chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her patient got the Pfizer shot, got sick/ her patient got the Pfizer shot, got sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): US-PFIZER INC-2021386008 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "her patient got the Pfizer shot, got sick/ her patient got the Pfizer shot, got sick".  Additional information: It was reported that patient already got the 1st dose and had illness. Reporter asked if she needs to restart administering the vaccine or go ahead to give the 2nddose or should make it 3 doses instead. Came down with an illness and they are just now getting over it, so that's probably been more than 42 days. Reporter stated, "So I have a patient that had a Pfizer COVID shot and then before they could get the second one they came down with an illness (Clarification unknown) and they are just now getting over it, so that's probably been more than 42 days, so my question is do they have to restart the whole process or do they just give the second one as soon as they are well enough." When informed about Pfizer Medical Information department, reporter stated, "Is it So I thought that is where I was getting transferred to an hour a half ago, you don't have any answer for me or any other thing than that other than that I might wait for somebody else." Upon Follow-up she said that her patient got the Pfizer shot, got sick and it's now more than 42 days after the first dose. Can he take second dose. Does he need more doses.  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) : US-PFIZER INC-2021391027 similar report from same reporter
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age. Concurrent condition or medical history was unknown. On an unknown date the patients were vaccinated with doses of incorrect stored (Merck) PROQUAD (dose, route and lot# were unknown). No adverse effects were reported. This is one of several reports received from the same reporter (1505USA005210, 1505USA004053). Additional information has been requested.
Patient that got his first injection on May 18, 2021 and has not yet received second vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient that got his first injection on May 18, 2021 and has not yet received second vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient that got his first injection on May 18, 2021 and has not yet received second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient that got his first injection on May 18, 2021 and has not yet received second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Experiencing "Covid arm"; swelling of the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Experiencing "Covid arm") and PERIPHERAL SWELLING (swelling of the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Experiencing "Covid arm") and PERIPHERAL SWELLING (swelling of the arm). At the time of the report, VACCINATION SITE REACTION (Experiencing "Covid arm") and PERIPHERAL SWELLING (swelling of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product details were provided by the reporter. No Treatment information was provided.
This information has been received from a registered nurse concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX with lot number M006729 and expiration date on 08-FEB-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent. The reporter stated that the diluent (lot number and expiration date were unknown) was stored properly. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 6 hours and 35 minutes. There was previous temperature excursion between -14 Centigrade degrees and -10 Centigrade degrees for 35 minutes and another excursion between -9 and 8 Centigrade degrees for 2 hours and 10 minutes. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009912:
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
On the 29th, I had a runny nose and tons of drainage, and increased the couple of days after. I maybe ran a fever, but did not check, was not high if I did. I started having joint aches and so I took Tylenol. By the 31st I felt better but my stomach was acting up. I tested for Covid and tested positive. I have since then tested negative, but I still have a cough and some drainage. On the 19th of October, almost a month later, I felt tightness in my chest and felt like I couldn't breathe so I went to the doctor. The doctor increased the protonics to twice a day, since my stomach was acting up so much I could barely eat. She also put me on in inhaler. She tested me for pnemonia and believed I have it, she tested me by listening. All my symptoms have not gone away and it lingers.
Irregular and extended menstruation. Period arrived 2 weeks early, heavier than normal.
This spontaneous prospective pregnancy report has been received from a female pharmacist referring to herself. The pharmacist was 27 weeks and 4 days pregnant (date of Last Menstrual Period (LMP): 04-MAY-2015), reported that while administering ZOSTAVAX (dose and lot# not reported) to an unspecified patient on 13-NOV-2015, some of the reconstituted product leaked onto her own skin. The pharmacist stated that she did not experience any adverse symptoms due to this exposure. This is two of reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a doctor of pharmacy refers to a 73 year old male patient with cholesterol, diabetes, depression and anxiety. On 05-OCT-2012, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number reported as 0363AE expiration was 16-MAR-2013), subcutaneously on the right arm. Concomitant medications included cholesterol medication, diabetes medication, MAO inhibitor medication. The patient had no drug reactions or allergies. On 06-OCT-2012, the patient experienced phlegm production, diarrhea, mental cloudiness and was being tired after receiving ZOSTAVAX. There was no treatment rendered for the events. There were no labs or diagnostic tests performed. The outcome of the events was reported as unknown at the time of this report. The patient sought medical attention (pharmacy visit). Additional information has been requested.
heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PALPITATIONS (heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding). At the time of the report, PALPITATIONS (heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding) outcome was unknown.            No concomitant and treatment information were reported by the reporter
Patient broke out in Shingles rash 3 days after vaccinations given on the left shoulder/back area.  Patient requested to have both vaccines on the right arm due to previous history of left breast mastectomy.
Day after vaccine, 11:00 am, the following symptoms began:  - Throbbing migraine headache  - Skin sensitive and sore to the touch - 100.7 degree temperature, rising to 101.1 degrees after Tylenol, later that day - Dizziness  - Chills and sweating - Nausea - Sore arm  - Fatigue All symptoms went away after 24 hours, except migraine headache. Headache remained for about 48 hours.
Vaccination Adverse Reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a 21-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.
expired PROQUAD was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 02-OCT-2020 the patient was vaccinated with an expired of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5ml, one time dose, lot # S009758, expiration date 27-SEP-2020; route was not reported) for prophylaxis (expired product administered). The reporter inquired information if administered product was supported.
It was flu-like. I had a fever, weird aches in my left calf below my knee. Like a pulse feeling.
Pt to ED 10/13 for SOB. Pt COVID+ 10/13, remains on 4L of oxygen saturation is 94%. 10/15 pt AOx4, able to walk a short disdance with minimal assist, O2 at 4 L NC. 10/19 code stroke called. 10/20 Patient is A&Ox4, vss, no c/o pain. 10/24 Pt A+ox4 c no c/o p or discomfort pt on 3L NC. Pt discharged 10/24.
pt recv vax JUN98 & immed p/vax pt exp pruritus & redness @ inj site;next day area was hot to touch & swollen;as per medical advice, pt alternated heat & ice packs & took Ibuprofen for the pain;pt began to exp chills & not feeling well;
I began feeling extremely tired about 4-5 hours after receiving the injections. I have had the flu shot in the past and not had any reaction other than mild soreness in my arm. During the night of 11/15/19, I woke up with chills, skin very warm to the touch and generally feeling terrible. The next morning, I had blurred vision, dizziness and still felt terrible. I was sitting in a chair and apparently fainted, fell and hit my head. My husband said I was out for about one minute. When I regained consciousness, I was disoriented and confused. I went to Hospital Emergency Department.
flushing, redness on left arm and leg. Evaluated by EMS-Refusal to transport.
On 01Mar2021 she had her 2nd vaccine and it was again irritating/ could see a lot of white mucous in there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 14:30 (Lot number: EN6198) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, 6pm in her left arm, Lot #: EM9808), administration date: 09Feb2021, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "experienced peeling in her mucosa", "really groggy", "ANA screen and it was positive", "her mouth has not stopped since she got the 1st vaccine, it's just there and it's irritating", "had a hard time swallowing anything", "has a constant feeling of peeling in her mouth and it irritates her tongue and is sensitive", "has a constant feeling of peeling in her mouth and it irritates her tongue and is sensitive". The following information was reported: STOMATITIS (non-serious) with onset Mar2021, outcome "unknown", described as "On 01Mar2021 she had her 2nd vaccine and it was again irritating/ could see a lot of white mucous in there". The event "on 01mar2021 she had her 2nd vaccine and it was again irritating/ could see a lot of white mucous in there" was evaluated at the physician office visit. Therapeutic measures were taken as a result of stomatitis.  Additional information: It was reported that, after dose 2 it was again irritating a week after and went to ENT. He looked at it and could see, right now it was not as visible, he could see a lot of white mucous in there and gave steroids. Patient took that for 2 and a half weeks the complete dose and even after that she did not see any difference in there. She was treated with dexamethasone liquid 5mg and rinsed 4 times a day for 2 weeks. She started using on 5May2021 or 6May2021. It was stated that, ENT then said to go and check with dental and oral pathology and around the time she started to realize the vaccine and looked at the dates and that just may be a coincidence but it started right after the dose 1. She stated that "her brain is always there, her mouth is irritated". Additional vaccines administered on same date of the Pfizer suspect were none. Adverse events did not result in emergency room visit. Prior vaccinations within 4 weeks were none hence, adverse events following them were none. Patients medical history (including any illness at time of vaccination) were none.  No follow-up attempts are possible. No further information is expected.
lt side of body was very sore day p/vax;also felt discomfort in breathing, upset stomach, chills & diarrhea that evening;pt feels that had a 48hr flu
Itching and redness at injection site developed 8 days after vaccination. 9 days after injection the itching subsided but red area grew substantially and area was slightly swollen. By that night injection site was hot to the touch. No pain or discomfort. No fever or body aches. By day 10 reduced redness but spread to a larger area on arm. Redness gradually subsided a little each day and was completely gone by day 14.
Achy joints all over body. Temp 101. Raised, red, hot, swollen area size of palm of hand at injection site (R) deltoid.
Patient states that she started having diarrhea and vomiting on 12/8/2019 at 10:00AM. This was about a day after receiving the vaccine. Counseled patient to start drink Gatorade and Imodium to replenish her electrolytes and to stop the diarrhea. Currently monitoring patient, will follow up with patient on 12/9/2019.
Had a feeling of a panic attack with sweating; After injection nauseated and weak.; After injection nauseated and weak.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PANIC ATTACK (Had a feeling of a panic attack with sweating), ASTHENIA (After injection nauseated and weak.) and NAUSEA (After injection nauseated and weak.) in a 9-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (Had a feeling of a panic attack with sweating), ASTHENIA (After injection nauseated and weak.) and NAUSEA (After injection nauseated and weak.). At the time of the report, PANIC ATTACK (Had a feeling of a panic attack with sweating), ASTHENIA (After injection nauseated and weak.) and NAUSEA (After injection nauseated and weak.) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Patient was in her mid-80's. After the first injection patient was needed to lay down and had a feeling of a panic attack with sweating. After the second dose of injection patient was nauseated and weak. Needed to stay in bed a couple of weeks.   Treatment Medication use information was not provided by reporter.
CDC Reports: 2mo infant received DTP/OPV on 27SEP89 and died 29SEP89.
Patient stated they experienced the following: redness at injection site, fever, swelling, hard knot that they have never experienced with any other vaccine before.
One week after vaccine, the spot where my vaccine was administered swelled up, along with the lymph nodes under my right and left arm (my right underarm was more swollen). I felt very fatigued.  The swelling went down after 5 days, but I still have a dark mark on my arm where the swelling was.   A day after my shot, I felt very dehydrated and and fatigued (which I know is normal).
On my 12th day after vaccine, I started feeling horrible. I was drained and had no energy. So I went to the doctor and was given blood test and referred to an Oncologist/Blood Specialist.
Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 8-month-old male subject  was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 20 June 2011, 23 August 2011 and 24 October 2011 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 13 January 2012, approximately 2 months after the last dose and paroxysmal cough on 20 January 2012 with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included negative PCR on 18 January 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 18 January 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 39 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report has been received from a nurse and refers to a 31-year-old female patient. The patient's concomitant therapies included methotrexate (manufacturer unknown) and concurrent conditions included arthritis. The patient did not have any known drug reactions or allergies. On 21-MAY-1987, the patient was vaccinated with measles virus vaccine, live (enders-edmonston) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) and on 08-OCT-1997 with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (unknown if these were monovalent components or a combination vaccine) (dose, route of administration, lot # and expiration date were not reported). On 21-JUL-2017, the patient had negative measles and mumps titers and on 01-AUG-2017, the patient was vaccinated with M-M-R II. The treatment was given for the adverse events. The lab diagnostic studies included blood work. The patient sought medical attention by visiting the office. No product quality complaint was involved. The outcome of the events and the relatedness between the events and suspect therapies were not reported.
MOP reported lesions around site approximately 10 day after administration. Full body rash 12 days after administration of vaccines.
symptoms were itching and swelling  and area turned red and had fever.  treatment was an ice pack and used Cortizone cream.
Patient inadvertently received vaccine after published expiration date. Moderna  analyzed lot 031L20A and advised vaccine maintained activity needed to protect against covid 19 on day vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Mother called health department today. Took son to family MD because of red, raised, baseball size knot to right thigh. MD diagnosed a cellulitis infection and prescribed antibiotics. MD encouraged mother to notify health department of condition with regards to shots being administered.
Patient wasn't feeling well after she got vaccinated and had syncope 10-15 minutes post vaccination. She did hit her head when she fell, but seemed to have no major injury. 911 was called, she was laid in floor until ambulance came.
Immediately after vaccination pt reported dizziness. Vitals: 152/56, 76, 20 Pt states she took Oxycontin 20mg 1 her ago and she did not eat all day.   A&O x4 Pt responds appropriately to verbal stimuli. No c/o pain or discomfort.  No further dizziness.  Assisted to car in w/c.  Pt stable and released from the vaccination site.
Patient called a few hours after administration of MMR stating she had throat discomfort and swollen glands in her neck. She denied any swelling, pain, redness at injection site. Reviewed the Vaccine Info. Stmt with her and she noted that this reaction is listed, though it stated it was rare. She also called 8/19, reported same symptoms. Spoke with employee on 8/23/10. She stated she went to an urgent care facility on 8/21 - was diagnosed with (R) ear infection and placed on antibiotic drops BID.