chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
IBS flare event. Symptoms not fully calmed after two weeks despite significant dietary control. Strong intestinal pain. Loose bowels until effects of dietary restriction kicked in. Still unable to fully reintroduce 1 serving of well-cooked leafy greens after 2 weeks without discomfort.
Child's hands red, hives to hands bilat, "hard to bend fingers".  Reaction isolated to hands.  No other reaction noted.  Evaluated by physician on call.
Severe burning in chest immediately after injection, sudden severe weakness, severe headache onset within 5 minutes, with some queasiness, subsequent chest congestion, cough, pain in chest area, sore throat.
TESTING POSITIVE FOR COVID BY BOTH A RAPID AND PCR TEST; This spontaneous report received from a patient concerned a 60-year-old White male of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 07-SEP-2021) dose was not reported, dose number in series was 01, 01 in total administered on left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  Following administration of covid-19 vaccine ad26.cov2.s, no events were reported (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company vaccine as MRNA 1273 (moderna) (form of admin, route of admin were unknown, and batch number: 069f21a, expiry: unknown) dose was not reported, dose number in series was 02, administered on left arm on 15-NOV-2021 for prophylactic vaccination.  Following administration of vaccines, on an unspecified date the patient tested positive for covid by both rapid and polymerase chain reaction (PCR) test (dose number in series was 02). The action taken with MRNA 1273 was not applicable. The outcome of testing positive for covid by both a rapid and PCR test was not reported (dose number in series was 02). This report was non-serious. This report was associated with product quality complaint: 90000211870. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.
Approximately 4hrs after shot, nausea, severe vomiting chills/shaking followed by leg cramps, went to ER at 8:30pm, temp was 101.5. They gave injection of anti-nausea medication. She went home, slept, and awoke feeling normal next morning.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient. The patient had no pertinent medical history and drug reactions/allergies. On 20-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as J011337, Exp date 13-DEC-2014), subcutaneously (dose unspecified). Concomitant therapy included unknown number of unspecified medications. The patient was prescribed SOLU-MEDROL for an unspecified reason on 25-JAN-2014 (treatment for the adverse event was also reported as no). No lab diagnostics studies were performed. The outcome of the event was unkonwn. This is one of several reports received from the same reporter. Additional information has been requested.
Same happened in 1991. Warm and heavy (R) shoulder 1-2 hours after injection. Evening felt lousy took TYLENOL, worked next day. Chills Fri PM, took TYLENOL. Could not eat following 3 days, could not get up from bed. Chills stopped on Sunday. Pain in bones all over.
BELL'S PALSY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient was not involved in any accident nor had any prior history of Bell's palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 on left deltoid for prophylactic vaccination.  On 22-MAR-2021, the patient developed slurred speech. On 08-APR-2021, the patient had drooping eyelids, was unable to close mouth and had puff cheeks. On 12-APR-2021, the patient visited her doctor's office and diagnosed with Bell's palsy which was further confirmed with computerized tomography (CAT) scan. On an unspecified date in APR-2021, Laboratory data included: computerized tomography CAT) scan (NR: not provided) Bell's Palsy. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bell's palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210436167-covid-19 vaccine ad26.cov2.s-Bell's palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Momentary loss of consciousness followed by seizure. After two hours of rest, symptoms including dizziness and vomiting remain.
Mom reports via phone on call MD dx reaction to H1N1.  Patient with hives covering entire body, itching areas.  MD on call prescribed BENADRYL 1 tsp every 6 hours.
enlargement of lymph nodes on the left neck; Slight headache; sinus drainage; morning stuffiness; enlargement of lymph nodes on the right neck; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus drainage), DYSPNOEA (morning stuffiness), LYMPHADENOPATHY (enlargement of lymph nodes on the right neck), LYMPHADENOPATHY (enlargement of lymph nodes on the left neck) and SINUS HEADACHE (Slight headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (seasonal allergies). Concomitant products included AZELASTINE for Allergy, ATORVASTATIN for Cholesterol, METOPROLOL for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced SINUS DISORDER (sinus drainage), DYSPNOEA (morning stuffiness), LYMPHADENOPATHY (enlargement of lymph nodes on the right neck) and SINUS HEADACHE (Slight headache). On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (enlargement of lymph nodes on the left neck). At the time of the report, SINUS DISORDER (sinus drainage), DYSPNOEA (morning stuffiness), LYMPHADENOPATHY (enlargement of lymph nodes on the right neck), LYMPHADENOPATHY (enlargement of lymph nodes on the left neck) and SINUS HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Z-pack (Azithromycin) as per prescribed by the Physician and Tylenol as treatment.
Fever; Chills; Nauseous around food; Body aches; Swollen lymph node underneath right arm the size of an egg; array of side effects; Dizzy; Tired; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food), MYALGIA (Body aches) and LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was reported.  Concurrent medical conditions included Allergy to antibiotic (Sulfa).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (Tired) and DIZZINESS (Light headed). On 23-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food), MYALGIA (Body aches), LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) and ADVERSE REACTION (array of side effects). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food) and LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) had resolved and MYALGIA (Body aches), DIZZINESS (Dizzy), FATIGUE (Tired), DIZZINESS (Light headed) and ADVERSE REACTION (array of side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was included water, Gatorade, Flonase.
Recieved Moderna Vaccine and  it formed blood clots in patients legs and blood system, resulted in a fall and brain bleed and hospitalization on March 13th, and in and out of Medcial facilities and Nursing home and rehab  facilities till May 5th 2021.
muscle pain; joint pain; feeling unwell; low blood pressure; tiredness; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el9265), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 83-years-old). Medical history included high blood diabetes. The patient's concomitant medications were not reported. Patient had not known allergies. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3249), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 83-years-old). Patient visited to doctor or other healthcare professional office/clinic visit for reported events. Patient had not taken any treatment for reported events. On 10Feb2021 (at 12: 00 AM), the patient experienced muscle pain, joint pain, feeling unwell, low blood pressure, and tiredness. The outcome of all the events was not recovered.  Follow-up attempts completed. No further information expected.
Approximately 3:30 FLUVIRIN given RD. 3:40 Sweating - prone. 3:50 - Pt. given juice & ice pack & prone with feet up. 4:00 Sitting - (-) sweating. 4:10 - Walked sitting (-) sweat. 4:15 - Left office with father & sister. States "I'm okay." Walked unassisted to car. 3:40 160/110 - P 48. 3:50 122/82 P 54. 4:00 146/90. 4:10 142/72 - P 50.
Rash and fever 8 days following vaccination. Fever to tmax 103. Also found to have right otitis media at the time
Stepped on cactus about 2-3 hours before 1st shot. Had increased pain in foot. Saw MD and substance removed. TD and Ig given at that time. Two days, post vax, 2nd TD, felt "pinging" feeling in chest. Then developed muscle aches on right side that progressed to neck. Experienced tightening muscle spasms to neck. Seen in ER and given Valium and Toradol. Is to follow-up with neurologist.
This spontaneous report as received from a physician via field representative refers to his/her 12 year old daughter. The patient's pertinent medical history and concurrent conditions were not reported. Approximately in 2013 (reported as almost 3 years ago), the patient was vaccinated with GARDASIL (dosing details were not reported). Concomitant medications were unknown. On an unknown date (reported as unspecified amount for time after the dose was administered), the patient experienced rash on her face and torso. The outcome of rash on her face and torso was unknown. The relatedness of the events with GARDASIL was not reported. This is one of the reports from the same reporter. Additional information has been requested.
Intermittent heart palpitations, chest pain,  left upper arm pain, dizziness, lightheadedness. This happened a  couple of times in the following 3 weeks.   Please note that this was not the first time that this has occurred. It has also happened BEFORE being vaccinated.
per PCP note, patient reports some leg weakness after having covid vaccines, feels like spine falls asleep
About 5 hours after vaccination I started to get dizzy, nauseous, lethargic, fever, uncontrollable chills, tremors, day 2 I become very ill throwing up, complete body shakes blood pressure got up to 212/91 tremors got worse, I slept about 24 hours straight. Day 2 I also started to get swollen lymph nodes under my armpit right side side of vaccination my right breast is swollen and very tender as is my whole right arm and armpit. Still having severe pain.
Case number PHEH2013US016340 is an initial spontaneous report received from a consumer (who is a pharmacist) on 31 Jul 2013. This report refers to a 39-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 111772P1) intramuscularly on an unknown date. It was mentioned that one month after receiving FLUVIRIN, on 01 Oct 2010, she experienced significant neurological issues that progressively worsened. The events first started with a drooping eyelid and later she had trouble swallowing due to swelling in her throat followed by hip,leg and arm pain. She also noticed in pictures that one month after her flu shot, her eyelid drooped compared to the pictures taken before the flu shot. The reporter stated that she could not lift her arms for months after injection and had a torn tendon. It was reported that it had been one event after another since then (unspecified). The outcome was reported that she had been in extreme pain, muscle weakness and lots of unspecified neurological symptoms since the FLUVIRIN administration, three years ago. The outcome of the other events was not reported.
I suddenly started to feel nauseated with no fever (and nothing in the way of food that would have caused it), followed by extreme chills and fatigue. I spent 20 minutes trying to get warmed up in a shower but that didn't work, and I collapsed, shivering violently. Got some help getting to bed and piling on blankets and heating pads. Shivered for over an hour until I fell asleep. Three hours later I felt fine like nothing had happened. Had no previous reaction to either vaccination.
The adverse reaction was swollen left facial gland. I did not seek treatment. I placed a warm compress on my face. I lasted for about 6 hours.
headache; tired; general feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 06May2021 as dose 2, single (Lot number: EW0172) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots" (unspecified if ongoing), notes: She also had covid before any of the Pfizer shots; "Breathing issue" (unspecified if ongoing), notes: 4 days in hospital breathing issue on oxygen supply for 3month; "Osteoporosis" (ongoing); "Thyroid" (ongoing); "high cholesterol" (ongoing); "Stomach ache" (unspecified if ongoing), notes: Protect stomachache from prednisone. Concomitant medication(s) included: ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE lot no. EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "headache", "tiredness", "general feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell".
pt recv vax & devel an inj site rxn characterized by a lump & redness;
Pt had seizure lasting approx 5 seconds. After seizure pt complained of continued dizziness and pain in the arm that vaccine was given. she remained at vaccine site for an hour or more with her husband , then they left together.
Full body hives started on 1/9/21. (About 80% coverage) Started taking Benedryl and Zyrtec before going to  Urgent Care.  I was prescribed Prednisone and to continue taking Benadryl and Zyrtec on 1/10/21.  By the evening of 1/10/21 about 80% of the hives were gone with just red blotches left.  I took another benedryl that evening.  Woke up 1/12/21 and immediately started being covered in hives again about 80% of my body.  Took Zyrtec and Prednisone.
Employee states developed rash around injection site 1 of hep B vaccine, no treatment,Hep b series discontinued per order of employee health services MD/
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 12:00 as dose 1, single (Lot number: EP6955), in right arm and on 08Apr2021 at 12:00 as dose 2, single (Lot number: ER8720) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 20May2022 at 18:00 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Primary Immune Deficiency" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: The patient started COVID 19 treatment from 15Jul2022 till 19Jul2022, lot number 2815213.
Information has been received from a physician concerning an approximately 2 month old patient, who on approximately 22-MAY-2008 was vaccinated po with ROTATEQ. It was reported on approximately 24-MAY-2008 the patient experienced prolonged diarrhea. The patient's out was reported as not recovered. Additional information has been requested.
The pt received immnizations in between 10-11 am. He states that he began "feeling bad" at 8pm with headache, weakness, dizziness, sudden chills and muscle ache. Went to the emergency room at 11pm and by morning he was feeling better. Went back to normal in 2 days.
Pt was admitted for metastatic cancer to the brain and acute respiratory failure with hypoxia on 8/3. Pt was not tested for COVID on admission. She was tested on 8/9 due to placement and was found to be positive.
Pt. received DTaP, IPV & MMR vaccines 3/9/04. Arm that DTaP was injected in became swollen & extremely red on 3/10/04 was checked in Emergency Room 3/10/04 & saw pediatrician 3/11/04. Child had no fever or other adverse problems. Child checked at health Dep. 3/12/04- Called mother 3/16/04- Swelling & redness completely gone.
During mass flu clinic for adults and children a vaccine administrator by mistake gave a child "Fluarix" which is meant for adults 18 and over.  No known adverse events.  No adverse events occured. 3-28-07.
My Son took the Johnson&Johnson vaccine on 7/30 at 2:35pm. Then was unresponsive by 8:25pm. His father performed CPR and blood was coming out of his nose and mouth. EMS, fire department came and his dad did enough until help came. He was in the ICU with blood in his lungs, the doctors did not know what was wrong with him. I explained he took the shot and had stated minutes earlier his foot was itching and then he went to sleep with gasps trying to breathe. He is still in the hospital. He knew that it was the vaccine, as soon as he was able to talk that is what he stated, the vaccine almost killed me. These are facts and he is still in the hospital, off the ventilator after two days but his breathing is off. as of today 8/2/21 he is still in the hospital. His Blood pressure is high and he is running a fever. Breathing is erratic still.
lethargic; couldn't eat; started vomiting and become worse and worse; started vomiting and become worse and worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 23Nov2021, for COVID-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 18Dec2021, outcome "unknown", described as "lethargic"; FEEDING DISORDER (non-serious) with onset 18Dec2021, outcome "unknown", described as "couldn't eat"; VOMITING (non-serious) with onset Dec2021, outcome "not recovered", CONDITION AGGRAVATED (non-serious) with onset Dec2021, outcome "unknown" and all described as "started vomiting and become worse and worse".  Additional Information: It was reported that as of right now patient has been out on an anti-nausea medication and will be seeking more help from PCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, body rash, cough x 10-12 days after MMR injection of mild to moderate severity. Fever and cough meds presented.
Fever for 48 hours. Rash with blisters on face, legs, hands and buttocks.