chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on her abdomen; itchy; full body rash like hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her abdomen), PRURITUS (itchy) and URTICARIA (full body rash like hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on her abdomen), PRURITUS (itchy) and URTICARIA (full body rash like hives). At the time of the report, RASH (rash on her abdomen), PRURITUS (itchy) and URTICARIA (full body rash like hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-081665 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081665:CROSSLINKED WITH DOSE 2
Slight nausea; aches over entire body; headache; slept for 36 hours.
Developed petichiae on 3/20. Labs drawn 3/22 showed Platelets of 20,000. Started 150mg prednisone 3/29. Neurological symptoms that week. Seizure and brain bleed noted on 4/3. Intubated and transferred from local hospital to neuroscience hospital.
Patient received H1N1 vaccine, 12/20/2009-Noticed pain in left upper arm that began around 2 weeks after receiving vaccine. Patient denies fever or rash. States arm still hurts when moved and reports pain more severe now. Denies redness or swelling. Referred to MD for evaluation.
Pt went to ED. 1/9/10 Pt came for allergy injections, states she had been to ER 1/4/10. Pt had H1N1 and seasonal flu vacc. 1/4/10 5 hours prior to sx begin. Began with throat hoarseness and wheeze, progressed to difficulty breathing, chest tightness, rapid heart beat, jaw itching, there was a red band around injection site in R arm. Was given IV at ER and neb.-sx subsided. Today only complains of fatigue. Allergy injections were held this wk. Pt has FU with Dr 1/21/10 and this will be fu'd. Pt advised to call with any new allergy sx or concerns. Dr will be contacted. Pt denies any allergic rx to eating eggs or nuts. 1/5/10 Above reviewed with DO, advised 1 wk ER F.U. with Dr, appt 1/8/10 2 PM. Records requested from ER. 1/8/10 BP 116/78, T-99.1, 80, R-16.
3cm oral red swollen area left bicipital area. Entire left arm in bicipital and deltoid area swollen and tender. No itching. Began 1 day after receiving vaccine. Instructed re: Motrin, Allegra and ice packs. F/U with MD in AM.
Sore arm, nosebleed 3 hrs after the shot. 21 hrs later, headache and nosebleed. No treatment. Nosebleed able to stop
Flu vaccine given too high within hour unable to move shoulder and extreme pain. Went to on 10/17/18 and approximately 2 weeks later then had MRI last Monday which showed partial thickness bursar surface supraspinatus tendon tear with associated rotator cuff tendinitis still have pain and decreased range of motion due to increase pain with movement.
Inappropriate schedule of vaccine administered; Henoch-Schonlein Purpura; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Jun2021 as dose 2, single (Lot number: EN6200) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: other medical history: HTN; "dyslipidemia" (unspecified if ongoing); "allergic to scallops" (unspecified if ongoing), notes: allergic to scallops; "fatty liver" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose:1, lot number=EL9265), administration date: 04Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Jun2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; HENOCH-SCHONLEIN PURPURA (non-serious) with onset 2021, outcome "not recovered". The event "henoch-schonlein purpura" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of henoch-schonlein purpura.  Additional information: The patient also received Pfizer COVID vaccine as dose 4, single on 22Apr2022 and as dose 3, single (lot number: EW0164) on 20Oct2021. No other vaccine received by the patient in four weeks, The patient received other medications in two weeks. The patient in the wound clinic, who developed Henoch-Schonlein Purpura (biopsy proven) on her leg. No other symptoms. She said it started about 3 months after her second COVID vaccine shot. Patient still got booster shots, patient was treated at wound clinic. The patient did not have COVID prior vaccination. COVID was tested post vaccination.
pediatric / patient had received an adult dose; pediatric / patient had received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HAV (Havrix adult) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. The action taken with Havrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that the pediatric patient had received an adult dose of Havrix, which led to overdose and adult product administered to the child. The reporter consented to follow up. No further details were reported at the time of the call. The case was linked with US2021174391 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174391:Same reporter
Vaccine administered was later determined to have been past its beyond-use date of 11/16/2022 (though still within its manufacturer's expiration date of 12/31/2023).   I notified patient on 1/17/2023, as of this date patient reports no ill effects and is feeling her usual self.
Sweats day after 2nd dose; Weak after 2nd dose; Low grade fevers day after 2nd dose/she is run down and has a fever of 99.9 degrees F; Nausea day after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats day after 2nd dose), ASTHENIA (Weak after 2nd dose), PYREXIA (Low grade fevers day after 2nd dose/she is run down and has a fever of 99.9 degrees F) and NAUSEA (Nausea day after 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats day after 2nd dose), ASTHENIA (Weak after 2nd dose), PYREXIA (Low grade fevers day after 2nd dose/she is run down and has a fever of 99.9 degrees F) and NAUSEA (Nausea day after 2nd dose). At the time of the report, HYPERHIDROSIS (Sweats day after 2nd dose), ASTHENIA (Weak after 2nd dose), PYREXIA (Low grade fevers day after 2nd dose/she is run down and has a fever of 99.9 degrees F) and NAUSEA (Nausea day after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (High) 99.9 degrees F.         Treatment information not provided. Concomitant medications were not provided.
I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & malays.  My estimated date of deliver is 03/05/2021 and I am 32 weeks gestation.
Patient noticed itching and redness at injection site few hours after vaccination. Continued throughout next 24 hours itching, swelling, redness, warm to touch. Patient showed arm to pharmacist 830AM 1/11/13, contacted primary MD. Advised to ice area & take oral antihistamine product. Diarrhea reported 1/11/13.
I developed issues with an increase in my blood pressure and developed diabetes. Found out after Wellness appointment. I was referred to a primary care physician and placed on medication for the blood pressure and diabetes. They also found that I had vitamin D deficiency. I have taken the medication for 1 week so I am uncertain whether it is helping yet.
Received a call from Lead RN at facility, patient received Pfizer vaccine @ 1200, patient became diaphoretic, passed out hitting the floor.  Per RN patient lost consciousness for a few seconds, awoke and answered all questions appropriately.  No lacerations or open areas noted.  Vital signs and blood glucose within normal limits.  EMS called and arrived at 1215, evaluated by EMS, per patient she does not want to be transported to the hospital.  Patient left site via private vehicle in stable condition.
Sore arm.  Starting at night, slight fever and headache.  Feverand headache  persisted through much of the next day (04/07/2021).  During the day, temperature checks (with infrared thermometer on forehead) ranged from 99.1 deg F to 100.1 deg F.
8 days after vaccine I developed intense itching at injection site. When I scratched it  I discovered a large, hard lump approximately 2.5 inches in diameter which was also red and resembled a rash. Not sure if related but I also developed mild flu-like symptoms and a cold sore on lower lip 7 days after vaccine ( one day prior to injection site symptoms).
Just received 2nd vaccine today, nurse suggested I let you know of 1st vaccine reaction.  Pain in left armpit, which a bit later began several sharp shooting pains in lymph nodes under left breast. Started Feb 27 in the evening. Same occurrence  Feb 28 between 8 am and 3pm intermittent sharp pains only on left side under breast. Quick sharp pains that would come and go.  Nothing since then.
lightheaded, sweaty, BP113/77. Administered vaccine supine as patient indicated history of fainting with injections. Symptoms resolved shortly after administration.
Patient received Janssen vaccine and immediately reported feeling dizzy and blurry vision. Vital signs were monitored and were stable. Patient taken to private area to rest. Given juice and after 30 minutes reported symptoms were resolved.
Pt experienced high fever, confluent bright red rash on face and other areas coalescing, some with bluish tinge in center. On fifth day nearly gone.
Patient had a high fever for 3 days and chills. Two or three days post injection the patient started to develop a rash on his left arm. After visiting the doctor/hospital, they diagnosed him with a bacteria infection.
3 months postpartum and breastfeeding, had low grade fever to 99 within hours and fatigue/myalgias. This increased to chills, a temp of 101f (baseline 97.8), and myalgias/fatigue so severe Going to the restroom felt like running a marathon (which I have done). I had to fully lay down and couldn?t carry my 15lb son. I also had marked breast tenderness greater on the side of the injection. My son seemed to have trouble staying latched (?due to tiredness from my direct warmth), and had increased fussiness.  I have never had more than a mild local injection reaction w tenderness with any other vaccine
A rash on the back of my neck below my hairline. I have a picture of the rash if needed.  Left arm sore.
Area around arm turned bright red and had a burning sensation. Very hot to touch and had a mild itch.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 98 and started having confusion on 2/11/21 due to a suspected UTI but daughter had difficulty bringing him in for urinalysis. She eventually brought him to facility on 2/15/21 where he had a Klebsiella UTI. Patient eventually became bedridden and required home hospice. Other comorbidities included COPD, DM, HTN, and HLD.
Patient first had an adverse event noted 3 days after vaccination. She developed pneumonia, chills and cough. Then in June started having leg pain.  Found to have a tumor to left tibial shaft showing adenocarcinoma. Found to have cancer in lungs and brain. Metastatic
Having ringing in her ear today; This is a spontaneous report from a contactable consumer.  A female patient (Age: 67; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had ringing in her ear on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Received flu vaccine on 11/4/02-3 days later pt felt tingling in hand, pain radiated down arm to fingers, dropping pen, limited range of motion. Referred to neurologist for nerve conduction studies.
Patient given Influenza vaccine, Intranasal at 1 year, 11 months.
Abnormal chest x-ray; Altered mental status, unspecified altered mental status type; Arrhythmia; Bradycardia; CHF (congestive heart failure); Cardiac arrhythmia, unspecified cardiac arrhythmia type; Essential hypertension; Heart failure with preserved ejection fraction, unspecified HF chronicity; Hypothermia, initial encounter; Pneumonia of right middle lobe due to infectious organism; Right middle lobe pneumonia
Started feeling tightness in my chest towards the beginning of June, especially when exercising. This continued for weeks and I contacted my doctor about the possible reasons (06/26). I scheduled an appointment with my doctor on 07/09 after some discussion. At the appointment I was given an EKG and was diagnosed with Pericarditis. I took ibuprofen for a couple of weeks and the symptoms went away.  In early October I started to feel the symptoms once again and scheduled an appointment with my doctor. At the appointment I was given another EKG and was once again diagnosed with Pericarditis. Again, I took ibuprofen.  The symptoms went away but then returned mid November. I was given a prescription of Colchicine and have been taking it since November 27th. The symptoms have come and gone since. On December 15th I was given an ultrasound on my heart and the results came back fine.
PATIENT ACCOMPANIED BY HIS WIFE REPORTED TO PHARMACY FOR HIS FIRST DOSE OF THE COVID-19 PFIZER VACCINE. THE PATIENT REPORTED THAT HE DID NOT LIKE NEEDLES AND ASKED IF HIS WIFE COULD BE WITH HIM DURING HIS VACCINATION. THE PATIENT WAS VERY ANXIOUS BUT THEN HAD CALMED DOWN. AFTER COMPLETING THE VACCINE , THE PATIENT STATED THAT HE WAS FEELING OKAY PRIOR TO PROCEEDING TO A VACCINE WAITING CHAIR JUST OUTSIDE THE PHARMACY BUT INSIGHT OF THE PHARMACY STAFF. THE WIFE AFTER ABOUT 4 MINUTES POST VACCINATION ASKED IF WE COULD LAY HIM DOWN. ONE OF OUR TECHNICIANS STATED THAT THE PATIENT WAS STARTING TO SEIZE. LAYING THE PATIENT ON THE FLOOR. CONFIRMED THAT 911 SHOULD BE CALLED. OUR TECHNICIANS, COMPLETED THE CALL AND NOTIFIED MANAGEMENT PER POLICY. BY THE TIME THE PATIENT WAS TO THE FLOOR, HIS SEIZING  HAD SUBSIDED (~20-30 SECONDS TOTAL). THE PATIENT WAS ON THE FLOOR AT APPROXIMATELY 09:29 AM ON 4/21/21.STABILIZED THE PATIENTS' NECK AND HEAD WHILE HIS WIFE, A REGISTERED EMERGENCY ROOM NURSE  OBTAINED A PULSE. GRABBED THE CLEAN BLOOD PRESSURE DEVICE SPECIFIC FOR VACCINE EMERGENCIES. A BLOOD PRESSURE WAS OBTAINED 120/63 WITH A HEART RATE OF 57 (NORMAL ADULT CUFF, LEFT ARM, IN THE SUPINE POSITION ).  THE PATIENTS' FEET WERE ELEVATED ON A CHAIR TO RETAIN BLOOD FLOW AND COLOR.  SHORTLY AFTER EMERGENCY MEDICAL SERVICES ARRIVED AND COMPLETED THEIR ASSESSMENT.
This spontaneous report was received from a nurse concerning an unspecified patient (demographics unknown). On 05-OCT-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot # L009209; expiration date: 17-SEP-2016) (dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Got 3 covid shots - First shot 04/23/2021 - Second shot 05/21/2021 - Booster shot 01/24/2021  About 12 days after my booster shot, I got extremely itchy. This led to redness and hives. Running my nail softly over skin will cause a red mark to appear a couple minutes later and will disappear eventually. I believe I have developed Dermatographia. I have been using Claritin and using Cortizone on extreme spots.
Received Flu vaccine on 10/26/07 during day. On 10/29/07 reported she developed hives on the evening of 10/26/07. 10/29/07 hives observed on both arms with itching. Tr: Medrol dose pack, Claritin, Benadryl. Resolved.
Was a hard spot where the injection was placed; This is a spontaneous report from a contactable consumer (Patient's mother).  A 10-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on 01Apr2019 for immunisation.   The patient medical history and concomitant medications were not reported.  The patient developed a hard spot where the injection was placed on 02Apr2019. The outcome of the event was unknown.
sinus infection; dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy) and SINUSITIS ( sinus infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included Hiatal hernia and Chest pain.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS POSTURAL (dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy). On an unknown date, the patient experienced SINUSITIS ( sinus infection). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 1 dosage form; CEFTRIAXONE SODIUM (ROCEPHIN) for Sinus infection, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 1 dosage form. At the time of the report, DIZZINESS POSTURAL (dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy) had not resolved and SINUSITIS ( sinus infection) had resolved.            Action taken with mRNA 1273 in response to event was not applicable. Patient Concomitant medication includes unspecified blood pressure medication,unspecified cholesterol medication,unspecified allergy pill,acid reflux medication.   This case was linked to MOD-2021-234035, MOD-2021-234035 (Patient Link).
Patient in with sore throat, fever, and scarlet rash. SA positive diagnosed with Strep pharynigitis with scarlitone form rash. Mom asked me to look at injection site where he received his Influenza vaccine 3 days prior. The injection site was swollen and erythematous and somewhat tender. Treated with Keflex 250 mg/5 ml 1 1/2 tsp TID for 6 days.
Received dose Amox 2-5-09. C/o HA + nausea on 2/6/09 with some soreness and stiffness to (R) arm - 2/7/09 C/o tiredness +redness + warmth to (R) deltoid area.  2/9/09 Presented to H.D. Band Aid removed- area around injection site-left arm red + tender. Referred to MD 2/9/09. DX with Cellulitis - Rx with BACTRIM DST BID X 2 days - 2-10-09 redness is resolving -Feeling better.
(L)  hive shaped 9 x 9 cm erythematic area cellulitis, cellulitic area.
sx onset 9/30/21. Sx started with headache, chills, pain at injection site, warmth at injection site, burns, itching. Hard lump noted at injection site which progressed to swelling. Swelling spread to 4 inches above elbow.
My daughter started complaining that she couldn't breathe and said my heart hurts then she said her stomach hurts and then started throwing up really bad. She was pale but seems to have gotten better once she vomited.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine in 2016, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review varicella pneumonia was considered a medically significant event. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in an 81-year-old female patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 16th May 2018 and it was well tolerated). On 12th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold sores, pain in toe, skin discoloration and neuropathic pain. On an unknown date, the outcome of the cold sores, pain in toe, skin discoloration and neuropathic pain were not recovered/not resolved. It was unknown if the reporter considered the cold sores, pain in toe, skin discoloration and neuropathic pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called to report on behalf of one of their patients. Since the 2nd dose of SHINGRIX, the patient had a lot of symptoms like cold sores, terrible pain in one toe, she got a red or bluish circle that kept coming back on her toe. The pharmacist said that the patient seemed to have neuropathic pain. The pharmacist could not retrieve the lot number for the 1st dose. No further information was provided.