chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature 102.3  highest. Up and down temperature.  Cold chills, headache, body aches, nauseous, arm soreness, malaise  Rash and arm soreness with 1st vaccine
Mother reports noticing a red area on 8/5/10 and she called and spoke to a person giving immunization. She was told that redness/swelling at injection site was normal. By 5 PM on 8/5/10 the redness was expanding so she marked it with a marker. On 8/6/10, redness had expanded outside marked area so she brought child in to be evaluated by a PA.
On 12/16/99, the pt developed generalized chicken pox with about 12-15 lesions. He had a fever of 100. He was seen by a physician on 12/21/99 and was dx with chicken pox. It was indicated that no treatment was initiated. The pt received the vax in 1995.
I just received my first dose of the Pfizer covid19 vaccine yesterday morning. I'm reporting this reaction because what I experienced  is not listed as a common side effect.  Approximately 3-4 hours after receiving my shot at the pharmacy, I started feeling an unusual sense of urgency just before urinating and within less than an hour, it progressed to pain similar to a urinary tract infection that I have had in the past. However, compared to the two UTIs I have experienced in the past, the pain was not felt deep in my urinary tract in my abdomen. Rather, the pain was focused right inside the urethra.  There were two types of situations where I would feel the pain.  The first type of situation was while I was doing nothing in particular and did not feel the need to urinate (sitting, lying down, anything), and the painful sensation would come on as a throbbing pain and then stop.  Then it would start again maybe 5 minutes later.  The second type of situation where I felt the pain was when I sat down on the toilet to urinate, just before the urine passed through the urethra.  I would feel the throbbing pain as I felt the urine get to my urethra and then right when the urine would start coming out, the pain would stop and what I felt instead was the sensation of swollen vulva and urethra but not pain.  In the past, a UTI would take several days to clear up.  I would be in pain urinating for at least the first 3 days.  This time, however, the pain got very intense and frequent lasting into the night, then within 14 hours of the onset of symptoms, it had stopped altogether. I'm certain it was related to the vaccine as it came about within a couple of hours after my shot and went away after 14 hours.   I am not someone who gets UTIs frequently.  I have only had 2 in my lifetime, and the last one was 11 years ago.
1-14-2010 @ 5 pm vaccine received. 1-14-2010 @ 8 pm pt developed hives, redness, itchiness with slight swelling at his face. 1-14-2010 Pediatrician consultant advised BENADRYL to be administered. 1-15-2010 Symptoms improved required 2nd dose of BENADRYL.
patient was administered ACTHIB post excursion with no reported adverse event; Initial information received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 1 years old male patient who received vaccine HIB (PRP/T) vaccine [ACT-HIB] post excursion with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 16-Dec-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine dose 4 (Powder and solvent for solution for injection) (lot U7261AA and expiry date: 07-Apr-2023) via intramuscular route in the right thigh for Immunization.  On 16-Dec-2022, (latency: same day) due to a refrigerator malfunction temperature excursion occurred at a low of 31.1F for 1 day, 22 hours, and 7 minutes and patient was administered ACTHIB post excursion with no reported adverse event (poor quality product administered).    Action taken: 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
booster; under a lot of stress right now; nausea; soreness in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: 330308D) as dose 3 (booster) , single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose:1, Lot EL9265), administration date: 20Feb2021, when the patient was 70 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2, Lot EL9264), administration date: 13Mar2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021, outcome "recovering", described as "soreness in her left arm"; NAUSEA (non-serious) with onset 13Dec2021, outcome "not recovered", described as "nausea"; STRESS (non-serious), outcome "unknown", described as "under a lot of stress right now". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Time the Vaccination between 11:45-12:00 as patient reported. Additional vaccines administered on same date of the Pfizer suspect: None. Prior vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. Event nausea was reported as worsened. She was having no other respiratory signs and her energy level has not been impacted really. She was not going to worry about it unless she gets a lot sicker. AE(s) did not require a visit to emergency room and physician office. Investigation assessment: No  No follow-up attempts are possible. No further information is expected.
Patient felt a sudden rush of tingly feeling from chest down to arms. Did resolve, lasted a few minutes.
On 2/18/03, 2 spots on elbow and right leg, thought they were bug bites; appeared larger and itchier 2 days later. On 2/22/03, another mark appeared on right calf. Seen in ER at 15:00, on 2/24/03. Treated with antibiotics (Dicloxacillin). Returned to ER on 2/26/03 for re-evaluation. No diagnoses at this time.
Headache and new uncontrolled hypertension  where BP was previously controlled.   New sinusitis infection.  Otitis media.  Now on antibiotics and flonase
5 days out, injection site is still hot & red. 3 1/2"(h) x 3"(l) No pain, occasional itch, warm to touch
Pain at sjte,fatigue,muscle pain at site, swelling of upper arm,red raised rash,upper arm itching, severe gout pain in left toe and swelling of toe.
Chills; Hives (big red circle) about 6 inch long (4 inch wide) in the injection site; Injection site swelling; Hives (big red circle) about 6 inch long (4 inch wide) in the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VACCINATION SITE URTICARIA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced CHILLS (Chills), VACCINATION SITE URTICARIA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VACCINATION SITE URTICARIA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. patient took diphenhydramine twice a day starting 15Jan2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given her flu shot she sat and we talked for about 10-15 minutes, her daughter met her back by the pharmacy, they left the store and as she was getting into their van she fainted in front of our store, I was called and ran out, she was clammy, and out of it for a little while, she was breathing fine pulse was good she was a little disoriented, she came back to it and was talking to us and answering our questions an ambulance was called and I went back into the store at the time the paramedics arrived she was taken to the hospital for further evaluation, I am calling family to follow up with them.
Red swollen arm.  Bid red spot.   My arm hurt,  was hot and itchy. Very low energy Nausea Low Fever Dizzy at times Hot flashed with night sweats Excessive sweating when doing activity. Headache Needed to take Tylenol regularly to function.
Approximately 1 hour after receiving vaccine I began throwing up every 15 minutes for about an hour and a half.
Fever; Congestion; Runny nose; Didnt feel good , felt like dragging; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didnt feel good , felt like dragging), NASAL CONGESTION (Congestion), RHINORRHOEA (Runny nose) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didnt feel good , felt like dragging). On 10-Jan-2021, the patient experienced NASAL CONGESTION (Congestion) and RHINORRHOEA (Runny nose). On 11-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Didnt feel good , felt like dragging), NASAL CONGESTION (Congestion), RHINORRHOEA (Runny nose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1 day after immunziation w bivalent Moderna, chest pain/tightness L side (ipsilateral side of vaccination), squeezing tightness for 2 days. No fever or chills, Resolved after 2 days. Tired as well for 2 days.
Headache, Myalgia, Mild site pain, fatigue, chills Narrative: Claims myalgia was severe
Dizziness, vomiting, fatigue,  brain fog  of unknown cause .  Hospitalization, Physical Therapy, Meclizine ,  ENT evaluation
lymphangitis; serum sickness; hypocomplementemic vasculitis; This spontaneous report was received from a currently 83-year-old female patient who reported on herself. The patient's medical history included reaction / allergy for tetanus vaccine and for sulfites. No information regarding the patient's concurrent conditions or concomitant medications was not provided.  On an unspecified date in 1990, the patient was vaccinated wit the first and the second doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, lot #, expiration date, route of administration were not reported) injection in arm for prophylaxis (reported as "she was working in the intensive care unit (ICU) in Critical Care and 3 physicians were diagnosed with Hepatitis B so the employees were advised to get the vaccine").  On an unspecified date in 1990, reported as after the first two doses, she experienced malaise and "vaccination reaction". On an unspecified date, she received the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). On an unknown date, after the third dose, she developed a red streak from elbow to shoulder area, lymphangitis, and serum sickness. The patient was eventually diagnosed with hypocomplementemic vasculitis. She was on "cortisone/steroids" for approximately 1 year after the reaction to the vaccine (conflicting information, it was also reported that the patient was not given any treatment for adverse event). It was reported that the patient sought medical attention and spoke to several physician. She also had unspecified testing by dermatologist (result not reported). The outcome of the events was reported as recovering.  The causality assessment between the aforementioned events and the suspect vaccine was not provided, however upon internal review, it was considered related to the suspect vaccine.  Upon internal review, the events of lymphangitis and hypocomplementemic vasculitis were determined to be medically significant.
Patient reported feeling weak and unwell. She said she said was in bed all day and experienced headaches. She got red patches on her left arm below the site of administration of her SHINGRIX vaccine and also reported some swelling.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP (High Blood pressure)" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 25Oct2022 to 30Oct2022. Clinical course: The patient had Paxlovid rebound on 04Nov2022, which was recovering with no treatment at the time of the report.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A patient received  the sterile diluent and its states on the bottle not to give it alone, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00557535) and transmitted to Sanofi on 12-Apr-2021.  This case involves a two-month-old female patient who received 0.5 mL of the sterile diluent and its states on the bottle not to give it alone of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ340AA and expiry date: 21-Jun-2022) via an intramuscular route in the left thigh for prophylactic vaccination on 09-Apr-2021 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination.  The caller would like to know the reason that why the Dtap and IPV variants cannot be given alone.  This was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
soreness in arm; Fever; body aches; tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), PYREXIA (Fever), MYALGIA (body aches), FATIGUE (tired) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ATORVASTATIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), PYREXIA (Fever), MYALGIA (body aches), FATIGUE (tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. On 10-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm), MYALGIA (body aches), FATIGUE (tired) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient presented to hospital late 10/25/2021 with shortness of breath and chest pain that had started on 10/25/2021. Patient found to have large pulmonary embolus within distal right main pulmonary artery extending into segmental and subsegmental branches of right lower lobe and small pulmonary embolus involving segmental branch of left upper lobe and lingula. Also small pulmonary embolus within subsegmental branch within inferior medial left lower lobe with a small triangular shaped opacity consistent with developing pulmonary infarct. Patient still undergoing additional evaluation including bilateral lower extremity venous dopplers and echocardiogram. She remains hemodynamically and did not require oxygen. Patient initially started on heparin infusion but will plan to transition to oral anticoagution.
Severe arm pain has not improved after administration on the  Oct 8th. No improvement of pain 11 days later.
pt was 16 years old at the time of vaccination.  This is an off label use of Moderna
This spontaneous report as received from a medical assistant refers to a 29 year old female patient. On 16-JUL-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the right arm. Lot number H019992, expiry date 09-DEC-2013. On 16-JUL-2013, the patient experienced redness, swelling and pain at the injection site of her right arm. The patient called the clinic on 17-JUL-2013 to report the reactions. The patient was instructed to apply some ice to her injection site and use ibuprofen to reduce the swelling and pain. The patient was seen by the medical staff at the clinic on 18-JUL-2013. After she was seen in the clinic the patient was prescribed cephalexin. The outcome of the events was reported as recovering/resolving. Causality assessment was not provided. Additional information is not expected.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B. In July 2014, the patient received the 1st dose of ENGERIX B. On 1st January 2015, the patient received the 2nd dose of ENGERIX B 1 ml. On 21st May 2015, the patient received the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information provided: a patient received 3 doses of ENGERIX B but subsequent lab work showed "titer not sufficient". She does not have immunity, on 12 June 2015, a lab report showed quantity less than 5.
Administered Pneumococcal vaccine which expired on June 04 2005, no adverse events.
Vomiting began 9pm on 2/4 & hasn?t stopped yet (9am 2/5). Unbelievable body aches, unable to move out of bed, cannot do anything but lay flat on back. Temperature of 102.3. Major fatigue. Chills and heat flashes combined.
Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfully tender, lumpy under the skin, over an irregular area approximately 4x5 inches. Doctor diagnosed infection as cellulitis,  and prescribed doxycycline 100mg for 5 days. Because of the underlying primary immune deficiency,  this will be a difficult adverse event to overcome. First noticed on February 25, 2021. Covid-19 vaccine was administered on Monday February 22nd 2021.
Headache; Body aches; Extreme tiredness; Body heaviness; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 at 23:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took modafinil (PROVIGIL) and cisapride (PROPULSID) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 12:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 the patient experienced headache, body aches, extreme tiredness and body heaviness lasting through the next day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with alternate paracetamol (TYLENOL) and ibuprofen (ADVIL) as per doctor instruction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, extreme tiredness and body heaviness were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Anxiety  Difficulty breathing  Swelling of face and throat  Fast heartbeat  Bad rash  all over  Dizziness