chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a sales representative concerning a female patient of unknown age who on an unknown date was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced swelling at the injection site in her arm within an hour after administration. The patient did not seek medical attention; and did not receive any treatment for the event. The outcome of swelling at the injection site in her arm within an hour after administration was unknown. The relatedness for swelling at the injection site in her arm within an hour after administration was unknown for ZOSTAVAX. Additional information has been requested.
According to doctor, patient developed a sudden onset of painful lesions across the left side of his face with intense allodynia; left V1, V2, V3 distributions with lesions ending at the chin at the tip of the dermatone.  Nose and eye are univolved.  Patient given Vancyclovir 1 gm. tid q day x 1 week and Prednisone 60 mg. daily x 1 week,to 30 mg.daily x 1 week to 10 mg. daily x 1 week and then stop.
Information has been received from a physician concerning a 9 week old male patient with no pertinent medical history and no known drug allergies who on 29-JAN-2010 was vaccinated with the first dose of ROTATEQ (lot# 663842/0068Y, expiration date: 18-NOV-2010) orally. Concomitant therapy included PENTACEL, PREVNAR and multi-vitamins (unspecified). After the first dose of ROTATEQ, on 01-FEB-2010, the patient experienced loose bowel movements, behavioral change (became fussy) and his abdominal area was hard. The patient was better after treated with TYLENOL. On 27-APR-2010, the patient was vaccinated with the second dose of ROTATEQ (lot#: 664779/1439Y, expiration date: 02-APR-2011) orally. within 24 hours of receiving his second dose, the patient also experienced behavioral change, a decrease in appetite and a decrease in sleeping. On 29-APR-2010 the patient was very fussy and would just cry. He normally would eat 5 to 6 ounces of formula or breast milk per feeding but now the mother stated it was a struggle to get him to eat 2 ounces. On 30-APR-2010, the child refused to eat and would have screaming episodes. He was brought into the office and kept for an hour for observation. His abdomen was soft and there was no blood in his stool. The physician felt he was possibly experiencing abdominal cramps. He was afebrile. No laboratory test was performed. On 03-MAY-2010, the patient ate almost 5 ounces of formula again and he slept through the night. At the time of the report, the patient was recovering. Loose bowel movements, behavioral change (became fussy), his abdominal area was hard, abdominal cramps, decrease in appetite and decrease in sleeping were considered to be disabling. Follow-up information has been received from a receptionist who provided the patient's full name. She further stated that the physician had not talked to the baby's mother since 03-MAY-2010, so the current status was left at recovering. Additional information has been requested.
Mild chills; Moderate headache/ Mild headache; Moderate fatigue; booster; Moderate Injection site pain/Mild Injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 13:00 (Lot number: 330308D) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 24Mar2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 03Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 13:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 13:00, outcome "recovered", described as "Moderate Injection site pain/Mild Injection site pain"; CHILLS (non-serious) with onset 07Dec2021, outcome "recovered", described as "Mild chills"; HEADACHE (non-serious) with onset 07Dec2021, outcome "recovered", described as "Moderate headache/ Mild headache"; FATIGUE (non-serious) with onset 07Dec2021, outcome "recovered", described as "Moderate fatigue". Therapeutic measures were taken as a result of vaccination site pain, chills, headache, fatigue.  Additional information: Patient received AE treatment in the form of Advil. Patient had covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. no further information is expected.
Received Pfizer vaccines on 1/18, 2/8, 8/27 COVID-19 positive by PCR on 1/6/22 admitted to hospital on 1/6 d/t pneumonia d/t COVID
On 02/09/2002 raised mocular rash on trunk but also head, extremidies. No hives, no spots.
This spontaneous report as received from a nurse refers to a 12 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUN-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous report as received from a pharmacy technician refers to a 41-year-old female patient. Current conditions included migraine, muscle inflammation, hypothyroidism, allergic to latex, allergic to sulfa and drug allergy. Historical drugs included cephalothin hydroxyzine, IMITREZ, PAXIL, penicillin, PROZAC, sulfa, vancomycin, sertraline and zolmitriptan. Patient experienced drug reactions/allergies with these drugs. On 06-OCT-2012 the patient was vaccinated with, 0.5 milliliter (ml) PNEUMOVAX 23 (lot # (H010661), expiration date unknown) intramuscularly. No concomitant medications were reported. The reporter mentioned that on 06-OCT-2012 patient developed fever after receiving PNEUMOVAX 23. Outcome of the reported event was unknown. It was unknown whether this was a 1st dose or (reported as of) 2nd dose. Patient sought medical attention, but unknown how did she sought it. No further information is available. This is second of the two reports from the same source. Additional information has been requested.
Im just really cold about 12 hours after vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Im just really cold about 12 hours after vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Im just really cold about 12 hours after vaccine). At the time of the report, FEELING COLD (Im just really cold about 12 hours after vaccine) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
shingles on the right side of the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles on the right side of the neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HERPES ZOSTER (shingles on the right side of the neck). At the time of the report, HERPES ZOSTER (shingles on the right side of the neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.    The patient was prescribed an antiviral (unspecified) by her HCP.
pt recvd vax;became nauseated, felt flushed & became very diaphoretic; c/o hurting rt side of chest;
vision became blurry/I couldn't focus on objects; I could not read at all; severe sinus headache; This is a spontaneous report from a contactable Other HCP (patient). A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 13Oct2021 10:30 (Lot Number: 301308A) (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Sep2021 11:00 AM (lot number=FC3183) (at the age of 55-year-old) in left arm for COVID-19 immunisation, and the patient experienced COVID-19. Medical history included COVID-19 prior vaccination. No COVID tested post vaccination, there was no known allergies. There were no concomitant medications. On 13Oct2021, the patient's vision became blurry. She couldn't focus on objects. She could not read at all. It lasted about 15-20 minutes. Also, on 13Oct2021, a severe sinus headache came on shortly after her vision recovered, lasting approximately 24 hours. No treatment received. The patient was recovered from vision became blurry and could not read at all on 13Oct2021, recovered from severe sinus headache on 14Oct2021.
Within 24 hours of HPV in (L) arm with pain at site devel. pain down to elbow then (L) hip and (L) leg. Exam 11/3/15 NL except pain perception. No clear nerve distribution sxs most c/w Complex Physical Pain - following (fam hx similar pain issues).
pain left arm progressively getting more sore/more painful, lump at site of injection, pink at injsection site
5cm x 5cm area of redness & swelling at site of injection of VARIVAX.
Patient described paresthesia down left arm into fingers after vaccine. Approximately one hour post vaccine she began to have "brain fog" and appreciated left hand swelling.
Shortly after receiving vaccine, patient began to feel intense pain in their joints and elbow on right arm.
Hep B given on 2/3/04 outdated on 1/11/2004.
ADMINISTRATION PAST EXPIRY DATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced administration past expiry date. The action taken with covid-19 vaccine was not applicable. The outcome of administration past expiry date was not reported. This report was non-serious.
On 09/19/22 I started getting with just one fever blister on my upper lip, I treated it with Valtrex and it went away.  A week later the fever blister came back and was very persistent and was not as responsive to my medication. As I was getting it to go away then a large cluster broke out between nose and lip. I have not had outbreaks in years, I have not had to take medication for years. I am making an appointment to see my PCP to get my prescriptions updated. I have noticed that with the boosters that I feel like my bodies weakneses were ramped up especially my asthma and now on the fifth dose my herpes simplex I.
3RD MODERNA COVID VACCINE GIVEN 10/25/21, LOT #012F21A; 4TH MODERNA COVID VACCINE GIVEN 4/5/22, LOT #033K21-2A; 8/5/22 pt seen in cardiology office with increasing SOB; sent to hospital; CT showed atypical pneumonia; negative COVID test; started on IV ABX, steroids, heparin; 8/16/22 pt had a positive COVID test; pt's respiratory condition deteriorated requiring maximum O2 support; transitioned to full DNR; pt passed away in the hospital; PCP on file.
Pt came into pharmacy on 11/11/15 with an injection site reaction on her right arm where her Zostavax rx was given of a significant area raised, red and feverish.  The area also had a small bruise on the edge of it.  Pt stated that she thinks it is starting to get better but wanted a second opinion.  Also stated that her armpit was itching every once in a while no signs of swollen lymph nodes.
After my booster shot on 01/10/2022, I tested positive for COVID. The day before I stated with sore throat, I have body aches, 3 days I had flu like symptoms. I had dry Cough. My ribs hurt when I cough. On 01/14/2022, I had a horrible sinus infection. I went to an urgent care and got a tele conference with the doctor prednisone, antibiotic. I was on bed for 3 weeks.
Patient came to pharmacy to pick up an antibiotic for Doxycycline today and mentioned that when she went to the PCP today they her that her arm looks infected. she said she got a TDAP on 5/11 and most likely she had a rash, swelling aroud the injection site and it spread down her arm.
This spontaneous report as received from a consumer's mother refers to a 18 year old male patient. In April 2017, the patient was vaccinated with first dose of GARDASIL 9 (unspecified dose administered intramuscularly for an unknown indication). The second dose was administered in August 2017. No adverse effect reported. Additional information is not expected. The reporter did not wish to be contacted.
ARM EXTREMELY SWOLLEN; SHE SPIKED A HIGH FEVER OVERNIGHT; LOT OF REDNESS AT INJECTION SITE  NO TREATMENT SOUGHT
Information has been received from a physician concerning a 74 year old female patient with a history of splenectomy who on approximately 6-JAN-2009 was vaccinated with a dose of ZOSTAVAX. On approximately 20-JAN-2009 the patient developed shingles and pain. The patient's outcome was not reported. Additional information has been requested.
Patient became blind overnight in both eyes about 4 and a half months after 2nd vaccination. Blindness occurred due to an "immunological event" of white blood cells blocking the retina / optic nerve.  Once the blindness occurred the longstanding dementia devolved quickly to death in about 9 weeks.    Following eye surgery it was an exteme decline with respect to the dementia, both mentally and physically.  She was not capable of eating or barely drinking during most of the final week of her life.  Referencing a database, there have been 24 deaths post vaccination from the batch number on her first dose, and 13 deaths post vaccination of her 2nd dose batch.
Started itching yesterday in his hands and back; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient started itching yesterday in his hands and back. The events were reported as non-serious. The outcome of itching in his hands and back was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
took my tremfya shot and have had flu symptoms since an hour after shot. Nausea chills headache for 36 hours so far. Manageable with Tylenol and Pepto but never had any side effects when took in the past. Been 14 months since last injection. Wondering if reaction could be due to having received Covid vaccine and booster. Only thing different.
It has been almost a month an the arm still aches.  There has been no erythema, fevers or any other symptom.  The only symptoms is pain at the injection site with certain ROM. Painful to abduct the arm to the side.
Patient presented to pharmacy 9 days later with a large bruise over the left deltoid and very unhappy with result of vaccination administration. Patient also stated that vaccination was painful at time of injection. The vaccine was administered into left deltoid muscle; however it is possible based on appearance of arm that a few capillaries were damaged leading to formation of bruise.
6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a six years old male patient who a 0.50 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1909 via intramuscular route in the left arm on 02-Oct-2019 in error due to the syringes of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and the flublok quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered, product label font size complaint and product packaging confusion.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Fever and headache on date administered. Intense lingering injection site pain. Limited range of motion due to pain and stiffness in the appendage where vaccination was given.  Pain and stiffness continues a week after injection was given.
DTaP administered on 9/28/04 in LAT. Pt returned to clinic on 9/30/04 with complaint of redness, edema, vomiting, began after shot administered on 9/28/04. Treated for possible cellulitis with Keflex and to follow up if needed.
Red spots were breaking out / size of a pinhead; Very itchy; A clear liquid comes out of his mouth / when he sits still; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included sulfa drug (allergic to sulfa drug). Concurrent medical conditions included systemic antibacterial therapy.   On 31st March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 5th April 2021, 5 days after receiving Shingrix, the patient experienced red rash, itchy rash and salivation. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved and the outcome of the salivation was recovered/resolved.   It was unknown if the reporter considered the red rash, itchy rash and salivation to be related to Shingrix.  Additional details were provided as follows:  The patient was allergic to sulfa drugs and antibiotic. The age at vaccination was not reported.  The patient received Shingrix vaccine in left arm and about five days later he noticed red spots were breaking out on both forearms and on his chest and they were the size of a pinhead and very itchy. The patient had also noticed a clear liquid comes out of his mouth for about 30 to 45 seconds when he sits still.
Over the last two days I?ve had a fever, cold chills, weakness in muscles, irritable skin to the touch, diarrhea, cough, and upset stomach.
hospitalized on 08/02/2021. still current pt as of 8/17 J&J 6/9. Stated in MD note. Positive on 8/3
Typical response after second dose including full body aches, fever, chills, fatigue and muscle soreness at the injection site. However, about 4 days after my second dose, I began to menstruate even though I am on birth control and in the middle of my menstrual cycle.
Redness and swelling affecting the area of the L arm just distal to the location of the 2 vaccines.  Also, she c/o itchy skin.
Case number PHEH2014US009946 is an initial spontaneous report received from a health care professional via sales representative on 12 May 2014. This repot refers to a patient unknown age and gender. It was reported that the patient received MENVEO (batch number: unknown) subcutaneous on 09 May 2014. Outcome of the event, seriousness and causality assessment was not reported. No further information was provided.
I started experiencing throat swelling within the first five minutes of receiving the vaccine. within ten minutes, my vision was blurry and I started to experience light headedness and vertigo. I tried to notify the staff within 15 minutes but had to wait 5 minutes before being acknowledged.
Guillian Barre-was totally paralyzed; Guillian Barre-was totally paralyzed; This is a spontaneous report from a contactable consumer (patient). An 80-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809) at the age of 79-years, via an unspecified route of administration, administered in left arm on 09Feb2021 at 12:00 at single dose for COVID-19 immunisation; second dose of other vaccine (unspecified, lot number: ENG205) at the age of 79-years, via an unspecified route of administration in left arm on 09Feb2021 for immunization. Medical history included esophagus cancer. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks were none. On 31May2021 at 12:00, the patient experienced Guillian Barre-was totally paralyzed. The events were reported as life threatening illness (immediate risk of death from the event). The patient received oxygen and medicines as treatment. On 03May2021, COVID-19 virus test (nasal swab) was negative. Outcome of the events was unknown.   Follow-up actions are needed. Further information has been requested.