chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got Covid; got Covid; changes in her cycles; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "got Covid"; COVID-19 (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "got Covid "; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "changes in her cycles".  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 information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2.(COMIRNATY).
she complained of injection site pain; This spontaneous report was received from a pharmacist, via company representative, referring to an adolescent female patient, whose age was reported as " 16 or 17 years old". The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.      On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose number, frequency, route of administration, anatomical location of injection, lot # and expiration date were unknown by the reporter).        Afterwards, on an unspecified date in February 2019, the patient experienced injection site pain.      At the time of this report, the outcome of injection site pain, and the causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event's occurrence, were both unknown.
Rash on chest, upper arms bilateral, 2MNS diameter. Hyperpigmentation and slight firmness upper rear left arm measures 2cm by 2cm diameter.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 26-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles shot and got shingles right after. Additional Supportive Information: The follow up would not possible as no contact details were available.
patient became diaphoretic and light headed.  Patient was anxious and did not eat breakfast before vaccine.  Patient was instructed to lay in the floor and she did so with no difficulty and did not pass out.  BP and pulse taken all within normal limits and juice and fruit snacks given and consumed with no difficulty
Second Dose One Week After First Dose; Initial Report Received on 23-Aug-2022  A pharmacist in the reported that a patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one week after the first dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date in Jul-2022, the patient received the "first dose" of HEPLISAV-B (Lot #, expiration date and NDC # not specified).   On 25-Jul-2022, the patient received the second dose of HEPLISAV-B (Lot # 937780, expiration date 13-Sep-2023 and NDC # 43528000305) in the left arm, route not provided which was "one week after the first dose".  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This is a spontaneous report from a contactable consumer reported for herself. A 71-year-old female patient received PREVNAR 13 as Pneumonia prevention on 17Nov2017 at single dose in the left arm via unspecified route. Concomitant medications included omega-3-acid ethyl ester (LOVAZA) for High cholesterol and high triglycerides at 1000mg, capsule, takes two capsules in the morning total dose of 2,000mg, pravastatin to control high cholesterol at 80mg, lithium carbonate for Bipolar disorder at 300 mg, lamotrigine for depression 200 mg, Levothyroxine for low thyroid and for depression at 25 ug, linaclotide (LINZESS) for  constipation 145 ug, plantago ovata (METAMUCIL) to prevent colon cancer and to fight constipation, docusate sodium (COLACE) for Constipation 100mg twice a day, ascorbic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate  (SUPER B COMPLEX) to keep her brain healthy so antidepressants work better, xantofyl (LUTEIN) 25 plus and Xanthan for Eye health, Glucosamine Hydrochloride, Chondroitin Sulfate Sodium for Sore knees, Calcium with Vitamin D and Minerals to prevent osteoporosis,  Magnesium acetylsalicylic acid (BABY ASPIRIN).  Relevant medical history included High cholesterol diagnosed about 10 or more years ago, High triglyceride diagnosed about 10 or more years ago, bipolar disorder diagnosed around 5 years, depression (From: 1999) Hospitalized in 1965 but it was not called depression, the patient was probably depressed since being a preteen, it has been a long standing problem, Low thyroid (From: May 2017), Constipation diagnosed when she was in college, Sore knees, Osteoporosis  diagnosed about 15 years ago with osteoporosis, has received shot that helped reverse it, the patient was on Forteo for 2 years, which reversed osteoporosis to osteopenia at the end of the shots of Forteo. It has stayed stable to osteopenia, Lymphedema (From: Jan 2001) and the patient had two Staph infections. One in May2017 or Jun2017, she had to go to wound care to clear it up. Before this in Mar2017 until Jun2017 the Staph infections required 2 hospitalizations. On 21Nov2017 the patient experienced pain in the injection with outcome of not recovered, he had mild systemic problems from 17Nov2017 to 18Nov2017 with outcome of recovered, small bruise on 21Nov2017 with outcome of recovering and Vaccination site warmth on 21Nov2017 with outcome of not recovered.
Received his first Pfizer dose (EL9262) on 3/10/21 and was given a Moderna second dose on 4/1/21 accidently. Has been informed on the incident. The clinic manager conducted the investigation and found that the event  was human error. The clinic process of keeping the vaccinations separate are in place. There are a list of Pfizer second doses on each table to ensure these individuals receive the correct vaccination. The nurse retrieved a Pfizer dose from the bag (away from Moderna) and placed it on the table and told the administering nurse this is a Pfizer second dose, here is the Pfizer vaccine. The nurse still picked up a Moderna vaccine from the other end of the table. The nurse noticed when the bandaid was being placed on his arm that the Pfizer dose was still on the table. When she inquired the administering nurse stated it was Moderna.  The clinic will speak to the administering nurse again to identify any barriers  and continue to evaluate the  processes to ensure this does not happen again.
11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D29A21A and 00BB21A or 008B21A) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy. Concomitant products included TIMOLOL for Glaucoma, unspecified, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue). At the time of the report, RHINORRHOEA (nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue) outcome was unknown.            Action taken with suspect drug Moderna 1273 COVID-19 vaccine was not applicable. No treatment medications provided by the reporter.
Pt Had headache and Nausea within 15mins of receiving the 2nd Pfizer Vaccine.  Lightheadedness and face tingling. Applied O2 via NC 4L which relieved the nausea and reduced headache symptom.  medics evaluated
Later in the day of receiving vax pt developed an injection site reaction characterized by pain, erythema, and hardness. She recovered. Manufacturer's Comment: This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23.
I had fever, chills, dizziness and headache for 2 days.  Now the dizziness and lightheadedness is intensifying and been bad for days.  I also have intense hot flashes which I did NOT have before (menopause symptoms are long gone) and have NEVER had this dizziness before in my life.  Also tingling in legs and feet.  I am a very healthy, avid exerciser and masters swimmer.  THIS  NOT MY IMAGINATION AND I AM ENTIRELY PRO-VACCINE.
02/06/22 presents to ED for "SOB". PMHx of "DM II, hypothyroidism, HTN, NICM, HFrEF"
It kind of knocked 'me' out/fatigue; This is a spontaneous report from a contactable consumer reporting for a patient. An adult male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 12Apr2021, in an email to the reporter, the patient (vendor) mentioned that after getting second dose of vaccine it kind of knocked him out. The reporter took this to mean fatigue since the patient did not elaborate. The clinical outcome of the event It kind of knocked 'me' out/fatigue was unknown at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 3/19 random red, itchy spots appeared on both hands, wrists, and elbows.  Suspected bug bites, however this morning 3 more smaller spots appeared on hand near thumb as I worked out.  Not bites. Wondering if this is a delayed sided effect of moderna vaccine.  I would also note my mother, who live in , ( I'm in ), received Moderna vaccine 3 days after I and has had similar effects.
1st vaccination on March, 4, 2021 -   Right arm, soreness at injection site for 2-3 days. No swelling. After that I was fine.  2nd vaccination on April 1, 2021 -  Right arm, Slight bodily flushing within 15 minutes of injection. About 4:00 PM started to develop mild aches and chills.. As the day progressed, aches and chills became substantial with a 2:00 AM temperature of around 102 degrees F headache and mild nausea. now 5:00 PM the following  day ,i.e., now,  with a temperature of 100.5. F. Injection site slightly diminished in pain. No swelling.  Monitoring my condition.
Case number PHEH2014US025356, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 65 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 16 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this maladministration error (incorrect storage of drug).
she contracted COVID-19 in Feb of this year; she contracted COVID-19 in Feb of this year; patient received BNT162B2 via subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 35-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE]; SPIRIVA [TIOTROPIUM BROMIDE]; SYMBICORT; ALBUTEROL [SALBUTAMOL SULFATE]; PEPCID [FAMOTIDINE]; TRULANCE. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Aug2021, outcome "unknown", described as "patient received BNT162B2 via subcutaneously"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "recovered" and all described as "she contracted COVID-19 in Feb of this year". Clinical course: A female patient with a history of asthma reported in market research that she contracted COVID-19 in Feb of this year. Her most recent Pfizer COVID-19 vaccine was in Aug2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Could not and did not go back for second dose; Both arms broke out in a terrible rash; Redness, red marks, and oozing; Redness, red marks, and oozing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient himself). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206, Expiry Date: Unknown not provided on vaccine card via intramuscular route of administration in right arm on 06Apr2021 in the morning at the age of 66 years-old as dose 1, single for COVID-19 immunization reported as to prevent self from getting Covid disease. The patient medical history (including any illness at time of vaccination) reported as none. The concomitant medications (other Products) were not reported. Family medical history relevant to adverse events was none. Historical vaccine included Shingles vaccine (shot) (VARICELLA ZOSTER VACCINE, Lot number- UNKNOWN) via an unspecified route of administration an unspecified date as dose 1, single and Shingles vaccine (VARICELLA ZOSTER VACCINE, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 12Mar2021 as dose 2, single for immunization. Adverse events following prior vaccinations reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the pfizer suspect reported as none. Vaccination facility type reported as organized through Medicare and vaccine was not vaccine administered at facility. The patient experienced both arms broke out in a terrible rash bilateral upper extremity rash that is persisting on 07Apr2021. Patient states there is redness, red marks, and oozing on an unspecified date in 2021. He was supposed to have received the second dose 30Apr2021. Patient could not and did not go back for second dose on 30Apr2021. Patient missed his second dose of the Pfizer Covid vaccine and wants to know if he can receive the Johnson and Johnson vaccine, is that ok to do. He had a horrible reaction. The report is not related to a study or programme. No investigation assessment was done. The rash has improved about 50%. Relevant tests reported as none. The patient visited physician office for both arms broke out in a terrible rash. The doctor prescribed Prednisone for the rash. The clinical outcome of the events both arms broke out in a terrible rash, redness, red marks, and oozing was recovering (reported as improving, Ongoing).  No follow-up attempts are needed. No further information is expected.
Immediate urticaria beginning on left arm and progressing to total body. Facial swelling and emesis sent to ER required epi.
Wave of discomfort, pins and needles in arms & hands and lower legs & feet, sweaty palms, feel like going to pass out, episode lasts for approximately 3 hours at a time, has occurred 4 times since shot, most recent being 9/26/21. PCP recommended B12.  Also had chest pain starting 4 days after the shot and still continues. Intensity varies and lasts majority of the day. Dull pain mostly but some sharp stabbing pains.
heavy and unusual period bleeding; her menstrual time schedule totaly chaged and became irregular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "heavy and unusual period bleeding"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "her menstrual time schedule totaly chaged and became irregular". Therapeutic measures were taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information: After reporter's wife got last shot of COVID-19 vaccine, she had heavy and unusual period bleeding and her menstrual time schedule totally changed and became irregular. In the last two months her bleeding increased and was non-stop. It seemed very dangerous and hard situation to reporter. She took medicine but nothing changed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
on about 6/15  my thumbs were numb,by the next couple of days my fingers on both hands were tingling feeling cold. I began to have great difficulty walking , standing,and,dexterity. This continues today 8/7 with no improvement.
Patient received both FLUZONE HD and PNEUMOVAX 1/23, and began experiencing symptoms 1/24. Symptoms included swelling and redness at injection site ("large hard knot"), pain so severe that patient "could not lift her arm", fever/chills, dry cough and pain in the chest. Most symptoms were resolved by 1/25, except for the swelling and redness at injection site.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.08 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature range of 29 to 32 Degree Fahrenheit from 09:00 AM to10:00 AM. These vials were moved to fridge on 29-Sep-2021 and 5-Oct-2021 and beyond use date for the vials was reported as 29-Oct-2021 and 4-Nov-2021 respectively. Product moved to clinic on 27-Oct-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported
Left sided migraine lasted for more than 24 hours presenting with blurry vision and jaw pain. Nausea and GI upset as well.
Patient was mistakenly given FLUARIX instead of BOOSTRIX. No other adverse events were reported.
his face was all red; he broke out in sweats; couldn't breath; could not get up from couch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (his face was all red), HYPERHIDROSIS (he broke out in sweats), DYSPNOEA (couldn't breath) and DYSKINESIA (could not get up from couch) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Apr-2021, the patient experienced ERYTHEMA (his face was all red), HYPERHIDROSIS (he broke out in sweats), DYSPNOEA (couldn't breath) and DYSKINESIA (could not get up from couch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 21-Apr-2021, ERYTHEMA (his face was all red), HYPERHIDROSIS (he broke out in sweats), DYSPNOEA (couldn't breath) and DYSKINESIA (could not get up from couch) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.