chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced bilateral pulmonary embolism two days after receiving the BNT 162 Covid vaccine.; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bilateral pulmonary embolism (PE) two days after receiving the BNT 162 Covid vaccine. Patient was hospitalized (dates unknown) and treated for his bilateral PEs and was currently home recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Current information is limited and does not allow full medical assessment.  The patient's relevant medical history and concomitant medications are not reported.  Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
From initial information received on June 27 2005 from a health care professional regarding an adverse event, it was reported that an 11 year old male patient received a dose Decavac vaccine, lot number U1370BA, administered in the right arm at 2:50pm on June 23 2005. Ten minutes later the patient felt faint and his legs became stiff. It was not reported if the patient required any treatment, Reportedly the patient recovered from this event. The reporter of this case is the same reporter of cases: 200501235, 200501237, 200501238, 200501239 and 200501240.
Throat is very scratchy; Headache; Diarrhea; Bright red rash from shoulder to elbow/rash on other arm in patches; Swollen with pain; Itchy, itching from back of shoulder to back; Swollen with pain; Very burning; Bright red rash from shoulder to elbow/rash on other arm in patches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Bright red rash from shoulder to elbow/rash on other arm in patches), SWELLING (Swollen with pain), PRURITUS (Itchy, itching from back of shoulder to back), DIARRHOEA (Diarrhea) and OROPHARYNGEAL DISCOMFORT (Throat is very scratchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Seasonal allergy since 10-May-2021.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced RASH ERYTHEMATOUS (Bright red rash from shoulder to elbow/rash on other arm in patches), SWELLING (Swollen with pain), PRURITUS (Itchy, itching from back of shoulder to back), PAIN (Swollen with pain), SKIN BURNING SENSATION (Very burning) and RASH (Bright red rash from shoulder to elbow/rash on other arm in patches). On 08-May-2021, the patient experienced DIARRHOEA (Diarrhea). On 09-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat is very scratchy) and HEADACHE (Headache). On 09-May-2021, DIARRHOEA (Diarrhea) and HEADACHE (Headache) had resolved. At the time of the report, RASH ERYTHEMATOUS (Bright red rash from shoulder to elbow/rash on other arm in patches), SWELLING (Swollen with pain), PRURITUS (Itchy, itching from back of shoulder to back), OROPHARYNGEAL DISCOMFORT (Throat is very scratchy), PAIN (Swollen with pain), SKIN BURNING SENSATION (Very burning) and RASH (Bright red rash from shoulder to elbow/rash on other arm in patches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant details were not provided. Treatment details include Cooling Cream.   This case was linked to MOD-2021-213523 (Patient Link).
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-May-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications  were reported.   This case was linked to MOD-2021-222173 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information was received contains No new information
Muscle and joint aches (low back, hips, thighs, shoulders, neck), headache, irritability, malaise
Sore shoulder; metal taste in mouth; tiredness; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 7-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, the patient experienced sore shoulder, metal taste in mouth, and tiredness lasting about a day after the second COVID shot. The outcome of all the events was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
diarrhea; chest tightness; shakiness; dizziness; vertigo; chills; aches; fever; vomiting; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), DIZZINESS (dizziness) and VERTIGO (vertigo) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), DIZZINESS (dizziness), VERTIGO (vertigo), CHILLS (chills), MYALGIA (aches), PYREXIA (fever), VOMITING (vomiting) and ARTHRALGIA (joint pain). At the time of the report, DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), VERTIGO (vertigo), CHILLS (chills), MYALGIA (aches), PYREXIA (fever), VOMITING (vomiting) and ARTHRALGIA (joint pain) had resolved and DIZZINESS (dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Pt recv vax on10/9/97; 1 hr later pt exp achiness, leg pain; 10/10/97 unable to walk; dx=bilateral hip pain, decreased mobility, arthralgia, myalgia; tx=Motrin.
Within 4-6 hours, post vax, child became irritable and mother noticed a red macular rash from head/face to feet. Upon office visit, rash had already dissipated to about 75% gone.
Two people died after taking the vaccine because of metal in the vials; Product contamination metal; Poor quality product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Two people died after taking the vaccine because of metal in the vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Two people died after taking the vaccine because of metal in the vials) (seriousness criteria death and medically significant), PRODUCT CONTAMINATION PHYSICAL (Product contamination metal) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). The patient died on an unknown date. The reported cause of death was two people died after taking the vaccine because of metal in the vials. It is unknown if an autopsy was performed. At the time of death, PRODUCT CONTAMINATION PHYSICAL (Product contamination metal) outcome was unknown and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved.            Concomitant product use was not provided by the reporter.   The patient was clearly venting his frustration. The patient also states that two people died after taking the vaccine  because of metal in the vials.  No treatment information was provided.  Company Comment: Very limited information regarding this events has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-307513 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Two people died after taking the vaccine because of metal in the vials
Information has been received from a physician concerning a 11 year old male who on 27-MAY-1997 and 09-OCT-2007 was vaccinated SC with a first and second (lot number: 658375/1118U) dose of VARIVAX. Subsequently, the patient developed a severe case of chicken pox and was hospitalized. The case of chicken pox was considered to be disabling. No additional information. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a female nurse (Certified Diabetes Educator (C.D.E)) of unknown age refers to herself. On an unknown date the nurse was vaccinated with a dose of ZOSTAVAX she had significant swelling and local injection site reaction that required antibiotics for treatment. The nurse reported it did completely resolve. The nurse did report a relatively significant even there. She also had difficulty with a tetanus vaccination. The outcome of "had difficulty with a tetanus vaccination" was unknown. Additional information has been requested.
fever, diarrhea, nausea, chills. called in sick to work 2 days.
Initial report received from the nurse on 28 Oct 2010: This patient was vaccinated with both FLUVIRIN (lot number 111625A05) suspension, intramuscularly and MENVEO (batch number unknown) on 20 Oct 2010. The patient experienced the event inappropriate age at vaccine administration. No adverse event other than this was reported. The outcome of event was not reported.
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant medication not reported. Dose 1, dose 2, dose 3 were administered on unknown date by route intramuscular and on deltoid. Dose 4 administered by 3:16 PM with dose 0.5. Treatment medication not reported.
Continuous irritation and redness of left eye along with excessive tearing/watering of left eye.  Initially treated for traditional  conjunctivitis, however, treatment has not been effective.  Concerned vaccine has caused permanent damage to my eye.
Flu-like symptoms, chills, nausea, headache, redness and swelling to right arm. IV with Rocephin IM test dose then Rocephin, Motrin 800mg. Dx'd with encephalitis due to DPT, local reaction in right arm to Hep-B vaccine.
Extreme swelling at sight, leg cramps, neck muscle weakness. Pt was told to see MD.
pt experienced flushing in face, neck, spreading down chest approx 45 min after vax.  Reports no difficulty breathing, hives, or swelling.  Pt was already at home.  Advised to take an antihistamine and f/u with provider or urgent care to see if they want her to come in for follow up care.
Pt is a 25 yo male who denied any previous problems with immunizations. On 04 Oct 2013 he was vaccinated with inactivated influenza vaccine. He denied any immediate problems. Ten days after vaccination he reported the onset of intermittent headaches and sought medical evaluation on 21 Oct. Headaches persisted and he began to note increasing vision loss. Ophthalmology exam on 24 Oct noted bilateral disc edema concerning for optic neuritis. He was admitted and received IV steroids and was discharged on a tapering dose of oral steroids. MS and Infection was ruled out. DX: bilateral optic papillitis.
hives head to toe,wheezing,eyes swelling shut,0.1mg Epi given SQ,1 teas. benadryl,0.5cc NS albuteral nebulizer-20 mins. 0.63 xopenex nebulizer still has hives,redness, swelling decreasing, child playful,sent home after 2 hrs. 2/6/04 f/u-still some swelling, treating with benadryl at home.Rec:allergy testing. The medical record received on 2/19/04 states anaphylaxis.
Patient right arm very sore & painful. Received pneumococcal vaccine 9/19/11. Taking APAP for pain.
arm became swollen; swollen area is hard; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd September 2021, 1 days after receiving Shingrix, the patient experienced swelling arm and induration. On an unknown date, the outcome of the swelling arm and induration were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and induration to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received the dose of Shingrix and one day after the vaccination the patient's arm became swollen and the swollen area was hard. The patient stated that, her arm was still swollen at the time of reporting. The reporter did not consent to follow up.
4/5 - Fever and chills started also severe headache.  4/8 eyes started to burn, blurry vision numbness in extremities.
about 45 minutes after I received the Pfizer booster (3rd dose), I feeling dizzy like walking during the earthquake.  satrted high fever 102-104 F the same night with nausea, bodyache, headache all continued for 3-4 days that I cannot eat anything and just lethargy and sleep.  the 5th days after the vaccine, no more fever.  Therefore, I went in to work.  Not even half day through, I started feeling dizzy, memory lapse.  I went home early that afternoon and did not complete my shift.  Then, I called my PCP and got a telephone appointment with Dr. on 09/30/2021.  I took tylenol during my fever days for temperature control.  I return to work on the next Monday (10/04/2021) on full capacity.  The memory lapse almost completely gone now.
Pt presented to health center today with redness and itching to left deltoid. Pt states painful at first then itchy. Better today. Cetirizine 10 mg tablet administered to pt.
Felt very nauseous; Low fever; Left arm was painful in large area of bicep for 24 hours; Left armpit lymph node swelled up for 3-4 days; Had 2 inch red area on left arm a few inches from vaccine injection point.; Area was warm and firm, created pain; Area was warm and firm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 16:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications included ethinylestradiol; norethisterone acetate (JUNEL) for birth control from unknown start date, cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL) for unknown indications from unknown start dates and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 36-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 of vaccination. On 08Apr2021 at 08:00, the patient had felt very nauseous, had a low fever for 36 hours, left arm was painful in large area of bicep for 24 hours. Left armpit lymph node swelled up for 3-4 days. Area was warm and firm, created pain. He had a 2-inch red area on left arm a few inches from vaccine injection point. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events low fever was recovered on 09Apr2021 after the duration of 36 hours and left arm painful was recovered on 09Apr2021 after the duration of 24 hours. The clinical outcome of the events felt very nauseous, left armpit lymph node swelled up, area was warm and firm, created pain and 2-inch red area on left arm a few inches from vaccine site was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2011US02107 is an initial spontaneous report received from a consumer on 19 Aug 2011. This report refers to an 18 years old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: X10034) intramuscularly on 11 Aug 2011. No other adverse reaction was reported.
Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Sudden onset ear congestion both ears accompanied by minor ringing in right ear and feeling off-balance at 11am on 06 DEC 2021. Right ear more impacted than left. Symptoms did not resolve by end of the day despite taking 200mg Advil sinus congestion pill.   Note, during injection, a vessel was hit and there was bleeding followed by a 1" diameter black and blue bruise at site. Entire left arm was sore for 48 hours. At time this event is being reported only the bruised area is sore.
This was a new nurse that was hired. She told me she received Pfizer at previous employer but did not have card with her. She requested a dose of Pfizer at the end of our clinic so as not to waste. When she got home and pulled her vaccine card out she realized she had received Moderna from previous employment. She had no adverse side effects or reactions.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981: