chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. called next day and spoke w/Rph on duty. Pt. reported fever, aches, chills associated with a silver dollar sized swelling with a hard area in the middle. Had ave. 24 hr soreness.
Expired MMRII vaccine used; Information has been received from the physician assistant, concerning a 1-year-old patient (gender not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 13-JAN-2022, the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (first dose, lot # and expiration date were not provided), Hepatitis A Vaccine, Inactivated (VAQTA) (first dose, lot # and expiration date were not provided), and an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (first dose, lot # T001215, and expiration date on 12-JAN-2022).  This is one from two cases receved from the same reporter.; Sender's Comments:  US-009507513-2201USA003103:
due for my monthly Cycle on April 14th.  Did not receive until April 21st; extremely light in flow and bright red in color; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 14:00 (Lot number: ER8726) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: MVI [VITAMINS NOS]; LEXAPRO. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 14Apr2021, outcome "not recovered", described as "due for my monthly Cycle on April 14th.  Did not receive until April 21st"; MENSTRUAL DISORDER (non-serious) with onset 14Apr2021, outcome "not recovered", described as "extremely light in flow and bright red in color".  Additional Information: It was stated that there was no other vaccines in four weeks the patient received second dose on 28Apr21. Was 6 days late with next Cycle also very light in flow, lasting only 1 - 2 days and extremely bright red in color. Her most recent & 3rd Cycle since receiving the 1st vaccine was 5 days late and similar in nature to the previous two. Not usual for her a clearly different than normal. prior vaccination and post vaccination the patient did not test for covid.   No follow-up attempts are possible. No further information is expected.
72yo female presenting to the ER complaining of sob and cough. ss x 1 day. +hx  copd. patient states her family member was dx with covid 1 week ago. Chief Complaint: Visit CC: COVID, SOB SPO2 39% (SON positive covid at home)
Excruciating left shoulder pain; This is a spontaneous report from a contactable consumer. A female patient (reporter's girlfriend) received a single dose of BNT162B2 (COVID-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: arm left) on an unspecified date for COVID-19 immunization. Medical history included trauma in shoulder, so she got metal in there. The patient's concomitant medications were not reported. The patient, who was a nurse Practitioner, got her vaccine on an unspecified date (reported as Tuesday) in her left arm and she had developed excruciating left shoulder pain. Reporter stated "it's not cleared, can't really figure it out;" patient  had a history of trauma in that shoulder, so, she has got metal in there, so reporter just wanted to know if the company has heard from any other people complaining the same thing after getting the injection. The outcome of the event was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to a 31 year old female patient. No information about medical history, drug reactions and allergies was specified. On 16-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA002854, 1410USA005583, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005583). Additional information has been requested.
body ache; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (mild fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER (LOT- EN6201) on 24-Jan-2021 and PFIZER (LOT-EN5318) on 13-Feb-2021. Concurrent medical conditions included Immunocompromised. Concomitant products included METFORMIN, GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LISINOPRIL, TRAZODONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-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 MYALGIA (body ache) and FATIGUE (mild fatigue). At the time of the report, MYALGIA (body ache) and FATIGUE (mild fatigue) had resolved.            No treatment reported. It was reported that patient also received 2 doses of COVID-19 vaccines from Pfizer and experienced localized tenderness around the area of the shot.   This case was linked to MOD-2021-355779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: The follow up includes no new information.
Patient received the first dose on 04/14/2021 at a vaccination site. The site was opened but covered. After 2-5 minutes, patient experienced difficulty swallowing. She was able to talk. Throat swallowing was intermittent; notes she was unable to swallow 2-3 times every few seconds. Able to drink water. After 30 minutes observation, she drove home. After 20 minutes, she arrived home. She experienced some throat itching after a total of 45 minutes since she received the vaccine. Visited Urgent Care same day, was recommended diphenhydramine 25 mg  taken orally. Took diphenhydramine, slept through the night, and symptoms resolved the following day
Employee received her 2nd Hepatitis B shot and began feeling lightheaded, weak nauseated, hot and c/o chest pains. The employee was pale and sweaty. Comfort care measures were implemented by means of allowing the employee to lay down/sit on the examination table as well as giving her ice packs and fluids. The employee stated that she has anxiety and had not eaten since 0900 and that might be the reason why she is feeling this way. She was sent to an outside medical facility for further evaluation. The employee's reaction lasted about an hour while she was still in my care.
Light case of intestinal disturbance; Have to make frequent passess; Chills in the afternoon and not in morning; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), GASTROINTESTINAL DISORDER (Light case of intestinal disturbance), FREQUENT BOWEL MOVEMENTS (Have to make frequent passess) and CHILLS (Chills in the afternoon and not in morning) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Feb-2021, the patient experienced GASTROINTESTINAL DISORDER (Light case of intestinal disturbance), FREQUENT BOWEL MOVEMENTS (Have to make frequent passess) and CHILLS (Chills in the afternoon and not in morning). At the time of the report, PAIN IN EXTREMITY (Sore arm), GASTROINTESTINAL DISORDER (Light case of intestinal disturbance), FREQUENT BOWEL MOVEMENTS (Have to make frequent passess) and CHILLS (Chills in the afternoon and not in morning) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Eight days after the shot my baby developed fever which lasted for about 48 hours and went as high as 105.5 She had an unusual smelling diaper and her bowel movements were looser than usual. She also had some scattered dots on her bady. This is my fourth child to have this reaction from this shot. For treatment, she was given Tylenol and Motrin as well as a tepid bath when the fever reached over 104.
Approximately 24 hours after receiving HEP A #2, developed hives on lower arms and lower legs and tip of head.  I saw her at 48 hours post vaccination - had gotten Benadryl 25 ml and was better - hives noted on forearms.
8yo pt given DTaP instead of Td.  Age out of range for DTaP.  Pt did not suffer adverse event.
This is a spontaneous case, received on 15-Oct-2018 from a pharmacist (Initial and follow-up 1 combinedly processed), concerns a 53-year-old, adult, male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252268 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804542 was cross-linked to source case: 201804533 due to same reporter.
Within 5 minutes of receiving his first dose of the Pfizer COVID vaccine, patient was feeling lightheaded, sweating, and began vomiting in a waste basket.  He never fainted, but was looking pale.  I had him remain seated and gave him a cold bottle of water and cool damp paper towel to put on his forehead.  After vomiting a few times and waiting for a period of time, the patient said he was feeling better and not lightheaded any longer and wanted to leave.  His girlfriend was with him and she went to get the car.  The patient said he just wanted to sit in front of the air conditioning of the car as he felt the bright lights and heat of the store were not helping.   He was able to walk out on his own.
The first day I had severe chills that lasted through the night and I was unable to sleep.  I had severe muscle pain, headache, itching in left arm and arm pit, nerve and back/flank pain.  The next morning, I had developed a fever which ran throughout the day, reaching at least as high as 102.3 by the next evening.   The left arm was red and had some pain at injection site.   The chills lessened as fever began.  The back pain was in lower back and down the back of my legs.  By the second day, I took Gabapentin to try to lessen the pain  so I could get some rest. By the the third day, the symptoms lessened.  In the next few days, some pain at the injection site continued but got worse about four days after the injection.  My left started to have a deep ache and I have tingling in my fingers.   The arm aches in the deep tissues and feels weak.  I called my doctor on the 5th day post injection to ask what would cause my arm to be getting worse.  They advised me to take advil.   I have taken some advil but it is not working.  Now I am 8 days post injection and the pain is a lot worse and not getting better.   It seems that the nerve and muscle are inflamed.
3/8/2022 admitted to hospital  with acute bilateral pulmonary emboli  and stroke?showering of clots in three lobes  Unknown if VACCINE RELATED.  ALSO POST SURGERY LEFT SHOULDER DEBRIDEMENT ON 3/3/2022. However, I have had many surgeries in the past and never had blood clots issue.    All labs normal, no clotting deficiencies
Tuesday, 4/27,  had extreme fatigue  In the middle of the night, woke up ad she could not breath. Eventually went back to sleep 4/27 in afternoon, had another instance where could not breath, then sat up and felt better. Almost went to ED, but it resolved. Then 4/29, in AM,  was taking grandchildren to school and started to feel squeezing both sides of lungs.  When she takes a deep breath she has pain. She feels the pain is worsening and her SOB is worsening.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-SEP-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-DEC-2015, the patient was treated by a physician assistant for a blistering vesicular outbreak, which was diagnosed as severe shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 10-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Terrible Headache, Whole Head Hurting, especially right ear. Antibiotic prescribed by Dr. on Monday, Friday woke up very dizzy/imbalanced/headache. Went to Dr. said ear was clear. ENT the next Wednesday 12/12/12, set up MRI and Audio tests. MRI results clear, Audiology tests result said balance system not working - nothing to be done. Set up app (for second opinion) for office visit, then ENT specialist. He said this was caused by Virus...I have not had a virus, but had gotten a flu shot the day before all this started. Coincidence? I don't know! I experience imbalance continuously.  Facility has me scheduled with PT at 1:00 on Tuesday 2/19/2013.
I received my 2nd booster shot on 06/17/2022 and my adverse event started on 06/18/2022 at around 05:00PM. I had fever 101.05; chills; slight headache; body aches lasted for 4 days. On 06/22/2022 no fever I started heat palpation with skipping beats. I went to the clinic the same day just to check if this was normal. On 06/29/2022 I went to the clinic back because my heart palpation was still there. They did EKG. 07/06/2022 I went to a cardiologist she did blood test; EKG; and heart monitor. My heart palpation is going away naturally. Am still recovering as of now 07/11/2022.
ActHIB portion only of a Pentacel vaccine was given, diluted with 04 % sodium chloride. The DTaP/ IPV portion was not given, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 15 months old male patient who received a fourth 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ097AA and Exp. Date 19-Sep-2020 via intramuscular route in the left vastus lateralis, on 03-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was reported that the ActHIB portion only of a Pentacel vaccine was given, diluted with 0.4 % sodium chloride. The DTaP/ IPV portion was not given.  At the time of reporting no adverse reactions were reported.  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.  List of documents held by sender: none.
Information has been received from a licensed practical nurse concerning a 15 year old female patient, who on 05-Oct-2007 was vaccinated with a dose of Gardasil (lot # not provided).  On 15-Nov-2007, she reported an injection site rash, as well as mood swings.  At the time of this report, the outcome of the events was unknown.  The patient sought medical advice from the office (details not specified).  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Initial follow up information has been received from a licensed practical nurse concerning a 15 year old female student with a drug allergy to AMOXIL, and food allergies to wheat, milk, peanuts and corn syrup. Who on 05-OCT-2007 was vaccinated in the right deltoid with the first dose of GARDASIL vaccine (lot # not provided). On 15-NOV-2007, at 3:15 pm. She reported an injection site rash, as well as mood swings. Follow up information indicated the patient also developed a rash on her belly, and was crying all the time. At the time of this report, the patient had recovered from the events (duration not specified). The patient sought medical advice from the office, but did not require a visit. Additional information is not expected.
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 7-decade-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot number and expiration date was not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that one person had Bell's Palsy (medically significant) after the receiving the first vaccine and they did not get the second dose. Outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Presented to the emergency room via EMS with complaints of cough; dx w/ sepsis due to COVID-19 infection/hypoxia; tx w/remdesivir, steroids, abx, zinc; did not require O2. Dc'd home
overweight; diarrhea like everything I eat into me just goes out of me; I am sick like, I am really sick; Stomach cramps; It's like menstrual cramps, menstrual cramps to tenth degree; The severe side effects I am having and it's been bad; I have severe and severe abdominal cramping; my arm that's been sore; light heart burn; Stomach cramps; It's like menstrual cramps, menstrual cramps to tenth degree; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 at 02:30 PM (at the age of 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation. When asked about the first dose LOT number patient reported that it's EW0170 or it could be EWO70 (Further not clarified hence not captured in tab). Medical history and concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EP7533), via an unspecified route of administration on 06May2021 (at the age of 49-year-old) as DOSE 1, SINGLE for covid-19 immunisation. On 07May2021, the patient experienced diarrhea like everything i eat into me just goes out of me, i am sick like, i am really sick, stomach cramps; it's like menstrual cramps, menstrual cramps to tenth degree, the severe side effects i am having and it's been bad; i have severe and severe abdominal cramping, my arm that's been sore, light heart burn, stomach cramps; it's like menstrual cramps, menstrual cramps to tenth degree, on an unspecified date patient experienced overweight. Patient reported that I don't know my weight, I would say I am overweight, but I am probably around 150. It was reported that now its 5:30 it's like 24 hours later, I got the shot yesterday. Therapeutic measures were taken as a result of stomach cramps; it's like menstrual cramps, menstrual cramps to tenth degree, my arm that's been sore, light heart burn. It was reported that patient received only Topcid for light heart burn or stomach, nothing for cramps like I don't have anything for that and some Tylenol for my arm that's been sore. So, that's all. It's for heart burn, it's not for stomach cramps, I don't have anything for stomach cramps actually it's like menstrual cramps, menstrual cramps to tenth degree, you know, it was just bad. The outcomes of events (diarrhea like everything I eat into me just goes out of me, I am sick like, I am really sick, my arm that's been sore, light heart burn, Stomach cramps; It's like menstrual cramps, menstrual cramps to tenth degree, overweight) were unknown, the outcomes of events (Stomach cramps; It's like menstrual cramps, menstrual cramps to tenth degree, The severe side effects I am having and it's been bad; I have severe and severe abdominal cramping, ) were not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
inj site red, swollen & painful;afeb ice packs used @ inj site 24hr later;entire lt arm, hand & fingers swollen & painful;gave DPH;
Left Deltoid swollen and reddened, applied Ice and Cortisone cream to the Inj site. By Monday 11/14, swelling better and redness gone. On Wed 11/16, Mom noted "hives" on chest "from neck to pant line "blister type". Denies any new meds, change in detergent or any other exposure to anything new. Mom states he had a similar reaction when he got his "one Yr Shots". Mom concerned regarding whether or not to complete the HPV series as this was Dose #1.