chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown , single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful arm". Additional information: Caller said he had the Pfizer COVID-19 vaccine also before and he only had a painful arm and no other symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were provided.   Treatment information was unknown.   Reporter did not allow further contact
Within 15 minutes of having the injection I noticed my throat was swelling--a first.  My breathing was labored & I had to not exert myself.  I did not go to the hospital.  The next morning I blacked out, too.  Again, I did not seek medical attention.
This is a 55-year-old male patient Came into the ER with a complaint of cough shortness of breath and fever For last 24 hours T-max recorded in ER 100.9 Patient feels complain of myalgia and fatigue
Lips are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips are swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced LIP SWELLING (Lips are swollen). At the time of the report, LIP SWELLING (Lips are swollen) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not provided.
Pfizer given accidentally as second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pfizer given accidentally as second dose.) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Pfizer given accidentally as second dose.). On 19-Jun-2021, WRONG PRODUCT ADMINISTERED (Pfizer given accidentally as second dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.
over 48 hrs after vaccination, significant erythema and edema of my injection site occured with tender skin.  Expanded to approximately an area approximately 20 cm in diameter
Lymph nodes under right armpit tender; Lymph nodes under right armpit swollen; Continues Throbbing; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 19May2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, fruit allergy and honey allergy. Patient received no medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 28Apr2021 at 16:45 (at the age of 46-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 20May2021 at 16:00, the patient experienced lymph nodes under right armpit swollen and tender. Continues throbbing. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lymph nodes under right armpit swollen and tender, continues throbbing was unknown.  No follow-up attempts are needed. No further information is expected.
sore arm like normal; Received dose and is 17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose and is 17 years old) and PAIN IN EXTREMITY (sore arm like normal) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00157606) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose and is 17 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm like normal). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose and is 17 years old) had resolved and PAIN IN EXTREMITY (sore arm like normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment product information was provided  Patient confirmed that she has been trying to schedule second dose, but no one will administer it. She wonders if she should switch over to Pfizer to get the remaining dose because the second dose might go past the 42 days.
mom called & states for 9sec pt whole body shook @ approx 845PM; mom called MD & will obtain rx for ped DT-no more pertussis;temp p/incident 101 ax;pt was given lower dose of APAP;
Client received single dose CanSino vaccine in on 08/29/2021.  Client requested COVID Pfizer vaccine series. RN submitted a medical consult via text message t, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer was obtained from medical consult team via text message. Client received the 1st dose COVID vaccine (Pfizer, lot#FF8839) at 0450 in the L deltoid.
dizziness so bad he almost fainted; a very bad headache; shortness of breath; coughing; dizziness so bad he almost fainted; elevated heartbeat; he could not eat; had watery eyes; sneezes; His triceps (in the left arm) would shake a lot/shaking on the muscles if his face; general weakness; that this situation is very scary; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller wants to know if the side effects that he is presenting with the first dose of the Pfizer COVID-19 vaccine, two weeks after he received the first dose he started to develop: a very bad headache, shortness of breath, coughing, dizziness so bad he almost fainted, elevated heartbeat (specially at night), these side effects were so bad that he could not eat at all, he also had watery eyes, sneezes, his triceps (on the left arm) would shake a lot, general weakness, shaking on the muscles if his face, he stated that he never had these type of problems before the vaccination and that this situation is very scary. Caller stated that her sister called Pfizer and his information was captured by a nurse, during the call he was contacted back by (Name) and accepted to get contacted by them in the future.  Response: Per fact sheet: what are the risks of Pfizer- Biontech covid-19 vaccine? There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. Signs of a severe allergic reaction can include:  Difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness and weakness. Refer to his physician for treatment recommendations. The patient underwent lab tests and procedures which included heart rate: elevated on unknown date. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: original positive Covid test; Positive, notes: home Covid test had faint positive line; Positive, notes: On Day 10, bright pink positive line after only 3 min. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies. Rebound on Day 10 from original positive Covid test. Nasal congestion, runny nose. On Day 8, home Covid test had faint positive line. On Day 10, bright pink Positive line after only 3 min.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events DRUG INEFFECTIVE and COVID-19 cannot be ruled out.
This spontaneous report as received from a physician refers to his friend of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot number not provided). The patient had a negative titer to Rubella as an adult, following completion the primary M-M-R II series as a child(other titers were acceptable). Unspecified titer was performed). No adverse event reported other than the negative titer to Rubella. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Within 10 min of receiving the vaccine, patient began feeling lightheaded, vomited after being given juice by staff.
pt to ED with increasing hypoxia; states had a positive COVID test day before coming to ED; PCP encouraged him to come to ED; O2 sat 89% on RA in ED; pt had a positive COVID test in ED: given IV steroids, remdesivir, baricitinib; cardiac consult for aortic stenosis; pt didn't want to be intubated; NRB, high flow NC with blended O2; pt's condition worsened and he passed away in the hospital
10:25am Pt received vaccination, came to recovery and walked to EMS on staff c/o of feeling light headed, dizzy. They sat her in a chair and rolled her eyes back and had a syncopal episode that lasted approx 30 sec. They put her on 4L oxygen. She became diaphoretic, pale and warm. Ice pack to back of neck. VS 116/70 HR 72 Reg. resps 16 reg non labored. 100% SPO2. gave water to hydrate, within 5 min color came back face. diaphoresis ended. Monitored for 30 min. VS before exiting 120/80, HR 88 reg, resps 12 reg NL. provided reassurance. Encourage hydration. V-safe site. Ok'd to leave site. RN 3/9/21 - called pt to check condition left message no call back RN
Then 2 weeks later till now (so about 3 days) the injection site is hurting again.; Sometimes it is so bad that it affects  movement; 3 hours after I received the shot my arm at the site of the injection hurt for about 2 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to unspecified chemicals and allergy to formaldehyde. On unknown dates, the patient received bacitracin (MANUFACTURER UNKNOWN) and neomycin (MANUFACTURER UNKNOWN) for unknown indications and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. 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 COVID vaccine. On 29Mar2021 at 16:00, the patient experienced at that the site of the injection hurt for about 2 days. On 11Apr2021 at 09:00, 2 weeks later till the time of report (about 3 days), the patient experienced that the injection site was hurting again and sometimes it was so bad that it affected her movement. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event of at the site of the injection hurt was recovered on 31Mar2021. The clinical outcome of the events exacerbation of pain and affected movement was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   On 13-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported for the long-term prevention of shingles (herpes zoster) and/or zoster-related conditions.   On an unspecified date, Subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles (herpes zoster) to be related to zoster vaccine live (ZOSTAVAX).
poison ivy; Itching; Hives; Redness/redness on her skin; Nausea; feeling faint; felt faint and dizzy /lightheaded; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, manufacturer: Pfizer) at 70-year-old, dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 13:37 (Batch/Lot Number: EKC0177; Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation In Physician Office. Medical history and concomitant medications were none.  History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. none other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations was None. Family had cancer and heart disease. Caller is a consumer that was calling about the Covid-19 vaccine and reported that she took her first dose on 19Jul2021. She said that she was calling about the adverse reactions. Caller reported that she felt faint and dizzy immediately after taking the first dose and that went on for 6 hours. She had to lay down. Several days later (21Jul2021) she developed itching, hives, and redness on her skin. She is using Caladryl. She thought she had poison ivy. The cream her doctor prescribed was for poison ivy, but was not working. Caller said that the Caladryl was helping. Caller said that she felt a little nausea the first day but that quickly passed. The caller said that she took the vaccine at the doctor's office. The caller said that the feeling faint and dizzy passed after 6 hours. She was lightheaded at the office, but she was able to drive home, but it got worse after she got home, the whole room was spinning. She took 2 Aleve and laid down and took a nap.  The caller said that the itching hives and redness was on her arms and her face. She washed herself in hot water and put the Caladryl on to treat it and the itchiness is improved, but is still there. Second dose is due on 11Aug2021. She said that no one she spoke with said that they had reaction to the first shot and everyone said that they had reactions to the second shot. She said that it threw her for a loop as she had reactions to the first shot. She hopes the second shot is better. Caller asked if her side effects were normal. Caller then looked at the information from her doctor's office and said that she answered her own question. She has a list of side effects that she got from the doctors office. They are on the list that she has from the doctor's office. Poison Ivy Cream was Triamcinolone Acetonide (NDC: 0713-0225-80, Lot: 11-22580GW4, Expiry: Jun2018, also reported Lot: 1012774, Expiry: Feb2022). Event were not required a visit to Emergency Room nor Physician Office. Relevant Tests was None. Outcome of faint and dizzy, Nausea were all recovered on 19Jul2021. Outcome of other events was recovering.
cyst formation-aspirated old blood 14JUN96;I&D-purulent/sero sanguinous D/C 17JUN96;2cm area on surface, drain placed, rx keflex probably 3cm cyst s/q, onset p/inj currently in tx
No adverse effects reported; patients received unspecified doses of PEDVAXHIB, MMR II, VAQTA that were improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-MAR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N024698, expiration date 08-SEP-2019, albumin status of rHA (recombinant human albumin) (exact dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 10.9 degrees Celsius for 1 hour 14 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003833: US-009507513-1904USA003832:
Sore throat 11/6/99.At admission, mouth was covered w/white sores, painful peeling of surface,progressed to ulcers of oral mucosa of the throat and lips.Dehydration, weight loss.Rash, peripheral injection of both eyes. 60 day follow-up received on 10/10/00 states the pt has recovered.
I started with a crazy headache in the top of my head and after a week I contacted my Dr. we did a telehealth  2/23/2021 and the Dr. sent me to get a Covid test. However it came back negative. I started swelling the next day and it continued . I was admitted in the hospital on 3/1/2021 because of the continuous swelling, weakness and fever . I was discharged when swelling went down 3/4/2021.
After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minutes. Almost 7 hours later and the pain has increased to the surrounding area in an approximate 2" radius around the site of injection. I am also experiencing a lymphatic response, mostly felt in my neck, and also have some muscle soreness in my neck. I also experienced a few PVCs...I was diagnosed 4 years ago with heart arrhythmia that was mitigated through reduction of stress and caffeine. So, I don't consider it to be a "chronic" condition and it is not something I normally experience, but I have felt a few PVCs happen since being vaccinated today along with some very mild heart pain that is just beginning.   For treatment of muscle soreness at injection site, I am just applying a bit of ice. For lymph nodes, I've been doing some lymphatic exercises and trying to not to sit too much. I also have a little bit of headache that is just developing.   These symptoms are mildly uncomfortable over all. The arm tenderness does give me a general feeling of discomfort and limits my desire for movement, but does not seem to impede my ability to move. For headache, I would normally take a 400 mg of ibuprofen, but I'm not going to take any kind of NSAID at this time. I will monitor my heart but am not concerned.   I cannot be certain the vaccine is the cause of any of these symptoms, except for the arm tenderness and probably the lymphatic response as well. Headache and PVCs can be caused by a lack of sleep and possible dehydration, and I've had a bit more caffeine than I normally might.
Vasovagal syncope: provided cold pack and monitored him for 30 minutes before he was released
arm swollen, red and feels warm "swollen like a balloon" advised ice packs, ibuprofen, get medical attention if it gets worse or shows signs of infection