chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient?s daughter, reported that her mom received the Moderna COVID-19 vaccinations on the following dates: Moderna 1st dose 3/18/21 Lot# 047A21A Moderna 2nd dose 4/15/21 Lot# 040B21A Moderna Booster 11/01/2021 Lot# 039F21A  patient?s daughter, noted that she noticed her mother?s state of confusion on Wednesday, January 5th, 2022, the day prior to her birthday, when the family was discussing plans to celebrate her birthday the next day.  Patient responded in confusion, thinking that it was currently October, not January.  The following day, the family took her to the ER with extremely high blood pressure and confusion.  The results of the CT were negative, but MRI showed Acute Ischemic Stroke around the thalamus.  Patient was hospitalized and became worse.  By Friday, patient?s face began to droop, she had difficulty swallowing, was not able to walk, could not eat, and had slurred speech.  As of today, January 21, 2022, patient is still hospitalized, does not recognize her daughter, still has slurred speech, and has cognitive impairment.  Patient is in rehab and is able to walk with the assistance of a walker.  Pts daughter noted that MD?s were unaware of the trigger of her mom?s stroke
we provided the booster shot (0.25ml) 3 weeks too early for the patient. His last dose was 5/18/2021
No adverse event; Improperly stored dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a healthcare professional referring to a patient of unknown age. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were not reported. On 01-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, formulation, dose/frequency, route were not reported) lot # R025726 expiration date reported as 26-MAY-2021, but upon internal validation established as 08-OCT-2018, for prophylaxis. On 01-NOV-2019, the patient was administered with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product storage error). The vaccine was stored at a temperature of 50 Fahrenheit for 2 hours, 20 minutes. Previous temperature excursion was 50 Fahrenheit for 30 minutes. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
pt recv vax 7MAY98 & presented w/a significant local rxn including swelling;pain, itching, redness & heat over arm of 12 x 15cm;
Nonfebrile seizure 07/02/2003 associated with breath-holding.  2 minute generalized tonic-clonic.
Recipient reported pulsating around the injection site during the 15 minute observation period. HR- 77-82, O2- 100%
Vertigo.  Did Epley Maneuver.  Did not make better.  Had Vertigo for 20 days starting April 17, 2021 and continued with dizziness for the next week.  Then received my next dose had Vertigo next day and 4 days to follow and had dizziness for the next 2 days.  Today is May 10, 2021 and vertigo and dizziness has subsided.
Persistent hives all over body; Itching; Systemic rash; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Nov2021 12:00 (Lot number: 30155ba) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0153, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 21Apr2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: er8727, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 15Nov2021 08:00, outcome "not recovered", described as "Persistent hives all over body"; PRURITUS (non-serious) with onset 15Nov2021 08:00, outcome "not recovered", described as "Itching"; RASH (non-serious) with onset 15Nov2021 08:00, outcome "not recovered", described as "Systemic rash"; IMMUNISATION (non-serious) with onset 12Nov2021 12:00, outcome "unknown", described as "Booster". Therapeutic measures were not taken as a result of urticaria, pruritus, rash.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not received other medications in two weeks. Patient did not have Covid prior vaccination. Patient did not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Trigger finger - Left Middle Knee joint pain - Right Foot Patience has taken Tylenol and Aleve prior to visiting his doctor. Doctor prescribed Meloxicam.
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
0400 am on 1/12/21 hot flashes began. Lasted until 1900 Soreness to injection site and arm Body aches  GI upset
About an hour after receiving her 2nd dose, she went to a restaurant and ordered her favorite shredded beef burrito. After only a few bites, she experienced non-stop "burping" and swallowing any liquid became impossible. We were at a useless ER hospital from 2-6 pm when they finally saw her and said they did NOT have any means of looking down her throat.  Long story short -- the next day I drove her to another Hospital. We were there from 2-8 p.m. The Dr. removed a bolus at 7:15 p.m. - 7:45 p.m. and he said "everything looks good". HOWEVER -- my mom continued having "esophagus" issues from that time on. And ALSO, on April 4, she told me, "I don't feel good" and she proceeded to fall asleep on her couch and did NOT WAKE UP for about 6 weeks except to use the bathroom, take her morning and evening pills and eat a tiny bit of soft foods. I can't think of any other reason for this bizarre "sleeping" except for that 2nd Covid shot. I've taken her tour GP 2 times since then and all blood work comes back normal. And a few visits to the ER within the last 3 months only showed  she's had another UTI within 6 weeks  and her swollen lower legs/feet can only be cured with lack of gravity. Weeks ago I took her to her annual checkup with her heart doctor and he said her blood pressure was on track. So as of today, I am waiting a call-back from hospice to see if I can get someone to help me with her bathing, etc. at home. Just wanted to tell somebody that since her second dose of Moderna Covid vaccine, it's been downhill for her and it's hard for me to believe the cause can be anything other than that 2nd vaccine.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Transient joint pain, chest pain, late severe fatigue , headache for 8 weeks. Elevated liver enzymes Concerned about a possible autoimmune disease that had never been diagnosed. Nothing was found on diagnostic tests.
Patient is COVID positive on 11/13/2021.  3 doses of COVID vaccine given.  Last dose given 11/2/2021.Over the past week patient has developed a cough and some slight shortness of breath. Cough productive of some sputum. Patient also complaining of slight chest pain.Denies any history of DVT/PE.  Treatment:  fluids and antibiotics.  Decision to dicharge patient.  Patient told to return to ED for worsening symptoms.
This spontaneous report has been received from a nurse referring to a 32 year old male patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions. Concomitant therapies included sterile diluent (MERCK). On 26-FEB-2018, the patient was vaccinated with PROQUAD (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Gall bladder removed; I never had gout before but was diagnosis & prescribed Meloxicam; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 11:45 (Lot number: EW0172) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing); "Venous inefficacy" (unspecified if ongoing), notes: Venous inefficacy; "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin; Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine; Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. The following information was reported: CHOLECYSTECTOMY (non-serious) with onset 21May2021, outcome "unknown", described as "Gall bladder removed"; GOUT (non-serious) with onset 2021, outcome "unknown", described as "I never had gout before but was diagnosis & prescribed Meloxicam". Therapeutic measures were taken as a result of cholecystectomy, gout. No follow-up attempts are possible. No further information is expected.  Additional information: Patient had gallbladder removed 21May2021 and surgery follow-up was 01Jun2021. Few days after surgery patient called the nurse to inquiry about scheduling 2nd injection. She stated after follow up appt. Patient had a good report but never had gout before but was diagnosis & prescribed Meloxicam. Symptoms on day of 2nd injections; temp of 102, fever blister, skin darken around mouth/chin, injection site sore, felt weak/nauseated' pain all over and thirsty. Symptoms lasted about a week except skin peeling around mouth/chin is on going. The 1st injection no symptoms. Ae treatment: Home remedy Tylenol, Hydrocodone, rest. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination.
Pt became septic almost immediately after the booster dose, was admitted then went hospice, and passed away 3 days after the booster.
i have a lot reactions/ mi frontal swallow some partas of mi bodie; i have sometimes big mouth; big eye; I have chest pain; i tink mi heart stoped for a second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i have a lot reactions/ mi frontal swallow some partas of mi bodie), ORAL DISCOMFORT (i have sometimes big mouth), EYE DISORDER (big eye), CHEST PAIN (I have chest pain) and EXTRASYSTOLES (i tink mi heart stoped for a second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (i have a lot reactions/ mi frontal swallow some partas of mi bodie), ORAL DISCOMFORT (i have sometimes big mouth), EYE DISORDER (big eye), CHEST PAIN (I have chest pain) and EXTRASYSTOLES (i tink mi heart stoped for a second). At the time of the report, VACCINATION COMPLICATION (i have a lot reactions/ mi frontal swallow some partas of mi bodie), ORAL DISCOMFORT (i have sometimes big mouth), EYE DISORDER (big eye), CHEST PAIN (I have chest pain) and EXTRASYSTOLES (i tink mi heart stoped for a second) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he had appointment for second schedule on the day of reporting. No concomitant medications were reported. No treatment medications were reported.
This is a spontaneous report from a contactable pharmacist, who reported the same event for 2 patients. This is the second of two reports. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13 (Lot L99271, Expiry date 31Mar2017) in the arm on 07Oct2015. Medical history and concomitant medications were not reported. The patient had a cellulitis type of reaction on the same day. The outcome of the event was unknown. The pharmacist believed that the cellulitis occurred after having shot of PREVNAR 13 as it was at same arm as the injection site.
Constant pain in entire left arm, pain moves around arm, increase in pain at times, radiates to shoulders / upper back.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were each vaccinated with a dose of improperly stored of GARDASIL 9 (lot # M018810, expiration date 28-MAY-2018, dose and route were not provided) for prophylaxis, which were exposed to 28.8 Fahrenheit (F) for 8 hours 43 minutes. There was no previous temperature excursion. No adverse effects were reported. The data logger issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009007: US-009507513-1612USA009008.
I had both shots and have them/Suspected vaccination failure; I had both shots and have them.; Worse pain i ever had!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both the shots of Shingles and still had shingles. The patient stated that worst pain event had. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Arm ached; massive headache; extremely tired; weak; This is the second of two reports. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose number unknown, single dose at the age of 59-year-old for covid-19 immunization. Patient's past medical history included: mumps, bladder Issues. Patient's concurrent condition included: type 2 diabetes, loss of hearing, tired, relapsing remitting multiple sclerosis, hypothyroidism, hiatal hernia, depression, anxiety, tremors. Concomitant medications included ocrelizumab (OCREVUS); metformin; diphenhydramine hydrochloride (BENADRYL); paracetamol (TYLENOL); omeprazole, all taken for an unspecified indication, start and stop date were not reported. On May2021, it was reported that patient experienced: arm ached, massive headache; was extremely tired, weak. The outcome of the reported events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother called; child crying, unconsolable, red, knot at injection site: advised mom to bring child back to office immediately. Mom called back 1 hour later . Child calm: red area going away. No treatment given.
The patient's parents brought him back to the physician's office with a rash all over his body, fever and congestion; The patient's parents brought him back to the physician's office with a rash all over his body, fever and congestion; The patient's parents brought him back to the physician's office with a rash all over his body, fever and congestion; This spontaneous report had been received from a nurse reporting a 13-month-old male patient. There was no information about the patient's medical history, drug reactions, allergies, concomitant medications or concurrent conditions to be reported.  On an unspecified date, the patient was vaccinated with doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, indication, lot number and expiration date not reported) administered concomitantly. Sterile diluent injection used was also reported as suspect.  Subsequently, on an unspecified date (reported as seven days later), the patient's parents brought him to the physician's office with a rash all over his body (rash generalised), fever and congestion. It was reported that the physician was following up with laboratory tests to confirm whether this could be a case of measles, but the results were not provided. The outcome of the events and the causal relationship between the events and the suspect vaccines and sterile diluent were not reported. No product quality complaint (PQC) was reported due to the occurred.
Left arm, at site of injection, with 3" X 3" reddened area, hot to touch, non-tender. No other symptoms or complaints stated. Event began 1 day, post vax. Referred client to PMD. Client was to see MD that afternoon.
Client  presented to the vaccination site on 11/04/2021. The client notified nurse that she received a single dose of CanSino, COVID vaccine in country on 04/20/21.  A  medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen. Per CDC guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team via text message from Vaccine Operations Lead. Client received COVID vaccine Janssen  on 11/04/2021. The client did not report any symptoms during the 15-minute observation period. Nurse educated client on possible adverse reactions and when to seek medical care.
CHILLS; BODY ACHES; SORE INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included supraventricular tachycardia (svt), and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, once a total administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced sore injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, and sore injection site. This report was non-serious.
Complaints of altered mental status, auditory hallucinations. tested positive for Covid-19.  Supportive treatment with zinc, Singulair, vitamin-C, vitamin-D, NAC. PRN antiemetics, antitussive, bronchodilator.  oxygen saturation at greater than 92%.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received BOOSTRIX (batch number 9N74F, expiry date 19th August 2017). Concomitant products included ESTRACE, FLEXERIL, PROTONIX, PROZAC, XANAX and ZANTAC. On 28th August 2015, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 28th August 2015, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX vaccine in left arm. The patient experienced soreness at injection site (left arm). In 2015, less than a month after receiving the vaccine, the patient could not lift her injected arm (injected limb mobility decreased). The patient came back to visit the doctor and the physician assessed the arm and noticed that there was no injury. The patient might had taken some medicine for the pain. The day before the time of reporting, the patient was feeling much better but still a little sore. The reported batch number (9N74S) of BOOSTRIX did not exist and was updated to 9N74F as per the sales database.