chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient administered with dose of 0.25 mL instead of 0.50 mL of  bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with dose of 0.25 mL instead of 0.50 mL of  bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with dose of 0.25 mL instead of 0.50 mL of  bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with dose of 0.25 mL instead of 0.50 mL of  bivalent booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with dose of 0.25 mL instead of 0.50 mL of  bivalent booster).    No concomitant medications were reported.  Reporter mentioned that no AEs were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662377, US-MODERNATX, INC.-MOD-2022-662382, US-MODERNATX, INC.-MOD-2022-662383, US-MODERNATX, INC.-MOD-2022-662384, US-MODERNATX, INC.-MOD-2022-662386, US-MODERNATX, INC.-MOD-2022-662387, US-MODERNATX, INC.-MOD-2022-662388, US-MODERNATX, INC.-MOD-2022-662389, US-MODERNATX, INC.-MOD-2022-662390 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662391:same reporter US-MODERNATX, INC.-MOD-2022-662377:same reporter US-MODERNATX, INC.-MOD-2022-662382:same reporter US-MODERNATX, INC.-MOD-2022-662383:Same reporter US-MODERNATX, INC.-MOD-2022-662384:Same reporter US-MODERNATX, INC.-MOD-2022-662386:Same reporter US-MODERNATX, INC.-MOD-2022-662387:Same reporter US-MODERNATX, INC.-MOD-2022-662388:Same reporter US-MODERNATX, INC.-MOD-2022-662389:Same reporter US-MODERNATX, INC.-MOD-2022-662390:Same reporter
Encephalitis; Losing ability to hear; Dementia like symptoms; Loss of Mobility; Urinary incontinence; Having trouble walking; Having trouble talking; This is a spontaneous report from a non-contactable consumer (patient daughter). An unspecified age male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The medical history and concomitant medications were not reported. The patient was in the hospital after getting Encephalitis, which she stated was resulting from the Pfizer COVID vaccine.  The patient also had multiple negative responses from the vaccine.  The reporter would like to know if there was an antidote for the vaccine.  The reporter did not think it was the vaccine that caused this,  but his doctors did.  The patient was also having loss of mobility and tested negative for Coronavirus.  The patient was losing the ability to hear, having urinary incontinence, and was having trouble walking and talking.  Also reports dementia like symptoms that came on after the vaccine. The CDC had already shown up in his hospital room and had been asking questions.  The reporter did not want his private medication information put out there.  The reporter did not wish to create a report and requested to be transferred to have her question answered.  The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
A small localized reaction (small than a dollar bill) with a redness around the injection site; A small localized reaction (small than a dollar bill) with a redness around the injection site; The vaccine was not administered via IM; This spontaneous case was received on 17-Oct-2022 from other healthcare professional (nurse) via agency (reference number: SEQW22-04563) and concerned a 59-year-old, female patient.  The patient's concurrent conditions included blood pressure and cholesterol. The patient's concomitant medications included unspecified blood pressure and cholesterol pills.  On 10-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. As reported, the nurse reported that she clearly saw that the vaccine was not administered intramuscularly (IM) (explicitly coded as 'Inappropriate route of vaccination') for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving the Flucelvax Quadrivalent, the patient experienced a small, localized reaction (small than a dollar bill) with a redness around the injection site.  On 14-Oct-2022, the patient recovered from the events of 'local reaction' and 'vaccination site erythema'.   The reporter did not provide a causality assessment.     The case was assessed as non-serious.  Company comment: A 59-year-old female patient was vaccinated with Flucelvax Quadrivalent. The vaccine was not administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed local reaction and vaccination site erythema. Inappropriate route of vaccination is assessed as not related per company's conventions. Causality for other events is assessed as possibly related due to biological and chronological plausibility.; Sender's Comments: A 59-year-old female patient was vaccinated with Flucelvax Quadrivalent. The vaccine was not administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed local reaction and vaccination site erythema. Inappropriate route of vaccination is assessed as not related per company's conventions. Causality for other events is assessed as possibly related due to biological and chronological plausibility.
This spontaneous report was received from a physician via company representative to a 74 year old male patient. On 25-SEP-2013, the patient was vaccinated with ZOSTAVAX lot # H013938, subcutaneous as directed. Concomitant medication included AFLURIA. On 05-NOV-2013, 42 days after onset of therapy, the patient experienced pain in his right thigh. On an unknown date in November 2013, the patient was seen in the ER and was diagnosed with shingles. On 18-NOV-2013, the patient sought medical attention and visited the office for treatment. The patient was treated with VOLTAREN Gel, acyclovir, LYRICA and CYMBALTA. The patient had multiple follow up visits on 18-DEC-2013 and on 22-JAN-2014 to proceed with the treatment. The outcome of the event shingles was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Shortness of breath; she hasn't felt well ever since she received her first dose; This is a spontaneous report from a contactable consumer reported for herself. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration, administered in arm right on 27Jan2021 12:00 as dose 1, single (age at vaccination: 69 years) for COVID-19 immunisation. Medical history included vitamin from an unknown date and unknown if ongoing. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) 500 to 1000 mg, through the year taken for vitamin supplementation, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX COX) through the year taken for vitamin supplementation, start and stop date were not reported; fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3) taken for vitamin supplementation, start and stop date were not reported. He drank cup of herbal tea this before vaccine. On 27Jan2021, the patient experienced shortness of breath. Patient had a bad experience with the first shot reporting that 3 minutes after receiving the first shot breathing changed and did not feel right and it lasted for 11 days. She has not felt well ever since she received her first dose. She spoke with her doctor who she reports said its up to you and he did not guide her in one direction or the other. She calls now to ask if she should get the second dose. Caller reports that she missed her second dose, but the facility called her to get her rescheduled for the second dose tomorrow, 02Mar2021 and she is scared to get it stating that I have not responded to them because I dont know what to do and asked will the first shot protect me. Pfizer COVID-19 Vaccine dosage temporarily discontinued. She asked if there was something else, she should take instead of the second dose of Pfizer COVID-19 Vaccine and if you are supposed to get the Pfizer COVID-19 Vaccine injections in the left or right arm. She did not had any emergency room visit or hospitalization related to this event. She did had a physicians office visit due to this event. The patient underwent lab tests and procedures which included chest x-ray resulted as ok on an unspecified date thinks they said it was ok, 3 weeks ago. The clinical outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
chill-paged PCP and was told that pt has to take tylenol if fever developed
Left thigh very swollen, very red, very hot to touch.  Swollen from knee to groin.  Nurse practitioner looked at leg.  Advised cold compresses and motrin, continue to monitor.  No shortness of breath.
p/ pt recv vax subsequently devel herpes zoster, w/clusters of vesicles on left side of body. rash described very strange & unusual. lesions were purplish in color, pt had itching. treated w/calamine, aveeno. This is in follow-up to report (s) previously submitted on 05/14/1999. Information has been received from a health care porfesional concerning a 4 year old female patient who on 05-Jun-1998 was vaccinated with the first dose of VARIVAX. 0.5 ml in the left arm. Subsequently the patient developed herpes roster, with clusters of vesicles on the left arm, left hand and left side. As of 05-Aug-1998 the patient had no new lesions. On 06-Aug-1998 the patient presented for a follow up visit. The rash was described as "very strange and unusual". The patient had a "big vesicle" on her palm, and several additional clusters of vesicles on the inside of her arm extending to the elbow. Once the clusters reached the elbow area, the line of clusters began to wrap around the arm, and wre located on the back side of the upper arm. The patient also had some dry lesions on the left side of her neck and lower back. She indicated that there were "dry ptaches" around most of the vesicular clusters; however the reporter was unable to lift any acaba from these areas. The lesions were "purplish" in color. The patient had itching, but no pain, and was afebril. The patient's mother thought that her daughter had poison ivy and treated her with WESTCORT and AVEENO. On 06-Aug-1998 a sample was obtained from avesicular lesion for PCR analysis. The results of the speciment revealed the OKA/MERCK vaccine strain virus. Subsequnetly, the child recovered fully. No further information is available.
about 6 hours after vaccination with both flu and covid vaccines, experienced fever, chills, nausea, palpitations, dizziness, light headedness, joint and muscle pain generalized (not just local to injection sites), fatigue.  very severe and should have gone to urgent care for my palpitations but did not.   severe symptoms as described above, lasted for about 36 hours, dizziness and light headedness and nausea lasted addition 24 plus hours, still occurring 72 hours after vaccinated
pt hosp w/sx severe hair loss; cardiac problems; skin rash; joint pain; muscle spasms; splenomegaly; inflamed liver. Annual FU indicates pt has developed pulmonary problems, autoimmune hepatitis and continues to take immunosuppressants and steroids on a daily basis.
Menveo reconstitution with regular diluent; Menveo reconstitution with regular diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The health care professional reported that the patient received a dose of Menveo vaccine reconstituted with regular diluent and not the one provided by GlaxoSmithKline. The reporter did not consent to follow up. Additional supportive information: The health care professional reported that the patient received a dose of Menveo vaccine reconstituted with regular diluent and not the one provided by GlaxoSmithKline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Pt developed a pimple-like, non-pruritic, red rash over shoulder blades, both sides of abdomen, both legs and arms. It started 5 days post vax. Mother advised to call PMD, but she did not. She used topical Benadryl for rash and stated pt was fine. Mother encouraged to call PMD for further instructions. No further info obtained. Parent did not return calls.
Bump progressively getting bigger every day, looks red, hurts a little bit - on exam: L upper arm with approx 2 cm indurated area 1cm redness overlying, slightly ttp, also with yellow bruise surrounding area, no streaking  - TX: Cool compresses, MOTRIN, gentle cleansing BID, KEFLEX 750 Mg Oral Capsule Take 1 capsule po bid x 10 days.
Child had inadvertent contact with his father who had just been vaccinated for smallpox.  The patient was not vaccinated, but had developed a rash on both hands consistent with smallpox vaccine reaction.  Rash was mostly resolved by time of appointment.
noticed a metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 33-years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in left arm on 24Mar2021 at 11:45 (at the age of 33-years old) as a single dose for COVID-19 immunisation and took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 30Apr2021 at 19:00, 2 weeks after second dose, the patient experienced metallic taste in her mouth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Weakness; Vomiting; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Weakness), VOMITING (Vomiting) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products LENVATINIB MESILATE (LENVIMA) for Colon cancer and PEMBROLIZUMAB (KEYTRUDA) for Colon cancer.    Concurrent medical conditions included Colon cancer metastatic (with liver metastases).   On 12-Feb-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 mg and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) 200 mg. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VOMITING (Vomiting) and HEADACHE (headache). On an unknown date, the patient experienced ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness), VOMITING (Vomiting) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients Treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNII
Week long severe headache.  Large, itchy red spot at injection spot appeared week later.  Still have a headache at the time of this entry.  Nothing is making headache go away.
Patient developed 7 cm erythematous patch at injection site (right thigh) of DTAP and IPV. Indurated and warm with mild bruising. No fever, able to walk and move leg freely. Treated with KEFLEX for mild cellulitis as not improved at day 3.
Initial report received on 04 June 2007 from a health care professional.  A 53-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date.  On an unspecified date post-immunization, the patient experienced a metallic taste in her mouth.  Medications included Claritin, "pseudopherine", and bio-identical hormone replacement.  No further follow-up was required after the vaccination.  At the time of this report, recovery status was not reported.  Follow-up information received on 30 July 2007 from a health care professional.  The date of vaccination was 30 October 2006, and the adverse event onset was 30 October 2006, four hours post-immunization.  The Fluzone lot number was U2193AA, and Fluzone was administered intramuscularly in the left deltoid.  Per the reporter, the duration of the event was 36-40 hours, and the patient recovered.  The reporter in this case is the same as in cases 2006-02707 and 2007-02049.
Pt received 1.0ml of influenza vaccine. Progress call to parent on 9/19/14 - no fever and no sore arm, redness or swelling at site.
Workup significant for acute respiratory failure with hypoxia, COVID-19 infection, increased anion gap metabolic acidosis, left lower lobe pneumonia noted on chest x-ray, soft blood pressures responsive to IV fluid hydration all present on admission.     -admit, inpatient -Rocephin and azithromycin for antibiotic coverage for community-acquired/lobar pneumonia  -IV fluid hydration  -systemic steroids initiated -Lovenox for anticoagulation  -patient is stable on 2 L oxygen via nasal cannula.  Wean as tolerated -remdesivir  -p.r.n. bronchodilators
Patient reported to pharmacy to get 2nd dose of pfizer vaccine, showing pharmacy staff his left arm, rash down to wrist, red and white postules stating it showed up after first dose and has not disappeared, pt was advsd to speak with doctor to determine if second dose should be administered due to allergic reaction resulting in chronic rash for 2+ months since original shot reported
first 2 days after vaccination - soreness and weakness to left arm, then symptoms progressed to extreme fatigue and covid-like symptoms on 10/8 lost the ability to walk, unable to hold herself up on her legs - came into the hospital from 10/10-10/14 and discharged to a skilled nursing facility for rehabilitation. Increasing AMS and involuntary muscular movements - came back to hospital on 10/21, continues to have intermittent confusion, spasticity/involuntary movement to bilateral upper and lower extremities, episodes of diaphoresis and cool clammy skin, bilateral hands are cold and slightly discolored, patient states she feels like electricity is coursing through her arms and legs, feels like she's being shocked.
got so sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got so sick".  Additional information: She was calling because her daughter who has a rare blood type or disease was forced for get the Covid-19 vaccine; had the 1st shot and she got so sick (date was not specified) and is scheduled to get the 2nd dose on the 18Feb2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications: birth control from 01Oct2022 to 20Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Oct2022) Positive, notes: Positive test. Therapeutic measures taken because of the events included PAXLOVID from 20Oct2022 to 24Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning an adult male. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.