chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT REPORTED MODERATE-SEVERE NAUSEA, FATIGUE (WEAKNESS), AND BACK PAIN WHICH BEGAN THE MORNING AFTER RECEIVING THE VACCINE.  PATIENT TOOK ZOFRAN FOR NAUSEA BUT IT DID NOT HELP; THE NAUSEA STAYED CONSTANT.  PATIENT WAS TOLD TO MONITOR WORSENING/IMPROVEMENT IN SYMPTOMS FOR THE NEXT FEW DAYS AND TO CONTACT PRIMARY CARE PHYSICIAN.   PRIMARY CARE PHYSICIAN PRESCRIBED ZOFRAN AND PHENERGAN BUT PATIENT'S SYMPTOMS DID NOT IMPROVE CURRENTLY PATIENT STILL EXPERIENCING SAME SYMPTOMS 18 DAYS POST VACCINE ADMINISTRATION
Shot 2, increased my blood pressure and gave me migraine headache.  Side effects not listed on site.
3 people died.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "3 people died.". The patient date of death was unknown. The reported cause of death was "3 people died.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200071657 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: 3 people died.
Itching after first shot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6203 and Expiration Date: 30Jun2021), via intramuscular, in Left Arm, on 24Feb2021 at 10:00 (at the age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunization in hospital.  Medical history included allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Cyst on kidneys diagnosed in 2010, Hypertension and lipids increased. Concomitant medications included valsartan Started taking many years ago reported as 1998 or something like that, taken for hypertension and spironolactone taken for hypertension from 2010 and  atorvastatin (LIPITOR) taken for lipids increased from 2004. The patient previously took flu vaccine 20 years ago and had a reaction. But the past 2 years, the patient decided to take it to have protection. The patient had a lot of itching and hyperventilating. On 24Feb2021 at 16:00, after first shot, the patient experienced itching. The outcome of the event was recovered in 25Feb2021.  No follow-up attempts are needed. No further information is expected.
As of 4-11-22 Patient has reported no ill effects from the vaccination. The event being reported is an early booster dose. Patient would have been eligible for her 1st  booster dose in mid May 2022, but was administered her dose on March 25th, 2022, almost 2 months early.
VACCINE ERROR: PATIENT RECEIVED MODERNA  COVID-19  VACCINE ON 08/09/2021 AND A NURSE  INADVERTENTLY GAVE THE PFIZER COVID-19 VACCINE  TODAY.  NO ADVERSE REACTION WAS NOTED.  THE PATIENT WAS INFORMED OF THE ERROR AND DENIED ANY COMPLAINTS.
I woke up with neck pain on the right side of the back of my neck on Sat 4/24. Thinking I just "slept wrong", I ignored this symptom initially.  Over the course of Sunday and Monday, this neck pain worsened culminating in severe pain by Monday afternoon with significant decreased ROM (inability to turn my head from side).  At approx 1800, while inactive and sitting, I lost vision in my left eye.  Since I am fairly recently post partum (delivered 3/20/21), I took my blood pressure as a precaution.  My initial reading was 161/108 with repeat 5min later 156/106.  I was instructed to go to the nearest ER.  My BPs there were 171/86 and 166/96.  Labs and diagnostic imaging were performed and I rec'd IV fluids, Reglan, and IV Tylenol.  I was discharged around 0045 with a diagnosis of Migraine Headache.  I woke up on Tuesday 4/27 with a worsening headache.  My BP was 148/91, 141/100 and 130/100 throughout the morning.  I was seen by my chiropractor in an attempt to resolve the neck pain around noon, my BP afterwards was 149/99 142/97-No resolution of headache.  At this point I was instructed to go to Medical Facility for further testing and admission to the women?s services unit.  My BP just prior to admission was 146/107.  I was admitted, given an IV infusion of magnesium sulfate and am currently inpatient with plans to be discharged tomorrow.
When I caught COVID-19 I had a very husky low voice. I had a fever of 101 degrees, a persistent dry cough, achy joints, body aches, exhaustion, a runny nose, sore throat, and a headache. The coughing resulted in me having shortness of breath. I went to an urgent care, and I was prescribed Paxlovid. When I tested negative for COVID-19 I still had a lingering cough and felt exhausted.
Note: According to the Immunization Registry (IR), patient received ZOSTAVAX 12/2009. I labeled this as the second dose in the series as that's how the IR labels it. This was her first dose of SHINGRIX. Patient noticed pain, swelling, redness below the injection site (not immediately around it as noted by bandage still being in place) that started the day after receiving the SHINGRIX. She came into the pharmacy this morning with same symptoms and the area felt warm to the touch. I recommended for her to continue to monitor, use an ice pack to reduce swelling, and her TYLENOL as needed for the pain. I will follow-up with the patient via phone call 6/25/18 and alert her primary care provider listed above.
Full body rash that subsides with allergy medicine and quickly returns. It is itchy, hot and prickly feeling.
Painful and itchy hives. Have never had hives before vaccination. Saw doctor and put on prednisone for 6 days, came back after finishing Med. Took Allegra and started to work, but came back after couple days. Went to dermatologist and he wanted me to take antihistamine.  Keeps coming back
Symptoms started 2 days post vaccination. Started with severe back pain then sharp shooting leg pain bilaterally with pain and tingling in arms, wrists and hands. Denies fever or runny nose. Was seen by PCP and Neurologist. Prescribed indomethacin 50 mg BID x 1 week on 10/15/19 but did help.  Administered dexamethasone 4mg/ml injection and Ketorolac 60mg/2ml on 10/16/19 and 10/18/19. Prescribed Medrol pack 10/18/19. Also prescribed Soma 250 mg and Tramadol 50 mg on 10/16/19. Most relief received after steroid injections per patient.
flu like sxs: gastro problems, upper resp prob; body aches, joint pain, elevated temp, malaise
I had a cardiac ablation done in Dec 2016 and had not experienced any symptoms until my first shot, which only caused one incident at the time of the first dosage, which went away within 30 minutes.  Since the second dosage, I experience rapid heart rate immediately at the time of the vaccination, which occurs periodically, mainly in the late evening hours and during the night, causing me to be awaken.  Pulse goes from normal mid-60 resting heart rate to low 100's.  Dissipates after approximately 30-45 minutes.   Working with Cardiologist to get a Halter Monitor to get details as the events happen.  No treatment plan until they receive better data.
Information has been received from a physician concerning a female patient whose daughter on 24-APR-2007 was SC vaccinated with a dose of Proquad (Lot # 657190/0349U). It was reported that patient's mother developed shingles before 02-MAY02007. Unspecified medical attention was sought. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been requested.
pt recv vax 21NOV97 & reported inj site was painful, red, swollen, indurated area approx 2 inches in diameter;also noted swelling & soreness o axillary lymph node;25NOV97 pt examined @ clinic & reported sx were beginning to subside;
I woke on September 13, 2022, feeling absolutely terrible: body aches, headache, no energy, could barely get out of bed on my own.  Slight congestion. Terrible feeling of malaise. Began Paxlovid 9/13 for 5 days. Symptoms improved next day. I tested negative 9/17. felt fine for several days. runny nose on 9/22 and tested positive on the same date. had runny nose and congestion for 5 days, lethargy and increased fatigue through October 4. Had to take a daily nap which is unusual for me. Tested negative 9/30. Still have slight chest congestion as of 10/12.
joint pain; muscle pain; was misserable; fever 102.5; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Pyrexia: high (High) 102.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information ibuprofen 600 mg was reported.  Concomitant medication use was unknown. Patient  was taking medications for other health conditions but did not want to provide that information. patient was hesitant to get the booster because does not want to get sick but is going to consult her doctor.     This case was linked to MOD-2021-363565 (Patient Link).
Pt was a non-responder p/receiving a series of 3 Engerix-B vax; pt did not devel antibody titer when tested one month p/3rd vax & then one month subsequently;
under diluted vaccine given. vaccine site burning itching, red streak at site. video visit with primary physician.
Reaction: Mild reaction resulting in welt, pain to touch and moderate muscle soreness around injection site. Treatment: Ice pack Outcome: none yet - waiting for welt and soreness to subside Pregnancy hx: Gestational diabetes Due date: 09/03/2017.
I had tingling in the back of my mouth about 45 min after injection. It wasn't to bad. Woke up the next morning with itchy skin and a hive rash on my lower belly, my body was achy arm was really sore did tylenol and heat pack on my arm, moved it and massaged the area very gently. The next day arm pain was gone but skin was very uncomfortable. By the end of the day around 7:30 I started to feel difficulty swallowing and got raspy and my skin was breaking out in more tiny follicle irritation bumps. Took zyrtec but headed to the er. Was discharged around midnight. I was given predniSONE, and a prescription for more over the next 4 days. I still feel really tired and sore. My breathing is better though and I will keep taking zyrtec. Was also adviced not to get second dose. I will follow up with my regular doctor next Thursday.
I have not been able to smell . I first became aware of this on the morning of 10/31/2009. My nasal passges became completely clogged the evening of the vaccination. I have no smell sensation. This could potentially be a vary dangerous conditon as many life  threatening conditons can be detected through the sense of smell.
Softened stools x3 days, severe chills x24h, and itchy gums/jaw that starts on day 3.
Had shingles after the shot/ suspected vaccination failure; Shingles; Had to get better to feel terrible/ miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles after the shot/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling miserable (Verbatim: Had to get better to feel terrible/ miserable). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and experienced shingles and it was miserable disease. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Inflammation occurred on upper left arm at the site of immunization. Patient noticed inflammation getting worse that Sunday on the 27th and it was painful to the touch. Review of the site showed moderate inflammation about 6 inches in diameter. Site did not show any signs of infections. Patient did not complain of fever or systemic infection. Patient was advised to use ice packs for 15 mins on and 15 mins off as needed for the pain and inflammation. Ibuprofen was not advised due to patient taking clopidogrel.
Pt called Pharmacy on 1/22/20 stating she had received Boostrix vaccine 1/17/20.  She stated the previous evening (1/21/20) the arm where the vaccine was administered felt tight/hard and was painful to the touch.  She had consulted a friend who was a nurse and was advised to apply heat stating that it might loosen up the area and that the vaccine may have stayed locally.  Pt did as advised but described in phone call to pharmacist that heat did not help and the arm felt worse (felt hard as a rock by 1/22/20 and was painful to touch).  She stated she was concerned an abscess may have formed.  Pharmacist advised pt to seek medical attention and that she would be in contact with her Manager and the immunization manufacturer.  At this time, there is no more information, as pharmacist has contacted market manager and patient is waiting for call back once pharmacist has more information.
Dizziness, uneasiness within minutes of receiving shot. Found to have pallor, cold clammy skin, thin thready pulse. Was given BENADRYL and Epinephrine. Free flow oxygen. Took 15-20 minutes for recovery of good pulse volume and blood pressure.
2 days after injection, mom noted red swollen warm area left upper arm. Pt was brought to office and area red, warm to touch. Tender measuring 4 inches x 3.5 inches.
Left hand, wrist and elbow are paralyzed. Experiencing extreme nerve and muscle pain continuing for four months, so far. EMG of arm shows nerves firing out of control. MRIs of cervical spine, shoulder and brachial plexus don?t explain condition. I have areas where there is no feeling but I?m also experiencing various types of pain.
had reaction after the second dose; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown); Expiry date: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had reaction after the second dose and she was wondering if she needed, that can she get another dose like they need to in future or was she considered allergic to it. Product details (asked that would be on the card they gave her), causality, treatment and other details were unknown (Limited information was available over the call).The outcome of event allergic reaction after immunization was unknown.  Follow up attempts were completed. No further information is expected.
Immediately after receiving vaccines child was fussy and crying took a nap and woke up - had an episode of ALTE. Infant was taken to ED then transferred to another hospital admitted x2 1/2 days.
Received vaccine in clinic room.  Eight minutes after receiving COVID-PFE vaccine, patient complained he was ready to go and felt drowsy.  The temperature did seem warm in the clinic room, so I escorted them 30 feet to the lobby.  As the patient passed through the door to the lobby, his gait, he seemed to lose his ability to remain upright and started to collapse.  I was able to catch him prior to hitting the floor.  He never lost consciousness, but we moved him into a clinic room to evaluate and further monitor him.  His blood pressure was a little low initially at 110/50, but came up to 112/60  (closer to his normal) after five to ten minutes.  His pulse was strong and regular.  We gave him a cool, wet compress to the forehead, cool water to drink, and chocolate candy.  He was able to answer questions appropriately.  We monitored him for another 30 minutes before releasing him. His mother was present with him and is a nurse practitioner.  I called the Mom on 6/22/21 (the day after the event).  She (Mom) reports the patient went home, laid down for about 45 minutes, then played video games.    I recommend she considers getting the second dose at either Hospital, so that a higher level of care is available if needed.
SUSPECTED COVID-19 INFECTION; STOMACHACHE; METALLIC TASTE IN MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and sulfur allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was other health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 59 years old. The batch number was not reported and has been requested. Concomitant medications included metformin hydrochloride, and pioglitazone. On 29-JUL-2022, the patient experienced stomachache, and metallic taste in mouth. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomachache, and metallic taste in mouth, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Bad head ache Neck pain Exhaustion  Nausea  All over body aches Chills
A few hours after her place of employment gave her the vaccine in left deltoid, pt felt feverish and had left axillary pain. Saw me at Student Health the next day, no fever but tender 2 cm left axillary node. A 2 cm node left supraclavicular noted 9/22/14 on recheck by me with persistence of L ax node. Pt also having persistent arthragias, had diarrhea on 9/19 and 9/20 that resolved.
3/16 - 3/23 : fewer ( 100 -101 F), headache. used Tylenol 3/24 : fewer, headache, nausea, vomiting. used Tylenol 3/25 : fewer, headache, watery eye. stayed in ER. diagnosed sinus infection. treated with Amox/clav 875mg-125mg; claritin; Tylenol 3/26 - 3/28: fewer, serious headache, double vision. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg; waiting for schedule MRI.  3/29 - 3/31: fewer, serious headache, double vision. stayed in  hospital. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg.
Patient reported nerve pain (traveling from injection site down to hands on right arm 2-3 weeks after vaccine), numbness, tingling, soreness.
Outbreak of cold sores on lip; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6201, Expiry date: Unknown) via an unspecified route of administration in the right arm on 08Mar2021 at 09:30 (at the age of 62-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Patient did not have known allergies. Patient's medical history was not reported. Concomitant medications included vitamin E, probiotic, fish oil (OMEGA 3), dexpanthenol, lidocaine hydrochloride, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COMPLEX) and vitamin D. Patient does not have COVID, prior vaccination. Patient has not been tested for COVID post vaccination. No other vaccine in four weeks. On 11Mar2021, the patient experienced outbreak of cold sores on lip. Therapeutic measures were not taken as a result of adverse events. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Itchiness.  Developed redness in neck and chest area.  Resolved is approximately 30 minutes.
Sleepy; Sore arm; Tired, Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired, Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Anemia.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired, Fatigue). At the time of the report, SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired, Fatigue) 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 assessment.  Concurrent products included medicine for high blood pressure and anemia. No treatment details were provided
R upper arm was swollen, reddened and warm to the touch. Advised Ibuprofen B10, cool compresses to area-elevate arm. RTC PRN.
No adverse events listed - tested positive for COVID-19 on 4/16/21  04/16/21 1654  COVID-19 (SARS CoV-2,RNA Molecular Amplification)  Collected: 04/16/21 0818 | Final result | Specimen: Swab from Nares   COVID-19 SARS-CoV-2 Overall Result DetectedCritical