chrisvoncsefalvay/vaers-outcomes huggingface dataset:
These symptoms may not be related to my COVID vaccine, as it was 6 months ago. But beginning on July 14 2021 I developed neuropathy first in my left hand, then my right hand 2 weeks later, along with parasethesias all over the body. It does seem to be improving now, but it's been going on for almost 6 weeks.
This spontaneous report was received from a registered nurse reporting on a 19-year-old old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 17-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
gave IPOL 0.1 ml intradermally for TB skin test with no adverse events; gave IPOL 0.1 ml intradermally for TB skin test with no adverse events; gave IPOL 0.1 ml intradermally for TB skin test with no adverse events; Initial information was received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 19 years old female patient who experienced gave IPOL 0.1 ml intradermally for TB skin test with no adverse events while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 29-Jun-2022, the patient received 0.1 ml of suspect IPV (VERO) (lot V1A022M) (formulation, strength and expiry date: unknown) via intradermal route in unknown administration site for routine TB skin test (Tuberculin test).    On 29-JUN-2022 the patient developed a non-serious gave IPOL 0.1 ml intradermally for TB skin test with no adverse events (unapproved dose administered, inappropriate route of vaccination and unintentional use for unapproved indication) (latency same day) following the administration of IPV (VERO).  Action taken: not applicable.  Outcome-Unknown for all events   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 guidelines. 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.
Large red rash at injection site (4? X 2?).  Itchy and warm to the touch.  Appeared morning of 4th day after second injection.   Also want to note that within 12 hours of second injection experienced fatigue, chills, muscle ache, and low grade fever (flu-like symptoms).  Lasted 48 hours.
5 hours after receiving the shots I felt sick: disoriented feeling and didn't know if I'd vomit or have diarrhea - but neither happened.   From the waist up every nerve felt like it was being stabbed by a thousand knives - VERY uncomfortable!  12 hours after the shots (about 4 a.m.)  I felt I would pass out, got to the bathroom, then woke up later (I don't know how long) on the floor with my head jammed against the door frame.  I couldn't turn my head from the impact and laying in an unnatural position for some time.    I got back to bed around 6 a.m. and slept 3 hours.  I've had 8 chiropracter treatments for my neck, which turns a little better now, but not fully.  I will seek physical therapy since my neck is still in pain.
Pt was vaccinated on 3/9/21 and 4/6/21 with Pfizer vaccines. Prior to her recent hospitalization she or the daughter had no knowledge of her severe hiatal hernia but she did admit to early satiety and poor po intake for a few months. Patient is an 84-year-old female with a past medical history significant for hypertension, hyperlipidemia, recurrent urinary tract infections who presented to the emergency room on 6/1/2021 due to some dysuria, frequency, nausea, vomiting and increased confusion. She denied any fever or chills or any abdominal pain but did report some acid reflux symptoms and poor appetite. she was ultimately admitted with a suspected urinary tract infection. She was also profoundly electrolyte depleted with hypokalemia, hypomagnesemia and hyponatremia due to poor p.o. intake. She was started on IV fluids and electrolyte repletion was also started on Rocephin based on her old cultures and subsequently admitted. Patient's urine and blood cultures ultimately produce no growth and a urinary tract infection was ruled out. She was found the day after admission with a large amount of black emesis covering her sheets. When questioned patient reported that she had been vomiting during the night. Stool OB was ultimately positive. Her DVT prophylactic heparin was discontinued. She was started on IV Protonix. CT of the abdomen pelvis was ordered. CT revealed nearly the entire stomach was above the left hemidiaphragm with air-fluid levels but there was no significant distention seen. The case was discussed with our general surgical team and the decision was made to transfer the patient to a higher level of care for a GI/EGD evaluation .She was transferred on 6/3/21. She was ultimately discharged on 6/7/21 home after being found to have a gastric volvulous. On 6/21 she returned for Robotic-assisted laparoscopic repair of a giant hiatal hernia with Bilateral placement of pleural pigtail catheters as both pleural linings were densely adhesed to the hernia sac. The plan was to discharge her home on 6/25/21.
dizziness especially when getting up from bed; mild achiness for a couple of days.; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness especially when getting up from bed), PAIN (mild achiness for a couple of days.) and ARTHRALGIA (sore shoulder) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery (The dizziness is possibly because of his neck- had 3 neck operations).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness especially when getting up from bed), PAIN (mild achiness for a couple of days.) and ARTHRALGIA (sore shoulder). At the time of the report, DIZZINESS (dizziness especially when getting up from bed) outcome was unknown and PAIN (mild achiness for a couple of days.) and ARTHRALGIA (sore shoulder) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-120698 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 AE follow up  pain and arthralgia event  outcome recovered.
Difficulty sleeping; body ache; headache; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), PAIN (body ache), HEADACHE (headache) and MYALGIA (Muscle ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery in October 2020. Concurrent medical conditions included Anxiety, Depression and Limb discomfort.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping), PAIN (body ache), HEADACHE (headache) and MYALGIA (Muscle ache). At the time of the report, INSOMNIA (Difficulty sleeping) had not resolved and PAIN (body ache), HEADACHE (headache) and MYALGIA (Muscle ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication includes depression, anxiety. Treatment information was not provided.
8cm x 6cm area of erythema on left upper arm. Warmth over area of swelling. No discharge, tender to touch, afebrile. Diagnosed vaccine reaction with sterile abscess versus infection. Treated with Keflex, ice and Motrin. To contact office of worsens or develops fever.
really bad headaches after each dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headaches after each dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (really bad headaches after each dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (really bad headaches after each dose) outcome was unknown.            No Concomitant Drug details were reported.   This case was linked to MOD-2021-417033, MOD-2021-417051 (Patient Link).
Maternal exposure during pregnancy; really bad headache/headache; arm is sore and hurting; feel exhausted; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore and hurting), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), FATIGUE (feel exhausted) and HEADACHE (really bad headache/headache) in a 91-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache). In August 2021, the patient experienced VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Headache, at an unspecified dose and frequency. On 04-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Patient was pregnant before she received her vaccination and currently, she was 32 weeks pregnant. Her second dose would be due on 30-Aug-2021. She had headache on the 1st day and went away. That evening, she got really bad headache and took some Tylenol, and she thinks it had gone now. On the second day and third day, she felt exhausted. Her arm was sore and hurting. She read about Moderna COVID 19 vaccine and that people can get blood clot. Although she didn't get blood clot with her first dose, she was worried that she can get it with the second dose. She asked if she could get blood clot with the second dose. Also, she wants information on blood clot like what types of people can get it and why. She was frustrated that agent didn't have information on this, and she didn't feel comfortable about providing further information about herself. She disconnected the call immediately after agent sated no information.; Sender's Comments: This is a case of product exposure during pregnancy with associated adverse events for this 91-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events headache, vaccination site pain and fatigue, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring during the pregnancy. Patient´s date of birth confirmation has been requested.
Patient received the Moderna shot on Tuesday (4/20/21), then had nausea and chest pain on Wednesday evening. Chest pain came and went with help of Motrin. Friday morning at 6 am, she had extreme chest pain that prompted an ER visit. They diagnosed her with pericarditis.
pt recv vax;devel localized tenderness&mild swelling on lt deltoid area;no redness noted;pt instructed to apply ice pack compress as needed and to take apap per MD;
feverish and sick (in bed); feverish and sick (in bed); This is a spontaneous report from a contactable consumer. This consumer reported for a 54-years-old-male patient that this patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; unknown), lot unknown reason; not available/provided to reporter at the time of report completion, via an unspecified route of administration from 03Feb2021 to 03Feb2021 at single dose (dose number; 2) for covid-19 immunization. Patient's medical history and concomitant medications were not reported. If covid prior vaccination or covid test post vaccination was reported as unknown. Known allergies and other medical history was reported as not known. If other vaccine in four weeks and other medications in two weeks was reported as unknown. The patient had 2nd vaccination and next day on 04Feb2021 felt feverish and sick (in bed). It was unknown if treatment AE was given. The reporter confirmed the awareness date of this report via query response mail that "I became aware of this report on 05Feb2021 when talking on the phone with a friend of mine, (Name). She first texted me about her husband (which I filled out a separate report on,(Name) and when I called her to get details on her husband's report she told me about her sister's report as well (Name). I became aware of both on 05Feb2021 and filled out the online form later that night." The outcome of events was recovered on an unknown date.   Information on the lot/batch number has been requested.
severe headaches began about 6/21/21 and were so severe we decided to start tracking them on 9/23/21 along with food ate and etc to see if there was something causing them.  She has had sinus headaches for years but she said these were different and quite intolerable and as the days went on approaching the 26th and were unbearable.  She tried execdrin, ice packs, heating pad, sinus spray and nothing were easing up.  The worse during the night.  On the night of the 25th she had one of those headaches and after trying all avenues to make them go away, she decided to take a hot shower in hopes this would help.  This was somewhere between 3 & 4 am of the 26th when the stroke hit and paralyzed her completely.  At the time we did not have any special commnications to us as we stayed upstairs and she was downstairs and thus we did not discover her until around 7am of the same morning.  EMS was called and she was sent by ambulance to a local hospital.  Where she was diagnosed with a basal ganglia bleed and immediately vented.  Doctors said it was typcially due to high blood pressure, but she was never diagnosed with high blood pressure issues.  As of today (12/17/21) a healthy woman who was still working and driving with no immediate health issues is now bed ridder and minimal progress is being made.
A little bit of pain, not hot, not tender. Redness spread over 2 days, slight blisters, localized. Saw doctor antibiotics cleared it up.
Hepatitis B was ordered. Hepatitis A given instead. Hepatitis B #2 will be given at 4 months and Hepatitis B #3 will be given at 9 months, then series will be complete.
Inappropriate scheduled of second dose (within 25 days); Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)). On 26-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.  This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown, with pain in extremity.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown, with pain in extremity.
I experienced mild full body itching immediately following the vaccine injection for approximately 4 hours.  Then 48-72 hours after I experienced a sore throat, body aches & fatigue that kept me from doing my regular activities, including work.  These symptoms lasted less than 24 hours./.
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. During 2015, 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 and the patient subsequently contracted a persistent strain of herpes zoster. On or about May 2016, the patient was treated by a physician and was diagnosed with painful herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles 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.
TWO DAYS AFTER INJECT, LOCAL REACTION- MODERATE AMOUNT OF REDNESS AND PAIN.
aended up in hospital with a very bad reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a child patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a flu shot a few years back aended up in hospital with a very bad reaction then found out I had bad reactions from vaccines.
Swelling and pain at injection site; Swelling and pain at injection site; headache for 2 days; malaise for 3-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacture unknown), for COVID-19 Immunization; Covid-19 vaccine (First booster), for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Oct2022, outcome "unknown" and all described as "Swelling and pain at injection site"; HEADACHE (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "headache for 2 days"; MALAISE (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "malaise for 3-5 days". The events "swelling and pain at injection site", "headache for 2 days" and "malaise for 3-5 days" required physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain, headache, malaise. Additional information: Ae resulted in: Doctor or other healthcare professional office/clinic visit. If covid prior vaccination: Unknown. If covid tested post vaccination: Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm to the point I could not lift it above my shoulder for three days and still counting. Red rash evening of the second day find the injection. Headache on the second day following the injection. Fatigue slight flu like symptoms second and third day following injection. Swelling around injection begin hoursAfter the injection it?s still very swollen going into the third day following the injection. Injection site is still very hot and sore even to the light touch of a finger.
fatigue, stiff lower back (moderate), stiff muscles (mild), sore swollen site (moderate), headache, low grade fever. Treated with arnicare & messaging site, ibuprofen QID, resting. This was day after shot. By next day, all symptoms are improved (although i am not well yet). You should also know that my first dose 21 days before was Phiser.
Pt developed severe body aches, fever 101, and headache and feeling of clogged ears approx 20 hours after vaccination. At this time, she has not seeked medical care.
Initial misuse report received from a healthcare professional on 17 September 2013. The cases were received on 21 March 2014 at GPV. A 2-month old patient received 0.25 ml dose of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
8 days after receiving the injection, my arm was warm, itchy, painful, pink, and my skin was raised up around the injection site. I did have a different feeling headache on this day but it went away on its own-I don?t know if it was related. This pink rash part lasted for about 4 days. The pain and itchiness still comes and goes, however it is less than before when the rash was its reddest. My are looks like it is back to normal, but it still itches/hurts every once in a while.