chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; fatigue; low grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (fatigue), PYREXIA (low grade fever) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 014C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: HERPES SIMPLEX 1 VACCINE;HERPES SIMPLEX 2 VACCINE (50 MCG/0.5ML) on 05-Apr-2021. Concurrent medical conditions included Depression, Anxiety, Genital herpes and Vulvodynia. Concomitant products included CLONAZEPAM for Anxiety, ESCITALOPRAM and SERTRALINE HCL for Depression, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes genital, GABAPENTIN for Vulvodynia.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (fatigue), PYREXIA (low grade fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (Dizziness), FATIGUE (fatigue), PYREXIA (low grade fever) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-116582 (Patient Link).
nipples are more sensitive/tender; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; This is a spontaneous report from a contactable consumer. A 33-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL9261), via an unspecified route of administration in right arm 20Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation . The patient's medical history was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid-19 prior to vaccination, not been tested for COVID-19 prior to vaccination. Concomitant medications were not reported. She had her first dose of bnt162b2 (lot EJ1686) on 30Dec2020 via unknown route in the right arm. The patient's concomitant medications were not reported. She reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine (Dec2020) but it has gotten more noticeable since the second vaccine.  She has also reported that her nipples are more sensitive/tender since vaccination (20Jan2021). No treatment was given to the events. The outcome of events was not recovered.
the booster dose which was her third dose of Pfizer Covid Vaccine today, 13Dec2021 at around 11:45; She did not know she was not supposed to get booster dose because she is on blood thinner: Atorvastatin; Does not feel good; Really tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Dec2021 11:45 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN taken for anticoagulant therapy, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (First dose: Lot/NDC/Expiry: Unknown, the only only number on the card is unlabeled and is: RA721), administration date: 03Feb2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (second dose: Lot/NDC/Expiry: Unknown, the only only number on the card is unlabeled and is: RA721), administration date: 24Feb2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 11:45, outcome "unknown", described as "the booster dose which was her third dose of Pfizer Covid Vaccine today, 13Dec2021 at around 11:45"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 13Dec2021, outcome "unknown", described as "She did not know she was not supposed to get booster dose because she is on blood thinner: Atorvastatin"; MALAISE (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Does not feel good"; FATIGUE (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Really tired".  Additional Information: Patient stated that she got the booster dose of the Pfizer Covid Vaccine and she didn't know she wasn't supposed to get it because she is on blood thinners; She clarified only on 1 product she provided as a blood thinner: Atorvastatin. She didn't feel good after receiving the shot. She clarified that she does not feel good, really tired since after she was administered booster dose of Pfizer Covid Vaccine. Time of onset of events queried but only provided by patient as when she came home; she felt alright when she was out, but when she came home that was when she started to not feel good and feel really tired. She stated that for the lot number of the suspect product that the only number on the card was unlabeled and that was RA721. Atorvastatin Start date was unknown other than about 1-2 months ago in 2021. This dose completed her prescribed therapy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No additional AE; Customer reporting an expired dose of GARDASIL 9 given to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 14-SEP-2020, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R000303, expiration date: 29-AUG-2020) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events were reported. 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: R000303; expirationdate: 29-AUG-2020; 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
RN administered the incorrect COVID-19 vaccine to patient.  The patient was expected to received the Pediatric Pfizer (0.2ml) 2nd vaccine today, but was incorrectly administered a Moderna booster (0.25ml) dose.  The father was present and immediately notified.  Father enrolled in program.  The patient did not experience any immediate side effects or symptoms.  The father was informed that a VAERS report would be filed and we would follow up to check on patient in regards to any side effects or adverse effects of this error.
This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 16-year-old female patient who received BEXSERO (batch number L045711, expiry date 8th May 2017). Concomitant products included GARDASIL. On 27th February 2016, the patient received 1st dose of BEXSERO. In February 2016, 1 day after receiving BEXSERO, the patient experienced facial swelling. On 5th March 2016, the outcome of the facial swelling was recovered/resolved. It was unknown if the reporter considered the facial swelling to be related to BEXSERO. Additional details provided were as follows: The patient had received GARDASIL previously with no adverse reactions. The patient experienced face swelling which lasted for 1 week and which was described as severe, uncomfortable, and embarrassing. There were no other associated symptoms.
Patient's arm where she received the vaccine was red and warm. Over the course of the next week the redness became worse which led her to return to the pharmacy to report the problem.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 14-SEP-2018, the patient was vaccinated with a improperly stored dose of PNEUMOVAX 23 lot number R005345, expiration date 01-MAR-2020 (strength, dose, dose number and administration were not reported), for prophylaxis. The data logger registered a temperature excursion below 0 Celsius (C) for 41 hours and 0 C to 1 C for 49 hours. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA013661: US-009507513-1809USA013662: US-009507513-1809USA013663: US-009507513-1809USA013664: US-009507513-1809USA013665: US-009507513-1809USA013666: US-009507513-1809USA013667.
BLOOD CLOTS IN EACH LUNG; This spontaneous report received from a consumer via social media through a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in each lung. It was reported by reporter that, "Cousin has blood clots in each lung." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in each lung was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220161645.  Version created to amend previously reported information on 06-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid); Sender's Comments: V1- Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events. 20220217296-covid-19 vaccine ad26.cov2.s-Blood clots in each lung.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
got blurry, unfocused vision; felt spacey/confused; felt spacey/confused; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO187), at the age of 27 years old, in left arm on 09Jun2021 at 13:00 at single dose for COVID-19 immunisation. Medical history included known allergies: lactose intolerance. The patient was not pregnant at time of vaccination. It was unknown that the patient was diagnosed with COVID-19 prior to vaccination.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Immediately after vaccine the patient got blurry, unfocused vision on 09Jun2021 at 13:15 for a week. The patient also felt spacey/confused immediately after the shot on 09Jun2021 at 13:15 and that continued for about 1 week as well. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of all events was recovered.   No follow-up attempts are possible. No further information is expected.
high temp 101-107 would not go down;chills, flu like sx, runny nose
9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, 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 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date).    This case contains information for the 4thof 9 patients described by the reporter.  No concomitant medications were reported.  Dates of administration of vaccine on different dates, one dose given on the 13-Jan-2023, 4 doses on the 14-Jan-2023 one dose on the 16-Jan-2023, one dose on the 17-Jan-2023 and two doses on the 19-Jan-2023.  Patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine reported as unknown.  Date vial was initially stored in the fridge 14-Dec-2022.  Vial size reported as 2.5 milliliter.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)
I received the vaccine at 3:30 pm, at my job. I  went home and later that event around 8:30 pm, I became severely fatigued,  weak, tingling in both my legs and a severe headache. Those symptoms  have lasted since receiving the vaccination. I developed chest pain and shortness of breath on the 18th of August. I was seen in the emergency room on the 19th and had blood work done. D-dimer test came back elevated and a Ct scan was done on my chest only. No pulmonary clots were been found.  Symptoms are still present. I take Tylenol for the headache which offers temporary relief.
Injection site soreness returned, but additionally it is hot, swollen and itchy.   About 2-3? estimated diameter.   Applying Benadryl cream.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient. The patient had no drug reactions or allergies. The patient's pertinent medical history and concomitant medications were not reported. On 08-NOV-2016 the patient was vaccinated with PNEUMOVAX 23, one injection (1 DF), (lot # M000592, expiry date 21-OCT-2017). The patient called the pharmacist at an unspecified time (approximately November 2016) after being administered the PNEUMOVAX 23, her arm was extremely sore and she couldn't use her arm. Approximately in November 2016, the patient also experienced, swelling, pain and numbness in the left arm. The pharmacist referred to the physician or the hospital. But the patient did not want to do that. The pharmacist followed up with a phone call to the patient on 10-NOV-2016. The patient stated she was getting a little better, the swelling was going down but she was still in pain. No laboratory tests were done. It could not be confirmed if the patient called the physician but she was using "icing and MOTRIN as treatment". The patient had not completed recovered but was still improving (outcome of pain in extremity was considered not recovered while outcome of the other events was reported as recovering). No product quality complaint was filed. Causality assessment was not provided. Additional information has been requested.
Patient experienced progressive worsening of side effects from pfizer vaccine per husband. Patient experienced headache, congestion, back pain, dizziness and extreme fatigue. Recommended that patient get a PCR test for covid-19 because some of the symptoms described by patients husband seemed abnormal. Recommended to follow up with PCP in a week or so if symptoms continue to worsen.
The patient received a 4 day expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Shingles on my cornea on my right eye - vision impaired; Shingles on my cornea on my right eye - vision impaired; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 14:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 08Apr2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jul2021, the patient experienced shingles on her cornea on her right eye - vision impaired. The events resulted in doctor or other healthcare professional office/clinic visit. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of shingles on her cornea on her right eye - vision impaired and included treatment with Eye drops and oral medication. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events shingles on her cornea on her right eye - vision impaired was not resolved at the time of this report.
Pt present with dizziness. Pt stated that he wanted to go to bathroom and began feeling lightheadedness. Pt stated he has had 10 syncopal episodes in the past. Pt was immediately put into supine position with lower extremities elevated. Vital signs stable: BP 122/70, HR 92, RR 16, temp 97.8, and spO2 98%. Pt felt better after hydrating and laying down. Wished to go home, so went home.
This was my second booster and I got a terrible rash from chest to my neck and throat which laster 6 weeks and I developed rosacea on my cheeks, chin and nose and eyes. which I still have 9/2022 and will have always although I am seeing a doctor for light treatment. I also had diarrhea and still have to a lesser extent.  I wish I never got it.   After my second Moderna shot I got vertigo for 4 weeks and still am not as steady as I was but the vertigo is gone thank goodness.  The rash I was told by Dr. that I had enough in me already and the 2nd booster make my whole immune system get messed up.
Pain in the arm and in the shoulder/Arm is very painful; Swollen; Difficulty of breathing; Arm completely red; Pain in the shoulder; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm completely red, pain in the arm and in the shoulder, very swollen, arm was very painful, difficulty of breathing.  The patient's medical history included chronic gastritis, allergies and high blood pressure. Concomitant medications reported were Omesartan, Modetine, Vitamin D, C, and antacids (for gastritis).  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013620A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced redness and swelling. The arm was very painful. Also she experienced difficulty in breathing and  pain in shoulder.Treatment details included ice on the arm and has taken several medications.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events - arm completely red, pain in the arm and in the shoulder, very swollen, arm was very painful, difficulty of breathing-were unknown.
Patient history of renal transplant presneted to hospital on 02/23/2022 as a transfer with SOB, hypoxia in the setting of a recent  diagnosis of Covid-19.  Patient was admitted to ICU with acute hypoxemic respiratory failure 2/2 Covid PNA.  She required high flow nasal cannula, and progressed to needing BIPAP and then required intubation.  Patient was treated with steroids.  Blood cultures negative for any type of new bacterial infection.  Patient was treated empirically with antibiotics for most of her hospital stay as well and amphotericin given persistent shock and leukocytosis.  She required CRRT for worsening renal failure.  Patient continued to decline and was transitioned to comfort measures.  Patient expired on 03/12/2022.
Grandmother reported p/vax 11OCT93 pt had fever >105; states mom took to ER later that evening recvd pink meds that was not refrigerated; no other problems reported;