chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 18 year old female with no medical history or drugs allergies, who on 04-JAN-2007 was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL (lot # 662404/0312Y) on 17-AUG-2009. Secondary suspect vaccination given on 17-AUG-2009 included a second dose of VAQTA (manufacturer unknown). Concomitant vaccination given on 17-AUG-2009 included a second dose of MENACTRA. After the vaccination the patient sat for 15 minutes and when she stood up to leave the patient fainted. No laboratories studies performed. The physician reported that the patient recovered on 17-AUG-2009 and was then able to leave. Follow-up information has been received from a licensed vocational nurse regarding the 18 year old female patient who on 17-AUG-2009 at 9:30 a.m. was vaccinated intramuscularly in the left arm with the second dose of GARDASIL. Suspect vaccination on the same day at 9:30 a.m. in the right arm included a second dose of MENACTRA (lot # U2919AA). There was no illness at the time of vaccination and no adverse event following prior vaccination. The licensed vocational nurse reported that the patient fall out after she received the vaccines, GARDASIL and MENACTRA. It was noted that the patient was still conscious but felt hot. The patient's vital signs were re-checked and the patient was evaluated by a physician. On 17-AUG-2009 the patient had recovered. Additional information is not expected.
General body fatigue; mental fatigue (moderate); This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at single dose for COVID-19 immunisation at the age of 32-year-old. Medical history was none. Concomitant medications were unknown. On 05Feb2021 at 05:30, the patient experienced general body fatigue and mental fatigue (moderate). The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever started at 12 hours after injection. Body ache, headache and reoccurring fever followed for 10-12 more hours.
1/3/21 2100 slight rapid heart rate when laying down in bed. (Could of been anxiety) 1/4/21 0700 rash across chest, that lasted the day, when down with taking Benadryl            Left deltoid pain, hard, red hot lump at 7 o'clock from injection site, that is still slightly present today 1/11/2021.            0830 noticed left side of face swelling, that continued into 1/5/21            Extreme fatigue and body aches that lasted 3 days            Intermittent left arm tingling, and hand numbness since the vaccine.
Flushing of face chest and arms with burning sensation.  Resolved an hour after receiving an antihistamine(Zyrtec)
blurred vision starting the night of vaccination, then developed floaters bilaterally and "vitreous opacity" over the next week, lasting >2 weeks now.
Pt seen 12/13/07, gave LMP as 11/16/07 and MMR given.  Pt returned to clinic 2/22/08 giving LMP as 10/29/07 and began prenatal care.
Severe pain, to the point the patient said they were debating whether or not to go to the emergency department. They are on oxycodone once daily as needed, they've used that as well as applied ice. Advised OTC acetaminophen, patient can not take NSAIDs. Advised patient to try to contact primary physician for a second opinion, if pain was the only concern may not require visit to emergency department. Discussed signs and symptoms of allergic reaction, doesn't sound like an allergic reaction upon talking with patient. Only severe pain.
Pt contacted us on 2/5/13 stating after receiving flu vaccination on 12/12/12 she began to lose her hair just as she did during her cancer treatment. Primary MD was contacted -> did not see a link, offered referral to dermatologist, pt said - not needed.
Decreased po 1-2 d after vaccines, "fussy" 2-3 d after vaccine rash to back, face, torso approx 4 d after vaccines fever (102) 1 hr after vaccines -irritability -> to ER and had septic w/u with pleocytosis-admitted for meningitis.   10/7/08 Reviewed hospital medical records of 9/4-9/7/2008. FINAL DX: aseptic meningitis. Records reveal patient experienced rash all over that resolved after 2 days, irritability, conjunctival injection, loose stools & fever x 4-5 days s/p vaccinations. Had irritability, fever & loose stools s/p 2 mo vaccines as well.  Seen in ER where CSF (+).  Initially tx w/IV antibiotics until c/s neg.  ID consult done.  Fever resolved & improved.  D/C to home w/PCP f/u.
Pt was responding well before the injection. After receiving the vaccine, he walked over to the waiting area to sit for his 15 minutes. After a few minutes, pt was seen slumped over in his chair and his phone fell to the floor. Nurse came out to check on him and started rubbing his back. Pt was rocking back and forth in his chair and looked like he was slightly shaking. Paramedics were called. Several seconds later, pt stated he saw spots and felt dizzy and nauseous. Pt was given a cup of water. Then after a few minutes, pt stated he felt better than earlier. Paramedics arrived to assess the pt and took him to the ER for further assessment.
More than 35 days between the First and the Second Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-237460 (Parent-Child Link).   See case MOD-2021-237460 for details regarding the child case.
Information has been received from a pharmacist concerning an 87 year old female patient in a nursing home with anaemia being treated with PROCRIT from time to time by a hematologist and no known allergies who in September 2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported). The pharmacist was unsure if this was the first dose or revaccination dose. Concomitant therapy included hydrochlorothiazide (manufacturer unspecified), SPIRIVA, SYNTHROID, glipizide ER, calcium (unspecified), vitamin D (unspecified), docusate Na, lorsatan potassium(MSD), COREG, furosemide, magnesia [milk of] and insulin. On the same day of vaccination the patient had significant arm pain. The patient developed cellulitis within 2 days of vaccination. On an unspecified date, the patient recovered. Additional information has been requested.
itching with welts on her arms, legs, and chest; itching with welts on her arms, legs, and chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (itching with welts on her arms, legs, and chest) and PRURITUS (itching with welts on her arms, legs, and chest) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (itching with welts on her arms, legs, and chest) and PRURITUS (itching with welts on her arms, legs, and chest). At the time of the report, URTICARIA (itching with welts on her arms, legs, and chest) and PRURITUS (itching with welts on her arms, legs, and chest) had resolved.            No concomitant medications were reported.  No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-MAY-2021 included AE information.
HIGH BLOOD PRESSURE; HIGH PULSE RATE; BODY ACHE; BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 103/69, 102/68, and Pulse rate (NR: not provided) High. On 17-MAY-2021 14:00, the subject experienced high blood pressure. On 17-MAY-2021 14:00, the subject experienced high pulse rate. On 17-MAY-2021 14:00, the subject experienced body ache. On 17-MAY-2021 14:00, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, high blood pressure, high pulse rate, fever, body ache, and back ache. This report was non-serious.
My menstrual cycle started early and has not stopped/a similar side effect; My menstrual cycle started early and has not stopped/a similar side effect; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 3 patients (herself, sister, and friend). This is the second of three reports for the consumer's friend. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced similar side effect to the reporting consumer. The reporting consumer described that the week after her second vaccine shot she had experienced her menstrual cycle started early and had not stopped with 12 days of menstrual bleeding as of 10Apr2021. The consumer stated her sister and friend had a similar side effect. The outcome of similar side effect was unknown. The consumer stated they thought it was a side effect of the "COVID-19 cmvacvine."  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407009 same reporter/drug/event, different patient.;US-PFIZER INC-2021392948 same reporter/drug/event, different patient.
Patient reported new onset dyspnea, dysphagia, and dysgeusia starting several hours after vaccination, but in the same day. Patient reached out to me on 5/24/21 reporting that her symptoms were worsening, not improving at that time. Based on her symptoms, I advised she seek medical care. She did not report having a primary care physician.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 61 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 16Apr2021 as dose 2, single (Lot number: EP7533), on 24Nov2021 as dose 3 (booster), single (Lot number: FH8030) and on 03Jun2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken (Paxlovid) as a result of vaccination failure, covid-19.
Extreme vertigo; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 30Apr2021 at 14:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history and known allergies. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 21:00, the patient experienced extreme vertigo. Therapeutic measures were taken as a result of the event of extreme vertigo and included treatment with upper cervical chiropractor. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event of vertigo was recovering at the time of  this report.  No follow-up attempts are needed. No further information is expected.
I woke up at 4:00 AM with chest pain which was constant and severe in a V shape from sternum to jaws and down into my left arm. Went to ER at about 7AM. Was admitted to the hospital after tests showed no sign of heart attack and nitro and morphine didn?t touch the pain.  After many tests the doctor diagnosed me with pericarditis.   Was prescribed  therapeutic dose of  Ibuprofen (3 weeks) and colchicine (3 months)
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed arthralgia (had the hip pains/joint pains), with outcome of unknown. Additional information: Reporter stated his girlfriend had hip and joint pains from taking the vaccine. He confirmed vaccine she took was the Pfizer COVID-19 vaccine. Reporter stated he will have her call, that way she can answer additional questions. Batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Really bad itchy sensation on my face. Started itching really bad. Then my arms, my whole body started basically itching; itching non stop for the last 2 and a half hours; Like a racing heartbeat, heart is racing; Dizzy; Have a rash almost all over my body; This is a spontaneous report  from a contactable consumer (patient). A 39-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose  via an unspecified route of administration, administered in arm right on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunization. Medical history included asthma and hypertension. The patient's concomitant medications were not reported. The patient was calling because the patient had first dose of vaccine in the morning of 15Apr2021. And after contacting patient's healthcare provider because the patient went to a walking clinic. They advised that patient needed to call this number regarding side effects the patient had. On 15Apr2021, 25 minutes after patient got vaccine, because the site where patient got it at when the patient waited there for 15 minutes. The patient started experiencing like really bad itchy sensation on the face. It started itching really bad. Then patient's arms, whole body started basically itching. And from there it just, it got, like a racing heartbeat. The patient haven't had type of difficulty in breathing (not clarified further), but at time of the report, the patient like was dizzy, the patient had a rash almost all over the body and patient's heart was racing. They told patient to report it, but they don't know that if patient can get the second dose. The due date of second shot of COVID-19 Vaccine is on  06May2021. The patient had lab test done in Mar2021, but not in last 15 days. The patient contacted primary care doctor. The patient took some diphenhydramine hydrochloride (BENADRYL) because the patient had been itching non stop for the last 2 and a half hours, 25 ml. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Fever, NauseaVomiting, ARM INJECTION WAS GIVEN IN WAS SORE Narrative:  Other Relevant History:
booster; Pediatric dose (orange cap) was administered to three individuals.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 80 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Pediatric dose (orange cap) was administered to three individuals.". The lot number for bnt162b2 was not provided and will be requested during follow up.
On 09AUG 2021 a vial of Janssen was mistake to be Pfizer. Janssen vial was given 1.8ml of Pfizer diluent and then 0.3ml of diluted Janssen was given to 16 year old female (instead of scheduled second Pfizer dose).  Family notified immediately and reported no symptoms.  Family offered evaluation in hospital's which they declined. Per CDC Administration Error guideline, no further doses should be given.  will discuss with state covid team to see if diluted Janssen should be then followed by Pfizer vaccination.
Temperature of 102.6, chills,  sore arm from injection site to wrist, body aches, headache. Just a feeling of being ill.
Pt returned to pharmacy counter after 15 minutes to pick up her vaccination card, and at that time showed us the rash on her arm. Pt was asked to remain in the pharmacy for an additional 15 minutes for observation. Pt stayed a total of 40 minutes after vaccination. Pt had no difficulty breathing, and rash/itchiness did not spread beyond affected limb. Pt was instructed to take diphenhydramine 50mg and to seek immediate medical assistance if symptoms worsened or had any difficulty breathing.   Followed up with pt a day later, and pt's rash has resolved, but stated that she has slight numbness on tip and sides of tongue. Pt advised to follow up with primary healthcare provider
I would like to notify you that I did indeed have a bad reaction to the shingles vaccine. That evening my blood sugars spiked to 300s, I was severely chilled, I had some rapid heart beating, I had shooting pains in my shoulders and feet, I yawned uncontrollably followed by incontrollable weird need to stretch. I could not sleep at all. The following day my blood sugars continued to be high but otherwise besides exhaustion I seem fine. I am hesitant about getting any kind of booster - indeed I am scared to do so.
Received second dose, ears still muffle; Oddly ear temp much higher than forehead temp / 101.3 degrees; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Received second dose, ears still muffle) and PYREXIA (Oddly ear temp much higher than forehead temp / 101.3 degrees) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Received second dose, ears still muffle) and PYREXIA (Oddly ear temp much higher than forehead temp / 101.3 degrees). At the time of the report, HYPOACUSIS (Received second dose, ears still muffle) and PYREXIA (Oddly ear temp much higher than forehead temp / 101.3 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3.         Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-259153 (Patient Link).   Reporter did not allow further contact
Information has been received from a medical assistant concerning a female in her early 20's who in February 2008, was vaccinated with her first dose of GARDASIL (lot# unknown, injection site and route not reported). There was no concomitant medication. In February 2008, the patient developed a lump after her first vaccination. The patient came in today on 14-Apr-2008 (two months after the first vaccination) for her second dose and still had a "small lump" above the injection site. The second of the vaccine was not administered due to the lump. The physician of the patient could not be identified (group practice) at the time of the report. The patient was reported as not recovered. Additional information has been requested.
Pt had numbness on left leg X 3 days, muscle fatigue (general) X 7 days and overall physical fatigue X 2 weeks. No treatment given.
headache; Pain in arm.; tenderness; neck was hurting; swelling in lymph nodes; confused; fatigue; muscle pain and calf muscles hurting; Joint pain; stomach pain; chills; nausea; dizziness; weakness; chest pain; hiccups; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes) and CONFUSIONAL STATE (confused) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes), CONFUSIONAL STATE (confused), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (stomach pain), CHILLS (chills) and HICCUPS (hiccups). 19-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain and calf muscles hurting), NAUSEA (nausea), DIZZINESS (dizziness), ASTHENIA (weakness) and CHEST PAIN (chest pain). On 03-Apr-2021, the patient experienced HEADACHE (headache). Not Provided          Reporter did not allow further contact
Saw PCP With X 3days fever 99 , HA, myalgia on 11/12/08 Blood drawn for yellow fever IgG and Igm. Results was antibody low-unable to separate for IgG/IgM. Flu 11/14/2008 with improved symptoms, Concealed further appts with PCP. Symptoms resolved totally.
Abdominal pain, nauseated and vomited after flu shot administration. Rapid improvement in symptoms and returned to work same afternoon.