chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 1/9/2022 for pain control and inability to eat with oral pain due to chemotherapy. Positive for COVID on 1/17 tested due to the new development of a strong cough and increased O2 needs from nasal canula to face mask.
Pt reported swelling and redness to right arm within 3 hours of receiving Pneumonia vaccine. Pt went  to own physician 11/16/2001, received antibiotics.
p/vax pt exp fatigue & "felt shaky". Exp caused pt to fall out of bed. Pt has sulfate allergies but has not exp rxn to TD in past.
I got the vaccine at 1 pm. At 11 pm I got chills, a fever, and full body aches that lasted all night. I vomited 3 times from 7:00 am - 10:00 am. The symptoms started to improve about 20 hours after onset. I was very dehydrated for the first 24 hours and very tired.  By the next morning, I no longer had a fever or chills, but the body aches and tiredness were still bad but have been improving as the day went on.  It has been 48 hours since the vaccine and I?m now only having mild symptoms. I took Advil a few times over the 48 hours and that helped with symptoms. Pedialyte helped with the dehydration.
Mouth tingling / Lips tingling; Horrible taste of metal in mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Mouth tingling / Lips tingling) and DYSGEUSIA (Horrible taste of metal in mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA ORAL (Mouth tingling / Lips tingling) and DYSGEUSIA (Horrible taste of metal in mouth). At the time of the report, PARAESTHESIA ORAL (Mouth tingling / Lips tingling) and DYSGEUSIA (Horrible taste of metal in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 20 minutes after receiving the shot, the patient started feeling tingling around her month and lips. In addition, she had a horrible taste of metal in her mouth.  No relevant concomitant medications were reported.    No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given a Moderna vaccine on 7/15/22 and it was past BUD. Temperature excursion happened on 8/17/2022.
dose was given to adults mistakenly; COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    No concomitant medications were reported.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and were reported to VAERS and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  No treatment medications were reported.  This case contains information for the patient 86 out of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791, US-MODERNATX, INC.-MOD-2022-680489 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791: (Cross linked) US-MODERNATX, INC.-MOD-2022-680489: (Cross linked)
Body and muscle aches from 6 pm- 12 am  Arm of injection was painful and level of pain increased from 4 pm -9 pm 2 extra strength (500 mg each) Tylenol were taken at 8 pm   At approximately 5:25 am, I began to get body chills and felt very cold which was consistent with a flu symptom and fell asleep.  I woke up at 8:15 am and felt much better.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K018959, expiration date 15-OCT-2016, dose and frequency were not reported), which was improperly stored (Incorrect product storage). No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Pt has chronic pain on her shoulder from her car accident in September 2020; however, after the vaccination, the same where she was feeling pain was also the site on injection.  On 3/12/21, she started feeling jaw pain on same side of injection and shoulder pain intensified plus numbness.  Patient says the pain and numbness  comes and goes. She is due for her next  dose on Saturday, March 28 but decided to wait  a little bit longer before she gets her second dose.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient called stating that both vaccines given in the left arm. 3 days later still has redness and swelling that appears to be spreading down the arm. he is going to go to a near by urgent care to be evaluated.
Fever, severe body aches, chills and the injection site has spontaneously bled 3 times for upto 30 minutes.  Enough that soaked 2 sleeve blouses. Headache , shaking,  numbness in foot and hand
Physician gave a pregnant patient Fluzone Quadrivalent which was expired on 30-Jun-2019/No AE; Physician gave a pregnant patient Fluzone Quadrivalent which was expired on 30-Jun-2019/No AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female pregnant patient (age unknown) who was given a 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which was expired on 30-Jun-2019 administered by a physician lot number not reported via unknown route in unknown administration site on an unspecified date, while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Data regarding this pregnancy were received prospectively.  It was a case of vaccine exposure during pregnancy.  It was an actual medication error due to expired vaccine used.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  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.  Information on the batch number was requested.  List of documents held by sender: none.
This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were unknown. It was unknown if the reporter considered the erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced red itching of 4 inch in diameter on her arm post vaccination. The reporter did not agree to follow up.
Headache day of vaccine, itchy skin and hives developed on arms and legs day after vaccine, lasting 2 days. Swollen, painful  lymph node in armpit started the day after vaccine and continues to present, nearly a week post-injection.
Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 29-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F) injection 0.5mL IM left deltoid. On 19-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # 656372/0243U) injection 0.5mL IM left deltoid. Concomitant medication included ZYRTEC and PREVACID. The date of the patient's last menstrual period was 24-JUN-2007. On 23-JUL-2007, the patient reported that she tested positive for pregnancy. On 29-JUL-2007, the patient sought medical attention for a miscarriage (the estimated date of delivery was 30-MAR-2008). On 29-JUL-2007, the patient arrived at the emergency room with complaints of bleeding and cramping. An ultrasound performed showed no fetus/pregnancy. Additional information was received from the registered nurse via telephone. It was originally reported that the miscarriage was life-threatening. The nurse clarified that it was not life-threatening to the mother but was unknown to the fetus as it was very early on in the pregnancy. The relationship of the miscarriage to Gardasil was unknown. Upon internal review, spontaneous abortion was considered to be an Other Important Medical Event. No additional information is expected.
Four days after receiving the shot, I started to break out with a massive cold sore on my top lip and a second one on my lower lip. Luckily I had Valtrex which I started taking Monday morning when I realized that it was a cold sore.  It didn?t start the way it usually does (tingling, blisters).  I took Valtrex 1
I passed out and could not breath had to go by ambulance to the ER, they found that my lungs and legs were full of blood clots. Had surgery immediately and the pulmonologist had to suck out the clots lungs. ICU for 3 days and then now I am taking Eliquis and off birth control. Still have clots in lungs and legs.
Pt became clingy the night after vaccines were administered. The next morning and for 3 days since vaccine administration, pt developed fussiness and has had crying that does not improve with Tylenol or Motrin. After pain medications, pt sleeps for 30 minutes and then wakes fussy again. Consoled only when held by mother. Playing for short periods. No change in appetite. One large volume diarrhea since vaccines.
Patient became pale and experienced a vasovagal syncope episode. She never lost consciousness and once she vomitted she felt better. An IV was started and normal saline was given at a KVO rate and patient's status improved back to baseline within minutes. She was transferred to the local ER to be evaluated out of caution.
Very heavy period following 2nd shot. Similar to my period after the first shot but much worse. Intense cramping, fatigue and bleeding.
pt states after about an hour after vaccines, she was weak, had chills body aches, and fatigued.  She had sore throat so could barely swallow.  She had shallow breathing and fever.  She neck and back pain.  Her eyes were oozing mucus.  The following day she went to her PCP.  They told her she probably had a reaction to the flu vaccine.  She was taking left over antibiotics for her eyes.   She prescribed eye drops.  She has been sick and in the bed for over 2 weeks. Today is the first day she is feeling back to normal.
macular rash, t104.5, nausea, body aches, chills x 5d, mild dehydration, sore throat, tender parotids;
Pt was given the Covid vaccine at age 3, no known reactions or side effects. Pt notified error.
Migraine; Vomiting; Pain at injection site; Swollen and very painful lymph node in right armpit; Swollen and very painful lymph node in right armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the right arm on 04Oct2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included skin cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA) and lamotrigine (LAMICTAL), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin; clavulanic acid (AUGMENTIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 13Sep2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 06:00, the patient experienced migraine, vomiting, pain at injection site, swollen and very painful lymph node in right armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, vomiting, pain at injection site, swollen and very painful lymph node in right armpit was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
left thigh was red , felt warm to touch , had swelling in thigh .   pt had  two injections in his thigh left upper was infanrix  left lower was varicella
This case was reported by a nurse and described the occurrence of fever in a female infant who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The nurse reported that the office she represented did not administer the Pediarix. On an unspecified date in 2004, the pt received a dose of Pediarix (dose number and lot number not provided). At an unspecified time following the administration of Pediarix, on an unspecified date in 2004, the pt developed a high fever and fussiness. The pt was seen at a physician's office. The events resolved on an unspecified date in 2004. The immunization series with Pediarix was discontinued. The nurse considered the events to possibly be related to immunization with Pediarix. Report initially received via manf.
from her neck to her arm is having intense pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (from her neck to her arm is having intense pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032l208) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM), OMEPRAZOLE, blood pressure medication and blood sugar medication for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (from her neck to her arm is having intense pain). At the time of the report, PAIN (from her neck to her arm is having intense pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Tylenol to relieve the pain.   Reporter did not allow further contact
IPOL was opened since the excursion (11.22 degrees C for 10 hours) and was used once with no adverse event; IPOL had multiple temperature excursion with no adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient it was reported  IPV (VERO) [IPOL] was opened since the excursion (11.22 degrees c for 10 hours) and was used once with no adverse event and had multiple temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect IPV (VERO), suspension for injection,  (lot U1A452M and expiry date not reported) was opened since the excursion (11.22 degrees c for 10 hours) and was used once with no adverse event (poor quality product administered) (unknown latency) It was reported that IPOL had multiple temperature excursion with no adverse event (product storage error) (unknown latency) Prior excursions: 10.93 degrees C for 12 hours, 1.17 degrees C for 45 minutes; 11.22 degrees C for 10 hours; and 8.63 degrees C for 15 minutes.  Action taken : not applicable.  Outcome ; Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Mom states arm (left - inject site) red / swollen area 3.5 x 3.5" "size of orange".
booster; Booster could have happened between both covid cases/Covid ongoing for the current December-January case; Booster could have happened between both covid cases/Covid ongoing for the current December-January case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "has had issues with weight, unsure otherwise, potentially some mental health struggles" (unspecified if ongoing); "potentially some mental health struggles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), administration date: 12Mar2021, when the patient was 34 years old, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), administration date: 19Feb2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Booster could have happened between both covid cases/Covid ongoing for the current December-January case"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) positive; (Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received 2 doses of the Fluzone Quadrivalent 4 days apart.  First one was received at the Local Health Department and 2nd dose was received at his PCP office.  No complaints of any symptoms.
Patient stated having dizziness and nausea with one episode of vomiting. This occurred about 5 hours after the vaccine.
Information has been received from a nurse concerning a patient who on 02-FEB-2012, was vaccinated with a dose of ROTATEQ (lot# and dose not reported) and spit up the ROTATEQ after it was administered. This is one of several reports received from the same source. Additional information has been requested.