chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Soreness at the injection site; Pain in the left hip; Fever of 101 Degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 Degrees F), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Pain in the left hip) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101 Degrees F), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Pain in the left hip). At the time of the report, PYREXIA (Fever of 101 Degrees F), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Pain in the left hip) outcome was unknown. Not Provided          Reporter did not allow further contact
Patient here for first Pfizer COVID-19 vaccination.  Mom notified staff that with the last two vaccinations (influenza in 10/21 and 10/20). Patient had a vaso vagal response beginning with nausea and vomiting.   Injection at 5:44 At 5:04 Patient vomited 2Xand became pale in lips, ear lobes. He stayed alert and able to express how he felt. Patient stayed in mom's lap with legs elevated but color remained pale. 5:15 Patient moved to the bed with legs elevated. HR 47-52 with pO2 99% at first measurement. 5:18: HR 60  pO2 88%  5:20: HR62-67 pO2 99% 5:21-5:5:37: HR 67-99, pO297-99% color turning pink in lips, earlobes 5:40 BP 90/62 lying and given sips of water. Weak when standing and back to lying, tolerated second sips of water. 5:45 more sips of water 5:50 walked to the BR ( with mom) and urinated.. 5:55 sitting with sips of apple juice.playing video game on mom's phone verbalizing feeling well.  6:00 BP 90/70 standing. Able to now walk around room with normal gait expressing he feels himself again. 6:10 finishing juice box walking around, speaking and mom states ready to depart. Patient's dad here to meet them. Mom advised to continue fluids in small amounts initially and encouraged eating a meal as soo as tolerated.  If condition declines to seek medical care urgently. Advised mom to notify PCP for any advice prior to second COVID -19 vaccine. Mom agrees to above
Patient received Pfizer TS 5-11 Monovalent   NDC 59267-1055-04 on 11/29/2022 instead of the Pfizer Bivalent Booster   ( 5-11) 59267-0565-02. Mom was made of the incident immediately and pediatrician office was contacted .
Pt was advised by extenral PCP to call call center and report side effects experienced after both doses of Pfizer vaccine. Pfizer 1st dose 3/26 (Pfizer ER8730) only slight cough Pfizer 2nd dose 4/16: now intensified, chronic productive cough, light yellow sputum and ""SOB from coughing so much."" Pt reached out  To PCP, was given abx and codeine. Pt reports no improvement. Pt had chest xray & COVID testing, all negative. Pt denied emergency symptoms at time of call. Pt has appt to f/u with PCP
Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Botox (Botox started Botox therapeutic for migraine on an unknown date. Patient believes she's sick.). Past adverse reactions to the above products included No adverse event with Botox.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medication was provided. No treatment medication was provided. Received an email from SCC with SD AGN280226 on 06-Dec-2021. Syneos Health Form was attached on the email received for BOTOX THERAPEUTIC. A Botox Complete Support Specialist called on 06Dec2021 at 12:39 PM to warm transfer a patient to report adverse events. Patient's information obtained and permission to follow up granted. Medical history and concomitant medications obtained. HCP information obtained and permission to follow up granted. Botox started Botox therapeutic for migraine on an unknown date. Botox therapeutic wasn't working the first time she received it. Patient's migraines come back 3 weeks before her injections are due. Patient believes she's sick (continued). from COVID-19. She got tested today but hasn't received her results yet. Patient started to experience a headache that's different than a migraine. The headache is not in the same spot as her migraine. Started yesterday.
Discomfort in left underarm lymph nodes beginning 3/31 Increasing discomfort and swelling in left underarm lymph nodes on 4/1 Rash developed on/around injection site on left arm on 4/1 Above symptoms all remain as of 4/2
Patient received pneumovax in right deltoid IM on 10/15/2003.  Walked into clinic with sudden/warm on 10/17/2003.  Placed on Trimax 10/17/2003.
I had fever and lightheadedness following day. Chest pain/pressure and shortness of breath started with mild exertion on Monday evening (about 3 days after booster). It has gotten continually more severe and more constant. Went to primary care on Wednesday. They ordered an EKG and chest X-Ray for Thursday. Looked normal but I was told to go to the emergency room if got worst. By Sunday 12/19/2021, I was in the emergency room. They did another chest X-ray, EKG, troponin and other bloodwork (to check to infection etc.). Discharged with diagnosis of unspecified chest pain (not heart attack, clot, infection, etc.) and potentially pleurisy. Told to follow-up if pain continued with PCP. Followed-up with PCP on 12/21/2021 and he did not agree with pleurisy. He  thinks it's likely myocarditis instead of pleurisy given symptoms though won't rule-out some very coincidental sudden onset reflux.
Patient presented 3 days after vaccine administration with redness, warmth, swelling and pain to (L) arm. Pt. placed on 7 day regimen of KEFLEX.
pt admitted to hosp with increasing SOB; found to be positive for COVID; DNR/DNI; O2 supplementation; steroids, remdesivir; O2 needs increased; pt on 100% BiPAP with O2 sats in 50-60%; pt experienced a MI; asystole; pt passed away in the hosp
Rash across chest & stomach. Arm swollen up - whole arm. Arm pain for 2 weeks.
Patient states her arm/shoulder area was extremely painful within 2 hours of the vaccination and the pain is still going on 2 months later. She is going to get an MRI to determine if there is any damage to her shoulder/arm. She came in because she was concerned it may be the vaccine itself that is causing the pain.
tachycardia; Too bad with asthma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown", described as "tachycardia"; ASTHMA (non-serious), outcome "unknown", described as "Too bad with asthma". Therapeutic measures were taken as a result of tachycardia.  Additional information: The patient had horrible tachycardia due to which the patient had to use half a dose with distilled water and so I tolerate it a little. The patient was shot by that asthma monster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Registered Nurse (RN) concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. Concomitant therapies were not provided. On 19-JUL-2016 the patient was vaccinated with VARIVAX dose 1 and with PROQUAD (concentration and indication were not reported). No adverse symptoms were reported. Additional information has been requested.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route and frequency were not reported). The nurse reported that one of the facilities records the temperature of their freezer storing PROQUAD (Merck) only once or twice a week. The nurse stated that from 16-NOV-2013 to 29-JAN-2014, when the temperature was recorded, it was 6F. The nurse stated that it was not confirmed the overall average temperature of the freezer has been between -58F and 5F. On an unknown date, improperly stored PROQUAD (Merck) have been administered to patients. The nurse reported that he will provide the lot number and expiration dates of the doses and as well as dates of placement of the doses of product into the freezer and dates of administration of the doses to the patient. No adverse effect was known. This case is linked to the case 1402USA002366 (same reporter link). Additional information has been requested.
Patient is 17 years old and received the incorrect brand of the Covid 19 vaccine. No reactions happened during the administration or afterwards. Both her parents were notified and were told to relay the information to the patient as she does not have a phone. Interpreter utilized. Vaccine reactions and signs and symptoms of blood clotting were reviewed. Also given information about what symptoms to seek emergency care for.  Primary care physician notified.
2:45pm presented self in observation w/ c/o sm. rash area @ clavicle area.   Stated it just appeared, no pain.  No diff. breathing.  EMS onsite.  B/P 120/70, HR 64, O2Sat 97. 3:15pm stated wanted to leave and feels like raised area has gotten smaller. 3:15pm left observation area @ no further complaints.
received complete 4-dose series of pentacle, they inadvertently received a 5th dose with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 2-year-old male patient who received complete 4-dose series of pentacle, they inadvertently received a 5th dose with no reported adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 22-May-2023, the patient received 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) (lot: UJ799AA) (expiry date: 10-Feb-2023) via intramuscular route in the left vastus lateralis.  On 22-May-2023 the patient had an event of received complete 4-dose series of pentacle, they inadvertently received a 5th dose with no reported adverse event (extra dose administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel (Vero)) was not applicable.  Outcome: unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Started having really bad cramping,(labor pains) was not aware that was the problem, was 15 1/2 weeks pregnant took the H1N1 vaccination. On October 28th my water broke, October 29th, my baby was born dead at 16 weeks.  11/09/09 Medical records received for DOS 10/29/09. Preganat and c/o pf leaking fluid and cramping.Pain scale 7/10. EDD 4/13/2010. Gestational age 16.21. G4P2.   .
Information has been received from a women at the health department concerning a male, 7 years old at the time of the report, who on 10-MAR-1999 was vaccinated with a dose of Varivax (Oka/Merck) lot # "1743H". Subsequently the patient experienced "suspect varicella vaccine failure". The parents reported that the patient's brother had disease. No further information was provided. Additional information has been requested.
Pt's daughter came in and stated that the pt had to go to ER b/c of injection site issue. The daughter stated that arm was swollen and pt was taken to ER and according to the daughter the pt was diagnosed w/cellulitis & given rxs from ER doctor for Keflex 500mg and Prednisone 20mg. Daughter thought adverse event (infection) due to Zostavax SQ vaccination.
Child was given MMR vaccine that was meant for brother.  No signs or symptoms at time of vaccination outside of discomfort.  Mother instructed to monitor child for fever.
Started to have suicidal thoughts; I had suicidal thought prior but it enhance it.; Hard to breath; Depression; Lack of energy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 (lot number: EN6206) at the age of 55 years old as single dose for COVID-19 immunization. Medical history included had blood clot in lungs, had suicidal thought before this vaccine. Concomitant medications were reported as none. Historical Vaccine included first dose of BNT162B2 on 24Feb2021 at the age of 55 years old for COVID-19 immunization and experienced depressed feeling, lack of energy, hard to breath. After his second dose he started to have suicidal thoughts in 2021 and he had checked himself into a hospital. He did mentioned that he had these thoughts before this vaccine but they just got worse when he got vaccinated. Patient stated, "I had suicidal thought prior but it enhance it." When probed if patient experienced any adverse event after taking COVID-19 Vaccine, patient stated, "Depression, suicide (incomplete word), lack of energy, hard to breath and I think that is because of medical (Further clarification was unknown) because I had blood clot in my lungs (Intent: history)." Patient also stated "I (incomprehensible voice) for suicide and breathing in hospital for 3 days (Further details were not clarified over the call)." No treatment was received for the events. The outcome of the events were not resolved.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. The patient's medical history, concurrent condition and concomitant medication was not reported. On 29-OCT-2015, 09-NOV-2015, 10-NOV-2015, 11-NOV-2015, 13-NOV-2015, 16-NOV-2015, 20-NOV-2015 and 08-DEC-2015, multiple unspecified patients received improperly stored product VAQTA lot # L002717 with expiration date of 02-JUN-2017 (strength, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Red, Itchy, bumpy and oval shaped mark on arm of injection site, which appeared 8 days after vaccine.  This lump is warm to the touch and itchy feeling.    Sent a picture to my doctor and was advised to take Xuzal and Allegra every day until this resolves.
"significant pain in my joints for the past 2 months. It started in my neck where I could not find a pillow to support my neck for about 10 days. I would wake up during the night needing to manually turn my head. After settling on a feather pillow that has helped some. Then it spread down thru both shoulders, upper back, hips & knees. I have been trying to do some back stretches, leg lifts, neck exercises on most days without relief. It takes considerable effort to turn in bed, get out of bed, squatting low is near impossible. Prior to all the joints aching, my left leg was super tight with pain around the knee joint. My L knee doesnt appear to be swollen but is tender. I have not done anything traumatizing & have greatly reduced my ability to move items. I am not aware of any bug bites. I had the Shingrix vaccine #1 in late October with one day of malaise. My hip pain has mostly resolved since 12/24. I got a upper back/neck massage on 12/10 which eased some tightness."
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
PERIPHERAL NEUROPATHY 3/30/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE ACUTE PULMONARY EMBOLISM 3/30/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
VERTIGO; BODY ACHES AND PAINS; FEVER; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced vertigo, body aches and pains, fever, fatigue, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches and pains, fatigue, muscle pain, and vertigo. This report was non-serious.
Headache; for second dose interval is more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PRODUCT DOSE OMISSION ISSUE (for second dose interval is more than 36 days) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (Headache) and PRODUCT DOSE OMISSION ISSUE (for second dose interval is more than 36 days). At the time of the report, HEADACHE (Headache) and PRODUCT DOSE OMISSION ISSUE (for second dose interval is more than 36 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications provided by reporter No Treatment medications provided by reporter   Reporter did not allow further contact
Unable to walk, leg virtually paralyzed.  Arm movement severely restricted.  Hospitalized on 12/13/2021.  Little to no improvement as of 12/19/21
lack of energy, chills, feeling of sickness, loss of apatite from 8am to 4pm, next day after receiving the 2nd vaccine shot. Pain in the arm
Pt went to dr. office. Nurse called us to tell us Pt is experiencing 8th nerve palsy & no hearing in his (R) ear. Pt received Prednisone Rx to treat this. Being seen again in 3 days. May have to see an ear, nose, throat dr to have evaluation.
Throwing up, Dry heaves, aching at the spot of the shot. Chills, and Rash all over back and body and itching.
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold.  The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold 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.