chrisvoncsefalvay/vaers-outcomes huggingface dataset:
we end up giving the shingles to ourselves/ suspected vaccination failure; We end up giving the shingles to ourselves; Had a rash then; Still having burning in my back and face; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster Shingles vaccine.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In January 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, rash and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and burning sensation to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. After receiving 2nd dose of shingles vaccine, 2 months before the date of reporting, the patient had a rash then and still having burning in back and face. The patient was taking all kinds of medicine too. The patient stated what a big mistake the patient made here was that the patient thought that the vaccine was going to protect from the shingles and end up giving the shingles to the patient. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. This case has been linked with the case US2021AMR063255, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063255:Same reporter.
Body aches, headaches, cough, sneeze, chills and diarrhea.
3hr p/vax pt had a clonic like sx witnessed by parents only;then had another sz w/tonic/clonic activity lasting approx 45sec per parent;MD office called & advised observation @ home;
Developed hard reddened lump at injection site with soreness, size of nickel. Duration 1 week.
44 year old patient had a lot of vaginal bleeding, red, bright color for approximately 3-5 minutes after getting the vaccine. Patient reports bleeding for 2 days and went away. Patient refers not having pain or visiting her doctor. Patient refers visiting her Rheumatologist who recommended second dose.
doesn't feel the same anymore/ feels off; a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off; legs went numb/feet went numb; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (doesn't feel the same anymore/ feels off), DYSGEUSIA (a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off) and HYPOAESTHESIA (legs went numb/feet went numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, CD9D21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Drug allergy.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 16-Feb-2022, the patient experienced DYSGEUSIA (a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off). 16-Feb-2022, the patient experienced HYPOAESTHESIA (legs went numb/feet went numb). On an unknown date, the patient experienced FEELING ABNORMAL (doesn't feel the same anymore/ feels off). The patient was treated with IBUPROFEN at a dose of 1 dosage form once a day and PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form once a day. At the time of the report, FEELING ABNORMAL (doesn't feel the same anymore/ feels off) and HYPOAESTHESIA (legs went numb/feet went numb) outcome was unknown and DYSGEUSIA (a very distinct taste in her mouth/chemical taste/metallic taste/faded away over the next few days/very off) had resolved.            No concomitant medication were provided.   Patient reported that she had her wisdom teeth out in high school and was healthy prior to getting the Moderna vaccines.  No treatment medication were provided.   This case was linked to MOD-2022-508581, MOD-2022-508700 (Patient Link).   Reporter did not allow further contact
Headache, Myalgia, Fever,  painful lump in armpit on injection side  Narrative:
High anxiety, tachycardia, hypertension, chest tightness. BPs 103/61 (Pulse 154), 152/82 (pulse 109).
Recieved a dose of Moderna and then a dose of purple cap Pfizer; No Adverse Event; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer) and NO ADVERSE EVENT (No Adverse Event) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INTERCHANGE OF VACCINE PRODUCTS (Recieved a dose of Moderna and then a dose of purple cap Pfizer).    No concomitant medication provided. No treatment information mentioned.  Patient took Moderna first and then purple cap Pfizer dose.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
5m developed HA, dizziness, decreased concentration within hours of receiving vaccine. 6days later developed numbness along backs of both hands. Seen by neurologist. To ? MRI. Medical temporary exception for immunizations until after neurological evaluation and recommendations.
Guillain-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment product was not provided by the reporter.  Company comment: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.; Sender's Comments: 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.
Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 29-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: E28982), via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:15 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. Medical history included atopic dermatitis, anxiety, OCPD (Obsessive-compulsive personality disorder), Known allergies: Nickel, Known allergies: Grass/trees from an unknown date and unknown if ongoing. Concomitant medications included sertraline (SERTRALINE), dupilumab (DUPILUMAB), ethinylestradiol, levonorgestrel (AVIANE), ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: E13302) via an unspecified route of administration, administered in Arm Left on 21Jan2021 10:30 AM (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced massive headache/migraine, tiredness, apathy, body aches on 11Feb2021 14:00. The outcome of the events was reported as not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
A 26 year old male received his first anthrax immunization in his right arm with no adverse effect. Two weeks later he received the second immunization in the deltoid area of his left arm. He developed a small lump and mild soreness at the injection site and 10 days later noticed a rash distal to the injection site on his left arm. Four weeks after the immunization, he received a third injection; this time in his right arm. No lump developed but he complained of transient muscle soreness and a similar rash that developed after 3 days at the site distal to the injection on his right arm. He did not complain of pruritus or any systematic symptoms. He was evaluated by dermatology after this second eruption. On physical examination was a pink annular scaly plaque 3.5 X 4.0 cm (Fig. 1). This was KOH negative. A 4-mm punch biospy was performed from the leading edge of this lesion. The microscopic diagnosis revealed focal spongiotic dermatitis. He had similar resolving eruption on his left arm from his second immunization. (Fig. 2). He was given 0.05% halobetasol proprionate ointment to apply twice a day and the lesions resolved within days. He was administered an Allergen Thin-layer Rapid Use Epicutaneous Test and demonstrated no reaction to formaldehyde. Upon referral to the allergist, the patient was given a prick test to which he reacted with 10 mm of induration and 30 mm of erythema to the histamine positive control. He did not react to water-negative control. He was injected with full- strength anthrax vaccine and a 1:100 and 1:10 dilution. He displayed no immediate response (read at 18 and 31 minutes). On follow-up examination at 48 hours, he displayed 15 mm of induration and 40mm of erythema to the full-strength anthrax vaccine. The preceding allergy testing strongly suggests a delayed-type hypersensitivity reaction to anthrax vaccine. The patient complained of a similar pink annular eruption on his right hip developing 10 days after the anthrax prick test. He did not seek medical attention for this eruption and it resolved after several days of of treatment with 0.05% halobetasol proprionate ointment. On follow-up examination several weeks later, there was a small annular area of postinflammatory hyperpigmentation on the right hip. The patient was given a medical exemption from the anthrax immunization program and he suffered no further sequela.
A dose of Pediarix that was exposed to a temperature of -0.5°C for 23 minutes was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: A dose of Pediarix that was exposed to a temperature of -0.5°C for 23 minutes was administered to a patient.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date-31-OCT-2023 The healthcare provider called to inform that earlier on the day pf reporting, a dose of Pediarix that was exposed to a temperature of minus 0.5 degree C for 23 minutes was administered to a patient, which led to incorrect storage of error. Did not consent to follow-up.
On 10/1/22   Nurse observed resident struggling to breathe O2 sat 89% O2 was applied via n/c at 2L/mt. Resident was also disoriented. Vital signs BP 104/91, Pulse125 resp 34 temp 97.2 bs 204. O2 sat increased up to 98 % but resident remained confused.   Tele health visit noted,  resident  to be cyanotic and using accessory muscles  advised to call 911to senfd resident to ED. Resident was transported  to hospital for evaluation at  via stretcher. Family was notified. Resident was admitted to hospital with  acute resp failure.
She had cough that sounded different, it sounded wetter, was irritable, more tired. We did not do a home COVID-19 Test since my wife had tested positive. Doctor recommended that if needed to give her over the counter medication to control symptoms. We alternated with Motrin and Tylenol. She is back to her normal self since July 4, 2022.
Headaches, fatigue, joint pain, heart racing, numbness and tingling in hands, arms, feet, legs
Vomiting, lethargy, fever, red rash-like spots, lack of appetite.
the side effects were similar to what I experienced; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (the side effects were similar to what I experienced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (the side effects were similar to what I experienced). At the time of the report, ADVERSE EVENT (the side effects were similar to what I experienced) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or treatment information provided.
Pseudo exacerbation of MS symptoms, unable to move extremities for approximately 6 hours.
Appx 3:00 phone call from caregiver/aunt requesting evaluation from clinic and on her way to clinic, stated "I think he has had reaction to his vaccine this morning" Appx  5 to 6 hours from administration nurse observed raised rash on arms, legs, not on abd, or back, and rash  on side of face on right reaching to scalp and beginning on left side of face.  None on neck observed, lips and tongue normal, patient sitting w nurse playing and talking. v/s stable resp 18 no wheezing noted HR 112, b/p 96/60. Child complains of itching and is scratching lower legs. Public Health Director and MD contacted and per protocol allowed to administer oral liquid Benadyrl per pt weight. Spoke with caregiver on 07/27/2022 patient has no rash today, and is doing well.
BILATERAL FACIAL SWELLING, NON VERBAL, DROOLING, CONFUSED, HOLDING HER HEAD, ALTERED MENTAL STATUS; HOSPITALIZATION TWICE OVERNIGHT ONCE ON 01/26/2017 AND AGAIN ON 1/28/2017.
Dizzy, Left ear buzzing which lead to syncope upper arms tingling for 2-3 seconds
Two series of COVID19 vaccine  Received Moderna 09/03/2021 Recieved Janssen 09/13/2021  Refugee number A-241540920  The  Regulatory Authority has been requested to enter all COVID vaccines into system. The teams responsible for screening and administering vaccines to the refugees at the Vaccine site were/are all on duty staff. Staff is assisting with entering information into database and VAERS. Is assisting with entering information into Database and VAERS.
Had achiness; Therefore did not get 2nd shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Had achiness) and PRODUCT DOSE OMISSION ISSUE (Therefore did not get 2nd shot) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Had achiness) and PRODUCT DOSE OMISSION ISSUE (Therefore did not get 2nd shot). At the time of the report, PAIN (Had achiness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Therefore did not get 2nd shot) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.
both ankles swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (both ankles swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gout.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced JOINT SWELLING (both ankles swollen). At the time of the report, JOINT SWELLING (both ankles swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a history of blood word drawn that came back normal. No relevant concomitant medications were reported. No treatment information was reported.
Fever for 24 hours, muscle pain for 48 hours, diarrhea for 48 hours, Tired feeling for 72 hours
The 15 year old patient received the Moderna COVID vaccine today with parental consent. This vaccine is only approved under Emergency Use Authorization for 18 and older.
patient complained of pain in right arm after shots unrelieved by ice. shots given on 7/18/20. patient complains of pain not getting better and now cannot "lift" his arm.  I
sore arm; a little fatigue; OFF LABEL USE-under age; A spontaneous report () was received from a consumer concerning his daughter a 16-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events off label use-under age/product administered to patient of inappropriate age, sore arm/ pain in the extremity, fatigue.  The patient's medical history was not provided. Concomitant medications reported were none for drug use for unknown indication.  On 12 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) Intramuscularly for prophylaxis of COVID-19 infection.  On  12 Mar 2021, the patient experienced the event(s) product administered to patient of inappropriate age. On an unknown date patient experienced  sore arm and a little fatigue.  Treatment details was not included  Action taken with mRNA-1273 in response to the events was not provided  The outcome of event(s), product administered to patient of inappropriate age was considered resolved on 12 Mar 2021. The outcome of the events sore arm and fatigue were unknown; Reporter's Comments: This report refers to a case of 16- year-old female patient received Moderna's COVID-19 vaccine (Inappropriate age at vaccine administration) for mRNA-1273, 023M20A. and experienced sore arm and fatigue.  Based on a temporal association between the events of sore arm and fatigue and use of the product, a causal relationship cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.
Wheezing & tightness in throat. Took Benedryl & symptoms were relieved.
Body and muscle aches for about two weeks ongoing; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body and muscle aches for about two weeks ongoing) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body and muscle aches for about two weeks ongoing). At the time of the report, MYALGIA (Body and muscle aches for about two weeks ongoing) had not resolved.            No concomitant medications were reported. No treatment details were reported.
Pt recvd vax 28SEP90. Pt developed progressive muscle weakness. Hospitalized 11OCT90 w/acute Guillian-Barre Synd. The pt required plasmapheresis & respirator support.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
40 yo F,  NO prior history and healthy- presents 2 week post vaccine w decreased vision and eye pain, diagnosed with uveitis.  Also had concomitant arthralgias - RF elevated and newly diagnosed with RA and uveitis/scleritis.  Now in August, still dealing with persistent inflammation and needs to start methotrexate.