chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extended menstrual bleeding; spotting; This is a spontaneous report was received from a contactable consumer or other non hcp. This is report 2 of 3. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. It was reported that, while reporting on herself caller mentioned that she was talking to 2 girls in her office who also just had the second Pfizer COVID-19 vaccine and are having extended menstrual bleeding. They are not having it to the extent she was they are just having spotting. She wanted to call about that. She saw something online that some people are talking about it and maybe something was happening. It was coincidental that 3 of them in the office had the same thing. The other girls she talked to have extended menstrual cycles, but it was more like spotting that they think goes away but then it comes back. She declines to report on the 2 girls she had mentioned earlier. The one girl may call herself, she called to talk to her physician first. The outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021618069 same reporter/drug/AE, different patients
chills; could not get out of bed; I cant move my legs; Very weak; Soaking from sweats; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats), MYALGIA (Muscle pain) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL for Gout, ASA for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats) and MYALGIA (Muscle pain). On 14-Feb-2021, the patient experienced CHILLS (chills) and BEDRIDDEN (could not get out of bed). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-Feb-2021, LIMB DISCOMFORT (I cant move my legs), ASTHENIA (Very weak), HYPERHIDROSIS (Soaking from sweats) and MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (chills) and BEDRIDDEN (could not get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Event was updated, outcome of one event was updated and  Route of administration added
wife took him to the ER for adnominal pain and back pain and was found to have had a blood clot go to his left kidney
bumps are red in color; though in the beginning , those bumps as acne; bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (bumps are red in color), DERMATITIS ACNEIFORM (though in the beginning , those bumps as acne) and RASH (bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (bumps are red in color), DERMATITIS ACNEIFORM (though in the beginning , those bumps as acne) and RASH (bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm). At the time of the report, RASH ERYTHEMATOUS (bumps are red in color), DERMATITIS ACNEIFORM (though in the beginning , those bumps as acne) and RASH (bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains non-significant information.
No additional AEs; Caller reported expired dose of RECOMBIVAX HB was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.   On 21-NOV-2022, the patient was vaccinated with a expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, at dose 0.5 milliliter, administered intramuscularly for prophylaxis (lot number T036814 was verified to be a valid number, expiration date reported and established as 12-NOV-2022) (strength, anatomical injection site and vaccination scheme were not reported) (expired product administered). No additional adverse events were reported.
I had a headache the next morning but no other symptoms initially.  Then, Saturday evening, just over 24 hours after receiving the J&J vaccine I was sitting in landscape pavers outside in jeans and a long sleeve shirt next to the pool. My husband looked over and said what is wrong with your feet, they are blue. He said that is not good with circulation and you should probably talk to your doctor. Unfortunately I did not take a picture at the time and noted I was a little chilly but would reach out to my doctor if it continued and didn?t think anything more of it until I saw the reports Tuesday morning of them recommending to stop the J&J vaccine.   I called my doctors office Tuesday morning and they asked me to come in over lunch to see the doctor. While sitting waiting to see the doctor my feel replicated the situation from Saturday  night. My toes were especially blue up through my ankle and the doctor pointed out I had red patches looking like a rash. She also noticed my right leg was worse and more swollen up to just below my knee. We did take pictures that we can share if prompted.
After receiving the Pfizer 1st vaccine on March 17 and  next appt to take the second one is on April 7th but missed it due to I'm out of town  and I will take it after coming  back home. On the 9th of April starting to have an pulse tile feeling in my left ear so I made an appt to see my ear doctor  to see if something connected to my ear infection and had surgery last year but my Dr said everything is good my hearing test  is much better.  Mention to my Dr that what's going and about the vaccine I  had. He said possibly that is one of the side effect of the vaccine and heard some people who's got the same situation.
a 5 year old male patient received an adult dose (1ml) of Havrix; a 5 year old male patient received an adult dose (1ml) of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HAV (Havrix adult) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   On 15-AUG-2023, the patient received Havrix adult 1 ml. On 15-AUG-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: a 5 year old male patient received an adult dose (1ml) of Havrix) and adult product administered to child (Verbatim: a 5 year old male patient received an adult dose (1ml) of Havrix). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 15-AUG-2023 The reporter was a practice manager. No symptoms were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.  The reporter reported that a 5-year-old male patient received an adult dose (1ml) of Havrix, which led to overdose and adult product administered to child. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023111540:same reporter
Within one hour of receiving the vaccine @ pharmacy, I was shaking, freezing cold, shivering uncontrollably, had a headache, lower back, neck & shoulders were very painful!  It was so bad I was unable to work the following day, 10/09/2019, which I CANNOT afford to do! Although I had to return to work I am still suffering from body aches & general malaise. I have NEVER had a reaction to the flu shot in the past.
Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 sat dropped to 91% after event. Onset approximately 2 minutes following injection.
Extreme dizziness(cant stand or walk), Extreme headache, buzzing in ears, extreme fatigue, runny nose, cough, uncontrollable shivering(even after a hot drink and hot shower), counldnt move my entire body(especially arms, hands and legs), high fever, exhaustion
I am peri-menopausal; I did not have my period for four months prior, and then only very lightly. Within hours of getting my first Moderna vaccine, I started to menstruate, and very heavily. The bleeding has continued, in various flow levels, for eight weeks now, with only a few days without any blood or spotting. Blood is unusually red, and I'm getting cramps and headaches that are reminiscent of when I had my period as a younger woman.
erythema, itching to injection site that began few hours after injection. pt daughter states area has lessened. no further reactions, rashes, shortness of breath
got Covid between the first and second shot,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid between the first and second shot,) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid between the first and second shot,). At the time of the report, COVID-19 (got Covid between the first and second shot,) outcome was unknown.            No concomitant medications were given No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Additional information received
Redness and severe swelling at site of injection, itching and tingling sensation. She said she did not feel any breathing issues. Also she mentioned that she received flu vaccine long time ago but does not remember when. She salso said that she is doing fine now. We talked on phone.
Started running a fever at school.  Temp of 103.  Given Motrin went down to 97.3  Complained of stomach hurting but didn't eat breakfast. No rash, No pain at site.
Case number PHEH2012US020653 is an initial spontaneous report received from a pharmacist on 12 Oct 2012 with a follow-up received on 06 Nov 2012: This case refers to a 13-year-old female patient. Previous administration of MENVEO in the past was reported to be tolerated well. She was vaccinated intramuscularly only with MenCYW-135 liquid conjugate component of MENVEO (batch number: X10051) without MenA lyophilized conjugate component on 12 Oct 2012. The mother did not want to receive the lyophilized component. No adverse event was reported following this drug administration error. Follow-up received from the pharmacist on 06 Nov 2012: Updated comment from the mother.
blood vessel had busted in his right eye; Black Floaters in right eye; Muscle and body aches; Muscle and body aches; Fatigue; Lost of taste and smell; Lost of taste and smell; Headache; Runny nose; Nausea; This is a spontaneous report from a contactable consumer (patient).  A 74-years-old male patient received first dose of BNT162B2 (Lot Number: EL9267), intramuscular administered in the right arm on 25Feb2021 14:00 as SINGLE DOSE for covid-19 immunisation. Medical history included genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, compromised immune status, respiratory illness, diagnosed allergy, High blood pressure, Heart problems (Family medical history: Father died early of heart problems), all from an unknown date and unknown if ongoing; and Allergic to Latex and rubber products diagnosed 1990. Concomitant medications included medications for high blood pressure. The patient experienced blood vessel had busted in his right eye on Mar2021 14:05; black floaters in right eye on Mar2021; fatigue on 28Feb2021; muscle and body aches on 28Feb2021 15:00; headache on 26Feb2021 09:00; lost of taste and smell in the early morning on 28Feb2021; runny nose in the morning on 26Feb2021; and nausea in the afternoon on 25Feb2021. The clinical course was reported as follows: The patient mentioned that he received his 1st dose of the Pfizer COVID19 Vaccine and 5 minutes after, they noticed a blood vessel had busted in his right eye, the same side where he got injected on his right arm. He thinks some blood had dried in his eyes and it was red that afternoon and the next day. He had a right eye busted blood vessel and it turned red. The whole white turned red. They watched him for another 15 minutes and it just stayed red. After a few days, the redness went away, but it left floaters in his right eye. He mentioned that he got 50-150 floaters in his right eye. He has a bunch of black floaters. Floaters are not directly in his sight, but he can see them all around. It has not impaired his sight. If they move in his line of sight, he can still see through them. He did not take second shot. He was scared to because he would get more floaters. It has been 3 weeks already and he still has floaters and it has not changed. Second shot was scheduled for 19Mar2021. Two weeks after first and a week before second one, he decided he did not want to get second shot. Fatigue got better 7 days after. Taste and smell took longer to return but came back since then. He takes regular medications for high blood pressure and did not feel they were relevant. Headache comes and goes but improved. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No ER or physician's office required. The outcome of the event 'black floaters in right eye' was not recovered and outcome of the other events was recovering.  No follow-up attempts are needed. No further information is expected.
started w/redness around inj site the next day p/vax;redness spread about 10cm x 5cm (ant thigh) when seen on 6/11/99 & limping;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.75.  Concomitant products were not provided.  On 28-Feb-2021, Excursion time was 09 AM, 1 PM temperature was 27, 26 respectively total doses given for the day was 152 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 PM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Extremely sore arm for 2 weeks.  Developed rash approx 12-13 days after vaccination.  Rash continued to worsen and was diagnosed with Cutaneous Leukocytoclastic Vasculitis.  Have been having ongoing doctor's visits ever since.  Three months later, the rash has covered limbs and trunk.
This case was reported by a pharmacist and described a 28 year old male pt who did not respond to the Engerix-B immunization series. On an unspecified date, the pt received the 3rd dose of Engerix-B (lot ENG5466A4). Approx. 2 months after the 3rd dose of Engerix-B, on an unspecified date, a hepatitis B surface antibody titer indicated that the pt was "non-immune". The reporting pharmacist considered the event to probably related to vaccination with Engerix-B. The pharmacist reported that the pt had begun the "second series" of immunization with Engerix-B.
patient was administered with two 0.1 mL doses of IMOVAX RABIES vaccine intradermally with no adverse event; patient was administered with two 0.1 mL doses of IMOVAX RABIES vaccine intradermally with no adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old patient of unknown gender who was administered with two 0.1 ml doses of rabies (HDC) vaccine [Imovax Rabies] intradermally with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient was administered with two 0.1 ml doses of rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot: V1D771M) (strength; expiry date unknown) intradermally with no adverse event (incorrect route of product administration) (incorrect dose administered) (latency: same day) via unknown route in unknown administration for post-exposure prophylaxis (Immunisation).  It was reported, "A nurse manager asks if the 0.1 mL intradermal dose of IMOVAX RABIES vaccine is equivalent to the 1 mL intramuscular dose, and if we do manufacture intradermal IMOVAX RABIES. Patient already received two intradermal doses of 0.1 mL in the ER, and they will be giving the patient two intramuscular 1 mL doses; caller asks if those two different routes and doses are interchangeable."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Patient stated she felt heart racing/palpitations and SOB the evening of the same morning she'd received her Hepatitis B vaccination. Patient stated that an ambulance was called; she was taken to the ED and that multiple tests were performed, but that she recovered and was not admitted. Patient denied ever having had similar symptoms in the past or since.
Information has been received from a physician and certified medical assistant concerning a 16 year old female, who on 03-AUG-2007 was vaccinated intramuscularly with a 0.5mL dose of Gardasil (Lot# 655620/0171U). Concomitant suspect vaccinations included hepatitis A vaccine (inactive) (duration and dose not reported) and varicella virus vaccine live (duration and dose not reported). Other concomitant therapy included MENACTRA. On 03-AUG-2007 following the vaccinations, the patient fainted at the front desk when she went to make the next appointment. The patient hit the back of her head and lost consciousness for 1 to 2 minutes. When the patient regained consciousness, the patient was screaming and crying. When the paramedics arrived and tried to get the patient into the ambulance, the patient was fighting with the paramedics. The patient was taken to the emergency room at a hospital then was transported to a pediatric hospital where she saw a pediatric neurologist. The patient was found to have a small fracture at the back of her head. The medical assistant mentioned to the nurse that the patient was cold, clammy, and had high anxiety prior to all the vaccines. The father mentioned that the patient has been having anxiety attacks. The office had offered to give 2 vaccinations at one visit and the other 2 at another time but the patient had refused. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes.  My lips, tongue, lower jaw and teeth started to feel tingly and strange.  This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/7/2021 PRESENCE OF TRACHEOSTOMY  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 7/15/2021 PRESENCE OF TRACHEOSTOMY