chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 62 female with a history of breast cancer and in 1998 and a right breast lump excision who on 12-APR-2007 (also reported as 11-APR-2007) was vaccinated subcutaneously in the right arm with a dose of ZOSTAVAX (Merck) (lot# 656861/0329U). Concomitant therapy included levothyroxine Na (SYNTHROID), raloxifene hydrochloride (EVISTA), alendronate sodium (MSD), olmesartan medoxomil (BENICAR), alprazolam, loratadine (CLARITIN) and bupropion HCl (WELLBUTRIN). The physician reported that the patient was vaccinated on 12-Apr-2007 (also reported as 11-APR-2007) and 17-APR-2007 the patient had a mammogram that showed swollen right axillary lymph nodes present on the same side of her vaccination. Unspecified medical attention was sought. Patient had an ultrasound which showed an enlarged right axillary node probably reactivated to recent hormone changes or secondary to vaccination with ZOSTAVAX (Merck). No product quality complaint. At the time of the report, the patient had not yet recovered. No further information is expected.
Left deltoid red, warm, swollen; eyes (bilaterally) swollen; wheezing; eczema.
Smell Smokey car fumes most of the time. It does come and go but more at the moment.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD), COVID-19 and latex allergy. Concomitant medications were not reported. The patient previously took famotidine (MANUFACTURER UNKNOWN) and dexamethasone (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 16:30, the patient "smelled smokey car fumes most of the time. It did come and go but more at the moment. Began a few hours after injection". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event "smelled smokey car fumes most of the time" was not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
ten pound weight gain (5%) of body weight that has endured through the present time and is not attributable to an increase in calorie or decrease in activity
patient fainted 5 minutes after transfer to waiting area he fell and I run to see if he is ok He gained concious in less than 2 minutes , I applied cold compress to hid neck checked his BP and pulse it was ok but I already told my staff to call 911 once he fell, paramedics came and he was doing well watched him for another 20 minutes make sure he can leave and doing ok, he said he having phobia from needles and he didn't eat
Suspected vaccination failure; Shingles; Blistering; intense pain in right lower back area; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz Xr) for an unknown indication.   Previously administered products included Methotrexate with an associated reaction of hepatic enzyme increased (The form, route, and dose used by the patient was not specified).   On an unknown date, the patient received Shingrix and Xeljanz Xr 11 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and back pain. The action taken with Xeljanz Xr was unknown (Dechallenge was unknown). Rechallenge with Xeljanz Xr was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blister and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient had the shingles again, till the date of reporting and had blistering and intense back pain in right lower back area which had happened numerous times. The patient had Shingrix vaccine and has and had at least 3 outbreaks even since then. The reporter stated that the patient stopped her Xeljanz when the shingles breaks out. As per current medication, the patient was prescribed Xeljanz XR 11 mg one tablet daily. All quotations in that verbatim entered as they appear in the reporter's documentation. It was unknown if the reporter considered the shingles, blister and back pain to be related to Xeljanz Xr. No additional information provided. FBallentine LVN It was unknown if the reporter considered the vaccination failure, shingles, blister and back pain to be related to Shingrix. This case was considered as suspected vaccination failure, as the time to onset, details of primary immunization and laboratory confirmation for Shingles were not provided.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 63-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 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications are reported. No treatment medication details was reported.   This case was linked to MOD-2021-218790 (Patient Link).
Patient became lightheaded and nauseous approximately 15 minutes after receiving her vaccine. She also complained of having numbness that radiated from her neck to her fingers in the arm that had received the injection. Patient stated that she typically has low blood pressure usually in the 90/60 range. During the incident patient's blood pressure range from 108/74 to 123/69 with heart rates from 61 to 66 to BPM.  Oxygen levels remained normal. Patient took one puff of albuterol inhaler that she had with her at 1311 because she felt ?a little tight?. At 1325 patient stated nausea had subsided and that lightheadedness had transitioned to fatigue. Patient was A&OX4. Patient stated she felt well enough to drive home and be observed by spouse.
Pt arrived in clinic 8/18/03 at 16:00 for vax. Temp 98.5, weight 45 lbs, H 45, B/P 98/48. Vax given. After 5 minutes right arm became erythematous, 5-7mm. Claritin 10mg tab given. Pt improved after Claritin was given. Remained in clinic for 30 minutes to be watched. 8/21/03 at 8:30 AM pt arrived at clinic c/o mother worried about injection site. Redness had improved, but right arm still erythematous about 4-5cm. Temp was taken 97.6, pulse 88, resp 22. Claritin Pandy tab given for 3 days. Come back if further problems.
The patient has a known genetic predisposition to pancreatitis. He received his first Pfizer Covid vaccine on 5/23. On 6/13 he had mild pain consistent with his history of pancreatitis. He was able to treat this at home with oral pain medications so did not have to seek other care. He received his 2nd Pfizer Covid vaccine 6/19. On 6/24 he had onset of more severe abdominal pain so went to the ER.  There his lipase was found to be >6000. He was admitted for acute pancreatitis. He was given IV fluids, pain control until his symptoms resolved.
The nurse messed up the dates and she didn't get her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The nurse messed up the dates and she didn't get her 2nd dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The nurse messed up the dates and she didn't get her 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The nurse messed up the dates and she didn't get her 2nd dose) had resolved.            Concomitant product information was not provided. Treatment information was not provided.
I was diagnosed with idiopathic Premature Ovarian Failure/Primary Ovarian Insufficiency after receiving one dose of the GARDASIL QUADRIVALENT vaccine. I have no other health issues and have tested negative for Fragile X. I know this vaccine has been linked to ovarian failure so I felt the need to report it.
Rash at injection site, hot to the touch; difficulty breathing; patient reported to the ER at unknown time and date and was treated; patient reported to the pharmacy on 5/9/19 at 10am with no further s/s of reaction
Three weeks after vaccination I began being woken up around 6 AM with loud buzzing in my head and I would experience extreme fatigue for about 4 hours afterwards. Went to PCP and ER, lab work was performed but no irregularities were found. These events occurred for about 3 weeks and then resolved.
headache; Felt weak; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, brand: Pfizer-biontech, Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 at unspecified location as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-biontech, Batch/Lot number was not reported) for covid-19 immunisation on 08Feb2021 and had no side effects. On unspecified date the patient experienced, the day after second dose he experienced headache and felt weak however there was no fever, and he is feeling better now. Outcome of the events headache and felt weak was considered as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Report concerns a pregnant female with a history of varicella, who was splashed in the eye as her child was being vaccinated with varicella virus vaccine live (01/21/1999); pt gave birth to a normal healthy male (06/09/1999). Follow up: Concomitant therapy during the pregnancy included prenatal vitamin. The pt was 18 weeks pregnant at the time of exposure. LMP was 07Sep1998. Estimated date of delivery is 14Jun1999. Ultrasound performed five times during the pregnancy was normal each time. Maternal serum alpha fetoprotein test on 05Jan99 was normal. On 05Feb99 laboratory evaluation revealed human parvovirus B19 0.17. On 09Jun99 at 39 weeks from LMP the pt gave birth to a normal healthy male. Birth weight was 7lb, 6 oz. No further information is available. This is an amended report. The date of vaccination, vaccinated at, and vaccine purchased with were removed. This report is corrected as amended.
Unauthorized age group: 16yo received Moderna dose 1 on 4/27/21. Presents to clinic for dose 2 today (5/25/21). Patient and guardian counseled and consent form completed.
Long-lasting case of Covid after booster. Self-treatment with over the counter meds at home. I got the first symptom on March 30 and I still have symptoms today, April 27. Symptoms: headache, cough, sneezing, dizzy, fever and chills, upset stomach, ears plugged, sore throat, congestion, lack of energy, brain fog, lost sense of taste and smell.
I woke up fine with a slight headache. Within 30 minutes, the nausea and dizziness set in. I went to lay down and then experienced abdominal pain, dry heaving and vomiting. I took Tylenol, Gatorade,  ondansetron for nausea.
mild pain at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain at the shot site) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild pain at the shot site). At the time of the report, VACCINATION SITE PAIN (mild pain at the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medications were reported.
Lip swelling, starting on morning following 2nd COVID-19 vaccine. Treated with Benadryl.
Headache; Fatigue; Feeling unwell; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 MRNA VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 MRNA VACCINE number: EK5730), intramuscularly right deltoid on 21Dec2020 at a single dose for COVID-19 immunization but had tired, feeling unwell, lethargy, headache, and Covid 19 Ab on 05Jan2021 with + (positive) result, comments: (+) for antibody. The patient received the vaccine from a hospital that is not a facility. The patient reported that he was positive (+) for headache, fatigue and feeling unwell on the second dose with the "best & time" [pending clarification] of 5 days (16Jan2021). The outcome of the events was unknown. The reported considered the Pfizer product had a causal effect to the adverse events.  The following information on the batch/lot number has been requested.
Information has been received from a physician concerning a 72 year old female with no pertinent medical history or allergies who on 02-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX vaccine (OKA/Merck) in the deltoid area. There was no concomitant medication. On 04-JUN-2008 the patient developed pain and redness. No other symptoms and no treatment reported. No laboratory or diagnostics studies was performed. At the time of the report, the patient's pain and redness persisted. Additional information has been requested.
feeling "tired"; feeling/  "achy"; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.  The additional details were provided as follow: The patient self-reported the case. The patient received 1st dose of Shingrix and experienced tiredness and pain but these lasted for 12 hours only. No consent given to follow up with his HCP. The patient did not consent to follow up. The patient did not receive his 2nd dose, please refer case US2021AMR117971.; Sender's Comments:  US2021AMR117971:
Pain in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and flu vaccine with an associated reaction of pain in extremity (received on an unknown date, refer case US2019AMR197055).   On 5th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On 7th August 2019, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. A day after vaccination the patient experienced pain in her left arm that lasted for approximately 1 day. The reporter did not consent to follow up.
COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 020B21A-1) for COVID-19 vaccination.     Patient had no allergies to medications, food, and other product.  It was unknown patient had acute illnesses at the time of vaccination and up to one month before.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Company comment-This Spontaneous case concerns a 30-year-old, female patient with no medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), approximately 6 months 28 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 34 days apart. Hence vaccination failure is considered in the case. No further details on clinical course, lab test results and treatment received were reported.  At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19 could be confounding factor for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538933 (Patient Link). Sender's Comments: This Spontaneous case concerns a 30-year-old, female patient with no medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), approximately 6 months 28 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 34 days apart. Hence vaccination failure is considered in the case. No further details on clinical course, lab test results and treatment received were reported.  At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19 could be confounding factor for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt stated that for the first 24 to 36hr had a h/a & was sick to stomach;this passed;13AUG97 pt broke out in huge welts all over body;went to MD 15AUG97 was hosp for 24hr then released as an outpatient;
pt recvd vax & w/in 15 mins to 30 mins pt devel hives & an itching rash; pt was treated w/DPH;
9-16-13 Mom called to state took pt to ER 9-15-13 and family doctor on 9-16-13 for lt arm being swollen tender and painful and swelling going up arm. Pt went to see DR per mom DX with cellulitis given 3 medicines (steroids, antibiotics, mom not sure what third medicine was).
falling; paralyzed; my gait was extremely abnormal; L4-S1 fusion plus a spinal stimulator which blistered and burnt my back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: BURNS SECOND DEGREE (non-serious) with onset 2023, outcome "unknown", described as "L4-S1 fusion plus a spinal stimulator which blistered and burnt my back"; FALL (hospitalization) with onset 2023, outcome "unknown", described as "falling"; GAIT DISTURBANCE (non-serious) with onset 2023, outcome "unknown", described as "my gait was extremely abnormal"; PARALYSIS (medically significant) with onset 2023, outcome "unknown", described as "paralyzed". The patient underwent the following laboratory tests and procedures: Electromyogram: Unknown results, notes: EMG studies came back and I had to have an L4-S1 fusion plus a spinal stimulator which blistered and burnt my back.  Clinical course: Patient have never seen a Pfizer rep come to office and speak with patient. After having the booster shot for COVID 19, less than a week later, Patient started falling and then graduated from walker to wheelchair to hospital. Patient was paralyzed. About 6 months later gait was extremely abnormal. EMG studies came back and patient had to have an L4-S1 fusion plus a spinal stimulator which blistered and burnt back. All because of that vaccine patient had to have as a health care professional. Patient ended up with COVID anyway.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events  FALL , PARALYSIS  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300321159 same patient, different events after different doses of the vaccine;
After patient received the covid -19 vaccine, he reported: anxious, and does not feel good. We observed him for 15mins, after 15mins, patient reported he wants to pass out, developed cough and then he developed wheezing, his breathing is heavily, I gave him a dose of Epipen and called 911.
Pt presented for Meningococcal B vaccine. Pt received Hep. B vaccine. Pt in system. Pt tolerated well. Pt denied further questions.
Fever, chills, disorientation, inability to focus, "creepy crawly" skin, exhaustion.
Severe nausea, severe body aches, delirium and dizziness, severe stomach pain, interrupted sleep and tiredness and severe fatigue.  All the above named adverse events resulted in the interference of normal activities and in retrospect, I should have sought medical help to ease the severe nausea which prevented me from performing normal tasks and sleeping.