chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy Red Spots all over his body; Rash Spreading all over the body / Braking out; Red Itchy Rash appeared on both Arms and Chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Red Itchy Rash appeared on both Arms and Chest), RASH MACULAR (Itchy Red Spots all over his body) and RASH (Rash Spreading all over the body / Braking out) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced RASH PRURITIC (Red Itchy Rash appeared on both Arms and Chest). On 09-Apr-2021, the patient experienced RASH (Rash Spreading all over the body / Braking out). On 12-Apr-2021, the patient experienced RASH MACULAR (Itchy Red Spots all over his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Red Itchy Rash appeared on both Arms and Chest), RASH MACULAR (Itchy Red Spots all over his body) and RASH (Rash Spreading all over the body / Braking out) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications for the event included two doses of an unknown medicine. No concomitant medication was provided by the reporter. At the Follow-up report the reporter mentioned that it had been 16 weeks post vaccination, he had been to Emergency room thrice and visited his doctor nine times, taking medications twice daily and breaking out once weekly.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: significant follow-up appended
Day of shot erythema & swelling that progressed to shaking & chills the following day.  Erythema & swelling in left arm at nite of shot then into left elbow.
This spontaneous report as received from a 63 year old female consumer refers to herself. The patient was vaccinated with 1 dose of ZOSTAVAX (dose, frequency and lot# not reported) in her left arm on 01-FEB-2013. The patient stated that she was experiencing side effects, half dollar sized red mark with itching and swelling with onset date of 02-FEB-2013 and on 03-FEB-2013 (Sunday) it got larger. On 04-FEB-2013 (Monday), the patient went to the doctor and the doctor gave her "something that relieved the itching". The patient also experienced muscle tension on 02-FEB-2013. At the time of reporting, the patient's outcome was unknown. The relatedness for all events was related for ZOSTAVAX. Additional information has been requested.
the syringe came off and the needle stayed in his arm, the serum was everywhere.; A spontaneous report was received from a Healthcare Professional concerning a male patient, of approximately 50-60 years of age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination device connection issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced as reported, the syringe came off and the needle stayed in his arm, the serum was everywhere.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event(s) (The syringe came off and the needle stayed in his arm, the serum was everywhere) was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and syringe connection issue for mRNA-1273 with no associated AEs.
Patient suffered sudden death based on his wife's statement. The event occurred 24 hours after the vaccine administration. There has been no medical examination to determine the cause of death or to establish relation to vaccine.
Patient's mom report of daughter having fever, nausea, vomiting, and headache the following day after vaccination.  Symptoms have subsided during  follow-up with mom by pharmacist Friday morning.
Extreme fatigue, whole-body aches, diarrhea, inappetence. I had trouble sleeping the night after receiving the booster, but the body pain didn't kick in until early the next morning. It was so debilitating, I was not able to work remotely from home. Took Meloxicam 7.5 mg as I usually do for control of minor osteoarthritis pain, but took no other medications or supplements. Went back to bed and slept for approximately 4 hours. Am feeling a bit better now, 28 hours post-vaccination, less fatigued, but still have body aches. I assume I will be recovered by tomorrow morning. This is extremely unusual for me. I have never before had an adverse reaction to a vaccine.  Aside from some muscle soreness at the injection site, I did not experience any adverse events from the first injection in the series last fall.
On April 18, I woke up feeling "flu-ish" with chlls, headache and nausea. It went away, but then the next morning, I was working out and laying on my back. When I got up, I had vertigo and dizziness, which has come and gone over the week. Last night (April 21) I had another episode of vertigo getting into bed and then again this morning getting out of bed. It's more uncomfortable than debilitating, but I'm now scared to get my second shot.
Headache; body aches; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), NAUSEA (Nausea), HEADACHE (headache) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.  No Medical History information was reported.  On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VOMITING (vomiting), NAUSEA (Nausea) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (body aches). On 09-Mar-2021, VOMITING (vomiting), NAUSEA (Nausea) and HEADACHE (headache) had resolved. At the time of the report, MYALGIA (body aches) outcome was unknown.     No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-068382 (Linked Report).  Sender's Comments: MOD-2021-068382:Second dose case
Narrative: 68yo male patient died on 12/5/2021 of respiratory failure. Per, his family he had tested positive of Covid in November of 2021 and remained ill up until his death. Pt had received one dose of J&J vaccine on 8/30/2021 outside facility, location unknown. Pt struggled with homelessness and mental health issues. See pt's problem list below: PROBLEM LAST MOD PROVIDER Chronic pulmonary embolism 10/29/2020 (ICD-10-CM I27.82) Light cigarette smoker (1-9 cigs/day) (ICD-10-CM F17.210) Impotence (ICD-10-CM N52.9) 06/05/2019 Obstructive sleep apnea of adult (ICD-10-CM G47.33) House rented from housing association (ICD-10-CM Z59.8) Benign prostatic hyperplasia  06/05/2019 (ICD-10-CM N40.1) Impotence (ICD-10-CM N52.8) 12/17/2018 Pain in left knee 12/17/2018 (ICD-10-CM M25.562) Chronic obstructive lung disease 05/22/2018 (ICD-10-CM J44.9) H/O: pulmonary embolus 05/22/2018 (ICD-10-CM Z86.711) Pulmonary hypertension (ICD-10-CM 05/22/2018 I27.20) Homeless single person 05/09/2018 (ICD-10-CM Z59.0) Avascular necrosis of the head of femur (ICD-10-CM M87.052) Cocaine abuse (ICD-10-CM F14.10) 03/06/2018 Pain in left leg  (ICD-10-CM 02/19/2016 M79.605) Derangement of meniscus (ICD-9-CM 717.5) 07/24/2015 Chondromalacia of patella (ICD-9-CM 717.7) 07/24/2015 Gastroesophageal reflux disease 02/19/2016 (ICD-10-CM K21.9) Hip pain (ICD-9-CM 719.45) 07/24/2015 Hyperlipidemia (ICD-9-CM 272.4) 07/24/2015 Hypertrophy Breast (ICD-9-CM 611.1) 04/21/2014 Unspecified glaucoma (ICD-9-CM 365.9) 12/30/2013 (ICD-9-CM 266.2); Vitamin B 12 Deficiency 08/28/2013 (ICD-9-CM 266.2 ; will need B12 injections once established in PCC Hypertension (ICD-10-CM I10.) 02/19/2016 (ICD-10-CM F10.20); Alcohol dependence (ICD-10-CM Z59.0); Homeless 06/18/2018 (ICD-9-CM 309.0); Adjustment Disorder with 07/01/2013 depressed mood (ICD-9-CM 309.0) (ICD-10-CM F32.8); Depression No information in records of circumstances or place of pt's death. Pt did not test covid positive at facility. Potentially this is a breakthrough case of covid infection since pt had been vaccinated with J&J dose on 8/30/21 and potentially died of covid infection on 12/5/21, but unable to confirm since pt had not been seen for medical care at facility since 10/15/2021.
received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021) had resolved.            Concomitant product information was not provided.  Treatment information was not provided.
Information has been received from a 70 year old female registered nurse with allergies to morphine and "internal iodine" and with a history of reaction to "a dressing" and chickenpox at 14 years of age who on 24-MAY-2007 was vaccinated in the left upper arm with a 0.65 ml dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 07-JUN-2007 (also reported as Day 10) the patient experienced chickenpox.  The patient developed 3 pox at the injection site and injection site pain.  The rash (lesions) spread to the patient's shoulder, down her back to her legs and then her abdomen.  She had 300-500 lesions on her body.  She treated herself with BENADRYL and TYLENOL 3 at home.  She then presented to the emergency room became her primary care physician was not available.  She was diagnosed with chickenpox.  She was prescribed an "antihistamine", ULTRAM, KEFLEX and was referred for a chest x-ray.  Her maximum temperature was 99, pain was rated as 9 on a scale of 0-10 and other systemic symptoms included itching.  It was reported that the a patient had no recent exposure to chickenpox or herpes zoster.  Additional information on 11-JUL-2007 indicated that a few days after vaccination, the patient developed 3 small pox at the injection site.  About 10 days post-vaccination she developed a chickenpox rash all over her body.  As of 11-JUL-2007, her rash was somewhat better but still present.  The patient was enrolled in a program to identify of VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of a lesion was collected on 10-JUL-2007, lesion type a vesicle reported to be tiny scabs.  The PCR results for the specimen were negative.  No VZV was identified.  Additional information has been requested.
Swelling and redness of cheeks, hands and feet. Vomiting and fever.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In October 2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Same day post vax, the pt experienced soreness in arm. Also, she experienced flu-like symptoms accompanied by fever and pain. She had a fever of approximately 102-103.
severe headache, fever overnight 100F, chills, shivering, overall muscle aches, lasted about 24hrs, first 12hrs worst, very challenging to perform any sustained activity during course of symptoms.
reaction of a defined red circular area around the injection site.  involved whole thigh, no fever, or warmth to touch.  slowly resolving.
This spontaneous report has been received from a license practical nurse concerning a 14 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
C/o redness, swelling & pain at inj site advised to apply ice packs. 11/22/10 - second MD visit.
This spontaneous report was received from a licensed practiced nurse refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent. On 10-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N023969 and expiration date: 28-FEB-2018) subcutaneously at the temperature from -14 degree Celsius (C) to -10 C (-14 C) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the report received from the same reporter. Sender's Comments: US-009507513-1804USA005654: US-009507513-1804USA006162.
Pt is hospitalized with altered mental status, erratic behavior, non-purposeful and involuntary movements, dystonia, fleeting thoughts, hallucinations, impulsivity, balance impairments, inability to follow commands. Family states that this is completely off baseline for patient prior to this originally beginning 6 months ago. Family states that pt was able to administer her diabetes medication with no issue, was able to walk with a normal gait, and had no confusion. Pt had heart surgery on 3/21/21 where it is documented that she walked with normal gait and was alert and oriented with no confusion noted and able to understand her procedures. It is then documented that she followed up during recovery on 4/9/21 and was still walking with normal gait, exercising appropriately for optimal recovery, etc. First covid vaccine was given on 4/6/21 and second dose was given on 5/4/21. She then followed up with cardiology on 5/14/21 where it was again documented that patient was at baseline with no issues. Then on 6/14/21, patient presented to ER with complaints of jerking movements in all of her extremities (and then presented back to er again on 6/16/21) for appr. 3 weeks at that point. Pt has been in and out of hospitals since then with no answers yet.
Itchy patches, face, tops of feet, hands, palms and backs, wrists and ankles.
Started feeling an itchy rash on the left side of my neck, lips became numb, left side of my face became puffy and numb as well. Had this reaction previously so I didn't go to see my doctor this time. Also experienced Sciatica a few weeks later.
Patient said that the night of the shot it was a little swollen and hot to the touch. It hurt to lay on it. On the 13th, he called me back and reported having striations up and down his arm around the spot where he got his shot and said that it hurt really bad. He was going to take a ZYRTEC and try and get ice on it. On the 15th, I spoke with him and he said that he had called his doctor on the 14th. He said that the swelling had gone down and the pain was much better after sleeping for several hours, but he was still taking ZYRTEC.
Case number PHEH2014US024273, is an initial spontaneous report from  a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 02 Dec 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from the nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
t101;tongue-white & coated (red w/raised taste buds x 2 days); swollen glands
About 10 minutes after the vaccination was given, our technician noticed that pt leaned back and called out to his mom. Then,  pt  started to have a seizure.
Arm soreness in the hours after injection. Nausea developed that evening. Onset of 101F fever, nausea, and body aches overnight and into the following day. Some improvement with Tylenol, ibuprofen, and Zofran.
It was reported in a published article that a 16 week old male patient's mother was vaccinated with a dose of MMR (second generation) in the postpartum period. The patient breast-fed well and did not regurgitate. The patient had no problems until the age of 4 months when he reacted violently to a dose of diphtheria toxoid/pertussis vaccine/teta with a high fever and inconsolable screaming. He also developed severe gastroesophageal reflux which later required fundoplication. Because he had athetoid movements the patient was evaluated and diagnosed with cerebral palsy. He is now 13 years old and according to his mother does not respond and cannot be tested; he turns off the world, looks at the ceiling and rocks all day. Though these symptoms are very suggestive, a diagnosis of autism was never considered and he was therefore not included in the affected group. Upon internal review, cerebral palsy was considered to be an important medical event (OMIC).
pain in the joints of the feet, ankles, and wrist; pain happened on the right hand and feet; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing gout. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. On an unspecified date, the patient reported that in the last couple of days he had pain in the joints of the feet, ankles, and wrist and also mentioned that the vast majority of the unusual pain happened on the right hand and feet. Reporter asked what medication he can take for the joint pain and asked how long the possible side effect would last. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about batch number cannot be obtained.
Difficult walking; right leg pain; Joint pain/ Right ankle pain/Knee pain/painful/Left shoulder extremely painful/Left knee pain/Left knee pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult walking), PAIN IN EXTREMITY (right leg pain) and ARTHRALGIA (Joint pain/ Right ankle pain/Knee pain/painful/Left shoulder extremely painful/Left knee pain/Left knee pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced GAIT DISTURBANCE (Difficult walking), PAIN IN EXTREMITY (right leg pain) and ARTHRALGIA (Joint pain/ Right ankle pain/Knee pain/painful/Left shoulder extremely painful/Left knee pain/Left knee pain). At the time of the report, GAIT DISTURBANCE (Difficult walking), PAIN IN EXTREMITY (right leg pain) and ARTHRALGIA (Joint pain/ Right ankle pain/Knee pain/painful/Left shoulder extremely painful/Left knee pain/Left knee pain) had not resolved.            No relevant concomitant medications were reported  No treatment information was provided.
Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received 1st dose of covid vaccine on Friday. Monday patient had tested positive. Called would like to know if and when patient can get 2 dose of covid vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
A rash occurred 1 hour after administration of the vaccine, started on my left arm and progressed to my head and torso and arms.  Went to urgent care which gave me prednisone to take for 4 consecutive days and to take Benadryl with the prednisone
This spontaneous report was received from a medical assistant and refers to a 17-year-old non-pregnant female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 04-APR-2017, the patient was administered an expired dose of M-M-R II injected subcutaneously, (lot # L004658 with expiration date at 11-FEB-2017; albumin status, dose and anatomical location were unknown) for prophylaxis, which was reconstituted with sterile diluent (strength, dose, lot # and expiration date were not reported). The reporter verified that administered dose of vaccine was not exposed to any temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.