chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 at 17:00 as dose 3 (booster), single (Lot number: Ew0185) at the age of 58 years, in right 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's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=28Jun2022, treatment stop date=03Jul2022, lot number=00069-1085-30, indication=Treatment of COVID-19. This cased assessed as non-serious by the reporter.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at the community services as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 15-FEB-2016, the patient was treated by the physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX and gabapentin for management of her painful symptoms and chronic pain. On or about 29-FEB-2016, the patient subsequent treatment from the physician for another episode of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
started as warm to touch then to swell on Saturday, then on Sunday bumps and scratches appeared and swelling became bigger
5/2: Around noon became weak, feverish, muscle aches, headache, chilled, despite fever unable to get warm, nauseous. Left arm very sore. This condition persisted the next day with arm becoming red and swollen at injection site. By 5/4 symptoms began to improve, but arm was too sore to move much. By 5/5 began to feel better, after 2 1/2 days of bed rest. 5//7: Around 3 pm the symptoms returned suddenly -- weak, fever, chills, nausea, head ache, though arm was no longer sore. Returned to bed until symptoms began to improve in the evening of 5/9.
I noticed few weeks ago that I have spontaneous nose bleeding. I didn?t pay attention at this at the first time, but now I have once or twice a week bleeding from my nose. I did not have these issues before.  I manage to stop bleeding by applying mild pressure and putting a towel paper in my nostrils.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 11-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804090 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
On the day after the vaccine I was feeling lightheaded/tired. i was at a Doctors appointment for my eye and they took did a routine blood pressure check, which had dropped to 83/50. It is normally around 125/80.
Flu-like symptoms that had been gradually worsening day by day; Cough; Chest congestion; Difficulty breathing; Head has been hurting a lot like sinus congestion,; feeling tremendously thirsty; Loss of appetite; Loss of memory; Terrible taste in mouth- sour and bitter; Feeling more depressed than normal; somnolence and wanting to sleep all day; Feeling very down; Very anxious; Trouble remembering; Very tired; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu-like symptoms that had been gradually worsening day by day), COUGH (Cough), CHEST PAIN (Chest congestion), DYSPNOEA (Difficulty breathing) and SINUS CONGESTION (Head has been hurting a lot like sinus congestion,) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), NITROGLYCERIN, METFORMIN, LOSARTAN, GABAPENTIN, FAMOTIDINE, ATORVASTATIN and LINACLOTIDE (LINZESS) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On 31-Mar-2021, the patient experienced INFLUENZA (Flu-like symptoms that had been gradually worsening day by day), COUGH (Cough), CHEST PAIN (Chest congestion), DYSPNOEA (Difficulty breathing), SINUS CONGESTION (Head has been hurting a lot like sinus congestion,), THIRST (feeling tremendously thirsty), DECREASED APPETITE (Loss of appetite), AMNESIA (Loss of memory), DYSGEUSIA (Terrible taste in mouth- sour and bitter), DEPRESSION (Feeling more depressed than normal), SOMNOLENCE (somnolence and wanting to sleep all day), DEPRESSED MOOD (Feeling very down), ANXIETY DISORDER (Very anxious), MEMORY IMPAIRMENT (Trouble remembering) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NITROGLYCERIN for Chest pain, at an unspecified dose and frequency. On 31-Mar-2021, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, INFLUENZA (Flu-like symptoms that had been gradually worsening day by day), COUGH (Cough), CHEST PAIN (Chest congestion), DYSPNOEA (Difficulty breathing), SINUS CONGESTION (Head has been hurting a lot like sinus congestion,), THIRST (feeling tremendously thirsty), DECREASED APPETITE (Loss of appetite), AMNESIA (Loss of memory), DYSGEUSIA (Terrible taste in mouth- sour and bitter), DEPRESSION (Feeling more depressed than normal), SOMNOLENCE (somnolence and wanting to sleep all day), DEPRESSED MOOD (Feeling very down), ANXIETY DISORDER (Very anxious), MEMORY IMPAIRMENT (Trouble remembering) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included depression medicines.  Treatment information included hydration.
Shingles diagnosis; prescribed Valacyclovir HCL 1 g 3X daily for seven days.
Nausea and vomiting followed by vasculitic rash over lower extremities to low back.
Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored VAQTA (lot # L007559 with expire date 01-JUN-2017, dosage was not provided) orally. The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient began to experience a dull pain on left deltoid on 11/2715/about 3-4 days after PNEUMOVAX vaccination.
Experienced severe headache at 10pm on day of flu shot 10/5/2020 which didn't resolve with Aleve.  Headache persisted until the next day10/6/2020 (missing a day of work) with an episode of dizziness at 845pm.  10/7/2020 - woke up without headache but returned at 12 noon with nausea.
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient could hear her heartbeat in her ear/Patient could hear her heartbeat when laying down and even standing up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 010821A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Augmentin allergy), Asthma, Hypertension and High cholesterol. Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient could hear her heartbeat in her ear/Patient could hear her heartbeat when laying down and even standing up). At the time of the report, TINNITUS (Patient could hear her heartbeat in her ear/Patient could hear her heartbeat when laying down and even standing up) had resolved. Patient used inhalers for asthma, over the counter medication like calcium. Patient did not take any treatment medications. Patient did not have COVID-19 in the past. Patient had a office visit with HCP. The symptoms lasted 5-6 days.
had shingles shot, so my case was milder/suspected vaccination failure; shingles, milder case on head; marks on my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (outbreak when the patient was 6 years old).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and scar. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the scar was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 03-Jan-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient stated that Shingles was worse in the early 60s than his/her initial Chickenpox outbreak. The patient stated that it took over a year for the marks on his/her forehead to finally fade away from the shingles outbreak. The patient stated that his/her case was milder, but funny they started on top of my head, just like when he/she had Chickenpox as a kid. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient was incorrectly identified and pharmacy staff hosting a vaccination clinic administered the vaccine. Patient had already received two doses of the Pfizer vaccine and this was the patient's third dose of the vaccine which is just a two dose series. Patient has experienced no side effects nor issues after receiving the vaccine for a third time.
Red; Swollen; vaccinatio site Super itchy/extremely itchy reaction at injection site; Vaccination site Swelling; Vaccination site Redness; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain), ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 21-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Pain), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE SWELLING (Vaccination site Swelling). On 28-Jan-2021, the patient experienced ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 24-Jan-2021, PAIN (Pain), VACCINATION SITE ERYTHEMA (Vaccination site Redness) and VACCINATION SITE SWELLING (Vaccination site Swelling) had resolved. At the time of the report, ERYTHEMA (Red), PERIPHERAL SWELLING (Swollen) and VACCINATION SITE PRURITUS (vaccinatio site Super itchy/extremely itchy reaction at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used ice packs as treatment.   This case was linked to MOD-2021-229974 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-significant Follow-up received. Reporter AE contact information was updated. On 21-Jun-2021: Significant follow up appended to AER. Updated details:: Pregnant: No. Race: private. Dose1 time. Concomitant Drug: Vesicare.
NO SXS REPORTED, WRONG DOSE GIVEN. WAS SUPPOSED TO GET PFIZER BIVALENT BOOSTER.
Immediately after vaccine administration w/in <10mins. pt noted tingling and cold sensation in her left 4th and 5th digit with mild swelling, that extended laterally up to her left shoulder. Pt also noted cold sensation and tingling that started from her left hip that extended laterally down to her mid thigh. + bilateral hand shaking. Denied pain.   Treatment: 45 mins of observation Outcome: Released w/o any interventions, reassurance provided and f/u with her Primary Care Provider the next business day.
10/19/21 10:00pm feeling of bugs crawling on Right leg , from Pelvic-Hip area to Knee ( improved but sensation ongoing at times ). Bladder-uncontrolable Urine leakage (improved but peridoc leakage) , speech difficulty hard to speak in paragraphs (resolved after several days) , swallowing difficulty felt like something stuck in throat(resolved after several days), Right hand keep dropping items(resolved after several days) Dizzyness (resolved after several days)
1. I woke up with a severe migraine, which isn?t unusual for me, but what is unheard of for me is that my medications aren?t making any difference no matter what I take. So I have an uncontrollable migraine almost to the point of going to the ER. What?s stopping me going is that I do t know what else they can do that I?m not already doing.   2. Low grade fever and chills: not a big deal  3. Severe fatigue to the point that it feels like my brain is ?shutting down?; I feel like I?m passing out. Eventually fave up midday, went back to bed and been sleeping for 8 hours so far   4. Dizziness  5. Extreme nausea - keep thinking I?m going to throw up
PT CALLED PHARMACY TODAY AND DESCRIBES FEELING NUMBNESS IN THE SIDE OF HER FACE THE EVENING AFTER HER COVID DOSE. IT EXTENDED FROM HER CHIN UP THE LEFT SIDE OF HER FACE. SHE VISITED THE EMERGENCY ROOM AROUND 1030PM THAT EVENING, CONCERNED OVER POSSIBLE STROKE(?) ER DIAGNOSED AS ACUTE FACIAL PAIN BECAUSE SHE DIDN'T TELL ER THAT SHE HAD A COVID DOSE EARLIER THAT DAY.  SENT HOME WITH REST, TAKE ADVIL, ICE ON FACE. PT EXPERIENCED NUMBNESS FOR 3 WEEKS, HER BOTTOM LIP IS STILL "TINGLY" TODAY. A FAMILY MEMBER SUGGESTED TO HER THAT COVID SHOT MAY BE CAUSE OF HER SYMPTOMS AND SHE SPOKE TO THE PHYSICIANS OFFICE ABOUT HER SYMPTOMS. (SHE ALSO HAS THYROID CYCSTS, AND HAD A BIOPSY IN JUNE)
This spontaneous report as received from a physician via a company representative refers to a 36 year old female patient. The patient's current conditions or medical history were not reported. Approximately in January-2007, reported as six years earlier, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route, indication, lot and expiration date were not reported), administered concurrently with a dose of influenza (manufacturer unknown) (dose and lot number was not reported) in the same arm. On 14-OCT-2013, the patient received a second dose of PNEUMOVAX23 intramuscular (also reported as intermuscular) in the right deltoid (dose, lot and expiration date were not reported). On 14-OCT-2013, within two hours post vaccination, the patient experienced body aches, injection site swelling, fever, and stiffening of the arm. Within 6 to 8 hours, her joints stiffened further, limiting range of motion. The symptoms continued until range of motion returned, approximately seven days post vaccination. The patient recovered after stopping therapy and it was not reintroduced. It was also reported that no adverse reaction was reported with the first dose of PNEUMOVAX23. The patient sought medical attention. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (and also experienced chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling after receiving 1st dose on 9th september 2018, refer case US2018227676). On 13th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2018, 14 hrs after receiving Shingrix, the patient experienced fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling. The patient was treated with BENADRYL and TYLENOL. Rechallenge with Shingrix was positive. On 16th December 2018, the outcome of the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling were recovered/resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left arm. The patient took Benedryl and two Tylenol after getting the 2nd dose at about 8 PM on Thursday. Around 10:00 am in the next morning, the patient experienced fever, chills, shivering, myalgia, arthralgia, weakness, pain in periorbital bones and swelling under the eyes. The reporter had consented to follow up.
Vaccine expiration of 3/2/2018 on vaccination date of 3/24/2018. Attempted to contact patient by phone. No answer, but left message for patient to call. We will revaccinate when patient is able to come back in.
Discomfort R side back of neck, axillae area R within 12 hours of shot/vaccine - lasted 1-2 days, then discomfort on roof of mouth.
This case was reported by a pharmacist and described the occurrence of soreness in a 23-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Historic vaccination included previous completion of a two dose HAVRIX (GlaxoSmithKline) series given in 2007 (one dose possibly administered in June 2007). On the evening of 11 January 2012 the subject inadvertently received a 3rd dose of HAVRIX in an unknown deltoid. This was an extra dose administered. In January 2012, within 9 days or less, of vaccination with HAVRIX, the subject experienced soreness. At the time of reporting the outcome of the event was unspecified. Follow up from the pharmacist on 13 February 2012. The pharmacist noted that he did not say there was an adverse event. He reported that he said she had previously been vaccinated and wanted to know if there would or could be a problem. However, the initial report from the pharmacist stated the patient noted soreness to the pharmacist.
patient c/o feeling "something" in throat while waiting after her imm. patient denies shortness of breath, wheezing, dyspnea, chest pain, nausea vomiting, rash, headaches or abdominal pain.  Patient VS done x 2.frist set:BP: 127/81 HR: 65 sats:100% at RA done at 1:30 pm second set of Vs: BP: 130/74 HR: 65 Sats; 100% on RA done at 1:45 pm  Chest ; CTA bil no abnormal lung sounds appreciated  Heart: RRR no murmurs Patient assessed by doctor   Patient remained stable no changes in VS  monitored for 35 mins  ER precautions given to pt to go to ER or call 911 if any sx worsen or sx do not improve or new sx start patient left in stable condition at 1:45pm
Swelling and pain in splenectomy incision. Splenectomy performed 02/25/2022.
Patient had a syncopal episode within 15 minutes of vaccination.  He then had seizure-like activity.  He rested and felt better; patient was released to home.
Pain at the injection site. Slight swelling, fatigue, headache, muscle and joint pain ,chills,  fever, dizziness and nausea for about a week. The following week I  still had the headache, a little dizziness and nausea but started having ringing in my ears. Just softly in the morning but getting louder as the day goes by. Still have the ringing, slight headache fatigue and slight nausea more than a month out from the Second does.
Sudden increase in blood pressure culminating in Stroke on 9/15/21. No problems with blood pressure before this
fussy, body aches , hives red rash noted all over body. Doctor treated with benadryl,  oral steroid and steroid cream. Mother unsure for how long  the treatment is for.
Horrible headaches, horrible painful joint pain, back and neck pain, phantom smells.  ALL came AFTER my 2nd dose, I have NEVER had joint pain before or headaches like this, very scary..