chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hib component of the pentacel was not mixed and was not given to the consumer with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient and reporter reported hib component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was not mixed and was not given to the consumer with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 20v (crm197) (prevnar 20) for prophylactic vaccination; and rotavirus vaccine live reassort oral 5v (rotateq) for prophylactic vaccination.  On 23-Oct-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ861AA) (Expiry date: 30-Mar-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization.  On 23-Oct-2023, the reporter reported hib component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was not mixed and was not given to the consumer with no reported adverse event (product preparation error) (latency: same day).  It was reported, LVN called in because the HIB component of the PENTACEL was not mixed and was not given to the consumer. Caller wanted to know about what to do next. Provided the information via SRD, and information was also sent to the caller via email. This inquiry was submitted to PV since the vaccine was given inappropriately without the HIB component.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I got really hot; my face swelled; This is a spontaneous report from a contactable consumer. A 35-years-old Female (patient her-self) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an un-specified date (on 3Apr or 4) (Batch/Lot number was not reported) as single dose for covid-19 im-munization. The patient's medical history and concomitant medications were not reported.  The patient experienced I got really hot; my face swelled on an unspecified date. The patient stated that she got the first dose on 3Apr or 4 and about 4-5 hours later her face swelled and got really hot. he enquired if she could get the 2nd dose or get Johnson and Johnson instead? The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna Vial Lot # 069H21A first puncture on Wednesday 02/23/22 at 16:55 and had 2 dose drawn was put back into the refrigerator and used again the following day on Thursday 02/24/22 at 17:00, so that exceeds the 12 hours maximum time after puncture. I have already contacted the Moderna Medical Hotline and they will reach out in a few days.
Body aches, headache, fever, shakiness, nausea, vomiting. Started 11/23 as mild symptoms, more severe on 11/24, resolved on 11/25.
Soreness in arm at injection site.; General body aches and pains; intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Left Arm on 24Mar2021 01:15 am as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension (controlled w/medication). Concomitant medication(s) (received within 2 weeks of vaccination) included enalapril maleate (10 mg/day). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Other. Allergies to medications, food, or other products: No. Historical vaccine included BNT162B2 on 04Mar2021 01:15 am (First Dose, Left arm, Lot No EL3247). The patient experienced soreness in arm at injection site, general body aches and pains, intermittent headache; all (non-serious) on 24Mar2021 23:45. Treatment was not received for the adverse event Outcome of all events was recovering.    Follow up attempts are needed. Further information has been requested.
no adverse events reported yet; vaers site says it encourages healthcare professionals to report administration errors - the immunization was given without being shaken
I got very tired within 10 minutes.; I started sweating profusely; Then I got the sudden urge to poop; As I walked to the bathroom I almost passed out from extreme dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 22Apr2021 at 15:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 15:30, the patient got very tired within 10 minutes, then the patient started sweating profusely, also got the sudden urge to poop and as the patient walked to the bathroom, he almost passed out from extreme dizziness. The patient continued sweating and being very dizzy for about 5 more minutes, then the patient felt better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very tired within 10 minutes, sweating profusely, sudden urge to poop and dizziness was recovered on 22Apr2021.   No follow-up attempts are needed. No further information is expected.
Type 2 diabetes mellitus without complication, without long-term current use of insulin. Office visit within 6 weeks of receiving the COVID vaccine.
I tested twice and it was negative; then Aug 23rd my husband started with a bad cough. We had just returned from travel from the hospital. First came the really bad sore throat and cough that would not stop, fever, congestion, and fatigue. Six hours later no appetite. I called the doctor and started PAXLOVID on Aug 24th. I slept a lot and had a fever for the first 3 days. One of my worst symptoms was diarrhea that started on the Aug 26 (for 9 days day and night and was uncontrollable) really heavy with severe stomach cramps and had nausea for 2 days really bad. I also had dizziness. I went to urgent care because I was feeling really dehydrated. I had a temp on the 31st. The last day of PAXLOVID (day 5) I had severe diarrhea, went to the bathroom 9 times. In urgent care I was put on a BRAT diet and gave me a prescription for the diarrhea and stomach cramps. On 9/3 I was the last day of full diarrhea. By 9/6 I was feeling better but was still with a cough that last 6 weeks from that point. It was the first time I had COVID-19.
patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1 on 03-APR-2021. On 03-APR-2021, Excursion time was 9 AM, temp was 34.Excursion duration at 8 am 38, at 9 am 34, at 10 am 38, at 11 am 42, at 12 pm 41, at 1 pm 41, at 2 pm 41, at 3 pm 40 and at 4 pm 40 and 5 pm 41 taken using a Fisher brand traceable temperature monitor in F  On 03-APR-2021, total doses given for the day was 210, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 30-MAR-2021, vial was moved to clinic on  03-APR-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-APR-2021 for batch number 030B21A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration.Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided   This case was linked to MOD-2022-566976 (Patient Link).
One month after injection, noticed indentation in right breast area; then noticed hard cord (vein) running from abdomen to breast area (with the indentation). Saw urgent care doctor in early July who confirmed the symptoms looked like "Mondor's Disease."
This spontaneous report has been received from a 62 year old female consumer reporting on herself. Patients current conditions included diabetic and heart patient, drug reactions/allergies with nitrofurantoin (furadantin), LORABID, and LEVAQUIN. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, lot# and route not reported). Concomitant therapies included carvedilol (manufacturer unknown), hydrochlorothiazide, lisinopril (manufacturer unknown), PLAVIX, LIPITOR, glipizide ER (manufacturer unknown) and venlafaxine hydrochloride (manufacturer unknown). On 12-OCT-2013, the patient experienced redness, itchiness, stinging and burning all over her arm, her arm became extremely swollen, had a red know at the injection site, her arm felt feverish and developed a headache. It was not given a treatment for the adverse events. The patient did not seek medical attention. There was no laboratories diagnostic test performed. The outcome of the adverse events was not recovered. Additional information has been requested.
Patient woke up on Monday, 09/05/22, morning reporting that her hands were swollen and eyes were also swollen. Patient stated that her throat did not close. Patient states that symptoms began to disappear on Tuesday 09/06/22.
Had temperature: 99.9, 89.6, 97.6; feeling really cold; shaky; woke up during the night last night; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6202 and expiration date not reported), via an unspecified route of administration, administered in Arm Left (reported as left shoulder), on 05Mar2021 14:15 (at the age of 75-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included , surgery from Dec2020 to Dec2020 , arthritis, allergies , compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, breathing difficult, high cholesterol, gastric acid increased, infection, blood pressure, sleeping disorder, gas. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication; ipratropium bromide, salbutamol sulfate (COMBIVENT RESPIMAT) taken for breathing,; azelastine (nasal solution) taken for an unspecified indication; lovastatin taken for lowering cholesterol; loratadine (1 daily) taken for allergies; omeprazole taken for stomach acid; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) (capsule) taken for an unspecified indication; valaciclovir hydrochloride (1/2 pill daily) taken for infection; carvedilol taken for blood pressure; hydrochlorothiazide taken for blood pressure; zolpidem taken (1/2 pill) for sleeping, start and stop date were not reported; plantago ovata (METAMUCIL CITRON) taken for an unspecified indication; fish oil (4000mg daily 2-1000mg taken twice daily morning and night) taken for an unspecified indication; simethicone (taken as needed every once in a great while) taken for gas; acetaminophen (2-500mg pills taken 3 times daily or every 8 hours) taken for arthritis; multivitamin [vitamins nos] (1 daily) taken for an unspecified indication and unknown inhaler for breathing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9266 and expiration date not reported), via an unspecified route of administration, on 12Feb2021 (at the age of 74-year-old), as dose 1, single, for COVID-19 immunisation. No additional vaccines were administered on same date of the COVID vaccine and no other vaccines were administered within four weeks prior to the first administration date of the COVID vaccine. In Mar2021, the patient woke up during the night (reported as last night) as it was feeling really cold and real shaky. He went to the bathroom back to bed then got up the morning and was still real shaky. On 07Mar2021, the patient took his temperature around 08:15 and his temperature was up at 99.9 degrees Fahrenheit. He took his temperature again in 08Mar2021 (reported as this morning) around 03:35 and it was 99.6 degrees Fahrenheit, so it has improved. He asked if there was anything to be concerned about, if events are associated with the vaccine. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Pain; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and MYALGIA (Achiness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A71A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 31-Mar-2021, the patient experienced PAIN (Pain) and MYALGIA (Achiness). At the time of the report, PAIN (Pain) and MYALGIA (Achiness) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
I had congestion in my nose and chest along with a really bad headache. I had muscle aches and weakness in my arms and legs, chills, chest pain, a sore arm and fatigue. I was retested for COVID after I took the vaccine. The results came back negative. I was so weak that my husband had to lift me and carry me to the restroom. This pain lasted for about four to five days after my vaccine. I had to get 3 different infusions shot of solumedrol- IV steroid injection. This helped with the spasms and weakness. I still have pain in my upper thighs. Since I have taken so many medications, I am now having GI issues. I felt like everything became inflamed after receiving my vaccine. I never felt like this before even with already having MS.
Patient reported to ER at hospital with rash, patient is unaware if related to vaccine or not.
I have really bad headaches right after.  I slept a lot, was very tired that I could not keep myself to stay awake.  I keep getting bad headaches that keep getting worse that I could not do day to day work.  Throughout the day, I could not keep myself awake.  I took small naps. I contacted the neurologist on June 18th.  He did a motivity test on me.  I was diagnosed with migraines. I was referred to a sleep study, which the appointment is set in future date.
first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021; Received Moderna as second dose after Pfizer as first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021) and OFF LABEL USE (Received Moderna as second dose after Pfizer as first) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced OFF LABEL USE (Received Moderna as second dose after Pfizer as first). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021). On 12-Mar-2021, OFF LABEL USE (Received Moderna as second dose after Pfizer as first) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
First 48 hours included body aches, headache, chills, feverish, sore arm at injection site. Abdominal pain  existed, chest pain. 1 week later abdominal pain, chest pain still exists, similar to acid reflex or heartburn. Insomnia as pain persists at night.
presented with cough and increasing dyspnea; positive for COVID; hx of granulomatous polyangiitis and airway strictures; ARDS with intubation, mechanical assistance
Had 2 shots an still got it/Suspected vaccination failure; Still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 shots an still got it/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.    It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient's wife via interactive digital media. The patient had two shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENICAR; AMLODIPINE; PHENERGAN [PROMETHAZINE]; BACTRIM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment of oral paxlovid from 04Jul2022 till 09Jul2022 (Lot number=1111111111). Symptoms recurred 4 days after finishing course. Known allergies and other medical history reported as no.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
After Pt received 1st dose of pfizer vaccine, 2 min later pt states having itchiness left lower arm. Shortly after rash began on left lower only. Assessed Pt's body no other reaction only to left arm. Pt states no reactions in the past.  Offered Pt water. Vital signs stable. Pt refused benadryl stating she will take one when she gets home if it gets worse. She stated she felt better and could go home.  Explained to pt if it gets worse or anaphlaxis, go to the nearest ER and follow up with PCP. Pt verbalized understanding. Pt escorted home. VS: HR 55, Resp 20, BP 133/77, O2 99% RA
shivering, headache that lasted approximately 24 hours - neither acetaminophen or aspirin made a difference, fatigue, no energy, muscle soreness at injection site, underarm soreness the night of March 7th. Morning of March 8th, feel weak and a little dizzy, soreness at injection site, no other symptoms