chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and feeling bad. On an unknown date, the outcome of the pain and feeling bad were unknown. It was unknown if the reporter considered the pain and feeling bad to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter was not comfortable reporting this as an adverse event. The reporter did not provide any patient or vaccine data.
Narrative: COVID infection following COVID vaccine series 02/06, Pfizer, dose #1 NON-FACILITY 02/23, Pfizer, dose #2 NON-FACILITY 08/12 COVID swab, result: not detected 08/13 ESR RESULT: 9 08/15 pt cc: cough, fever, headache, exposure: unknown 08/17 COVID swab, result: detected 08/17 SARS-COV-2 LINEAGE result: AY.26 08/17 SARS-COV-2 CLADE result: 21A
Moderna  COVID-19  Vaccine EUA  Severe headache, Vomiting, Temp of 103.2, Fatigue, Diareha, horrible chills, no energy, Day 3 now, I've missed 3 days of work and will be off at least 2 more due to high temp and feeling so horrible
Patient walked out fine after receiving the vaccine. Was able to walk up to the registration desk and carried a conversation with the staffs. He sits down in the waiting area to be monitored. We heard his phone dropped, looked up and saw him tilting over on the right side was about to fall off the chair. Staff grabbed him and held him back onto the seat, proceeded to picked up his right arm and held him in place. He looked unconscious while staff held him. He came back to his senses approximately 10 seconds later. After he regained consciousness, staff took his blood pressure which was 111/44, SpO2 was 100%, and heart rate 58. Patient looked pale but not critical. Conversed with our staff and stated that this has happened before when he receives other vaccinations. Patient's father is a physician and reported that the patient is scared of needles and did not need any medications from anaphylaxis kit or crash cart. We gave him water and he left after sitting for a while.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound after getting better; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 09Sep2022 to 14Sep2022 for Covid-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lost my ability to focus. Vision blurred distance, middle and close.; periods have also been exceptionally heavy every cycle since the vaccine; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer (patient) reported for herself that:  A 42-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 14Apr2021 11:00 (at the age of 42 years old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store.  Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, strokes rom an unknown date and unknown if ongoing (family history of strokes).   The patient's concomitant medications were not reported.  It was reported that the patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient experienced lost my ability to focus. vision blurred distance, middle and close on 18Apr2021 10:00, periods have also been exceptionally heavy every cycle since the vaccine on 18Apr2021. Caller stated 4 days after the first (only dose caller received) lost ability to focus. Vision blurred distance, middle and close. Lasted about an hour and then reoccurred that night, caller had never experienced this. Caller stated had personal risk factors of potential stroke and the scary/odd loss of vision following  first dose. Caller did not receive the second dose. It was reported that Prolonged Hospitalization was no. Treatment Received was no. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jul2021. (Nasal Swab). The outcome of events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
I noticed a bad, inexplicable lower backache while traveling a week later, starting a familiar hotel with what I knew was a good mattress. From there, I?ve struggled with persistent lower back pain that doesn?t go away. My lifestyle hasn?t changed during this period.
arm was swollen; red rash; arm was sore for a week; A spontaneous report was received from a consumer concerning a 64-years-old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was swollen, red rash, arm was sore for a week.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) in right dominant arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) in right dominant arm for prophylaxis of COVID-19 infection.  On an unspecified date after vaccine administration the patient experienced arm was swollen, there was red rash, arm was sore for a week.  Treatment reported included Benadryl.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, arm was swollen, red rash, arm was sore for a week was unknown.
Feel light headed all the time.; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 04Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247 in left arm on 14Jan2021 at 17:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient received other medications in two weeks which included clonazepam (KLONOPIN), vitamin D (MANAFACTURER UNKNOWN), revuvastatin (MANAFACTURER UNKNOWN), ca (MANAFACTURER UNKNOWN), vitamin (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. 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 had no known allergies. On 06Feb2021, the patient noticed that in the month and a half since last vaccine, she felt light headed all the time. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of dizziness was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Please note:  I had documented symptomatic COVID19 infection March 2020.  Recovered fully without long term symptoms.  SARS-COV2 Ab testing was positive on 12/6/20 Dose #1 Vaccine was received 12/22/20 at 3:30pm - on 12/23 I woke up at 5:30am with fever, body aches and fatigue - fever went up to 103F and I spent the day in bed - symptoms resolved approximately 12hr later (around 5:30pm) I then felt fine until 1/2/21 (10 days later) when I awakened with fever, generalized body aches and fatigue - this time fever was lower to 100.4.  I again spent much of the day in bed and symptoms resolved after 8 hrs
Child developed pruritic rash around the mouth beginning a few hours after the vaccine.  He responded to Zyrtec given at home by the parent.   The next morning he still had some redness and itching around the mouth and complained of itchy eyes as well.
Swelling and pain right axillary lymph nodes tenderness; Swelling and pain right axillary lymph nodes tenderness; tenderness lateral right breast; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jan2022 10:45 (Lot number: 330368D) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 041L20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 29Jan2021, when the patient was 56 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 037K20A, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 30Dec2020, when the patient was 56 years old, for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 26Jan2022, outcome "recovering" and all described as "Swelling and pain right axillary lymph nodes tenderness"; BREAST TENDERNESS (non-serious) with onset 26Jan2022, outcome "recovering", described as "tenderness lateral right breast".  Additional information: Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. The patient had not received any other vaccine within 4 weeks. Patient was not taken any other medications with in 2 Weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. AE resulted in: None of the above.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient experienced swelling of throat, no acute respiratory distress. Had prior anaphylactic reaction to bee sting.
Muscle aches, headache, fever, chills, sore arm. Have to stay home from work the following day
Yesterday, after 8days, the vaccine site has a tiny pink color that I don't think it was there yesterday. At the same time, the site I had BCG shot as a child became pink, warm, raised, and very itchy. It had never happened before. The size of reaction is small, about half-inch diameter. Location is about 2inch above the Covid vaccine site.  Today, the 9th day since vaccine, previous BCG vaccination site is widely redder and warmer, and some pain to touch.
1/6/ - unusually severe right sided neck pain - persisted on the 7th - January 8 - rash on collarbone - and it spread January 9 rash spread up right side of neck and I started having right scalp nerve pain - all of these persisted worsened and went into the January 10th  - Telemed - when I discovered I had shingles and started Valacyclovir. The nerve pain stopped on the 17th and the rash continued to be painful and itchy through the 30th. I had some residual scars but symptoms were ended by 1st.
Body rash (chest, belly, legs, feet) and fever. No respiratory distress "seems uncomfortable" & cranky.
Patient returned 30 minutes after injection c/o L arm shaking unable to type. VSS, no SOB, chest tightness or rash. .Transported to medical clinic for evaluation
Arm is tender to touch; A spontaneous report was received from a health professional concerning a patient, of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and discovered her arm was tender to touch.  The patient's medical history, as provided by the reporter, included a COVID infection, almost a month ago. No relevant concomitant medications were reported.    In Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient's arm became tender to touch after receiving the vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event an arm that was tender to touch was unknown.; Reporter's Comments: This case concerns a female patient of an unknown age with a reported past medical history of COVID infection. The concomitant medications were not provided. The patient experienced a non serious event of her arm was tender to touch. The event occurred after the administration of the first dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had the shingles shot but got shingles anyway. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Developed chronic fatigue syndrome in temporal association to receipt of the anthrax vaccine. Did not seek care or evaluation at the time. Condition worsened and has been identified and diagnosed currently. Malaise and fatigue, Insomnia NEC, Altered Mental Status, Headache.
dizziness flashing lights in front of eyes nausea redness/warmth of arm where injection was given
Flashes in my left eye and a lot of floaters; cloudiness in my left eye; Flashes in my left eye and a lot of floaters; cloudiness in my left eye; 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 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), PHOTOPSIA (non-serious) all with onset 21Apr2021, outcome "not recovered" and all described as "Flashes in my left eye and a lot of floaters; cloudiness in my left eye".  Additional information: It was reported that, the consumer didn't know whether it was related to the vaccine or not, but to check on April 18th, the patient had the vaccine and on April 21, started having flashes in left eye and a lot of floaters that continue the next day and the patient's eye doctor prominently looked, she could not find anything wrong she said it could be a partial vessel, but she couldn't really anything, so, this was last week, so, it's still continuing. Stated that, the patient didn't have flashes as much, but the patient had, they know, cloudiness in left eye, so the patient just wanted to check in, whether it could possibly be related to it, it was right after vaccine, couple of days, so did that condition, that's been concerned or not. Consumer was informed about the role of Pfizer Drug Safety department and Pfizer Medical Information department. Stated that, could the consumer call this number with the extension. LOT#: Consumer stated, EWO164 (not appropriately paraphrased and clarified). Expiration date: Consumer stated, the only thing they have on here was the date the patient received the vaccine, which was on 18Apr2021. NDC# and UPC#: Consumer stated, not, not on the card, they gave. Contact details (mailing address, email address): Stated that, the consumer guessed to call back, one more time. Stated that, further probing could not be done. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AT 0600 WOKE UP NAUSEA THEN DRY HEAVES THEN VOMITING, VOMITED NUMEROUS TIMES THEN HAD EXPLOSIVE DIARRHEA, TOOK 25 MG BENADRYL ABOUT 1 HOUR AFTER TO MAKE SURE I COULD HOLD IT DOWN AND NOT VOMIT
On 01/14/21 @ 10am-post-injection site inflammation with redness, swelling, itching, warmth, and pain.  01/15/2021 redness and inflammation at post-injection site measures 6.5cm x 10cm.
Pt experienced pain at injection site radiating to lower arm as well as tingling & numbness extending to fingertips; this lasted 3 days; on 4th day site had only soreness at injection site.
The pt experienced a cough, congestion, maculo-papular rash, no vesicles.
no additional AE reported; patient received a dose of PEDVAX HIB and Pentacel on the same day; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 03-AUG-2022, the patient was administered a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # U034519, expiration date: 28-MAR-2024 (route of administration and anatomical location were not provided) for prophylaxis and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (doe, lot #, expiration date, route of administration, anatomical location and indication were not provided) (overdose). No additional events were reported.
Symptoms began approximately 11 hours post vaccine and occurred in the following order: -slightly achy -fatigued -chills -uncontrollable teeth chattering -fever up to 102.8 -significant nausea -diarrhea -inability to sleep -headache Symptoms resolved completely within 24 hours. Symptoms were very pronounced. I haven?t felt that sick in years.
Patient presented to ED 12/8/2021 with muscle aches and weakness, headaches, vomiting, and double vision. Over the next 2 days he had rapid progression of ascending paralysis and was diagnosed with Guillan Barre syndrome.
get this on head, shot does not help/suspected vaccination failure; get this on head, comes and goes at will; painful, sore; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got them on his/her head and its painful, sore and kinda gross lol.  The shot did not helped. The patient stated that it comes and goes at will. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sore arm following vaccination; tiredness in evening of 10/5; 100.4 degree F fever at 0400 on 10/6, aches, chills, weakness, sore arm.
Initial report received from a healthcare professional on 20 February 2013 and Follow-up information received on 25 February 2013. A female patient (age unknown) had received 5.0 ml of first dose of HRIG (Imogam), (lot number H1290-2) at infiltrated at site of scratch and 5.0 ml administered intramuscularly at separate site in gluteal area on 13 February 2013. The patient also received IMOVAX RABIES (lot number G1377-1, route and anatomical site of administration were not reported) and Tetanus shot (Manufacturer, batch number, route and site of administration were unknown), on unspecified date. The patient's illness at the time of vaccination and pre-existing physicain-diagnosed allergies, birth defects and medical conditions were unknown. On 14 February 2013, next day, the patient complained of distal swelling in the hand, tingling and pain and some swelling in forearm which had persisted, perhaps slightly decreasing over the past 7 days. The scratch area on hand/forearm was not red or warm and the reporter stated that the treating physicain ruled out infection. The patient had visited a hand surgeon because of her reported symptoms on an unspecified date and there was no evidence of a compartment syndrome in the report. The physician treated the swelling with a compression glove. Laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None.
On Sunday after the vaccine, he woke up and was peeing blood. We took him to the ER on Sunday. They put a catheter in and observed. There was no blood infection. We brought him home thinking he was better. He was still peeing blood with clots stuck in his canal. He had to be rushed to the ER again. They did an intervention to see what was going on in his bladder. There was nothing going on. Eventually, the blood ceased and after 7 days he was released. He received transfusions. His cirrhosis situation also got worse. All preexisting conditions he had were flared up. He had to receive more injections for his cancer as well.  After the hospitalization, he saw PCP who referred him to specialists. The specialists had no history on my dad so they were not able to tell if anything was abnormal or new. Also, prior to these events, my father was able to walk independently. Now, he requires assistance via a cane or walker.   He is now going to different Hospital.