chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOW BLOOD PRESSURE (USUALLY 120/80 WAS AT 90/60); WEAKNESS; DEHYDRATION; COULD NOT GET OFF THE FLOOR; SO SICK; VOMITING SO BAD; NAUSEA; FEVER; This spontaneous report received from a parent concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure (NR: not provided) 90/60 (units unspecified), 120/80 (units unspecified), and COVID-19 virus test (NR: not provided) Not reported. On 07-APR-2021, the patient experienced dehydration. On 07-APR-2021, the patient experienced could not get off the floor. On 07-APR-2021, the patient experienced so sick. On 07-APR-2021, the patient experienced vomiting so bad. On 07-APR-2021, the patient experienced nausea. On 07-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On an unspecified date, the patient experienced low blood pressure (usually 120/80 was at 90/60), and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration on MAY-2021, could not get off the floor, and vomiting so bad on 10-APR-2021, and so sick, nausea, fever, and weakness, and had not recovered from low blood pressure (usually 120/80 was at 90/60). This report was non-serious. This case, from the same reporter is linked to 20210901129 and 20210900297.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (BREAKTHROUGH); This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, non smoker, and alcohol user. The patient had no known allergies. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: unknown) dose was not reported,1 total, administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-OCT-2021, the patient experienced breakthrough (suspected covid-19 infection) and the patient tested positive for Covid-19 with mild symptoms (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (breakthrough) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211006677-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills
Patient reports, fever, muscle and left arm pain, weakness, pruritus on left arm and lump above left clavicle.
This spontaneous report was received from a pharmacist and refers to a 21-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 08-APR-2017, the patient received the first dose of GARDASIL 9 (lot number, expiration date, and dose regimen details were not provided) for prophylaxis. On 10-MAY-2017, the patient received the second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection; Headaches; Chills; severe muscle aches; Felt like she had the flu; Bladder hurt so bad; So sick; Sore Arm; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ILLNESS (So sick), INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad) and DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 706-042) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and FATIGUE (Fatigue). On 23-Sep-2021, the patient experienced ILLNESS (So sick). On 23-Sep-2021 at 1:00 PM, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (severe muscle aches). On an unknown date, the patient experienced DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection). The patient was treated with PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM) for Adverse event, at an unspecified dose and frequency; CRANBERRY [VACCINIUM MACROCARPON] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Sep-2021 at 1:00 PM, FATIGUE (Fatigue) had resolved. On 24-Sep-2021, PAIN IN EXTREMITY (Sore Arm) and ILLNESS (So sick) had resolved. On 24-Sep-2021 at 9:00 AM, INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad), DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (severe muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she has no other underlying illnesses. Patient also used cold packs for treatment of adverse event.
The Janssen vaccine was given to the patient. Patient previously received 1 dose of the Pfizer vaccine on April 23rd, 2021. On follow-up with patient, no adverse reactions were noted from the Janssen vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3247), on 09Feb2021 as dose 2, single (Lot number: EM9810) and on 13Oct2021 as dose 3 (booster), single (Lot number: BT5196248) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Low sodium" (unspecified if ongoing), notes: Low sodium. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient blacked out (10 sec) post vaccination-Mild, Additional Details: Post vaccination pt blacked out for 10 sec while sitting in the chair immediatly post vaccination. NP was called to assess. Patient became responsive shortly and was given water and chips via employee. Patient stated she has a fear of needles and always passes out while given blood for Hoshimotos which is in remission. Called paramedics and assessment was normal. Mother of pt came shortly after and confirmed daughter usually passes out from needles. Issued form for no liability was signed. Pt walk
Massive headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Aug-2021 and was forwarded to Moderna on 28-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Massive headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Massive headache). At the time of the report, HEADACHE (Massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided.  No treatment information was mentioned.   This case was linked to MOD-2021-300853 (Patient Link).
Injection was given into the deltoid at an almost vertical angle.  After about two hours, and lasting five days, the left arm was extremely sore to the point that assistance was needed to don and remove clothing.  This is considered adverse as compared to the initial injection into the left bicep which resulted in absolutely no side effects.  I believe the location of the second shot drastically effected the outcome.
Itchy, red rash with small bumps on skin aggravated by hair or friction points from clothes.
Patient stated she had redness around the injection site that became more prevalent on the morning of 8/11/19
left arm became sore after event and is still sore since 11-3-2021 and today is 12-29-2021. she said it feels like a charlie horse in her left arm is still very sore.
Pt recvd 4 doses of Hep B vax, 3rd given 22AUG90 & 4th given 18OCT90; It was determined that the pt was not immune to Hep B;
1. Weakness Active   2. Anxiety    3. Abnormal urine    4. Pulmonary artery hypertension     ASSESSMENT/PLAN/DECISION MAKING: -No etiology found for patient's weakness, D-dimer was elevated but PE ruled out with CTA. Patient improved with 1 liter normal saline bolus and reassurance she wasn't having a stroke. Patient's daughter in law and daughter are concerned that patient is more anxious. I'll let her PCP manage this as an out patient.  -Out patient physical therapy advised and referral placed -Follow up at the ED if concerns or symptoms worsen or persist.   Cardiac office visit 4/29/21: 1. Fatigue, unspecified type; ECHOCARDIOGRAM ADULT COMPLETE 2. Light headed; ECHOCARDIOGRAM ADULT COMPLETE 3. Palpitations; ECHOCARDIOGRAM ADULT COMPLETE  93-year-old pleasant female who I saw today in referral because of dizziness.  She is otherwise relatively healthy.  She takes blood pressure medicine.  She did have episode of lightheadedness that lasted about 30 seconds at home a few weeks ago.  She felt weak.  She eventually sought evaluation in the ED on 4/10/2021.  She has had no further episodes.  Otherwise, denies any chest pain.  She has mild dyspnea on exertion that has not changed.  No orthopnea or PND.     9/8/21: Acute cystitis with hematuria.    10/1/21: Hypertension, unspecified type   Burning with urination   Anxiety   Recurrent major depressive disorder, in partial remission     Plan: The patient will have a CBC, CMP, UA and covid test today. She will be notified when the results are available. For now she will continue on her current medications. Follow-up will depend on the results of the tests.   10/28/2021  Weakness -     URINE DIP, REFLEX TO MICROSCOPIC, REFLEX TO CULTURE; Future -     COMPLETE BLOOD COUNT WITH DIFFERENTIAL; Future -     COMPREHENSIVE METABOLIC PANEL; Future -     LACTIC ACID; Future -     XRAY CHEST PA AND LATERAL; Future -     SARS COVID ANTIGEN; Future   Fever, unspecified fever cause -     URINE DIP, REFLEX TO MICROSCOPIC, REFLEX TO CULTURE; Future -     COMPLETE BLOOD COUNT WITH DIFFERENTIAL; Future -     COMPREHENSIVE METABOLIC PANEL; Future -     LACTIC ACID; Future -     XRAY CHEST PA AND LATERAL; Future -     SARS COVID ANTIGEN; Future   Anxiety -     COMPLETE BLOOD COUNT WITH DIFFERENTIAL; Future -     COMPREHENSIVE METABOLIC PANEL; Future -     LACTIC ACID; Future     Plan:  Fluids and potassium replacement OP.
loss of hearing; Tinnitus\has roaring in her ears; bad asthma; This serious case was reported by a other health professional via other manufacturer and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER COVID VACCINE) for prophylaxis.   Concurrent medical conditions included allergy (allergic to Chinese hamster).   On an unknown date, the patient received Shingrix and PFIZER COVID VACCINE. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant), tinnitus (Verbatim: Tinnitus\has roaring in her ears) and asthma (Verbatim: bad asthma). The outcome of the hearing loss and tinnitus were not resolved and the outcome of the asthma was not reported.   It was unknown if the reporter considered the hearing loss, tinnitus and asthma to be related to Shingrix.     It was unknown if the company considered the hearing loss, tinnitus and asthma to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023. It was reported the patient try to figure out if it was the cause or the Covid vaccine. It was reported a lot of people were getting the same thing.  It could be caused by Shingrix vaccine because it was around the same time.  The patient had roaring in her ears, basically tinnitus and has seen 2 ENT's and they had the same answer, loss of hearing. Two years ago the patient hearing test and then this time to see what was going on with the noise in her ear and loss of hearing. The recent hearing test was identical to the other one.  It was not like she all of a sudden lost hearing and was having tinnitus. It was bothersome and it was getting louder.  The patient trying to figure out how to get rid of it and what could have caused it. The patient's friend's nephew took the Covid shot and he has the same problem, tinnitus.  A lot of people were talking about it online and are demanded testing.  The patient didn't have the problems two years ago and had regular hearing test.  At the time of reporting with tinnitus they said had a hearing test. They compared the two hearing test and they were identical.  It couldn't have been identical.  It couldn't take 2 years to get tinnitus with no change in hearing test.  It could have happened because of the Shingrix.  The patient clarified the Covid vaccine was the Pfizer Covid vaccine.  After the Shingrix she got bad asthma and couldn't shake it and she went to allergist and apparently there was chinese hamster in that vaccine and that was what she was allergic to. It was unknown if the reporter considered the hearing loss, tinnitus and asthma to be related to covid vaccine.
Patient rec'd vaccine in A.M. - by evening shoulder very painful and reduced range of motion. She waited approx. 4 wks with no improvement. Saw PCP who prescribed 3 days oral steroids and PT referral. Has had improvement and ongoing PT approximately x 6 wks.
No additional AE's; improperly stored PROQUAD vaccine was administered; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 29-APR-2021, an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T031603, expiration date on 15-MAR-2022) (strength, dose, route of administration, dose were not reported) for prophylaxis. No additional adverse event was reported.
am 2-21-02: Fever, stiff neck, headache. Pain in shoulders and muscles all over body. cough and wheezing loss of appetite, weakness in legs and body.
Patient got swelling in the injection site about 2-3 inches in diameter 1 day after the injection and swelling in the left side mandibular jaw, shin and lip. Patient took ibuprofen otc and CLARITIN beginning the day the swelling occured. Patient reported to the primary physician and was prescribed Valacyclovir 500mg four times a day for 6 days. Patient has yet to pick up the medication. Patient said the swelling started to subside on the 4th day even though she has not taken the anti-viral drug.
Pharmacist reported that an adult might have received PROQUAD.; No additional adverse events; This spontaneous report was received from a pharmacist concerning an adult patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient might had been vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
She still has a sore arm from shoulder to elbow after almost 2 months of getting the vaccine.
administered ACTHIB to a patient after it was expired for a week with no reported adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced administered acthib to a patient after it was expired for a week with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious administered acthib to a patient after it was expired for a week with no reported adverse event (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered ACTHIB to a patient after it was expired for a week with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered acthib to a patient after it was expired for a week with no reported adverse event.   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 the guidelines. 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.
Swelling, redness, itching and burning radiating out from injection site starting two days after, increasing in severity over time, got to the size of an orange, went to urgent care, treated with steroids and antihistamines. All localized, no other symptoms. Medication started 1/13/2021 but the initial antihistamine helped with discomfort.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID positive test result; Negative, notes: Then on day 9, a negative test result; Positive, notes: COVID symptoms returned and positive test result 12 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I experienced a rash that began in my perineum area with intense itching, pain, changing the nature, texture, and look of my skin in my whole vulva to rectum area. On 08/15/2021 I sought care from a gynecologist, but was not diagnosed or treated. On 10/13/2021 I was visually diagnosed with lichen sclerosis, and a biopsy to confirm diagnosis was scheduled. The steroidal ointment Clobetasol propionate 0.05% I was prescribed 10/2021 only helps with the itching and pain, while the rash is not improving. The cream is suppose to help prevent it from becoming cancerous, or causing such severe scarring I am unable to do normal body functions. On a subsequent doctors visit on 11/10/2021 my vulva biopsy on the rash was performed to confirm my diagnosis of lichen sclerosis, mild epithelial fibrosis result of biopsy. I have not recovered from this adverse event and am seeking ongoing care.
This spontaneous report as received from a pharmacist refers to a patient (id# 566) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 02-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.