chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bladder disorder; Had an infection with bacteria; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISORDER (Bladder disorder) and BACTERIAL INFECTION (Had an infection with bacteria) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Immune disorder (NOS).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLADDER DISORDER (Bladder disorder) (seriousness criterion hospitalization) and BACTERIAL INFECTION (Had an infection with bacteria) (seriousness criterion hospitalization). The patient was hospitalized on sometime in September 2021 due to BLADDER DISORDER. The patient was treated with Surgery (Bladder removed on 10-Sep-2021) for Bladder disorder. At the time of the report, BLADDER DISORDER (Bladder disorder) and BACTERIAL INFECTION (Had an infection with bacteria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101.6 degree F since 6am and 101.6 Degree F at 9:15am.         Patient state they had been sick and been taking antibiotics but has stop doing that for a few days to be able to get the shot. The patient had an infection with a bacteria from taking a lot of antibiotics.  Company comment: This case concerns a  63 year old female patient, with medical history of immune disorder and being under dialytic treatment, who experienced serious unexpected events of bladder disorder and bacterial infection after second dose of mRNA-1273. The events occurred 5 months after second dose of mRNA-1273. The re-challenge is not applicable. Patient´s medical history remains a confounder. The benefit-risk relationship of Spikevax in not affected by this report.   This case was linked to MOD-2021-346562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: This case concerns a  63 year old female patient, with medical history of immune disorder and being under dialytic treatment, who experienced serious unexpected events of bladder disorder and bacterial infection after second dose of mRNA-1273. The events occurred 5 months after second dose of mRNA-1273. The re-challenge is not applicable. Patient´s medical history remains a confounder. The benefit-risk relationship of Spikevax in not affected by this report.
devel rash on rt upper arm (tetra site) lt upper arm (MMR site); alert responsive, no resp distress while @ clinic; PMD contacted; MD instructed to send to ER: mom was offered amb declined; wanted to drive there left @ 11AM;
Severe chills and high fever (102). Severe muscle aches and insomnia for 1 day. Symptoms lessened after 24 hours. Fully recovered after 48 hours.
Tested positive for the Covid-19 virus after 1st dose; Tested positive for the Covid-19 virus after 1st dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for the COVID-19 virus on 22Feb2021 after 1st dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
My daughter who is 11 received the flu vaccine along with her brother. He had no reaction except for the usual body aches and fever for him.  She had no reaction at all initially which she usually does not. However, about 2 weeks or so after she received the vaccine she developed a linear rash that starts at her ankle and goes all the way up to her hip.  I took her to the pediatrician because she kept scratching at it and said it was itchy and she said it is Lichen Striatus.  Given the timing of the vaccine, and the fact that she had not been sick when the rash first started, it?s possibly due to the flu vaccine although I don?t know for sure.  I read online vaccinations can cause this.  It?s apparently a benign condition that goes away on its own but takes months to even upwards of a year to go away.  Her doctor gave her a cream to apply for the itching.
Suspected Vaccination failure; patients who have received both doses of Shingrix and had shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a an unspecifed number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist states that the patients received both doses of Shingrix and had shingles occurrences. The reporter consented to follow up. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for herpes zoster were not provided.
stroke; This is a spontaneous report from a contactable consumer. An adult female patient of unspecified age (reported as age: 62; Unit: unknown) received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on unknown date (Batch/Lot Number: not provided) as COVID-19 immunization. Then, the 2nd dose on unknown date. It was stated that the patient had a stroke following administration of second dose on unknown date. Outcome of the event was unknown.   No follow-up attempts are possible, information on batch number cannot be obtained.
Redness on L arm, and chest. Itchy on torso. Possible hives interior L arm. Pain in chest and L hip. Patient was admitted to hospital and received a prescription for a steroid. Patient picked up steroid approx. 0800 08/15/2016.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 at 12:00 pm (at the age of-29 year) as a single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm on 10Mar2021 at 16:00 pm. No treatment was received for the adverse event. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.
Pain in the left arm, especially when moving the arm or trying to put on clothing.  I suspect the arm was injured by the shot, not by the Covid vaccine.
Contacted patient to inform him/her of an issue that was discovered on the date of this patient?s covid vaccination  It was determined that this patient received a dose of the vaccine from a vial that was beyond the 12 hr post puncture time limit but within the expiration date of the product. No temperature excursion occurred. Pfizer, the manufacturer was contacted on 4/20/22 to inquire about the stability of the vaccine after more than 12 hrs post puncture.  The only relevant point to the 12 page information sent by Pfizer was with ?microbiological risk to be considered when using vaccine in vials punctured for longer than 12 hrs.?  This is a theoretical risk of this microbiological risk of decreased efficacy but this risk has not been scientifically proven or even evaluated.   This information was reviewed with 2 office physicians.  There was no consensus (as the risk has not been scientifically proven or even evaluated) that revaccination is needed.  Physicians advised that this is a case of shared decision making with the patient and that it would ultimately be patient preference once presented with this information.  If patient chose to be revaccinated the advice from one of the physicians was  to wait 5 days from previous vaccination, as that is the guidance to someone who is covid + and has not been vaccinated.  Once a person is out of quarantine, they are urged to get vaccinated right after that even though they have some antibodies from the resolved infection. Presented information to patient as above in very simple terms.   Patient asked questions about potential for waiting a few months. I indicated this would not be considered a revaccination as it is separate timeframe from this vaccination and we do not know if/when additional boosters might be needed within that timeframe.  I apologized for this experience and advised that we have instituted new practices to ensure that the discarding of the vaccines occurs promptly at the 12 hr mark to prevent any future occurences. Patient was thankful for the notification and information. Patient does not wish revaccination at this time.
PT was given COVID vaccine 7 days early. Pt was notified and instructed to contact the office or go to nearest ER if develops any adverse reaction. Patient waited 20 minutes after injection was administer and had no reaction.
red spot at the injection site (4inch diameter); Fever of 100.4F; Sore at the injection site/ Painfull at injection site; injection site is warm to the touch; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Sore at the injection site/ Painfull at injection site), VACCINATION SITE ERYTHEMA (red spot at the injection site (4inch diameter)) and PYREXIA (Fever of 100.4F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 207030m20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU. Concurrent medical conditions included Egg allergy (Raw eggs), Penicillin allergy, Sulfonamide allergy (Allergic to sulfa drugs.), Drug allergy (lopresser), Asthma since 1956, Hypothyroidism since 1969, Pre-diabetic since 2000, Acid reflux (oesophageal) since 2010 and Hypophosphatasia since 1985. Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN POTASSIUM, AMLODIPINE, AMITRIPTYLINE HCL and OMEPRAZOLE for an unknown indication.    On 19-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm to the touch) and VACCINATION SITE SWELLING (swelling). On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site/ Painfull at injection site). On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at the injection site (4inch diameter)) and PYREXIA (Fever of 100.4F). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site swelling, Vaccination site warmth and Vaccination site pain, at a dose of Hour after injection and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) 19-Mar-2021 for Swelling, at a dose of 1/2 hour before/1hour after. On 23-Feb-2021, PYREXIA (Fever of 100.4F) had resolved. On 10-Mar-2021, VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Sore at the injection site/ Painfull at injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site (4inch diameter)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 100.4 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: no new information was added. On 13-Jul-2021: AE outcome and other medical history has been provided. Treatment medication was updated.
Chills, fatigue, fever of 104 degrees, nausea, syncope which resulted in a neck injury from the fall.
Started at midnight after shot-Temp 102, stabbing pain in muscles, chills, Severe headache,, dizziness, weak, tiredness
I had a bad headache. It wasn't terrible, didn't need any other treatment. Just bed rest for the morning until it abated.
I received smallpox on 08-Aug & around the 17th of August I experienced a rash on both arms & spread to my legs, back, torso.
Increasing dizziness, pallor, right sided neck pain marked right sided neck pain, (L) arm pain, presyncopal unable to sit independently. Symptoms noted the next day. Pt was sent to the ED. Received IV fluids. Was discharged home. Had symptoms for several days. Lyme test was positive and pt was treated for Lyme.
This spontaneous case reported by a consumer, describes the occurrence of musculoskeletal stiffness (stiff arm) and peripheral swelling (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced musculoskeletal stiffness (stiff arm) and peripheral swelling (swollen). At the time of the report, musculoskeletal stiffness (stiff arm) and peripheral swelling (swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Starting about 3 weeks after 1st dose of Shingrix and lasting for about the next 4 weeks after that, began to have hives (pressure urticaria) most evenings around waist and groin where contacted by tight clothing. Hives lasted for short period each evening and were gone by bedtime. One one occasion had itching and burning pain of the plantar feet from evening until bedtime. In the mornings, after having had the evening shingles, had angioedema (swelling) around eyes, face, lips, which would subside about 2 hours after getting up in the morning.
So, Photo Phobia an eye pain. I was feeling myself for 5 days and I wore sunglasses because of the light. I was able to work but not really functional. It wasn't a margaine. Just a really bad headache. I was also confused for a day or so. That's not like me. I was having problems remembering things but it went away the following.
Started sweating really bad, high fever, sick of the stomach, extremely weak, extremely dizzy, diarrhea really bad, throwing up over and over, blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in my stomach from throwing up so bad, my esophagus had a big hole in it, large rip. My immune system is totally destroyed.
Fussy, irritability starting 6/3/15. Now URI, (L) OM.
Knot 4 cm on left upper thigh, tender to touch: mom noticed one day after 12 months shots was given. Treated: Benadryl tid, cool compresses prn.
On 08/31 playing catch with baseball. Ok at bedtime awoke approximately 0300 09/01 with pain (R) arm. Later in AM decreased ROM and strength of (R) arm for rest of day. 09/02 low grade temp with erythema -> 20cm with local tender (exquisite). 09/03 low grade temp. with 15 cm erythema and minimal tender. Saw MD minimal decreased ROM.
Swelling and itching in the right arm. Painful swollen itchy armpit lymph nodes on the right side.
Severe heart palpitations accompanied by dizziness and shortness of breath, lower heart valve malfunction
almost passed out; This spontaneous report was received from a Registered Pharmacist via an company representative concerning her two daughters of unknown age. Medical history, drug reactions or allergies and concomitant medication were not reported. On unspecified dates, her daughters were vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis when they were young (route, lot # and expiration date were not reported) and both almost passed out on unspecified dates. They were seen by physician for seeking medical attention. The patients recovered from the adverse event. The causality between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported. Product Quality Complaint (PQC) was not present.
Rx was written for varicella vaccine not SHINGRIX pt was given SHINGRIX. SHINGRIX is for the varicella zoster virus but Rx was intended to be for VARIVAX.
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after receiving vaccination patient reported headache and numbness in both feet and right hand. Twenty minutes after vaccination reported nasal congestion, worsening headache, and not feeling well. Initial vitals within normal ranges except blood pressure 159/85 mm Hg, repeated 15 minutes later at 144/80 mmHg. Medical evaluation team arrived and allergy provider contacted: patient administered oral diphenhydramine. Patient discharged to home from vaccination clinic improved and stable. On scheduled follow-up encounter with primary care provider three days later patient did not report any symptoms from vaccination.
cellulitis developed 24 hr after injection, admitted to hospital for IV antibiotic therapy 48 hr after immunization.  R arm swollen, nauseated, ill felling; pain, but no lymphadenopathy in R axilla; extensive erythema and edema in right upper arm.  Temp 97.5; pulse 64; resp. 16; BP 127/81.  Nurse follow up on 10/05/04 states: "Confirmed diagnosis of cellulitis following pneumovax and allergy shot in R arm. Agitation, shortness of breath, and headache to symptoms." Per annual report-Upon review of discharge summary, noted that patient also had received an unspecified "allergy shot" in same arm when pneumovax was administered. DC summary states that patient was responding well to presumed cellulitis caused by staph or strep.
Doctor felt it was an anaphylaxis reaction; Cough; Left arm is still so sore she can not lift it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COUGH (Cough) and VACCINATION SITE PAIN (Left arm is still so sore she can not lift it). On 17-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) outcome was unknown and COUGH (Cough) and VACCINATION SITE PAIN (Left arm is still so sore she can not lift it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with antihistamine for tingling in her lips and whole face became swollen and her lips were huge and it started to go away. On 18-APR-2021, it started again so patient had seen her physician on 19-APR-2021 who referred her to a specialist. The patient was tested for an allergy to the vaccine. The doctor felt it was an anaphylaxis reaction.  The reporter did not provide an assessment for the events.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Fever, fell asleep; when awake had a confused look on face, unable to play with toys, unable to speak. Over the next week developed scaly red rash over face & arms. Hair started to stand on end, became coarse & wiry. Started screaming/howling like a wild animal. Full regression complete within 1 week of vaccination.
Pain in the location of the vaccine.  Loss of range of motion when using the outer muscle/the location of vaccine.  Intense pain for 2-3 seconds, then cramping in this area, then aching for hours after any "stretching" of this muscle.  Ibuprofen does not lesson the pain.  It has been over 8 weeks.  The pain is in the upper arm radiating from the elbow to the shoulder.
Dosing interval between first and second dose was 14 days as opposed to the recommended 21 days.
Lack of energy; Nausea; Diarrhea; Stomach cramps; Cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration in the right arm on 30Mar2021 at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took dextropropoxyphene hydrochloride (DARVON), codeine (MANUFACTURER UNKNOWN) and paracetamol/oxycodone hydrochloride/oxycodone terephthalate (PERCOCET) and experienced drug allergy. On 30Mar2021 at 20:00, the patient experienced lack of energy, nausea, diarrhea, stomach cramps and cold sweats. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lack of energy, nausea, diarrhea, stomach cramps and cold sweats was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.