chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had stabbing pains in my legs and feet; Sharp needling pain, sharp pains and will go away on the top of my ankle and back and behind knees (where the lymph nodes are)/body aches (sharp pains in the area lymph node areas); Chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Guillain-barre syndrome, inflammation of muscle, muscles got weak, the sun turned green, it took a week for it to go away, allergy to cats and sulfur and heavy dust. Family history included her husband was allergic to everything and her son has lots allergies (not drug allergies) but he was allergic to nature. Her son took Claritin for allergies (but not when he got the vaccine) and she had sharp pains in the area lymph node areas in her early 20s with thimerosal derivative in it. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced stabbing pains in her legs and feet, sharp needling pain, sharp pains and will go away on the top of her ankle and back and behind knees (where the lymph nodes are)/body aches (sharp pains in the area lymph node areas), chills and fatigue. Patient stated, she had side effects too. She did not have chest pain. Information on taking antihistamines with the vaccine was not clear. She had a side effect after the first dose of the vaccine. Should she get the second dose. The prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The outcome of the events was unknown.  No further follow up attempts needed. No follow-up attempts are completed; information about lot/batch number cannot be obtained.
localized pain and lump at site developed within 2 hours of administration then developed redness that extended from the deltoid to the elbow. Developed bruising at injection site 3 days after injection. Treatment: Tylenol, warm compresses, elevation.
Period began a week early on 5/28 after receiving 2nd dose on 5/18; Currently 6/12 and period has not stopped. (Have been menstruating for 22 years and period is always 4-5 days.); This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18May2021 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 28May2021, the patient had period which began a week early after receiving second dose. As on 12Jun2021, the period had not stopped. The patient had been menstruating for 22 years and period was always for 4-5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period began a week early and period had not stopped were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm; body was cold; haven't got his second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING COLD (body was cold) and PRODUCT DOSE OMISSION ISSUE (haven't got his second shot) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING COLD (body was cold) and PRODUCT DOSE OMISSION ISSUE (haven't got his second shot). At the time of the report, PAIN IN EXTREMITY (sore arm) and FEELING COLD (body was cold) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (haven't got his second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-138168, MOD21-091086, MOD21-091084, MOD21-091085 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138168: MOD21-091086: MOD21-091084: MOD21-091085:
breathing issues, tightness in chest, fatigue, joint pain, fever, chills,, migraines all lasting more than 4 weeks.
Patient said that the day after the shingles shot, she felt back pain, difficulty breathing, weakness, and dizzy, not be able to walk without forcing herself.
MPX administration. No bleb noticed. Pt educated regarding re administration. Pt verbalized understanding, another vaccinator readministered the vaccine successfully.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION OF 0.2ML AT 12 YO. CLIENT SHOULD'VE RECEIVED GRAY-CAP FORMULATION OF 0.3ML.
Postural orthostatic tachycardia syndrome; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 03Aug2022, this case now contains all required information to be considered valid.  This is a literature report.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 12 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: positive, notes: Mildly  with a titer of 0.07 nmol/L (normal less than 0.02); Blood pressure diastolic: 14; Blood pressure systolic: 16; Blood thyroid stimulating hormone: Normal; Echocardiogram: Showed normal biventricular size and function; Electrocardiogram: Showed normal sinus rhythm; Electrocardiogram ambulatory: Showed normal sinus rhythm; Full blood count: Normal; Heart rate variability test: Normal; 47; Autonomic testing: showed orthostatic tachycardia without OH, consist, notes: ent with a diagnosis of POTS; Unremarkable; Normal; Maximum heart rate: 136; Sweat test: Normal; Tilt table test: Prominent orthostatic tachycardia (above), HR delt, notes: a 47 bpm, max HR 136 bpm with no significant orthostatic hypotension (below); Valsalva maneuver: Normal; Antiacetylcholine receptor antibody (normal high range 0.02): 0.07 nmol/L. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Postural Orthostatic tachycardia Syndrome and the suspect drug BNT162B2 cannot be excluded. 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,Linked Report(s) : US-PFIZER INC-PV202200037945 Same article/drug/event and different patient;US-PFIZER INC-202201040964 Same article/ drug/event and different patient.;US-PFIZER INC-202201040965 Same article/ drug/event and different patient.;
Swollen under her armpit, near breast; lymph nodes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen under her armpit, near breast) and LYMPHADENOPATHY (lymph nodes are swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 031M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CALCIUM, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SWELLING (Swollen under her armpit, near breast) and LYMPHADENOPATHY (lymph nodes are swollen). At the time of the report, SWELLING (Swollen under her armpit, near breast) and LYMPHADENOPATHY (lymph nodes are swollen) outcome was unknown.            Other relevant concomitant medicines included multi vitamin.  The action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided.
Pt devel swelling & redness @ site of inject approx 2 days p/receiving Td;
Pt received dose 1 of Pfizer vaccine on 4/15/21 at approx. 3:46pm at a clinic due to past allergies. While being monitored for 30 minutes post vaccine, pt complained of slight wheeze, pain in throat and tongue feeling heavy. Only visible sign was small red blotches on upper chest. BP was 159/95, pulse 75 and pulse ox was 97%. 25 mg Benadryl po  given at approx. 4:16pm. Pt remained at clinic to be monitored. At 4:50pm, patient left with husband feeling much improved: throat pain gone, wheeze gone, tongue feeling normal, swallows easily and red areas on chest visible, but diminished in size. Patient called on 4/16/21 and no further complaints. Felt much improved once home and no further symptoms. Encouraged to let staff know about incident when receiving dose 2 and to stay longer than 30 minutes for monitoring.
Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine; Body ache after receiving the second dose of the Moderna Covid 19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine) and MYALGIA (Body ache after receiving the second dose of the Moderna Covid 19 Vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MCOA) for COVID-19 vaccination.     The patient did not had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy (Penicillin), Food allergy (spicy food), Palpitations and Thyroid disorder NOS. Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA), CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine) and MYALGIA (Body ache after receiving the second dose of the Moderna Covid 19 Vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine) and MYALGIA (Body ache after receiving the second dose of the Moderna Covid 19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She had heart palpitations before due to her thyroid problems. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Live follow-up received contains no new information.
Drooping of right eyelid.  Started 2 days after injection. Symptom still persisting as of Jan. 30, 2021
3 to 4 days, post vax, the sitter noted baby's face was very swollen. She also had a low-grade fever. This resolved by the time the parent picked up the child.
Patient is a 65 y.o. female patient of MD presented with generalized weakness, SOB due to COVID-19 infection. She was treated with remdesivir and decadron while inpatient and requiring supplemental O2. She was successfully weaned on 9/19 and stable for discharge. Patient developed new onset atrial fibrillation while hospitalized. Rate controlled with Toprol XL 100mg, started on Eliquis prior to discharge with  plans for echo and cardiology follow up in one month.   COVID 19 infection Acute hypoxic respiratory failure Date of onset of symptoms: 9/14 Symptoms present on admission: Nausea, decreased oral intake, weakness and shortness of breath Date of covid positive test: 9/16 Vaccination status: vaccinated Moderna x2 in 2021 Imaging: Chest x-ray on 9/16 showed mild cardiomegaly, mild fluid/atelectasis in the right lung base.  Small fluid/atelectasis in left lung base Oxygen requirements on admission: 4 L Current oxygen requirements: 2 L Medical therapy: remdesivir and steroids Consultants following: ID consulted Anticipated special isolation end date: 9/26   AKI, improved Creatinine 1.86 secondary to dehydration and volume depletion, 9/19 labs in process SCREATININE 0.96 09/18/2023 Continue IV fluids Recheck labs while inpatient -improved on discharge     Atrial fibrillation with RVR As needed diltiazem Continue Lovenox 1 mg/kg twice daily Status post Cardizem x1 in ER Continue telemetry monitoring Initiated on Toprol-XL 25 mg, up titrated to Toprol-XR 50mg daily Cardiology consulted, increased metoprolol to 100mg Patient will require transition from lovenox to eliquis prior to discharge. Order placed, working on affordability/coverage. Medication covered. bubble echo ordered, if not completed inpatient, can be completed as OP procedure per cardiology Will require outpatient follow up with Dr.   Fall Denies hitting head or losing consciousness; able to walk and bear weight without pain Fall precautions PT/OT/UM consulted, discharge to home   Anemia         Lab Results Component Value Date   HGB 10.6 (L) 09/18/2023 Continue home iron Recommend continued outpatient follow-up   Essential hypertension Restarted home metoprolol but changed to XL, now 100mg. Continue BP monitoring while inpatient   Generalized anxiety/ depression Continue home Xanax and Effexor   GERD Continue home PPI
w/in 12 hrs of DTP pt had subjective fever, large red warm area @ inject site now indurated; tx moist heat; APAP;
I got I got both the Moderna Covid-19 shots. I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I got I got both the Moderna Covid-19 shots. I had a sore arm) 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 first 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) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (I got I got both the Moderna Covid-19 shots. I had a sore arm). At the time of the report, PAIN IN EXTREMITY (I got I got both the Moderna Covid-19 shots. I had a sore arm) outcome was unknown.            No concomitant products were reported. No treatment information provided.
arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted approximately 2 hours then passed.
Arm very sore, small red rash at the site of shot, warm to touch, palpable area about the size of a quarter, cheeks red and possibly a low fever; mother called about 4pm on 4/8/15 to report symptoms. Instructed to apply ice to the area and give pain medications if felt needed per recommendations in appendix D of pink book; instructed mother to seek medical attention if symptoms worsened; Mother did call pediatrician and was instructed to give Benadryl and she did administer to child; follow up call on 4/9/15 mother reported area a little bigger and still somewhat red with soreness being the same and she reported that her left arm is swollen and warm with no redness or pain where Kinrix was administered.
This case was reported by a healthcare professional and described the occurrence of leg pain in a 33-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. On 2 June 2011 the subject received 1st dose of TWINRIX (unknown route, left arm). On an unspecified date in 2011, less than one year after vaccination with TWINRIX, the subject experienced leg pain and cramping. The subject received the 2nd dose of TWINRIX on 11 July 2011 and reported the events of leg pain and cramping after the 1st dose. At the time of reporting the events were unresolved.
but the patient did not receive another dose of a varicella vaccine.; no other AE occurred.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date (reported as at 1-year-old), the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. The patient then received a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) according to the dosing schedule (date unknown by reporter), but the patient did not receive another dose of a varicella vaccine (product dose omission issue) and no other adverse event occurred.
This case was reported by a consumer and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 2nd May 2018 (experienced aches and pain, headache and debilitation: please refer case US2018151134 )). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that, after vaccination with SHINGRIX, the patient had sore arm. This case was linked with case US2018151134, reported by the same reporter for the same patient.
This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in August 2014 the patients were vaccinated with five unsupported, improperly stored doses of GARDASIL lot # K005083, exp. date: 04-NOV-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Felt very sluggish and no appetite the day after the vaccine.  About 24 hours after receiving the vaccine a severe headache started, fatigue increased, muscle aches, leg cramps, no fever but felt chilled and had the sweats. These symptoms lasted for about 16-18 hours.
PT CARE TAKER REPORT THAT ON 2/3/21 PT DEVELOPED GOLF BALL SIZED LUMP AT INJECTION SITE. ONE 2/4/21 LUMP INCREASED IN SIZE TO SOFT BALL SIZE
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-JUN-2014, the patient was vaccinated with an unspecified stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689  and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 248 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
The morning after receiving the vaccine, I woke up and was pretty dizzy which made me nauseous. I had to try a few times to get out the bed. It went off and on on Sunday then it went away.  (felt like I was suffering from vertigo) I do not think I have suffered from it since then.
I began having a persistent cough in January 2023. It became productive after a few weeks. The phlegm was kind of green, so I thought I must have an infection, so I called my PCP on 1/23/2023 and saw him in person on 1/24/2023. I underwent a chest X-ray, and I was put on Advair and prednisone. No anomalies were detected in the X-ray. After I started the Advair and prednisone, the productive cough continued, but I felt better and was able to sleep better at night. I felt like the medications were masking the underlying issue, though. On 1/26/2023, my PCP ordered a CT scan, which I underwent on 2/3/2023. The CT scan results were fairly inconclusive, though the radiologist thought they showed minor scarring of the lungs, which the pulmonologist thought later was an overread. The pulmonologist now thinks that the symptoms may be indicative of seasonal allergies and/or latent asthma. I am currently taking fluticasone and an albuterol inhaler, ipratropium bromide, and OTC decongestant with guaifenesin and dextromethorphan (as needed). My cough is now much milder, but it is still present.