breath (used an inhaler), resting bpm at 103, fatigue/lethargy, nasal congestion.  These symptoms lasted approximately 36 hours.  On the third day after the shot (05/24/2021), my left arm started hurting and was red, inflamed, hard, and swollen at injection site.  The area affected was about the size of my right hand.  Days later, (as of 06/04/2021), I still have a finger sized lump at the injection site.
experienced tiredness for one half of the day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced tiredness for one half of the day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2UA) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (experienced tiredness for one half of the day). At the time of the report, FATIGUE (experienced tiredness for one half of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Received second Moderna vaccine on 3/12/21,  and on 4/1 awoken with intense pressure in ears.    Contacted physician who prescribed antibiotics, and hydrocortisone ear drops on 4/2..    The pain intensified along with constant loud ringing in the ears.   Unable to sleep and with pain in both ears along with sensitivity to sounds increased.   Finally went to ER on 4/5.   Was diagnosed with Tinnitus.   This problem with the intense  and constant ringing in both ears has occurred after the second dose of the Modera vaccine.
This non-serious spontaneous case, initially received from a pharmacist on 27-Sep-2018, concerning a female patient of an unspecified age (reported as younger than 65 year). On an unspecified date, the patient was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number, expiry date: mot reported] (explicitly coded as inappropriate at vaccination). No adverse event was reported.
I tested positive for Covid on Wednesday I was prescribed PAXLOVID by my doctor; I was very tired dry cough and I was coughing green mucus and had sore throat for 1 day.
Approximately 1 week after my 1st dose, I felt two (2) little bumps on each side of my jaw (right below the ears) and it felt like mumps . This has never happened to me before and I was due for a regular check up with my doctor  so I discussed it with him and he said it might be from the Moderna vaccine and was advised that maybe it was one of the side effects and to not worry about it. I was not prescribed with anything but was told to keep an eye out of it for observation. It was there for a couple of days (estimated 2-3 days) and then it went away.
08/23/22 presents to EC ED for "low blood pressure". PMHx of "HTN, HLD, CKD Stage 3"
Bell's Palsy; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced Bell's palsy. The action taken with Shingrix was unknown. On an unknown date, the outcome of the Bell's palsy was unknown.   It was unknown if the reporter considered the Bell's palsy to be related to Shingrix.  Additional information:The patient had Shingrix and experienced Bell's palsy.
This spontaneous report was received from a physician via a company representative and refers to a 64 year old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 13-NOV-2012, the patient was vaccinated with ZOSTAVAX, (dose, frequency, anatomical location, lot # and expiration date were not reported), subcutaneously for prevention of shingles. On 20-NOV-2012, one week after the vaccination with ZOSTAVAX, the patient developed shingles (herpes zoster). The patient sought medical attention from an unspecified primary physician and received an unspecified treatment. It was unknown if laboratory diagnostic studies were performed. At the time of this report, the outcome of the event was unknown. The causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Thursday morning my right arm and stolen twice its size.. extremely hot to touch. A red rash had formed from my shoulder to my elbow.. around my whole arm except for a small section under leather arm
Around the holidays I just started to feel a lot of fatigue, weakness in my legs and lower back. I find myself crying a lot. With any kind of exertion, I am panting. I made an appointment with my doctor, who has ordered me to have a heart exertion monitor test. I have not had this done yet. There where severe snowstorms and I have not rescheduled them yet. I last saw my doctor in February.
The improper diluent (sterile water) was utilized to dilute the vaccine.  Reviewed with Pfizer as per CDC guidelines, who stated to follow CDC guidelines as mother was contacted and informed of CDC guidelines, "Contact the manufacturer for information on the stability of the vaccine. If the manufacturer does not have information to support the stability of the vaccine, repeat the dose immediately".
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-DEC-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB 0.5 ml, intramuscular, lot# 0384AE, expiry date: 02-NOV-2014). No adverse effect reported. Additional information has been requested.
first dose of Shingrix on November 2019 / when she was ready for the second dose, "covid struck"; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient wanted to know the time frame for the 2nd dose of Shingrix Vaccine. When the patient was ready for the second dose covid struck and the patient missed the 2nd dose. No further information available. The patient did not consent to follow up. The patient refused to provide email, home address, fax number, date of birth, vaccine rout of administration, expiration date or lot number. The patient refused to provide healthcare providers name, phone number, fax number and address.
pt recv vax & devel meningitis, reportedly caused by Haemophilus influenzae type b, & was hosp;this is a serous, labelled event;
Heart palpitations, heart rate would increase up to 120 BPM and remain high for up to 4 hours,  symptoms started 3 days after second dose.  Treatment with metoprolol er succinate.
Awoke the next morning with an extremely swollen arm - at injection site. The swelling is firm and is approximately 3" wide and over 4" long.  No apparent fever.
Soft walnut sized mass appeared under right armpit; This is a spontaneous report received from a contactable consumer via COVAES. A non-pregnant 74-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6205) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included peripheral neuropathy, allergies and chronic headaches, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient experienced a soft walnut sized mass appeared under right armpit on 12Apr2021. The event was reported as non-serious and did not require hospitalization. The event required a doctor or other healthcare professional office/clinic visit; no treatment was received for the event. The clinical outcome of soft walnut sized mass appeared under right armpit was not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Patient fainted while seated minutes after vaccine was given. Mother was next to her to prevent her from falling to floor. She complained of nausea and blurred vision. She was given water and Gatorade and began feeling better 5-10 minutes after fainting.
Hives to neck ,upper chest and axilla area . Very itchy. Took 50 mg of Benadryl @ hour of sleep. 3/28. Rash and hives continue today 03/29. NO Respiratory Symptoms  . Did NOT get this rash/hives with first dose of Moderna on 02/27/2021  This type of hives and rash has occured to me  after receiving flu vaccine this winter as well as when I received the Shingrix vaccine.
8 x 2.1/2 cm edematous, eythematous seen on site, warm to touch
numb tingling sensation in face on left side. starts at the left corner of eye and runs down the middle of cheek into left side upper and lower lips and tongue. comes and goes through out the day and night.
Information has been received from a health professional concerning a 7-year-old female who on 10-SEP-1999 was vaccinated with a dose of Varivax (Oka/Merck). Subsequently the patient developed a generalized rash illness. Vaccine failure was noted. It was unknown if this was MD evaluated/documented. Follow up information indicated that there was no further information. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with ROTATEQ via oral (dose, lot # and expiration date were not reported). It was reported that ROTATEQ was involved in excursion of 30.6 F for 90 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Red swollen warm at injection site at 1:00pm on 08/04/21. I also experienced nausea and a headache at the same time. As of today, 08/09/21, the injection site is still tender and a slightly swollen. The nausea and headache went away in 24 hours.
Acute onset swelling, redness within 3 hours of injection. Site (R) deltoid, swelling to (R) AC. Patient seen 2/10/12 with resolving symptoms.
diarrhea; very sore arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that,  A 83-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6199) (at the age of 83-years-old), dose 1 via an unspecified route of administration, administered in arm right on 04Feb2021 as dose 1, single for covid-19 immunisation. Medical history included uterine prolapse from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that patient got diarrhea. She also stated that she went about six or seven times from about 12 o'clock until 3:30 3:45 she stopped. She felt better. She reported that she got the Pfizer COVID-19 vaccine on 04Mar2021 and had a very sore arm that went away and the day after on 05Mar2021 she had diarrhea really bad and she was wondering if that could be one of the side effects. She also reported that diarrhea began on 05Mar2021 in the evening, and it went away itself and got better without treatment. She said her arm soreness carried over to 05Mar2021 while it was getting better. The outcome for the event of very sore arm was recovering and the outcome for the event of diarrhea was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
At 8pm, day after shot was given. Patient had a round swollen area about 3.5 inches in circumfrance that was red warm at injection site left. ER doc said it was infected & put patient on Zithromax for 3 days. Redness went away but area is still discolored.
No adverse event; supposed to get their first dose of the Moderna series and instead got a Bivalent booster; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 10-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (supposed to get their first dose of the Moderna series and instead got a Bivalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    No Concomitant medications were provided. It was reported that clinic Administrator had a person who was supposed to get first dose of the Moderna series and instead got a Bivalent booster. No treatment medications were provided.   Reporter did not allow further contact
Projectile vomiting, severe watery diarrhea, very painful abdominal cramps, lethargy, paleness.
Right arm aching, tired feeling with no strength.  R arm is painful with movement.  Unable to keep food down for 2 days.
Rash on anterior trunk, arms, and neck. The rash is characterized by burning, itchiness, redness and swelling (small bumps/blistery).
Headache, chills, sweating, nausea, dizziness, swollen throat, congestion, cough beginning around 9 hours after receiving the vaccine.
Woke up 6 am went to the bathroom had dizziness, lightheadedness, anxiety, difficulty breathing,  stomach pain, sweating  and chilling, Nausea, and fainted.  Both hand were tingling and  fingers were closing unable to open. Called 911.  Fire and paramedics came took to hospital
it's hard for her to walk to go and get it; Terrible nosebleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (ongoing), notes: Stated it's going away because she is no longer eating grains. Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. Past drug history included: Colloidal silver for Lyme disease, notes: She normally takes Colloidal silver, it cured her of Lyme disease. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer COVID Vaccine, Lot Number / Expiry Date: Unknown/Unknown, Route, Anatomical Location: Right Arm, Date: 26Aug2021), administration date: 26Aug2021, for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 18Sep2021 02:00, outcome "recovered" (18Sep2021 02:20), described as "Terrible nosebleed"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "it's hard for her to walk to go and get it". Therapeutic measures were not taken as a result of epistaxis.  Additional information: The patient did not receive Prior Vaccinations (within 4 weeks). Had no AEs following prior vaccinations. No additional Vaccines Administered on same Date of the Pfizer Suspect. Vaccination Facility Type: Pharmacy inside of the grocery store. The patient the first shot like three weeks ago, clarified to be 26Aug2021. Terrible Nosebleed- It started Saturday 2 AM. The patient got up with a drippy nose. Thought it was snot at first and it was not snot. The patient made it to the bathroom and stood over the sink and it poured out of nose. The nosebleed was for 20 minutes. It finally stopped. It was close to calling 911.  Had not had a nosebleed since she was a kid. The patient ended up staying up until about 4/5 AM and the nosebleed did not come back, but it scared the snot out of her. The patient did not visit Emergency Room/ Physician Office. The patient confirmed that does not had the lot/exp/NDC to provide from the first or second dose of the COVID Vaccine. She does not have the vaccination card with her. It's in her purse, it's hard for her to walk to go and get it.  The patient does not get sick. Does not take vaccines or anything. The patient normally takes Colloidal silver, it cured her of Lyme disease.  The patient has not had a cold or flu or anything. It keeps her from getting sick. Unable to clearly understand caller's statement due to distortion in the line.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101236148 Same reporter/drug/event for different patients
TOES BECAME WHITE FOR A PERIOD OF APPROXIMATELY 15 MINUTES. PATIENT IS PHYSICIAN-DIAGNOSED AS RAYNAUD'S EVENT. SPONTANEOUSLY RESOLVED NO FURTHER EPISODES EXPERIENCED.
About 20 seconds after shot patient became dizzy, sweaty and labored breathing.  He then told pharmacist that he had Covid in may of 2020.  He then fainted and lost bladder control.  The EMT's were called and about 45 minutes later his vital signs were normal and patient left under his own power.
Incorrect vaccine given to patient. Patient is 16 years old and was given Flublok
dizzy/Dizziness; nausea; body feels really heavy; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 11:30 (Lot number: ER8732) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing), notes: Verbatim: Multiple sclerosis. Concomitant medication(s) included: BABY ASPIRIN; COLLAGEN; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Product Details: First dose: Pfizer Covid-19 vaccine 8Mar2021, Lot number: ANW199. NDC and expiry date unknown. Right arm, dose unknown, and time administered unknown.), administration date: 08Mar2021, when the patient was 66 years old, for Covid-19 Immunisation. The following information was reported: DIZZINESS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "dizzy/Dizziness"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "body feels really heavy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional Information: The reporter stated that the patient received the second dose of the Pfizer Covid-19 vaccine yesterday, 29Mar2021, and stated it was normal for her to have an intense immune response to this but today she was experiencing nausea, light headedness and her body feels really heavy. States he was having her drink a lot of water and trying to get her electrolytes up and wanted to know if she could take Dramamine or nausea medicine.The reporter stated that the patient did take Tylenol and he was wondering if she can take Dramamine to help with nausea. Other Conditions was reported as patient was diagnosed in 2019. The reporter stated that the patient had been taking baby aspirin for a month or two exact dose was unknown and stated the patient hadn't taken it yesterday or today. The patient was taking concomitant Products baby aspirin for her blood thinner, had an echocardiogram.  No follow-up attempts are possible. No further information is expected.
Skin has a red circle, about 2 1/2 inches in diameter, radiating out from shot injection location on left arm. Sometimes itchy. (Note: after the first Moderna shot, the injection location was sometimes itchy, but I did not get a red circle like I did with the second shot.) I got the second shot Friday, April 23, 2021 at ~3:50pm, and the red circle is still present today, Monday, April 26, 2021 at ~2pm.
Severe Rash started on arm, face, penis and scrotum; Redness; Swelled; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9262) via an unspecified route of administration in the right arm on 03Feb2021(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seasonal allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA ALLERGY) received within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number:EL1284 ) via an unspecified route of administration in the right arm on 14Jan2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 vaccination. On 23Mar2021, the patient experienced severe rash which started on arm, face, penis and scrotum, swelled, itching and redness. The patient stated prednisone did not help and rash spread across most of body over 2 and a half weeks and finally has stopped spreading. Therapeutic measures were taken as a result of the events which included treatment with prednisone. The clinical outcome of severe rash started on arm, face, penis and scrotum, swelled and itch and redness were resolving.  No follow-up attempts are needed. No further information is expected.
Injection site pain, redness, and fever requiring Medrol dosepak and Benadryl. Symptoms resolved on 9/25/16 without the use of antibiotics.
11/20/21 presents to ED for "cough, fever and confusion". PMHx of "bell palsy, Dm, HTN".
Arm red and swollen and itchy 1 week after injection. Pain for 2 days at injection site for 2 days after injection.