chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date.  Information on the lot/batch number has been requested.
Initial unsolicited report received from a registered nurse on 07 Oct 2016. This case involves a 19 years old male patient who was vaccinated with a second dose of MENACTRA (Batch number- U5260AA, expiration date: 16 May 2017, route of administration was not reported) intramuscularly on right deltoid on 22 Aug 2016. Illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies (NKA). Concomitant medications were not reported. On 01 Sep 2016, 10 days of following the vaccination, the patient had Ringing in ears and hearing loss in both ears. Patient required emergency visit. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of the events were not recovered. Upon internal review, the company decided to consider the case serious because of important medical event hearing loss in both ears. List of documents held by sender: none. Sender's Comments: Patient had Tinnitus and hearing loss in both ears following MENACTRA vaccine. Time to onset is compatible, but additional information regarding patient medical history, any ear disorder or trauma, past vaccination history and its tolerance are needed to further assess the case.
pt recv vax 3NOV94 & 12NOV94 mom noticed mild rash over the rt side of the pt's body; noticed swelling & inflammation of both knees; pt was very irritable & feet were cold; also exp joint pain; presented to MD for eval @ that time sx mild;
A report received from a health professional on 06Feb03, concerning an adolescent male of an unspecified age who developed flu with fever, body aches and pain and unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. There was insufficient information to determine the reporters causality assessment.  Cross ref with: PJP200300060; PJP200300061, PJP200300062.
Start of ear pain on 12/24/21. By 12/27/21 ear pain had not gone away and swelling was noticeable.  At around 8pm that evening tongue started feeling numb. By around 6 am on 12/28/21 had partial facial paralysis most noticeable by lack of smile. Immediately went to ER . Upon clear CT scan and other tests was determine to have Bell?s Palsy and middle ear infection.
12/25/21 presents to ED for "worsening SOB". PMHx of "CHF, CKD (previously required HD), COPD on home 02 at 2L"
muscle and back pain; muscle and back pain; having trouble when she gets up; She's having to balance herself; Behind their knees, the back half of our legs are cramped and swollen with pain; Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen; face is swollen; joint pain; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reportedVaccination history included: Covid-19 vaccine (Primary Immunization completed, Manufacturer Unknown), for COVID-19 Immunization, reaction(s): "rash all over body".  The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "Behind their knees, the back half of our legs are cramped and swollen with pain/ hands are swollen"; BALANCE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "She's having to balance herself"; SWELLING FACE (non-serious) with onset 2022, outcome "unknown", described as "face is swollen"; DYSSTASIA (non-serious) with onset 2022, outcome "unknown", described as "having trouble when she gets up"; ARTHRALGIA (non-serious) with onset 2022, outcome "unknown", described as "joint pain"; MYALGIA (non-serious), BACK PAIN (non-serious) all with onset 2022, outcome "unknown" and all described as "muscle and back pain".  Additional information: Consumer was reporting that she and her husband received the booster bivalent dose on 24Oct and for the past week and a half both are having muscle and back pain. Caller mentioned that she was a nurse. Caller states that she and her husband received the booster bivalent vaccine on 24Oct and for the past 1 and 1/2 weeks, they've been having muscle and back pain. She's having trouble when she gets up. She's having to balance herself. Behind their knees, the back half of their legs are cramped and swollen with pain, hands are swollen. 'His face is swollen as well'. She states 'I think we had a delayed reaction'. They've never had these problems before. Her husband is worse. He's been using a walker for about 1 week. He fell on Friday and they went to the orthopedic clinic who told them it was arthritis. She had a reaction to a previous dose - she states 'last time I thought I'd been bit by ticks or fleas from walking in the grass.' I had a rash all over my body. It was itching and bleeding. She used lotion and ointment to sooth it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201309622 same product/event, different patient;
I developed a hive looking rash on my legs after I sat outside in the sun.   I stayed indoors and the rash subsided.  I sat in the sun the next day and it has not appeared again.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 16-Dec-2014. The nurse reported that received a patient was administered expired FLUMISTT on 16-Dec-2014. She started that the patient did not report any symptoms. The outcome of the event of EXPIRED FLUMIST ADMINISTRATION is unknown. The report was considered to be non-serious.
Dizziness/felt dizzy; can not balance herself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer, Dose number unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "Dizziness/felt dizzy"; BALANCE DISORDER (non-serious), outcome "unknown", described as "can not balance herself". Additional information: Patient after receiving the booster dose of pfizer BioNtech vaccine on 03Dec2021, has been experiencing Dizziness and would like to know if this was a side effect from the vaccine or it might be her iron level. She still felt dizzy up to date and cannot balance herself.  Follow-up attempts completed. No further information is expected.
Client had rash on body- seen by doctor who said just a localized reaction, decreased on 03/23/2006.  Reaction today- doctor did not feel a problem and was instructed to take Benadryl.
no adverse event; Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics).    No concomitant medication were reported. No treatment information was provided by the reporter.
nasal infection; The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.; This spontaneous case was reported by a patient and describes the occurrence of RHINITIS (nasal infection) and EXTRA DOSE ADMINISTERED (The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Extreme arthritis). Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Arthritis.    On 02-Jun-2022 at 11:00 AM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXTRA DOSE ADMINISTERED (The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.). On an unknown date, the patient experienced RHINITIS (nasal infection). At the time of the report, RHINITIS (nasal infection) and EXTRA DOSE ADMINISTERED (The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.) outcome was unknown.            The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose. He stated that taking Tylenol and Advil could affect the shot. He did not know until today 02 Jun 2022. He took those on a regular basis because he had extreme arthritis. He took Tylenol at 5 in morning and ibuprofen with it. He received the vaccine at 11 in morning. He found that taking Tylenol and Advil will reduce the efficacy of the vaccine because the immune response to the vaccine might not be as effective. He stated that he read that on the internet, so he did not know if that was right. The patient wanted to know if it was okay for him to take Tylenol and Advil prior to getting the Moderna booster. He also had a bit of a nasal infection, so his doctor prescribed him Bactrim. His nurse was not able to tell him information and told him to ask Moderna. He stated he had not taken Bactrim yet. He wants to know how many days he should wait. He stated that his doctor and the pharmacist did not know how the vaccine works because they were not scientists and virologists. The patient stated he wanted to speak to a supervisor. He stated that he already talked to three doctors and pharmacists.
About 5 minutes after receiving the vaccine, he fainted in the lobby of the building that the doctor's office is located. He fell forward and hit his chin on the ground.
So I have, Tinnitus both of  my ears. It was a constant ringing. Which is still going on. I went to the Dr. and he prescribe  prednisone.  The following day I felt very funny for about 3 hours.
About 3 minutes after receiving vaccine, my heart started racing . It lasted about 10 minutes. I felt slightly light headed for the first 5 minutes after, as well.; About 3 minutes after receiving vaccine, my heart started racing . It lasted about 10 minutes. I felt slightly light headed for the first 5 minutes after, as well.; This is a spontaneous report from a contactable consumer, the patient.  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6202), via an unspecified route of administration on 25Feb2021 at 15:00 (at the age of 69-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included hiatal hernia, gastroesophageal reflux disease, hypertension, atrial fibrillation, dilated aorta, osteoarthritis, asthma. The patient is allergic to tea tree oil and reports an allergy to shellfish about 20 years ago. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included rivaroxaban (XARELTO), atenolol (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN) all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that on 25Feb2021, about 3 minutes after receiving vaccine, her heart started racing. It lasted about 10 minutes.  She felt slightly light headed for the first 5 minutes after, as well.T he patient did not receive any treatment for the events. The clinical outcomes of the events heart racing and lightheaded were reported as recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
They missed their second dose yesterday; Husband felt really tired like three to four days, he doesn't have energy and can't move; Husband felt really tired like three to four days, he doesn't have energy and can't move; Muscle pain; This is a spontaneous report received from a contactable Consumer or other non HCP.  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic; "heart patient" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "They missed their second dose yesterday"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "Husband felt really tired like three to four days, he doesn't have energy and can't move"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm redness, edema, warmth, pain at injection site - Patient's PCP recommended ice and MOTRIN. 10/22 redness, edema and warmth gone but arm extremely sore.
This case was reported by a healthcare professional via a sales representative and described the occurrence of hives in a 3-year-old male subject who was vaccinated with HAVRIX for prophylaxis. There were no concurrent medications. On 27 June 2008 at 13:00 the subject received 1st dose of HAVRIX at 0.5 ml (720 elisa units) in right arm. On 27 June 2008, sometime after 19:00, the subject started to develop hives and urticaria all over his body (a systemic reaction). He was seen in the office the following day. The hives were 1 mm in size. The subject was treated with BENADRYL. At the time of reporting the hives and urticaria were improved. The healthcare professional considered that the events were probably related to vaccination from the same lot as this 1st dose of HAVRIX given. This was considered to be a product complaint.
Information has been received for the pregnancy registry for Gardasil from a 24 year old female healthcare worker with a childhood history of anaemia who on 11-DEC-2006 was vaccinated IM with a first dose Gardasil. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR). Subsequently the patient found out she was about 5 weeks pregnant (estimated LMP 10-JAN-2007, EDD 17-OCT-2007). The patient was scheduled to see her physician on 26-FEB-2007. On 22-JUN-2007 follow up information was received from a physician concerning the hispanic patient with a history of low grade squamous intraepithelial lesion (August 2004) and cryosurgery to cervix (September 2004) and 0 previous pregnancies. The patient underwent amniocentesis on 09-MAY-2007 (negative) and ultrasound on 23-MAY-2007 (19 weeks). Maternal serum alpha-fetoprotein (MSAFP) was 4; the patient also had an increased random glucose of 239. She was put on a 2000 kcl ADA diet. Her outcome was not reported. Additional information has been requested. Follow up information has ben received from an obstetrician concerning the patient with gestational diabetes since 09-MAY-2007 when screening chemistry panel revealed glocuse 239. On that date she received MACROBID 100 mg BID x 7 days as empiric Rx for urinary frequency. The patinet received glyburide 2.5 mg BID from 31-AUG-2007 to 12-SEP-2007, and 5 mg BID from 13-SEP-2007 to 13-OCT-2007. On 13-OCT-2007 a liveborn female infant was delivered at 39 plus weeks from LMP. Weight was 8 pounds, length 18 1/2 inches, APGAR score 3/3. The patient received prenatal vitamins from 26-FEB-2007 to 15-OCT-2007. Pediatric medical records were received and reviewed and the following experience was identified: the child was born with the congenital anomaly of mongolian spots. The infant subsequently experienced adverse events following vaccination with hepatitis B vaccine. Additional information is not expected.
After about a week, I feel irritated right armpit has ping-pong ball size lump like lymph node swelling. Still continue this moment
Suspected vaccination failure; Shingles; PHN; nerve damageon his thigh and groin; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: PHN) and nerve damage (Verbatim: nerve damageon his thigh and groin). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient's wife via interactive digital media. The patient got the worst case of shingles from the Shingles vaccine booster and 1 year plus later, he/she was still suffering from PHN nerve damage on his thigh and groin. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 25-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
after receiving  influenza, menactra and Men B vaccines, pt became light headed, clammy, sweaty and pale skinned
I woke up extremely fatigued; I woke up extremely fatigued and achy, just like I did when I had the actual virus back in December; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient 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 09Mar2021 at 08:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included peripheral arterial disease, blood pressure high and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin calcium (LIPITOR), metoprolol (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. On 10Mar2021 at 04:00, the day following the vaccine, the patient woke up extremely fatigued and achy just like how the patient had the actual virus back in December. The patient stayed home from work. The events did not result in doctor or other healthcare professional office/clinic visit, 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 event woke up extremely fatigued and achy was resolved on an unspecified date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
About a week after I received the vaccine, I developed a rash on my arm around 1-2 inches below the injection site (below my deltoid). The rash itself has grown over the past few days and is now around 2 inches wide, 3 inches long (an oval shape).  It is red and itchy and feels hot and bruised when touched.
Dizziness within 10 minutes that lasted 30 minutes or longer. Waves of nausea for over 24 hours