chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (05Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: Treatment of COVID-19; (05Nov2023) Negative. Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 31Oct2023 to 04Nov2023.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367612 Same patient, different drug/event;
Mother reported on 02/22/2002 involuntary movement while nursing. EEG abd CT scheduled. Both neg/ nl. Child also had visit with child neurologist on 03/15/2002 and 04/14/2002. Mother states these shaking spells happened while nursing on occasions from 01/15/2002 until 03/09/2002. He received 2nd Prevnar on 04/29/2002.
CLIENT CALLED 5/24/22 WOKE UP WITH RASH ON HIS ARMS AND CHEST. FEELS TIRED, NO FEVER BUT FEELS NASALLY CONGESTED. HE TOOK A BENADRYL AND SYMPTOMS ARE IMPROVING. CALLED 4 HRS AFTER BENADRYL SYMPTOMS ARE GONE
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# 664864/1365Y). Subsequently, the patient developed injection site reaction after receiving PNEUMOVAX 23. The patient developed arm swelling, redness and pain. It was unknown if the patient sought medical attention. The patient was not hospitalized. At the time of the report, the patient's status was unknown. Follow-up information has been received from the registered nurse concerning a 79 year old male patient with hypertension, osteoarthritis, hypercholesterolaemia and allergies to LIPITOR, WELCHOL and PRAVACHOL and a history of prostate cancer (1995) and pulmonary embolism who was vaccinated with previous dose of PNEUMOVAX 23 in 2003 without problem. In 23-DEC-2009, the patient was vaccinated with a dose of PNEUMOVAX 23 in his left arm. Concomitant therapy included metoprolol, COUMADIN and ZESTRIL. No other vaccines were given. It was reported that there was no serious criteria. At the time of the report, the patient was fully recovered. This is one of several reports received from the same source. No further information is available.
On February 15th, after work, I got into my car and my vision immediately went very blurry and I felt dizzy.  After about 30 seconds I was able to focus again and I drove home from work.  I began to feel dizzy again when I got close to home.  Upon arriving at home, I went upstairs to check on the thermostat (we were in winter storm).  As I came back down the stairs I began to lose my peripheral vision in my right eye.  My wife was then driving me to the urgent care when I completely blacked out and slumped over in the car.  When I came back, she was on the phone with 911.  The ambulance came and transported me to a local Hospital.  I was in the hospital for four days as they ran tests.  I had a CT scan and MRI on my head and an echocardiogram on my heart, all of which failed to show any symptoms of stroke or heart issues.  Over the next couple of weeks I dealt with vertigo.  I have since been to a cardiologist who had me wear a heart monitor for several weeks and had me do another echocardiogram and a stress test and said my heart looks good.  I have also been to a neurologist who had me do a EEG test.  He said that the test showed signs of seizure activity in the left side of my brain.  I have been prescribed Keppra for seizures, but have not had any further issues.
Shortness of breath, buzzing/ringing in the right ear, and continuous and painful tingling along the outside of the entire right arm and fingers.
Physician  ordered 1st dose Moderna vaccine for patient. The patient was given Moderna 0.25 ml booster dose instead by nursing student. Patient was called and asked to return to clinic for aother injection, but patient stated she would be unable to return to clinic until November 11th for additional shot.
Patient was schedule to receive 1st dose of Pfizer vaccine but instead receive Moderna booster vaccine dose.
no symptoms with 1st dose, got 2nd dose 03/22/21- symptoms started 03/24- mild fever 99.5,  HA, body pain- lasted 2 days then noticed had trouble searching for words and small motor skills decreased- started coming back 10 days ago much better now- occasional hesitation now searching for words on going but progressively better
freezing cold; shaking so violently; burning up; very achy; ankles were stiff; hands were stiff; hands were achy; could hardly walk; dry mouth; felt like I was going to pass out/ body felt traumatized; hungry; thirsty; fever chills; ankles were achy; threw up 2 or 3 times; exhausted/wiped out; couldn't sleep at all; really nauseous; arm was very sore/whole body was sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up) and PAIN (very achy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 046A21A and 008E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced INSOMNIA (couldn't sleep at all), MYALGIA (arm was very sore/whole body was sore) and NAUSEA (really nauseous). On 07-Oct-2021, the patient experienced FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), VOMITING (threw up 2 or 3 times) and FATIGUE (exhausted/wiped out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 07-Oct-2021, INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), MYALGIA (arm was very sore/whole body was sore), VOMITING (threw up 2 or 3 times), NAUSEA (really nauseous) and FATIGUE (exhausted/wiped out) had resolved.            Treatment medicine include Tylenol   This case was linked to MOD-2021-345821 (Patient Link).
Advised pt receiving pneumonia vaccinations prior to surgery. She received first PCV13 on 6/30/2015 (left arm) and was to get PPSV23 on 9/3/15 however she was given a 2nd dose of PCV13 instead (to left arm). She was called back and given PPSV23 on 9/9/2015 to same arm (left) reporting some site tenderness afterwards. Pt reported to go to ER on 9/11/2015 due to left arm pain - redness and swelling at injection site being given diagnosis of cellulitis and placed on antibiotics x 10 days. Pt/Pt husband reported she had immediate pain to vaccine site 9/9/2015 with dime size red splotch to area that progressed over the next 8-12 hours to include 1/2 her arm. Splotches went a few "inches" from injection site toward her elbow and she was unable to use left arm due to pain in arm/shoulder. She denied any fever, arm weakness, paresthesia, rash (other than site reaction), headache, or other systemic symptoms. An xray of arm 9/11/15 was normal. She advised it took 2 days on TYLENOL for pain to ease so she could use arm, and 3 days (9/14) on antibiotics before redness eased and another few days before all symptoms resolved. As of 9/18/2015 she is fine and skin left arm is normal with no pain.
Not sure which arm but I think it was in my right arm. I got my shot around 10AM on 04/01/2021 at about 6-8PM is when I first started noticing side effects. At 8PM I couldn't lift both arms. I have difficulty word finding, I was tired, and I got chills. The next day the symptoms persisted to the point to where I did not feel well enough to work. I was able to attend one work meeting toward the end of the day. I was really cold and wearing a sweatshirt in April. I just took the next day off and rested. I took Tylenol and got some sleep. I had upcoming doctors appointments for surgery at the end of month. I was recovered before the doctor appointments. A year prior to this in May I had very similar symptoms that were like Covid but I tested Negative for that and Covid antibodies test came back as negative as well. I had the exact same symptoms after my 1st dose.
Information has been received from a RN concerning a 23 yr old male pt with no allergies, no birth defects or medical conditions, who on 28Nov05 at 15:00 was vaccinated in the right deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 651362/0192R). It was noted that he was not ill at the time of vaccination. It was reported that he experienced nausea weakness and sweating for 30 minutes on 28Nov05, one hour after the vaccination. The pt recovered on 28Nov05. It was noted that the pt did not have adverse events following prior vaccinations. It was noted that on 04Oct05 prior to vaccination the pt had a hep b surface antibody lab study performed and the results showed less than 5 MIU/ML, which did not indicate immunity according to current guidelines. There was no product quality complaint reported. The pt sought unspecified medical attention. No additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/7/2006.  Follow information was received on 18-JAN-2006 which reported that the patient did not require medical treatment and that he recovered at a later time on the day he received the vaccination.  The patient sought unspecified medical attention.  No additional information has been requested.
Three days after receiving my first shot, I went into a "flare up" of almost constant migraines. Normally my migraines break after a day or so, and these have been laying weeks without relief. I went from my normal of about 7 migraine days a month to upwards of 17/18 migraine days  per month. It's been too the point where most days I'm non-functional, and it's all leading back to when I started my doses of the Moderns Covid vaccine.
Resident received the first dose of Moderna Vaccine on 01/12/2021 and Tested for COVID-19 on 01/12/2021. Resident tested positive on 01/13/2021.  Resident was transferred to acute hospital on 01/19/2021 due to desaturation.  Resident expired at Hospital on 01/24/2021.
Patient fainted 5 minutes after the vaccination. He regained his conscious but complained severe headache.  Patient also had some jerky motion after fainting.  Paramedics was called.  Patient's vital signs were normal.  He was taken to facility for further follow-up.
Systemic SX with fever, myalgia, tachycardia, hypertension, near syncope, large local reaction at site of administration 4x6 cm Rt arm.
This spontaneous report as received from a pharmacy student refers to a female patient 76 years (current age) with allergy to methylprednisolone, statin, morphine, and VICODIN. The patient's medical history included a previous episode of shingles. On an unknown date 3 to 4 years ago the patient was vaccinated with ZOSTAVAX (dose and route unspecified). The reporter stated that she believed that the patient may had a case of shingles which include itching and pain. The itching and rash appeared at an unspecified time. On an unknown date the patient experienced she may have a case of shingles, which included itching and pain. The patient's outcome was  not recovered. The patient sought medical attention contacting the pharmacy student. Additional information has been requested.
"Moderna COVID-19 vaccine EUA" Patient received 0.5ml instead of 0.25ml of COVID booster.
Pfizer on 4/12 and 5/3. Positive on 11/21
Got first dose on 16Mar2021 and second on 05Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got first dose on 16Mar2021 and second on 05Apr2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got first dose on 16Mar2021 and second on 05Apr2021). On 05-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got first dose on 16Mar2021 and second on 05Apr2021) had resolved.            The reporter was a Spanish speaker and was calling on behalf of their husband and brother-in law who received their first dose of the Moderna vaccine on 16-Mar-2021. Both of them received their first dose on the same day. The patient (brother-in-law) received the second dose on 05-Apr-2021 but the reporter's husband didn't receive the vaccine, even though the reporter insisted. The provider said that they only had orders for one.   No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
pt awoke w/fever 102.5 R;lethargic, lying around, didn't want to sit; c/o h/a;staring @ TV;won't change expression;did not resist mom picking him up;limpness;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). The pharmacist reported that the patient would now like to receive the third dose of GARDASIL, 11 months after the second dose was administered. No adverse symptoms were reported. Additional information is not expected.
Based on additional information received on 7 April 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 10 Mar 2015. A 46 year-old male patient, whose medical history, illness at the time of vaccination were none and concomitant medications were unknown, had received first dose of ADACEL (batch number C4472BA, route of administration not reported on right deltoid) on 19 Feb 2015 and also received first dose of FLUZONE (batch number U5064FA, route of administration not reported on left deltoid) on 19 Feb 2015. Prior exposure to vaccine was none and other vaccinations prior four weeks of administration was none. On 19 Feb 2015 after vaccination, the patient had pain in his right arm and later when he was seen in the office on 27 Feb 2015 he was diagnosed with nerve pain. The patient had ER/physician visit. Laboratory investigations were none and corrective treatments include pain medications and NEURONTIN. At the time of report patient had not recovered from the event. Documents held by sender: none. Follow-up information received from a healthcare professional on 7 April 2015. Patient's height was reported as 193 cm (76 inches) and it was also reported that the patient was previously vaccinated with a intramuscular dose of Tdap (batch no C4472BA exp date 27 Feb 2016) intramuscularly in right arm on 9 May 2014. Medical history was reported as no known allergies. And reporting physician's details were also updated. Laboratory investigations includes body temperature 97.6 degrees Fahrenheit on unspecified date and blood pressure 98/60 mm/Hg and 107 beats / minute on 27 February 2015 at 2:19 PM. The corrective treatment includes Hydrocodone-Acetaminophens 5-325 MG TABS (1 tab every 6 hours) for severe pain and NEURONTIN 100 MG oral CAPS (1-2 caps three times a day for nerve pain).
PATIENT HAS EXPERIENCED A FEVER UP TO 102 DEGREES F. SHE HAS HAD SOME MILD REDNESS AND A LUMP AT THE INJECTION SITE.
Patient felt like perhaps injection site was high on his arm and maybe missed his deltoid.  He felt no pain at time of injection or soreness after but suffered a shoulder injury one week later.  It is unclear if it was related to the vaccination.  The patient is trying to schedule an appointment to see his doctor regarding the matter.
No adverse event. Client had MMR vaccine on 6/7/23. Given another live, varicella vaccine on 6/14/2023
sore/achy; muscle pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019 11:00, the patient received the 1st dose of Shingrix. On 20th June 2019, several hours after receiving Shingrix, the patient experienced pain and myalgia upper extremities. On an unknown date, the outcome of the pain and myalgia upper extremities were recovering/resolving.   It was unknown if the reporter considered the pain and myalgia upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient received the vaccine and a couple of hours later the muscle in her arm started to ache. Till the reporting time, it was 50 % better but was sore.  The reporter did not consent to follow up.
Injection was given in my left arm. 2 days after the 2nd Pfizer vaccination, I noticed a large amount of swelling in my left arm pit and going into my breast tissue. The entire area was very tender for one day, but the swelling has persisted.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old female patient received bnt162b2 (BNT162B2) (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), outcome "unknown", described as "Booster"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shingles outbreak; rash; This case was reported by a pharmacist and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2020, the patient received Shingrix. In July 2020, 24 hrs after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable. On 6th July 2020 at 2.30 pm, the patient was vaccinated Shingrix in left deltoid. On 8th July 2020, the patient possibly having a shingles outbreak along the dermatome originating at C4. The rash was on the opposite side (right side).  The rash became apparent twenty-four hours post vaccination. It was not blistering at this point. It was pyretic and non-purpuric.  The patient had been prescribed Valtrex 1 gram by mouth three times daily for seven days.  The reporter asked, is there any recommended treatment for patients experiencing a shingles outbreak soon after a Shingrix vaccination. In our pharmacy, we have had approximately thirty doses from this lot and we had no other reported incidents. We had not spoken with all the other patients but we were in the process of making contact with them just to check-in.
Patient was exposed to COVID positive person on 4/14/21 and requested test for screening. Reported no symptoms at that time, but was positive. Presented to emergency department on 4/25/21 with complaints of sudden onset difficulty breathing and chest pain.  She was found to be in COPD exacerbation possibly caused by COVID-19 infection or allergies. She was admitted to hospital for further management until 4/26/21.
This spontaneous report was received from a pharmacist regarding 8 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates, patients missed a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) subcutaneous injection (lot number: M040146; expiration date: 26-DEC-2017) for prophylaxis, as a package of ZOSTAVAX were defective. A product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
This spontaneous report was received from a pharmacist regarding to a female patient on her 70's. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided. On 20-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M000592 and expiration date 12-OCT-2017. Dose and route were not provided. On 27-SEP-2016, the patient noticed red blotches on her arms and legs. The patient stated that the blotches were itchy at first but had stopped itching and were just blotches present on her arms and legs. It was not a product quality complaint involved. At the time of reporting the outcome of the events was unknown. The reporter's causality between the events and the suspect therapy was not reported. Additional information is not expected.
Super extreme headache and high fever.  Body ache and weakness.  Took ibuprofen whenever there was extreme pain (approx. 3 times). The pain reduced because of the medicine but it came back once the effect of the medicine subsided.