chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical librarian regarding unspecified patient (no specific patients mentioned) of unknown age. The reporter stated that she has read "anecdotal literature resources stating that ZOSTAVAX (lot # and expiry date not provided) cured cold sores, as well as reports that ZOSTAVAX caused cold sores. It was also reported that reporter wanted off-label information on "the usage of ZOSTAVAX as treatment of cold sores. There was no product quality complaint. The reporter was offered to discuss the PI but she disconnected without giving any demographic information. Action taken with the reported event was not applicable. Outcome and causality of the reported event was unknown (not provided). Additional information is not expected.
Pt presented to the ED on 1/23 with CC of abdominal pain and N/V.     IN ED pt with VS of temperature 99°, heart rate 118, respiration rate 16, blood pressure 116/67, and sats 97% on room air.  Labs with white blood cell count elevated at 15.32, absolute neutrophil count elevated at 13.39, potassium low at 3.4, albumin low at 2.8, AST ALT within normal limits, LDH of 174, lactate of 0.9, CRP elevated at 15.10, D-dimer elevated at 2214, ferritin elevated at 337.8, procalcitonin within normal limits at 0.10, influenza a and B PCR negative, RSV PCR negative, COVID-19 PCR positive.  UA appears contaminated and urine cultures currently pending.  C diff PCR positive.  Troponin x4 within normal limits.  EKG with sinus tachycardia, heart rate 111, T-wave abnormalities noted in inferior and lateral leads.  Chest x-ray within normal limits.  CT abdomen pelvis with contrast showed diffuse rocking pharyngeal mucosal thickening of the distal half with descending colon and sigmoid colon possibly due to colitis or diverticulitis extent of mucosal thickening in the colon slightly increased since previous exam. She continued to be asymptomatic for COVID during her hospital stay.
This spontaneous report as received from a physician assistant refers to a 94 year old female patient. On 19-JUN-2014 the patent was vaccinated with an expired dose of PNEUMOVAX 23 lot # H014196, expiration date: 19-MAR-2014, strength, dosage, route and indication unknown. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
The pt developed urticarial rash for 1 day post immuning. Benedryl was prescribed.
Vertigo; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient arrived to ED with CC of Focal/Febrile Seizure. Parents stated that pt was at home and began to become fussy and crying inconsolably and then began to stare off into space. Pt then proceeded to make a gagging sound and she started to then fall asleep. Upon arrival, pt is now mildly fussy but eating and acting normal.
4 month old patient being administered quadracel which is outside of the indicated age group with no reported adverse event; Initial information received on 26-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was being administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which was outside of the indicated age group with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 16-Aug-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation was unknown, lot C5916AA and expiry date: 06-Jul-2023) via intramuscular route in the left thigh for Immunization.  On 16-Aug-2022 the patient developed a non-serious event of 4 month old patient being administered quadracel which was outside of the indicated age group with no reported adverse event (Product administered to patient of inappropriate) (Latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. The patient was supposed to receive Dtap and polio  Action taken: not applicable.  Outcome: Unknown  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 the guidelines. 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.
soreness at injection site at hour 3; low grade fever at hour 8; This is a spontaneous report from a contactable physician reporting for him/herself via Pfizer sales representative. This patient of unknown age and gender received on an unknown date a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient noted soreness at injection site at hour 3, and low grade fever at hour 8. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Shortly after vaccination, patient developed hives, itching, induration involving left arm with welts also on chest. Symptoms resolved within 36 hours.
patient developed rash, had no cp or sob  bp 137/87 r 18  p 86 patient given Benadryl symptoms resolved
Pneumococcal vaccine given for PPD test intradermally. Pt seen at local ER for reaction on full left forearm raised, red, hard area. Given in error for PPD soln.
I was awake most of the night. I am not sure I fell asleep at all. I retired at 10:10 and got up at 7::30. I felt sleepy and uncomfortable. After breakfast of toast I laid down and felt better after sleeping on and off for two hours.
arm soreness; excessive fatigue; flu-like symptoms; chills; A spontaneous report was received from a consumer concerning a 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, flu-like symptoms, arm soreness, excessive fatigue, had to lay down yesterday.  The patient's medical history was not provided. Concomitant medications reported were Lipitor for an unknown indication and eye drops for glaucoma.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) chills, flu-like symptoms. On 16 Feb 2021, the patient experienced the event(s) arm soreness, excessive fatigue. On 24 Feb 2021, the patient experienced the event(s) had to lay down yesterday.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event(s), chills, flu-like symptoms, arm soreness, excessive fatigue, had to lay down yesterday was unknown.
L deltoid diffuse swelling, redness, warmth, itchiness day 8-12 post vaccine administration.
Heavy metallic taste; Heavy sweating at night; very swollen lymph nodes on right side base of neck and arm pit tender to touch; very swollen lymph nodes on right side base of neck and arm pit, sore to touch; very swollen lymph nodes on right side base of neck and arm pit; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch) and LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) in a 55-year-old female patient 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch), LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) and MYALGIA (Body aches). At the time of the report, DYSGEUSIA (Heavy metallic taste), NIGHT SWEATS (Heavy sweating at night), TENDERNESS (very swollen lymph nodes on right side base of neck and arm pit tender to touch), PAIN (very swollen lymph nodes on right side base of neck and arm pit, sore to touch), LYMPHADENOPATHY (very swollen lymph nodes on right side base of neck and arm pit) and MYALGIA (Body aches) had not resolved.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Intense vertigo approximately 2 weeks after 2nd dose.  Condition has not abated.
Vaccine was improperly stored in vaccine refrigerator beyond the 72hrs prior to administration.
Severe joint pain, in thumb joint, both thumbs, after first vaccine, and hurts more after the second vaccine; experienced pain after the first dose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as, dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe joint pain, in thumb joint, both thumbs, after first vaccine and experienced pain after the first dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Really itchy eyes, like bad; really uncomfortable; Itchiness on the eyelids where eyelashes are; This is a spontaneous report from a contactable consumer (patient) reported that. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 (Batch/Lot Number: EN6201) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 38 years). The patient past Medical history and concomitant medications were not reported. Consumer stated, after first dose and she never really thought about it until she saw her aunt with maybe a situation similar that she had it, she had allergies (not further clarified). All of a sudden, few hours later, she doesn't remember how many hours because she was not really paying attention and she wasn't thinking of anything of it, but it has not been gone, it is not going away since. she has really itchy eyes, like bad, it's really uncomfortable on an unspecified date in Mar2021. she has been having to take allergy Allegra medication every day and drops 0.035%. and then she has some little pads, it is for like eye scrubs or something like that they are called. But it is just constant. she means, it is all day long that she has. They are just really itchy, and she can't wear makeup around it because they just make it a lot more, not that she wears makeup right now, but she can't put anything around it just because it makes it a lot worse. The event outcome was Unknown.  No follow-up attempts are possible. No further information is expected.
Large area of Redness on arm (from deltoid to elbow), fatigue, headache, and could not obtain other information. These were reported the day after vaccination administered.
Beginning September 28, 2021, I developed a dry, itchy spot on my right hand, around a cut on my knuckle, that continued to grow, itch, and peel, often blistering . November 6, 2021, I developed a blistered, round, itchy spot at the nape of my neck that I believed, at the time, to be poison ivy.  The lesion on my neck and on my hand did not and have not gotten any better with OTC ointments such as 1% hydrocortisone, triple antibiotic ointment, or moisturizers. Starting around November 18, 2021, the number of itchy, red, scaly and blistering lesions erupted and spread to now cover my face, my groin/pubic area, neck and a spot near my right knee. I have continued to treat the areas with 1% Hydrocortisone cream, antibiotic ointment,  eczema cream, eczema lotion, and a "borrowed" tube of Triamcinolone Acetonide Cream USP, 0.5%, until I can get in to see my doctor.
The day after the second dose of the vaccine I had a sudden shortness of breath. I could not get out of the car. It was very hard to walk any distance. I was hospitalized and my Atrial Fibrillation was uncontrolled. I was treated with Cardioversion. I was given a Pacemaker and treated with an AV node Ablation. I have been doing better recently but I am still in treatment. During the time I started to get a funny pain in my leg. I also had a rash around my waist. I went to urgent care and I was diagnosed with Shingles.
Reporter states that 191 people were vaxed & 17 were found to be non-responders;
After the first dose of the Pfizer COVID-19 vaccine on 1/13/21 I notice some thinning of my hair. After the second dose on 2/3/21 my hair loss accelerated dramatically. It is unknown whether I will go completely bald and/if hair will regrow.
Sometimes when she breathes it gives her a little pain; Little headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Sometimes when she breathes it gives her a little pain) and HEADACHE (Little headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Sometimes when she breathes it gives her a little pain) and HEADACHE (Little headache). At the time of the report, DYSPNOEA (Sometimes when she breathes it gives her a little pain) and HEADACHE (Little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Information has been received from a health professional concerning a 75 year old male who on 10/15/2002 was vaccinated with hepatitis A virus vaccine inactivated.  It was reported that the vaccine had expired on 05/27/2002.  The patient did seek medical attention.  It was also reported that a 72 year old female was vaccinated with hepatitis A virus vaccine inactivated that had expired (WAES # 0210USA01672).  Additional information has been requested.
"vaccinated at 1330 at left arm, noted redness/rash to face at 1346 and notified staff.  Denied; CP/tightness/swelling/difficulty swallowing. COVID vaccine 007M20A exp: 7/14/21; 1346- 146/80  97  98%; 1350- med w/ benedryl 50mg po; 1355 133/87  98  96%; 1400- rash already improved; 1415- patient reported feeling fine- back to baseline and released"
Sore arm; Vertigo, which was quite severe; Pretty severe with nausea and vomiting; Pretty severe with nausea and vomiting; Eight weeks of dizziness; Unable to drive a vehicle; Vestibular nerve was inflamed in one ear; Ringing in the ear, tinnitus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (in her 50s) received bnt162b2 (formulation: solution for injection; Batch/Lot number: not reported; Expiry date: not reported; NDC number: not reported), dose 2 via an unknown route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 as dose 1 single for COVID-19 immunisation on an unknown date. Patient said she was not on medications and had no health conditions at all, she was healthy and normal. The patient experienced sore arm, vertigo, pretty severe with nausea and vomiting, eight weeks of dizziness, unable to drive a vehicle, vestibular nerve was inflamed in one ear, ringing in the ear, tinnitus. Patient stated that nine days after the second dose, after not having any other symptoms, except a sore arm, there was vertigo, which was quite severe. And about ten hours later it was pretty severe with nausea and vomiting, and everything, went into close to eight weeks of dizziness, four of those weeks unable to drive a vehicle, it was really in one ear, all on an unknown date. Actually, and the audiologist said that she had seen patients who lost their hearing from the vaccine, that the vestibular nerve was inflamed, and following that, the dizziness, subsided after eight weeks, now it was ringing in the ear, she thought they call it tinnitus. She stated that she was normal in weight, thin, healthy person and never had issues with vertigo or anything like that. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
5 year old received Pfizer 6mo-4y covid vaccine X 2 11/4/22 and 12/23/22; No adverse effects. Mother notified . Encouraged to complete series with appropriate dose as CDC recommends.
Over dosaage was administered to the participant, 1 ML of influenza was given instead of the recommended does of .5ML.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID-19 Treatment (Brand: Paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 07Dec2022, Treatment stop date: 13Dec2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT WAS GIVEN HIGH DOSE FLU VACCINE INSTEAD OF REGULAR IN LINE OF RESIDENTS FOR FLU CLINIC; FACILITY AWARE OF MISTAKE AND SAID THEY WOULD LET  THE PATIENTS KNOW WHO RECEIVED THE HIGH DOSE FLU SHOT WHO WERE UNDER 65 YEARS TOLD. NO REPORTED ADVERSE EFFECTS FROM THE FACILITY
Lymph nodes in left and right armpits swelled (5 in left, 2 in right).  One erupted to the surface expelling pus and blood.
passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) 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 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passing out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment details not provided.; 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.
Patient received Varicella vaccine at age 1 year old.  He was seen in our office on 2/16/07 with four day onset of marked herpes zoster in right C4 dermatome.
30minutes after injection: Swelling lips, eyes, face , throat red face fast heartbeat dizziness fatigue and headache next morning
redness at the site that was more noticeable; some tenderness; This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EH9899), via an unspecified route of administration on 21Dec2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at the site that was more noticeable, and some tenderness in Dec2020 with outcome of unknown.
I'm 66 and in good health. I was given a pneumonia vaccination, pneumovax 23. Since shortly after that I've had fairly severe itching and spots over my body, especially my back and legs.
Patient developed chronic inflammatory demyelinating polyneuropathy. The first symptom of this condition was right Bell's palsy (right facial weakness) that started on 3/10/2017.
coughing more; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing more) 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 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced COUGH (coughing more). At the time of the report, COUGH (coughing more) had resolved.            No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Event outcome updated
Local erythema, tenderness after getting shots as below (these two event happened within couple of wks).