chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or about 02-AUG-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In approximately 2014, the patient was treated herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
It was reported that the pt's last menstrual period was 2 weeks prior to vaccination. In October 2000, the pt informed her physician that she had a miscarriage. No further information is available.
Case number PHEH2012US013201 is an initial spontaneous report received from a health care professional on 28 Jun 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M10134A) intramuscularly and GARDASIL (other manufacturer, batch number: not reported) through unspecified route in the same arm on 22 Jun 2012. On 23 Jun 2012 he developed redness and blisters at the vaccination site. It was reported that the symptoms were improved on an unspecified date. The final outcome was unknown. No further information was provided.
This spontaneous report as received from a 53 year old female, obese patient with no drug reactions or allergies. The patient stated she had shingles three times before and in the past her physician has prescribed valacyclovir whenever the shingles reoccurred. On 28-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered in the left forearm as one single shot (strength, dose, route of administration, indication, lot # and expiry date unspecified). Concomitant therapies included BENADRYL and hydrocodone. The patient reported to her physician and pharmacist the  next morning, on 29-OCT-2014, that she felt electric shocks on her right shoulder. The electric shocks were occurring every ten minutes in between her neck and shoulder blades. The patient sought medical attention, but no treatment was given and no laboratory test were performed. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the reporting healthcare professional has  not seen this patient and has no other information to provide.
Severe case of Pityriasis Rosea with itching and rash covering back, arms, legs and upper chest.  This then led to a severe eczema type rash with burning and itching from July 2022 through December 2022.  Pityriasis has returned as of one wee ago, January 2023, on chest.
The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.; administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) and PRODUCT STORAGE ERROR (The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) and PRODUCT STORAGE ERROR (The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was in freezer at 34 F for 24 hours and refrigerator at 62 F for 24 hours.  No treatment information was reported.
Dermal Hypersensitivity after 1st dose on1/21/2021. It got better and then I had the 2nd dose on 2/14/2021 and it is back
(eyes jerking back and forth, nausea, vomiting, light headed) (7 days) (Benadryl, Tylenol)
Extreme all-over body pain . Muscle and bone pain and tender skin  also reacted to original shots.  1st one soreness entire arm. 2nd shot had severe chills and 4 degree fever. Reactions to all 3 shots began about 8 hours after shot and lasted about 30 hours.  Treated with Tylenol
At the end of December, I noted that when I woke up in the morning that my left calf was painful. I walk on a daily basis: 2 miles a day. I proceeded to do that later in the morning. In the next morning, it was too painful to do my usual walk so I did 2 laps. By new year's I didn't walk because it was too painful. After new year's, I decided to push through the pain and go for a walk and could only do half of what I normally do. So because the leg was swollen and there was a lump on the outer portion of my left calf, I decided to call the doctor. After consulting with him, he said it was phlebitis. And he put me on Eliquis 10mg twice daily for one week, and he said to cut back to 5mg twice daily after that week and he said to check in with him after 3-4 months. It has slowly resolved and I would say it took 10 days until it really felt good enough to continue walking again. So now I continue to walk but only 1 ½ miles daily because I do not want to aggravate it.
3-5 mins p/vax pt fainted-eyes roll & then close & both of legs twitch; exp sz-like activty lasted approx 30 sec; pt was then conscious & oriented x3, but confused about how got on the floor;
-Nausea, episode of vomiting - occurred about 11 hours post-vaccination (1st dose), vomiting episode lasted half an hour. Nausea improved afterwards and was barely there in the next 16 hours.  -Significant chills/shivering - started about 11 hours post vaccination and lasted about 2 hours. Improved after taking Tylenol and managed for the next 16 hours with Tylenol.  -Low-grade fever.  -Dizziness/lightheadedness/near syncope episodes- started about 11 hours post-vaccination at time of vomiting episode (middle of the night) and lasted about 6 hours. Systolic BP was in the high 80's, usual systolic BP is in the 120's. Managed by increasing fluid intake & drinking caffeinated beverages to increase BP.
Severe headache chills fever body aches  Could not get out of bed for a whole day
Mom called state child approx 45 minutes - 1 hour child was screaming and holding neck and would not close mouth and began to drool.  Mom reports her throat appeared to be swelling.  She administered liquid Benadryl.  Her condition improved in approx 15 minutes child's condition was fine.  Mother did contact emergency room by phone.
Pain and stinging at injection site/; shingles rash that looks like pimples/rash that looks like pimples on her face,scalp,ears,chest, and back; Shingles / Shingles rash that looks like pimples; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and brain injury (had brain injury from a car accident several years ago).   On 8th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th June 2020, 3 days after receiving Shingrix, the patient experienced shingles and vesicular rash. On an unknown date, the patient experienced injection site pain. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the shingles, injection site pain and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had outbreak of shingles that began 3 or 4 days and lasted about 3 to 4 weeks before resolving. The patient reported a second outbreak of shingles began 4 days ago and was ongoing currently.  The patient stated currently has a shingles rash that looks like pimples on her face, scalp, ears, chest, and back that began 4 days ago and has been using a steroid cream to treat this.  The patient reported pain and stinging at injection site and these had resolved.  The reporter did not consent to follow up. No lot number or expiration date information was available The reporter did not get consent to follow up with HCP.
pt was given her 2nd dose  at 21 days not 28 days   pt reported no additional symptoms other then typical sore arm
blood blister at injection site; terible itching; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (blood blister at injection site), VACCINATION SITE PRURITUS (terible itching) and VACCINATION SITE ERYTHEMA (red at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE VESICLES (blood blister at injection site), VACCINATION SITE PRURITUS (terible itching) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, VACCINATION SITE VESICLES (blood blister at injection site), VACCINATION SITE PRURITUS (terible itching) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Thyroid meds, Acid reflux for drug use for unknown indication. No treatment medication information was provided.
This spontaneous report was received from a physician, referring to a female patient of unknown age. Information regarding patient's concurrent conditions, pertinent medical history or drug reactions was not mentioned. On 18-AUG-2016 the patient was vaccinated with ZOSTAVAX which had a lot # L036823 with expiry date on 24-DEC-2016, 0.65 ml, subcutaneously for prophylaxis. Concomitant therapies included atorvastatin calcium (LIPITOR) and propranolol hydrochloride (manufacturer unknown). On an unknown date in December 2016, the patient sought medical attention because since an unspecified date she experienced redness at the injection site (injection site erythema) and the site was uncomfortable (injection site discomfort). On 06-DEC-2016, the patient was seen in the physician's office because she had developed hyperalgesia at the injection site (injection site hyperaesthesia) and basically persistent pain since an unreported date. There was no product quality complaint involved. The outcome of pain, injection site erythema, and injection site hyperaesthesia was unknown.  No causal relationship was provided between vaccination with ZOSTAVAX and the events. {Additional information has been requested. / Additional information is not expected.}
It was about a week I started noticing arthritis problem. I took ALEVE and more than often I would take CBD capsule and cream. I did this for a while and saw my doctor on 01/07/2022 and I was given a cortisone shot. I have had arthritis for years but since getting the vaccine it has gotten so much worst.
This spontaneous report was received from a a registered nurse via company representative referring to 3 unspecified adult patients of unknown gender and reported as in their 20's. The patients' concurrent conditions, medical hisory, drug allergies and concomitant therapies were unknown by the reporter. On an unspecified date, the patients were vaccinated with VARIVAX (strength, dose, frequency, lot number and expiration date were not provided) as prophylaxis.      Within the next 24 hours from VARIVAX administration,  the 3 patients experienced cellulitis. Two of them were vaccinated with the same unspecified lot number and the other patient received a different unspecified lot number. The patients sought medical attention and the reporter stated that one of the patients received 2 rounds of unspecified oral antibiotics followed by an unspecified intravenous antibiotic. It was unknown which treatments did the other two patients receive and if laboratory diagnostic or studies were performed. At the reporting time, the patients had recovered from cellulitis. Relatedness between the event of cellulitis and VARIVAX was not provided. Upon internal review the event of cellulitis was found to be medically significant.
Patient had nausea immediately after receiving vaccine.  Woke up during the night with fever of 103.  Feels her heart is racing and is short of breath when walking up stairs.  Has also had a headache.
PYREXIA. Medication error. Rhinorrhoea, Runny Nose. Sneezing. Information regarding Flumist 2003-2004 Formula (influenza virus vaccine, live intranasal 2003-2004 formula nasal solution frozen was received from a mother regarding her 24 month old son who accidentally received Flumist, and experience a runny nose, sneezing, a fever of 102 degrees F and looks like a "sick kid". At 24 months of age, the patient received a dose in early December 2003. Approximately 5 days post-immunization, the child developed a runny nose and sneezing. On 30-Dec-2003, he developed a fever of 102 degrees F and was treated with Children's Motrin (Ibuprofen). On 31-Dec-2003, he developed a fever of 102 degrees F and was treated with Children's Motrin (ibuprofen). On 31-Dec-2003, the fever resolved, but the mother stated he looked like a sic kid. As of 5-Jan-2004, the runny nose persisted. No additional information was available at the time of this report.
Patient is 17 year old and required a dose of Pfizer BioNTech 0.3 ml, but received Pfizer BioNTech (5-11Y) 0.2ml. Parent notified. No adverse reaction noted. Immunization Program notified.
First shot:  102 fever for first 3 days after vaccination.  Then chest pain day 4-6.  Shortness of breath, fatigue for 7 days.    Resting heart rate elevated from 60 to 90 for 13 days.   2nd Shot:   Same response & duration.  Not as severe.  Fever was 100.     My heart rate monitor measured high Heart Rate Variation during both shots.  2-1/2 months after first shot, resting heart rate & heart variation returned to almost normal.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with asthma. The patient has unspecified reactions to codeine and tetracycline. On 22-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # J004196 (exp06-DEC-2014), 0.5 ml once, intramuscular in the left arm for having asthma. Concomitant therapies included Diazepam (manufacturer unknown), pantoprazole and Qvar. The pharmacist reported that after the patient received PNEUMOVAX23, she experienced redness at the injections site and swelling of the "entire" injected arm. The patient received the vaccine in the left arm. Event onset date was unspecified. The pharmacist reported that the patient came back into the pharmacy on 23-NOV-2013 to report this reaction. No treatment was given. No lab test was done. Outcome of the event was unknown. Additional information has been requested.
Moderna COVID-19 vaccine administered to 14 year old female; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to 14 year old female) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to 14 year old female). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to 14 year old female) outcome was unknown.        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.
Mild red raised rash with no itching. Not hot to touch, but was blotchy. About a 1/2 inch to 1 inch from actual injection site. Some pain when significant pressure added. Took some Benadryl and has seen it stop getting worse.
Received H1N1 vaccine on 1/16/2010. Returned to clinic on 1/22/2010 with moderate macular-papular rash. Patient says hives appeared 1/21/2010 and much improved today. Mild itching. *No treatment prescribed.
Fatigue, tingling to extremities, fever of 102, headache, and nausea.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 05/06/2021 and 06/03/2021. They presented to Emergency Department on 10/22/2021 with primary complaints of fever, shortness of breath, and anxiety. They were admitted to hospital same-day. They also tested positive for COVID-19 on 10/22/2021. They also died later the same day, after suffering a cardiac arrest.
This spontaneous report was received from a physician and refers to a 19 year old non-pregnant female patient. The patient's concurrent conditions included adjustment reaction, childhood asthma and unspecified allergies. The physician indicated that the patient had no drug reactions/allergies. There was no information about the patient's medical history. The patient's concomitant therapies included LEXAPRO. On 08-AUG-2017, the patient was vaccinated with GARDASIL 9 dose 1, 0.5 ml, intramuscular for prophylaxis, lot # N007931, expiry date 17-NOV-2019. On 31-AUG-2017, the patient experienced swelling and tenderness at the injection site. The reporting physician indicated that there was no redness or heat at the injection site. It was reported that there was no lab diagnostics/studies performed or treatment given for the adverse events. At the time of the reporting, the patient was not recovered from the injection site pain and injection site swelling. The causal relationship between the events and therapy with GARDASIL 9 was not reported.
DTAP-IPV (Quadracel) was administered to a 2 year old. Patient has not experienced any adverse reaction.
p/vax pt devel inj site react; edema; redness & hard knot beneath the inj site;
Injection site pain; Blood pressure high; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and INJECTION SITE PAIN (Injection site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055C21A, 015M20A and 027L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 07-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced HYPERTENSION (Blood pressure high). On 17-Aug-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 17-Aug-2021, INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, HYPERTENSION (Blood pressure high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: Blood pressure high.         Concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of pain at injection site with humira(adalimumab) was no reasonable possibility and the event of high blood pressure was not provided.   Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt stated that she developed pain to the left arm and points to the Left shoulder blade area. She tnen had a muscle spasm to the left arm on the following Monday.  She also developed numbness and tingling in left neck, shoulder and elbow.  Her pain worsened in the left shoulder blade area and not at the injection site.  No fever or chills.
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine had expired on 23-Dec-2021 No concomitant medication were provided. No treatment information were given.
Leg weakness, exacerbation; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2023BI01180152.  A 70-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Leg weakness, exacerbation".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.