chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 2019, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received back in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The report called to inquire about Shingrix information for a person who received the first dose back in 2019.  The reporter wanted to know when should they get the second dose. The reporter stated that pharmacy told her to call us and during gathering additional AE details about the person before transfer to agency. The caller stated that let me get back with you and then caller hung up. The reporter did not provide vaccine or patient details. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's historical drugs, medical history concomitant therapies and concurrent conditions were not reported. On 25-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL lot # L043213 and expiration date 28-AUG-2017 for prophylaxis. Strength, dose, route and frequency were not provided. No adverse effects were reported and there was no product quality complaint involved.
Complained of dizziness, nausea.  Became pale, diaphoretic.  B/P 110/50, pulse 98.  Positioned in supine position with leges elevated. Symptoms subsided after 40 minutes.
Patient received the above vaccine after the "Use By" date after the vaccine was removed from the freezer.
Patient brought to ED on 12/19/04 in full arrest and could not be resuscitated. That ED notified our hospital that patient had died. Our hospital does not have further details at this time.
Child stated their arm started to hurt on the day of the injection.  Mother put ice pack on injection site.  The day after injection, the child's arm was red, swollen, and warm to the touch.  Mother marked with marker the size of the affected area, gave child Benedryl, and put a warm compress on the site.  She will assess in the morning to see if Dr. visit is warranted.
Accidental overdose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Accidental overdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021 at 9:12 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose). On 21-May-2021, ACCIDENTAL OVERDOSE (Accidental overdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-162399 (Linked Report).; Sender's Comments:  MOD-2021-162399:Patient no. 4 case linked
None from this shot.  I only checked off seeing doctor today, due to persistent cough since having Covid in September.
following inject pain radiated to elbow, wrist & shoulder; pain dwscribed as aching; unable to cont typing due to pain; @ home pain worse-aching @ shoulder & chest; some difficulty breathing from feeling sick to stomach from the pain; went;
8.6.2020 68 yrs old male presents to Urgent Care with vaccine site reaction. He got vaccine yesterday at about 5 pm, noted swelling and redness after about 3 hours. He said he has myalgia and chills. Has been using Tylenol. Denies any fever, hives, shortness of breath and chest pain   Review of Systems  Constitutional: Negative for fatigue and fever.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative.   Musculoskeletal:       Left arm swelling and redness  Neurological: Negative for dizziness and headaches.
pt recvd vax & w/in 3 days post vax pt exp arthralgia;sx were treated w/Naproxen;
palpitations worsened after 2nd dose.; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Feb2021 12:00 (Lot number: EL9266) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "Back Spasm" (unspecified if ongoing); "Sleep" (unspecified if ongoing). Concomitant medication(s) included: HAILEY 24 FE taken for contraception, start date: 2013 (ongoing); MONTELUKAST taken for hypersensitivity (ongoing); SOMA [CARISOPRODOL] taken for muscle spasms (ongoing); DOXEPINE taken for sleep disorder (ongoing); ATROVENT taken for hypersensitivity (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Note: Dose: 1st, Date (dd-Mmm-yyyy): 23Jan2021, Time (24 hr): 14:00, Anatomical Site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN5318, Patient started having heart palpitations at night after 1st dose of vaccine), administration date: 23Jan2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "heart palpitations". The following information was reported: PALPITATIONS (non-serious) with onset 2021, outcome "not recovered", described as "palpitations worsened after 2nd dose."; TACHYCARDIA (non-serious) with onset 2021, outcome "not recovered", described as "tachycardia". The events "palpitations worsened after 2nd dose." and "tachycardia" were evaluated at the physician office visit. Therapeutic measures were taken as a result of palpitations, tachycardia.  Additional information: Palpitations worsened after 2nd dose. Pt. went to PCP on 01Mar2021 for treatment, Dr. diagnosed with tachycardia due to unknown cause (Not sure if vaccine or panic attacks). Pt. has no history of anxiety or panic attacks. Heart palpitation decreased slightly in Jul2021. Pt. still has heart palpitation at night and is still taking atenolol 25 mg/Daily. Pt. also seeing endocrinologist. Pt. had no heart or anxiety problems before vaccine. Dr. not sure if heart palpitations from vaccine but pt. did not have then before vaccine also with no heart problems in history. Family Medical History relevant to AE(s) was None.  No follow-up attempts are possible. No further information is expected.
A serious spontaneous report of Bell's Palsy has been received from a physician concerning a four year-old male subsequent to FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient had a recent infection in his mouth from Herpes virus. Concomitant medications were not reported. On 24-Oct-2008, the patient received FLUMIST. The lot of the vaccine came from an Air Force base. One and a half hours after FLUMIST administration, the patient experienced Bell's Palsy with symptoms of inability to close left eye, decrease in sensation on left side of face, and an "unsymmetrical" smile. As of 28-Oct-2008, the patient showed minimal improvement. The sponsor considered Bell's Palsy to be serious important medical event. The reporting physician did not thin there was a cause and effect relationship.
Sore arm, Body aches/chills, skin hypersensitivity followed by a gradual fading of those symptoms and new symptoms emerging  including pain and swelling in lymph node of axilla with linear Petechiae rash going down inner portion of upper arm. Headache.
On April 15th I started having sharp pain at the injection sight traveling all the way down my left arm. Then a rash developed again traveling down the left arm. It was diagnosed as shingles the next day. I am fully vaccinated for shingles.
Patient received 0.2ML of reconstituted ADULT covid vaccine vial instead of 0.2ML of the pediatric covid vaccine vial.
pt recv vax 7NOV95 & immed p/vax devel tingling down arm to wrist & fingers;
Extreme joint pain/achiness over entire body; extreme fatigue; fever that ran from low grade up to 101.5; cloudy peripheral vision (cloudy vision only lasted about 30 minutes). Fever does respond some to ibuprofen, but ibuprofen does not help joint pain or achiness.
Vomiting and Diarrhea. Followed by a Fever. All symptoms lasted 6 days.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8736), in left arm, on 03Nov2021 as dose 3 (booster), single (Lot number: FH8023), in left arm, on 22Apr2022 as dose 4 (booster), single (Lot number: FKA893), in left arm and on 12Aug2022 as dose 5 (booster), single (Lot number: FP1260) at the age of 65 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYCLOSPORINE, start date: 04Jun2020, stop date: 03Sep2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Experienced symptoms on 30Aug2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (26Aug2022) negative, notes: Tested negative on 26Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Vaccine received was mentioned as Yes, There was Other medication in 2 weeks. Known allergies was mentioned as None. Other medical history was mentioned as None.
I have concerns the actual injection was not even administered.  There was no feeling of an injection at the time of administration,  no discomfort,  no normal pin prick of an injection,  no "blood dot" on the bandage,  no indication at the supposed injection site,  no afterward discomfort of any kind,  and the young girl was so nervous she dropped the retractable syringe into my vehicle at the time of the supposed injection. How do I confirm the injection was actually made!?
Narrative: COVID infection following COVID vaccine series 01/04, Pfizer, dose #1 01/25, Pfizer, dose #2 09/13 COVID swab, result: detected 09/8 pt cc: chills, cough, diarrhea, fever, headache, myalgias, sinus congestion, sore throat, exposure: unknown
There is not an option to enter in the booster shot. I received my Pfizer booster shot on 12/06/2021, Lot Number: FJ8757.   At the time I was 10 weeks pregnant, with a 07/09/22 due date. This was my first pregnancy. 24 hours post-injection, I felt terrible; muscle aches and joint pain. I did NOT take any additional medication to help with the discomfort.    On 12/10/21 I had a miscarriage.
Extreme chills, could not get warm despite layers of clothing, socks and piles of blankets, body & teeth shivering, accompanied by flu-like body aches, especially in the back and back of the neck. Shivering and chills lasted 4 hours, mild body aches next morning. Took Naproxen and felt better throughout the day.
18 year old female suffered a heart attack/swelling of the sack around the heart die to the second Pfizer vaccine. Spent two days in the hospital/cardiac wing. She is still being monitored by doctor to this day.
Sore arm for 2 days; shortness of breath; palpitations; irregular heart beat; chest pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Aug2021 10:00 (Lot number: FC3182) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "Sore arm for 2 days"; DYSPNOEA (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "shortness of breath"; PALPITATIONS (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "palpitations"; HEART RATE IRREGULAR (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "irregular heart beat"; CHEST PAIN (non-serious) with onset 02Sep2021 20:45, outcome "not recovered", described as "chest pain". The events "sore arm for 2 days", "shortness of breath", "palpitations", "irregular heart beat" and "chest pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, dyspnoea, palpitations, heart rate irregular, chest pain.  Additional Information: Patient did not take any other vaccine in four weeks prior COVID -19 vaccine. If covid prior vaccination was reported as no. Covid test post vaccination: covid test type was Unknown, covid test date was 02Sep2021, covid test result was Negative. Known allergies was reported as no. Other medical history was reported as no. Adverse event: Sore arm for 2 days, then developed shortness of breath with palpitations, 3rd night I developed irregular heartbeat, palpitations, and chest pain and it is still continuing intermittently.  No follow-up attempts are possible. No further information is expected.
Then a sudden spike in my blood sugar. It was almost 600; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: Er8727) (at 48 years old) as unknown, single for covid-19 immunisation. Medical history included Type 2 diabetes for about 10 years. But always well maintained. Concomitant medication included metformin. No problem the first 5-7 days. Then a sudden spike in patient's blood sugar. It was almost 600 on 07Apr2021 12:00. Treatment Received was IV and insulin. Patient visited Doctor and was brought to Emergency room/department or urgent care. Patient was hospitalized for 1 day. The outcome of the event was unknown. Prior to vaccination,the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
pt recvd vax & react occurred 5 days p/inject & lasted 3-4 days; pt had high pitched scream/cry & was irritable had a personality change & needed neb for resp problems;
Fever; Cervical lymph nodes swelling; Body pain; A lot of tiredness; Muscle aches; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via intramuscular route of administration in the left arm on 14Apr2021 at 16:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 17:15, next day after vaccination, the patient experienced a lot of tiredness and muscle aches. On 20Apr2021, 6 days after vaccination, the patient experienced 101.2 fever, cervical lymph nodes swelling and body pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MOTRIN) and paracetamol (TYLENOL). On 15Apr2021, the patient underwent body temperature test and the result was 101.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a lot of tiredness, muscle aches, 101.2 fever, cervical lymph nodes swelling and body pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
unable to take deep breath's; cold; fell to the floor; nausea; dizzy; passed out; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Sep2021 14:30 (Batch/Lot Number: Ff2587) (at the age of 51 years old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included celiacs, primary biliary cirrhosis, lupus, Sjogren's syndrome and allergy: gluten. Concomitant medication included ibuprofen (IBUP) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine taken for an unspecified indication, start and stop date were not reported; Tyl; and Ursodial gabe. The patient previously received BNT162B2 in left arm on 27Aug2021 15:00 (lot number Ff2588) dose 1 for COVID-19 immunisation. The first dose was ok however she did have more dizzy spells than she normally do. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose approximately 8 hours later she was experiencing nausea and very dizzy. On 17Sep2021 (time reported as 12:00), the patient experienced passed out, nausea and dizzy. On 18Sep2021 07:30, patient had cold and fell to the floor. On 19Sep2021 14:30, patient was unable to take deep breath's. At 17 hours post vaccine, she passed out cold (as reported) and fell to the floor for approximately 1 minute. She did not go to the ER because she hate it, but called the pharmacy and was told that fainting can happen. She was told to go to ER if it happens again. She was at 48 plus hours post vaccine and she felt like she was unable to take deep breath's, still very dizzy. She will call the doctor tomorrow to be seen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no treatment for the events. The report is serious - medically significant. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Week, wheezing, cough.  low O2 saturations admitted to the hospital where he later died
This spontaneous report was received from a nurse via a company representative refers to a 12 years old female patient with no drug reaction/allergies. On 15-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot# H021346, expiration date: 01-OCT-2015) of series of three intramuscular (dose unspecified) at unspecified location, a dose of VARIVAX (Merck) (lot# unspecified), unspecified route and dose at unspecified location, a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown) during the routine check up. On 15-JUL-2013, the patient experienced syncope while receiving the first dose of GARDASIL. The nurse reported that she lied the patient down after the patient experienced syncope, and it took the 15 seconds for the patient to wake up. The patient had sought medical attention, the patient was in the doctor's office when the adverse reaction happened. No treatment was given. None lab diagnostics studies was performed. On 15-JUL-2013, the patient recovered from syncope. Additional information has been requested.
Significant redness and swelling with discomfort throughout upper arm (from shoulder to elbow) surrounding injection site. Lasted 5 days. Treated with antihistamine.
Large urticarial area at site of Prevnar #1 and DTAP/HIB. No previous reaction to DTAP.
7 days post vaccine, under arm pain in lymph nodes, sudden cramping/muscle spasms and pain from shoulder to elbow.
Patient reported feeling fatigued and having visible moderate rash on stomach and back the day following her vaccinations.
four hours after vaccination with Shingrix , pt developed shivers, fever, and aches. Symptoms persisted for 4 days.
Swollen arm after Tdap vaccine given on 3/16/09. Small amount of redness noted after injection. About 3/19/09 employee noted increase redness, swelling and itching. Employee treated with Clindamycin 300mg PO q8h x 7 days.
shock like state, turned blue, stopped breathing; paramedics administered 02 & recovered spontaneously; observed ER 1 hr; given APAP & had fever all evening; was not measured;
Injection was at 4:30/pm on January 26.  January 27, 2021 I woke at 4:15/am with  a major headache which lasted  for approximately 15 hours.    January 29, 2021 woke with swollen and sore lymph node under right armpit.
Patient reported a pruritic large (8 x 9 cm) rash on the arm she received the vaccine.
-Bigenimy (sporadic, often lasting a few hours), 6/-17 to present. Went to ER 7/27 for it, prescribed beta blockers and given holter monitor for 48 hours, awaiting cardiologist appt. -Chest tightness/difficulty breathing, not often during the heart issues but on its own- As if enough air isn't getting in and I have to take a big breath. My NP said it sounded like air was actually getting "stuck" coming out. Levalbuterol inhaler as needed but does not really change anything, awaiting pulmonologist referral
His arm became swollen, red and warm.  Mother brought child to the doctor with a fever (we have attempted to contact the mother weekly for further information and have been unsuccessful.
Swollen red left arm about 5 inches long by 3 inches wide. Reported by grandmother 3/29/05 by phone and brought in by mom 4/1/05 to be checked.
Started about 24 hours after shot. Full body rash and a little difficulty breathing/tightness. I get these type of reactions often with vaccines but this was more on the severe end. It lasted about four days. I didn?t take any medication?s to treat it; usually antihistamines etc. make it worse so I just had to ride it out. I had no other typical moderna side effects other than a little arm soreness the first 24 hours. When I took shot number one I had no side effects other than a little arm soreness the first 24 hours and I received that shot in the same left arm.