chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; Sore injection arm; Sore injection shoulder; Fever; Chills/shivering; Tiredness; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), MYALGIA (Sore injection arm), ARTHRALGIA (Sore injection shoulder), PYREXIA (Fever) and CHILLS (Chills/shivering) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), MYALGIA (Sore injection arm), ARTHRALGIA (Sore injection shoulder), PYREXIA (Fever), CHILLS (Chills/shivering), FATIGUE (Tiredness) and HEADACHE (Pounding headache). At the time of the report, PAIN (Body ache), MYALGIA (Sore injection arm), ARTHRALGIA (Sore injection shoulder), PYREXIA (Fever), CHILLS (Chills/shivering), FATIGUE (Tiredness) and HEADACHE (Pounding headache) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
FOLLOWING VACCINATION ON 11/2/07, THREE DAYS OF HIGH FEVER (104 DEG F, 103 DEG F) AND ONE DAY OF 101 DEG TEMP.
5mins after vaccine, pt c/o flushing, dizziness and fatigue. Pt monitored for 45mins. No treatment given. Flushing and dizziness resolved. Pt still fatigued. Pt vommitted four times within an hour after leaving vaccine clinic. Pt unable to work the day of vaccination.
Information has been received from a healthcare professional concerning a 26 year old female who received a first dose of Gardasil (lot # 657005/0314U) IM into the left deltoid on 06-Jun-2007. Five minutes later she felt lightheaded and experienced a tonic-clonic seizure and urinary incontinence that lasted 1-2 minutes in duration. She was awake, alert and oriented X 3 post event. Upon internal review tonic clonic seizure was considered to be an other important medical event. Additional information has been requested.
Caller received his second dose of the vaccine on 27MAR2021; tenderness at shot site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received his second dose of the vaccine on 27MAR2021) and VACCINATION SITE PAIN (tenderness at shot site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included TETANUS VACCINE from 12-Mar-2021 to an unknown date for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received his second dose of the vaccine on 27MAR2021) and VACCINATION SITE PAIN (tenderness at shot site). On 27-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received his second dose of the vaccine on 27MAR2021) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness at shot site) outcome was unknown.            Concomitant medications included tetanus shot on 12 Mar 2021. No treatment information was provided.  This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 031A21A  with associated AE vaccination site pain.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 031A21A  with associated AE vaccination site pain.
Pt report states while driving back to city from another city, started with itching eyes.  When at home eyes were swollen and right arm started feeling hot and swollen as well as some throat tightening.  Went to the medical center and received Benadryl injection.  This information was given per MD report.
following vax pt became limp, lethargic, went to sleep sleep 6 hrs straight, didn't wake for feedings entire time;
rt arm swelled up 3/4 around arm; red & hot to touch, hard; lasted about 5-6 days; pt was out ot town & did not report the reaction until came in for booster; incidentally the booster was not given;
On July 2nd I started feeling very nauseated and had a little bit of back pain, the next day I started to experience a high fever and was feeling very exhausted. Two days later, on the 5th I started to come down with fatigue to the point I was very tired and only could sleep for 5 minutes. I then started to realize I had an itching and burning sensation on my shin due to having a rash. I did a virtual doctor's appointment and they thought it could have been cellulitis forming on my shin, I still have to go in to receive the test before ruling that out. I also experienced teeth pain throughout the day which made it uncomfortable to chew.
Patient came into the clinic to receive the Moderna Bivalent but was inadvertently given the Moderna pediatric 0.5 mL dose. Agency, CDC and Moderna Helpline were notified this same day for guidance. Patient was notified same day of the error.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 14-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II lot # M015931, expiry date 30-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable Licensed Vocational Nurse. A 12-year-old male patient received TRUMENBA (lot number: S58895, expiry date: Jun 2019), intramuscular on 14Aug2018 at 0.5 ml, single(0.5ml intramuscular injection) for immunization. The patient's medical history and concomitant medications were not reported. The patient administered meningococcal group b rlp2086 by accident on 14Aug2018, the patient was supposed to receive the MCV 4 vaccine instead. He is 12 years old. He was in an express care complaining of headache and swelling at the injection site on unknown date in 2018. The outcome of the events was unknown.
Swollen tongue. tickling on the tongue. little difficulty breathing. dry cough with a  "strange sound". headache and joint pain. Little desire to eat due to stomach discomfort. insomnia and a lot of anxiety; It has improved after 24 days.
This spontaneous report was received from a medical assistant and refers to a 67-year-old male patient with diabetes mellitus, lipidaemia and anaemia. Concomitant therapies included aspirin (ASPIRIN). On 21-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105 with an expiration date 15-NOV-2018 , 0.5 ml, intramuscularly for routine vaccination (anatomical location was not reported). On an unknown date in December 2017, also reported as "an unspecified time after receiving PNEUMOVAX 23", the patient developed cold-like symptoms, was very weak and passed out. The patient did not receive any treatment for the events. There was no laboratory test performed. At the reporting time, the patient, was scheduled for the consultation, in regards to the reported reactions. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided.
The day of the shot my lips and tongue were numb until the next morning.  The next couple of weeks my tongue would go numb often.  I was also feeling tired and unsteady. 12 days after the shot I became very sick for 10 days with severe diarrhea, no energy,  stomach pains, weak, shaking, no more motivation.  I saw a doctor and was given antibiotics to stop the diarrhea. Now 1 month after I have no diarrhea but still get nausea and shakes . I feel very anxious and will see a therapist and prescribe medication for my anxiety that I have due to the vaccine reaction.  I took the vaccine so I can travel abroad much easier but now afraid to travel because of my symptoms.  I will get blood tested tomorrow to see if all is ok.  This vaccine is very dangerous as it has affected my DNA.
Received 15 mos vaccines. Developed swelling and erythema, first noticed by mom the following day at 11:00AM. Approx 5x9 cm swelling and erythema on exam.
Prevnar given at 10:45 AM. On 4/19/01, pt developed a fever at 02:00 on 4/20/01. Mother didn't take temperature. Had red blotch (the size of a dime) at injection site. Pt complained of pain at the site today.
Irregularity with menstrual cycle.  My cycle is usually like clockwork every 21-24 days and lasts 5 days.  After my vaccine my cycle came every 2 weeks for 2 Months.  Light flow for the 2 Months.  I seem to be back to the 21 days currently, but my flow is heavier.  I even got a test to see if I was pre-menopausal and it came back normal. As there was no other change to my medication the covid vaccine is the only thing that I can link to this change.
5/20/03 Dad called at 4:30 PM, stated child had 103 degrees fever. Advised to administer Advil, alternate with Tylenol. If fever rises, tepid bath. If symptoms worsen, to ER. 11:00 PM - to ER, fever 104.8. Advised to continue same tx but increase Advil dosage.
This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a receptionist in a physician's office concerning her daughter who was "not too long ago" vaccinated with a first dose of Gardasil. The patient stated to her mother that the injection site burned like fire. The patient also developed a headache after leaving the office. The patient's physician was not contacted by the reporter or the patient regarding the patient's experience. It was reported that the patient's injection site irritation and headache did improve. Follow-up information was received from the physician's office indicating that they do not know which patient this event pertains to. Additional information is not expected.
Breastfeed 8 month daughter got sick (coughing, sneezing, runny nose, congestion) 3 days after mother's first series of COVID-19 vaccination.
Patient received the Moderna COVID-19 vaccine on 08/16/2021. She states she had the usual S/E (sore arm, HA, etc) but then 3 days post vaccination developed tingling on the entire right side of her body. She denied associated weakness, difficulty breathing, chest pain, HA, blurred vision, difficulty with ambulating, or changes in speech, facial movements. The tingling was transient, lasting only 1 day. Day 4 post vaccination she developed chest pressure, "like something was stuck." She denied difficulty breathing, SOB, HA, blurred vision, cramping in extremities, N/V/D.  Per patient she has an oximeter at home and the "readings were good." The episode was also transient, lasting about a day and then disappearing. She did not seek medical attention at the time. She also had a repeat of the feeling of chest pressure September 6-10. She did not seek medical attention at that time. Chart review revealed she has called in for similar symptoms of chest discomfort on 06/01/2021, at that time stating they were similar symptoms to how she felt when her child passed away, however there weren't any associated emotional triggers with episode from 06/01/2021 , 08/20/2021 or 09/06/2021.  Patient counseled on choice of receiving vaccine, consulted with MD regarding vaccine administration. Patient would like to proceed with 2nd dose, 2nd Moderna dose given. Patient monitored for 30 min post administration with no adverse S/E. ED precautions given. Advised patient schedule F/U for symptoms of intermittent chest pressure from 06/01/2021 and repeat chest pressure. Patient d/c from clinic in stable condition.
small spot on her Cornea; sore arm; headache; right eye pain; A spontaneous report was received from a healthcare professional concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right eye pain, small spot on her cornea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) right eye pain. On 10 Feb 2021, the patient experienced the event(s) small spot on her cornea.  Treatment details included Valtrex (1gm tid).  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), right eye pain, small spot on her cornea was unknown.
exposure during pregnancy; Shingles; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included valacyclovir pills.
Patient's husband states malaise, inflamed injection site area, soreness/pain, flu-like symptoms.
Headache, muscle weakness, injection site pain, and enlarged lymph nodes under armpit. Same arm the injection was given.
Experienced pins and needles throughout her whole body; Experienced burning in her 4th finger of her left hand; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 08Feb2021 09:15 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced experienced pins and needles throughout her whole body, experienced burning in her 4th finger of her left hand. Patient stated that she did not take the second shot because she experienced burning in her 4th finger of her left hand, which went away the next day. She then experienced pins and needles throughout her whole body which lasted three weeks and is now resolved and wanted to know if it is ok to take the second dose, long she could wait before getting the second dose. The outcome of events was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a public health nurse concerning a male (age unknown) who on 20-APR-2007 was vaccinated with a dose of Zostavax (656561/0329U). Suspect therapy included ENGERIX-B. It was reported by the public health nurse, that she heard the male client is a professor at a local college, was vaccinated at the health department on 20-Apr-2007 and developed shingles. The client kept a log of events and followed up with his primary care physician. Nurse stated the primary HCP is aware of the VZV ID program, but did not take a specimen because there was no blisters or fluid filled vesicle formation, just red blotch. Client told the nurse on Day 2, he had 30 to 35 millimeters of redness over the left temple. Day 3, there was swelling under the reddened area, scalp and upper face tender to the touch. Day 4, tenderness of neck region below the left era, at the angel of the mandible. On a pain scale of 1 to 10, with 10 being the highest, client rated pain at a 6 or 7. Day 5, client consulted with his primary care physician. No blisters, no vesicle formation, just red blotch. No VZV analysis performed. Client treated with half of vicodin. Day 6, left eyelid had swelling and facial pain, served by "cranial V2." Day 7, eyelid swollen pain reduced. Day 9, neck pain gone, eyelid normal. Day 10, "pain persists in the area of cranial V1:. Day 12, client told nurse on a scale of 1 to 10, with 10 being the highest, he was at pain level 2. Client is recovering. Unspecified medical attention was sought. This event was considered serious by the patient as a significant disability or incapacity. No product quality complaint. No further information is available.
Information has been received from a medical assistant concerning a healthy 7 year old female who was vaccinated with a dose of varicella virus vaccine live. On 3/7/04, the patient developed an unknown type of rash. It was reported that the physician did unspecified blood work which came back positive for varicella. The rash was on the patient's body and face was itchy and she had a fever as high as 102 F. It was reported that hydroxyzine hydrochloride was prescribed for itching. Subsequently, the patient recovered from varicella. There was no product quality complaint involved. Additional information has been requested.
arm soreness within 12 hours persisting for 3 days. Fever after 1 day. Headache still occurring after 4 days.  Swelling and redness at injection site after 2 days and continuing growth. On day 2, size of dime. Day 4 (today) size of tennis ball.
Ever since I got the Pfizer COVID19 vaccine, there's been something wrong with my heartbeat. It feels stronger, to the point where it keeps me up at night sometimes. At first it was subtle, and I thought it could have been indigestion (I have IBS which sometimes causes gastrointestinal distress), or anxiety. However, both of those conditions have been with me for many years, and this particular event began precisely when I got my first dose of the COVID19 vaccine - that night. The first time, it went away after a few days, but after my second dose, it came back (again, the same night the vaccine was administered) and hasn't gone away since. It's still subtle enough that I don't notice it during the day, but it's there quite clearly every single night now. I'm getting used to it, and it doesn't seem to be causing any other health problems or adverse effects, but something has definitely changed.
Fever with hives and swelling of face and extremities. Improved with Benadryl and Motrin.
Patient noticed redness and irritation at injection site. Started on the next day after his vaccine was administered. Patient went to his doctor on 8/4/17 for treatment. MD diagnosis was (Cellulitis - allergy initial encounter).
No adverse event.   Original vaccination was Janssen vaccine on 3/8/2021.  Patient came for a Moderna Booster (.25ml dose) but instead received a full does of Moderna (.5ml). Patient is NOT immunocompromised.  Followed up with patient the following day of vaccination and he reported the night of vaccination he could not sleep, and sweating, which are all listed side effects of Moderna.
Patient said that on tuesday morning her arm starting getting really sore. She said that it has continued to get worse. She said that it feels like a bad bruise that someone keeps pressing on and it hurts. She said she was afraid to take tylenol or ibuprofen to lessen the immune response. She said she is going to try ibuprofen and if no better will follow up with her md on monday. If it gets worse, she said she will head to medical facility.
pt recvd vax & devel either a loss or lack of response; No further details were provided;
Soreness throughout body, injection site soreness, tiredness that did not allow me to do my normal routing.  Resolve after 2 to 3 days.
Fever - 102.3, Headache, body ache, joint aches.  Later that night experienced itchy rash on chest and low grade fever.  Next day had pain in lower back and was sensitive to touch.  Advised to take Tylenol & Benadryl and call if symptoms got worse.
Left arm with 2 shots states started swelling the day of injection and states hasn't gotten better. States hot to touch. Received Td and Hep B in left  deltoid. Also received Hep A in right deltoid. Per annual report-Called patient later and she did not go to MD but her arm did improve after 4 days.
Headache, Myalgia, Arthralgia, PAIN, REDNESS, SWELLING AND PITCHING AT INJECTION SITE; SWOLLEN GLANDS AND CHILLS Narrative:  Other Relevant History:
Patient experienced a "seizure" during his workday on 4-2.  Store Management called 911 and he was sent with ambulance personnel.  Patient reported another event  a couple of days later.  Patient reported 4-8 that he is Covid positive.
Developed MRSA infection (swollen red abscess). Received medical attention on 10/14, 10/15 and 10/17. BACTRIM used to treat infection.
A non-serious spontaneous report of vomiting and 103F fever has been received from a non-health professional concerning a four-year-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither past medical history nor concomitant medications were reported for this patient. On 18-Nov-2010, patient received FLUMIST. On 18-Nov-2010, the patient experienced vomiting all night after receiving FLUMIST, and on 19-Nov-2010, developed a fever of 103F. The outcome of the events of vomiting and fever was not resolved.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: Unknown, Anatomical location: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 26Oct2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; BNT162b2 (DOSE 2, SINGLE, Lot Number: Unknown. Anatomical Location: Arm Left, Vaccine administration time: 07:30 AM), administration date: 05Apr2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; BNT162b2 (DOSE 1, SINGLE, Lot Number: Unknown. Anatomical Location: Arm Left, Vaccine administration time: 07:30 AM), administration date: 15Mar2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "bronchitis-like cough"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseous". Additional Information: The patient had no known allergies or other medical history. The patient did not receive any other medication in 2 weeks. The patient was nauseous and had headache. When she first started feeling sick, she was experiencing only a bronchitis-like cough. In fact, that was what she thought she had.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.