chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had tje typical sore arm; headache; later that night I got a muscle spasm in my lower back; My entire back was inflamed; My back still hurts but not as bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10May2021 12:00 (Lot number: EW0165) at the age of 64 years (not pregnant) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: Years ago when I got the shingles vaccine it took me 3 years to get the inflammation to settle down. Concomitant medication(s) included: AMBIEN; XANAX; VICTOZA; BASAGLAR; CLONIDINE.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "Had tje typical sore arm"; HEADACHE (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "headache"; MUSCLE SPASMS (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "later that night I got a muscle spasm in my lower back"; INFLAMMATION (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "My entire back was inflamed"; BACK PAIN (non-serious) with onset 17May2021 16:00, outcome "not recovered", described as "My back still hurts but not as bad". The events "had tje typical sore arm", "headache", "later that night i got a muscle spasm in my lower back", "my entire back was inflamed" and "my back still hurts but not as bad" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, headache, muscle spasms, inflammation, back pain.  Additional Information: Route of administration for Dose 1 was intramuscular in Arm right. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the 1st vaccine at noon. Had tje typical sore arm and headache but later that night she got a muscle spasm in her lower back which she could not get rid of with muscle relaxers. Her entire back was inflamed. She called her doctor and doctor put her on a steroid dose pack for a week. Her back still hurts but not as bad. She is really scared to get the 2nd one because she heard that the 2nd one has worse side effects. Years ago when she got the shingles vaccine it took her 3 years to get the inflammation to settle down. Treatment received for the adverse event was Steroid pack. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 on 28May2021 saliva was tested with results negative.  Follow-up attempts are completed. No further information is expected.
Fever 104 on 30PAR91; Also had runny nose & eyes; Seen @ hosp ER told rxn to immun; tx APAP for fever; all sx gone by 1MAY91;
Administration of expired moderna vaccine that were given as booster shot to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient ) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient ). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. It was reported that the booster vaccine was stored in freezer and they took out one to two vials and placed in fridge each day as needed.
I've had a pain on the left side of my head that's  tender to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: Ibuprofen. The following information was reported: HEADACHE (non-serious) with onset 02Sep2021 18:30, outcome "not recovered", described as "I've had a pain on the left side of my head that's  tender to the touch". Therapeutic measures were not taken as a result of headache.  Additional information:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient said a week after the immunization her arm started with a dull throbbing pain. She still has the pain the majority of the day and she can't lift it all the way up.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012147: US-009507513-1704USA012148: US-009507513-1704USA012149:
Pain in arm - Difficult breathing - Tightness in chest starting 1 week after injection.
21OCT mom reports t103.4 ax on 20OCT; taken to ER & given APAP according to mom, however was not seen by MD; mom reports no seizure activity or change in LOC; playful today c/o rt leg pain-no swelling;
Headache, Myalgia, Fever Chills Narrative: No further details given
Evening of 4/2 starting feeling like I had UTI. 4/3/21 Itching hives on face, neck, arms, back, stomach.  Headache.     On 4/4 ER shot, steriod fast acting and slow acting then had pill to take for 7 day.   Had headache and nausea for more than week after steriod, then developed scratchy throat, sinus.  sweaty and chilling went to doctor .
This spontaneous report as received from a pharmacist refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 24-OCT-2014, the patient was vaccinated inadvertently with expired dose of PNEUMOVAX23 (lot number, dose, frequency and route unspecified) (expired product administered). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX23 was not reported. Product quality issue was not involved. Additional information has been requested.
Patient received the Pfizer COVID-19 vaccine (both doses) and had just recently tested positive for COVID-19; Patient received the Pfizer COVID-19 vaccine (both doses) and had just recently tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient who is a healthcare worker). A patient of unspecified age and gender received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via unspecified routes of administration, on unspecified dates, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine (both doses) and had just recently tested positive for COVID-19 this past weekend (Apr2021). Although the patient was very aware that breakthrough does occur, from what the patient understands, it is still a fairly rare phenomenon. The patient was reaching out to see if there is any way he/she could be of assistance for research purposes to better understand why he/she was a breakthrough. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID-19 based on the known safety profile.
Approximately a week after the 2nd dose   I experienced extreme ringing in both ears.  It has been constantly present ,sometimes worse than others..I thought it would subside and when it didn?t I made an appt to see an  ear doctor.  My ear doctor has confirmed there has been recent complaints re tinnitus after receiving vaccine. I will be scheduled for hearing test. Also was informed there is no current treatment. Suggested white noise to mitigate the severity of the ringing. It is very debilitating to have constant noise in my ears
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Reporter reported that the patient had an adult niece and an adult nephew who both recently tested positive for Covid. They had received the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200004383 Different patients, Same reporter, drug, event.;
Beginning about 18 hours after my 2nd dose of the Moderna Vaccine, I began running a fever, had a headache, chills and nausea.  I expected some of this as I'd experienced those symptoms following the 1st dose.  However, 4 days post my 2nd dose, I still have headache, chills and nausea.  I had expected ill effects to last not longer than 24 hours.   I have not sought the assistance or treatment of a medical professional as these symptoms seem manageable in the short term - they are however continuing (unexpectedly).  I wonder if others have experienced prolonged adverse effects?
Started slurring his words and became off balance. Had a lot of pain on the right side of his head. Server head paind.
When sleeping it's body startle it like if gasping for air happened several times; Exhausted.; Mentioned that it had nausea and that couldn't do anything but says it feels much better; Arm is still sore; Arm is still red; Sickness; Heart racing; Throwing up; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PALPITATIONS (Heart racing), DYSPNOEA (When sleeping it's body startle it like if gasping for air happened several times), FATIGUE (Exhausted.) and VOMITING (Throwing up) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ILLNESS (Sickness), PALPITATIONS (Heart racing), VOMITING (Throwing up), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced DYSPNOEA (When sleeping it's body startle it like if gasping for air happened several times), FATIGUE (Exhausted.), NAUSEA (Mentioned that it had nausea and that couldn't do anything but says it feels much better), VACCINATION SITE PAIN (Arm is still sore) and VACCINATION SITE ERYTHEMA (Arm is still red). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness), PALPITATIONS (Heart racing), DYSPNOEA (When sleeping it's body startle it like if gasping for air happened several times), FATIGUE (Exhausted.), VOMITING (Throwing up), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Mentioned that it had nausea and that couldn't do anything but says it feels much better), VACCINATION SITE PAIN (Arm is still sore) and VACCINATION SITE ERYTHEMA (Arm is still red) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  The patient received both doses on left shoulder.  The patient reported gasping for air was intense for 15 hours and that 44 to 45 hours finally felt like it was somewhat ok. The patient reported she couldn't function for a long while, like for the first 12 hours, then throwed up and for 4 more hours it was intense.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
pt recvd vax; pt menstrual period consisted of some spotting; she was subsequently found to be pregnant;
Swollen Arm with intense pain, Extreme Headache, 102 Fever, body weakness, extreme fatigue
Metallic taste in mouth, lasting 2-3 weeks; symptoms of Urinary Tract Infection (urgency, burning, tender bladder area, frequency of urination).  No treatments were provided by my doctor.
approx 5PM 11MAR93 t102 ax w/irritability & crying; 12MAR93 AM t101AZ; mom states gave APAP since shots given; refuses to eat;
Punctured vial was store in Fridge; 2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Punctured vial was store in Fridge) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was store in Fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Punctured vial was store in Fridge) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. The vaccine administered more than 24 hours after the vial was initially punctured. On 8Jun2022 @ 1:10pm,the vial was first punctured. On 27May2022,the vial was initially stored in the refrigerator. On 9Jun2022@ 2pm & 2:01pm, the vaccine administered. The vial does not undergone any temperature excursions. Treatment information was not provided.   This case was linked to MOD-2022-587247 (Patient Link).
In evening  severe left arm and neck soreness, very tired, followed by prolonged diarrhea which continued until next day.
During administration of COVID-19 vaccine, needle became disconnected from syringe and vaccine sprayed into pt. eyes. Pt. taken to eyewash station and eyes flushed for 10 minutes. Pfizer called and notified of event. Pt. monitored for 45 minutes. Denies eye pain, itching, tearing, or visual disturbances. Pt. instructed to report any change in vision or eyes to me immediately. Pt. verbalized understanding and wishes to remain at work.
Patient reports severe headache, nausea and vomiting starting about 6 hours after vaccine. Sometime during the night a fever of  104 which went away with Advil. Nausea/Vomiting/Headache still occurring 14 hours later.
Exact date when reaction started is unknown. Patient states he has a rash/pain in arm after receiving flu shot. The pain is radiating down his arm. He has had torn rotator cuff before, so he is not sure if the pain after flu shot is just coincidence or if the pain/reaction is specifically related to the flu shot.
this is one of four pt to devel an inj site rxn characterized by pain, swelling, & redness following vax;MD recommended DPH for this rxn;pt has recovered;
Pt fine after vaccinations. Approx. 11 hours after, pt became "tired" and fussy. No fever. MOC gave TYLENOL. Was laying in bed approx. one hour later and pt rolled over with face in pillow and became stiff. MOC rolled her over. Pt was "extremely hot", eyes rolled back in head, and cyanotic.  Pt vomited and was breathing on own, but still cyanotic for another 5-10 min until EMS arrived.  Normal ER evaluation and has been fine since.
Hearing loss began several days after vaccine.  Approximately 10 days after vaccine hearing loss became severe.  Approximately 20 days after vaccine hearing began to restore.  It is about 80 % restored now.
Post vax, while mom was giving child a bottle she pulled her arm up with fists clenched and stared up blankly. Mom thought it lasted about 45 seconds. This happened two more times. As of 5/3/00, there has been no further episodes.
Rapid heart rate, elevated BP, rash on neck & face, headache, numbness on lips & tongue.  Monitored for about 45 mins until heart rate & BP went down. Took Benadryl.  Headache lasted 24 hours.  On 3/22 started experiencing outbreak of hives, red dots (looked like chicken pox), extreme itching - mainly on torso and down legs.  Saw family doc 3/23 prescribed Methylprednisolone 4mg, Trimcinolone and continue with Benadryl. As of today 3/29 outbreak continuing hives, itching and red marks on torso, buttocks, thigh.
So, I woke up on a day about a week after the vaccine and I was having clots of blood in the bed from my period, and every time I go to the restroom it is always clotting, it was not a flow of blood it was just clots that kept coming out. It was no cramps; it was just clotting, and I did not know what was going on. So that is basically the only issue that I had. I contacted the DR and made an appointment so I could make sure that there was nothing major going on with me. They stated that I was having pre-menopause they think.
Information has been received from a health professional concerning a 17 year old white female who on an unspecified date was vaccinated with the first dose of Gardasil.  On 07-JUL-2007, the patient was vaccinated with the second dose of Gardasil (lot #0469U) in the left deltoid at 9:30 AM.  On 07-JUL-2007, at 10:00 AM, the patient developed a raised welt that left a scar at the injection site.  The patient recovered from the welt but the outcome of the scar was unknown. Addional information was received from a healthcare worker. When the welt resolved a permanent scar was left at the site. No further information is available.
Received the 2nd COVID vaccine (Pfizer lot #EW0185, use by 05/23/2021 at 1240, expiration date 08/2021) at 1015. Client reported having a headache to  EMT who immediately gave the client water, juice, and Pringles and offered to recline the anti-gravity chair back for the patient, but the patient stated, " No thank you." then notified the vaccination lead, RN, RN then assessed the patient while , EMT took the patients vitals. The patient denied  experiencing shortness of breath, chest pain,  difficulty swallowing, or facial flushing. Client denied having any chronic medical conditions and is allergic to amoxicillin. Reported taking an anti-depressant medication daily, name and dosage of antidepressant unknown. Vital signs taken at 1032: BP- 135/82 (Right arm, sitting upright), HR- 71, RR-16, oxygen saturation- 98%. The patient was alert and oriented to person, place, time, and situation. The patient was smiling and talking to her mother while she was sitting in the anti-gravity chair. Vital signs were taken at 1045, BP- 132/88 (Right arm, sitting upright), HR- 69, RR-16, oxygen saturation: 98%. Client reported that her headache was very mild. Patient reported having a history of intermittent headaches. Denied shortness of breath, dizziness, lightheadedness, difficulty swallowing, and chest pain. Vital Signs were taken at 1054- BP 132/84 (R arm, sitting upright), HR- 70, RR- 16, oxygen saturation at 98%. The client stated, " My headaches gone now." Client denied any vision changes, lightheadedness, chest pain, or difficulty breathing. The client was in no apparent distress. A final set of vital signs were taken at 1102, BP- 138/86 ( Right arm, sitting upright), HR- 69, RR-16, oxygen saturation at 97%. RN educated the client and her mother about V-Safe. Educated the client to follow-up with her primary care provider if symptoms returned and/or worsened, educated the client about Emergency Room precautions such as if she experienced dizziness, changes in vision, difficulty swallowing, or shortness of breath, to immediately call 911. The client verbalized understanding and left the site at 1105.
Information has been received from a physician concerning a female who on an unknown date was vaccinated with a dose of MMR II (route, site, dose and lot number not reported). On an unknown date, the patient experienced mumps. The outcome for mumps was not reported. No further information is available.
I21.4 ACUTE NON ST ELEVATION MI 4/3/2023 ELEVATED TROPONIN I