chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle used to be 4 weeks on the dot. Now it is 6-7 weeks between cycles.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 2, single (Lot number: FF2588) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "gluten" (unspecified if ongoing), notes: Known allergies: gluten, dairy; "dairy" (unspecified if ongoing), notes: Known allergies: gluten, dairy. Concomitant medication(s) included: JUICE PLUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: FC3180, vaccine location: Left arm.), administration date: 13Aug2021, when the patient was 16-year-old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Oct2021, outcome "not recovered", described as "Menstrual cycle used to be 4 weeks on the dot. Now it is 6-7 weeks between cycles.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient menstrual cycle used to be 4 weeks on the dot. Now it is 6-7 weeks between cycles. The patient did not have covid prior to vaccination. Also, the patient was not tested for covid post vaccination. The patient was also taking Lauricidin as concomitant drug. The patient had no other vaccine in four weeks.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-NOV-2017, the patient received a dose of ROTATEQ (strength were unknown) (lot# M042169 and expiration date 22-JUN-2018). On 08-JAN-2018 and 16-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# reported as M022173 and expiration date reported as 15-MAR-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
My child cried, napped and went from being a happy, sociable and bubbly baby to screaming for hours and not making eye contact within hours of taking the vaccine. I even have video evidence of her cooing and what sounds like babbling days before her vaccine. I had never heard this scream from my child before or she had never cried that long. After that, it was 10 hours of screaming each day. My child gradually improved. However, to this day, she still has bouts of the same high-pitched screaming out of the blue, though not as often. Her other sibling did not take the vaccine and does not have this problem.
This spontaneous report was received from a pharmacist regarding an unspecified infant of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed a small amount of redness at injection 1-2 days post vax. This resolved, then 6 days post vax pt developed egg size swelling and redness at the same site. Examined the next day 3 X 7 cm area erythema, no induration, no tenderness. Hypersensitivity reaction?
so sick; weak; pain in arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (so sick), ASTHENIA (weak), PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     No medication history was reported by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and OMEPRAZOLE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (so sick), ASTHENIA (weak), PAIN IN EXTREMITY (pain in arm) and CHILLS (chills). At the time of the report, MALAISE (so sick), ASTHENIA (weak), PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Patient stated that she felt "like a horse kicked her in the arm" a few hours after vaccination.  She had chills and was shivering and had pain in her arm.  She took some tylenol and went to sleep. The next day, she felt like she was going to vomit all day and felt "fuzzy" and "woozy".  She drove to pick up her granddaughter from school and tried to park the car in the garage.  She says she was so dizzy that she pulled the car in sideways and claims that she had "an out-of-body experience".  She says that they did not react to the first dose, but was sick all day from the second dose.
5 minutes after receiving vaccine patient complained of having a metallic taste in her mouth after about 30 minutes she complained of having chest pressure but denied chest pain. EMS was called.  Vital signs were taken but no other medications given.
fever; feeling weak; unable to walk independently; no appetite; This is a spontaneous report from a contactable consumer via social media. A 73-year-old male patient received the second dose of (lot number: EW2243), via an unspecified route of administration on 12Apr2021 09:45 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The other medications that the patient received within 2 weeks of vaccination were insulin and for blood pressure. Prior to vaccination, the patient was not diagnosed with Covid-19. The patient previously received the first dose of bnt162b2 (lot number: ER4812), via an unspecified route of administration on 16Mar2021 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced fever, feeling weak, unable to walk independently and had no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the events. The outcome of the events was fatal. The patient died on 19Apr2021. Cause of death were fever, feeling weak, unable to walk independently and had no appetite. An autopsy was not performed. Since the vaccination, the patient hasn't been tested for covid-19.; Reported Cause(s) of Death: fever; feeling weak; unable to walk independently; no appetite
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2017, the patient was treated by a hospital for a blistering vesicular outbreak, which was then diagnosed as herpes or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heavy" and hard to keep eyes open. Also reported feeling like heart was "racing"
Patient developed a flat red rash near injection site, which is suspected to be related to bandage adhesive vs vaccine reaction.
Lymph node on my left clavicle popped out; Extremely tired; Felt nauseous; Hang over for a few days; Did not feel myself; This is a spontaneous report from a contactable other healthcare professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, 24 hours after the second dose, the patient experienced a lymph node pop out on her left clavicle. She was extremely tired, felt nauseous like and hang over for a few days. She did not feel herself until 5 days after the second dose and the node was pretty much gone then, it was very visible and then it was not. She still can feel a very small bump. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events lymph node on her left clavicle popped out, extremely, felt nauseous, hang over for a few days, did not feel herself, nose is pretty much gone and still feel a very small bump was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Left arm-deltoid injection site-erythema, warm to touch, induration, pruritis, c/o pain.
Pain with movement in upper left arm, began morning after shot, has persisted to mid-morning 02/06/21.
Presented to ER with skin blisters and rash on the inside of joints such as elbows, backside of knees,ankles, waist, neck and arm pits with extreme itching.  Patient was given 5 days of Medrol pack, Tagament, Ativan and Benadryl
Patient received vaccines on 6/16/16. Patient diagnosed with cellulitis on left bicep on 6/20/16, treated with KEFLEX 500 mg QID x 7 D starting 6/20/16.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/23/2021 and 2/23/2021. On 1/14/2022 presented to physician office, COVID positive with O2 sat of 88%. Sent to ED.  Reported 5 days of HA, sore throat, body aches, and cough. Afebrile in ED but tachypnea required 4L NC admitted for acute respiratory failure due to Covid PNA. CT chest negative for acute thromboembolism, positive for COVID PNA on chronic bronchiectasis. CT Chest with contrast revealed the presence of pulmonary thrombi treated w/heparin. Covid treated w/remdesivir and decadron. Respiratory status declined. Transitioned to palliative care 1/21/22, expired 1/22/22.
Approximately two weeks after my booster shot, I developed severe whole body weakness, myalgia, burning in my muscles and pain. The severe weakness has persisted along with all of the symptoms. I have had difficulty walking, rising from sitting, climbing stairs and even getting out of bed.
Patient started having a seizure and fell out of his chair 10 mins after getting the vaccination. The pharmacist called 911 and attended to him. Got him back in the chair and then the patient had a second seizure. The paramedics came and checked him out and said he did not need to go to the hospital if he didn't want to and the patient declined.
sore arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is first of 2 reports. A female patient of an unspecified age (Age: 79; Unit: unknown) received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 27Jan2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 patient received vaccine and have only developed a sore arm on an unknown date in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106968 Same reporter/drug/event, different patient.
patient's left arm (injection site) got very sore and painful and it was difficult to lift; patient's left arm (injection site) got very sore and painful and it was difficult to lift; This is a spontaneous report from a non-contactable pharmacist (patient). A 57-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 13Jan2021 at 19:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 13Jan2021, after the vaccination, the patient's left arm (injection site) got very sore and painful and it was difficult to lift the next day (14Jan2021). The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered from an unspecified date.   No follow-up attempts are possible. No further information is expected.
Left arm Soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient experienced left arm soreness from 1st dose of Shingrix which was received in left deltoid. The reporter provided limited information and stated her phone was going to fail shortly, and subsequently the call ended abruptly. The patient consented to follow up.
sore injection site; very swollen area in right arm pit; low grade fever; Diarrhea; upset stomach; fever (102 degrees F); chills; extreme fatigue; headache; migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Sep2021 18:00 (Lot number: Fc3184) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE HCL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer, Lot number=Ew0181, Lot unknown=False, Administration date=18Aug2021, Administration time=11:30 AM, Dose number=1, Vaccine location=Right arm}]), administration date: 18Aug2021, when the patient was 41 years old, for covid-19 immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "upset stomach"; PYREXIA (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "fever (102 degrees F)"; CHILLS (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "extreme fatigue"; HEADACHE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "headache"; MIGRAINE (non-serious) with onset 10Sep2021 08:00, outcome "recovering", described as "migraine"; VACCINATION SITE PAIN (non-serious) with onset 11Sep2021, outcome "recovering", described as "sore injection site"; LYMPHADENOPATHY (non-serious) with onset 11Sep2021, outcome "recovering", described as "very swollen area in right arm pit"; PYREXIA (non-serious) with onset 11Sep2021, outcome "recovering", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, abdominal discomfort, pyrexia, chills, fatigue, headache, migraine, vaccination site pain, lymphadenopathy, pyrexia.  Additional information: Patient has not received any other vaccine in four weeks. Patient had no covid prior to vaccination and not tested post vaccination and had no known allergies.  Follow-up attempts are completed. No further information is expected.
p/vax pt devel swelling of hands, feet, ears & urticaria rash; seen in ER; records not yet available
Booster dose COVID-Moderna accidentally given prior to 6 month interval.  Booster was administered 5 months and 16 days after 2nd dose.  Patient did not have COVID-19 issued vaccine administration card.  As previous administration was being verified by clinic staff, vaccinator misunderstood clinic staff directions and booster dose was administered by vaccinator.  Patient was advised of error on site after vaccine administration when error was discovered.  Both clinic staff and vaccinator were advised of incorrect procedures and re-instructed on correct process for given situation.
Patient experienced palpitations and dizziness, and chest pains.  Client was cleared with EMS and advised to go to Emergency Room.  Patient had driver to drive them to emergency room.
Body aches, Chills, Very sore arm, and red solid circle at injection site. Body aches and chills lasted around 24-28 hours. Sore arm is still here 72 hours after but is improving. Red solid circle at injection site showed up 24 hours after injection and is still there 72 hours after.
About 12 hours after receiving 2nd dose, I experienced heart pains, shortness of breath, shivering, and fever over 105. Most symptoms subsided after 24 hours after the second dose, except chest pains and shortness of breath continued for over 3 months after 2nd dose. Received EKG from primary care, results were consistent with previous EKGs. Shortness of breath and chest pains continued until July 2021.
Severe chills, vomiting, dizziness, lost control of my legs while walking and collapsed, did not lose consciousness, tiredness. Lasted for 3 days.
could not sleep last night; my arm last night pained right up to my neck ; real hurting me; my arm last night pained right up to my neck ; real hurting me/hand pained so badly; itchy nose or some kind of allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8732) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: diabetic and I take my medication. Concomitant medication(s) included: INSULIN; ASPIRIN (E.C.); METFORMIN; GABAPENTIN; FUROSEMIDE; LISINOPRIL. Vaccination history included: Covid-19 vaccine (Dose 1,manufacturer unknown), for Covid-19 immunisation. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "could not sleep last night"; NECK PAIN (non-serious), outcome "unknown", described as "my arm last night pained right up to my neck ; real hurting me"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm last night pained right up to my neck ; real hurting me/hand pained so badly"; NASAL PRURITUS (non-serious), outcome "unknown", described as "itchy nose or some kind of allergy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, pain in extremity.  Additional information: Reported as, yesterday patient had second dosage and from the minute she got the injection her arm start to pain, real pain she could not sleep last night she had to put ice on it, it was real hurting and she was not able to sleep, and my arm last night pained right up to my neck right patient have to put ice on it but it is still paining right but not that much because she put put a ice(Treatment) on it. Patient was very disappointed. When probed for causality,consumer further stated, "Yes, because in the first dosage patient didn't have these kind of symptoms, a little itchy nose or some kind of allergy and it went away cause she talked to his doctor but this one yesterday it was so painful she couldn't sleep.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning an 8 year old male with no known medical history who was vaccinated at 12 months of age with a does of varicella virus vaccine live. There was no concomitant medication. In February 2006, the patient developed breakthrough with less than 50 vesicles on torso and thorax. Unspecified medical attention was sought. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.