chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Arm hurts; Soar arm; Knee hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (Arm hurts), MYALGIA (Soar arm) and ARTHRALGIA (Knee hurts) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Diabetes. Concomitant products included OXYGEN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Pain), PAIN IN EXTREMITY (Arm hurts), MYALGIA (Soar arm) and ARTHRALGIA (Knee hurts). At the time of the report, PAIN (Pain), PAIN IN EXTREMITY (Arm hurts), MYALGIA (Soar arm) and ARTHRALGIA (Knee hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included rheumatoid arthritis and diabetic medications. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No new information was updated.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 11:00 (Lot number: EL3249) at the age of 58 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3249; Vaccine location: Left arm; Administration time: 12:00 PM), administration date: 22Jan2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Nasal Swab Positive". The following information was reported: HEADACHE (non-serious) with onset 24Feb2021, outcome "not recovered", described as "Constant headache". The event "constant headache" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. No follow-up attempts are possible. No further information is expected.
After vaccine, allergies seem exacerbated. Friday woke up crying - couldn't swallow. Mom gave BENADRYL 50mg po and then symptoms resolved slowly over next 24 hours.
myocarditis; severe chest pain; developed severe flu symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 02Feb2021 at 08:30 AM (at the age of 39 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no medical history and had no known allergies. The patient had no COVID prior to vaccination. Concomitant medication included testosterone. The patient had no other vaccine in four weeks. The patient previously received the first dose of BNT162B2 on 12Jan2021 at 12:30 AM (at the age of 39 years old) in the left arm for COVID-19 immunization. The patient developed severe flu symptoms on 02Feb2021 at 20:30. The patient experienced chest pain and myocarditis on 12Feb2021 at 03:00 AM. It was reported that after 12 hours, the patient developed severe flu symptoms for the following 48 hours. Then she developed severe chest pain and was hospitalized for myocarditis. The patient was hospitalized in Feb2021 for 5 days. The patient received treatment for the events which included heart medications and heart angiogram. The patient was tested for COVID post vaccination which included blood test and nasal swab, both with negative results on 12Feb2021. The outcome of the event was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: The event myocarditis was most likely due to influenza, which was an intercurrent infection, and unrelated to suspect vaccine BNT162B2. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile. 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.
thrush on her tongue; cold sore; pulsing in her right ear; States she had a lot of wax; dry skin; earache; This is a spontaneous report from a contactable consumer(Patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration on 05Feb2021 as SINGLE DOSE for covid-19 immunisation.   The patient medical history and concomitant medications were not reported. On an unspecified date, It was stated that after the 2nd dose about 2 days later the patient had experienced got thrush on her tongue, she has never had thrush in her life and her doctor prescribed her a swish in her mouth for 4 days, 4 times a day. on the 5th day she got a pulsing in her right ear that started, and she still has that and it seems like just today it may be getting a little dimmer and not as bad and then she had cold sores and has been prescribed with NYSTATIN 1000, she was 79 years old and is healthy.  she walks every day for an hour, doesn't take any medications, states her ear doctor wants to do a scan of her head and throat. The patient wanted to know if there are other complaints about ear complaints after getting the shot. And she had also stated that she had a lot of wax and dry skin and her ear was compacted in that right ear. The patient also experienced thrush on her tongue (oral candidiasis), cold sore (oral herpes), pulsing in her right ear (tinnitus), states she had a lot of wax and dry skin and her ear was compacted in that right ear (excessive cerumen production) , states she had a lot of wax and dry skin and her ear was compacted in that right ear (dry skin) , earache (ear pain). The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Infant was well on examination at visit when got her vaccines but was  apparently found unresponsive that night.
Information has been received from a physician concerning a 61 year old male with an unspecified cardiac disorder and diabetes who on 09-JAN-2008 was vaccinated with a "single dose" of Zostavax (Oka/Merck) (Lot # "1131U"), site of administration unspecified.  It was reported that on 15 JAN 2008 the patient developed herpes zoster, with dermatome C2-3 involvement.  Vesicular lesions were present on the patient's head and neck.  It was also reported that on 15 JAN 2008 the patient developed a shingles like rash on the forehead.  On a pain scale of one to ten, the patient's pain was assessed at three.  The patient "was given some topical cream and acyclovir".  Unspecified medical attention was sought.  There was no product quality complaint.  A direct fluorescent antibody was not collected.  It was reported that the specimen for the VZV identification program was obtained from a vesicular area (site unspecified).  At the time of reporting the patient had recovered (date unspecified).  Additional information has been requested.
I had a scratchy throat, I was achy, started feeling feverish, chill, fatigue. Each day I experienced a new symptom, by day two I could not stand, open my eyes. I took a home COVID-19 test, it came back positive. I had a telehealth visit and was prescribed Paxlovid. My throat really started hurting then, I tried using an over the medication, it did not help. I had to get lidocaine viscous. The next day I started to cough uncontrollably, I called my doctor, was prescribed a cough syrup with codeine that I only needed to take for a day.
Shortly after receiving Gardasil on 4/24/07. Pt became "dizzy and lightheaded and heart was racing" - was reported to us today 6-25-07 also headache.
Terrible headache; Severe bone pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the arm left on 02Apr2021 at 14:00(at the age of 41-year-old), as a single dose for COVID-19 immunisation. Concomitant medications included levothyroxine (L-THYROXINE) started on an unknown date for an unknown indication. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced terrible headache, severe bone pain. The bone pain went away the second day; however, still have headaches. The headache was not severe, but had it constantly. On 26Apr2021, lab test included salvia test and the result was negative. The clinical outcome of the event severe bone pain was recovered on 03Apr2021; and that of the event terrible headache was not recovered.   No follow-up attempts are needed. No further information is expected.
pain in intestines; nose bleed; headache was terrible; shoulder and arm kind of sore; Hurt everywhere (head, shoulders, stomach, rib cage, back); A spontaneous report was received from a healthcare professional concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in the intestines, blood in mouth,  headache , shoulder and arm soreness, and  hurting everywhere all through their body.   The patient's medical history included Crohn's disease. Concomitant medications reported were atorvastatin calcium and  gabapentin.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient began experienced pain in the intestines, shoulder and arm. It was also reported that the patient woke up with blood in the mouth, from a nose bleed. On 27 Jan 2021, the patient experienced headache , shoulder and arm soreness and  pain everywhere all through their body, so much pain could not lay in bed, could not lay down or sit up, hurt everywhere (head, shoulders, stomach, rib cage, back). Treatment details included Vicodin..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event,  intestine pain, blood in mouth, headache, shoulder and arm soreness, pain everywhere,  was considered recovered/ resolved on 01 Feb 2021.; Reporter's Comments: The events were consistent with increased risk of complications associated with Crohn's disease confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Seizure 12/4/10. Admitted to hospital thru ER. Discharged 12/6. CSF neg, CT head neg, EEG neg. Visited PCP for ER f/u 12/8/10.
lt upper arm localized redness, warmth, swelling, lump; tx on 17JUL92 w/Rocephin;
Arm was "so painful" that night, took Advil.  Next morning woke up with flu symptoms - joint pain, arm pain, skin sensitivity.  Neck became "beet red", sore to the touch.  Took Chlortrimeton.  Had Fluzone High Dose last year also with no problems.
Pt received flu vac in Nov.@ PMD.  24-36 hours later developed deep pain in the upper arm to the shoulder blade and neck.  7 days later, about 2 inches above injection site, pt developed one shingle.  Severe pain x 2 nights, but had pain X 2 weeks.  Went to PMD, received Acyclovir.
Approximately 6 to 7 hours after receiving the COVID-19 booster shot, patient experienced chest pain in the left side of the chest near the heart.  Pain persisted throughout the night along with insomnia and heart palpitations (strong heartbeat, heart rhythm felt normal to patient).  Pain was persistent and diminished morning of 10Mar2022.    Flare up of Raynaud's syndrome and cystitis morning of 10Mar2022 along with neck pain and stiffness (worse than usual).
My throat was a little itchy and I got a few hives on different parts of my body including arms, stomach, back and legs. There were only a few on each area and not all at the same time. Different patches on different days. I thought it could be allergies, so cleaned my house (I have a cat), but it persisted. On Tuesday night, I realized what was going on and took two Benedryl, which helped.
Developed pain (R) upper arm the morning after receiving influenza vaccination. Continues to have pain (R) deltoid/shoulder & at times neck & decreased ROM despite use of ibuprofen. PT & analgesic prescribed.
sorness in the gums / sensitve gum; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of GINGIVAL PAIN (sorness in the gums / sensitve gum) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (sorness in the gums / sensitve gum). At the time of the report, GINGIVAL PAIN (sorness in the gums / sensitve gum) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment drugs are provided.
pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days
Localized painful mass/swelling. Recommended BENADRYL and Ibuprofen. If no relief, see physician.
one of the pre-filled syringes break at the top, the glass part/we went to fold the plastic protective of the needle and the whole top of the prefilled syringe broke off; The initial case was missing the following minimum criteria: [no adverse event]. Upon receipt of follow-up information on [02Jun2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team and product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2604, Expiration Date: 30Jun2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "one of the pre-filled syringes break at the top, the glass part/we went to fold the plastic protective of the needle and the whole top of the prefilled syringe broke off". Additional information: Caller states: We were about to administer a PREVNAR 20 dose to a patient and I had one of the pre-filled syringes break at the top, the glass part. We put our syringe, our-like syringe that you screw on onto it and before we went to inject the patient we went to fold the plastic protective of the needle and the whole top of the prefilled syringe broke off. Caller clarified the patient that was intended to receive this dose was not administered this pre-filled syringe.   No follow-up attempts are possible. No further information is expected.
Woke up in the night feeling the sensation of being under water/pressure, and ears ringing. Outcome is mild hearing loss in one ear, and ringing in the ears.
The patient states 1st time was in the middle of the night around 1:30-2:00 AM. There was a rapid heartbeat, dizziness that lasted about 1/2 hour. The 2nd time was while driving, she had a rapid heartbeat, got very hot, and felt like she was going to pass out; that lasted about 15 minutes and started to subside. She does not take flu shots since then.
cerebral palsy; injured her heart valves; This case was reported by a consumer via other manufacturer and described the occurrence of cerebral palsy in a female patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix and Fluarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix and Fluarix Pre-Filled Syringe Device, the patient experienced cerebral palsy (serious criteria GSK medically significant) and cardiac valve injury. On an unknown date, the outcome of the cerebral palsy and cardiac valve injury were unknown.   It was unknown if the reporter considered the cerebral palsy and cardiac valve injury to be related to Fluarix and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. The caller stated a coworker had a reaction to Fluarix in 2016. The caller stated that the vaccine injured her heart valves and caused cerebral palsy. The caller did not want to provide any patient and additional information. The caller stated the side effects were already reported to the manufacturer. No additional adverse event and no product quality complaint reported. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015. a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old (reported as 1-year-old) patient of unknown gender. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L003775. The vaccine was purchased with public funds as a part of vaccine program. This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Patient fainted within approximately 5 minutes of receiving 2nd dose of Moderna COVID vaccine. Pt was breathing normally but momentarily lost consciousness. Patients hands were shaking and she reported feeling nauseous. Patient was evaluated by EMS but did not require treatment. Patient was able to sit up on her own within minutes. She consumed a  few sips of water and held onto an ice pack for a few minutes until being able to walk out of the store.
This spontaneous report was received from a registered nurse regarding a multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (therapy type unspecified) (lot # L041629, expiry date 22-APR-2017 and lot # L051101, expiry date 17-JUN-2017) dosing details was unknown. Concomitant medications were not reported. Temperature excursion and time frame were not provided. Product quality complaint was not filed. No adverse effects were reported. This is one of the three reports received from the same reporter (MARRS # 1605USA012070 and 1606USA000381). Additional information is not expected because the primary reporter did not want to be contacted.
Information has been received from a pharmacist who reported that on 20-NOV-2014 a patient received an expired dose of RECOMBIVAX HB (lot# J014312, expiration date 07-SEP-2014). No known adverse effects. All of the data listed here was reconfirmed by the pharmacist. No further information provided. Additional information has been requested.
Soreness in arm immediately after injection on Saturday 2/15/2022. Next morning Sunday, did not feel well, I felt lethargic and slight fever. Monday felt worse, had redness in area of vaccination. Took Ibuprofen to help. Today, Tuesday feel better, still have big red spot on arm, again took Ibuprofen.
This spontaneous report as received from approximately 59-year-old female patient refers to herself. The patient's concurrent conditions included anaemia, arthritis and penicillin allergy. At the end of 2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. It was reconstituted with sterile diluent. Concomitant therapies included NEURONTIN, acetaminophen, VICODIN and LYRICA. At the end of 2016, the patient experienced shingles. She had blisters and rash all over her bottom and private parts and reported having a fever. She also experienced extreme nerve pain. On an unknown date, the patient was hospitalized and treated. The outcome of events was reported as not recovered/not resolved. Causality assessment was not provided.
Had both FLUZONE High Dose and PNEUMOVAX 23 on 8/29/17. First time for the PNEUMOVAX and within 1 day I felt itching all over and still persists. Told pharmacy, primary Dr. and Allergist. No answers on remedies.