chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; body aches; and it got worse; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 17:00 (Lot number: FA7485) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number / Expiry Date: FA748, Route, Anatomical Location: into the muscle; Left arm), administration date: 08Jul2021, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset Aug2021, outcome "not recovered", described as "dizziness"; VOMITING (non-serious) with onset 08Aug2021, outcome "not recovered", described as "vomiting"; PAIN (non-serious) with onset 08Aug2021, outcome "not recovered", described as "body aches"; CONDITION AGGRAVATED (non-serious) with onset 08Aug2021, outcome "not recovered", described as "and it got worse".  Additional information: Vaccination facility was Pharmacy/Drug Store. No emergency room visit or physicians office visit was required for the adverse events.   Follow-up attempts are completed. No further information is expected. No new information was given.
A nurse reported the occurrence of vomiting in a female subject of unspecified age who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 10/14/02, the subject received her first injection of Engerix-B (lot ENG5294B6; expiry, 10/19/03). On 10/24/02, 10 days later, she experienced a subcutaneous rash, vomiting, and flu-like symptoms. Medical attention was required at the physician's office. The subcutaneous rash and vomiting resolved on 10/26/02. The outcome of the flu-like symptoms was unknown. The reporter considered the flu-like symptoms to be possibly related to Engerix-B administration. The relationship of the subcutaneous rash and vomiting to Engerix-B administration was not specified.
Sore arm; some fatigue in the joints; felt a feverish sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (some fatigue in the joints) and PYREXIA (felt a feverish sensation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza vaccine in 2017. Past adverse reactions to the above products included Adverse event with influenza vaccine.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 IN EXTREMITY (Sore arm), FATIGUE (some fatigue in the joints) and PYREXIA (felt a feverish sensation). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (some fatigue in the joints) and PYREXIA (felt a feverish sensation) outcome was unknown.            Patient allergist/immunologist and cardiologist were very pleased my COVID vaccinations went so well.  Patient was having hereditary alpha tryptasemia genetic trait, confirmed by a Gene-by-Gene genetic test. No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-318734 (Patient Link).
I was given the shot around 1 pm and didn?t have any reaction throughout the day besides my arm becoming sore around the injection area. I later went to bed and woke up from my sleep at 12am, shaking uncontrollably (It?s like I had the chills but the shaking was much worse that I contemplated going to the emergency room ). I felt very cold, my heart was racing,& I couldn?t catch my breath. The shaking lasted for about two hours. I finally fell back asleep and woke up again at 1am and woke up sweating, my whole body was hot and fighting off one of the worse fevers I had. Another hour passed as I tried to fall asleep and not soon after I was awoken from my sleep. At 3 am I woke up very nausea  and also had to use the restroom , it felt like everything wanted to come out both ways. During this time time on the toilet I felt exhausted, dizzy, & my whole body was just aching. 2 hours later I finally fell asleep. When I awoke in the morning I still felt nauseous, had horrible body aches, & had the chills. I genuinely hope this helps someone else who May experience the same symptoms!
This patient presented to the emergency department with runny nose, congestion, and accelerated hypertension.  She was found to have acute COVID-19 after admission.
The injection site was tender; The injection site was sensitive; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site was sensitive) and VACCINATION SITE PAIN (The injection site was tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE REACTION (The injection site was sensitive). On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (The injection site was tender). On 05-Mar-2021, VACCINATION SITE REACTION (The injection site was sensitive) had resolved. On 05-Apr-2021, VACCINATION SITE PAIN (The injection site was tender) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-396089 (Patient Link).
while administering shignrix to a patient, splashed on pharmacist face and eyes; splashed on pharmacist face; splashed on pharmacist eyes.; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 5th January 2023, the patient did not receive Shingrix. On 5th January 2023, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product, exposure via skin contact and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product, exposure via skin contact and exposure via eye contact were unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The reporter was also the patient. The pharmacist reported that, while administering Shignrix to a patient half way through the patient moved and only received 3 quarters of half of the dose and the rest splashed on (her) pharmacist face and eyes. The reporter consented to follow up. Additional Supportive Information: The pharmacist got exposed to Shignrix while administering to the patient, which led to occupational exposure while administering product, exposure via skin contact and exposure via eye. This case had been linked with US2023001206, reported by the same reporter.; Sender's Comments:  US-GSK-US2023001206:same reporter - patient´s case
clear nasal drainage, mild cough, low grade fever, chronic migraine/headache radiates pain on left side of body from head to feet,
Two days after pt had Zoster vaccine administered at office her injection site started with redness. Pt is having pain in (Lt) arm w/difficulty raising arm due to pain. Pt is unable to sleep due to pain. Pt given script for baclofen and TYLENOL with codeine.
Information has been received from a physician concerning a 20 year old female who in 2007 was vaccinated with the second dose of GARDASIL. On 31-DEC-2007 the patient experienced pain at the injection site, swelling at the injection site and redness at the injection site. The patient sought unspecified medical attention. No further information was available an no lot number was provided. Additional information has been requested.
excessive tiredness day following injection; Muscle pain in arm where vaccine was injected; headache on day of injection; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 right arm on 27Feb2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, obesity, unspecified allergies, bronchitis, and pneumonia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications for high blood pressure from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021 at 14:00, the patient experienced muscle pain in arm where vaccine was injected and headache. On 28Feb2021, day following injection, the patient experienced excessive tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain in arm where vaccine was injected, headache, and excessive tiredness was recovering at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced shortness of breath, chest pain, and back pain. Patient sat down for about 15 minutes and symptoms abated. During that time EMS was called as precaution. They evaluated the patient and determined she was no longer in distress. Patient was advised to seek emergency care if symptoms returned. Patient left store.
Feeling Sick/she does not feel well.; Muscle Pain; Joint Pain; Left Arm injection site pain; Fever 99.9 F; Chills; Headache; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feeling Sick/she does not feel well.), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain) and PYREXIA (Fever 99.9 F) in a 72-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.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced MALAISE (Feeling Sick/she does not feel well.), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain), PYREXIA (Fever 99.9 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). On 05-Apr-2022, MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain), PYREXIA (Fever 99.9 F), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, MALAISE (Feeling Sick/she does not feel well.) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2022, Body temperature: 99.9 (High) Fever 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient reported that she received 4 doses of  Moderna COVID-19  She remembers that all 4 shots were Moderna COVID-19 vaccine brand and her first booster shot (3rd shot) was administered about 4.5 months ago. After the 2nd booster she was feeling better on 05-Apr-2021 but she was still feeling fatigue and she does not feel well.  No treatment information was provided.
Woke up at 12:00am today with headache, lots of discomfort (especially in stomach), and for the most part could only fall back asleep for short intervals while being awake most of the night.   At around 2:30am, could barely walk into the front room. Just very slowly and painfully. Ended up in such a state that I absentmindedly urinated onnthe bathroom floor while pulling pant leg up to scratch an itch while urinating in toilet. Laying on back caused butt and thighs to hurt significantly more. Same for stomach. Getting up from and laying down on my floor mattress was and still is difficult.   Later into the morning at around 6:40am, had to crawl slowly on hands and knees to get back in the front room. By around 8am, I could walk around without it being unbearable. Just slow-ish. Ate breakfast, so stomach is more uncomfortable than in pain. Can lay on it without too much problem, but butt is still hurting. Stretching legs forward caused some pain.  Possible fever.
Site of injection is lumpy; Site of injection is itchy; site of injection is hard; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Site of injection is lumpy), VACCINATION SITE PRURITUS (Site of injection is itchy), VACCINATION SITE INDURATION (site of injection is hard) and SNEEZING (Sneezing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE MASS (Site of injection is lumpy), VACCINATION SITE PRURITUS (Site of injection is itchy), VACCINATION SITE INDURATION (site of injection is hard) and SNEEZING (Sneezing). At the time of the report, VACCINATION SITE MASS (Site of injection is lumpy), VACCINATION SITE PRURITUS (Site of injection is itchy), VACCINATION SITE INDURATION (site of injection is hard) and SNEEZING (Sneezing) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
A spontaneous report was received on 19JUN2015 from a 57 year old female consumer (who is also a nurse), reporting about herself. The consumer/patient reported that she had received an unspecified dose of ZOSTAVAX on 18JUN2015. On the morning of 19JUN2015 she developed a sore throat, injection site pain, and injection site arm heaviness. The patient reported that she took TYLENOL "18JUN2015" for the pain. The patient planned to call her physician's office when they open (today), 19JUN2015 to make an appointment. Concomitant medication included NEXIUM for the treatment of gastroesophageal reflux disease (GERD), and SYNTHROID for the treatment of hypothyroidism. The patient reported a history of drug allergies to codeine, morphine and epinephrine. No further information was available. Additional information has been requested.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (pediatric- of an unknown age) who received 0.5 mL dose of vaccine FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was actual medication error due to overdose as adult dose given to pediatric age patient. It was unknown whether patient experienced any adverse reaction after the injection. 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. Documents held by sender: none.
Imm. givEN 11-13-19 - c/o PAIN, REDNESS, WARMTH TO TOUCH ON 11-14-19 = WORSENING Sx 11-15-10 = SEEN IN OFFICE APPROXIMATELY 7cmx14cm red, warmth, SWelling to INJ. AREA Tx CooL ComPRESSES
Initially pain in the arm then the next day she developed tender red nodules on the upper arm not in a nerve distribution.
Patient is 11 years old and was administered the age 12 and above formulation instead of the pediatric formulation. No adverse reaction reported by parent 2.5 hours later.
C/O's feeling flushed, dizzy 20 minutes after receiving flu shot. (+) face, neck flushing four hrs later. Dizziness four hrs later. V.S.S. no SOB. Tx: Benadryl 50mg po q 6 hrs s/s lasted 24 hrs.
This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of not eating in an 18-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on 29 March 2011, 19 May 2011 and 21 July 2011. The subject had no reactions to her prior PEDIARIX vaccinations. On 27 July 2012 at approximately 16:00, the subject received a dose of INFANRIX (intramuscular, right thigh) as the 4th dose in series. On 27 July 2012, hours after vaccination with INFANRIX the subject experienced not sleeping and on 27 or 28 July 2012, less than one week after vaccination with INFANRIX, the subject experienced not eating and fussy. The subject did not have redness, but "will not eat, is fussy and wouldn't sleep last night" (27 July 2012). At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Friday. See cases A0989417A, A0989437A and A0989438A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Tired; Sick; Fevers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Oct2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of covid-19 vaccine), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; PYREXIA (non-serious) with onset 16Oct2021, outcome "not recovered", described as "Fevers"; ILLNESS (non-serious), outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, pyrexia, illness. Caller, who was calling about the Pfizer Covid shot and who explains her son who was in withheld, took the second shot and had a fever since Saturday. It goes up and he takes ibuprofen and then it comes down but still going on right now. It goes up to 103 at night then he takes Ibuprofen and it goes back down. She wants to know what else can he take. No additional information provided for the Ibuprofen taken for the fever that is still ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My arm began itching at the injection site. I had a chemotherapy treatment two days later and was given Benadryl as part of my usual dose of medicines, therefore the itching stopped. However, by Wednesday night, 10 days after getting the vaccine, my arm swelled a little, was very red, and hot to the touch.  I called my doctor who told me I could take Tylenol if I needed to, but that this should go away in 24-48 hours.
Varivax administered 04/02/2007. On 4/3/07, notice redness @ injection site @ (R) thigh area, size of a silver dollar, slightly raised. Area doubled in size by this morning. Area warm, red, tender to touch. Mom administered Ibuprofen 200mg last night and this AM
0937 - states left wrist feels "clogged", can feel the blood flowing through, denies headache,   itching or nausea 0940 - given Benadryl 25 mg po 0950 - states left chest feels heavy, feels dizzy, left arm tingling - escorted to EMS tent 0954 - HR 73, BP 133/93, pulse ox 97%, 12 lead ekg initiated 0957 - called individual @ patient's request - advised that patient will be late returning to work 0959 - HR 76, BP 133/93, pulse ox 93% 1005 - states chest heaviness, left arm tingling resolving, no longer dizzy 1007 - declined transport to hospital, will go home  - wife is at home, feels fine to drive, not dizzy.             call to individual advising that patient is going home for the day 1015 - left clinic to go home, feeling better
Infant went to sleep with apnea monitor device in place. Monitor vibrates after 15 seconds and then will alarm if no breaths detected after an additional 15 seconds, totally 30 seconds of no respirations. Monitor alarmed and I ran to get him out of his crib. He was lethargic and limp. Flipped him onto his stomach and vigorously rubbed his back, at which time he responded slowly. Monitor had never gone off prior to this event, and didn't alarm again until after his next round of shots (which will also be reported). The second set of shots caused multiple instances of apnea.
At time of appointment, patient was noted to have 1 HPV vaccine given 8/28/06. Then when rest of records were received and obtained after patient left, patient was noted to have HPV vaccine on 8/7/08, 8/6/07, 8/5/08 and 11/6/06. Therefore, she would have gotten a 6th dose of the vaccine today.
Low grade temp 100 seen 27DEC91, malaise systemic effects 24DEC-27DEC91, achey, large local rxn w/mild serum sickness;