chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received their second dose of the Moderna vaccine 8 days prior to the 28 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history provided.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their second dose of the Moderna vaccine 8 days prior to the 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report). This case was linked to MOD-2021-050270 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs. US-MODERNATX, INC.-MOD-2021-098304:
Employee came in for a Varicella shot (Booster) was given in Lt. arm SQ on 7/18/13. EE came back in on 7/19/13 for a blood draw and was given a second varicella shot Rt. arm SQ. On 7/27 the site on the Lt. arm was painful, red, hot, swollen and a lesser reaction on the Rt. side. EE wand 2nd shot 7/19/13 APN. To Occ Health to be seen 7/29.
left shoulder hurts; Bleeding Injection Site; Bruised Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site), VACCINATION SITE BRUISING (Bruised Injection Site) and ARTHRALGIA (left shoulder hurts) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A)) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site) and VACCINATION SITE BRUISING (Bruised Injection Site). On 18-Mar-2021, the patient experienced ARTHRALGIA (left shoulder hurts). On 25-Feb-2021, VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site) had resolved. On 18-Mar-2021, VACCINATION SITE BRUISING (Bruised Injection Site) had resolved. At the time of the report, ARTHRALGIA (left shoulder hurts) had resolved.            no Concomitants product was reported.  no treatment product was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: TCR received on 11-06-2021 updated the outcome of the event. AE was resolved.
pt recvd vax 91JAN95 & on 20JAN95 pt mom reported extreme fussiness & temp to 102.8; advised APAP q 4 hrs;
3/20/06 Mom reported that on the 3rd day after his immunizations son developed a square area at the back of his arm that was red and then it spread some to the front of his arm. Mom took son to the DR on 3/22/06 and was told that it was just a rash that had nothing to do with the shots he received. Prescribed hydrocortisone cream.
pt died during the noc p/1st set of immun were given @ clinic that day; exaxt time of death unk;
Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given.  Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning.  Additionally endorses feeling a dry mouth sensation.
Information has been received from a registered nurse concerning a 10 year old male with a history of a grade 4 splenic rupture and no known allergies, who on 25-FEB-1997 was vaccinated SC with a first dose of Varivax (lot # 620622/1342D). There was no concomitant medication. There was no illness at the time of vaccination. On 03-FEB-2007 the patient broke out with 15-20 itchy, erythematous papules most prominent on the trunk, some were reported to have a "dewlike substance" centrally. The patient was seen in the office on 04-FEB-2007, the patient had no fever. No treatment was provided. There were no lab studies performed. It was reported that the patient had four classmates who had chickenpox within the last couple of weeks. On 05-FEB-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Pt stated he got arm soreness 1 week after vaccine administration.  (1st week he was pain free) & 1 mo. after vaccine admin, he can only raise his arm up to 90 degrees.  Stated he did not have pain or swelling upon receiving the vaccine.
Redness, edema at injection site approximately 5-6 inches in diameter 1 day after receiving vaccine, edema all the way down to elbow area.
Fever started 10 days after immunizations and lasted 4 days.  Rash started 6 days after immunizations and lasted 6 days.
Pt eyes rolled back in head, upper arms jerked.  Lowered to floor and elevated feet.  Monitored for 30 minutes.  Pt able to walk out without assistance
Fever, chills, joint pain, headache, swelling at the injection site.  All but swelling resolved after 48 hours.  Injection site continues to have redness and swelling about 3 inches in diameter, 72 hours later.
Multiple patients (25) had wrong lot number entered in database (was FK9729, should have been listed as FK9894).
PT REPORTED 2 BY 2 RAISED BUMP NEAR INJECTION SITE.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 16 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, got the last dose of the primary series (Pfizer-BioNTech COVID-19 Vaccine) on Jun2021), administration date: Jun2021, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "muscle and armpit pain after getting the booster dose". Therapeutic measures were taken as a result of myalgia, axillary pain. Additional information: Reporter stated that her daughter (16 years old) got the last dose of the primary series (Pfizer-BioNTech COVID-19 Vaccine) on Jun2021 and this Friday on 18Feb2022 got the booster dose. Reporter would like to know the difference between the primary series and the booster in terms of dosage and queried were they the same or was it just half the usual dose like Moderna. Reporter also stated that her daughter (16 years old) has experienced muscle and armpit pain after getting the booster dose and queried other than applying ice and taking Tylenol, what can we do, was it normal. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Second shot received 03/23/21.  In mid-May upon going to bed, I realized that I could not feel the sheets against my legs (from my knees down). The next morning my legs below my knees were tingling.  That sensation never goes away.  Sometimes the tingling is also felt in other parts of my body, including up to, and in my face and lips.  I have also, on occasion, experienced weakness in my left arm.  I have been seen by my general practitioner asn a neurologist. Neither has an idea as to what's causing the sensation.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 25th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, gastric disorder, headache, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, gastric disorder, headache, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, gastric disorder, headache, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced gastro issues after receiving SHINGRIX. The patient did not elaborate as to what the gastro issues were. The patient declined to participate in the report.
Red rash, muscle pain, it has been over 1 week, the red rash , stiff muscle, and pain not going away
After the Anthrax injection my right shoulder was very sore for several days on the October 10 I ended up in the emergency room since I could move my arm.  I was diagnose with frozen shoulder.  I was given several medications for the pain and a steroid injection.  I'm currently doing physical therapy.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M03616; expiration date, dose and route were unknown). On an unknown date, the patient experienced cellulitis. It was unknown if the patient sought medical attention. No treatment was given for the event. The outcome of cellulitis was unknown. The causality was not reported. Upon internal review, cellulitis was considered to be medically significant. Additional information has been requested.
Client had an anxiety attack and EMS was called.  Due to HBP, EMS monitored and administered a steroid.  They indicated that her existing asthma was aggravated.  Spoke with Client today, a day later and she indicated over the phone she is doing well.
Had VARIVAX vaccine administered on 3-26-12 at about 9:00 am - a little after felt light head & headache late afternoon was nausea and lightheaded worsened. Was having difficulties breathing about 5:pm went home rested. Next day 3-28-12 at about 8:00 am came to notify symptoms to Occ Health - cont with difficulty breathing, rash to chest & (Lt) area = went to her MD was told had minor anaphylactic reaction not totally sore & was given ER work up - that same afternoon was better.
At approximately 26 hours old, the pt received a Hep B vaccine. The pt developed apnea and cyanosis approximately 21 hours later. The pt was admitted to the hospital, where apnea and cyanosis worsened over the next 3 days, progressing to tonic seizures. EEG was abnormal on 4th hospital day. Phenobarbital started, apnea, seizures and cyanosis stopped. EEG improved. Treated with IV antibiotics and IV acyclovir. The pt was discharged after 12 days in the hospital without etiology for seizures and apnea. Cognitive and motor skills delayed at about 9-12 months. Hepatitis B vaccine has now been questioned as etiology. On 60 day FU diagnosis of developmental delay. The annual follow-up states seizure disorder and development delay.
After receiving the vaccine, client lost consciousness and collapsed to the floor. EMS was summoned. Client had two separate seizures, regaining consciousness in between and after. Client was taken to local hospital for care via ambulance. Attempts to contact client on 3/21/2021 and 3/23/2021 unsuccessful.
Muscle pain; Joint pain; Lymph node pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and LYMPH NODE PAIN (Lymph node pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-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 MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and LYMPH NODE PAIN (Lymph node pain). At the time of the report, MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and LYMPH NODE PAIN (Lymph node pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a physician, via field representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dosing details unknown). Concomitant medications were not reported. On an unknown date the patient experienced cold-like symptoms, after each dose of GARDASIL. Patient experienced fever, nausea and cold like symptoms and had to stay in bed for a couple of days after each dose of GARDASIL that she received. Patient sought medical attention (unspecified how). Physician decided not to administer the third dose of GARDASIL. The patient was not hospitalized for the events. The experience was not life threatening nor did it cause a significant disability or incapacity. The patient recovered from cold like symptoms, fever and nausea. Causality assessment was not provided. Product quality complaint was not involved. Additional information is not expected, since no further information was provided and physician could not be contacted.
first booster it was a terrible headache that went on for longer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "occipital neuralgia" (unspecified if ongoing), notes: She had preexisting conditions prior to the Covid vaccines and that condition is occipital neuralgia. The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Caller had a mixture of both Pfizer and Moderna. Caller has filed VAERS on Moderna.), for Covid-19 Immunization; Bnt162b2 (Caller had a mixture of both Pfizer and Moderna. Caller has filed VAERS on Moderna.), for Covid-19 Immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "first booster it was a terrible headache that went on for longer".  Additional information: The patient reported that she had a really horrible reaction to the last booster of the Pfizer COVID-19 vaccine (gray, monovalent).  She reported a history of "occipital neuralgia" which she had before receiving any covid vaccines.  She stated that it felt permanent, like a worsening of the occipital neuralgia noting it starts days after the vaccine. I think this last time it started 5 days... but before that with each vaccine. She had occipital neuralgia and she didn't get it from the vaccine, but originally, she just had a terrible headache for a few days, the second one she had a terrible headache for like 2 weeks, then the first booster it was a terrible headache that went on for longer, and this last one just killed me, it just killed me.  She noted, "I haven't gotten over that one yet and that was almost 2 months ago, maybe I'll never get over it, I don't know".  She also said, "I don't think this last vaccine did anything for BA4 &5, everyone I know who's also worn a mask, has gotten it, and they all got pretty sick, too."  She also stated that she would not be taking another booster "until 6 months go by". She does report having a mixed series, "I had a combination of both Pfizer and Moderna trying to see if one worked. " and "I think I did a VAERS on the Moderna".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8 hours post injection lymph nodes swollen in head and neck with pounding headache. 9.5 hours in fever of 101.1 oral temp. Breaking on or about 0430 3/13/21 down to 100.4. Shivering on and off during fever with whole body aches for full 24 hours with lose of appetite as well. 3/14/21 diarrhea x3 but starting to feel a less aches. 3/15/21 headache  tired with diarrhea x1, and hopefully the end of it.
Patient experienced headache, tightness in chest and throat, pain throughout the body, and a swollen tongue. Patient took BENADRYL and felt better the next day, but still has pain in the body.
VOMITING; CHILLS; FEVER; HEADACHE; NAUSEATED; TIREDNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no medical conditions and no chronic medications. Patient had no known allergies. No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-NOV-2021, the patient experienced tiredness. On 27-NOV-2021, the patient experienced nauseated. On 28-NOV-2021, the patient experienced headache. On 29-NOV-2021, the patient experienced chills. On 29-NOV-2021, the patient experienced fever. On 30-NOV-2021, the patient experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient recovered from tiredness, and headache on 28-NOV-2021, and had not recovered from chills, fever, nauseated, and vomiting. This report was non-serious.
large swollen area on lt anterior thigh, sore, mild itching, area 3.5 x 3;temp 101, tx DPH, Advil & cool compresses;19MAy95 area on thigh is discolored, swollen 4-5 inch in diameter & warm to touch;
1st dose vaccine 1/21/21; developed nausea, weakness, vomiting, diarrhea, and chills on 2/4/21; seen at ICC 2/5/21.
flu like body aches; This case was reported by a consumer via call center representative and described the occurrence of flu-like aching in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis multiple joint. Concomitant products included paracetamol (Tylenol) and diclofenac (Voltaren Gel).   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2020, 1 days after receiving Shingrix, the patient experienced flu-like aching. On 9th October 2020, the outcome of the flu-like aching was recovered/resolved.   It was unknown if the reporter considered the flu-like aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu like body aches during the day and these resolved. The reporter stated this pain interferes with sleep.  The patient was able to sleep and arthritis pain resolved and it did come back. The reporter consents to HCP follow up and did not had address.  No additional information was available from customer. This case linked with US2020208339, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208339:same reporter
Post vax the patient's arm was swollen from the injection site down to the elbow. The patient was treated with Benadryl.
received an ActHIB vaccine with an expired diluent; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA096852 (same reporter).  This case involves female patient of an unknown age (child) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent of 18-Feb-2019 lot number not reported via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Expired vaccine used. The office that received an ActHIB vaccine with an expired diluent of 18Feb2019.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Allergic to Cephalosporin anitbotics" (unspecified if ongoing); "ITP" (unspecified if ongoing), notes: IVIG medical treatment for ITP; "IVIG medical treatment" (unspecified if ongoing), notes: IVIG medical treatment for ITP. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: I first tested positive for covid; (Dec2022) Negative, notes: testing negative; (Dec2022) Positive, notes: started getting symptoms again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment was started on 05Dec2022 and treatment was stopped on 10Dec2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.