chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Early period; swollen lymph nodes; Very tender breasts; This is a spontaneous report received from a contactable consumer, the patient. A 43-years old Caucasian non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/lot number: Unknown) via an unspecified route and site of administration for COVID-19 immunization on 08 March2021. Medical history included covid-19 and the patient was not allergic to the medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. The patient did not receive any Concomitant medication within 2 weeks of vaccination. On 14March2021 the patient experienced Very tender breasts, swollen lymph nodes and early period. No therapeutic measures were taken as a result of these events. The clinical outcome of very tender breasts, swollen lymph nodes and early period was unknown. No follow-up possible. Batch/lot number cannot be obtained.
Redness, swelling, itching, hot to the touch, hard knot subQ. Ibuprofen.
A non-serious spontaneous report of administration of expired product was received from a physician concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. On 17-Jan-2012, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Both hands are jerking up. It started out with one hand doing it and now both hands are jerking up. It causes me to drop things out of my hands. These has been going on since Feb 18th.
Patient felt like she was going to pass out; hypotension; Patient had trouble breathing; Patient became dizzy; Patient became numb; Patient's lips turned blue and grey; Patient started to sweat; Tingling feeling in throat, tingling in body; Stabbing feelings in her throat; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy) and HYPOAESTHESIA (Patient became numb) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy), HYPOAESTHESIA (Patient became numb), LIP DISCOLOURATION (Patient's lips turned blue and grey), HYPERHIDROSIS (Patient started to sweat), PARAESTHESIA (Tingling feeling in throat, tingling in body) and OROPHARYNGEAL PAIN (Stabbing feelings in her throat). At the time of the report, PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy), HYPOAESTHESIA (Patient became numb), LIP DISCOLOURATION (Patient's lips turned blue and grey), HYPERHIDROSIS (Patient started to sweat), PARAESTHESIA (Tingling feeling in throat, tingling in body) and OROPHARYNGEAL PAIN (Stabbing feelings in her throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (Low) Blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. 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.  Further information is not expected.; 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.  Further information is not expected.
Where I got my shot in my left arm the muscle of that arm became very weak. Two weeks later it got worse and continues to get worse. I?m to the point now where I can?t even with 10 pounds. Normally I can lift 50 pounds with one arm. The fix for that is therapy. Hopefully that?ll work.
I have black and blue marks and sore spots all over after second Moderna shot; I have black and blue marks and sore spots all over after second Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (I have black and blue marks and sore spots all over after second Moderna shot) and PAIN (I have black and blue marks and sore spots all over after second Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (I have black and blue marks and sore spots all over after second Moderna shot) and PAIN (I have black and blue marks and sore spots all over after second Moderna shot). At the time of the report, SKIN DISCOLOURATION (I have black and blue marks and sore spots all over after second Moderna shot) and PAIN (I have black and blue marks and sore spots all over after second Moderna shot) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Patient came in for first Pfizer Covid vaccine. Patient received vaccine in right deltoid and was asked to wait 15 minutes after vaccine in case of reaction. After 15 minutes patient complained of burning sensation in right arm). Stated that he had burning sensation in bicep area instead of deltoid area. A few minutes later he said he was having a burning sensation in right lower leg. Says he felt flushed. Vital signs obtained . EMS called as a precaution because this was first Covid vaccine. EMTs checked patient and cleared to leave clinic. Symptoms improving before leaving clinic.
Pt felt no pain at the time of the vaccine administration, but felt pain 2/10 at rest, increasing to 8/10 with palpation, within 2-3 hours after administration.  Deep bruising noticed within 2-3 hours after administration, that is still visible today, 8 days later.  The arm is still tender on palpation.
Total confusion and disorientation - he did not know where he was or how he got here the morning after the shot.  He has Alzheimer's, so he is confused and disoriented normally but this was way above and beyond his ususal state.  Not sure if it was the vaccination that caused it, but reporting it just for your information.
is patient pregnant: no; patient became pregnant; This spontaneous report was received from a pharmacist and refers to a 27-year-old female patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  On an unspecified date, the patient was administered with the 2 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot number and expiration date were not provided).  On another unspecified date, after receiving the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient became pregnant. The patient was not pregnant for either dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). Aside from pregnancy, no symptoms were reported.  On an unknown date, the patient pregnancy end.  The outcome of the events was unknown. The causality assessment was not provided.  Upon internal review the event of abortion was determined to be medically significant.
A 16 year old received the Moderna vaccine.  He had fever and chills after that lasted for 5 days and some lingering effects according to the mother.  He received the second dose on 9/23 after consulting with the CDC and the child's physician.  He had loss of taste and smell after the second dose according to the mother.
3 x 2 1/2 inch area of mild erythema at injection site.
Fine macular rash - generalized over trunk, all extremities, but none on face, none on soles or palms.
Syringe came apart from syringe contents. No vaccine administered to pt. No AE from injection. Pt. was revaccinated later on.
Engerix B series was incomplete; 1st Havrix 13jul2018, Twinrix Aug2022 / 2nd Engerix B Aug 2018, Twinrix Aug 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) (batch number j477y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Havrix (received a dose of Havrix on 13th July 2018 with lot number 4h37y expiration date of 8th November 2020), Engerix B (received 1st dose on 13th July 2018 with lot number of 94s22 and expiration date of 4th September 2020 ) and Engerix B  (received 2nd dose in August 2018 ).   In August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Engerix B. In August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose Twinrix (booster dose was late for Hepatitis A) later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting the patient did not receive 3rd dose of Engerix-B, which led to incomplete course of vaccination. In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix can be given. Alternatively, subjects primed with Twinrix may be administered a booster dose of either of the monovalent vaccines. Therefore Twinrix coded with lengthening of vaccine schedule event was coded considering Twinrix as a booster for Havrix.
A nurse reported that a 65 year old female received an injection of Pnu-Imune 23 on 10/6/99. On 10/7/99, she was seen in the ER. The pt reported to the nurse that the ER physician made a dx of cellulitis, that extended up the entire arm. The pt recovered.
8/12/2021- about 4 hours after vaccine started with headache, chills, body started hurting, then I went to bed and all through the night I was sick to my stomach and got a vest bad sore throat. Ankles started to have swollen into them.  9/10/2021- Started throwing up a few hours after with pains in my stomach and swelling of my legs again and now my hands as well. Red dots start on my legs and would come and go blow my knees.  2/11/2022- After the booster I ended up with swelling of my hands and feet. Little red dots on my legs would come and go way more than I got on my legs after 2nd shot Started with a lot of cramping in my toes and very bad headaches worse then i have ever had in my life
10/09/2022: Viral gum infection, right side only, upper and lower, 11/02/2022 Non Arteritic Ischemic  Optic Neuropathy affecting right optic nerve, resulting in partial blindness in R eye.
prescribed Paxlovid  after vaccination; prescribed Paxlovid  after vaccination; Partial Facial Paralysis; Bell's Palsy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 04Dec2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bell's Palsy Earlier in the Year" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: None, reaction(s): "Allergy". The following information was reported: BELL'S PALSY (medically significant) with onset 04Jun2022 at 18:30, outcome "unknown"; FACIAL PARALYSIS (medically significant) with onset 04Jun2022 at 18:30, outcome "unknown", described as "Partial Facial Paralysis"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "prescribed Paxlovid  after vaccination". Therapeutic measures were not taken as a result of facial paralysis, bell's palsy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blurred vision; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, sleep apnea, blood pressure high, depression and fish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously 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 03Feb2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation.  On 24Feb2021 at 17:00, the patient experienced blurred vision. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurred vision 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.
pain feels like it is "going down my right leg; lower right back pain/bcak pain is very mild nowbut still there, lower right back; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain feels like it is "going down my right leg), BACK PAIN (lower right back pain/bcak pain is very mild nowbut still there, lower right back) and FATIGUE (Fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain feels like it is "going down my right leg) and BACK PAIN (lower right back pain/bcak pain is very mild nowbut still there, lower right back). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 500 mg twice a day. On 09-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (pain feels like it is "going down my right leg) and BACK PAIN (lower right back pain/bcak pain is very mild nowbut still there, lower right back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment includes muscle relaxer and he is doing a lot of stretching and using an inversion table which usually helps but didn't this time.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.; 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. Further information has been requested
Not really an adverse event - Dr.  was diagnosed with Covid on 4/17/21 despite completing vaccination
Pt had a big bruise on her arm extending down to her elbow. She had to be taken to the ER to get it checked. It is getting better and doesnt hurt like it did before as per the patient on 10/24/20
Patient administered Pfizer vaccine to R deltoid, hub leaked vaccine during injection and patient received less than 50% of the 0.3ml dose.  Readministered second vaccine to L deltoid with full dose completed.
I experienced severe chest pains and difficulty breathing the next day after receiving the booster shot (showing 200 BPMs). My husband took me to the ER. The doctors triaged me and did an EKG and was immediately taken into a room, administered IVs. I alerted the doctor that I have a heart condition that may be the cause of my heartrate increasing. The doctors decided admit me and had to shocked my heart to beat normally. An Echo-Cardiogram was done along with blood work. The doctors could not say whether the Moderna booster shot caused my symptoms. On, 11/02/2021, an heart ablation was performed at the hospital by the Cardiologist.
Breakthrough case of covid-19 confirmed via PCR lab test sent out to Lab center.  Patient first noticed symptoms on Thursday 6/23 while on a trip. Returned home to on Friday 6/24, went to clinic at pharmacy & had sample taken for testing on 6/25.  Symptoms - feverish on 6/23-6/24, but temperature normal on morning of 6/25 & thereafter. Cough, sinus drainage, congestion in nose & chest. Treatment - steroid pack, albuterol inhaler, tessalon cough capsules. Cough had resolved by 6/30. Some minor congestion continuing as of 7/7/22.
OBSTRUCTIVE SLEEP APNEA 3/11/2022 COPD STAGE 2 MODERATE (FEV1 50-79%) ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/18/2023 COPD STAGE 2 MODERATE (FEV1 50-79%) HYPOXIA 4/18/2023 COPD STAGE 2 MODERATE (FEV1 50-79%)
Rheumatoid arthritis mostly on left hand  Ankle pain on left foot felt like I sprained my ankle. Couldn?t put full weight. Lasted til 2nd vaccine then I got it again even worse on both hands. Could not manipulate a spatula very well, close my hands or grip an object after 2nd vaccine. Left pinky still hurts.
pt recv vax & felt very faint & exp nausea & vomiting;the reporter noted 3pt & WAES95081085 through 95081087 were assigned;no further details were provided;
Blood clot in right leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose 1), administration date: 26Apr2021, when the patient was 47 years old, for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant) with onset 02Aug2021, outcome "recovering", described as "Blood clot in right leg". The event "blood clot in right leg" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) negative. Therapeutic measures were taken as a result of thrombosis. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient has not been diagnosed with COVID-19. Treatment received included blood thinner.  The lot number for bnt162b2 was not provided and will be requested during follow up.
sore deltoid muscle--advil 2/tidx 2d, site swelling-ice 10 min/hr. No temp-began 10 hrs after shot.
fatigue; cough; nasal congestion; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An 85-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), administration date: Mar2021, for Covid-19 immunization.  The following information was reported: FATIGUE (non-serious) with onset 18Oct2021, outcome "recovering", described as "fatigue"; COUGH (non-serious) with onset 18Oct2021, outcome "recovering", described as "cough"; NASAL CONGESTION (non-serious) with onset 18Oct2021, outcome "recovering", described as "nasal congestion".  Additional information: The symptoms were improving. She does not recall having these symptoms after the first 2 Pfizer-BioNTech COVID-19 vaccine doses (2nd dose was around 7 months ago)  No follow-up attempts are possible. No further information is expected.
14jul89 pt vax hepta B. pt developed myalgia & polyarthralgia w/ joint swelling.  Lab evaluation revealed ESR and an arthritis workup.  patient symps persisted.
My son got the flu shot and now has hives, a rash all over his back , kneck, sides, face and arm. Arm is also swollen.
I am no longer testing positive for antibodies; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 07Mar2021 11:30 AM(Batch/Lot number: EN6205 ) as dose number 1, single for covid-19 immunisation and administration date 26Mar2021 11:45 AM(Batch/Lot number: EP6955 ) as dose number 2,, single for covid-19 immunisation   The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIBODY TEST NEGATIVE (non-serious) with onset 18Aug2021, outcome "unknown", described as "I am no longer testing positive for antibodies". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (12Oct2021): This is a follow-up spontaneous report from a contactable Nurse. This 54-year-old Nurse reported in response to Non-HCP letter sent which included that: Patient details, Batch/LOT number were updated  Follow-up attempts are completed. No further information is expected.