chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflamation; My left hand became very red; very servere itching; sever head pain; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 01:30 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. On 01Feb2021 13:00, the patient experienced inflamation, my left hand became very red and very servere itching, sever head pain. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of inflamation, my left hand became very red, very servere itching, sever head pain. The outcome of events was Recovering.
In the observation area for 5 minutes and started to feel light headache and hot. transported to observation with medics. In observation for 30 minutes. 12:50 PM sitting and eating a granola bar. 1:00pm went home on her own.
This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a Nurse Practitioner concerning a 25 year old female with no allergies and no pertinent medical history who on 26-JUN-2007 was vaccinated with 0.5 ml intramuscularly GARDASIL.  There was no concomitant medication.  On 03-JUL-2007 the patient had a rash that initially itched but did not anymore.  The rash was located on the arms and legs and the patient still had it.  The patient took 7 medications (one of which was a steroid, others were unspecified) to treat the rash.  The patient underwent 7 different blood tests which revealed a positive ANA.  As of 21-AUG-2007 the patient was recovering.  Additional information has been requested. Additional information is not expected.
Slight swelling at injection site, redness, skin is warm to touch and itching is present none
Narrative: Headache, Fever, left arm hurt so can't move it. body aches. called out sick
Pt. called 4/12/2021 to report that the night of her 2nd Moderna vaccine 4/9/2021 she started experiencing H/A, fever, chills, sweating, fatigue, loss of smell, sore throat with occasional cough, and occasional shooting nerve pain to the front of her body. All of this lasted through Saturday and subsided except the H/A has lasted through today 4/12/2021.
Patient's grandmother asked about side-effects of fever blisters on top lip and swollen, throbbing gums. 4 blisters on patient's top lip with some swelling. No swelling of face or tongue. No difficulty breathing. Patient has history of fever blisters, but not for a long time. Grandmother told to inform patient's physician, take antihistamines and acetaminophen.
Telephone call 5/5/04: left arm area from DTaP shot warm, red, itchy 1"x4". Denies pain. Ordered Benedryl, ice, Motrin to call if redness increases. 5/6/04 visit : on Benadryl every 6 hours, Motrin: left arm very, red, swollen, warm to touch. Afebrile. MD ordered augmentin 600mg TIDx10days and continue benadryl.
erythema and swelling surrounding injection site approximately 12-24 hours after immunization, parents treated at home with benadryl, symptoms resolved after 2-3 days
Prolonged neutropenia; This is a spontaneous report from a contactable Physician. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6204), via Intramuscular route of administration in the Left arm, on13Mar2021 at 06:00 AM, as single dose for COVID-19 Immunisation (age at vaccination:63-year-old). Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9210), via Intramuscular route of administration in the Left arm, on 10Feb2021 at 07:00 AM, as single dose for COVID-19 Immunisation. On 01Apr2021 at 12:00AM, the patient experienced prolonged neutropenia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Neutropenia and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Employee began to have a large red lump develop on his left shoulder that is warm to the touch  that began 5 hours after the injection. Employee currently has lump still on his arm and it is warm 48 hours later.
It was reported that a 2-year-old female received a dose of Tripedia(lot#U0582AA) vaccine on 7/24/02. Patient developed a large local swelling and induration at injection site measuring 8x8cm. There were two other patients who experienced the same reaction with this lot number.
At injection site, redness measuring 5cm at widest part and swelling measuring 8cm diameter surrounding injection site. Pain and difficulty lifting arm
sneezing a lot; flu-like symptoms; runny nose; feels congested stuffy nose; her head feels congested; cough bringing up phlegm; feels a little tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose) and HEAD DISCOMFORT (her head feels congested) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, ATORVASTATIN and VITAMINS NOS for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired) had resolved.            Concomitant products also included Water pills. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Updated event outcome to Resolved and treatment medication taken.
About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger.  I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger.  I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away.  I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.
PATIENT EXPERIENCED SORE KNEES A FEW HOURS FOLLOWING VACCINATION. BY NOVEMBER 1 PATIENT STATES SHE HAD MORE LEG AND KNEE PAIN AND IT WAS DIFFICULT TO WALK. SHE ALSO STATES HER BACK WAS STIFF.
Syncope probable approx. 15min after vaccination. Patient claimed she had not eaten all day. No injury when fall to floor- she slumped to floor kept patient in pharmacy for another 10-15 min. and pt wanted to leave. Most symptom resolved after hydrating with electrolytes ie Gatorade. Follow up with pt later in evening-showed no symptoms.
Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am.
Severe Pain, Swelling, Redness Near Injection Site, Stiffness in Right Arm, Headache, Tiredness.
Swollen upper limb, hot to touch, painful, went to ER and was diagnosed as infected and ultrasound done.  Treated with Keflex.
This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 48-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration (at the age of 48-years), administered in arm right on 10Apr2021 at 17:30 as dose 1, single for COVID-19 immunization. Medical history included primary immune deficiency, cvid, lyme and other tick borne diseases, mold toxicity, chronic sinusitis and known allergies food sensitivities, Igg infusions, anti-histamines, some antibiotics from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), aloe spp. leaf, althaea officinalis root, herbal nos, magnesium oxide, rheum spp. root, ulmus rubra bark (COLONMAX), fish oil (FISH OIL), vitamin d3 (VITAMIN D3), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient has not been diagnosed with covid prior vaccination and had not been tested for covid post vaccination. On 11Apr2021 at 09:00, the patient experienced swollen right hand with numbness, severe headache with severe light sensitivity, weak legs and arms, racing heart/palpitation, high blood pressure, chest pains, swollen lymph nodes pressing on ear drum, extreme fatigue, low grade fever, face pain, stabbing pains in legs, arms and ribcage, weird feeling in chest. The treatment was received for all the adverse events. No treatment other than anxiety medication. The adverse events resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: high on Apr2021. The clinical outcome for the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected
Patient was a breakthrough COVID case and died due to COVID-related causes on 8/18/2021.
pt brought to ED with increase in weakness, N/V, anorexia;  had a positive COVID test on 9/8/21; admitted 10/26/21 with AKI; transitioned to in-hospital hospice care with comfort focused care; pt's condition worsened and she died in the hospital; per death certificate, hx of COVID infection listed as a contributing factor to death
Pt came in for Spikevax and Flucelvax. Vaccines administered. Shortly after leaving pharmacy patient was involved in car accident in which he died.
Pt recvd vax & approx 5 wks ago exp inc bruising tendency, flu-like sx, lethargy, muscle & joint aches, tired, blood p/bowel movements; pt indicated donated blood approx 2 wks ago; blood would not be used because sign of Hep B;
10 minutes after Td booster pt c/o lip swelling, redness and burning. Treated w/ Benadryl 50mg IM and IV line started. 10 minutes later c/o throat tingling treated w/ Solumedrol 125mg IV and Epinephrine .3ml sp. Also Albuterol nebulizer.
Patient said that within 2 hours of the shot he experienced shortness of breath and his throat tightened up. He does have asthma but said the this was nothing like any of his asthma flare ups in the past. He also experienced a low grade fever for 2 days and felt like he has the flu. He did not seek medical attention and is fully recovered.
Starting approximately 9/28/2021 I had several brief episodes of feeling like going to pass out, few times winded walking up a flight of stairs and hand/feet swelling was worse.  On 9/26/21 was at a friend's house and swam 15 laps in the pool then one week later 10/3/21, back at that pool, was unable to catch breath enough to swim one full lap.    Then on 10/5/21, all afternoon i couldn't catch my breath, so I went to the ER.   Shortness of breath and swelling of hands and feet continues. August 16th 1st Covid vaccine -headache, earache, body aches, muscles and joints, sore throat started a couple days after the vaccine. August 30th - Video appointment for ears, throat, and headache, started penicillin Tuesday 31st, seemed a little better during the week then woke up Sept 4th with much worse headache, ear, throat, side of face. Sept 4th - urgent care prescribed Cefdinir 300 mg 2 per day. About second week of September - feet and hands started swelling. Sept 14th - Video appt for headache, earache, body aches, muscles and joints, hands and feet swelling. Sept 15th bloodwork, CT of head, referral to Neurologist. 9/20 Neurologist had no specific answers. 9/20 second covid. 9/21 ENT said no signs of ear infection. 9/23 Dentist said possible TMJ, try night guard, but no teeth pain which is abnormal for my TMJ symptoms. On 9/20 got second covid vaccine. Starting approximately 9/28/2021 I had several brief episodes of feeling like going to pass out, few times winded walking up a flight of stairs and hand/feet swelling was worse.  On 9/26/21 was at a friend's house and swam 15 laps in the pool then one week later 10/3/21, back at that pool, was unable to catch breath enough to swim one full lap.  Then on 10/5 21, all afternoon i couldn't catch my breath, so I went to the ER.  ER completed EKGs, chest xrays, blood work, nebulizer treatment.  The Nebulizer did no improve symptoms.  All other tests normal.  Referred to Cardiologist. Cardiologist,  Dr.  Stess Echocardiogram, echocardiogram, Ankle-Brachial Index, Carotid Doppler, multiple EKGs - found nothing. Currently still having headache, earache, muscle and joint pains, feet and hand swelling and shortness of breath. I have spent a ridiculous amount of time at doctors appointments, medical test appointments. Not counting ER and urgent care, 19 appointments, most of which required me to miss work!  All from these symptoms that started with the covid vaccine. I am unable to do daily tasks as I normally would like cleaning, exercise, yardwork, standing very long, because of pain and shortness of breath.  I must do small tasks like vacuum one room, then rest, then vacuum another room.
30 minutes post receiving Hepatitis b 1st dose , facial flushing c/o light headedness, c/o glands swelling, increased anxiety, 140/80, 85 22, 90 mins. later No facial flushing, continue light headed 118/70 72 24, decreased anxiety, 3 hrs later no c/o refused hospital or ambulance.
Site of injection started itching; site of injection started itching and developed red mark/Red mark is 2 inches by 3inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection started itching) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark/Red mark is 2 inches by 3inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection started itching) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark/Red mark is 2 inches by 3inches). At the time of the report, VACCINATION SITE PRURITUS (Site of injection started itching) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark/Red mark is 2 inches by 3inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up appended.
The above lot expired on 9-21-2021 and the Janssen vaccine was give on 9-24-2021.  No other symptoms beside an expired dose.
I had other symptoms earlier on that I reported using v safe but today I started my period (while on birth control) two weeks and one day early. I normally have a very light bleed in day one and it is very heavy and has lots of clots. My first spot of blood appeared around 3 pm and I have bled about 15 ml since then. I know the volume as I use a menstrual cup. My first bleed day I normally don?t bleed but one small clot ~2 ml in volume.
Moderna COVID?19 Vaccine EUA Had some arm soreness in day following vaccination but went away quickly.  Last evening (just over one week later), had itching sensation at vaccination site.  This morning, noticed that the site was red (circular area) and tender.
1 day post Engerix-B labs showed: "abnormal lab values." Resolved in about a week.
Temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 27-JUL-2020 (also reported as 28-JUL-2020), varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On an unspecified date in 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #S032357 and expiration reported as 14-OCT-2021 and lot #T002843 and expiration date reported as 23-JAN-2022 ) (strength, frequency and route of administration were not reported)  The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was no previous temperature excursion.   A digital data logger was involved.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2008USA014701: US-009507513-2008USA014711:
Previous focal seizures progressed to generalized within few hours of vaccines requiring intubation. ICU care.
2 swollen lymph nodes; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (2 swollen lymph nodes) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (2 swollen lymph nodes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (2 swollen lymph nodes) had resolved.        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 relevant concomitant medications were reported. No relevant treatment medications were reported.
Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not able to reach patient for follow up.
Upon receiving the vaccine patient stated he thinks may have hit a nerve in his arm.  He did receive the vaccine and was observed for the 15 minutes and did not indicate any arm pain or muscle pain and that his arm was fine.
Tinnitus in right ear, approximately 18 hours after receiving booster shot; a feeling like my body was on fire.  Not just warm, but literally on fire; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 09:30 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "Tinnitus in right ear, approximately 18 hours after receiving booster shot"; FEELING HOT (non-serious) with onset Jan2022, outcome "unknown", described as "a feeling like my body was on fire.  Not just warm, but literally on fire".  Additional information: The patient didn't received any other vaccines within four weeks. The patient was not diagnosed with COVID prior vaccination and not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe arm pain; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain) and PAIN (soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Blood pressure high, Diabetes and Joint ache.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain) and PAIN (soreness). At the time of the report, PAIN IN EXTREMITY (severe arm pain) and PAIN (soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for rheumatoid arthritis, high blood pressure, diabetes and joint pains.  No treatment information was provided.
Patient received the J&J COVID vaccine on 4/12/21 and she started feeling COVID symptoms on 4/18/21 (fever, cough, body aches, and dyspnea). She has 3 members of her family who tested positive for COVID. Patient  tested positive for COVID as well on 4/18/21. She presented to the ED for worsening symptoms on 4/23/21 and was admitted to the hospital for COVID treatment since she was hypoxic in the ED.
Sharp pains in area of shot when I move my arm. Arm unusually very sore.