chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began to feel very tired and weak the same day slept through the night and all day the next day And all night the second night till 10 o?clock in the morning on the 13th. Within 12 hours my kidneys were working overtime I was running to the bathroom constantly. Couldn?t hold It  at all. Made me incontinent for at least 24 hours up three or four times to go to the bathroom. Lack of appetite. Arm is aching at site of injection  and a little red.
Initial and follow up information has been received from a retired certified medical assistant, who is also the mother of the patient and a member of the certified nurse midwife's office, for the Pregnancy Registry for GARDASIL, concerning a 16 year old female with allergies to sulfa antibiotics and prior history of smoking. On 27-FEB-2007, the patient was vaccinated with her first dose of GARDASIL (Lot #, 654702/00110). On 02-MAY-2007, the patient was vaccinated with her second dose of GARDASIL (Lot # 657617/0384U). On 28-AUG-2007, the patient was vaccinated with her third dose of GARDASIL (Lot # 658556/1060U). Concomitant therapy included TANDEM OB. On 25-SEP-2007 it was reported that the patient was 8 weeks and 6 days pregnant. On 25-SEP-2007, 10-DEC-2007, 10-APR-2008 and on 18-APR-2008 the patient had an ultrasound due to large for gestational age and right testicle hydrocele. On 26-NOV-2007 the patient had an elective serum alpha-fetoprotein test. The patient sought unspecified medical attention in the office. It was reported that on an unspecified date the patient had unspecified blood  work and a urine pregnancy test. "As far as the delivery went everything was fine" (no further information was provided). The patient delivered a normal male infant on 04-MAY-2008, weighing 8 pounds and 15 ounces. It was reported that the baby experienced fetal distress during labor and delivery. There were no congenital anomalies, complications or abnormalities. It was reported that the mother experienced a 50 plus pound weight gain. On 04-JUN-2008, the patient went to the office for her postpartum visit (not otherwise specified). On 11-JUL-2008, the infants pediatrician was contacted regarding whether or not the baby had any right testicular hydrocele (earlier identified on a sonogram). He said that after doing several exams on the infant there was no hydrocele noted. It was also reported that he had no access to the prenatal ultrasound reports and was not aware of these findings. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm, on 01Jul2022 as dose 4 (booster), single (Lot number: FN2908), in right arm and on 29Nov2022 at 11:30 as dose 5 (booster), single (Lot number: GH9703 FMMJ) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL0142), in right arm and on 22Jan2021 as dose 2, single (Lot number: EL3249), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "Thyroid disorder" (unspecified if ongoing); "Nerve Damage" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Sinus disorder" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma; GABAPENTIN taken for nerve injury; MUCINEX taken for sinus disorder; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; SYNTHROID taken for thyroid disorder. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 17Jan2023 to 22Jan2023.
My adverse event started on 01/2023. It stared in the morning through all day. After eating I get abdominal pain and  feeling bloated.      . I stopped eating Gluten food which it helped. I took Famotidine It also  helped but I still  felt full and the pain was more manageable with medication.  I tried to avoid acid foods which it greatly helped but I didn't recover.   I spoke with my doctor on Tuesday 04/11/2023 .  He said you have to eat gluten for a week and  schedule blood work  for next week. As of now am waiting to get my blood work done and then will discuss options with my doctor who is also trying to rule out the problem I am experiencing.
12MAY92 irritable-sore leg; 13MAY92 AM looked nervous had jerky movements; less jerky w/APAP; by PM-1 1/2 hr unconsolable crying; cont w/jerky movements till Friday PM & was listless till following morning;
vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 051C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022).    Vaccine coordinator reported that a nurse put a vial of Moderna back in the fridge after puncturing it and administered a dose 3 weeks later. More than 12 hours post puncture dose was administered. Individual vials or unbroken cartons were 1 vial. Vial size was 2.5 mL 10 dose. The vial was initially stored in the refrigerator on 07-Dec-2022. Vial was first punctured on 08-Dec-2022. The vial was stored in fridge post puncture. The vial does not undergo any temperature excursions. It was reported that they pulled the dose for the patient and put it back in the fridge. No concomitant medication was reported. No treatment medication was reported.
Initial unsolicited report received from a Nurse on 06 October 2016. This case involves a five-month-old patient (gender not reported) who was vaccinated with a dose PENTACEL (batch number: C5055AB, expiration date: 03 June 2017) intramuscularly in right thigh, a dose of Hep B (manufacturer: Pfizer) intramuscularly in left thigh and a dose of PCV intramuscularly in left thigh (batch number, dose and expiration were not reported for Hep B and PCV) on [date]. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was denied. Concomitant medications were not reported. On 06 October 2016, same day following the vaccination, the patient experienced redness at the injection site (right thigh) and "inconsolable crying". Patient's Lab data was not reported. Corrective treatment included to apply ice at the injection site. Patient was advised to go for consultation if symptom persists. Outcome of the event was reported as unknown. List of documents held by sender: none.
Redness at injection site; shortness of breath; Feverish; lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 13:15 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation in hospital.  Medical history included, drug hypersensitivity (Penicillin allergy) from an unknown date and unknown if ongoing known allergies. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid-19 immunisation.  The patient was feverish and had lethargy on 13Apr2021, a day after receiving COVID-19 vaccine. The patient developed redness at injection site and shortness of breath on day 2. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient was wellness director who helped going thru rounds and getting residents and staff to get vaccine, around 20 minutes after the shot when patient stood up, patient got lightheaded and had some tingly sensation in her mouth and around the top area of her face. patient mentioned she had anxiety, patient was given Benadryl, bottle of water, soda and orange juice. her friend helped her do breathing exercises to calm down her anxiety, patient was fine afterwards.
Headache, Myalgia, Fever, fatigue, swollen hands Narrative:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER8732), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN-D; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]; IBUPROFEN; ALPRAZOLAM. Past drug history included: Bactrim, reaction(s): "Known Allergies: Bactrim", notes: Known Allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative; (May2022) Positive, notes: Took a second and it was positive too. Therapeutic measures were taken as a result of covid-19. Treatment drug included Paxlovid from 18May2022 to 16May2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Rebound of Covid after taking Paxlovid. Took the 5 day treatment. Tested negative on day 8, symptoms improving (had been mild - mainly congestion, fatige, minimal cough, never had a fever). Day 13 work up with sinuses very congested and feeling generally crappy. Thinking patient might have sinus infection but also took a rapid test and it came up postive. Took a second and it was postive too.
Patient had side effects from 2nd dose of Covid vaccine and 1st booster of a flare up of her atrial fib.
his wife has tested positive for COVID-19; his family is concerned that he might have COVID, as well, as he has had a recent cough and some apparent respiratory distress.
Severe headaches; increased high blood pressure; Diagnosed with acute cerebral venous sinus thrombosis.; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in arm right on 15Apr2021 08:30 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe headaches, increased high blood pressure and was diagnosed with acute cerebral venous sinus thrombosis on 17Apr2021. The patient was hospitalized for the events for 3 days. The clinical course was as follows: Severe headaches began 2 days following vaccine which continued straight for 2 1/2 weeks followed by extremely increased high blood pressure. Sent to hospital emergency. Admitted and diagnosed with acute cerebral venous sinus thrombosis. The patient underwent lab tests and procedures which included blood pressure measurement: increased (Extremely increased high blood pressure), SARS-COV-2 test: negative (Nasal Swab), both on 03May2021. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all events (Blood Thinners and BP Medication). The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
1 week after 1st dose, hard, hot, hive-y, raised, itchy, red bump near injection site. Arm feels heavy.  Went to urgent care at 11:30 PM. Warm compresses, Benadryl. So far, not resolved as of next day.
mom called clinic 26OCT92 to report pt had reddened & swollen eyes 23OCT92 (48 hrs p/vax) Friday & Sat had red itchy blotches on cheeks & neck; 24OCT92 became itchy all over but sx began to resolve 25OCT92;
Vomiting for 48 hours following vaccination and then on 05/05/21 I gave a urine screen at Dr office for my pain mgt. And was advised of positive for fentanyl
Visual diagnosis of varicella by 2 providers on 9/20/2007 after prior vaccination on 10/4/1999 according to previous vaccination records provided to this office by parent.  Exposed at school to reported varicella, according to mother.
On 08/17/22, I started feeling achy, the next day I was still achy and very tired, I tested with a home COVID-19 test but it came back negative. On 08/19/22, I had a fever of 104F but with TYLENOL it was 102F, I did not have an appetite but made myself eat. I had an unproductive cough that made my muscles hurt. I was very tired, slept a lot. I called my doctor, had a telehealth, he prescribed PAXLOVID, that I started immediately. I did start feeling within 48 hours after taking the PAXLOVID, but I did get rebound COVID-19. I do feel better, but I feel that COVID-19 left me some lingering effects, I cannot regulate my body temperature and my vision is off.
Pt was given a dose from a vial that was >12 hour post puncture. Vial was left at room temp at 6pm and pt was given dose at around 10:50am. Pt was informed of error and pt reported feeling "bad" after receiving shot. Pt did not elaborate on symptoms. Explained to pt that common side effects of Covid-19 vaccine include, headache, fever, fatigue, etc.
sz-temp x 3 days tx w/APAP;convuls-taken to ER tests, x-rays done;parent feels DTP caused rxn;
SSwollen painful glands on the back of neck and on Scalp; headache; Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (SSwollen painful glands on the back of neck and on Scalp), EAR PAIN (Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced EAR PAIN (Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away). On 11-Apr-2021, the patient experienced LYMPHADENOPATHY (SSwollen painful glands on the back of neck and on Scalp). 11-Apr-2021, the patient experienced HEADACHE (headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Apr-2021, LYMPHADENOPATHY (SSwollen painful glands on the back of neck and on Scalp) and HEADACHE (headache) had not resolved. At the time of the report, EAR PAIN (Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient reported that her head and neck hurt for 2 weeks, and it hurt to wash and brush her hair after second dose of vaccine.  It was reported event resolved in 2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up was received. Event was added and outcome was updated.
One day after discharge for decompensated heart failure and non-ST elevation myocardial infarction, patient was transported by ambulance to hospital with complaints of shortness of breath, cough, and chest pain. Required increasing chronic oxygen supplementation from 4 L/min at baseline to 6 L/min and treatment with bronchodilators, corticosteroids, diuretics, adjustment of heart failure medicines, and management in a coronary intensive care setting. Patient improved over the ensuing 8 days and was discharged home in medically stable condition with follow-up in place for home health care services as well as physical and occupational therapy.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: friend came in with a picture of her arm.  it was red, spotchy and blistered.  recommended pt go to urgent care or er in case of cellulitus
This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported same events under same the suspect product for 10 patients. This is 1st out of 10 reports. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on 30Apr2021 as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. On unspecified date in Apr2021, the patient experienced low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. Call received from patient who believe that she received the modern vaccine stating that since receiving her 2nd dose in April she has low estrogen cannot sleep, focus, depressed has anxiety and cannot concentrate she was tested and test prove that she has low estrogen she wanted to make sure to notify because this could impact people who want to have babies. her two nieces are waiting because they are young. Patient stated that she is thankful that she no longer wants to have children she went on to state that she is aware of 10 people who experienced the similar reaction and did not mention the nationality of other 5 upon request of the date of vaccination and lot number expiration date for the moderna vaccine patient realized that she called the wrong number because she received both losses of Pfizer vaccine 2nd dose on 30Apr2021. Patient also stated that she called, because doctor does not believe her. Reported seriousness of the events was not life threatening, no intervention or medically important, not resulted in death, hospitalization prolonged, disabling or incapacitating, congenital anomaly or birth defect and no hospitalization required and also no other. The patient underwent lab tests and procedures which included estrogen results low on unspecified date in Apr2021. There is no product complaint associated with this case. The outcome of the events was unknown.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533633 ;-PFIZER_INC-202101533634 ;-PFIZER_INC-202101533635 ;-PFIZER_INC-202101533636 ;-PFIZER_INC-202101533637 ;-PFIZER_INC-202101533638 ;-PFIZER_INC-202101533639 ;-PFIZER_INC-202101533640 ;-PFIZER_INC-202101533641.
Numbness in face; diagnosed initially as potential bell's palsy then later updated to psychosomatic reaction; This is a spontaneous report from a contactable consumer (Pfizer Colleague).  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 23Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes COVID-19 from unknown date and unknown if ongoing (reported as if covid prior vaccination Yes). There were no concomitant medications. It was unknown if other vaccine in four weeks and if other medications in two weeks. It was reported that the patient experienced numbness in face, diagnosed initially as potential bell's palsy then later updated to psychosomatic reaction on 23Aug2021. The event resulted in Emergency room/department or urgent care and hospitalization. It was unknown if treatment was initiated. The patient was not covid tested post vaccination. The outcome of the events was recovered.   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Patient fully vaccinated against Covid-19, died on 10/07/2021 from complications of Covid-19 pneumonia respiratory failure, sepsis, and uncontrolled diabetes. Second Moderna dose administered on 03/31/2021. Second Moderna dose Lot # 025B21A. Patient