chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received for the Merck Pregnancy Registry for Gardasil from a licensed practical nurse concerning a 20 year old female with a history of 2 pregnancies and 0 live births (2 miscarriages) who on 18-DEC-2007 was vaccinated with Gardasil (lot# 654540/1209U).  The patient's date of last menstrual period was 18-DEC-2007.  Subsequently the patient became pregnant.  On 04-FEB-2008 the patient experienced a spontaneous abortion.  On 04-FEB-2008, a pregnancy quantitative was < 5.0.  On 21-FEB-2008 the patient was vaccinated with a second dose of Gardasil (lot# 0530U).  Upon internal review spontaneous abortion is considered to be an other medical event.  Additional information is not expected.
Case number PHEH2012US013091 is an initial spontaneous report received from a nurse on 28 Jun 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with 0.5 ml MENVEO (batch number: A11071, expiry date: Dec 2013) intramuscularly on to unspecified site on 25 Jun 2012. On an unknown date, she experienced localized reactions at vaccination site which was described as red, hard and hot swelling. The outcome and causality of the event was not reported.
Severe sweating; Itchy feeling in throat; Aching in bones; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe sweating), THROAT IRRITATION (Itchy feeling in throat), BONE PAIN (Aching in bones) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HYPERHIDROSIS (Severe sweating), THROAT IRRITATION (Itchy feeling in throat), BONE PAIN (Aching in bones) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Severe sweating), THROAT IRRITATION (Itchy feeling in throat), BONE PAIN (Aching in bones) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
A few hours after injection. Injection site slightly red all around about the shape of grapefruit. Circle size not swollen. Warm to touch and sore. Patient took ALLEGRA 180mg and TYLENOL on 9/26/15. Patient's 1st dose of HIGH DOSE. She normally gets regular flu shot.
Patient got second dose at 845am this morning. Around 9am, patient started feeling light headed and flushed, with tingly fingers. Patient was given water and juice, started to recover. At 0945am, client started feeling that her "breathing" was "off", and was having chills. Medics called over to assess patient, vital signs taken and listed below. Client was able to safely ambulate and began to feel better with walking. Client was reassured. Client was deemed stable/recovered and discharged home without the need for additional care.
b/L UE muscle ache and soreness. 10/21/08 continues with some improvement in the LUE. No weakness no numbness Advil as needed. Vaccine administered 10/17/08 RUE.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. On 11-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees Centigrade for 19 hours. No adverse effects were reported. This is one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
The site was sore as I left the pharmacy. The left arm was painful to touch for 4-5 months - event to have clothes touch the arm when getting dressed. Arm muscles very sore, currently tricep muscle has caved in - atophied ? - and pain is also in forearm.
body aches pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 08:00 (Lot number: EN6201) 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 (Dose 1, lot number=EN9264, Administration time=3:00pm), administration date: 02Feb2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "Blood pressure increased", "skin in the neck was burned", "Base BP: 105/110 over 65/70/ 85". The following information was reported: PAIN (non-serious) with onset Feb2021, outcome "recovered", described as "body aches pain"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered", described as "fatigue". Therapeutic measures were taken as a result of pain, fatigue. Additional information: No reaction at the time of the second shot waited 1/2 hour post shot. Within 24-48 hrs., body aches pain, fatigue but no symptoms like for the 1st shot. Symptoms lasted 3days & took Tylenol/Motrin BID.  No follow-up attempts are possible. No further information is expected.
NONE. Patient received doses of vaccine after 10 weeks from the use date. NO REACTIONS.
At an unspecified date, the pt received first Havrix vax. Five days post vax, the pt experienced facial flushing and joint tenderness of the elbows and knees. The most recent information on 05/07 does not provide an outcome.
Case number PHEH2013US026014 is an initial spontaneous report received from a pharmacist on 13 Dec 2013 and a follow up report received from the consumer on 10 Jan 2014. This report refers to a 59-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml FLUVIRIN (batch number: 13391P) intramuscularly on 09 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm at 08:55 am and on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reaction was experienced by the patient following this medication error. Follow up report from the consumer received on 10 Jan 2014: The patient's condition was updated.
Soreness, redness, tenderness @ site of inject, fever to 103 several hrs later, vomiting 10PM, hives began 10AUG91; MD tx DPH;
no symptoms for 8 days following injection.  on 8th day, redness appeared at site of injection.  very red, 3x2 inches in size, hot to touch and itchy.  started taking 800mg at primary care physican's recommendation
treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at patient place, for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated by a healthcare professional at the patient place, since she experienced shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided and the causality of the events was related.
Much joint pain/aching, lack of energy, listlessness, lack of motivation, night sweats. Joint pains/aching strongest for 36 hours after onset; rest of symptoms persisted for 48 hours. Used Tylenol q8h (something I rarely take - maybe once a year, some years not at all). Redness, swelling, hot to touch, painful to slightest touch, and itching starts approximately 3 inches below injection site in a somewhat oval shape - 2 inches wide and 3 inches long. Itching is most severe in a 1 inch tail at bottom right of oval.  (This report is being filed approximately 91 hours after injection, and arm symptoms remain.) This was my second SHINGRIX shot. After the first shot, I had arm soreness at site of injection but none of the other symptoms.
Patient complained of pruritus and reddened bumps to extremities. Patient stated she took BENADRYL and the symptoms subsided.
patient received covid vaccine and went to sit out in waiting area.  about 5 min later patients eyes rolled back, became unresponsive, was grunting, stiff muscles, and had uncontrolled urination. this continued for a few minutes. was able to get patient on the floor and in doing that he became responsive and alert.  patient almost immediately felt fine.  paramedics were called and they did check him out but he left without going to the hospital
Onset of visual disturbances including blurred vision, enlarged blind spot, flashing lights, severe migraines - working diagnosis of acute idiopathic blind spot enlargement (as of 2/28/22) Began experiencing a large blind spot in the left eye - went to eye doctor who found swelling in optic nerve, issues with visual field tests, referred to a neuro-opthamologist - symptoms continued to worsen for the next two months (vertigo, nausea, vomiting, flashing lights, tunnel vision) before beginning to improve (acute symptoms) - blind spot has not improved, headaches continue, sensitivity to light and sound continues
Breakthrough case. About 45 days after vaccine I started to have a bad headache, a sore throat with fever and chills. Took a Home COVID-19 test and it was positive. Had a telehealth appointment with a NP at the Hospital and was prescribed Paxlovid. Took full course and quarantined for 10 days. Started feeling better, didn't retest.
Menstrual  period began two days after 1st Moderna vaccine with spotting on 3/27/21. One week after vaccine, heavy period began with several fist-size clots the evening of 4/1/21. Today is 4/12/21 and I am still having my period. It has lightened up but not stopped after more than two weeks. My age is 50 and I am in peri-menopause.
Headache, Myalgia, NauseaVomiting, fatigue Narrative: NA
Woke up knowing something was very, very wrong. My body was in so much pain shooting throughout my body. I had fever, chills, headache, extreme weakness so bad I was unable to get out of bed. I needed assistance getting up to go to the bathroom. I had hives on my upper right arm where injection was administered. I still have a circular reddish purple spot on my arm.
0830 - ZYRTEC given 1007 - Flu vaccine given 1030 - increase HR to 120, decrease O2 sat 90 1040 - hives noted on body 1050 - MD notified, face flushed 1055 - epinephrine given 1110 - Prednisone given, continued for 4 more doses q 12 hours 1149 - child had 8 mins of intermittent seizure activity (child has a seizure disorder).
After vaccination patient ambulated with steady gait to waiting area to sit recommended 15 min, after sitting in chair in waiting area (1310) reports feeling "hot & dizzy", skin became pale and diaphoretic, eyes rolled back and didn't respond for a few seconds then was able to answer questions, kept complaining of feeling hot & dizzy, and yawning. EMS was called at 1:12 pm and arrived on scene at 1:18 pm. Patient was responsive, sitting BP 58/22, SaO2 96% on room air. Denies shortness of breath or chest pain/discomfort. 1:23 pm BP 98/60, 1:30 pm  BP 108/75, 1:26 pm BP= 116/74; alert and oriented x3, speech clear and appropriate, ambulates 50 feet with steady gait/balance. Refused medical care and treatment. Signed refusal form for EMS. Patient's wife, son and parents present with him. Wife reports that he gets worked up about needles especially with blood draws. Patient leaves ambulatory with steady gait in stable condition accompanied by his wife, son and parents. Followed up via phone on 4/8/21 at 12:30 pm, patient reported he is feeling fine with no problems at present time. Reported that approximately 10 min after leaving he had another feeling of being hot for a few seconds then went away after drinking some water then had no other episodes.
Td administered - pt. went to waiting area & sat down next to her mother.  When she got up she fainted, then woke right back up, no problem or complication.
about 12 hrs later woke up w/ shaking chills, all joints painful. 2 hrs later got up to urinate & temp 100.4 but normal is 97.0-97.4. Rested in bed until 10am. Did sip water. Diet that day light & easy to digest. Physical activity very minimal for rest of the day.   As required by RA physician also received super flu immunization but have had that past 3-4 years w/ no adverse reaction. Had to have both at same time so I could receive my Rituxan infusion for my RA on  10/26/2021. Contacted Rheumatology via telephone to advise them. Was told Doctor will discuss future immunizations at next office visit.
Tachycardia within 15 minutes of injection. Within 2 weeks, the following symptoms developed: numbness and tingling all over body; tightness/stiffness (compression, banding, wrapped in tape feeling) and constricting feeling in ankles, knees, forearms, abdomen, forehead/temple; joint and muscle pain; backache; head pressure (makes head feel heavy, squeezing inside); fatigue; elevated heartrate when standing or walking; burning skin; anxiety attacks (adrenaline rushes); insomnia; night sweats; loss of appetite; rapid weight loss; mild tinnitus in left ear; tremors in left hand; random twitches throughout the body; feeling of internal vibration/humming/buzzing; erythromelalgia; chills; low fever; cold hands/feet
The adverse reaction is an ongoing effect from the injection shot's placement (left arm/shoulder) and down to the end of my left hand which is best described as an undesired tremor. ~ arm and hands have a feeling since the shot acting as relentless shaking in relative location to shot. Happens multiple times a week, sometimes all throughout the day. Unclear triggers.
Temperature excursion was 68F; total time of excursion was 8 hours with no reported adverse event; Initial information received on 24-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had temperature excursion of  68f; total time of excursion was 8 hours with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had temperature excursion was 68f; total time of excursion was 8 hours with no reported adverse event (intercepted product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Temperature excursion was 68F; total time of excursion was 8 hours with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion was 68f; total time of excursion was 8 hours with no reported adverse event.  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 the 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.
Information has been received from a pharmacist concerning a 71 year old male patient with high blood pressure, seasonal allergies, no past drug history and no drug reactions/allergies who on 12-JUN-2010 was vaccinated SC with a 0.6 ml partial dose of ZOSTAVAX (Merck) (lot# 665531/0698Z), due to leakage from the attachment of the needle to the syringe. There was no concomitant medication. On 12-JUL-2010, while receiving the injection, the needle was not screwed tightly onto the syringe and three large drops of ZOSTAVAX (Merck) dripped out of the syringe where the needle was loosely screwed in. After administering the dose , as the pharmacist pulled the syringe out of the patient's arm, the needle separated from the syringe and stayed stuck in the patient's skin. The needle was removed and immediately after administration, a local skin reaction to the shot developed "just like you would expect", a "raised area" at the site of injection. At the time of the report, the patient had not recovered. No laboratory or diagnostic studies were performed. No further information is available.
7FEB96 4PM t98.8 c/o stomachache,mom felt pt anxious about shot;6PM @ home eyes watery,not feeling well,stomachache,red throat;8FEB96 periorbital edema,facial swelling,gen red bumpy rash,t101-notified PP started DPH;
I had numbness in my lower jaw, pain in the jaw hinges, and facial flushing in about 30 minutes or less. I called 911". The paramedics ran an EKG without finding problems. I declined transport to a hospital after talking to the paramedics. In their view, this was a side affect rather than an allergic reaction. At 12:24 PM, the facial flushing is essentially gone. I still have the jaw pain and numbness and a now a pain in the lower part of my throat.
Dispensed dose of expired Moderna COVID-19 vaccine; Slightly sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Slightly sore arm) and EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions.  Patient neither diagnosed with COVID-19 nor tested positive.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Anticoagulant therapy.    On 06-Apr-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna COVID-19 vaccine). In April 2022, the patient experienced PAIN IN EXTREMITY (Slightly sore arm). At the time of the report, PAIN IN EXTREMITY (Slightly sore arm) and EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursion and it was unknown when the vial initially stored in the refrigerator as transferred from another store.  It was reported that patient did not experience any adverse events besides a slightly sore arm similar to his previous Moderna doses.   Treatment medications were not reported.   This case was linked to MOD-2022-544635 (Patient Link).
pain in the breast; breast is tender; allergic reaction to the second dose; itchiness, itchy on the arm; itchiness and redness on the arm and it's swollen and itchy; redness on the arm and said that it spread; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain in the breast), BREAST TENDERNESS (breast is tender), ALLERGY TO VACCINE (allergic reaction to the second dose), VACCINATION SITE PRURITUS (itchiness, itchy on the arm) and VACCINATION SITE SWELLING (itchiness and redness on the arm and it's swollen and itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: flu shot (The patient had similar reaction as when it had the flu shot.). Concurrent medical conditions included Blood pressure abnormal.   On 30-Nov-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (pain in the breast), BREAST TENDERNESS (breast is tender), ALLERGY TO VACCINE (allergic reaction to the second dose), VACCINATION SITE PRURITUS (itchiness, itchy on the arm), VACCINATION SITE SWELLING (itchiness and redness on the arm and it's swollen and itchy) and VACCINATION SITE ERYTHEMA (redness on the arm and said that it spread). At the time of the report, BREAST PAIN (pain in the breast) and BREAST TENDERNESS (breast is tender) had not resolved and ALLERGY TO VACCINE (allergic reaction to the second dose), VACCINATION SITE PRURITUS (itchiness, itchy on the arm), VACCINATION SITE SWELLING (itchiness and redness on the arm and it's swollen and itchy) and VACCINATION SITE ERYTHEMA (redness on the arm and said that it spread) had resolved.            Concomitantly, patient was taking Triaminitron for blood pressure.  The patient did not take any treatment.
I started getting dizzy and ears ringing almost 15 minutes after I got the shot.  I told my husband I didn't feel right and then passed out.  I am told I turned white and my chest was not noticeably moving.  Nurses tried for about 30 seconds or so to get me to wake up before I came around.  I laid on the floor for a few minutes.  When they tried to get me to sit up I started to feel quite dizzy again and asked to lay down.  After a few minutes they brought a wheelchair and started wheeling me from the vaccine clinic to the ER.  While in the wheelchair I passed out again.  I also noticed tingling in the outer half of both hands, and my hands were curling up involuntarily.  It took a couple of hours for me to start to feel like I could think clearly.  I did not feel well for several days after receiving the vaccine.  I was extremely tired and got a lot of dizzy spells for about 4 days afterwards.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild