chrisvoncsefalvay/vaers-outcomes huggingface dataset:
More frequent, heavier menstrual cycles. Increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping; More frequent, heavier menstrual cycles. Increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping; More frequent, heavier menstrual cycles. Increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping; This is a spontaneous report from a non-contactable other hcp. A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 13Jan2021 09:00 (age at vaccination 40 years) as dose 2, single for covid-19 immunisation. Medical history included diabetes, fibroids, high cholesterol. Concomitant medication(s) included lisinopril (LISINOPRIL); atorvastatin (ATORVASTATIN); insulin glargine (LANTUS); dulaglutide (TRULICITY); metformin hydrochloride (METFO).The patient previously received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK5730, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Dec2020 11:00 (age at vaccination 40 years) as dose 1, single for covid-19 immunisation. Patient visited doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jan2021the patient experienced more frequent, heavier menstrual cycles. increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping. Patient received treatment for reported events Procedure to replace IUD. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
After his shots, I nursed him then he took a nap, upon waking at 3:30 he was extremely fussy, crying, would not eat... I called the Dr. they said he could go up to 12hrs without eating.  At 7:30pm I took his temp, by this time he had only taken 1oz (I pumped so we could monitor how much he was eating).  At 7:30PM his temp registered at 101.4 and still he had not eaten (last full feed was at 12:30pm).  Dr. suggested I give .04 of Acetaminophen.  At 9:30 PM his temp was down to 99.8 and he ate another 2oz (totaling 3oz over a 10hr period of time).  For the past 48 hrs he has continued to be lethargic, fussy and not eating well.  We took him in today and he weighs in at 13lb 3oz (whereas the day of his shots he was 13lb 14oz).  The Dr. says since she did not weigh him the day of the shots she cannot verify he lost that much weight.  I am taking him in on Monday for continued monitoring.  He still is not eating well, just wants to sleep and is not his perky usual self though the Dr. stated by her standards he appears to be "thriving" I again stated perhaps but he is not his normal very active and bubbly self.
Redness and itching left upper arm at injection site- started day 5 after injection given. Self treatment with topical steroid cream and oral antihistamines. This is consistent with known delayed cutaneous hypersensitivity reaction occurring with Moderna COVID 19 vaccines. (husband and I are both physicians)
Fever/chills (for 1-2 days) 2 days after vaccinations. Ongoing knee/hand (bilateral) and posterior neck stiffness of intermittent severity.
Flu-like symptoms; Upset stomach; Bowel movement; Headache; Fatigue; A spontaneous report was received from a type concerning a 64-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-like symptoms/influenza like illness, headache, fatigue, upset stomach/abdominal discomfort, bowel movement/bowel movement irregularity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events flu-like symptoms, headache, fatigue, upset stomach, bowel movement.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu-like symptoms, headache, fatigue, upset stomach, bowel movement was unknown.
High Fever - 103, Chills, Joint pain, Fatigue, Headache. Started at about 6 hours after injection and lasted 2 days.
Patient has been scheduled for appointment with DOB -05/14/2005 but Patient's actual DOB is 05/14/2010, Patient is 11 years old and given 1st dose of adult Pfizer vaccine NDC #59267-1000-02 on 11/10/2021, came today for 2nd dose of Pfizer vaccine and Pharmacist verified DOB  and found out that patient needed pediatric Pfizer vaccine that approved for - 5 to 11 years Patient does not have any side effect of any symptoms from the 1st dose pf adult Pfizer vaccine.
Breakthrough COVID infection. Symptoms of sore throat, shortness of breath, and chest pain. Unsure when symptoms started. Positive COVID test collected 12/18/2022.
Entire body aches and pains, unable to move my left arm where the injection was given for several days.  Weakness, unsteadiness, fever, itching, redness and swelling.  Had to see my family physician twice and was told by two different nurses/doctors that the pneumonia injection was given approximately 2-3 inches lower than it should have been.
Information has been received from a RN concerning a 6 year old female pt who on 02/16/2000 was  vaccinated with varicella virus vaccine live at another location, so the lot number is unknown. It was reported that the pt now 02/01/05 has varicella reproted as a breakthrough. The RN reported that the pt first broke out with a lesion overnight between 01/31/05 and 02/01/05. The RN  described the breakthrough as a mild case  with less than 50 lesions with a low grade fever. The physicain started Acycylovir ( Zovirax). It was noted the the pt was not hospitalized and the chicken pox was not considered life threatening and did not result in a disability. There was no product quality complaint reported. There was no further information available regarding this event. Additonal information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-FEB-2009, the patient was inoculated at a medical office facility with the ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster related injuries. The vaccine did not prevent shingles and zoster-related injuries as intended. On or about 19-JAN-2016, the patient was treated by the hospital (healthcare professional not specified) for Herpes zoster, or shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and or despite receiving ZOSTAVAX vaccine for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complaining of severe left arm pain states happened day after PNU injection, states cannot move left arm without pain.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal solution (frozen)) was received from a pharmacist regarding a 5 year old female pt who experienced fever of 104 deg. F.  The pt received a dose on 12/17/03. The child received Zyrtec (cetirizine) and albuterol in the summer of 2003 for a cough.  She did not have asthma.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/17/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The pharmacist stated that on 12/19/03, 2 days post-immunization, a father reported that his daughter had a fever of 104 deg. F., when she was picked up from school.  The child's temperature was later rechecked and found to be 102 deg., F.  On follow-up (date not specified), the father reported that his daughter was "fine".  No additional information was available at the time of this report.
Patient called to report that she was pregnant when MMR vaccine was administered. Vaccination was given on 3/18/16; patient reported LMP as 2/24/16.
covid test date=31Dec2021; covid test result=Positive; covid test date=31Dec2021; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 05:00 (Lot number: ERV0168) at the age of 41 years as dose 1, single and administered in arm left, administration date 02Sep2021 05:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "covid test date=31Dec2021; covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Covid was tested post vaccination. No other vaccine was administered in four weeks or two weeks.   Follow-up attempts are completed. No further information is expected.
vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Patient received the Pfizer vaccine on 2/18/21 and 3/11/21 so was fully vaccinated when they tested positive for COVID-19 on 9/17/21.
pain in underarm; chest pain; Soreness in her arm; Chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in underarm), PAIN IN EXTREMITY (Soreness in her arm), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary edema. Concurrent medical conditions included Diabetes mellitus, Hypertension, Hyperlipidemia, Allergy to molds, Dust allergy and Drug allergy (Amoxicillin, sulfa drugs, Zestril, actos, Avandia, most statins). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm) and CHILLS (Chills). 10-Feb-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in underarm) and CHEST PAIN (chest pain). The patient was treated with PREDNISONE for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in underarm), PAIN IN EXTREMITY (Soreness in her arm), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive.         This case was linked to MOD-2021-026807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: significant follow up, event added On 28-Apr-2021: Non significant follow up
caught covid of December of 2021, sneezed all day; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (caught covid of December of 2021, sneezed all day) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (caught covid of December of 2021, sneezed all day). At the time of the report, COVID-19 (caught covid of December of 2021, sneezed all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient sneezed all day. It was also reported that patient just got a Moderna bivalent booster and wanted to know if it will do any good since he received the bivalent. Treatment medications were not provided.
Bad itchy rash all over body; tiredness; chills; dizziness; This is a spontaneous report from a contactable patient. A 51-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 09Mar2021 (at the age of 51-years-old) as single dose, for COVID-19 immunisation. Medical history included slight hypothyroidism started on an unknown date. The patient had no known allergies to medications, food, or other products. The patient neither had a COVID-19 test nor had symptoms associated with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ramipril (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. Past drug history was not reported. On 09Mar2021 the patient experienced bad itchy rash all over body, tiredness, chills, dizziness. No treatment was taken for the events. The clinical outcome for events bad itchy rash all over body, tiredness, chills, dizziness was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's name added in patient tab. 2. Lot# UNKNOWN was removed from dosage regimens tab. 3. Patient's age was updated as 51-years in narrative.
lips swollen; Tongue got cut; This is a spontaneous report received from a contactable consumer (patient). A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 05Mar2021 at 10:00 AM as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included blood pressure, cholesterol, panic attack, macular degeneration from an unknown date and unknown if ongoing. The patient has allergies to Cipro XR; Macrobid; Keflex; Levaquin. No family medical history was provided and no relevant tests were performed. Concomitant medications included azilsartan kamedoxomil (EDARBI) 40 mg for blood pressure; azilsartan medoxomil, chlortalidone (EDARBYCLOR) for blood pressure; nebivolol hydrochloride (BYSTOLIC, take once daily by mouth) 5 mg for blood pressure; rosuvastatin calcium (CRESTOR) 20 mg for blood cholesterol; aspirin [acetylsalicylic acid] 81 mg for anticoagulant therapy; pregabalin (LYRICA) 25 mg; midodrine hydrochloride 2.5 mg; olanzapine (ZYPREXA) 2.5 mg; omeprazole (OMEPRAZOLE) 40 mg; alprazolam (ALPRAZOLAM) 0.5 mg for panic attack; ciclosporin (RESTASIS) 0.05 mg for macular degeneration; captopril (CAPTOPRIL) 50 mg, (take only as needed) for blood pressure; linaclotide (LINZESS) 72 ug; triazolam (TRIAZOLAM) 0.25 mg; doxepin (DOXEPIN) 10 mg; diclofenac (DICLOFENAC), 1 % gel apply as needed for arthritis. Concomitant products from a list written by patient's caregiver. He doesn't know the dosage or how long his mother has been taking many of the mediations. Patient had no previous history of immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. His mother got the first dose of the Pfizer COVID 19 vaccine two weeks ago 05Mar2021 at 10:00AM in the right arm. In about four hours after the vaccine, on 05Mar2021 her lips were swollen; they read that it is one of the known side effects. Then next day they went to the family doctor who prescribed Benadryl. She took it for about a week but her lips are still swollen. His mother told him she noticed her tongue has had a few cuts in it but he is unsure of the exact date. His mother is not in bad condition and but she did have a severe reaction. She is scheduled for the second shot next week 26Mar2021. They stopped the Benadryl a few days ago because they are planning to see a specialist in allergies and heard they might want to do some testing so he wanted his mother to be clear of the Benadryl. Not have any product or information to provide NDC, UPC, lot or expiration for the Benadryl his mother took. The events resulted in a visit to physician or ER: Monday they saw the family doctor who prescribed Benadryl for lips swollen. The outcome of lips swollen was recovering, while with other events was not recovered.  Information about batch/ lot number has been requested.
Joint pain from behind left shoulder to left elbow, tingling and numbness in left hand. Discomfort travels throughout  arm
lt proximal arm w/4x6 violaceous, sl raised, sl indurated, tender area; treated w/DPH;
Vaccine administered from another clinic. Patient reported to emergency center for chest pain/tightness the morning after vaccination. History of MDS and pulmonary fibrosis. Discharged home, no further information available.
Temperature of 102, severe headache, chills, sharp, shooting body pains, weakness to the point of not being able to get out of bed, stomach pains, mild nausea. Lasting approximately 36 hours.
Arm swelling - hard lump, redness, warmth coming from injection site. Very painful.
Received Hep B in pm: By 5:00 pm was complaining of headache. Next day complained of headache and nausea and abdominal pain. Mom states son did this similar symptoms with first dose of Hep B.
Awoke from sleep & began having a seizure. Continued for 20 minutes until it was stopped by lorazepam administered in the hospital emergency room.
This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a 80-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 79 year or 80 year. The patient came to see doctor 2 weeks after receiving a dose of SHINGRIX. The patient was having an herpes zoster outbreak.
Hallucinations... Seeing things on the wall floor, couch... Thinking people that are elsewhere were at her house.
Information has been received from a healthcare worker referring to various unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2015, doses of PROQUAD (Merck) (lot # M003436 with expiration date of 19-JUL-2017 (therapy type: rHA); lot # L050910 with expiration date of 14-JUN-2017; lot # L046506 with expiration date of 17-MAY-2017 and lot # L051098 with expiration date of 17-JUN-2017, dose, frequency and route unknown) were exposed to a temperature excursion at 0.2 degrees Celsius for 4.5 hours and back in range then. Subsequently the vaccines were exposed at minus 4.9 degrees Celsius for 1 hour and 42 minutes and back in range after that (incorrect product storage). Since 03-MAY-2016, the vaccines were administered to unspecified patients. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chronic Spontaneous Urticaria, typically in the evening; treating daily with allergy medication to control systems.
vaccine she received has expired for 72 hours on her receipt; 0.5mL was administered for all 3 doses including the booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine she received has expired for 72 hours on her receipt) and ACCIDENTAL OVERDOSE (0.5mL was administered for all 3 doses including the booster shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included LIFITEGRAST (XIIDRA) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine she received has expired for 72 hours on her receipt) and ACCIDENTAL OVERDOSE (0.5mL was administered for all 3 doses including the booster shot). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine she received has expired for 72 hours on her receipt) and ACCIDENTAL OVERDOSE (0.5mL was administered for all 3 doses including the booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.