chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 3 doses of Recombivax/ had titers for anti-HB concentrations, drawn for nursing school entry, that were negative; This spontaneous report was received from a nurse and refers to a 20-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On unknown dates, the patient was vaccinated with three doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number, expiration date, anatomical location, route of administration and dose were not provided) for prophylaxis.         On an unknown date, the patient had titers for anti-HB concentrations drawn for nursing school entry, that was negative. The patient sought medical attention.    The outcome of negative titers for hepatitis B was unknown.  The causality assessment between the event and the suspect therapy was not provided.
Sore left arm; Redness; Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy), PAIN IN EXTREMITY (Sore left arm) and ERYTHEMA (Redness) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Hypertension (Father), Diabetes (father and mother), Hyperlipidemia (Father), Gout (Father) and Hashimoto's disease (Mother). Concurrent medical conditions included Hypertension (Stage 1), Sinus tachycardia since 2015, Polycystic ovarian syndrome since 2015, Obesity since 2015 and Vitamin D deficiency since 2015. Concomitant products included METFORMIN, METOPROLOL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm) and ERYTHEMA (Redness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore left arm) and ERYTHEMA (Redness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided..   This case was linked to US-MODERNATX, INC.-MOD-2021-057797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057797:CROSSLINKED WITH DOSE 2
red rash around the injection  with swelling , hard lump. chills. body aches.
Patient G1 received vaccine at 32 weeks of pregnancy and presented with rupture of membranes at 34.6 weeks followed by vaginal delivery.  Birth weight 5 lbs 5 oz.
13MAR92 had Hep B vax & started aching w/severe leg & stomach pains; rash all over looked like had fantastic suntan; vomited x 1; had t100 x 4 days; seen by MD;
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome. Concurrent medical conditions included Salicylate, Caffeine and Food allergy (Coffee).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  Treatment medication included daily vitamins.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12-Jul-2021 Contact details and email ID are provided.
sore arm from site of inj;devel welts site of inj 12MAY97;48hr p/inj arm cont to hurt;was seen on 13MAY red raised;
Intense Swelling in both legs, ankles, feet with severe pain, itching, burning, which resulted in Red knots/nodules under the skin on both lower legs that were hot to the touch. I went to the Emergency Room on March 22nd only to be given an X-ray. I attempted to go and get my 2nd Dose of Moderna at the Community Vaccine Site on March 30th, 2021 and was told they recommend me not move forward with the 2nd dose due to the swelling, tenderness and redness that 2 different staff observed because they couldn't guarantee that what was going on wasn't blood clots that could prove to be fatal due to my body's reaction to the 1st dose.
Headache  Narrative:  2PM DAY AFTER INJECTION REPORTS EXPERIENCING A SEVERE MIGRAINE. PATIENT DOES SUFFER FROM MIGRAINE EPISODES, HOWEVER, ALL USUAL METHODS FOR EASING MIGRAINES WERE  UNSUCCESSFUL (CAFFEINE, EXCEDRIN,SLEEP). EXPERIENCED CONTINUING THROBNING OVER LEFT EYE THAT ALSO AFFECTED VISION IN THAT EYE. STILL SOME THROBBING BUT NO LONGER LOSS OF VISION.
Arrived with SOB and wheezing. Admit for COVID infection. Aggressive care declined and pt transferred to hospice. Pt expired 8/21.
Got very sick; Itchy at injection site; Arm swelling at the injection site; Hard knot at the injection site; Red at injection site; Threw up twice; Very bad chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (Arm swelling at the injection site), VACCINATION SITE INDURATION (Hard knot at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A44821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ILLNESS (Got very sick), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (Arm swelling at the injection site), VACCINATION SITE INDURATION (Hard knot at the injection site), VACCINATION SITE ERYTHEMA (Red at injection site), VOMITING (Threw up twice) and CHILLS (Very bad chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, ILLNESS (Got very sick), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (Arm swelling at the injection site), VACCINATION SITE INDURATION (Hard knot at the injection site), VACCINATION SITE ERYTHEMA (Red at injection site), VOMITING (Threw up twice) and CHILLS (Very bad chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
mild achy feeling in her arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and ZOSTAVAX. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Zostavax previously and other flu shots and experienced a mild achy feeling in her arm, however, it was nothing like what she experienced with the Shingrix vaccine. This case linked with US2020107109, US2020AMR107530 and US2020107111, reported by same reporter. It was unknown if the reporter considered the pain in arm to be related to Zostavax.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107111:same reporter US-GLAXOSMITHKLINE-US2020AMR107530:same reporter US-GLAXOSMITHKLINE-US2020107109:same reporter
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-APR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a physician for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by the physician for the following injuries resulting from their use of zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a physician concerning a patient who on 01-MAY-2008 was vaccinated with a second dose of MMR II. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified). On 01-MAY-2008 the patient developed an extrapyramidal reaction. The patient had no problem after vaccination with the first dose of MMR II. It was unspecified if medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been received from a physician indicating that the patient did not experience an adverse event, only a febrile response. Additional information has been requested.
local reaction -rt arm; screaming epiosde-2 1/2 hrs; MD did not feel it was true adverse reaction;
a 44 y.o. female who is being evaluated today for evaluation of symptoms since getting covid vaccine last Friday 8/6/2021. This was her first dose. Reports receiving the Moderna dose from Pharmacy. Given in her left arm.    Reports feeling tired same day of getting vaccine into the weekend. On Monday reports feeling chills, body aches, & headache. Felt slightly lightheaded as well. She reports having diarrhea that same day of vaccine, lose watery stools which appear to be improving. Felt some sob/wheezing/ dry cough on Sunday. Used her inhaler w/ improvement of symptoms. Has taken Tylenol x 1 since symptoms occurring.    She reports also numbness sensation in her fingertips bilaterally, especially if grasping a cup for a period of time. She feels this sensation is improving. The numbness sensation is still present in her fingertips is still present following up w/ her 2 days after her initial dose.    She missed work on Mon, Tues, & Today. She works uses her hands frequently & requires frequent walking.  Has been trying to rest.   Seems to be improving slowly. Concern over numbness since not present prior to getting vaccinated
1557: Pt went up to nursing staff ~15 minutes after vaccine administration, to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care Pt received diphenhydramine  PO and methylprednisolone  IV in the ED
On the third day of the application the discomfort woke me at 4am; the symptoms were compatible with atrial fibrilation, strong palpitations and irregular pulse; after 20' the palpitations ceased but the pulse was tachycardic at 100, During the day the frequency was decreasing and stabilized at 80; I did not consult a doctor.  I'm a Doctor; I'm a citizen and I'm on vacation.
c/o sore throat, gen rash that started on 28FEB98;no c/o SOB, alert, coherent, ambulating;mom stated will take to PMD 3MAR98 825AM;stated rash & fever did not come from vax;
Mild fever - reached 99.5 degrees, global body ache, fatigue, severe headache, and joint pain in all major joints; both knees were the most affected and were erythematous and hot to touch. All symptoms resolved within 24h.
generalized tonic-clonic sz 45 mins p/vax lasting 1 minute w/post ictal state for 10 mins;
Information has been received from a nurse concerning a patient who was vaccinated with ROTATEQ.  The patient developed intussusception 9 days after the second dose of ROTATEQ and was hospitalized.  It was reported that the patient has recovered (date unknown). No product quality complaint involved.  Additional information has been requested.
Flu like symptoms, headache, fever, body/muscle aches, stomach upset, nausea, fatigue, dizzy.
I received the vaccine believing that I had never received the bivalent update. I later realized that I had already received the bivalent update on 9/29/2022 at the same pharmacy. The 9/29/22 dose was also listed on the vaccination card I presented.
07/19/2006 received Tdap, 07/20/2006 developed sore, hot arm for 7 days developed sore, painful, tender jaw approximately 2 weeks following Tdap to present.  Jaw locked shut approximately 3 weeks following Tdap to present.
Sudden death at home morning of 1/28/09.  6/1/09 Autopsy report states COD as sudden unexpected infant death & manner of death as natural.  Report also states patient found dead in crib, tox screens & cultures all neg.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown ages and genders. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, starting on or after 02-FEB-2017, the patients were vaccinated with doses of improperly stored ROTATEQ lot # M038846 with expiration date on 26-APR-2018 (dose of administration were not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 2 hours. Digital data logger was used to record the excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006089:
stomach cramps; diarrhea; intense cramps; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "stomach cramps"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "intense cramps". Additional Information: She received the first dose of the Pfizer Covid-19 vaccine on 13Apr2021 and she experienced stomach cramps and diarrhea as side side effects. She would like to know if these symptoms have been reported and how long will those last. She missed her second dose due to something with his husband. She added that she was still having stomach cramps and occasional diarrhea. She had diarrhea and intense cramps for two weeks and she was glued to the pot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of tenderness of arm in a 10-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 14 October 2010 at 13:00 the subject inadvertently received a dose of FLULAVAL 0.5 ml left arm. On 14 October 2010, at an unspecified time after vaccination with FLULAVAL, the subject experienced tenderness of arm. This was also a maladministration (asymptomatic/child too young). FLULAVAL is not indicated for use in pediatric subjects. At the time of reporting arm tenderness was resolved. It was reported that this maladministration occurred in three brothers under the age of 18. Arm tenderness only occurred in this subject. Linked cases include A0888123A and A0888124A.
My last mensuration date before the vaccine was on October 5th, 2021. Before the vaccine it was between 29-32 day cycles, so my period was supposed to begin approximately beginning of November. I experienced spotting, very  painful cramps and heightened PMS symptoms around the end of October. My next period however did not arrive until November 14th. This cycle was 41 days.  For the next cycle it was very similar very painful cramps and heightened PMS symptoms around 1-2 weeks before my period began. This time my period started on 12/31/21, which was a 45 day cycle.
Pt recvd vax & 24 hrs exp a rash; rash ? has never resolved completely; it appears as mild ring outlininng area where inject was given;
Slightly red area on right thigh afterwards, now getting bigger approx. 1.5cm right outer thigh.
INCORRECT VACCINE ADMINISTRATION  10/25/2023 @ 1:30PM- Staff SPOKE WITH MOM AND EXPLAINED ANY POSSIBLE REACTIONS AND MOM DID CONFIRM PATIENT DOING OK AS OF NOW, WILL FOLLOW UP WITH PATIENT AGAIN AND REPORT ANY CHANGES ASAP
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 06-APR-2015 the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency, lot# and route were not reported). No symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, the patient experienced VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness), NAUSEA (nausea) and HEADACHE (Headaches). At the time of the report, VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness), NAUSEA (nausea) and HEADACHE (Headaches) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was receiving blood thinners. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. At some point after Moderna vaccine the patient fall, head got struck. MRI was done with no findings. 9d post Pfizer booster dizziness was returned when upright. This was a return of symptoms after 8 weeks of normalcy. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. It was unknown, since the vaccination, has the patient been tested for COVID-19. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
A cluster of 4 cases out of an unspecified number of vaccinees, who received Fluzone (lot number U2177AA) and experienced adverse events which reported by the same physician. Initial report received from a physician on 02 November 2006. Two unidentified patients received Fluzone (lot number U2177AA) on an unspecified date, into the deltoid (side, site and dose was not reported) and experienced sore throat, muscle and joint aches for one week. No corrective treatment was reported. The patients had recovered. The patients' medical history, concomitant vaccines and prior exposure to Fluzone were not reported. This report (for the two unidentifiable patients) has the same reporter as cases 2006-02938 and 2006-02641.
A 16 year old received 1st dose of Moderna Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old received 1st dose of Moderna Vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old received 1st dose of Moderna Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old received 1st dose of Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Patient received both vaccines at 3:53PM, around 3:55PM claimed she was light heated and began to faint., 911 called. Pharmacist and other patient lowered her to ground. Patients feet are elevated and vital signs are starting to be tracked, low oxygen, fast heart rate, good pulse, low respirations, 4:00pm, police arrive on the scene. 4:01 EMT arrive and place oxygen on patient in which she improved significantly soon after.
Throat swelling and dyspnea about 16 minutes after vaccine given. Patient given epi pen and 2-3 minutes later was feeling better, but 5 minutes later symptoms recurred. EMT arrived and took patient to the hospital