chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Dose 1 8/2/21 (lot NA) Moderna Dose 2 8/30/21 (lot NA) COVID Positive 12/31/21  1/8/22: Patient is a 66 year old male with past history of tobacco abuse, anxiety, and COPD who was admitted with chest pain and found to have an inferior STEMI.  History is obtained from chart review as well as discussion with the patient, and the ED provider.  Also discussed with the cardiologist.  Patient denies a history of heart disease. He does smoke 2 packs of cigarettes per day.  Does have a history of COPD and uses albuterol inhaler as needed also another unknown inhaler 2 puffs in the morning.  Does have a history of anxiety and did have a remote history of an overdose in 2014. Patient states he did test positive for COVID-19 just before new year's but has been symptom-free for at least the last 6 days or so.  He has received 2 COVID-19 vaccinations.  On Thursday the patient had a 2 hour episode of chest pressure which resolved spontaneously.  He states he was at work delivering pizzas. Around 9:00 p.m. tonight he developed recurrence of the symptoms which improved slightly and then became much more severe so EMS was called.  Was found to have an inferior STEMI and MI alert has been called.  Still having chest pain although is little better after receiving some pain medications.  Does have some shortness of breath as well as nausea and diaphoresis.  Denies any fevers, chills, abdominal pain.  1/9/22: 66-year-old male with COPD, tobacco abuse and recent diagnosis of COVID-19 presented with the chest pain. He was found to have inferior STEMI, underwent emergent coronary angiogram with  drug-eluting stent to RCA, LVEF 40%.  Post intervention chest pain has resolved patient remained asymptomatic.  Patient was cleared for discharge by cardiology. patient will be on dual anti-platelet with aspirin and Brilinta for 1 year, started on atorvastatin metoprolol.  Due to low normal blood pressure Ace inhibitors/ARB have not been started.  On discharge patient was a febrile and hemodynamically stable.  He was discharged home
pt in clinic given TD;approx 1 1/2hr later pt cousin call & reported pt covered w/rash;denied problems breathing  just scared;described rash as hives, raised welts covering entire body;
Information has been received from a 54 year old female with a history of shingles in right eye in Feb 1998 and no drug allergies who was vaccinated with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot # not reported0 for prevention of shingles on 17-DEC-2008.  It was reported that the patient experienced pain on the left side of her face, ear ache and swollen glands 2 days ago, on 06-JAN-2009.  The patient sought medical attention.  No lab tests were performed.  As of 08-JAN-2009, the patient was not recovered.  Additional information is not expected.
Extreme fatigue started immediately and has lasted two weeks plus she has developed a pain or burning under shoulder blade that worsens as she lies in bed overnight.
VS:  HR: 70s  BP: 131/74  O2: 95%  Symptoms:  Felt mildly SOB.  Did not feel anything like her MI, nor her allergic reaction to Dilaudid.  No N/V/Diaphoresis.  No itchiness, throat closing, tongue swelling sensations.  Normal exam.  Pt feeling better and wanted to just go home with her family member driving.  Aware that if feels worse or any concerns to go to the nearest hospital.  Will take antihistamine H1+H2 blocker as a precaution when gets home.
hyperventilation; half of her body was paralyzed/left side of patient body was paralyzed; This is a spontaneous report received from two contactable reporters (Consumers) from medical information team for a Pfizer sponsored program. The reporters are the patient and patient's daughter. Other Case identifier(s): US-PFIZER INC-202200065168.  A 41 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Apr2021 09:15 (Lot number: EW0171) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Family Medical History included the patient's grandfather had a reaction to a vaccine, but it was amoxicillin. But he died. There were no concomitant medications. No vaccines administered on same date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: HYPERVENTILATION (medically significant) with onset 19Apr2021 09:20, outcome "recovered" (2021), described as "hyperventilation"; PARALYSIS (medically significant) with onset 19Apr2021 09:20, outcome "recovered" (20Apr2021), described as "half of her body was paralyzed/left side of patient body was paralyzed". The events "hyperventilation" and "half of her body was paralyzed/left side of patient body was paralyzed" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (Apr2021) less. Therapeutic measures were taken as a result of hyperventilation, paralysis. Clinical course: On 19Apr2021, the patient received the Pfizer vaccine and 5 minutes later half of her body was paralyzed. (withheld) called an ambulance and administered her Benadryl. The ambulance took the caller to the emergency room and then sent her home 2 hours later. Patient diagnosis was hyperventilation. Further details reported that 5 minutes after the vaccine the left side of patient body was paralyzed, she couldn't move it and she couldn't feel it. That lasted the whole first day and then half of the second day. It didn't go away until 20Apr2021. Patient was calling to find out if she can get another dose of the vaccine if she would have a similar result as the first dose. Also it was mentioned that the patient was participating in a study on how many antibodies were in her system. The last study showed that she had less now so she was concerned. The doctor told the patient that there was a risk and that she should not get a second dose of the vaccine.
feeling bad all week; felt dizzy; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad all week), DIZZINESS (felt dizzy), HEADACHE (headache) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A211A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING ABNORMAL (feeling bad all week), DIZZINESS (felt dizzy), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (feeling bad all week), DIZZINESS (felt dizzy), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant medication history included Blood pressure medication,Thyroid medication,heart medication. Patient took Tylenol and medication for the nauseas since 01Mar2021.
The spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and genders. The patients' pertinent medical history or concurrent conditions were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored M-M-R II Subcutaneous injection (lot # L012480, expiration date 10-MAY-2017) (route, dose and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. It was reported that the therapy was not discontinued. There was no product quality complaint (PQC) involved. This was one of several reports received from the same reporter. Additional information has been requested.
Since 10/09/2017, the patient has felt pain at site of injection. It hurts when he lifts his arm above his head or behind his head. No fever or discoloration.
H Flu Shot 7/18/05 - flu symptoms 10/1/2005 another H Flu Shot -flu symptoms very tired 5/18/2006 H Flu Shot given - flu symptoms  and very tired 5/19/2007 MMR-extreme fatigue and flu like symptoms.  3 flu shots by 2 years old.  8/5/08 Reviewed PCP medical records & vax records which did not include lot #s. Records reveal patient received HAV #1, HIB #2 & MMRV on 5/18/2006; influenza vax #1 on 11/22/2005, #2 12/29/2005 & #3 1/31/2007.  Prevnar #1 7/18/2005, #2 10/1/2005, #3 11/22/2005 & #4 1/31/2007.  On 5/18/2006 pt w/cold s/s x one week of nasal congestion, throat congestion, decreased appetite, sleeplessness, fever.  Dx w/acute URI.
Patient received MenQuadfi booster vaccine administered on 09/20/2022.  Patient developed fever and ear pain on 10/05/2022, a PCP visit was completed, and patient diagnosed with left otitis media, acute pharyngitis, and prescribed Amoxicillin  875 mg to be taken twice per day for 7 days. A few weeks later, around 10/21/2022, patient began noticing tingling sensation in toes. This progressed to numbness, which then progressed to the hands as well. About 1 week later motor deficit symptoms began to develop. Presented to ED on 11/6/22, notes indicate diminished sensations along hands, arms, feet and legs. Most of the labs were unremarkable and no other symptoms present. Patient did have an elevated rheumatoid factor. Patient Discharged home  with Gabapentin 100 mg prescribed orally to be taken three times per day. Over the next few weeks symptoms were persistent with no improvement on medication. Patient was direct admitted from an outpatient neurology follow up appointment. Patient admitted to Hospital on 11/10/2022 and discharged home on 11/18/2022 with a diagnosis of Guillain Barre Syndrome.
Patient said he was thirsty and had some tightness in his chest after about 15 minutes. Administered epipen. Called 911 - EMS responded. Patient recovered in store.
This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on 04Jun2015, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced a lot of coughing that was making her choking, pneumonia, taste something it irritated all her throat (taste in the mouth effect), redness in the throat. The patient also mentioned that she had allergy to medicine and that she had a third set of antibiotics and nothing seemed to be helping. Somebody told her that it could be associated with the vaccination because it was a live virus and she wanted to know if it was possible. Outcome of the reported events was unknown. Follow-up (14Sep2015): New information received from the same contactable consumer (patient) includes: vaccination date updated, events updated, treatment detail.
Swollen tongue; Swollen lip like an allergic reaction; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip like an allergic reaction), CHILLS (Chills) and PYREXIA (Fever) in a 26-year-old female patient 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 SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip like an allergic reaction), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip like an allergic reaction), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not provided.   Treatment information was not provided.   This case was linked to MOD-2021-252814 (Patient Link).
5SEP95 gen hives; 6SPE95-12SEP95 gen hives swelling around eyes-& some around ankles: 12SEP95 arthralgia
patient experienced low BP (68/39) and passed out, fell off the chair and onto the floor, woke up on the floor within 30 seconds.
In order of appearance of symptoms: swollen tongue, numb roof and sides of mouth, cough, rash on chest and arms, hives, elevated pulse, drop in blood pressure, lightheadedness, dizziness, weakness, chest pain. Given 50 of benadryl (injection) upon return to clinc around 2PM, monitored for 20 minutes or so but my conditioned worsened and an ambulance was called. I was taken to the ER and given more benadryl, steroids, epinephrine, and IV saline and kept for around 5-6 hours for observation. Released with prescriptions for more benadryl and steroids for four days.  12/7 and 12/9/2009 ED record for 12/3/2009, patient with hives, SOB, swollen tongur, tx'd with benadryl/steroids DC Dx Allergic reaction
pain in joints, muscles, fatigue, swollen lymph nodes under arm towards the side, large in size
Wron technique; Rash Papular; Itching; vaccination site pain; Incomplete dose administered; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incomplete dose administered), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wron technique), RASH PAPULAR (Rash Papular), PRURITUS (Itching) and VACCINATION SITE PAIN (vaccination site pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg/dl. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Incomplete dose administered). On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wron technique), RASH PAPULAR (Rash Papular), PRURITUS (Itching) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, INCORRECT DOSE ADMINISTERED (Incomplete dose administered), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wron technique), RASH PAPULAR (Rash Papular), PRURITUS (Itching) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported,.
This spontaneous report was received from a pharmacist refers to a 72 year old male patient. On 14-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unknown date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL (lot # K010215, exp.date: 05-MAY-2017) (route and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
fatigue Narrative: 62 yo male with PMH:  pain in L knee, tobacco use, tinnitus, and barrett's esophagus reported having fatigue after his first Pfizer covid19 vaccine on 2/11/2021. This ADR was reported on 3/4/021 when he received his second dose of vaccine. Pt said he was still tired at that time. Pt received both vaccines without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy
Eczema vacinatum; without spreading itching rash for 1-week. Patient with macular rash on chest/back/upper extremities/hands. Patient complaint of profuse itching affecting sleep and work activity.  Symptomatic treatment provided with Atarax 25mg Qhs, Allegra 180mg daily and light duty for 3 days.
Spasm, pain right arm with touch numbness noticed July 13. Saw Dr and has had 2 PT with no help. Thought that Hep A could have caused problems. Does report slipped neck disc may be herniated. Having MRI this week.
Had Hep A, MENACTRA and Tdap on 7-15-14. Per ED note, had pain in right axilla and swelling anterior chest on 7-16-14. Pain progressed thru the day. Fever developed in the evening of 7-16-14. Increased swelling in arm early 7-17-14; fever spiked to 102. Mom took him to local ED. Venous/doppler was negative. Dx with vaccine reaction. Discharged from ED with KEFLEX Rx to fill if redness spreads/fever persists. Mom states symptoms are improving.
Experienced vomiting morning after shot along with fever of 101 and dizziness with standing, sweating and chills (1/28). Experienced  Severe swelling of axillary lymph nodes (1/28-1/30). Severe swelling of supraclavicular  lymph nodes ( 1/29-2/01) . Mild swelling of cervical lymph nodes (1/30-02/02). Mild swelling of submandibular lymph nodes (02/02)   Lymph node swelling  seemed to spread superiorly each day. Limited ability to raise arm/ sleep and pain with coughing breathing and swallowing.
Localized-firm, red, warm, mildly swollen left upper arm. Amoxicillin 250 mg TID x 10d + cool compresses.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A male patient in his late 60s of an unspecified ethnicity received either PREVNAR 13 or PNEUMOVAX 23, via an unspecified route of administration in the arm on an unknown date in 2015 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  On an unknown date in 2015, the patient experienced some swelling around the injection site in the arm that the vaccine was given. The outcome was unknown.
Severe cramping and menstrual bleeding early by two weeks. This happened with my second vaccine as well but I did not feel it was vaccine related
Patient needed a walker because she can hardly walk; pain in her right leg and she cannot even put pressure on it; Patient needed a walker because she can hardly walk; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (Patient needed a walker because she can hardly walk), PAIN IN EXTREMITY (pain in her right leg and she cannot even put pressure on it) and WALKING AID USER (Patient needed a walker because she can hardly walk) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (Artificial colors and flavors). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced GAIT INABILITY (Patient needed a walker because she can hardly walk), PAIN IN EXTREMITY (pain in her right leg and she cannot even put pressure on it) and WALKING AID USER (Patient needed a walker because she can hardly walk). In March 2021, GAIT INABILITY (Patient needed a walker because she can hardly walk), PAIN IN EXTREMITY (pain in her right leg and she cannot even put pressure on it) and WALKING AID USER (Patient needed a walker because she can hardly walk) had resolved.            No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-658243, MOD-2022-658252 (Patient Link).
pt recvd vax; 2 febrile sz, lasting 2-5 mins;apap & Ibuprofen given;
Baby had high pitched screaming > 3 hours. Temp 98.9 but had given Tylenol every 4 hours.
Tired all day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired all day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     no medical history was provided by the reporter.     On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Tired all day). At the time of the report, FATIGUE (Tired all day) outcome was unknown.  Action taken with mRNA-1273 in response to the event was unknown            This case was linked to MOD-2021-100394 (Patient Link).
The patient experienced a titer drawn, a titer was not sufficient amount; Case reference number BN-2022-000891 is a spontaneous case report initially received from a physician via Communication (reference number: USBAV22-0117) on 05-Apr-2022 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 15-Sep-2021, the patient was vaccinated with the first dose of Rabipur (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown), intramuscularly, at an unknown dose or site of administration, for pre exposure.  On 22-Sep-2021, seven days after the first dose, the patient was vaccinated with the second dose of Rabipur (batch number: unknown), intramuscularly, at an unknown dose or site of administration.  On 06-Oct-2021, 21 days after the first dose, the patient was vaccinated with the third dose of Rabipur (batch number: unknown), intramuscularly, at an unknown dose or site of administration.  On an unspecified date, reported as last month, the patient experienced a titer drawn, a titer was not sufficient amount. The patient was informed that should be covered for 2 years.   At the time of this report, the outcome for the event antibody test abnormal was unknown.  Seriousness and causality assessment were not provided for the event.  Additional information received on 06-Apr-2022 included the local case ID.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of antibody test abnormal, an unknown amount of time after the patient was vaccinated with 3 doses of Rabipur for pre exposure, as reported. The event of antibody test abnormal is not listed for Rabipur according to the Datasheet v6. Time-to-onset was not provided, therefore, chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. Reportedly, the outcome for the event antibody test abnormal was unknown. Considering the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded with certainty, at this moment, the event of antibody test abnormal has been conservatively considered as related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of antibody test abnormal, an unknown amount of time after the patient was vaccinated with 3 doses of Rabipur for pre exposure, as reported. The event of antibody test abnormal is not listed for Rabipur according to the Datasheet v6. Time-to-onset was not provided, therefore, chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. Reportedly, the outcome for the event antibody test abnormal was unknown. Considering the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded with certainty, at this moment, the event of antibody test abnormal has been conservatively considered as related to the suspect vaccine. This case is considered as non-serious.