chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was inadvertently administered an expired dose of Menactra, no AE; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 years old female patient who was inadvertently administered an expired booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6486AC and expiration date :10-Jan-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 25-Jan-2021.  Patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL).  It was a case of actual medication error due to expired vaccine used (expired product administered, latency on same day). And they wants to find out if the medication needs to be re-administered   No adverse event were reported at the time of reporting.   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 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.
On 10/29/2022, I was exposed to COVID-19. On 10/31/2022, I got a slight sore throat in the evening. I woke up on the morning on 11/1/2022 with slight nasal congestion, and my sore throat was much worse. On 11/2/2022, the sore throat was even worse, and my congestion was slightly worse. I took a home antigen test and got a positive result. For an entire week, I had a nasty sore throat. The congestion remained relatively mild, though. It basically felt like strep throat. On 11/3/2022, I called my doctor to see if I should take the antivirals, but it turned out that it was already too late to benefit from the antivirals by then. The doctor told me that I would just need to ride out the symptoms, and I was advised to take throat lozenges, which I was already doing. The symptoms tapered down on 11/9/2022.
Severe rigors, nausea, lightheaded ness, loose stools, fever up to 102.
light headedness; shortness of breath; heart palpitations, nearly fainted 3 times symptoms began before 2nd dose but NO ONE THOUGHT OR SAID THEY THOUGHT IT WAS ABOUT THE VACCINE. they were happy to say it was because of my weight.... but I'd been heavier before and NEVER had symptoms like these!
This is a medication error report. Several final doses were drawn from the final vial near the end of the clinic.The final dose draw was an insufficient dose of 0.4 ml and set aside for disposal. It was subsequently inadvertently co-mingled with the other full doses and administered. This was discovered after at least 5 people were vaccinated and brought to  my attention. Immediate review could not determine an exact recipient. Review of information from moderna regarding dosing errors indicate that antibody response in the trials were comparable for both the 50mg and the 100mg doses studied and that an error producing between a 50 and 100mg dose should not be repeated.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with doses of COMVAX (lot # J013884 with expiration date of 19-AUG-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended storage range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Started with tingling in fingers and toes, then achy legs, aching back, aching jaw, trouble keeping left eye open, light sensitivity, vomiting, staggered walking, falling down, extreme fatigue, weakness, loss of appetite, loss of personality.
Patient passed out while waiting (in lobby/waiting area) after the 2nd dose of vaccine.
Caller reported an improperly stored administered Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 15-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) lot number T013539 was verified to be valid, expiration date reported and  established as 17-OCT-2021 (dose, frequency and route of administration were not provided) for prophylaxis.   The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for 25 minutes. There was no previous temperature excursion. Digital Data Logger was involved.
swelling; inflammation; Painful; BAD REACTION; red; Exhausted; Back went out; Extreme headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), INJECTION SITE INFLAMMATION (injection site inflammation), PAIN IN EXTREMITY (Painful), MUSCLE STRAIN (Back went out) and ADVERSE REACTION (BAD REACTION) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included MS.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (tired). On 01-Mar-2021, the patient experienced HEADACHE (Extreme headache). On 03-Mar-2021, the patient experienced MUSCLE STRAIN (Back went out). On 04-Mar-2021, the patient experienced SWELLING (swelling), INJECTION SITE INFLAMMATION (injection site inflammation), PAIN IN EXTREMITY (Painful), ADVERSE REACTION (BAD REACTION), INJECTION SITE ERYTHEMA (injection site redness) and FATIGUE (Exhausted). At the time of the report, SWELLING (swelling), INJECTION SITE INFLAMMATION (injection site inflammation), PAIN IN EXTREMITY (Painful), MUSCLE STRAIN (Back went out), ADVERSE REACTION (BAD REACTION), INJECTION SITE ERYTHEMA (injection site redness), HEADACHE (Extreme headache), FATIGUE (Exhausted) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Redness spread down arm; Heat; Tenderness; Numbing; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Sep2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose COVID-19 immunisation. On 26Sep2021 at 00:00, the patient experienced redness spreading down arm, heat, tenderness, numbing and itchy. 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 redness spreading down arm, heat, tenderness, numbing and itchy was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
VACCINE BUD WAS 04/29/2022 BUT WAS MARKED INCORRECTLY AND GIVEN TO THE PATIENT ON 05/20/2022.  THE VACCINE WAS KEPT AT THE CORRECT REFRIGERATED TEMPERATURE THROUGHOUT BUT AS PAST BUD.
Chronic foot pain in my joints and tops of toes. Inflamed joints all over. Irritated cyst in my body. Infections in cyst. UTI. Heart palpations. Shortness of breathe. Chest pains on my right side. Racing heart. High blood pressure. Test came back showing positive for Lupus and that has never come up before.
On 8/2/2017, pt came into office for 12 yr WCC. Dad refused HPV vaccine stating pt had a reaction to the 1st dose on 8/10/2016 vaccine. Dad reports pt was fine during WCC visit, but once he was home, he developed an upset stomach, with nausea and vomiting. Dad states no one else in home became sick. Dad also did not contact our office after incident.
Localized reaction: Patient reported vaccine initially stung and remained sore, pain for initial 3 days after receiving vaccine, erythema started 4 days after receiving vaccine. Treated with doxycycline 100mg twice daily for 7 days.
On 4/25/2022, I received my second Moderna booster against COVID-19. On 4/26/2022, I began to have abdominal cramping and frequent watery diarrhea. Ever since then, I have been unable to eat as much in one sitting or in general as I was before the second booster. I also still have abdominal pains and frequent watery diarrhea. I went to an urgent care clinic that is run through the hospital system a week or two after receiving the shot, and a number of blood tests were ordered. I received news via email that I was diagnosed with eosinophilic gastroenteritis. On 6/7/2022, I saw my PCP for a follow-up. My doctor recommended a course of budesonide. However, as of now I am holding off on doing this. While I was at my doctor's office, I underwent more blood tests, and we're going to see if there have been any changes since my first blood test.
Shingrix subcutaneously instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 14th December 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix subcutaneously instead of Intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
The evening is the vaccine I was very fatigued.  On Day eight  I started having itching at the injection site and  worsened today. There is a large hive and its red. It?s sore to touch and is achy.
Reporter states pt did not seroconvert p/receiving Engerix-B series; all injections were administered Im;
Patient booked appt with incorrect date of birth. It was discovered once she had been vaccinated that she  was in fact 17. No adverse reactions reported.
hives within days at injection site then systematically [...] without anaphylaxis; Information has been received from the Food and Drug Administration (FDA) AGENCY (Agency Control # 6230318) on 12-MAY-2020.  This spontaneous report as received from an other health professional refers to a 12-year-old female patient.    On 21-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: vial, lot # R026716, expiration date was not reported but upon internal validation established as 30-MAY-2021, intramuscularly in the left deltoid for prophylaxis. On 23-MAY-2019, 1 day 9 hrs 47 min after onset of therapy the patient experienced hives at injection site without anaphylaxis. The outcome of infusion site urticaria was reported as recovered/resolved.  The relatedness between the event and the suspect vaccine was not reported.  Follow-up information has been received from a physician on 17-AUG-2020. The reporter stated that the patient in this report was not seen in the physician's office (wrong office).
Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by afternoon of 1/19/21. Arm pain and body aches resolved around same time. Significant left jaw pain which began evening of 1/19/21 and continue into 1/20/21. All symptoms alleviated by ibuprofen.
Shot at 12:18 Friday afternoon.  One hour later increased pain in neck where my cervical issue is a current problem. Around 7:30pm overwhelming fatigue and the beginning of chills and the start of low grade pain in joints throughout my body.  I took my medications and was in bed by 8pm. Over the course of the next 6 hours, The chills increased, sweating, fever 99.5, the feeling of my muscles and tendons tightening up and I would have to repeatedly stretch to relieve the accompanying pain, extreme thirst, nausea - at one point vomiting bile. The pain in my joints was around a 7 on pain scale. I could not get comfortable and was writhing from side to side. Around 2am I took a 2nd Hydrocodone for the pain. At 10am  I finally took Nurtec for the massive migraine.  At 11:30am (about 23 hours after injection) the headache was relieved, the joint pain had significantly decreased. My neck still ached. I was very fatigued and it was with effort to move from the bed to the couch. I slept on and off throughout the remainder of the day.  I had no appetite but forced myself to eat yogurt with fruit. It is now 11:44am Sunday. I still have no appetite. With exception of some mild fatigue and loss of appetite, all other symptoms have improved.
I was asked to talk to pt at his OV yesterday.  He had received a Tdap in his R deltoid on the 9th & became so ill that he went to ER late Sat night (about 10 pm).  He said sx started about 4 hrs after shot given.  Got the chills, body aches & H/A.  Sx's much improved after ER visit.  Full recover took about 2 wks.  Asking about the injection site, he said it was sore but he was more concerned about his overall feeling bad he didn't pay much attention to the injection site.  Today, I called ER report. Hosp ER notes:  Now feels like he is having an allergic reaction to the injection.  Headache, body aches, irritable, anxious.  Injection site does not show abnormal signs  This patient presents with generalized body aches, arthralgia's, headache, feeling hot and cold, abdominal discomfort, nausea and headache.  Symptoms started today.  He is concerned because he had a tetanus shot yesterday.  He is concerned this might be an adverse reaction.  He has not taken any Tylenol or Motrin for the discomfort.  He has not noticed redness of the joints, fever, vomiting, diarrhea, neck stiffness P 85, R 16, BP 119/74, T 98.3  I (ER phy) spoke with the pharmacy and many of his symptoms can occur after a tetanus injection.  His symptoms can also be seen with a viral syndrome.  Irregardless he is nontoxic appearing and will be treated symptomatically.  He has not taken anything today for the discomfort was given a dose of ibuprofen and Norco in the emergency department.
Moderna COVID-19 Vaccine EUA The afternoon of the day I received my first injection I started with a headache.  Upon waking the following morning I had injection site sore/stiffness, severe body aches, headache, joint stiffness, slight nausea at times and occasional dizziness.  I developed a fever during the night and woke up with my clothing wet.  My symptoms except for the injection site soreness were resolved.
Younger sister dx. with strep throat 2/14/11 with 103 fever. Pt. spiked fever 102.5 the afternoon of getting vaccines. She just lied around on mother. Did not walk. Woke up with 99 temp 2/23. Had not walked until mother took to doctors at 4:30pm. Took 3 steps to mother at office. Dr. dx. Transient Synovitis.
Within 10 minutes of first shot, my vision got really off...eyes have been jumpy ever since ..Almost like a vertigo. Also, a couple of weeks after my first shot, my legs became very heavy and weak. Between the two issues, I have fallen twice since then.
This spontaneous report as received from a 71 years old female consumer concerned herself with diabetic, high blood pressure and allergy to morphine. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (lot # not reported) on 30-JUL-2012. Concomitant medications included hydrochlorothiazide (+) triamterene, COZAAR, clonidine hydrochloride, KLOR-CON, simvastatin, omega-3 marine triglycerides, glyburide, cyanocobalamin, gabapentin, vitamin D (unspecified), LANTUS, aspirin, "Pransdon HCL" and ZYRTEC. The reporter stated that on 01-AUG-2012 she had a sensation "like running a finger over your skin". She stated similar to a tickle, no pain, no itch. She had consulted her pharmacist and she was referred to her doctor. She also stated that she had a knot and redness after injection on her right arm. She stated that she had shingles prior, too. No treatment was given for adverse events. No lab diagnosis was performed. At the time of reporting, the outcome of adverse events was unknown. Additional information has been requested.
Patient fainted and became pale. Patient sat in waiting area for 10 minutes and was provided with water.
This spontaneous report as received from a medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of PNEUMOVAX 23 (Lot # reported as M018624, expiry date: 28-MAY-2017) were administered to the patients on unspecified dates (incorrect product storage). No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving pneumococcal in the left leg and meningococcal in the right leg the patient developed redness and swelling near the knee of his left leg and could not bear weight on that leg. Patient was also found to have tissue swelling and leukocytosis and increased CRP.
Muscle pain in arms at joints. right hand swelled up and hurt skin red. Happened next day, inability to lift right arm up past shoulder without pain. Both arms muscle pain at shoulders, elbows and wrists. Using tylenol, muscle relaxants, heat, rest.
Mother reports excessive crying x24 hours after 1st set of vaccines.  *PEDIARIX - HIB - PREVNAR - Rotavirus.
pt recvd Engerix-B vax on 26JUN92; several hrs later exp fever > 101, malaise, sore throat, nausea, vomiting, body joint pain (all over), pharyngitis & dehydration; hospitalized due to dehydration;
My father had interstitial lung disease for about 10 years at this point. He never received a flu shot before, & in the fall of 2009, there was widespread worry about swine flu.  Because of his condition, he decided it was prudent to get a flu shot.  Within 2 weeks of receiving the flu shot, his lung capacity went from 88% to 44% and he ended up in the hospital on oxygen.  His condition continued to downgrade until 1-1-10 when he received a lung transplant (he was in such need at that time, he was placed on the list and called for a transplant in less than a week).   I believe he would have died within a week or two of that time.  He did eventually die on May 16, 2010 due to complications of the lung transplant.
Hallucinating by hearing things falling doors opening throughout her house when no one is living with her.
Reactions were arm sore; Tiredness; Body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) dose 2 via an unspecified route of administration, administered in right arm on 05Feb2021at 15:30 as single dose for covid-19 immunization. historical vaccine include dose 1 via an unspecified route of administration, administered on 14Jan2021, (at the age of 90 years-of-old).  Medical history included Heart failure, Chronic high blood pressure, Obesity, Kidney Disease, penicillin, sulfa, dairy allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Aldactone, Bystolic, Lisinopril, Zetia, and Cymbalta. The patient stated that 1st Dose was on 14Jan2021, of Pfizer Vaccine did NOT produce any side effects that she was aware of. However, the 2nd Dose on 05Feb2021 07:00pm, of Pfizer Vaccine produced side effects about 3 hours after the injection. Reactions were arm sore, tiredness, body ache, head-ache; no diarrhea, temp not taken and went to bed and slept. These side effects continuing February 6 and February 7. On February 7 took Tylenol to help with aches and pains. She stated that the side effects were continuing. The outcome of the events was reported as not recovered.   Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected
After immunization patient stated he felt lightheaded then passed out in the chair and remained unconscious for approximately 3 minutes.
started to exhibit symptoms of Bells Palsy; This is a spontaneous report received from a contactable consumer reported for himself. A patient of unspecified age and gender received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 via an unspecified route of administration in Dec2020 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received Pfizer vaccine dose 1 in Dec and dose 2 in Jan. Before dose 2 patient started to exhibit symptoms of Bells Palsy. Pictures were sent to provider and a family member who was also a provider verified it was Bells. Symptoms lasted close to 2 months before any visible change noticeable. Patient attempted to also report to DOH without much luck and the VAERS seemed not to work right. Patient just would like to get it reported with Pfizer to assist patients in making vaccine decisions. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Left arm soreness; She cannot sleep on the left side; Chills at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), SLEEP DISORDER (She cannot sleep on the left side) and CHILLS (Chills at night) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, VITAMIN D [VITAMIN D NOS], PRAVASTATIN, LISINOPRIL, PAROXETINE and OMEPRAZOLE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm soreness), SLEEP DISORDER (She cannot sleep on the left side) and CHILLS (Chills at night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), SLEEP DISORDER (She cannot sleep on the left side) and CHILLS (Chills at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Tylenol as treatment medication.
Pfizer 5-11 formulation administered to a person age 12-17 years.  no adverse reaction noted