chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started running fever today; Booster; Arm hurting; We both felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Arm hurting"; PYREXIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Started running fever today"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "We both felt sick".  Additional information: NDC and UPC number of COVID-19 Vaccine were unknown. Reason for no lot number of COVID-19 Vaccine was complainant hung up abruptly/transfer incomplete. Patient stated "I just want to double check on the side effects of the booster, Pfizer booster. We had on 01Dec, my husband was sick the second and third day and other than the arm hurting I have started running fever today, today is the 4th, so it is third day, is that normal?"  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.
Post vax, the patient developed a rash, hives on her back and neck, and lip swelling. The patient refused treatment. The symptoms started resolving within 45 minutes.
Case previously recorded as MA2009-3917. Initial case report received via MedCom from a health care professional on 09 NOV 2009: A 9-month-old male patient, was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 100923) on an unspecified date. No adverse event was reported. MedCom ref. no.: NA09-007863.
Pt's left arm was severely swollen from elbow to shoulder with redness in this entire area.
I got my second Moderna booster for COVID-19 on 6/3/2022. On the evening of 6/14/2022, as I was leaning over a vacuum cleaner while cleaning it, I started to feel dizzy. I got up from where I was, because I thought that maybe the dizziness was caused by the position I was in. However, every time I would turn my head to the right, I would feel dizzy. This worsened on 6/15/2022. At one point that day, I thought I was going to pass out while I was leaning my head into the refrigerator to find something. Thankfully, there was a chair nearby for me to fall into. That same day, I went to the urgent care clinic. I was run through a battery of tests to ensure I hadn't had a stroke, which I had not. I was then prescribed meclizine. Since I had a breakthrough case of COVID-19 in December 2021, I have occasionally had dry mouth accompanied by burning tongue; I feel that the meclizine has exacerbated it.  In conjunction with the dizziness I experience when I look to the right, I also have twitching in the right eye. At the time of this writing, I am unable to lie flat on my back or tilt my head to the right, because the vertigo gets worse if I do; I have to sleep on my left side with a pillow under my head. I am also unable to lift either of my arms above my head, because I then get dizzy. The same thing also sometimes happens when I lean over to pick up something. I went to a cardiologist on 6/27/2022. He told me that I could be tested for balance issues, plus he recommended that I take a stress test. However, I have not yet undergone the tests.
pain in the arm; bone pain; difficulty to see or keep view on something; difficulty hearing; fever; chills; body aches; joint pain; headache; sweating; fast heart beat; vertigo; blood pressure was a little low; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), HYPOTENSION (blood pressure was a little low), HYPERHIDROSIS (sweating), PALPITATIONS (fast heart beat) and PAIN IN EXTREMITY (pain in the arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VERTIGO (vertigo), HYPOTENSION (blood pressure was a little low) and PALPITATIONS (fast heart beat). On 23-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (pain in the arm), BONE PAIN (bone pain), VISION BLURRED (difficulty to see or keep view on something), HYPOACUSIS (difficulty hearing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg every 5 hours. On 22-Mar-2021, VERTIGO (vertigo), HYPOTENSION (blood pressure was a little low) and PALPITATIONS (fast heart beat) had resolved. On 24-Mar-2021, HYPERHIDROSIS (sweating), BONE PAIN (bone pain), VISION BLURRED (difficulty to see or keep view on something), HYPOACUSIS (difficulty hearing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in the arm) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100f (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
The night of the 16th, I had just finished working. I started driving for two hours to hotel. While I was driving - I noticed that my muscle would just die in my arms (both) when I let go of the steering wheel. It continued the next day when I drove another 8 hours back. Tuesday the 19th, I was at work, and I was walking around and started getting very lightheaded. My muscles were still very weak. I collapsed into the chair because my muscles kind of gave out. They took me to the Hospital ER. They took an MRI and did a bunch of blood tests. Those tests came out okay - I have a couple of pinched discs in my neck but they did not think my symptoms were related to that injury. I received IV fluids and they gave me some pain killers (very mild). That did not help with my symptoms. They prescribed a corticosteroid to try to see if that would help. It's called: Methylprednisolone. I finished that - it was a six-day thing. I still have the same symptoms of muscle weakness and lightheaded at this time.
over 42 days, 1st dose 09/7/21, 2nd dose 10/23/21
Information has been received from a nurse concerning an 11 year old female patient who on 15-JUL-2009 was vaccinated with GARDASIL (Lot # was not provided). Concomitant therapy included meningococcal vaccine (unspecified) (manufacturer not reported). On 15-JUL-2009 the patient experienced fainting and syncope after getting GARDASIL (Lot # was not provided). Patient was empty stomach before getting GARDASIL. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Dizzy, pinching feeling in left shoulder, tingling down left leg, pins and needles. Gave patient banana and water, checked pulse and observed. Patient started to resolve in 10-15 minutes,  at 8 PM, resolved, pulse back to normal.  Called Chief Medical Officer to consult, patient detained for 30 minutes before release, at patient request and CMO approval.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unknown dates, the patients were administered improperly stored doses of VARIVAX (dose and route unknown, lot # M023384, expiration date: 05-NOV-2018) for prophylaxis. The vaccines were exposed to 7 Fahrenheit degree for 30 minutes. These temperatures were not logged with a data logger and there were no prior excursions. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014050.
Patient reported swelling underneath her eyes after the 3rd COVID booster Pfizer vaccine. It started immediately after vaccination and lasted for about 30 minutes. Pt was monitored for 40minutes and it reduced afterwards. These symptoms occurred before with her previous doses. No treatment wasa given.
This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patient was not reported. On 11-APR-2016, the patient was vaccinated with improperly stored M-M-R II lot # L034368, expiry date 01-JUL-2017 (dose, frequency, route and anatomical location were not specified). Concomitant medication were not specified. There were no adverse effects reported. There was no product quality complaint (PQC) involved. Vaccine was stored at temperature of 20 degree centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Heat, redness and swelling at site of injection. Diarrhea and nausea.
Kinrix was administered to 2 year old at clinic visit for vaccines. Recommended/Licensed age 4-6years of age. No symptoms or signs of any adverse events/reactions at this time.
As I was walking to my car after I had received the vaccine, my legs became extremely itchy, Once I had gotten to my car I rolled my pant legs up and was scratching them excessively, I did not see any rashes. Today is the second day and I have itching all over my body and my face is reddish like I?m blushing but not too severe. Alongside I had the normal side effects such as chills, body aches. Etc. I am just concerned with the itching.
Reportedly 24 hours post vax, she developed a severe local reaction which was very red, swollen, and painful.
20 hrs. post injection - temp 100.5, 2 hrs. later extreme chills temp 102.5,1 hr. later temp 102.6; Extreme chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737), via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypercholesterolemia and BPH (benign prostatic hyperplasia) and the patient did not had any known drug allergies. Concomitant medications include amlodipine (MANUFACTURER UNKNOWN), lovastatin (MANUFACTURER UNKNOWN), Alfuzosin HCL ER (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) received on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6995), via an unspecified route of administration in the left arm on 18Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 11:45, 20 hours post injection, the patient experienced temperature of 100.5 (unspecified units) and took 600 mg (milligrams) of motrin, two hours later the patient had extreme chills with temperature of 102.5 and took acetaminophen 500 mg and after 1 hour, the patient had temperature of 102.6. Therapeutic measures were taken as a result of the events which included treatment with 600mg motrin, acetaminophen 500mg and Tylenol. The patient underwent lab test on 09Apr2021 which included body temperature test and the result was 100.5(unspecified units) at 11:45, after 2 hours it was 102.5(unspecified units) and 1 hour it was 102.6(unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of high temperature and extreme chills were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Quit eating; went from 3-4 bottles and cereal daily to 2 bottles. Thrush in mouth. Unknown temperature. Warm around injection area. On 6/23/00 start of immunizations and 12/20/00 end of immunizations. But doctor shows last 1 on 1/15/01. No record found on that date in doctor's notes. I thought he had 2nd polio shot in 11/00 and last on 12/20/00. Still there is no record for either date. I stopped going to this doctor as we did not feel safe with him because on 12/20/00, he stated it had to be because of my husband because I have 2 other healthy children from different fathers. My immunization record show no lot number for Polio number 1 on it for same date; then also different lot numbers for Hib number 3 and all different lot numbers for Hep-B's 1-3 (dose).  Diagnosis of CP. Also diagnosed with seizure disorder. Follow up information received 10/18/02, stated " Brain damage occurred. He is now 28 months old functioning as a six month old, Diagnosis was now determined - Chores Athetotic Spastic quadriparesis (Cerebral Palsy)"  Follow UP: Diagnosed with Choreathetotic Spastic Quadraparesis (codes to Quadriplegia)
breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected; Got sick; headache; reaction of the Moderna on lymph node; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CELLULITIS (breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 012A21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (diagnosed in May) in May 2021, Mastectomy (got the surgery "lateral mastectomy" on June) in June 2021, Breast prosthesis removal and Mastectomy.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST CELLULITIS (breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected) (seriousness criterion medically significant), ILLNESS (Got sick), HEADACHE (headache) and LYMPHADENOPATHY (reaction of the Moderna on lymph node). At the time of the report, BREAST CELLULITIS (breast inflame, left side affected by the cancer also the side that got inflame, immediately in a couple of days, red and inflame was infected), ILLNESS (Got sick), HEADACHE (headache) and LYMPHADENOPATHY (reaction of the Moderna on lymph node) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient got the surgery "lateral mastectomy" on June  Company Comment: This case concerns a 73-year-old, female patient with a history of breast cancer diagnosed recently and mastectomy, who experienced the unexpected serious event of breast cellulitis. The event occurred at an unknown day after the third dose of Spikevax. The rechallenge was not applicable as the events happened after the third dose. The medical history of breast cancer diagnosed recently, and mastectomy remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-344360 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, female patient with a history of breast cancer diagnosed recently and mastectomy, who experienced the unexpected serious event of breast cellulitis. The event occurred at an unknown day after the third dose of Spikevax. The rechallenge was not applicable as the events happened after the third dose. The medical history of breast cancer diagnosed recently, and mastectomy remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.
feverish; tired; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, lot number: EW0181) via unknown route of administration on 23Jun2021 06:00 PM in left arm as dose 2 single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included hypertension, hyperthyroidism. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included losartan potassium at 100 mg, levothyroxine sodium at 75 ug. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, lot number: EW0180) on 02Jun2021 (at age of 36-year-old) in left arm for COVID-19 immunization and did not get many symptoms except sleep was disturbed for a while. After second dose it made me feverish on second day. I was tired and also headache all on 24Jun2021. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
VARICELLA VAC. GIVEN 8-25-03. PT RETURNED 8-28-03 WITH RASH COVERING MOST OF HIS BODY,SWOLLEN TESTICLES AND "MARKED ERYTHEMA AT THE SITE.  NO FEVER OR OTHER C/O NOTED.  TREATMENT WITH ZITHROMAX 5MG. AND FLUIDS.
Headache, Arthralgia, Fever,  FATIGUE. CHILLS, PAIN/SWELLING INJ SITE, Narrative:  2/1/2021 - SARS-CoV-2 PCR test, Influenza A & B and RSV negative. Noted to be still out (2/4/2021 Reports she had developed fever of 101.3 at 0430 no other symptoms. She has contacted her PCP and is waiting for a work up. She was directed to contact employee health regarding plan for return to duty after she is fever free for 24 hours without use of antipyretics CRNP
had rash on 26MAR95 x 3 days; t104 sl cough on 12APR95 woke up w/swollen glands (salivary); glands are approx 3cm in diameter;
Pt. experienced dizziness, tired and lethargic, migraine, burning inside his body, mild fever, numbness, itchy. Reaction took place one hour after vaccination.  Was taken out of school & given Benadryl (day 1) and rested.  Next day went to school and same reactions took place only this time the nurse gave him an epinephrine injection (Epipen) and he was taken by ambulance to the nearest emergency room. The doctor only gave fluids and monitored since the Epipen was what helped address the adverse/allergic reactions.
104 degree fever, difficulty swallowing, yellow discharge from eyes, body aches, headache.
Initial unsolicited report received from a office person medical assistant on 15-Jun-2018. This case involves a patient of an unknown demographics who was vaccinated with a dose of ACT-HIB (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to wrong solution used in drug reconstitution. It was reported that ACTHIB mixed with sterile water and given to the patient. No adverse event was reported. 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.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-MAR-2015, the patient was vaccinated with an expired dose of MMR II expiration date 12-MAR-2015, subcutaneous. No adverse event was reported. Additional information has been requested.
Patient became infected with monkeypox  virus on 09/18/2022, breakthrough case.  Patient had received one subcutaneous injection on 08/15/2022 and then returned to the clinic for his second dose on 09/12/2022. Client received two intradermal JYNNEOS doses, due to one dose not creating a bleb.
Information has been received from a other health professional referring to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (lot #, expiry dare, dose, route of administration were unknown). Other suspect and concomitant therapies were not reported. No adverse effect reported. No product quality complaint (PQC) involved. Additional information has been requested.
mild symptoms like sore arm during maybe 2 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (mild symptoms like sore arm during maybe 2 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Blood pressure abnormal and Allergy to antibiotic (unspecified).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (mild symptoms like sore arm during maybe 2 days). At the time of the report, PAIN IN EXTREMITY (mild symptoms like sore arm during maybe 2 days) outcome was unknown.            Concomitant medication include unspecified blood pressure medications.  Patient experienced mild symptoms like sore arm during maybe 2 days with all doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-656089, US-MODERNATX, INC.-MOD-2022-656089. This case was linked to MOD-2022-656135 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656089:Husband's case US-MODERNATX, INC.-MOD-2022-656089:Wife's case
Pt recvd 1st & 2nd dose of MMR; One day p/vax w/2nd dose, pt devel pharyngitis, asthenia, & a flu-like illness; Reporter attributed pt's exp to exposure to unk virus prior to vax w/MMR;
I95.9 HYPOTENSION 2/7/2023 PNEUMOPERITONEUM J96.00 ACUTE RESPIRATORY FAILURE 2/7/2023 PNEUMOPERITONEUM