chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not going to get her second dose; Her mind is not quite the same, she is not as sharp as she was after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not going to get her second dose) and VACCINATION COMPLICATION (Her mind is not quite the same, she is not as sharp as she was after first dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Surgery (Recovering from Back Surgery.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not going to get her second dose) and VACCINATION COMPLICATION (Her mind is not quite the same, she is not as sharp as she was after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not going to get her second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Patient observed itching in chest area 15min following vaccination, but did not initially report symptoms to clinic staff. When patient did report ongoing symptoms at 12:45pm, clinic staff administered liquid diphenhydramine 40mL/100mg PO and stayed for continued observation by clinic staff. Patient notes symptoms completely resolved at 1:15pm and was released from clinic.
severe right sided facial nerve pain and sensitivity; developed herpes simplex sore on right side of mouth/ cold sore; low grade fever; fatigue; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 03Mar2021 09:00 (Lot Number: EJ1685) as single dose for covid-19 immunisation; lidocaine hcl and bupivacaine hydrochloride (BUCAINE), both via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at unknown dosage for numbing the right upper molar area. Patient is not pregnant. Medical history included known allergies to Latex and hypertension. Concomitant medications in two weeks including vitamins. No other vaccine in four weeks. Patient had dental procedure on 06Mar2021 on including Lidocaine/Bucaine injection to numb the right upper molar area. On 08Mar2021 patient developed severe right sided facial nerve pain and sensitivity. On 08Mar2021 patient developed herpes simplex sore on right side of mouth, low grade fever, fatigue. Evaluated by HCP on 10Mar2021 who was going to prescribe steroids but did not due to receiving the Covid vaccine on 03Mar2021. HCP unsure if the herpes simplex, low grade fever, fatigue are due to dental procedure or Covid vaccine. Have been taking Ibuprofen & Acetaminophen. Facility type vaccine at Workplace clinic. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. On 16Mar2021, patient stated cold sore symptoms began on 08Mar2021. patient became aware that the facial pain symptoms may or may not be related to the Covid vaccine and/or the cold sore on 10Mar2021 when seeing a physician. The action taken for lidocaine hcl and bupivacaine hydrochloride was unknown. The event outcome for all events was recovering.  Pfizer is a marketing authorization holder of lidocaine hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of lidocaine hcl has submitted the same report to the regulatory authorities.
fever of 101.7/ fever was at 101.5; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported that a male patient of an unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took 1st dose of BNT162B2. The patient received second COVID shot on Wednesday (06Jan2021). On 06Jan2021, had a fever of 101.7. This morning (08Jan2021) fever was at 101.5. Patient was advised by his HCP to call and report side effects. Outcome of the event was unknown.   Information about lot/batch number is requested.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Symptoms below have been noticed for 2 days after receiving vaccine.  - Fever,  - Sweating,  - Chills, - Nausea   Treatment: Over the counter medication  - Paracetamol (Trade name: Dolo 650) - 650 mg taken b.i.d) - Vicks vapor inhaler
Flu-like symptoms; This is a spontaneous report based on the information received by Pfizer (Case number: 01868196). A non-contactable Nurse reported similar events for two patients (herself and her husband). This is first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. After their second dose of Pfizer vaccine on an unspecified date, the patient had experienced flu-like symptoms. The outcome of the event was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021222426 same reporter/drug/event & different patient
No additional AE/PQC reported.; PEDVAX HIB and ROTATQ administered after temperature excursion. Temperature 23.8C . Time frame 9 Hours 45 minutes.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 25-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: W004502 has been verified to be a valid lot number with expiration date on 09-OCT-2023); and a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number U039951 has been verified to be a valid lot number with expiration date on 22-JUN-2024 (doses, strengths, routes of administration, anatomical injection sites and frequencies were not reported), both administered for prophylaxis. Both vaccines were  stored at a temperature of 23.8 degree Celsius (C) for the time frame of 9 hours and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Became extremely dizzy Monday night, 48 hours after receiving the vaccine.; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL3249), via an unspecified route of administration on 16Jan2021 16:15 at a single dose for covid-19 immunization. The patient's medical history included migraine (migraine headaches) from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included apple cider vinegar, butalbital, caffeine, paracetamol (FIORICET) and multi-vitamin. On 18Jan2021 at 21:15, the patient became extremely dizzy Monday night, 48 hours after receiving the vaccine. The episode was brief and went away, but was very scary, as this has never happened before. The patient did not received treatment for the event. The outcome of the event was recovered in Jan2021. The patient has not had vaccine in four weeks. The patient has not had Covid prior to vaccination and not tested for Covid post vaccination.
Blurry vision in left eye for past 4 weeks. started day after second dose.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 16Mar2021 at 20:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), valaciclovir hydrochloride (VALTREX), vitamin b (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) all from unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not  tested for COVID-19. On 17Mar2021 at 14:00,day after second dose, the patient experienced blurry vision in left eye for past 4 weeks. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of blurry vision in left eye was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
RASH, HIVES, SCRATCHY THROAT,  SWELLING , ITCHY TONGUE, ITCHING SENSTAION
depression; anxiety; brain fog, brain zaps,; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included anxiety and depression. Concomitant medications included fluoxetine hydrochloride (PROZAC) and bupropion hydrochloride (WELLBUTRIN). The patient had no allergy to any medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 19Feb2021, the patient experienced an increase in mental health issues such as depression, anxiety and had brain fog, brain zaps, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the events. The clinical outcome of the events increased mental health issues such as depression, anxiety and had brain fog, brain zaps, and fatigue were resolved after a week on 26Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe joints pain; Got fever a 100 and 101; Headache; Severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0170) via unspecified route of administration on an unknown date in left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication (Other medications: Consumer stated I am taking something for prostate and Lipitor I think) was not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8737) via unspecified route of administration on an unknown date in left arm as a single dose for COVID-19 immunization. It was reported that patient received his second shot of COVID vaccine and at around 2:00  had the adverse reaction got fever a 100 and 101, headache, severe joints pain and severe fatigue. The outcome of the events was unknown.   No follow-up attempts are needed. No further information was expected.
Information has been received from a physician concerning a 10 year old male who on 12-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). After receiving his second dose of varicella virus vaccine live (Oka/Merck), on 14-JUL-2007, the patient developed redness and swelling of his arm from the deltoid (where the vaccination was given) down to his elbow. This reaction prompted a visit to the emergency room. The patient was not admitted to the hospital. The patient went back to the emergency room on  15-JUL-2007 for a second visit. The patient also experienced a low grade fever and was said to be "delirious." The patient was not admitted to the hospital. The patient was prescribed Augmentin during one of the emergency room visits. As of 16-JUL-2007, the patient was said to be recovering. Additional information has been requested.
This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored ROTATEQ reported lot number N030364, expiry date 06-MAR-2019 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine ROTATEQ, experienced a temperature excursion of 9 degrees to 25 degrees Celsius for 13 minutes, with a previous temperature excursion of 9 degrees to 25 degrees Celsius for 15 hours, as recorded by a data logger. No adverse effects were reported. No product quality complaint was filed.
After second dose, tiredness, achy body, and headaches 6 hours later. All day day after headache and body aches continued. Evening of second day fever and chills through the night. Aches and headache was present when I woke the second morning after the shot, and were completely gone by 5pm the second day after shot.
Cardiac arrest; This is a spontaneous report received by a contactable consumer.  A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Recently the patient received the first shot of COVID-19 vaccine and subsequently went into cardiac arrest. He unfortunately passed away one week later. It was unknown if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest
Patient received flu shot in the morning and returned to Health Services later in the day. Her arm was swollen about the size of a golf ball. She is a petite person. Health services used first aid treatment with ice and Motrin. She returned the following day and the arm was less swollen. She did have redness across her arm and band of redness about 2-3" wide.
Initial case received on 24 July 2014 from a consumer who is the patient. A 56 year old female patient was vaccinated intramuscularly into the left deltoid on 06 November 2012 with FLUZONE, lot number reported as A726EA (not valid). The patient has NKA (no known allergies). The patient has a history of many previous doses of FLUZONE. The patient denied illness at the time of vaccination. Concomitant medications were not reported. On 06 November 2012, within 10 minutes of the vaccine, she had a 20 minute nose bleed and left arm pain. She has been sick with left arm pain, a frozen shoulder and a variety of other symptoms like vertigo, severe flu for 2 months, laryngitis and increased secretions, falling, right neck pain from shoulder to right neck, fever, numbness and swelling in left axillary area with neuropathy in left arm. Increased sleep of 20-22 hours. Lumps develop on her left arm, back and mild thoracic area around the injection site whenever she uses her left arm. "When the lumps are touched they cause changes in her brain function with brain drifting and memory disorders with a metallic taste in her mouth with chills and general weakness." Dyspnea and cardiac changes with weight gain of 22 pounds overnight when she fell asleep on her left arm. She had high blood pressure and continued weight gain when the doctor pressed on the lumps with irregular heart rhythm. Unable to eat due to edema pressing on her stomach. She had keytones, blood and mucous in her urine. The patient outcome is not recovered. It is reported that the patient was hospitalized (no details). Documents held by sender: None.
3-2-90 RECVD VAX. 3-8-90 HEADACHE,BODY ACHE,LYMPH NODES SWOLLEN,FEVER 101.4 F DROPPED A DAY LATER.3-17-90 PT EXP RASH WHICH PERSISTED 2.5 DAYS.PHYS MISTAKED GERMAN MEASLES BUT IMMUNE TO.FURTHER DIAG WAS VIRAL ILLNES.3-19-90 JOINTS ACHED
Mild discomfort and swelling in the (L) deltoid area where vaccine administered. Raised pink lesions in area as well. Treated with prednisone and CLARITIN.
left arm pain, swelling at injection site the next morning, more swelling below the injection site the day after, low fever 24 hours after injection,  Early on 3rd day itchy rash, bubbles appear at lower swelling site (below injection point)
fever; headache; This is a spontaneous report received from a consumer(patient). A 56-Years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry Date were not reported) dose 1, via on an unspecified route on 22Mar2021 as DOSE 1, SINGLE for COVID-19 Immunization (at the age of 56-Years-Old). Medical history included Leukaemia and Lymphoma on an unknown date. The concomitant medications were not reported. It was reported, is it normal to have fever of 99 degrees and headache for 2 weeks after the first Pfizer covid-19 vaccine. And asked what is the incidence of these and how long do they last and are side effects worse with the second injection and this male consumer reported receiving his first injection of the Pfizer covid-19 vaccine about two weeks ago. Ever since the injection, he had been experiencing headaches every day and fever off and on. The consumer has a history of leukaemia and lymphoma and is being treated with Imbruvica. The consumer also takes hydrocodone as well as some other unspecified medications and that he's not sure if that's part of the side effects that he is experiencing or not. Caller reported that he was told not to take Aleve, so he has been taking Tylenol for his headache and also doesn't last all day, but that most of the day he has a headache even if he takes Tylenol and also stated, he did not want to return a sample of the acetaminophen if a sample was requested that he just wanted something that worked for his pain (included Tylenol, Acetaminophen 500 mg; 100 tablets (Lot Number: ACA120055/A, Expiry date: Apr2022)). Once in a while he had a fever after receiving the Covid-19 vaccine, but the fever goes away quickly. The patient needed to reschedule second vaccine appointment for next week has a dental appointment the day before scheduled vaccine. The patient underwent lab tests and procedures which included fever of 99 degrees after first vaccine on an unspecified date. The clinical outcome of the events were unknown.     Further information needed, Information about batch/lot number has been requested.
muscle aches, fever, chills, headache, joint pain, lethargy, skin sensetivity
On the day of my booster 10/05/2021, I started to feel sick for 5 days and had total lack of clarity and was barely able to teach. On the 6th day, I could not speak and had to drive myself to the hospital I felt like I was having a stroke. I was admitted overnight and they ran 12 tests on me. I saw two different Neurologists. I saw a Cardiologist wore a heart monitor for two weeks and have a follow-up on May 9th. I seen a ton of doctors including my PCP. I was prescribed Atorvastatin but I did not take it. The hospital provider told me to see my PCP in a week which I did. I am not sure if I had a blood clot and if it has moved or gone away.
Pt recv vax on 11/2/98; on same day pt exp pain/swollen/red/itchy vax site, increased heart rate & dry mouth; tx=Benadryl, Keflex, Tylenol, ice packs &heat to site
Extreme fatigue on Fri. the day after vaccine.  Foggy and disoriented on Sat. 3/6. I needed to cancel and change a 3/6 flight by10:30AM on Sat 3/6.  Thinking that it was still Friday, I failed to show up for my Saturday morning flight, was considered a "no show" by the airline  (something I'd never do) and forfeited my ticket. Only later on Sat 3/6 did I realize what had happened.
After vaccine given pt. immediately c/o severe neck pain and nausea. The physician's assistant examined her & felt she was stable. Pt was asked to rest in exam room for 45 mins. Then felt better. Left in good condition. Later had OV 3/29/23 & c/o fillings fell out of bottom teeth.
Information has been received from a Licensed Practical Nurse and a Registered Nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 18-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot# K023328, expiry date 23-JUN-2016) (route and dose unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Received 2nd dose of Pfizer COVID vaccine. on 3/24/2021.  On 3/28/201 developed body aches, headache and rhinorrhea.  Tested positive for COVID-19.
Patient received Moderna for the second vaccine after receiving Pfizer on 4/16/2021. Troubleshooting: Scribe and vaccinator did not validate the first vaccine although the first vaccine is listed on the computer;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day. The original appointment was made for tomorrow (a Pfizer day) but he came today. Counseled that this is a complete series and no other vaccine needed per safety officer.
Patient reported that she experienced swelling of the lower lip along with slight numbing and tingling sensation in that area after receiving the influenza vaccine on 8/25/20. Patient reported that symptoms started around 7:00pm on 8/25/20. Patient states that she did not receive any treatment or take any medications to mitigate adverse reaction. Patient presented to pharmacy on 8/26/20, I observed slight swelling of lower lip. Patient reported that she was not having any trouble breathing or tightness of chest. Patient was advised to take Benadryl OTC and contact her PCP.