chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry lips; chapped, dry lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHAPPED LIPS (non-serious) with onset 2021, outcome "unknown", described as "chapped, dry lips"; LIP DRY (non-serious) with onset 2021, outcome "unknown", described as "dry lips". The events "dry lips" and "chapped, dry lips" required physician office visit. Therapeutic measures were taken as a result of lip dry, chapped lips.  Additional information: The patient received two Pfizer Covid vaccines and two boosters. Her first vaccine was given on 27Feb2021 and a couple of days after this, she began to experience very dry lips.  Dry lips progressed to chapped, dry lips. Nothing she did helped the situation. The patient has seen 4 dermatologists. No one knows the source for the dry lips. The patient wanted to know if there are other reports regarding patients getting dry, chapped lips as an adverse effect of the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
day following vax pt had red, swollen, welted achy arm more than a usual rxn of redness/swelling;this was given in lt arm-pt was still able to use arm & p/4-5 days arm was back to nl;pt used APAP & cold compress;
patient reported after  the vaccine for 2 days, her arm hurting and feeling tired.  After the 2 days, her left hand became swollen and appear darkish blue brusie like.  6 inches from her arm where shot given also is red.
He got his vaccine, it hurt immediately after he got it as she hit something in there, and he thinks it went up too high in his shoulder.  That night no matter which way he would move it it hurt.  He cannot raise his arm still to this day as it hurts.  The shoulder itself hurts, he starts to hurt as he raises his arm up to his face, and can get it up a little and taking his shirt and coat on and off is hard for him to do.  He has taken Tylenol for his symptoms, which is not helping too much.  He has not contacted his doctor.  He just has pain moving his arm and cannot move it.    The injection was given up to the top of the shoulder.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Sep2021 as dose 3 (booster), 0.3ml single (Lot number: 30135BA) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Shingles (Event: arm swelled from elbow to shoulder, Brand: Shingles, unknown brand, Age: probably 65, Vaccination date: unknown, NDC, Lot, expiration: unknown), for Immunization, reaction(s): "arm swelled from elbow to shoulder". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "recovered" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller is a retired pharmacist calling for herself who stated she was given Paxlovid on 30Apr due to a positive COVID test. Caller is asking when she can receive her 2nd booster of Pfizer COVID19 vaccine since she is already overdue for it. She already has 2 doses and 1 booster of Pfizer COVID19 vaccine. She wanted to know when she can receive her booster shot after treatment with Paxlovid. Tested positive for Covid 19, on 30Apr2022, and took Paxlovid after diagnosis of Covid from 30Apr2022 to 05May2022 as 3 tablets in the morning and 3 tablets in the evening. She has a child and mother to protect. Caller stated that she was told, she could not get a second booster dose for 90 days after taking Paxlovid, that came from another source. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. The adverse event did not require any emergency room visit. Prior Vaccinations (within 4 weeks): unknown if she had a flu shot. There are no predisposing factors. Other conditions and medical history were none.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Vaccine given 7/22/04. On 7/23/04 about midnight started with hive on left upper am. 2am headache- progressing to migraine headache, nausea. Wheezing in chest. Took Ibuprofen, Vicodin which she had order for previously. Recovered sat am. No treatment or evaluation my MD. Resolved on left arm.
Approximately 5 minutes after vaccination, recipient became dizzy and reported that he felt like he was "going to pass out".  Mask was removed and feet were elevated. Symptoms quickly began to improve. Kept in observation for approximately 45 minutes. Vaccine recipient reported feeling back to normal at time of release.
Hospitalized (10.29.21);  COVID-19 positive (10.29.21);  Fully vaccinated  Discharge Provider: MD Primary Care Provider: MD (Inactive) Admission Date: 10/29/2021 Discharge Date: 10/30/21 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COPD exacerbation (HCC) [J44.1] Anemia, unspecified type [D64.9] COVID-19 virus detected [U07.1] COVID-19 virus infection [U07.1] HOSPITAL COURSE: Patient is a 82 y.o. male with a 31 pack year smoking history and COPD who presented to the ED with progressive exertional dyspnea for 1 month. Patient states he had productive cough with quarter sized pale green sputum on 10/1/21 and saw an urgent care provider who gave him a 5 day course of oral Azithromycin. He continued to have the cough and began developing SOB with exertion that was getting progressively worse. He got a CXR before seeing his pulmonologist on 10/13/21 which was negative for pneumonia, he was prescribed another 5 day course of Azithromycin with oral prednisone taper and nebulized albuterol for the diagnosis of Acute COPD exacerbation. His cough improved significantly, however his SOB with exertion persisted. 10/28/21 he states his exertional SOB was severe enough to warrant a hospital visit. Notes getting his Covid19 booster shot on 10/27/21. No other symptoms than SOB with exertion and fatigue.    ED course: patient was afebrile with O2 sats in the 90's at rest, but desaturated to 89% when up and moving around. He tested positive for Covid19. Lungs clear bilaterally, no conversational dyspnea. CTA chest showed emphysematous changes with no evidence of infiltrates/pneumonia. ECG was NSR with PAC. His labs showed normocytic anemia with Hgb of 8.9. Troponins were normal. CMP showed hyponatremia with Na of 127. He was given solumedrol 125mg IV, and was admitted for Acute COPD exacerbation. Upon admission, patient remained afebrile with stable vitals within normal limits, and saturating in the upper 90's on room air. Hyponatremia improved with Na to 132, CBC stayed within normal limits, and patient was eating and drinking without difficulty. Patient remained asymptomatic with current Covid19 infection. Discussed need of pulmonary function testing to reassess COPD severity and likely home oxygen needs for exertion and potentially beneficial changes to his daily breathing treatments that are confirmed with repeated PFT's . Patient and wife preferred to rest at home with oral steroid taper and 2 days of oral antibiotics rather than remaining in hospital. Patient is medically and vitally stable for discharge home.
blister at the injection site that has turned into a scab; blister at the injection site that has turned into a scab; This is a spontaneous report from a contactable other health professional (nurse practitioner). This other health professional reported similar events for three patients. This is the 3rd of three reports. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), intramuscular at deltoid right on 06Jan2021 at 0.3 mL at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blister at the injection site that has turned into a scab. The patient outcome of the events was unknown.
positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare professional (patient).  A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date unknown), via an unspecified route of administration in right deltoid, on 18Dec2020 07:15 at a single dose for Covid-19 immunization.  Medical history included ongoing hypothyroidism and hysterectomy. Concomitant medications included estradiol (taking after hysterectomy) and levothyroxine for hypothyroidism, both ongoing. The patient has no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated that she received the Covid vaccine mid- Dec2020. She stated she was supposed to receive the 2nd dose 2 days ago, 06Jan2021. On 03Jan2021, she started feeling bad the day before testing positive, went to urgent care to be tested, thought she had the flu.  She tested positive for Covid on Monday 04Jan2021, so she has been in quarantine. She was unable to receive her 2nd dose because she was in quarantine. She wanted to know if it's ok to delay the second dose or if she needs to re-start the series. The reporter assessed the event relatedness was unknown, patient stated that she doesn't know the causality, she has not been in contact with anyone that was known to be positive, but she is a healthcare worker who sees multiple patients a day, so one of them could have been asymptomatic. Outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Pt called 8/26/05 stating several minutes after HBV, on the way home she experienced pain in her joints. later experienced tightness in chest and her throat felt swollen. (not bad enough to go to ER). Tightness in chest passed a few minutes after resting. Now has headache & joint discomfort (two days later). Rec'd to contact her doctor & consider taking Tylenol/Motrin for headache & joint pain. TD 10/6/05 Client has not seen MD- no more problems - states her arthritis is worse that it was.
having trouble hearing; fatigue; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS ("I am having trouble hearing" Patient says her daughter asked "do you need hearing aids"), FATIGUE (fatigue) and HEADACHE (slight headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis of leg and Sleep disorder NOS. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder NOS, AMLODIPINE, METOPROLOL, APIXABAN (ELIQUIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FUROSEMIDE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (slight headache). On 13-Apr-2021, the patient experienced HYPOACUSIS ("I am having trouble hearing" Patient says her daughter asked "do you need hearing aids"). On 12-Apr-2021, HEADACHE (slight headache) had resolved. On 13-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, HYPOACUSIS ("I am having trouble hearing" Patient says her daughter asked "do you need hearing aids") had not resolved.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications included Tropivite supplement and unspecified antibiotic that is 500mg four times a day for cellulitis of leg.  Treatment medication included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-077592 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077592:First dose
sore jaw on rt side 21JUL93; all over muscle stiffness (AM) of 22JUL93; advised to see MD or go to ER: pt thinks sinus infect;
left side of her jaw mildly feeling numb; her left eye red on the side and with a lot of discharge; her left eye red on the side and with a lot of discharge; mild headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient) communicated to Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 13Mar2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Mar2021, the patient experienced her left eye red on the side and with a lot of discharge, left side of her jaw mildly feeling numb on 15Mar2021 and mild headache on an unspecified date in Mar2021. The clinical details of the events as follows: Patient received her first dose of the Pfizer Covid-19 Vaccine on 13Mar2021 and was asking if it is ok that she was scheduled to receive her vaccine for yellow fever tomorrow before travelling to Africa. Additionally, she woke up yesterday 14Mar2021 with her left eye red on the side and with a lot of discharge, so she tried treating it with a tea bag to avoid taking over-the-counter medicines. This happened this morning 15-MAR-2021 as well with the left side of her jaw mildly feeling numb like given Novocaine at the dentist. She also felt a mild headache. She would like to know if she would be able to take any medications for the symptoms she was experiencing. There were no unaddressed medical questions referred or forwarded to Medical Information. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was diagnosed with Shingles around the eyes. Monday, I had a slight swelling in the left upper eyelid. There was sensitive pain and redness in an area of my forehead and below my left eyebrow and upper eyelid. The pain became more and swelling increased. I had an appointment with an ophthalmologist. At this time, I was experiencing pain in the left eye. She prescribed valacyclovir HCL to be taken 3 times a day. I started in yesterday afternoon and the pain has reduced. She also ordered bacitracin ophthalmic cream which I have not started taking. I am in the first stage of shingles so this will likely go on for a few weeks. I have a history of chicken pox around age 6 or 7 years of age.
No adverse event; bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent doses administered after the BUD to patients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (bivalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 51 doses from Lot AS7140C Bivalent doses were administered after the BUD to patients. Treatment medications were not reported.
She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered.; This non serious spontaneous safety report,  was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, and additional information was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023 from a health professional.  The causal relationship between Vaxelis and reported event" She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered" was assessed as not applicable due to the nature of the event.  For reference purposes, the case is linked to MCM-005121, MCM-005126, MCM-005127, MCM--005141, MCM-005135, MCM-005138, MCM-005140, MCM-005128, MCM-005142  Further information is expected.
Patient came to mass vaccination community event for COVID 19 vaccine.  After the patient was vaccinated with Johnson and Johnson vaccine, it was noticed he was <18 years of age.
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered beyound 30-day use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 64-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered beyound 30-day use by date).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730554 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730554:same reporter
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
This spontaneous report as received from a consumer (patient's husband) refers to a 83 year old female patient with no drug reactions or allergies and with no medical history. On 15-MAY-2009, the patient received the first dose of ZOSTAVAX and on 19-MAY-2014, the patient was inadvertently administered the second dose of ZOSTAVAX injected in the arm (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were taken. Approximately in June 2014 (reported as "about 2 weeks later"), the patient started experiencing tingling feeling in her legs, headache and weakness. The patient's husband further explained that the patient sought medical attention and was seen by several physicians including a Neurosurgeon and Neurologist (all unspecified) and had been prescribed medications: levothyroxine, duloxetine and ATIVAN, however nothing had helped. The reported also stated his wife had to visit 2 different local emergency rooms 3 different times (dates unspecified) for treatment of her symptoms, but was never admitted. The patient had several diagnostic tests performed: magnetic resonance imaging (MRI), glucose intolerance and various unspecified tests, but no results were provided. The patient's husband also stated that at some point, on an unspecified date, his wife was diagnosed with neuropathy. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.