chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased her neuropathy symptoms and triggered a flare of her Trigeminal neuralgia.
Full body hives Treated with 2.5 weeks of prednisone (2 rounds). And 20mg of Zyrtec 2x per day. The severity of the hives decreased but we?re still present daily. Upon finishing the prednisone, the hives continue and the severity is increasing again.
On 4/3/23 gave Moderna Monovalent and after the patient left the clinic, I went online to see what the expiration date was and realized it was 3/30/23. I immediately notified by Supervisor who suggested I contact the Health Dept. The Health Dept suggested I contact Moderna directly. Moderna emailed me the Vaccine Adverse Event Reporting form and it was faxed back to them on 4/7/23. On 4/11/23 I received an email indicating that because the vaccine was stored correctly that it was found to be active enough to protect the patient from Covid.
Patient reports the next day having a bruised arm, rash, and it is warm to touch. It remains today when she called at day 13. It is 3inches by 3 inches. It did not bleed at the site of reaction during the vaccine. She said it is improving but still there. I recommended that she go see a doctor if she is still concerned.
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest.  Her face and upper chest did appear flushed.  She was administered Benadryl, and her symptoms resolved after half an hour.
Pt's arm became swollen, red, and sore below the site of injection (not on the site).  It is still currently red, swollen and sore. He developed a fever of 103.5 F for 3 days which has resolved as of the time of reporting (11/7/2016 11:50 AM). Has been treating with acetaminophen and ice, and is currently in constant contact with the doctor regarding his condition.  He has not been physically seen by the MD.
Not feeling good; Patient's body felt hot; Running a fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good), FEELING HOT (Patient's body felt hot) and PYREXIA (Running a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (Not feeling good), FEELING HOT (Patient's body felt hot) and PYREXIA (Running a fever). At the time of the report, FEELING ABNORMAL (Not feeling good), FEELING HOT (Patient's body felt hot) and PYREXIA (Running a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Approximately 30 minutes after receiving first dose, patient felt a big  lump in the throat.  Cleared up with Benadryl.
Approximately 6 hours after receiving the vaccine, I had a sudden sharp throbbing migraine in the lower back of my head, slightly to the left.  I took ibuprofen.  Over the course of about 5 minutes, the pain increased to the point I would have gone to the ER if I had someone to drive me.  The pain was debilitating - at level 8.  I could only hold my head and walk slowly around the room to distract myself from it.  I was at that level of pain for about 5-10 minutes.  About 25 minutes after the migraine started, it became tolerable - more like a level 5/6.  About 3 hours later it was at a 3/4.  The throbbing didn?t go away until after I got a shot of Tiraspol at the urgent care the next day.  I continued to have a low pain constant dull headache until 4/1.
When I received my first shot my arm was very sore.  The second injection my arm turned red and swollen.   I kept applying ice and taking tylenol for the pain and it helped some, and the swelling went down some.  I continued having pain in my left arm, decided to call the FDA to ask questions about the shot and try to find out if others are having an issue with a sore arm.
Patient, who is 18 y.o.a. was given an adult dose of Hepatitis B when pediatric dose is indicated until 19 y.o.a. No adverse reactions or side effects were noted. Incident was reported to facility as well.
10/25/11 caregiver called to report 3"X3-1/2" local reaction around injection site. Says it was a white ring surrounding a pink ring. No breakage or discharge. No other symptoms.
Modern a COVID-19 Vaccine EUA Received first vaccine on 1/15/21. Began to develop a rash near injection site on 1/22/21. Redness, swelling, itching, and heat continue to worsen. As of today, 1/25/21, I have a large oval rash approximately 3? wide and 6-7? long on my left arm surrounding the injection site. Rash appears as a red band/ring circling the site somewhat mimicking bullseye design commonly associated with Lyme disease tic bite.
pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 22-Jan-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
patient stated she woke up next morning with rash/red bumps over torso and spread in random spots around body. she said they itched and she noticed it after working out. she had applied an anti itch cream that seemed to help. there did not seem to be anything at the sight of injection except soreness.
Fever, nausea, stomach discomfort, pain in back, arm, waist.
Patient reported a large, deep purple bruise at the site of injection that progressed in size to approximately 2 inches in diameter. She also reported pain at the injection site lasting more than 1 week.
Doctor ordered DTaP. I administered the shot. Pt is 13.5 years old and should have received Tdap instead.
Symptoms began as LUE pain in the early morning the day after vaccine. Body pain and muscle aches began by 10 am. Chills and fever came next, at around noon. Sudden onset of Shortness of Breath came on around 1:30 pm, with O2 sat dropping to 79-80% at home. Went to ER by 2:00 pm. Fever spiked to over 102. O2 sat fluctuated between 80s and low 90s %. Admitted with new onset of mild CHF and SOB.  Remained in hospital for 2 days/nights until O2 stayed in the 90s. Fever and other symptoms remained, and I have continued taking Tylenol every 4-6hours.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because  facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment information was provided.
Patient called to report that she had a very bad nose bleed the morning of 3/16/21. She couldn't get it to stop at first and was afraid it would not. She reported never having had a nose bleed in the past.
currently having dental issues; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer reported for a male patient (reporter's husband) that a male patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced currently having dental issues on Aug2021.  received his 1st dose 28Jul and has been having dental issues may need to start antibiotics. The caller wants to know if there are contraindicatios  bewteen the vaccine and antibiotics. Will Fax AE for dental issues after the 1st dose. Relayed PMI and transferred to PMI withheld for more information. Support CEP. The outcome of the event was not resolved.
Hives - all over BENADRYL given. Hives started 9 hrs after admin. of vaccines.
Pt recvd 3 doses of Engerix-B 16NOV89, 12DEC89, 11JUN90; 20SEP90 it was determined that titer was neg; booster dose of Engerix-B was administered on 27SEP90; 3DEC91 titer was neg; 2nd booster dosse was administered 13MAY91;
Muscle spasms and twitching throughout my body (eyes, face, arms, abdomens, glutes, legs) starting the day of my vaccine and continuing now for over 4 weeks. Spasms are sporadic and fairly constant, though as time goes by they seem less persistent (I have also started magnesium and vitamin B12 supplements)
There is a red, blotchy, swelling that is hot to the touch. A circle of red about 2.5" in diameter.
This spontaneous report was received from a healthcare worker refers to a 23 years old female patient. Patient's current conditions included asthma and SUPREX allergy. The patient's medical history included depression, anxiety disorder and attention deficit-hyperactivity disorder (ADHD). On 27-SEP-2012, the patient was vaccinated intramuscularly with 0.5 ml dose of PNEUMOVAX23 (lot # 672369/1850AA, expiry:28-JUL-2013) and was also vaccinated intradermally in the left arm with a dose of Influenza Virus Vaccine (manufacturer unknown)(lot # not reported). Concomitant medications included WELLBUTRIN, TOPAMAX, oral hormonal contraceptives (unspecified) and budesonide, SYMBICORT. On 27-SEP-2012, the patient experienced headache, vomiting, nausea, fever and extreme swelling of her right arm at the injection site after receiving PNEUMOVAX23. The patient went to the emergency room, where she was treated with unspecified pain medication and released after about 3 hours. On an unspecified date an unspecified white blood cell count test was performed with elevated result. The patient was recovering from headache, fever, nausea, vomiting and injection site swelling. The outcome of elevated white blood cell count was unknown. Additional information has been requested.
Severe chills, severe body aches, moderate headache, severe weakness, severe imbalance, severe cognitive ability- onset 14 hrs post booster injection- treatment ibuprofen liquid gels, oral hydration- AE resolution 19 hrs post booster injection
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: F39943), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). The patient has no known allergies. Concomitant medications included: ARMOUR THYROID; ATORVASTATIN; MELOXICAM; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative; (2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: On 07Jan2023, the patient had a positive rapid test following previous 2 negative tests post 5 days after completing Paxlovid.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: After receiving vaccination and waiting in the observation area, the patient stated he felt dizzy/lightheaded and \"like he was going to faint.\" He was brought over to our Clinic area for further observation and assessment. His blood pressure was taken and it was with normal range and not low. He stayed seated in a chair for awhile until he started to feel \"normal\" again. He then left with his wife. He did not faint or become unconscious.
9 days after the patient's second vaccination dose he experienced a facial paralyze on the right side  a pin point headache behind the right ear proceeded the event ( DX : Bell's Palsy)  A stroke was ruled out at  the emergency room with CT scan , blood work , and pt had a negitive chest x-ray.
Brought to ED via EMS following 2nd vaccine for allergic reaction. Pt reports approximately 20 mins after she started with warm feeling, shortness of breath, nausea, dizziness. Pt went to clinic and was given Benadryl 50 mg and Solumedrol 125mg IM.
4months female baby who received Kinrix; This vaccines is her s econd dose of Dtap and IPV too; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The healthcare professional stated that the 4 months old patient received Kinrix, which led to inappropriate age at vaccine administration and it was her 2nd dose of Dtap and IPV too, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up.
Observed patient aggressively scratching arm. Occurred ~ 5 mins, lasted 30 mins. vitals/ lung sounds clear. administered 25mg Benadryl + 40mg Pepci AC patient left under own accord. 61 y/o female who presents with (L) arm itching shortly after her vaccine, no other symptoms. No significant Physical findings Probable localized allergic rxn.
Severe headache, fatigue, chills, low grade fever, and nausea from 10 p.m. 3/08/21 until around 9 a.m. 3/10/21.  Also experiencing severe pain at injection site and in lymph nodes in left underarm (swollen and painful).  Tylenol helped, but had to take every 4 hours to get any relief at all.  I've never had a reaction this severe to a vaccination, even the Shingles vaccine was not this bad, and I get a flu shot annually.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: after getting second dose of vaccine pt felt dizzy, lightheaded and little faint. pt was place on floor in supine position result in improvement of symptoms. bp and pulse was normal. emt and 911 was called to be on safe side and pt ngot checked up in ambulance in case of additional issues.
Covid Arm - inflammation of the skin, large swelling and painful to touch (4+ days)  Fever, chills, joint pain in knees, nausea/lack of appetite for 36 hours from vaccine dosage. Arm stiffness and enlarged bump still existent after 4 days
Severe fatigue, headache, neck and midline back pain, unable to bend forward, weak, feet tingling and going numb, throat and neck pain and tightness, no itching in throat, just hard to talk and strained to talk.
125/72  97% 93 h  itchy tongue  difficulty swallig  transported @ 1442
12/17/21 Pt's BF tested (+). Pt began having symptoms on 12/18/21, feeling runny nose, body aches, chills.  12/19/21 Pt tested (+) for COVID which resulted on 12/20/21.  She spoke with someone from facility but doesn?t recall who and has not called the COVID hotline. Pt spoke with DOH, release date is 12/29/21.  Pt is still experiencing stuffy nose; other symptoms have resolved.  Pt to call back on 12/29/21 for clearance for RTW.
Patient does not have Lot# available.  Chills, body ache. Woke up sweaty. Went to work and vomited during work. Nausea.
Pt vax w/ 3rd dose Engerix-B and experienced menstrual flow increase, also seen for coughs & colds.  21MAR90, dx = pregnancy; had D&C 18APR90 for miscarriage of 3 mo pregnancy.
Fever > 100.5, tiredness, achy - reaction at injection site: pain, redness, warm to touch, induration of 4cm X 6 cm
Had the shots, still got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots, still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that not true and had the Shingles shots and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
I had a significant uptake in fainting spells. When I stand up my blood pressure and heartrate plummets. This started happening a lot after my third dose. I am still dealing with this at this time. No medications have been prescribed.
Nausea, vomiting, diarrhea, intensely sensitive/painful skin, muscle aches, insomnia. I tried to take Tylenol to help with aches but threw it up almost immediately. Almost all symptoms resolved after about 12 hours.
Per mother pain, swelling bil legs. Using MOTRIN, intermittent ice. Brought to clinic - Rt thigh 7cm area of redness/edema, Lt thigh 2cm area slight redness.
Severe chills, aches, fever, soreness, fatigue, mild headache onset 2 am
Information has been received regarding a case in litigation from a lawyer, an female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-MAY-2009, at age 75, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Herpes zoster ophthalmicus. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster ophthalmicus is unknown. Upon internal review, Herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Patient developed 4 x 6 cm area of swelling and redness on (L) thigh.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 08-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
a month or so after the first vaccine I noticed difficulty limping with my left leg.  it was mild at first but then progressively worsened causing atrophy of my left calf and left foot muscles. I saw an orthopod in July 2021 because of these symptoms He noted left MTPJ swelling, left calf atrophy of the medial gastroc, with calf weakness , normal knee exam. Left Knee and foot MRI noted atrophy of the of left medial gastroc and intrinsic muscles of left foot consistent with a neurogenic cause. EMG/NCV showed axonal sensorimotor neuropathy with elements of denervation /reinnervation in S1 root. LS MRI unrevealing for source. Neurologists don't have a diagnosis or etiology for this unusual  case.