chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. On an unknown date in May 2011 (reported as 18 months ago) the patient was vaccinated with dose 2 GARDASIL (route and lot # not reported) dose and route not reported. No concomitant medications were reported. Nurse reported that a patient was in the office at the time of the report (08-NOV-2012) to receive dose 3 GARDASIL (lot # not reported) which will be late. Dates of administration of dose 1 and dose 2 GARDASIL (route and lot # not reported) were unspecified because the patient received the doses from another healthcare provider. The patient stated dose 2 GARDASIL was administered 18 months ago (on an unknown date in May 2011). No symptoms reported. No other details. Additional information has been requested.
Red Spots 3/8? to 1/2? diameter on both calves.  Constantly Itchy but not unbearably so.
pt recv vax & pt noticed a red blanched mark on site of inj;w/in a couple of hr pt noted this;also some local itching;did not report this until Thursday;no other sx;
Next day after vaccination, experienced body aches, headache, fatigue similar to that of the flu.    Mild, low fever.    Lasted all day ( 24 hours).
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: patient states night after recieving vaccine had sob and chest tightness \"like someone sitting on chest\" patient said harsh symptoms lasted 1.5 days but slowly felt better some lingering sob but patient does have astha. Almost went to ER but severity of symptoms she felt didnt prompt it yet but she was close to that feeling. Directed patient to consult with her pcp before second dose.
Fever 101, chills, R deltoid at site of injection reddened,firm, warm to touch. IV abx started, 10/29 fevers >101, increased redness, tender with pain extending into R neck.   11/25/09:  Infectious disease consultation and hospital and prenatal records received for date of service 10/29/09.  Dx:  Cellulitis.  Immunized one day post partum.  Pt. with fevers, increased R arm pain, erythema and warmth of deltoid.  Positive for chills and sweats.  Started on Benadryl and antibiotic therapy.
affected area was right knee which was replaced last September. Swelling, pain, both of which were more severe than after the 1st shot. The pain has remained and has not decreased to the point of waking me up during the night. The swelling has decreased. I am seeing the orthopedic surgeon for regularly scheduoed checkup on the knee, but I will ask him about the effects
Bexsero administered 2/2/22 and expiration date was 1/31/22. Given by, RN.
Pain from injection site down to finger tips. Waves of extreme chills for about five hours. Fever. Rapid heart beat. Massive headaches and nausea. Headaches lasted three 1/2 days. Muscle weakness in legs on fourth and fifth days. Today is fifth day. Also had shingles shot same day.
DTaP given 8/4/03, 8/6/03 Grandma brought child in 2 hours redness in left leg, injection site with blisters, surrounding erythema and warmth.
Right upper arm became red and swollen on day of vaccine administration approximately 11 hour after. Became increasingly red, warm, itchy, and swollen the next day. Given antibiotics for reaction.
Burning sensation on my forehead and i been using a ice pack but not helping. Tried to sit in cold water and didnt help
Extreme body pain lasting three days. Chills. Nauseous. Stomach cramps. Diarrhea. Extreme fatigue.
p/ pt recv vax approx 1yr later pt lab results indicated pt did not seroconvert
This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 64-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2019) for prophylaxis. On 24th August 2018 15:30, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced malaise, influenza-like symptoms, injection site erythema, headache, injection site warmth and injection site tenderness. In August 2018, the outcome of the malaise, influenza-like symptoms and headache were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were recovering/resolving. It was unknown if the reporter considered the malaise, influenza-like symptoms, injection site erythema, headache, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient developed malaise, headaches, flu like symptoms and an injection site reaction described as a big red splotch approximately 5 to 6 inches in diameter that was warm and painful to the touch. This case is linked with US2018155165, reported by same reporter.
Fever~ 101 , body aches Malaise. 9/22 pain at injection site, large  ulcer on roof of mouth. Arm sore for 12 days, fever ~ persisted for 48 hours boday aches and malaise several days. Ulcer healing slowly, not completely resolved after 20 says.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. Patient received 2nd booster dose. No treatment information was provided by the reporter.
SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 23 January 2008 from another manufacturer who received the report from a physician. A physician reported that a female patient had developed "cardiomegally" after receiving a pertussis vaccine (brand and manufacturer unknown) "years and years ago". The patient was a female in her late teens or early twenties and had received treatment of the event however the reporter could not recall who the patient was. Information regarding who administered the vaccine and the vaccine manufacturer was unknown. No further information was provided.
Parent requested Moderna series on the admission paperwork,  Pfizer (correct pediatric dosage) was given instead
t105 2hr p/vax;APAP supp given w/instructions for APAP use for fever
STILL HAD LITTLE DISCOLORATION IN SOME SPOTS; HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS; Swollen lips; 1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (STILL HAD LITTLE DISCOLORATION IN SOME SPOTS), IMMUNISATION REACTION (HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS), LIP SWELLING (Swollen lips) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 15-Nov-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISCOLOURATION (STILL HAD LITTLE DISCOLORATION IN SOME SPOTS), IMMUNISATION REACTION (HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS), LIP SWELLING (Swollen lips) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021). At the time of the report, SKIN DISCOLOURATION (STILL HAD LITTLE DISCOLORATION IN SOME SPOTS) was resolving and IMMUNISATION REACTION (HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS), LIP SWELLING (Swollen lips) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021) outcome was unknown. Not Provided          No concomitant medications were reported. Humira: Solution for injection in pre-filled pen), Citrate free.  The reporter causality for the events of Still had little discoloration in some spots with HUMIRA was a reasonable possibility and had reaction to COVID vaccination due to antibiotics and swollen lips was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
Patient came to Pharmacy along with 3 other family members for their first Pfizer vaccines. The patient, was first to be vaccinated amongst them. All family members were in the room. Patient was stable and in good health immediately after being vaccinated. However, while the third and last member was vaccinated, PT stated she was beginning to feel dizzy. I directed the patient to be seated with legs elevated. The patient was pale in color, but was conscious and alert and well-oriented. The patient was then given water and I had then brought the pharmacy manager, into the vaccine room during this time as well. Her blood pressure was taken and was initially 57/39 mmHg with a pulse of 60 bpm at around 3:55 p.m. I then proceeded to call 911 as the manager watched the patient in the vaccine room. The AGM of the warehouse was also notified to prepare for paramedic arrival. We continued to monitor her blood pressure every few minutes with the second reading at 90/63 mmHg and 70 bpm. I then called the paramedics to update them on her improving health status. The patient's facial pallor was noticeably better and color was restored and she seemed more alert and stable. The third blood pressure reading was 97/64 mmHg and 74 bpm. The paramedics arrived at that point and decided to take her to the hospital after assessment. The patient was monitored for over 20 minutes and accompanied by her family members.
PERSISTENT SORENESS IN AFFECTED SHOULDER (LEFT) THROUGH 28 DAYS WHERE HE PRESENTED TODAY FOR HIS SECOND DOSE.
Pt complaints of stomach ache, no dizzines or SOB. No pain on palpation of abd. Stomach pain resolved quickly w/laying down & relaxing.
Patient beforehand reported having a phobia of needles. Immediately after immunization patient was feeling fine. About 3-5 minutes after vaccine as patient was waiting for the observational period, patient felt dizzy. He was clammy, sweating, and pale. He had no breathing problems. After about 15 minutes symptoms resolved after deep breaths and cold compresses.
Information was received from a physician via a field employee, referring to a 17 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 29-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (concentration, frequency, route, lot # and expiration date were unknown), and a dose of MENACTRA (in the opposite arm; concentration, frequency, route, lot # and expiration date were unknown), both for prophylaxis. Shortly after the vaccination, on the same day, the patient "passed out". The physician stated that the patient "came to, and was fine" The outcome of event was unknown. The causality between event and suspect therapies was not provided. Upon internal review, "passed out" was determined to be medically significant.
Experienced significant edema and redness at injection sight and severe pain for greater than 3 days. Mobility was severely impacted. Patient could not put on or remove shirt without assistance and required passive ROM in her right shoulder for one week to assist with improving mobility. In comparison, she had MenACWY vaccine in left deltoid the same day with no impairment in mobility or complaints. Patient typically has a high pain tolerance; has had knee surgery and broken wrist with minimal complaints during recovery. The pain following TRUMENBA was severe. Redness and swelling were greater than 10 cm for 3 days. No rash (other than the erythema) or respiratory or GI symptoms were noted.
little fatigued; teeny bit sore; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a dose Shingles vaccine and still a tiny bit sore a few days later and a little fatigued. The patient reported that his/her sister in law had shingles. The patient would take the shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Patient came to see Dr. today after doing a home pregnancy test. Pregnancy is confirmed by serum. Patient states she received a H1N1 Flumist last week at the Nursing Home where she works. 11/4/2009 PCP visit for 10/29/2009. Patient did home pregancy test which was + and verified per HCG, no c/o's at this time. Approx 5 weeks pregnant, received H1 N1 3 weeks prior. OB-GYN MD consulted and tx was observation at this time since asymptomatic. 11/6/09:  HCG Quantitative from received 11/5/09 results 0.2 (L).
No adverse event occurred. After we administered the Covid bivalent booster, and went to enter in the state IIS, it was then we noticed she had received the same booster on 9/20/2022. Before we administered we had asked and she claimed she had not received any vaccines recently. We also gave her Fluzone HD. We failed to check the state database in advance.
Left shoulder is swollen and red. The following day of injection the arm was weak to the point I had trouble raising it up. The redness has increased to a flat rash with increased swelling. My arm has regain ed strength but is still somewhat weak reminding me of when I had my shoulder injury.  I had a jacket all day so when I removed it I noticed the flat rash and increased swelling which alarmed me.
11/03/2006 at 4am clt developed sx of Nausea, Vomiting and diarrhea. Clt stated she felt very tired with episodes of chills and sweating and sore upper abdomen. No fever. Client states she had GI problems and often experiences GI side effects with medication. 11/09/06 TC to client states n/v stopped on 11/03, but continued to have extreme hotness and sweating thru 11/4. Client was fine on 11/05/06.
Subsequent to receiving two doses of Lymerix, the pt was found to be pregnant. The date of her last menstrual period is 05/13/2000 and the estimated date of delivery is 02/17/2001. As of 08/18/2000 she was 14 weeks pregnant. The outcome of the event is ongoing. A 15-day follow up report received 03/02/2001 adds: The pt developed pregnancy-induced hypertension on an unknown date. Labor was induced and the pt delivered a healthy male at 36 3/7 weeks of gestation on 01/25/2001. The birth weight was 5 lb 11 oz, and the Apgar scores were 8/5/9. The reporter considered the pregnancy-induced hypertension to be unrelated to previous injection with Lymerix.  This report is considered medically serious. As of 02/26/2001 mother and infant are doing well. As of 4/15/01, the condition of the mother and child was unknown.
injection site pain (current with itching); injection site pain (current with itching); tiredness/fatigue; tooth pain; joint pain; chills; low-grade fever (100.4); This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELo142), via an unspecified route of administration in right arm on 21Jan2021 09:15 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the workpalce clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included hypothyroidism and high blood pressure from an unknown date and unknown if ongoing.  Concomitant medication included losartan and levothyroxine sodium (LEVOTHROID). On 22Jan2021, the patient experienced injection site pain (current with itching), three days of tiredness/fatigue, tooth pain, joint pain, chills and low-grade fever (100.4). The patient recovered on unspecified date. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first two doses of GARDASIL (lot number, expiry date, route and dose were not reported) intramuscularly in the gluteus muscle and no adverse effect reported. Follow up information has been received from the licensed practical nurse refers to the 21 year old female patient. On 23-OCT-2012 at 2:50 PM the patient was vaccinated with the second dose of GARDASIL (lot # 668554/0306AA; expired on 10-MAY-2013 (intramuscular in gluteus). No adverse events reported. The outcome , action taken and causality were not provided at the time of report. Additional information is not expected.
Symptoms occurred in the following order: Soreness in arm, fatigue, body ache, fever, nosebleed, chills, headache, mouth dryness.
blood at the injection site; joint pain; Skin irritation; mild arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Apr-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of SKIN IRRITATION (Skin irritation), MYALGIA (mild arm soreness), VACCINATION SITE HAEMORRHAGE (blood at the injection site) and ARTHRALGIA (joint pain) 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 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced SKIN IRRITATION (Skin irritation) and MYALGIA (mild arm soreness). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (blood at the injection site) and ARTHRALGIA (joint pain). At the time of the report, SKIN IRRITATION (Skin irritation), MYALGIA (mild arm soreness), VACCINATION SITE HAEMORRHAGE (blood at the injection site) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          No concomitant and treatment medications were provided.  Action taken with mRNA-1273 in response to the events were Not Applicable.
At 3:30pm the same day of the vaccination, the patient developed marked swelling at the injection site with a rash on her abdomen and unconsolable crying. The patient recovered.
UPPER LEFT ARM IS SWOLLEN,RED,HOT,AND TENDER. THE ENTIRE UPPER ARM IS SWOLLEN.
A 73 year old male patient indicates suffering from prostate cancer and after receiving his third dose of Moderna, he reports enlarged prostate. We contacted someone because the patient mentioned it after being vaccinated.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Past drug history included: Neosporin, reaction(s): "Allergy: Neosporin", notes: Known allergies: Neosporin. 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: (28May2022) Negative, notes: on Day 8, I tested negative with a rapid test; (30May2022) Positive, notes: I took a rapid test and was Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Hi Dr. withheld, I wanted to let you know that I went through the 5 day Paxlovid, felt better, but didn't test negative until Day 8, which was last Friday. On Day 10, Sunday, I started to have a stuffy head and a bit headachy, and tested Positive with a rapid test. I did not take anything except Tylenol for the first 3 days. From what I've read, this is probably Paxlovid Rebound, so I just wanted to report this to you. I am still extremely stuffed, no headache and self isolating again for 5 days and will again wear a mask through Day 10. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.