chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on Sept 23rd noticed the inside of 2nd toe of left foot pink, which became progressively darker red with noticeable purple mottling .  Area with  sensation not intact, ie. numbness noted.  Symptom has continued for two days until present.  No worsening or improvement noted. No itching, swelling, or open areas noted. N.P. at work concurs that it doesn't appear to be cellulitis, as it is not warm to touch or appear inflamed, and skin intact without drainage. This could be Covid toe but could not locate anyone who has seen/ Dx'ed this condition. Contacted both locale hospital systems to locate someone who has seen and Dx'ed this condition, but unable to find at present; still working on this.
Information regarding PREVNAR 13 was received from a consumer regarding a 23-month-old female patient who experienced severe pain and tenderness at injection site, would not let anyone touch her, began limping and began crying. The patient received a dose on 19-Aug-2010. The patient experienced tender to the touch and severe pain at injection site, would not let anyone touch her, began limping and began crying on 19-Aug-2010. Outcome for all events was unknown. No additional information was available at the time of this report.
Injection site swelling. Patient was given BACTRIM 400-80mg one twice daily for 3 days on 9-9-14.
The day after I was vaccinated, I woke up and noticed my arm had a red, swollen, and hot rash (it almost looked like an infection). It appears almost scaly and looks like the ?COVID arm? in the pictures presented on various websites. The area continues to be red and swollen on 5/21/2021 at 11 PM. The area causes my arm to feel pressure under my armpit since it is located on the outer area of my arm. I still continue to become chilled and hot/sweaty randomly through out the day as of 5/21/2021 as well.
covid arm yes, expected that, dizzyness lasting 3 days, tired, flu like symptoms. chills, anxiety, that was no big deal but last night I had severe stomach pain and rushed to the bathroom , then had severe nautious, I had diarrhea, at the same time. I nearly blacked out. I got very hot and had to take off all my clothes, then when I got up to the toilet to diarrhea again I needed to vomit, I blacked out on my bathroom floor. when I woke up I went back to bed. at the time of the occurence I was too delusional to call for help. I barely ate that day because I felt so bad. I did notice the second day I felt worse after drinking 1,000 mg of vitamin C from one of those Emercencey Packets with lots of water. and the next day I took twice as much to (knock out) what ever I was feeling.
The same night approximately 8 pm, pt developed blisters to total body and inside mouth. No fever, These blisters made her scratch. He had tachynea with snoring. Mom took baby to ER  on 07/30/02 where he was diagnosed with allergic reaction. Prescribed antihistamine.
Hives began to appear behind knees, down calves shortly after getting home from vaccine. Overnight, the hives spread from ankles up to hips on both left and right side.
Initially after the shot I had fatigue and arm pain and nausea that would come in waves. As the days went by the fatigue and arm pain went away, but I continue to have waves of nausea if I move around, almost like motion sickness. In the past 10 days I?ve completely lost my appetite. I gag at the thought of eating food, despite 24 hours going by with nothing being eaten. I?m forcing myself to eat at least once/day, but am full after half a portion.  I still experience the ?motion sickness? when I am physically active.
Tingling and numbness on left hand; Tingling and numbness on left hand; Pain inside both legs similar to a electric shock; Headache; Light headiness,dizziness; Flush; Pain in left arm,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headiness,dizziness), FLUSHING (Flush), PAIN IN EXTREMITY (Pain in left arm,), PARAESTHESIA (Tingling and numbness on left hand) and HYPOAESTHESIA (Tingling and numbness on left hand) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (Light headiness,dizziness), FLUSHING (Flush) and PAIN IN EXTREMITY (Pain in left arm,). On 29-Apr-2021, the patient experienced PARAESTHESIA (Tingling and numbness on left hand), HYPOAESTHESIA (Tingling and numbness on left hand), PAIN IN EXTREMITY (Pain inside both legs similar to a electric shock) and HEADACHE (Headache). At the time of the report, DIZZINESS (Light headiness,dizziness), FLUSHING (Flush), PAIN IN EXTREMITY (Pain in left arm,), PARAESTHESIA (Tingling and numbness on left hand), HYPOAESTHESIA (Tingling and numbness on left hand), PAIN IN EXTREMITY (Pain inside both legs similar to a electric shock) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Patient reported that Her HCP said it was okay to receive the second shot but she is worried that she should not take the second dose.
Headache, bodyaches, and intermittent nausea and dry heaving peaking 26-32 hours post vaccine.
Mother reports that patient felt like his heart was going to explode, dyspnea, rapid breathing, chest pain, doom sensation about 5 minutes after receiving the Covid 19 vaccination. Pharmacy witnessed the event and watched pt for 15 minutes. Mom states they did not advise him to go to the hospital after the reaction. Has been taking Benadryl at home x 4 days.
Dizziness, chills, chest pain Narrative: employee states: 4 days after vaccination she is still experiencing the side effects of: light headedness, room spinning ever sincxe 1/21/21 on and off. Tightness in her chest has subsided. She also has chills on 1/23/21. She left work on 1/21/21, stayed home 1/22. She comnteacted he PC 1/25 who recommended hydration and rest.
Patient found dead in his chair 36 hours after vaccine.  Had not been acutely ill prior to vaccination.  11/02/07 Received medical records from reporter which reveal patient w/extensive medical hx.  H&P of 5/07 indicates had recent diarrhea, apple core lesion in mid to distal sigmoid colon, severe dementia, SOB & extremely poor appetite who had been admitted to hospital then transferred to LTC due to lethargy, fatigue & falls.  Had cellulitis &  inflammation of lower leg but afebrile on day of vax.  Next day had congested productive cough w/green phlegm & vomiting. 10/28 had increased congestion, unresponsive w/dusky color.  BP 89/66 & placed on O2 due to sats of 50-60%.  Taken to hospital. 11/16/07 Received hospital ER medical records of 10/28/2007. FINAL ER DX: respiratory failure, sepsis Records reveal patient experienced fever, lethargy altered mental status & abdominal guarding. Exam revealed bilateral diffuse rhonchi, increased respiratory rate, diffuse abdominal tenderness & guarding, decreased bowel sounds, pitting edema of LE's & tachycardia, temp 101.3.  Patient was DNR & comfort measures provided until expiration.  ME declined case.
HEART RACING; HEART IRREGULAR; CHILLS; HEADACHE; FATIGUE; SORE ARM; VOMITING; SORE FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:45 in right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced sore face. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart racing (NR: not provided) 100 beats per minute. On 12-MAR-2021 17:00, the subject experienced heart racing. On 12-MAR-2021 17:00, the subject experienced heart irregular. On 12-MAR-2021 17:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart racing, vomiting, sore arm, sore face, fatigue, and heart irregular, and the outcome of headache and chills was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as Nonserious.
developed severe hives all over her body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mildly allergic to Cat" (unspecified if ongoing); "Mildly allergic to Pollen" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FJ4991, Location of injection: Arm Left), administration date: 16Jul2022, when the patient was 12-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (Dose Number: 2, Batch/Lot No: FK5618, Location of injection: Arm Left), administration date: 04Dec2021, when the patient was 11-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (Dose Number: 1, Batch/Lot No: PK5127, Location of injection: Arm Left), administration date: 13Nov2021, when the patient was 11-year-old, for COVID-19 IMMUNIZATION. The following information was reported: URTICARIA (disability) with onset 14Nov2022 at 17:00, outcome "not recovered", described as "developed severe hives all over her body". The event "developed severe hives all over her body" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Clinical course: Three-four days after taking the vaccination, patient developed severe hives all over her body. The hives could be controlled by taking 10 mg of generic antihistamine that she has to take every day. After consultations with her pediatrician, allergist and immunologist, (name withheld) was given five-day 15mg/5ml Prednisolone course but that did not help in the long run as she started developing symptoms a week after the treatment ended. Recently she completed six-day course of 4mg Methylprednisolone, and that has not helped either. Failure to take atleast one antihistamine dosage in a day resulted in breakout of hives all over her body. The hives continue to this day, 14Mar2023 - more than four months after she took her last dose of vaccine.
powder administered with unapproved diluent; powder administered with unapproved diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 4 April 2022 Reporter's Comments: Some months ago, the nurse from another facility administered a partial dose of Menveo as only the powder was administered with an unapproved diluent to the patient.  The reporter did not had any information about the patient and the vaccine as lot number and expiration date also did not had information about which diluent the nurse used to administer the dose.  The reporter consented to follow up. Additional Supportive Information: The patient received partial dose of Menveo as only the powder was administered with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-AE2022059676:Original case - Deleted
Moderna vaccine, first dose, administered to 17 year old.  Not approved for use under the age of 18.
entire upper arm; under arm; axillary-edema tenderness; injection site 4.5 cm diameter induration
Extreme temperature fluctuations, shivering, muscle aches through the night into the following day, weakness, dizziness, nausea.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature was 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83.  Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg  once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
I contracted COVID-19 coming home from a cruise. I felt tired and I needed to go by food even though I felt so tired that day. On the 5th I started not to feel well. I really don't remember how I was feeling. I think I started with a sore throat.  I tested at Home and I was positive. I contacted my PCP on that Monday, I was having a slight fever, cough and literally runny nose. She explained what we should do and recommended I take the antivirals, not Paxlovid. I don't remember the name I threw the bottle away.  It was 4 pills a day for 5 days, yellow capsules.  I am fine now.
My first done was April 27 and my second dose was May 25. Both times I was on my period. However, my current period came much lighter the previous period.
A physician reported the occurrence of diabetes mellitus in an infant of unspecified age and gender who was vaccinated with hep B vaccine (manuf unk) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of hep B vaccine (manuf unk). One week post-immunization, the physician made a diagnosis of diabetes mellitus. As of 2/4/03, the event persisted. The physician considered the diabetes mellitus to be unrelated to hep B vaccine administration. The diabetes mellitus in this report is considered medically serious (OMIC). F/U states that approx. 1 week, post vax, the pt began to experience lethargy, increased thirst and increased urination. He was admitted to the hospital on 11/20/02 for an unspecified period of time. On 2/25/03, the diabetes mellitus persisted. The vaccine provider considered the DM to be life-threatening, to involve severe or permanent disability and to be unrelated to Engerix-B administration. The Engerix-B immunization series was discontinued.
Fully vaccinated patient admitted for COVID, VAERs reporting required by health department. Patient lives in a SNF. Admitted 8/6/21 due to medication event but tested positive for COVID-19. Received Moderna vaccine on 1/23/21 and 2/20/21 per immunization registry. Patient remains in the hospital as of 8/9/21 (day of reporting)
Metallic taste with in 3 hours of vaccination. Numbness in tongue the next morning.  Loss of muscle control on left side of face 48 hours after vaccination.
sore arm (right arm where injection was administered); Headache; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular in right arm, on 18Dec2020 09:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products. Relevant medical history included Ulcerative Colitis. No other vaccines were received within 4 weeks prior to the COVID vaccine. The medications received within 2 weeks of vaccination included Mercaptopurine, Remicade, Mesalamine and Junel Fe. The patient experienced headache and sore arm (right arm where injection was administered) on 19Dec2020 12:00 PM. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
pt had johnson and johnson dose 4-7-21 and came in to get her booster of moderna. A miscommunication occurred and instead patient got a full dose of moderna billed as the first dose. Pharmacy thought she was starting her series not getting a booster. we had not administered the J&J dose. Pt is not experiencing any symptoms at this time.
severe body aches, chills, left arm pain, red, warm and swollen lump at injection site
This spontaneous report as received from a Licensed Practical Nurse. On 21-MAY-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees fahrenehit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Slight chills muscle pain in legs and achy joints. Pain n swelling n redness at injection site
After the vaccine I had headache for three days. (Cross reference to V-safe). I got COVID-19 last Saturday Jan 7th, at 4:00AM , I had very painful sore throat, so painful it was difficult to swallow, later on the day I had fever (101.7), sinus pain, headache, body ache, I had a home COVID-19 test and it was positive (very dark), I called my doctor, I requested PAXLOVID, I was told I had to speak to someone tele health appointment the next day, Sunday Jan 8th, I had the appointment with the TA and he prescribed PAXLOVID and ibuprofen, I never picked it up until that evening, the first dose 8PM January 8th. I am still taking PAXLOVID. I am on day 4th, symptoms are improving. On Monday Jan 9th coughing about 100 times a day. On Tuesday night January 10th at 9PM I started dry rapid pulse, take me from sleeping. Last night January 11th I took the first cough medicine, I called my doctor back, I lost my voice. The nurse told me that due to my symptom and my test results I had a huge Viral Load. She thinks I got the new Omicron Variant.
I woke feeling like I had a cold or sinus infection a real bad cough came next I also had a real bad headache and could no sleep at night.   My two COVID-19 tests were negative my Doctor prescribed medicine, I also was tacking Nyquil and Dayquil. I still have a cough and I am really tired and fatigued   A weird thing is I have a real sore finger or knuckle.
no adverse event; temperature excursion; This spontaneous report was received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 07-DEC-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route of administration were not reported, lot # T021638, expiration date was 21-DEC-2021) 0.5 ml for prophylaxis.         It was reported that the suspect vaccine was exposed to a temperature of minus 13.3 degree Celsius for a time frame of 4 hours and 15 minutes, as recorded by the digital data logger (product storage error). There were no previous temperature excursions. No further adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013539: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2101USA000121: US-009507513-2101USA000122: US-009507513-2101USA000144: US-009507513-2101USA000266: US-009507513-2101USA000151:
37 y/o male, admitted to medicine for suspected cellulitis, potential DVT. Pt. administered IM influenza and pneumococcal vaccines in right arm following admission. 24hr after administration, pt. febrile to 102.9 degrees, right arm tender, warm, erythematous around injection site. Fever abated over following day.
As I was sitting post injection fine rash went down my  RT arm and at injection site . Approx one half hour later later my right ear and upper chest became flush. Short while later felt tingling in arm and fingers some  other areas as the day progressed. Face and arms red. At the end of the day both palms were red and feet felt warm . On my way home from work approx 4pm . My Feet felt like they were on fire and had pins and needles in them  b. When I arrived home pantar feet bright red , I took 25mg benadryl  and went to sleep . Day 2 still had tingling in feet and hands . new symptom head ache , weak body aches . Was seen in my primary Physicians office and was given prednisone 10mg x 5 d
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient received expired dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (patient received expired dose). At the time of the report, administered expired product (patient received expired dose) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vaccine was actually expired five days ago, but given to a patient. Most recent follow-up information incorporated: On Apr 7, 2022: Follow-up received on Apr 7, 2022, included no new information.
Fever; chills; body aches; headache; super tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On the second day of vaccination, the patient experienced fever, chills, body aches, headache, super tired and took a one-hour nap at lunch and again at 7PM. On day 3, the patient had fever, chills, and nap one hour nap at 6PM. On the same day, the patient was perfectly fine, all back to normal. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.