chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my breath and wheeze/cough.  I had called my primary care physician and saw them and said I wanted a visit with a cardiologist.  Just one week later, during a work call, it the event happened so severely that I started passing out.  Thus, I went immediately to the ER and checked myself in.  It was not until mid-July that I got to see a cardiologist, and my symptoms were much less frequent or severe by that time.  For several weeks though, it was very uncomfortable and unnerving.
Patient developed fever, her blood pressure increased, she had itching all over, her throat was hoarse, she had a sore upper chest like a heartburn feeling. She also reported a sore ar. The ER doctor treated her with Benadryl. She also went to her regular doctor and he added Pepcid to her regimen.
pt states that immediately after getting the vaccine she felt like something was grabbing at her throat.  Her body felt itchy and she had dizziness.  She had a cool feeling all over her body and was feeling very uncomfortable.  She had tingling in the lips with no swelling. These symptoms lasted about forty minutes.  About an hour after she had itching on both ears and had swelling in both eyes.  She took Zyrtec and about an hour later she was back to normal.  She continued to take the Zyrtec and her symptoms did not escalate. Her left arm was tender to touch but no swelling.   Pt says these symptoms lasted about 24 hours.
passed out; Fever; Headache; body aches; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PYREXIA (Fever). On 12-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). In October 2021, the patient experienced DIZZINESS (Dizzy), HEADACHE (Headache) and MYALGIA (body aches). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (Dizzy), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. Treatment included injection for her dizziness.  Patient was scheduled to take her second dose on 13Nov2021.  This case concerns a 42-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Loss of consciousness. The event occurred approximately 4 days after the first dose of Moderna COVID-19 Vaccine. The event seriousness assessed as serious per IME list although information in the source document does not suggest seriousness criteria fulfilling the medically significant criteria. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 42-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Loss of consciousness. The event occurred approximately 4 days after the first dose of Moderna COVID-19 Vaccine. The event seriousness assessed as serious per IME list although information in the source document does not suggest seriousness criteria fulfilling the medically significant criteria. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
08/14/10 In AM observed redness, tenderness & swelling on Lt Arm. Started warm compress x 3-5 min then did cold compress x 5 min. Pt states redness goes down to elbow, measured site at 5" wide & 6" long, advised pt to call & go see her Dr.
Breakthrough COVID infection. On 08/21/2022, patient reports shortness of breath and chest pain "for a few days". Also reports a positive home COVID test on 08/14/2022.
having headaches so bad; nausea; body aches; chills; she is vomiting; muscle aches; This is a spontaneous report from a contactable consumer (patient herself). A 68 (units: unknown) aged female patient of an received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021 it was reported as patient stated that she received the second dose of the Pfizer vaccine on 09Feb2021 and the side effects are extremely worse than the first dose. She had headache, nausea, body aches, muscle aches and chills and she wants to know if she can take Tylenol. After this second dose, she is having headaches so bad that she is vomiting. She is wondering if Tylenol is contraindicated with the product. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Fever (101.3 with Meloxicam), headache, body aches.
Had very low back pain, not a big deal; A sore arm, no big deal at all.; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Had very low back pain, not a big deal) and MYALGIA (A sore arm, no big deal at all.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced BACK PAIN (Had very low back pain, not a big deal) and MYALGIA (A sore arm, no big deal at all.). At the time of the report, BACK PAIN (Had very low back pain, not a big deal) and MYALGIA (A sore arm, no big deal at all.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-392450 (Patient Link).
1350:C/O tightness in throat, headache, excessive saliva in mouth. B/P 126/78, SPO2-100%, Pulse-59. 1400 Given 0.3mg epinephrine IM in right anterolateral thigh, given by nurse. 1405:911 called for transport to ER for observation, vital signs followed: B/P 136/78, SPO2-100%, Pulse-62, Resp--20. 1410 Rescue Fire Department arrived. Assessment done by lead rescuer. Patient declined transport to ER via Rescue Unit. Traveled to ER via private vehicle.
Information has been received from a 73 years old female patient referring to herself. Pertinent medical history and drug reactions/allergies were not reported. On 23-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) in the left arm. Concomitant therapies included losartan for high blood pressure and omeprazole (manufacturer unknown). On 25-SEP-2015, the patient noticed a little pink area underneath her bra area with little bumps. There was no itching or pain. The patient sought unspecified medical attention on an unknown date. Outcome of the events and the causality were unknown. Additional information has been requested.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at injection site on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Coughing a lot, coughing every few minutes, 12/25/2022 conducted covid test which was positive.
Tachycardia at 65 and then shoot up to 120 and 125; Erratic heartbeat; She could not move; Bone pain; Diarrhea; Fever/Had at 103, 104.8; Nausea; Vomiting; Muscle pain; Lymph nodes swollen up underneath arm and neck; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia at 65 and then shoot up to 120 and 125), HEART RATE IRREGULAR (Erratic heartbeat), MOVEMENT DISORDER (She could not move), BONE PAIN (Bone pain) and DIARRHOEA (Diarrhea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis since an unknown date and Antiphospholipid syndrome (Patient had markers APS and rheumatoid arthritis but did not take medication) since an unknown date.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia at 65 and then shoot up to 120 and 125), HEART RATE IRREGULAR (Erratic heartbeat), MOVEMENT DISORDER (She could not move), BONE PAIN (Bone pain), DIARRHOEA (Diarrhea), PYREXIA (Fever/Had at 103, 104.8), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Muscle pain) and LYMPHADENOPATHY (Lymph nodes swollen up underneath arm and neck). At the time of the report, TACHYCARDIA (Tachycardia at 65 and then shoot up to 120 and 125), HEART RATE IRREGULAR (Erratic heartbeat), MOVEMENT DISORDER (She could not move), BONE PAIN (Bone pain), DIARRHOEA (Diarrhea), PYREXIA (Fever/Had at 103, 104.8), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Muscle pain) and LYMPHADENOPATHY (Lymph nodes swollen up underneath arm and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 103 f (High) AT 2am  had at 103, 104.8 for 5 hours straight.. On 04-Feb-2021, Heart rate: 65 Patient experience tachycardia at 65 and then shoot up to 120 and 125..         No relevant concomitant medications were reported. Treatment medications included Tylenol and Advil.
pt became pale, hypotonic & less responsive w/in 1 hr of vax; pt admitted to hosp;
No additional AE reported; his first dose of MMR II at the age of 29 years; This spontaneous report was received from a pharmacist referring to a 29-year-old male. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).
21JAN93 call recvd from med center stating that pt had died this morning-cause unk; also was informed that pt recvd vax on 9DEC922; 15JAN93 denied any hx of previous immun;
07Jan antigen positive and 10Jan PCR positive; 07Jan antigen positive and 10Jan PCR positive; 03Jan2022 mild ST congestion in the chest; 03Jan2022 mild ST congestion in the chest; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 30 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "07Jan antigen positive and 10Jan PCR positive"; OROPHARYNGEAL PAIN (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset 03Jan2022, outcome "unknown" and all described as "03Jan2022 mild ST congestion in the chest". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive; (03Jan2022) positive, notes: Home Ag, unknown; (10Jan2022) positive, notes: PCR,Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, oropharyngeal pain, respiratory tract congestion. Clinical Course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. 03Jan2022 mild ST congestion in the chest and 07Jan antigen positive and 10Jan PCR positive. Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown.Since the vaccination, has the patient been tested for COVID-19?:Yes. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and covid19 cannot be totally excluded.
Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Soreness in arm) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced AXILLARY PAIN (Soreness in arm).   On 14-Jan-2021, AXILLARY PAIN (Soreness in arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Outcome of an event updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
DTaP #5 given left thigh 08/14/2003.  Patient seen 08/16/2003 with 5 x 3 inch red, indurated area at injection site.  Mother with history of allergy to tetanus reaction about 10 years ago.  Treated with ice pack/Tylenol.  Diagnosis with localized reaction.
Patient presented to emergency department on 11/21/2021 with fatigue. She was diagnosed with COVID-19 infection on 11/16/2021. Patient was admitted for management of COVID-19 infection. She was treated with dexamethasone, barcitinib, and supplemental oxygen. Patient was not improving with treatment and decided against aggressive treatment. She was discharged to hospice on 11/30/2021 and expired on 12/2/2021.
Swelling in entire left axilla. Pain radiates from axilla to inside upper arm, down my side and into breast.  No relief with ibuprofen or acetaminophen. No relief with heat. Mild relief with cold application.
pt recv vax 26DEC97 & 30DEC97 pt devel a significant number of hive-like lesion son back & the front & back of torso;had no other signs or sx was running around & playing like a nl healthy child;
Shot given 12/02/02 to right upper arm secondary left mastectomy (1993), Began itching 12/08/02, Seen 12/09/02 with red, warm, indurated right upper arm, Muscle tenderness
dizziness p/vax; dizziness/hives/wheeze/SOB 1 1/2 hr p/vax;
painful, sore arm. could not lift my arm or move side to side. chills, fevers, body aches, eyes sensitive to light
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009933.
metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient).  A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization.  Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
on 8/31/23 pt reports to us that after the shingrix vaccine on 3/12/23 he had pain for approx 5 months (could not sleep on the left side) now at the 5 month mark he is experiencing a tremor in the left hand/arm.  He had trauma to that arm and some nerve damage from a previous incident years ago but nothing to this extent.
shortness of breath; fever; body aches; bad fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (bad fatigue), CHILLS (chills), PYREXIA (fever), PAIN (body aches) and DYSPNOEA (shortness of breath) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (chills). On 14-Jan-2021, the patient experienced FATIGUE (bad fatigue). On 15-Jan-2021, the patient experienced PYREXIA (fever) and PAIN (body aches). On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath). On 15-Jan-2021, FATIGUE (bad fatigue) had resolved. On 16-Jan-2021, PAIN (body aches) had resolved. On 17-Jan-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol and Ibuprofen.   Reporter did not allow further contact
arm sorneness Narrative: PT with sore arm starting day of administration location L elbow through forearm--difficulty raising arm or using cane--pain is now soreness that has it still current
On 11/29/2018, patient received PNEUMOVAX 23 (administered on Right Arm), FLUZONE HD (administered on the left arm) and BOOSTRIX (administered on the left arm). On 11/30/2018 the patient returned with a red spotted, swollen right arm.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  9/27/2021 Is this your first or second dose- 3rd (booster) Date of symptom onset - ? 9/28/2021 Symptoms - ? headache, body aches, chills, fatigue, and fever of 100.0 Last day of work and shift - ? NA Home remedies- Employee stated she just took Advil Any improvement- N/A Recommendation- Advised employee to continue taking Advil per pack instructions as needed for fever. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
PATIENT'S MOTHER REPORTED 100.8 FEVER STARTED AT 12 NOON. THE PATIENT WAS ADVISED TO PROVIDE TYLENOL AS PER THE DOSAGE INSTRUCTION ON THE BOX. IF THE FEVER GOES MORE THAN 101.4 OR SYMPTOMPS GETS WORST SHOULD VISIT DR. OFFICE.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 2nd dose of SHINGRIX. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, inability to work, appetite absent, fever and nausea. On an unknown date, the outcome of the injection site pain, inability to work, appetite absent, fever and nausea were unknown. It was unknown if the reporter considered the injection site pain, inability to work, appetite absent, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site pain, nausea, loss of appetite and fever of 101 degrees. The reporter noted that the patient was so ill that she could not go to work.
Patient reported that her heart is racing.  I checked her BP three times: 12:37pm 168/98 pulse 97 12:46pm 157/96 pulse 89 12:58pm 147/93 pulse 86 Patient said she felt anxious due to her allergy history. I had her sit in the observation area for 30 minutes and gave her water.  She displayed no additional symptoms and nothing that would have been indicative of anaphylaxis.   She was vaccinated at 12:30pm and left the store with her husband at 1pm.