chrisvoncsefalvay/vaers-outcomes huggingface dataset:
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20May2022) Positive, notes: Rebound Covid - Positive Again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took anti-viral Covid-19 Treatment of Pfizer brand. Treatment start date was 10May2022 and Stop date 5May2022. She did not had any known allergy. Other medication in 2weeks was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
pt recv vax & started to blotch w/in 10min of vax;24FEB97 mom states pt is fine & MD feels reacted to pertussis;
Significant arm pain that lasted 72 hours.  Also started a period in the middle of my menstrual cycle which had never happened to me before. Had my normally scheduled period 3/21/21-3/25/21. Started a period again on 4/5/21-4/8/21.
Approximately 4 hours after receiving vaccine, patient broke out in full body hives. Patient took Benadryl and Claritin that night and Claritin the next day and symptoms subsided.
No additional AE reported.; VARIVAX was administered during a T/E; This spontaneous report was received from a nurse and refers to a 51-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided.  On 16-OCT-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose subcutaneously in left arm, lot # X010525 expiration date 11-APR-2025 (exact dose was not provided), for prophylaxis. The vaccine was previously incorrectly stored at a temperature of 12.5 Fahrenheit degrees for 25 minutes. Varicella virus vaccine live (oka/merck)(VARIVAX) was administered prior to determining vaccine was viable. The vaccine was determined to be viable. No adverse event was reported.
Patient received Moderna 0.25ml IM (booster strength) on 12/22. She reported today, 12/24, that she has a silver dollar-size knot located slightly below injection site that is red, itchy, and warm-to-touch. Patient took Tylenol on the night after receiving the vaccine then took Ibuprofen on 12/23 when the symptoms started to appear. Instructed patient to take Benadryl to help alleviate some of the itching and to continue OTC pain medications, also to receive medical care if her condition does not improve after the holiday weekend.
Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibuprofen. Then came intense fatigue and malaise w/body and muscle aches. Lastly, swollen lymph nodes in armpit on arm of injection site and arm pain.
I had the normal sore arm and fever. I went to sleep on the 11 and had a earache. Woke up on the 12 and my left ear was swollen first. I went back to bed that night and felt my right ear swollen. Then I broke out in hives on the back of my head leg arm. They were burning and painful. On the 14, my hands were burning and itchy. The following night my feet were also itchy and red and very painful. I also continued to keep getting ear swelling and painful breakouts constantly.
3/23 tired slept on way to KY. 3/24 drove half way back to CLE. 3/25 through 3/31 low grade fever and fatigue.  3/31 thumbs turning purple and looked bruised. Went to hospital emergency room. All fingers were turning purple and swelling. Could not bend fingers. Hurt to touch anything, couldn't open containers.  Spent 2 nights (3/31-4/1)at hospital.  Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot.  Also CT scan at hospital showed a small nodule in the right lung.  There was no nodule in the CT scan from Februrary 9,2021  .4/3 fingers less purple and moving some. Saw Doctor 4/5, she wanted pulmonary appointment asap.  4/3 through 4/12 afterbiib fatigue.  Saw pulmonary dr. 4/14,  she and her colleague also agree the nodule is from the vaccine and I need another CT scan early May to see if it is gone.  Hands normal in color but the skin is peeling  off and they  itch and are still sensitive.
Sinusitis; headache; ear ache; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Lot number, expiration date: unknown) as unknown dose number, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient experienced sinusitis, headache, ear ache, dizziness on an unspecified date. She took Tylenol and wants to know if she can take other medications. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Swollen painful armpit left side; Swollen painful armpit left side; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 42-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 09:30 (at the age of 42-years-old); each as a single dose for COVID-19 immunisation. Medical history included migraine. The patient previously took CECLOR and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 12:00, the patient experienced swollen painful armpit on the left side. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of swollen painful armpit on the left side was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
There was an excursion from the freezer; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No treatment medications were provided y the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up document was received on 15-NOV-2021 and it includes patient demographics and dose number and the lot number was updated.
pains; extreme fatigue; extreme headache, like a migraine; aches; joint pain in knees and hips; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), FATIGUE (extreme fatigue), HEADACHE (extreme headache, like a migraine), MYALGIA (aches) and ARTHRALGIA (joint pain in knees and hips) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 026B21A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN B NOS, MAGNESIUM and VITAMINS NOS for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (pains), FATIGUE (extreme fatigue), HEADACHE (extreme headache, like a migraine), MYALGIA (aches) and ARTHRALGIA (joint pain in knees and hips). At the time of the report, PAIN (pains), FATIGUE (extreme fatigue), HEADACHE (extreme headache, like a migraine), MYALGIA (aches) and ARTHRALGIA (joint pain in knees and hips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported   This case was linked to MOD21-076332, MOD21-076420 (E2B Linked Report).; Sender's Comments:  MOD21-076332:Husband report MOD21-076420:
Follow-up information was received that upgraded this case to serious and provided vaccine information, event onset date, additional event of rash, outcome, and laboratory tests. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who received the first dose on 31-Jul-2007 along with the first dose of ACT-HIB (Aventis) and spiked a very high temperature and developed a rash. Relevant medical was not provided. Indication for PREVNAR was immunization. Product was administration on 31-Jul-2007. Dose regimen was 1 dose 1 time per day. Additional suspect medication included ACT-HIB. Concomitant medications were not reported. On 31-Jul-2007, the patient received the first dose of PREVNAR along with another childhood vaccine. On 02-Aug-2007, the child spiked a very high temperature (pyrexia) and developed a rash. The patient was hospitalized to rule out sepsis, and a blood culture revealed no growth. After three days a of hospitalization, the patient was discharged from the hospital. Both events resolved. See 'Relevant Tests/Laboratory Data" below. No additional information was available at the time of this report.
Reports severe GI pain, "kidney and liver pain," severe abdominal bloating, rapid heart rate, constipation
Developed bilateral tinnitus one day after receiving 2nd vaccination. No tinnitus prior to vaccination (or at any other time). Still experiencing tinnitus two weeks later. The ringing is almost constant.
This spontaneous report was received from a pharmacist regarding a 61 year old female patient. The patient's medical history included a rash across her stomach which she thought was shingles and so went to the doctor on 15-NOV-2016 prior to receiving ZOSTAVAX and was informed that she didn't have shingles. So, she wanted to get the vaccine. On the same day (15-NOV-2016), she was vaccinated with one dose of ZOSTAVAX (lot # M034766 and expiry date: 26-OCT-2017), 1 ml, subcutaneously. On the same day, within seconds of vaccination, she experienced cotton mouth, weird taste, blurry vision, dizziness, numbing in and around her mouth, felt funny and had trouble breathing. An ambulance was called and the paramedics took her in it because they were concerned about her blood pressure which was "through the roof". Her systolic pressure was in 200's and diastolic pressure was unknown. The reporter stated that her vision was coming back but she still felt dizzy while sitting up. The patient was given 25 mg of liquid BENADRYL and had started to feel better but was still experiencing symptoms. It was also reported that she started feeling better prior to receiving BENADRYL. As of 15-NOV-2016, the patient continued to experience the events even though they were improving. The causal relationship was not reported. The reporter considered the events to be serious due to other medically important and hospitalization. Additional information has been requested.
Redness at injection site, increased swelling, 15 cm round red, not tender.  Symptoms started 2 days after vaccine given (TDaP).  Treated with Benadryl 50 mg by mouth every 4-6 hours as needed, Keflex 500 mg 1 tab by mouth three times a day and cool compresses.
After the first shot a sore formed within the patient's mouth.; She thought the doctor's office was administering MMR 2, because her son only needed protection from measles, mumps and rubella; he didn't need protection from Varicella as well.; This spontaneous report was received from the patient's mother referring to a 14 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were reported as none.  On 14-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection into arm (0.5 ml, strength and route were not reported, lot# T005404, expiration date not reported, but upon internal validation established as 12-AUG-2021) to prevent measles, mumps or rubella, despite measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) not being approved for patients over the age of 12.  The reporter did not know that the patient was getting measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The reporter thought the doctor's office was administering measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), because the patient only needed protection from measles, mumps and rubella; he didn't need protection from varicella as well (wrong vaccine administered).   On 14-OCT-2020, after the first shot, a sore formed within the patient's mouth (sores mouth). On an unknown date, the patient did a blood work (result was not provided). The outcome of the event was reported as recovered on 21-OCT-2020. No treatment was given. The patient did not seek medical attention.  The relationship between sores mouth and both vaccines was not reported.
My right arm swelled initially the next morning and then my muscles began locking up.  My left arm, shoulder, trapezoid, neck were all locked up and in pain for 4 days.  I suffered a sever migraine for 3 days.   I have noticed that since the shot I see "floatees" in my right eye and other issues with my eyes.
her lymph nodes are swelling after the administration of the second dose of the Pfizer's COVID-19 vaccine.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date to a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the consumer reported that her lymph nodes are swelling after the administration of the second dose of the Pfizer's COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information regarding Lot/Batch/Expiry date could not be requested. No further information is expected.
The patient called to let us know that he arm that she had gotten her shingrix shot in was red, and hot radiating down from the injection site to her elbow. She did not notice this reaction until Friday morning and got the vaccine on Wednesday evening.
Arm throbs months after and seems to be worse in the sun. Rash comes and goes for months.
Terrible muscle pain at injection site.  Feels like muscle is torn.  Cannot lift arm up to shoulder.
Pt called office stated arm where vaccination given is itching, red, & swollen on 12/9/10 (vaccine given 12/8/10). Advised to apply ice and take BENADRYL.
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.    This case was linked to MOD-2021-316015 (Patient Link).
Itchiness started on scalp, then down to neck, back of neck and ears covered in hives, then down to back of body
Severe heart issues resulting in fall, loss of consciousness and a laceration to head. Brain hematoma which is effecting eye function.  HIGH blood pressure, pulmonary concerns, thyroid module.   Tests and treatment plans still in development. Patient did have a pacemaker inserted.  Multiple CAT scans, blood draws, x-rays have been preformed and 1 biopsy on the calendar.
Redness & swelling to left arm. Rash x 3 days. No SOB. No Distress.
Patient w/ history of anxiety, Pt felt dizzy, complaining of SOB, tongue swelling. Gave 0.3mg IM epi immediately. RRT called. Patient given 50mg of IM Benadryl. Patient escorted to the ED.  In the ED, serial exams normal since vss, nad, d/c around 10pm after more obs.
THE REACTION STARTED ON 09/20/17 FOR THE PATIENT. HER STATEMENT WAS THE FOLLOWING:  "I WAS DEATHLY SICK AND HAD PAIN IN MY LEFT ARM FOR ABOUT 48 HOURS (STARTING THE EVENING OF THE DAY I GOT THE VACCINATIONS). I HAD TERRIBLE CHILLS, FEVER, RUNNY NOSE, ASPIRATIONS IN MY LUNGS, A POUNDING HEADACHE AND i KEPT BURPING UP BILE.  MY LEFT ARM WAS SO SORE THAT I COULDN'T USE IT OR EVEN  TOUCH IT. MY TOTAL BODY WAS IN SHOCK...IT WAS BAD..."
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX. On an unknown date the patients received improperly stored ZOSTAVAX (approximately 10 doses) that were exposed to 32F for 12 hours. No adverse effects were reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. experienced syncope followed by seizure lasting approx. 30 sec. No hx of seizures.
very warm right arm with a 3D red area; very warm right arm with a 3D red area; very warm right arm with a 3D red area; This is a spontaneous report from a contactable nurse reporting for herself. A 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 05Feb2021 at 15:00 (at the age of 83 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient had a known allergy to codeine and scopolamine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL128401003592671000 231721043010EL1/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 15:00 (at the age of 83 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021 at 19:00, the patient experienced very warm R arm with a 3 D red area. The patient had no pain, and no fever. The very warm R arm with a 3 D red area was gone in the morning but reappeared around 7pm the next 4 days with the reddness decreasing each day. Each morning it was gone but reappeared each evening from day 5 to day 10. The event did not require a physician office, emergency room visit or hospitalization. The patient did not receive any treatment for these events. The outcome of the event very warm R arm with a 3 D red area was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19.
Narrative:  Patient received the 1st dose of COVID 19 vaccine on 6 August and test positive for covid 19 on 14 Aug 21 and was hospitalized with respiratory failure and COVID pneumonia. The patient was treated and discharged an oxygen on 8 September 2021. The EUA requires that any patients that test positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
On day one 06/29/2022 .I  woke up with a sore throat and a cough. I felt achy so I tested with a home test and it came back positive.  I contacted my PCP on telehealth she prescribed Paxlovid . I started taking Ibuprofen at that point, it help alleviate the achy ness. I feel great now. I started feeling better by 07/03/2022, the sore throat was gone and started feeling better and finally ate something that day .
Dizziness; Vertigo; About to fall and being off balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VERTIGO (Vertigo) and BALANCE DISORDER (About to fall and being off balance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received 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 DIZZINESS (Dizziness), VERTIGO (Vertigo) and BALANCE DISORDER (About to fall and being off balance). At the time of the report, DIZZINESS (Dizziness), VERTIGO (Vertigo) and BALANCE DISORDER (About to fall and being off balance) had resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-075059 (Patient Link).   Reporter did not allow further contact
Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt said her arm was sore for two days and also her Left Eye Burned and felt like acid was in her eye for about 90 second time periods about 3 episodes a day for 2 days.
Fever, began as low-grade (99-100) and reached a peak of 103.9 even with treatment with Motrin/Tylenol. Fever lasted a full 4.5 days, gradually tapering off. Patient vomited once during the highest point of the fever.  Mild rash also occurred on day 8 after the vaccine which was fully resolved within 3 days.
shingles. I developed shingles. 2 months after, so who knows, but ugh.