chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness in tongue; Numbness in lips; Dizziness; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 30Mar2021 at 16:30(at the age of 43-year-old) as a single dose for COVID-19 immunisation. The medical history was reported as no. Concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45(at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 16:45, few days after second dose, the patient experienced numbness in tongue and lips, dizziness and brain fog(fuzzy head). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of events numbness in tongue, numbness in lips, dizziness and brain fog were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
arm is very sore; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm, on 10Mar2021 at 09:30 (at the age of 39 years old) as 1st dose, single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient was not pregnant at the time of report. Concomitant medications included cyanocobalamin (VIT B12); iron; vitamin b complex (VITAMIN B); magnesium; loratadine (ALAVERT), all were taken for an unspecified indication, start and stop date were not reported, and an over the counter allergy medication. Historical vaccine included flu shot and experienced a very sore arm. The patient has no other vaccine in four weeks. On 10Mar2021 at 09:30 A.M, it was reported that the patient's arm was very sore, and no other sign occurred. She also experienced the same thing when she got the same flu shot every year. The patient did not receive a treatment for the adverse event. The patient had no COVID prior vaccination and she was not tested post-vaccination.  No Follow-up attempts are possible: No Further information is excepted.
Within 12 hours of the vaccination, I experienced shaking chills and a temp of 101.0, which spiked to 101.5 the next day.  These side effects resolved within 48 hrs post-vaccination.  I experienced no side effects at all after the 1st Pfizer vaccination.
About 2 weeks after the vaccination red rash appeared on my left side  and the gradually spread to my right side and abdomen. tried to treat with hydrocortisone cream, but it didn't help. Went to dermatologist on 10/13/21 and was diagnosed with Pityriasis rosea. The symptoms cleared completely a week after with no medical intervention. I was sick with COVID-19 back in late March 2021-early April 2021.
Patient received Paxlovid for COVID 19 Treatment; Patient received Paxlovid for COVID 19 Treatment; This is a spontaneous report received from a contactable healthcare professional (HCP) from product quality group. The reporter is the patient. A 53-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Patient did not receive other medication in 2 weeks. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. It was reported that patient received Paxlovid for COVID-19 treatment from 19May2022 to 234May2022. Outcome of the events was unknown.   Product Quality Group provided investigational results on 01Jun2022 for Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 (Lot#: FF8841): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF8841 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF8841, fill lot FF8835, and the formulated drug product lot FA9156. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Diarrhea and watery stools with colicky irritability beginning 3 days after ROTARIX. Breast fed baby. Symptoms resolved after 1-2 days.
Information has been received from a registered nurse concerning a 21 year old female patient who on 10-JUL-2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. On 12-JUL-2007 (more than 48 hours after her first vaccination), the patient became shaky, feverish and had heart palpitations and her heart was racing. It was reported that she called the paramedics but did not go to the hospital. Subsequently, the patient recovered. No product quality complaint was involved. The registered nurse considered the had heart palpitations, heart racing and being shaky to be considered other important medical events. Additional information has been requested.
Our daughter started getting fevers up to 103 degrees and then spiked to 105...we went to emergency room and then was advised that a staph infection formed inside the bloodstream that was risk of death.  We then had to spend 1 months in the hospital with continued fevers spiking to 104+ and 21 days of antibiotic treatments.  Eventually our daughter was diagnosed with neutropenia and her neutrophil count has not been able to rise over 900 since then.  1/9/09 Reviewed hospital medical records of 7/10-7/22/2008. FINAL DX: MSSA bacteremia & neutropenia Records reveal patient experienced fever, pink maculopapular rash.  Rash resolved but fever continued intermittently, decreased energy, oral intake reduced, increased irritability, SOB, vomiting, lymphadenopathy.  Seen in outlying hospital where dx w/multifocal pneumonia.  Transferred to higher level of care. ID consult done.  Tx w/IV antibiotics.  Improved & d/c to home w/PICC line for continued IV antibiotics for 21 days.  To f/u with ID & PCP & serial labs.  12/5/08 Reviewed hospital medical records of 7/6-7/10/2008. FINAL DX: Pneumonia Records reveal patient experienced worsening lethargy, fever, cough & respiratory distress x 1 week.  Admitted & tx w/IV antibiotics.  Condition worsened & was transferred to higher level of care.  12/11/08 Reviewed heme/onc medical records of 7/25-12/1/08. FINAL DX: autoimmune neutropenia, probably cyclic; anemia; s/p MSSA infection. Records reveal patient did well s/p hospitalization until late 11/08 when hospitalized x 2 days for fever & tx w/antibiotics.  Received neupogen multiple episodes for decreased neutrophils. 1/28/2010 Our daughter is still Neutropenic and still is affected. ANCA continues to cause the Neutropenia and we still feel the vaccination schedule is the primary cause.
2 weeks after taking 3rd shot developed fecal incontinence, a month after that I began to fall down, then have rapidly muscle weakness in arms and legs.  Difficulty in breathing.
Headache, Myalgia, NauseaVomiting, sweats,, HA, LOT/S Narrative: Reported symptoms and to completed testing by PCP
RN inadvertently administered the incorrect DTaP injection to the child. The child received an extra dose of polio. RN called the child's mother. Mom stated the child had redness and swelling at the injection site. Mom stated child was "fussier" than he has normally been when he has gotten his shots before. Mom gave the child TYLENOL and it seemed to help. Mom stated the child also has an ear infection, however she is aware that is not related to his shots. RN apologized to mom for the error and child's discomfort. Mom stated that it is not a problem and she understands and will return for next scheduled appointment.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of VAQTA injection (lots # K018181 exp date 04-JUN-2017, M009377 exp date 17-JUN-2017 and L015460 exp date 20-JUL-2017) (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001950: US-009507513-1612USA001951: US-009507513-1611USA009104.
Employee experienced nausea and blurred vision. Employee was given ice pack for the back of her neck.
MODERNA BIVALENT BOOSTER DOSE GIVEN INSTEAD OF MODERNA PRIMARY MONOVALENT DOSE.  OPTION IN 17 WOULD NOT ALLOW ME TO SELECT BIVALENT BOOSTER DOSE. NO ADVERSE EVENT WAS NOTICED
Pt. had rapid heart rate, I had him vagal down several times till it went down.
Patient reported one day post immunization to be experiencing extreme fatigue- unable to get out of bed for usual daily routine
Passed out; Body pains; Very dizzy; High fever for over 24 hrs; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration in left arm on 13Sep2021 at 13:00 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization in a pharmacy or drug Store. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to COVID vaccination. Prior vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient was not tested for COVID-19. The patient was passed out, felt very dizzy, had body pains and high fever for over 24 hrs on 13Sep2021 at 15:45. It was unknown if the patient received treatment for these events. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
blood clot in my lung; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 30145RA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Aorta aneurysm" (unspecified if ongoing), notes: other medical history: Aorta aneurysm. The patient took concomitant medications. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, is bivalent: False, prev dose lot number: EN6207, prev dose lot unknown: False, prev dose administration date: 13Mar2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 13Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, is bivalent: False, prev dose lot number: EN6200, prev dose lot unknown: False, prev dose administration date: 20Feb2021, prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 20Feb2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: PULMONARY THROMBOSIS (medically significant) with onset Sep2022, outcome "recovered with sequelae", described as "blood clot in my lung". The event "blood clot in my lung" required physician office visit. Therapeutic measures were taken as a result of pulmonary thrombosis. Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other medications in two weeks. The patient had no known allergies. The patient was diagnosed with a blood clot in his lung. Treatment included Eliquis medicine.
After the first injection, I got a upper chest rash but did not relate this to the vaccine.  After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
Pt recvd vax between AUG & SE92 & exp arthralgia, paresthesia, numbness of fingers, shoulder & knee pain;
Approximately 2 weeks and 3 days after second Moderna vaccine?I woke up itching?I had red raised hives on my body?-my left ear was red and warm to the touch. Rashes and hives would appear and itch on head, neck, face, arms, legs stomach. Then they would disappear and reappear in a different area of the body.  Occasionally, skin felt like it was sunburn even though it wasn?t. I took 50 mg of Benadryl Saturday, Sunday and Monday, which helped to relieve rash, hives and itching. Symptoms would immediately return when not taking Benadryl. On Monday, May 10, doctor prescribed tapering dose of  20 mg prednisone  (3 pills 3 days, 2 pills 2 days, 1 pill 3 days) I am still on this regiment.  I am on day 5 of prednisone and still experiencing smaller, break through rashes with itching on neck, back, chest, armpits, breasts, hands and feet mostly?but symptoms are lessening.  Still continue to take 50 mg of Benadryl at bedtime, when Itching seems to be worse.
DAPTACEL injection that was administered instead of Adacel with no AE; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old male patient who received 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5611BA, expiry date: 03-APR-2021) instead of Adacel via intramuscular route in the left deltoid on 18-Nov-2020 for prophylactic vaccination (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My brother in law got 1st dose of moderna vaccine and 2 days later he got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My brother in law got 1st dose of moderna vaccine and 2 days later he got Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My brother in law got 1st dose of moderna vaccine and 2 days later he got Covid). At the time of the report, COVID-19 (My brother in law got 1st dose of moderna vaccine and 2 days later he got Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
61-year-old male with history of chronic diastolic CHF, chronic lymphedema, hypertension, diabetes, hyperlipidemia, obstructive sleep apnea presented to the ER from his cardiologist office with worsening lower extremity swelling, abdominal swelling, concerns for lower extremity cellulitis.  Patient was admitted and treated with IV diuresis with improvement in his swelling.  Was empirically started on IV Ancef and infectious disease was consulted and evaluated and did not recommend any further antibiotics as lower extremity skin changes likely secondary to chronic lymphedema and improved with IV diuresis.  Patient was found to be COVID-positive but did not have any respiratory symptoms and did not require any oxygen. Decadron was started on the ER but was discontinued.  CT PE was negative for any PE on admission.  On discharge IV Lasix was just continued and was started on oral Lasix 40 mg twice daily.  Imdur 60 mg daily was reduced to 30 mg daily per cardiology recommendations.
Got COVID 19 shot on 01/11/2021. Then on 01/22/2021 when I got up at 5:00 am I was extremely dizzy. I could hardly balance myself. I am now about 90% back to pre  vaccine shot. So I had about a 24 hour extreme dizzy spell My second vaccine is due on 02/09/2021
Three hours after 2nd SHINGRIX began feeling very tired, fatigued, headache. In the night for the next two nights ran fever with chills. Took two and one half days to go away.
COVID Breakthrough-  94y.o. female who presented to the hospital on 12/22/2021 with loss of consciousness, found down by her home care nurse. EMS brought her to ED. She was awake but confused. Incidentally found to be COVID positive. Denies cough or SOB, on Room air.
Upset stomach and mild nausea for last two days, mild muscle aches over all body, tenderness at injection site.
Patient felt clammy at back of the head and back. Patient said she was in the process of being tested for MS. Patient also stated that she has Migraines She is currently on anti depressants for anxiety, cholesterol and migraine medications  No aberrations  Vitals  BP:128/73  sp02: 98% RESP: 14 HR: 90
skin irritation on the same arm as the injection site / expanding out 5" from injection site; fever; chills; tiredness; injection site soreness; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 15th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 15 hrs after receiving Shingrix, the patient experienced injection site pain, injection site irritation, fever, chills and tiredness. On an unknown date, the outcome of the injection site pain, fever, chills and tiredness were recovered/resolved and the outcome of the injection site irritation was not recovered/not resolved.   The reporter considered the injection site pain, injection site irritation, fever, chills and tiredness to be related to Shingrix.  Additional details were provided as follow: After received 2nd dose of Shingrix, the patient experienced fever, chills, tiredness, injection site soreness and skin irritation on the same arm as the injection site beginning 15 hrs after injection and continuing for 24 hrs.  Skin irritation expanding out 5 cm from injection site.  Skin irritation had not resolved 3 days post injection.  The reporter believes these symptoms were due to the injection of Shingrix. Requesting Consent to follow up.
Right posterior upper arm with redness, induration, and warmth at the injection site. 10 cm x 7 cm. Tx'd with BACTRIM DS 7 days for poss cellulitis.
prolonged pain at the injection site, the pain increased in intensity 72 hours after the vaccine was administered and is persistent after 10 days. no systemic symptoms, evaluated locally, no findings on exam.
PT rec'd incorrect dosage on 4/4/22 at dialysis clinic. This incorrect  dosage was less than the recommended dosage and the series was started  over today with the correct first dosage of 0.5mL of Moderna vaccine  per CDC's clinical considerations.
Rash on arm developed 11 days following injection.  Patient describes as "Itchy and lumpy rash"
Chills, fever of 102.5 for over three days, headaches, sharp pains all over body, cough, extreme fatigue, nausea to point of not being able to eat. Nausea, fatigue, dizziness, weakness, muscle pain has continued on. Extreme soreness of arm and arm is still swollen with red patches all over the area the shot was received.
Warm knot on my arm; Tenderness; Warm knot on my arm; Sore; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Warm knot on my arm), TENDERNESS (Tenderness), FEELING HOT (Warm knot on my arm) and MYALGIA (Sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Warm knot on my arm), TENDERNESS (Tenderness), FEELING HOT (Warm knot on my arm) and MYALGIA (Sore). At the time of the report, PERIPHERAL SWELLING (Warm knot on my arm), TENDERNESS (Tenderness), FEELING HOT (Warm knot on my arm) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication reported.