chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Awoke Friday to the sensation of the room spinning. It settled after a while but came back somewhat less after breakfast but then resulted in vomitting. Repeat settling and return, vommitting after lunch. Found symptoms faded on and off but no more vomitting Friday. Unsteady walking due to imbalance. Saturday, more spinning but no vomiting. Sunday it seemed to resolve so long as I didn't look down or to my left while lying down. Monday mild imbalance so I visited my PCP,  who said it was likely BPPV, prescribed meclazine for the vertigo, and gave order for a physical therapist which I scheduled for Monday, 3/22/21 which was the earliest available appointment. Friday, 3/19, no problem
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.      On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appeared pale Patient provided water and seen by medical team  Patients blood pressure was 86/59 and heart rate 97, patient provided with water Patient advised to be seen in hospital, patient refused medical transport and signed AMA form Patient agreed to go to hospital , driven by boyfriend
Day after 2nd vaccination I felt lethargic and had a low grade fever if 99.9. Felt flu like s  ymptoms with sight chills. This lasted for about 16 hours.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient still contracted chickenpox. The patient did not seek medical attention. The outcome of the adverse events was reported as recovered on an unknown date. The relatedness between the adverse events and VARIVAX was not provided. Additional information has been requested.
Initial report was received from a customer service representative on 12 October 2011. A 57-year-old female patient had received a FLUZONE injection in left deltoid, lot number UH463AB on 12 October 2011. On the same day, three minutes after the injection the patient experienced pain at the injection site. Three hours later, she developed watering eyes, hot flashes, nausea, swelling and warmth at the injection site. No further informational was available at the time of the report. The patient outcome reported as not recovered/not resolved. Documents held by sender: none
to notice a set bruises on her left arm(injection site) a few days after the first dose; she is not healing as fast as she used to; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0182; expiration date: 31Aug2021), via an unspecified route of administration in the left arm on 18May2021 (at the age of 67-year-old) as single dose for COVID-19 immunization. Patient had no medical history. Patient did not receive any other products (no concomitant medication). On an unspecified date in May2021, few days after the first dose of vaccination, patient started to notice a set bruises on her left arm (injection site). Patient reported that, "instead of a couple of days, it's taken longer or about 3 weeks to heal" and was not healing as fast as she used to on an unspecified date in May2021. Patient noticed this up to 3-4 weeks to the first shot. Patient had been rough housing with her grand-children, and the bruises are not disappearing as fast as before, like up to 2-3 weeks before the shot. It was taking her longer to heal. Patient looks like an abused woman right now. She used to work at Pfizer. She keeps seeing more and more of the bruising. Patient clarified that she first noticed it a couple of days after the first shot happened. It took her bruises about 3 weeks to disappear. She then was rough housing with her grandchild again, and she had black and blues on her arms again. This recurs because of something. The bruises are not popping up on their own. Usually if she has a bruise, they go away in 3 days or so. This was like multiplying it by 7. Patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiration date: 31Aug2021) in left arm on 08Jun2021 as single dose for COVID-19 immunization. Patient was wondering if this was because the vaccine was traveling through her system and asked if there has been reports of this as a side effect and how long will this side effect last. Outcome of both the events were not resolved.
Prevnar given 8/4/03 mid-morning, temp of 102 degrees that night along with Tues AM. Seizure occurred Monday night and Tuesday AM. Pt taken to ER on Monday PM.
Woke up with headache and body aches. I commented that "I feel like I was hit by a bus". I went to work at 6:30 AM and continued to feel worse even though I took 2 tablets of Ibuprofen. I could not complete my shift because I had difficulty concentrating because I felt ill. I left work at 11:15 AM. In the afternoon around 3:00 PM I became very chilled (teeth chattering). My temperature was 102. I had taken Ibuprofen around noon but it didn't alleviate my symptoms. At 3:00 PM I took 2 325 mg tablets of Tylenol which lowered my fever to 100. I continued to take Tylenol about every four hours. I woke up to use the bathroom at 12:30 pm and woke up realizing I was laying on the floor. I got up and blacked out again. I was sweating profusely, felt nauseous, and light headed. My son called an ambulance and I went to the ER at about 1:00 AM on 10/31/2012.
Localized area at site of injection:  2x2 inch irregular circle, red, warm to touch, painful.
This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. A 5-year-old male patient received BNT162b2 (BNT162B2), on 22Aug2022 at 17:00 as dose 1 (orange cap), 0.2 ml single (Lot number: FL8094, Expiration Date: 22Sep2022) at the age of 5 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING HOT (non-serious) with onset 22Aug2022, outcome "recovered" (23Aug2022), described as "felt hot"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 22Aug2022 at 17:00, outcome "unknown" and all described as "a dose of the Pfizer BioNTech COVID-19 orange cap vaccine to a 5-year-old male without dilution"; PAIN IN EXTREMITY (non-serious) with onset 23Aug2022, outcome "not recovered", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Vaccine was not Administered at Military Facility. Prior vaccinations within 4 weeks and adverse event following prior vaccinations were reported as none. The caller reported that they administered the vaccine to a 5-year-old male without the diluting the vaccine. The caller said that nothing bad occurred. This was the first dose. The patient has no allergies or conditions. The only thing is the patient felt a little bit hot yesterday, the patient's mom took the patient's temp, but he had no fever. The patient complained about pain in the arm this morning. The patient does not feel hot and had no fever this morning according to the mother.
bruising, shortness of breath fever severe headaches joint paint , bloody noses, left leg pain, body aches
Transverse myelitis has been diagnosed to me. I have undergone chiropractic treatment and am being followed by a neurologist. I have had numerous MRI's done and other tests. I am currently taking gabapentin and previously took duloxetine.  I have lower back pains, neuropathy was at one point in all my lower limbs. It is now periodically in different parts of my body. I have frequent headaches and spasms in my neck. I have a lot of aches and pains and sciatica.
On 5/28/99, the pt was seen by a physician who noted redness and swelling at injection site. A dx of injection site abscess was made. The abscess was incised and drained; cultures were obtained and found to be negative. The pt was treated with Ancef and Keflex. The abscess developed into an ulcer which was treated with packing that was changed every 2 days.
Patient started vomiting and running fever the evening vaccine was administered. Patient developed swelling, redness, warmth, and hard knot at site of injection in left leg.
Pt notes after receiving MMR vaccine 9/23/04 on 10/02/04 fever 101.7 throat tightness B anterior cervical node swelling dysphagia.
Information has been received from a physician concerning a 4-year-old male who on 22-JAN-2003 was vaccinated with a dose of Varivax (Lot #641162/0797M). There was no concomitant therapy. The physician reported that on 07-MAR-2006 the patient developed shingles on his left arm and shoulder. The patient was not hospitalized and did not require any special treatment or medication. In March 2006, the patient's shingles resolved. Additional information has been requested.
Client reported dry mouth occasional cough and feeling warm after.  Water provided leg elevation cool compress to neck   reports feeling much better
Pt was ordered PROQUAD by provider which is off label for pt due to his age-  pt experienced no side effects from vaccination at this time.
I tested positive for Covid-19 on November 15, 2022 I experienced severe body aches; Congestion; runny nose; fever; chills; I was taking mucus relief to help with my symptoms.
No adverse effect thus far. Patient inadvertently received extra ADACEL (prior dose on 4/10/08) and extra MENACTRA prior dose 01-26-09. MD
Patient given Flumist on 10/1/08. No problems noted at time of administration. On 10/6/08 patient developed pruritic rash.  Seen in office on several occasions. Started Orapred on 10/10/08. Spoke with mother on 10/23/08 and child has urticara-free since 10/14/08.
NAUSEA; DIARRHEA; GENERALIZED WEAKNESS; DECREASED APPETITE; URINARY URGENCY; PAIN DURING URINATION; ELEVATED LIVER FUNCTION TESTS; COUGH; SLIGHT DYSPNEA ON EXERTION WHILE AMBULATING; CONGESTIVE HEART FAILURE; FEVER; CHILLS; BCG VACCINE INFECTION; POSSIBLE SEPSIS; URINARY TRACT INFECTION; PYELONEPHRITIS; Information has been downloaded from Agency (US-SP-2005-02386).  This spontaneous report was received from a health professional referring to a 68-year-old male patient. The patient's medical history included prostate transurethral resection. The patient's concomitant medication was not reported. The patient's concurrent conditions included bladder cancer, benign prostatic hypertrophy, ulcerative colitis, deep vein thrombosis and hypercholesterolemia.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # was reported as 'LOT UNK' (strength, formulation, anatomical location, expiration date and indication were not reported).   On 26-OCT-2005, the patient administered bcg vaccine (THERACYS) (intravesical route for bladder cancer, batch/lot # was C2180A) (intravesical route for bladder cancer, batch/lot# was C2180A) (formulation, strength, anatomical location and expiration date were not reported).   On 29-OCT-2005, the patient experienced fever (pyrexia), chills, possible sepsis (sepsis), bcg vaccine infection (disseminated bacillus calmette-guerin infection), pyelonephritis and urinary tract infection and on an unknown date, the patient was hospitalized due to the events.   On an unknown date, the patient experienced nausea, congestive heart failure, slight dyspnea on exertion while ambulating (dyspnoea exertional), cough, elevated liver function tests (hepatic enzyme increased), pain during urination (dysuria), urinary urgency (micturition urgency), decreased appetite, generalized weakness (asthenia) and diarrhea and the patient hospitalized due the events. The action taken with suspect therapies was not reported.  On an unknown date, the patient was recovered from pyrexia. The outcome of chills, dyspnoea exertional, cough, hepatic enzyme increased, sepsis, dysuria, micturition urgency, decreased appetite, generalized weakness, pyelonephritis, urinary tract infection and nausea was reported as unknown. At time of report, the patient was not recovered from the events diarrhoea, congestive heart failure and disseminated bacillus calmette-guerin infection.  The relatedness between all the events and the suspect therapies was not provided.  The Agency considered all the events to be medically significant.; Sender's Comments:  2005-02399:
This case was reported by a healthcare professional, via Takeda Pharmaceuticals N.A., and described the occurrence of hive in male subject aged between 70 and 79 years old who was vaccinated with Influenza vaccine, (manufacturer unspecified) and DEXILANT over a period of 1 days for an unknown drug indication. Concurrent medical conditions included alcoholism. On an unspecified date, the subject received a dose of Influenza vaccine (unknown) and started Dexlansoprazole (oral) at 60 mg daily. Therapy dates and indication were not reported. Less than one day after receiving Influenza vaccine and starting Dexlansoprazole, the subject experienced hives, nausea, vomiting and being flushed. Treatment with Dexlansoprazole was discontinued after the first dose. Treatment included BENADRYL. At the time of reporting the hive, nausea, vomiting and flushing resolved. The healthcare professional considered the events were possibly related to DEXILANT therapy and provided an alternative etiology of alcohol consumption.
My entire family of 5 ended up getting COVID; had first vaccine in July, has not yet had her second as of yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet) 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet). At the time of the report, COVID-19 (My entire family of 5 ended up getting COVID) and PRODUCT DOSE OMISSION ISSUE (had first vaccine in July, has not yet had her second as of yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.; Sender's Comments: This case concerns a female with unknown age , with no reported medical history, who experience the unexpected events of Covid 19 and Product dose omission issue . These events occurred on  an unknown date after vaccination with the first doe of mRNA- 1273 (Moderna). The rechallenge is not applicable since there is no report yet of a  2nd dose. The benefit -risk relationship of mRNA-1273( Moderna ) is not affected by this report.
experienced severe swelling of the feet; difficulty walking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: SWELLING (non-serious), outcome "unknown", described as "experienced severe swelling of the feet"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking".  Additional information: A non-contactable consumer reported for a patient (reporter's family member). No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. That family member was scared to take 2nd dose and wondering if Pfizer would monitor them or screen them to see why they had reaction in the first place. Were any medical questions addressed by this program forwarded/referred to Medical Information? N/A.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 17 year old female who was vaccinated with a dose of GARDASIL vaccine (yeast). Physician reported the patient had upper leg thigh aches and pains in both legs post vaccination with GARDASIL vaccine (yeast). The patient has had 2 doses of GARDASIL vaccine (yeast). The physician did not provide any other information. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 25-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Coughing up blood; Cough; This is a spontaneous report from a contactable consumer (Patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 06May2021 11:00 (Age at vaccination: 23-years-old) as dose2, single for Covid-19 immunization. (Vaccination Facility: Campus). No medical history and no concomitant medications were reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:45 AM (at the age of 23 years) as single dose for Covid-19 immunization. Patient did not receive any other vaccine within 4 weeks of Covid-19 vaccination. It was reported that patient got my second dose of Pfizer Vaccine on 06May2021 and this morning(09Jun2021) he have been coughing up blood and actually in the past month he have been coughing but he took Mucinac last week and it help with her cough but this morning he had started coughing again and this time it was blood. Patient confirmed that both dose are with Pfizer. Stated just little bit of blood but you can see that this blood. He wanted to know what to do like do he see his Physician or do he just take some over the counter medications. The outcome for the event coughing up blood was not resolved and for event cough outcome was reported as resolving at the time of this report.  Follow-Up 20Jul2021: Follow-up attempts are completed. No further information is expected.
Elevated temperature (last reading 101.2F), malaise, nausea/vomiting, complaining of abdominal and injection site pain.  Vaccine was yesterday, symptoms have been getting progressively worse as the day goes on today.
Painful earache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Aug2021 at 11:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 09Aug2021 at 19:00, the patient experienced painful earache. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 event. The clinical outcome of the event painful earache was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 17:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 06Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 04Jun2022.  The following information was reported: VACCINATION FAILURE (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: Covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Treatment of covid-19 was with paxlovid with start date 04Jun2022 & stop date 08Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt started feeling SOB about 15 minutes after vaccination, feeling tingling in arms/hands. She then reported it was harder to breathe and throat was feeling weird. She was lightheaded.  EPI 0.3mg administered by autoinjector, then 50mg Benadryl administered. Shortness of breathe continued and chest pain developed. Another dose of EPI administered 5 min later. EMS arrived and transported pt. to ER.
0915)  Patient received his first Pfizer COVID vaccine in Left arm.  0918) Brother states that patient just passed out.  Patient is checked and is responsive, alert and oriented X3, pale, and diaphoretic.  He is lowered to the floor, feet elevated, ice pack behind his neck.  BP:116/68  P: 66  O2 Sat: 98%.  0921)  BP: 116/73  P: 73  O2 Sat:  98%.  0925) BP: 128/75  P: 81  O2 Sat: 98%  Patient got up and sitting in a recliner chair.  Patient drinking water and eating crackers.  States he is feeling better.  Color is no longer pale.  0927)  BP: 118/75  P: 82  O2 Sat:  98%.  0935) BP: 113/71  P: 82  O2 Sat:  98%.   0942)   BP: 112/74  P: 81  O2 Sat:  98%.  1000)  Patient stood up, feeling back to normal, and was discharged to home with his Mother.