chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knee hurting; could be arthritis; Knee hurting; could be arthritis; 3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 65 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Grave's Disease", start date: Oct2009 (ongoing), notes: Grave's Disease , Takes: Methimazole for condition. Concomitant medication(s) included: METHIMAZOLE taken for basedow's disease, start date: Oct2009 (ongoing). Vaccination history included: BNT162b2 (dose 1, single, lot number: EN6202, intramuscular in the left arm), administration date: 27Feb2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, lot number: ER2613, intramuscular in the left arm), administration date: 22Mar2021, when the patient was 65-year-old, for COVID-19 immunization; Shingles vaccine (prior to the first COVID vaccine; did not get at the same time as the COVID vaccine), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day"; ARTHRITIS (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Knee hurting; could be arthritis".
Pt was diagnosed with Lyme in Jan 1997 and treated with numerous antibiotics. Aching muscles continued. Received 2 Lyme vaccines in Feb and Mar 1999. Aching muscles, tingling, constant leg pain and weakness got worse since vaccines. Pt suffer these symptoms everyday- constantly. No treatment or doctors has been able to help at all.
muscle spasms from his lower back to his toes on the right side; sciatica; pain; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a first of second reports. This consumer reported for a male patient (Husband, Age: 71) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administation on 12Jan2021 at single dose on Arm Left for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer wanted to report an AE to the first dose of the covid 19 vaccine. The consumer states her husband experienced a twinge in his ham string 2 days before the vaccine but continues to play (caller motioned her husband is athletic) . Husband received the first dose of the vaccine on 12Jan2021, played on the 13th and could not play on the 14th two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed.( shot was in the left arm) Husband went to the hospital on the 16th and they discharged him and he went back on the 17th and did a mri and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and  gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and ride over there was hell, could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him toradol and then additional steroid injections. Husband was able to walk out with a walker. The consumer can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having PT come for consult. Husband insists on getting second dose and caller asked agent "what do I think?". Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the covid 19 vaccine. The consumer stated her husband insisted on getting the second dose of the covid 19 vaccine and asked the agent "what do I think?". The outcome of the event muscle spasms from his lower back to his toes on the right side was recovering. The outcome of the other events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078548 same reporter/drug/event, different patient
After Gardasil injection, pt became faint.  Pt was put in Trendelenberg with a cool cloth on forehead.  After 10 min complained of pain in back of neck with vision changes.  Stated vision going in and out.  Arms felt like jello.  Consulted Dr.  After he examined pt, an ambulance was called to take patient to the ER.  A spinal tap and CT scan of brain was done, which was normal.  Pt was discharged with pain meds.
Incorrect dose administered (0.25 mL), should have been 0.5 mL (booster dose NDC). No side effects reported by the patient.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: doxycycline, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202201212947 Same patient, different drugs and events;
Rash and skin bubbling on sides, arms, and upper legs at 10:10 p.m. on 4/14/21. By 6:30a.m. on 4/15/21, most of the rash had gone away.
welts which are raised, as big as 2 inches; red on both arms; Sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URTICARIA (welts which are raised, as big as 2 inches) and ERYTHEMA (red on both arms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Feb-2021, the patient experienced URTICARIA (welts which are raised, as big as 2 inches) and ERYTHEMA (red on both arms). At the time of the report, PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (red on both arms) outcome was unknown and URTICARIA (welts which are raised, as big as 2 inches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that the symptoms started 2 days after the vaccination with sore arm, which went away and a week later, she experienced sore arm again.  Concomitant medications were not provided.  Treatment included diphenhydramine (Benadryl), cortisone cream and cetirizine (Zyrtec).
Red, bumpy rash on the insides of my left and right forearms. Similar rash on the left side of my stomach, below my left arm pit.
Information has been received from an administrative assistant and physician concerning himself, a 78 year old male with hypertension and high cholesterol and no known drug reactions/allergies who on 25-AUG-2008 was vaccinated subcutaneously with a dose of ZOSTER (Oka/Merck) (Lot # 659268/0158X).  Concomitant therapy included losartan postssium-HCTZ (MSD) and LIPITOR.  On approximately 08-SEP-2008, 2 - 3 weeks later the patient developed itchy eyes, flushing of the face and a warmth sensation in his face.  The facial symptoms had not resolved but the intensity of the symptoms changed.  Following the development of the facial symptoms, the patient also developed pins and needles in the rest of his body that came and went.  The patient's adverse events persisted.  Blood work was completed and the results were normal.  It was unspecified if the patient sought medical attention.
Pt lost consciousness, fell to floor from seat shortly after receiving 2nd dose of Moderna.  Pt assessment was done, vitals were taken.  Pt was alert and oriented x4 when she regained consciousness, denied any neck/back pain.  Reported h/o migraines, denies other past medical history.  Pt sustained small cut to the bridge of her nose.  Pt was transferred to wheelchair where she lost consciousness again for approx 10 seconds.  RN supervisor called 911.  Staff monitored pt until ambulance arrived.   Pt was transported to ER.
One to two hours after receiving injection complained of generalized hives with sl difficulty breathing, took OTC Benadryl. No problems with breathing today 10/31/02 and only a few hives.
Started bleeding, as if she was beginning her menstruation/There was a lot of bleeding; Booster; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FE3590), via an unspecified route of administration, administered in the left arm on 18Oct2021 12:00 (at the age of 47-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient has no relevant medical history. Th patient has no known allergies. The patient has no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) on 18Jan2021 13:00 (lot number: EL3247) as dose 1, single, then on 08Feb2021 13:00 (lot number: EM9810) as dose 2, single - both administered in the right arm at the age of 47-years-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Oct2021 12:00, the patient received dose 3 (booster), single of BNT162B2. On 18Oct2021 16:00, the patient started bleeding, as if she was beginning her menstruation. There was a lot of bleeding, and she needed change her sanitary pad every hour. The bleeding lasted for 6 days. The patient reported that she was not due to get her period and she was not perimenopausal. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as result of the event. The outcome of the event was recovered on 24Oct2021.
Sore body; fever of 102 for 2 days; chills; sore throat; stuffy nose; migraine; lethargy; injection site is still sore; injection site red and hot to touch; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 11:00 as dose 2, single for COVID-19 immunization. Medical history included depression, migraine and COVID-19. The patient's concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 29Jan2021 11:00 as dose 1, single for COVID-19 immunization. Patient reported that she was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was diagnosed with COVID-19 prior to vaccination and since the vaccination, she does not have COVID-19. On 20Feb2021, patient underwent lab tests and procedures which included body temperature: 102. On 20Feb2021, patient experienced sore body, fever of 102 for 2 days, chills, sore throat, stuffy nose, migraine and lethargy. Even though fever broke after two days, still was experiencing all the other symptoms still. Also, the injection site is still sore, red and hot to touch. The patient did not receive any treatment for the events. Seriousness of the events was reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant concerning to multiple unspecified patients of unknown age and gender. The patients had no pertinent medical history, concurrent conditions and concomitant therapies. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot number L015460, expiration date 20-JUL-2017 (dose and route of administration were not reported). No adverse events were reported. There was not product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Caller reports he has noticed his hair falling out, more than normal for the past 2 to 3 months.; This is a spontaneous repot from a Pfizer sponsored Program. A contactable consumer (patient) reported that a 72-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 05Feb2021 (Lot number was unknown, reported as being either EK5318 or EN5318) as dose 2, single for COVID-19 immunization. Medical history included Large B-Cell Thyroid Lymphoma in Jan2010, Brain damage, cancer and has had chemotherapy he now has what is called Chemo brain, has lost a lot of his memory. His brother had a heart attack a couple of years ago; his mom had Alzheimer's; his dad passed away at 90 years old; his 2 brothers and sisters are still alive; his kids have no medical problems. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EK4176) administered in right arm on 06Jan2021 as single dose for COVID-19 immunization (at age 71 years old). The patient noticed his hair falling out, more than normal for the past 2 to 3 months and is persisting on unspecified date in 2021. He looked online and saw that Pfizer is working on a trial for people that are losing their hair.  He stated that he had a head full of hair and everyone commented about how nice it was at his age. He looked up online to see if the vaccine could have caused this. He can't think of any other reason that he would be losing hair. He mentions that he had cancer and has some brain damage. States he is a disabled veteran. He has had both doses of the Pfizer Covid 19 Vaccine and the booster dose in Oct2021. He clarifies that he has not received this dose yet.  After his first and second doses of the vaccine he had no pain and no other side effects. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a nurse concerning a 24 year old female who on 09-JAN-2009 was initial vaccinated with the dose of GARDASIL (LOT# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 09-JAN-2009, the patient experienced dizziness and palpitations after vaccination. On an unspecified date, the symptoms recovered spontaneously without treatment. Follow-up information has been received from the nurse who reported that the 24 year old female on 09-JAN-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (LOT# not reported). Other concomitant therapy included TRI-SPRINTEC. On 09-JAN-2009, the patient experienced heart compression and dizziness after vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered from heart compression and dizziness. The patient went to office on 13-MAR-2009 to receive the second dose of GARDASIL but nurse didn't give her the second dose due to the AE from the first dose. Additional information has been requested.
Bone pain (every bone in my body hurts), diarrhea, fever (100.6), fatigue, injection site pain (can?t lift arm). All movements hurt. Missed work.
Initial report was received from a health care professional on 06 March 2012, as well as another manufacturer under reference number 1-367160101. A 26-year-old male patient had received an intramuscular injection in the left deltoid of FLUZONE, sanofi pasteur Inc. lot number UH463AA on 06 March 2012. Right after the vaccination, the patient experienced dizziness and cold sweats. The patient was treated with BENADRYL and sat down for 10-15 minutes. After 10 minutes, the patient's symptoms subsided and the patient stated he "was fine". The patient also noticed "more bleeding at the injection site than any other injections he has received in the past." The patient had no illness at the time of vaccination and had no known allergies. It was unknown if the patient took any concomitant medications. The patient received no other vaccinations within four weeks of FLUZONE. The patient's outcome was recovered. Documents held by sender: None.
Soreness in injection site beginning around 3 PM on the 18th, with fever-like symptoms (hot and cold, soreness and sluggishness) starting around 3 PM and becoming worse throughout the night. Woke up on the 19th at 7:30 AM with continued injection site pain and fever like symptoms but no notable fever. Also began to feel nauseous on the morning of the 19th, which continued all day. Woke up on the 27th at 10:00 AM feeling mostly back to normal with a small amount of injection site pain left over.
Information has been received from a registered nurse concerning a 10-year-old male with seasonal allergies and amoxicillin allergy who on 17-NOV-2006 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 652450/0948R). Concomitant therapy that day in the other arm included influenza virus vaccine (unspecified). Other concomitant therapy included unnamed nasal sprays and eye drops for allergies. On 19-NOV-2006, the patient experience a six-inch raised red sore area around the varicella virus vaccine live (Oka/Merck) injection site. Medical attention was sought; treatment included ice and acetaminophen (TYLENOL). No additional information to report. There were no lab diagnostic studies performed. There is no product quality compliant. It was also noted that the patient's brother was also vaccinated with varicella virus vaccine live (Oka/Merck) and experienced a six-inch raised red sore area around the injection site (WAES #0611USA06125). Additional information has been requested.
This spontaneous report was received from a registered pharmacist concerning a 73 year old female patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). Other suspect therapy included Influenza Virus Vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. It was reported that on an unknown date, the patient experienced shortness of breath from the Influenza Virus Vaccine (manufacturer unknown) and experienced short term paralysis after administration of PNEUMOVAX23. It was reported that both the vaccines were administered at another unspecified site. The pharmacist had no information about the administration of the vaccines, including when they were administered or if they were administered together or separately. It was unspecified if any treatment was given or if any lab tests were performed. On an unknown date, the patient recovered from the events. The reporter considered the shortness of breath to be related to Influenza Virus Vaccine (manufacturer unknown). The relatedness for short term arm paralysis was unknown for PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown). Upon internal review, short term arm paralysis was considered as medically significant. Additional information has been requested.
I've had my Kyleena IUD since 1/2019 with no issues / symptoms out of the ordinary.  Following my first COVID vaccine on 3/25, I began missing periods (cycles went from a 30 day avg to a 70 day average), and had heightened, painful PMS symptoms in place of regular bleeding.  I've never had bad PMS symptoms before, even before the IUD insertion.  These symptoms included - nausea, loose bowel movements, painful breasts, cramping, and dizziness.  These symptoms began getting bad and occasionally kept me from work the week of 7/19. I sought treatment at the  on 7/28, and had a pelvic / intra-vaginal ultrasound on 7/30.  The ultrasound was normal (no cysts, IUD was properly placed, normal uterine lining).  I am to start taking naproxen (anti inflammatory) if symptoms persist.  I started my period 7/26, and symptoms went away shortly thereafter.
9-3-08 - Office visit - states child slept for 15 hours after MMR and Varivax that was given 9/2/08.  Pharyngitis, groggy when awake.
Preferred route IM. Was given SQ in error. Patient with local reaction, 2 cm warm indurated.
No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date).    No concomitant medications were reported.  Vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was 30-Dec-2022.   The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 5th of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:Master case