chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RINGING ON THE EARS; CONGESTION; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 147 kilograms, and height was 175 centimeters. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had not any drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced ringing on the ears, congestion and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing on the ears, congestion, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
STOMACH CRAMPING; NAUSEA; VERY SLEEPY; ACHY EVERYWHERE; SORE ARM; CHILLS; DIZZINESS; HEART RACING; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced heart racing. On MAY-2021, the subject experienced fever. On 11-MAY-2021, the subject experienced very sleepy. On 11-MAY-2021, the subject experienced achy everywhere. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced stomach cramping. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sleepy on 15-MAY-2021, and dizziness, heart racing, nausea, and fever on MAY-2021, and had not recovered from achy everywhere, chills, stomach cramping, and sore arm. This report was non-serious.
This spontaneous report received from a Medical Assistant refers to a 4 year old patient. On 25-JUN-2014 the patient was vaccinated with PORQUAD (lot# K004418, expiration date 25-SEP-2015, dose not reported) subcutaneous. There was no concomitant medication reported. The Medical Assistant reported that the PROQUAD administered to the patient was improperly stored, it was exposed to 18F for two hours. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
pt recv vax 24APR95 & 24 hr later lt arm @ inj site became very red, edema, hot to touch, hard;
fever; fatigue; headache; body aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches".  Additional Information: Patient reported one week of fever, fatigue, headache, and body aches after receiving COVID-19 booster vaccine (first booster). Awareness Date: 30Oct2022. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 8/15/02, at time of physical appt, received 2 vaccines: DTAP 0.5cc, IM, in right arm and IPV 0.5cc, IM, in the left arm. No prior reaction to vaccines. On 8/17/02, seen in walk-In care center. Appeared with skin reaction, blister 1/2cm with clear fluid, redness and swelling. No other symptoms.
Approximately 8 hrs after the Booster I started having the chills, shaking and my teeth were chattering.  I took my temperature and it was 100.3 and my heart rate was 118.   I had lymphedema after my first vaccine under my arm.  It went down under my arm.  But, not completely.  This time the lymphedema under my arm showed up with in 8 hrs.  The last two times it showed up the next day.  I continued to have fever, chills, and rapid heart  the next day.  Two days later I felt better.  Four days later I still have lymphedema under arm.
Arm is locking up; Can't elevate past a certain degree; Lost mobility on the same arm where she got the vaccine.; Achiness and discomfort where she cant sleep on her arm; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via an unspecified route of administration on 04Feb2021, as 1st dose, single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included paracetamol (TYLENOL). On an unspecified date in Feb2021, the patient's arm was locking up, could not elevate past a certain degree, lost mobility on the same arm where she got the vaccine, achiness and discomfort where she can't sleep on her arm. Treatment medication included application of ice pack on the affected area. Physician suggested a physical therapy which patient did not agreed to perform. Patient did not receive second dose, which was reported as off-label timing. The clinical outcome of the events was unknown.
Diarrhea; Stomach Pain; Chills; A spontaneous report was received from a consumer, concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, chills and stomach pain.  The patient's medical history included cholesterol and stomach. concomitant medications reported included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium phosphate, chlorine, colecalciferol, cupric oxide, ferrous fumarate, folic acid, iodine, magnesium oxide, manganese sulfate, molybdenum, nickel sulfate, nicotinamide, pantothenic acid, phosphorus, potassium chloride, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon, thiamine, tin, tocopherol, vanadium, vitamin b12 nos, zinc oxide; acetylsalicylic acid; diltiazem hydrochloride and aluminium hydroxide, dicycloverine hydrochloride, magnesium oxidum leve.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021 evening, the patient experienced some side effects includes diarrhea, chills, stomach pain. But however, currently, patient was not having fever. The patient took some medication to help with the symptoms.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), diarrhea, chills and stomach pain were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccination boot number 1 with healthcare provider. PT had just received his Pfizer immunization. PT stated he wasn't feeling well and needed a moment. Pt then became diaphoretic, pale, cool skins. Paramedic asked patient if we could take him to cot for observation. PT agreed and stood up turned and sat in wheel chair.  PT taken to cot and as we arrived pt became unconscious. Pt was unresponsive to verbal and painful stimuli. Pt remained unconscious for approximately 20 seconds. Once patient regained consciousness he was immediately Alert and Oriented x4, skins were pale, moist, cool. pt was carried to cot during his unconscious episode. pt layed down for a while, vitals were assessed at 1556: BP-128/88, HR 64, RR 22, SPO2- 94%. Pt immediately feeling much better and taken to observation for an additional 30 minutes. Pt advised to let us know if he was feeling faint again.
Patient received adjuvant suspension component only without vial of lyophilized gE Antigen. No adverse event has been reported by patient or caregivers. As soon as this clinic found out that patient only received adjuvant suspension component, patient was notified and received 1st dose of Shingrix with lyophilized gE Antigen on 8/17/23.
Pt had chills, very high fever (104.5 or higher) and vomiting.  Pt was delirious for 11 hours.  No treatment as pt was too sick to get anywhere and was not thinking clearly.
had shingles outbreak 9/2020 despite shingles vaccination 2 doses back in 2018
Stomach pain and headache lasting for several days, bloodwork and ultrasound done to determine possibility of acute or chronic pancreatitis, scheduled appointment with a pediatric gastroenterologist
Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, at approximately 66 years old, the patient was administered the ZOSTAVAX by pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Swollen arm, redness, rash at injection site. Brain fog that lasted about two weeks.
Fatigue, fever, headache, loss of appetite  lasting until morning of 1/30.  {24 hours}
headache; nausea; sore arm; feels weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), MYALGIA (sore arm) and ASTHENIA (feels weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), MYALGIA (sore arm) and ASTHENIA (feels weak). At the time of the report, HEADACHE (headache), NAUSEA (nausea), MYALGIA (sore arm) and ASTHENIA (feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe pain in the arm of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in the arm of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 582726) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain in the arm of the vaccine). At the time of the report, VACCINATION SITE PAIN (Severe pain in the arm of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
two days after his first dose of the vaccine He tested positive with the Covid-19; His Doctor advised him to get the second dose only after 60 days before getting his second dose; This is a spontaneous report from a Pfizer sponsored Program. A contactable male consumer reported that; a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 20Jan2021at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced two days after his first dose of the vaccine he tested positive with the COVID-19 and his doctor advised him to get the second dose only after 60 days before getting his second dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 22Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible. No information about lot/batch number has been requested.
LUPUS; This spontaneous report received from a patient via a social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with lupus and she never had any health issues. She was barely getting out of bed and very sick from vaccine. "The reporter stated,  Don't tell me there aren't 1000's like her". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lupus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220661401-covid-19 vaccine ad26.cov2.s- Lupus. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Redness about 1 1/2 in around vaccine area. Warm to touch, soreness to area, painful to touch.
Tested positive for COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
p/shot crying /screaming (<3hrs) would not move leg-t104 APAP given; temp lasted 24 hrs; 10APR93 mild sz pt has hx of sx; 5APR93 mild sz in freq 24APR93 until 4MAY93;
Hands are swollen; Pain much worse; Depression 10 fold; Anxiety 10 fold; headache; pain in back; This is a spontaneous report  from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. Medical history included covid-19 virus last year in 2020, ongoing chronic condition of pain, depression and anxiety. The patient's concomitant medications were not reported. The patient was experiencing side effects from the first dose, the patient had chronic conditions: pain much worse, depression and anxiety were 10 fold, the patient had headache and pain in her back, patient already had in her body its making it worse. Patient was in terrible in pain, patient was in anxiety. Her hands were swollen. The nurse said it may make her conditions worse, may magnify it. She was hesitant at the moment but said to go ahead. Any time patient put medicines in her body it made it worse. Her body was not as swollen as yesterday. Its been 11 days. Patient didn't go into shock. Patient wanted to know if she should receive the second dose. The outcome of the event 'hands were swollen' was recovering, and the outcome of the other events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Pt. states that after receiving the 1st dose of Influenza High-Dose 08/06/2021, started experiencing symptoms 08/07/2021 of nausea and vomiting (lasting 2 days). Pharmacy tested Covid/RSV/Flu Negative. No noted Primary visit/communications.
R tricep pm post inadvertent vaccination to SQ over R tricep 1-2in had lump erythema (+) painful tricep from no last duty time.
The left side of my body feels very sore not just the injection site sore from my shoulder all the way down to my ankle also sore throat really tired almost nauseous and headache that comes and goes
Serum sickness, (L) arm redness, mild joint swelling, (L) sided back pain.
Fever, Cough, shortness of breath, gait problem, weakness, light headedness
Patient woke up the morning of 04/13/21 and explained to his wife that he felt "foggy" mentally. He went about his morning chores on the farm. He came inside to sit in his recliner with his feet elevated for almost an hour.  At approximately 9:40 am, his wife observed that patient suddenly stiffened without warning and cried out. His arms stretched over his head in the chair and his legs stiffened like a board. His body was visibly contracted.  He continued to cry out. His eyes were closed, he was salivating, and his forehead was sweating.  His wife watched him move his arms suddenly to his lap, however, his fists were clenched tight.  She tried to get his attention by calling to him. She noticed his lips were turning blue. She continued shaking him, shouting and then slapped him. Patient did not respond.  She called 911. After 7 minutes, he finally relaxed some and started snoring loudly in the chair. He continued sleeping soundly for about 10 minutes while she waited for EMS to arrive.  The wife did elevate his head , as she was told by 911 to do so.  She was not able to wake him up during this time period. When the EMS arrived, he was just starting to move. They got him up to stand and he was able to verbalize his need to go to the restroom.  They arrived at the hospital at approximately 10:25 am and was released after testing at approximately 2:30 pm.
Had debilitating migraine the first 24hrs after injection. The next day, a "low grade" migraine came back and then faded away later in the day, then came back and faded again.  Tylenol and excedrin does nothing.  This had been happening for 6 days (will be 7 days 10/16/21). I've been having at least 3 headaches a day for 6 days now, with over the counter medication not working.
hair is falling out; sick; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 78-year-old female patient received bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 08:30 as Dose 2, single (at the age of 78-year-old) for covid-19 immunisation. Patient height (170 cm) and weight (210 pounds) reported. Medical history included cardiac disorder, three years ago from an unknown date and unknown if ongoing. Patient had a heart surgery and valve replacement. Concomitant medication(s) included rosuvastatin calcium, (ROSUVASTATIN CALCIUM, 40 mg, half a tablet a day), metoprolol succinate (METOPROLOL SUCCINATE, 50 mg, twice a day), lisinopril (LISINOPRIL, 5 mg, one tablet every day), acetylsalicylic acid (ASPIRINE, Low dose tablet everyday) all taken for an un-specified indication and spironolactone (SPIRONOLACTONE, 25 mg, one half tablet Mon-day, Wednesday and Friday.) taken for heart trouble, start and stop date were not reported. On 21Feb2021 the patient got sick for two days and her hair is falling out. Patient was okay on Saturday, but Sunday and Monday she was sick. Patient stated she got the shot at 8:30 in the morning in Hospital. Patient had undergone all kind of tests when she had a heart surgery but not recently. Patient was fine now. It took her two days to get rid of it. Patient did not receive any treatment for event. The outcome of the events was recovered on 23Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient had been feeling like she wanted to faint, tired and fatigue from the time she started her day at school. Once arrived home, she was weakened to the point that she couldn't hold herself up and kept falling to the floor. She was feeling hot as well. She laid out in the floor and didn't have the strength to get up. The EMS was called and she was transported to ER. She had an EKG done and she was administered 1,000 mL via IV Sodium Chloride 0.9%IV. She had blood drawn as well as a urine sample test completed. All results we negative. She was discharged the same day later that night. Upon arriving home, she complained of headache and body ache. She was given TYLENOL. On 9/14/15, she was doing better, but still somewhat tired. On 9/15/17, she returned to school and seemed to have no other problems from that point on.
I26.99 - Pulmonary embolism on right I26.99 - Other pulmonary embolism without acute cor pulmonale
Second dose administered 7 days after first dose.  Patient did not receive full dose, but unable to quantify amount administered.
Narrative:  94yo male Pt died during inpatient hospice admisssion on 12/23/2021. Death was caused by: complications from metastatic colon adenocarcinoma. Pt had received covid vaccines on 1/16/21, 2/13/21, & 10/5/21. This death is not related to the vaccinations.
INJECTION SITE REACTION, ARM WAS WARM TO THE TOUCH, SWOLLEN, RED, ITCHY.
Fever, chills, body aches,  accelerated heart rate lasted about 24 hours
Headache, Myalgia, Fever, NauseaVomiting, HYPERtension,  swollen lymph nodes  Narrative:  Employee reports normal blood pressure prior to COVID vaccine and chronic high blood pressure after second dose. Also reports rule out for heart attack - ultrasound and scan
Patient suffered fatigue and possible fever the evening after receiving the vaccine. She then reported a rash (blistery) that occurred a week later.
Pt c/o right arm hurting, said pain was shooting through it. Mom said she took pt. to ER, there she received a MOTRIN and was instr. to see MD. Mom took her home and gave her TYLENOL. Pt. said pain eased off, it is just sore. Inst. mom to give her MOTRIN every 6 hours today and tomorrow and apply ice pack. 2-26-15 mom brought pt in this am with her c/o pain in (R) arm and sore neck. pt texted whole visit. Instr mom to try heat to site and see her MD.
The patient received the Fluad vaccine on 08/23/2021 (lot no. 312832) and another dose of Fluad on 09/16/2021 (lot no. 312832). No side effects were reported by the patient.