chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe shoulder and joint pain on arm in which injection was given. Extremely painful to move arm. Pain is making me nauseous.
developed worsening of her breathing; nitial information regarding this unsolicited valid non-serious case from Agency (Reference number- 00420735) was received from a other health professionaland transmitted to Sanofi on 07-Jan-2021.  This case involved a 70 year old male patient who developed worsening of her breathing (dyspnoea), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included Pulmonary fibrosis.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included OXYGEN; Symbacort and CORTISONE.  On 30-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number- UJ511AB and unknown expiration date via intramuscular route at the left deltoid for prophylactic vaccination.  On 07-Jan-2021, the patient developed a non-serious developed worsening of her breathing (dyspnoea) 2 months 8 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
At 2100 on same day, noted stiff neck, increasing fatigue and vision changes. On 5/26/17 noted moderate headache, and fatigue. 5/30 f/u with Pt and she is doing much better ."It might have been from a cold".
Redness, swelling, warm to touch area on L shoulder measuring 7.5cm x 8.7cm area is painful to child.
sore arm; Runny Nose; not sure if 0.5mL. Had both injections; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (sore arm), RHINORRHOEA (Runny Nose) and INCORRECT DOSE ADMINISTERED (not sure if 0.5mL. Had both injections) in a 41-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm), RHINORRHOEA (Runny Nose) and INCORRECT DOSE ADMINISTERED (not sure if 0.5mL. Had both injections).   At the time of the report, INJECTION SITE PAIN (sore arm) and RHINORRHOEA (Runny Nose) outcome was unknown and INCORRECT DOSE ADMINISTERED (not sure if 0.5mL. Had both injections) had resolved.       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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
lt side of face noted to have whelp, swelling & rash to MMR inject site & rash over body immed p/inject; seen by MD; DPH given; rash improved over body; no further sx;
Medical history screened.  No personal or family history of hymenoptera.  Mild broncospastic episode, cleared with o.lec of Epinephrine 1:1000.  Given prednisone 20 mg x 5 days.
Adult dose of 1cc given. Should have received Hep B dose 0.5cc, Private pay.
soreness @ site of DTP restless, sleeplessness due to discomfort, refusing to stand, walk or allow mom to touch;
around the injection site there was a rash; woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.; woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (around the injection site there was a rash), SWELLING FACE (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) and EYE SWELLING (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN D NOS, COLLAGEN, MULTIVITAMIN [VITAMINS NOS] and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced SWELLING FACE (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) and EYE SWELLING (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.). On 23-Apr-2021, the patient experienced VACCINATION SITE RASH (around the injection site there was a rash). In April 2021, VACCINATION SITE RASH (around the injection site there was a rash) had resolved. On 17-Apr-2021, SWELLING FACE (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) and EYE SWELLING (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include, Benadryl, cold compress.
Patient describes "dry throat" and "metallic taste in mouth"  starting immediately after vaccination. Patient was observed to repeatedly clear her throat. Denies shortness of breath, denies difficulty swallowing, denies cough, denies  chest pain. After 30 minutes, she's no longer clearing her throat.  She continued to deny shortness of breath, difficulty swallowing, cough, chest pain.  She was advised to follow up with her primary care provider.  Discharged with her son. Son states understanding of all.  Patient was afebrile, pulse 72, BP 140/85, RR 16. Patients states that she took her hypertensive medications today and that her blood pressure is normally in this range.
Rash, irritability. Fever s/p 1 day 101.8 stated, 99.3 actual. S/p 2 day 105.3 R actual. S/p 3 day 103.7 actual.
SHE SAID THAT HER ARM BEGAN TO SWELL THE NEXT DAY AND STAYED SWOLLEN FOR ABOUT A MONTH AFTER THE INJECTION.
3 dime size bruises in arm which all contains a lump, arm hand a hot burning sensation, swollen,
6/12 by history hives like rash, fever, watery blisters mostly above waist & watery blisters down throat.  Seen in ER 6/12/09 flu & strep negative.
I have what appears to swollen lymph nodes in the collarbone, IT appeared on 03/08/2021, the day after the first shot/injection, and has been swollen to the touch, a sore and irritated sensation at times.  It is the size of an almond, and has not gotten any better.
Starting hurting, Terrible pain; Worst rash; Blister; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain (Verbatim: Starting hurting, Terrible pain), rash (Verbatim: Worst rash) and blister (Verbatim: Blister). The outcome of the pain, rash and blister were not resolved.   It was unknown if the reporter considered the pain, rash and blister to be related to Shingles vaccine.     It was unknown if the company considered the pain, rash and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shot day after starting hurting kept getting worse and worst rash and blisters came days later. Terrible pain and rash that doesn't let up still suffering going on close to two weeks now. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
patient who had syncope after received first dose of HPV series, GARDASIL 9; This spontaneous report was received from a registered nurse via a company representative and refers to an 18-year-old non-pregnant female patient. The patient had history of syncope after she received other vaccines (unspecified). No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, site and route of administration, lot # and expiration date were not reported). On the same day, she was also vaccinated with meningococcal acyw conj vaccine (crm197) (MENVEO), hepatitis B vaccine (manufacturer unknown) and hepatitis A vaccine (manufacturer unknown) (exact doses, sites and routes of administration, lot # and expiration dates were not reported), all for prophylaxis.  On an unknown date, after receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had syncope. Laboratory diagnostics were not performed and she did not receive any treatment for the event. The patient recovered on an unspecified day, after lying down and resting.   The relatedness between the event and the suspect therapies was not reported.  Upon internal review, the event of syncope was determined to be medically significant.
This spontaneous report was received from a consumer and refers to a 67 year old male patient. The reporter did not provided the patient or physician demographics. The patient's medical history, concomitant therapy and concurrent conditions were not reported. On an unknown date, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX injection (lot #, expiration date, dose and anatomical location were not reported). On an unknown date, the patient was diagnosed with shingles. The outcome of the event was reported as improved. The relatedness between the event and the therapy with ZOSTAVAX was not reported. Additional information is not expected, as the consumer did not wish to disclose her identity.
Fever of 102°F; Pounding headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102°F), HEADACHE (Pounding headache) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 102°F), HEADACHE (Pounding headache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 102°F), HEADACHE (Pounding headache) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Used to make patient very sick when she got.; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a unknown demographics patient who was very sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was very sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was illness.   Relevant laboratory data was not reported.  The patient was treated with VITAMIN D3.  The event outcome was reported as Resolving.  There will be no information available on the batch number for this case.
The left arm was much sorer with the 2nd shoot than with the first.  about 24 hours after the 2nd shot   I got chills and a fever.  My temp which is usually 97. 3 to 7 went to 100.0.  I took 2 Aleve about 2pm .  I also had muscle aches.  I was very tired.  I fell asleep on the couch about 7:45pm.  about 11pm I started to fell a little bit better.  This morning I was fine.  I never got a cough or runny nose.  Today 2/20 my arm is still painful to the touch.
Information has been received from a registered nurse concerning a currently 12 year old male patient who on 01-OCT-1999 was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). In September 2010, the patient experienced an outbreak of varicella. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
throw up; FEVER; headache; A spontaneous report was received from a consumer concerning herself, a female patient of 80-years-old who received Moderna (mRNA-1273) vaccine and experienced headache, she threw up (vomiting) and had a fever(pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first dose of Moderna COVID-19 vaccine on 19-JAN-2021, and the second dose on 16-FEB-2021 intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 17-FEB-2021, the patient started to have headache at the night. On 18-FEB-2021, the patient threw up and had a fever.  The laboratory details was not provided. The patient took Tylenol to subside the symptoms.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, headache, vomiting, and fever was not recovered/ resolved.
Patient, age 7, received Hep A and Varicella in her left arm. The next morning her mother noticed that the deltoid area was swollen, red, and hard. Mom states it feels like a "knot" 2 1/2 inches in diameter but is not warm to the touch. Child has no fever and states it only hurts if it is pushed on. On 9/17/07 mother stated child had marked improvement and was feeling better.
36 hours after the 2nd vaccination (with a temperature of 101.3 during that time), a molar in my upper left mouth became inflamed and was highly sensitive to both heat and cold.  I saw a dentist a few days later, after rinsing several times a day with salt water.  She did a thorough examination and could find nothing wrong -- it was her opinion that the nerve had somehow reacted to the inflammation caused by the fever.  The discomfort is still there, but is slowly subsiding.
6 hours - 36 hours after vaccine (starting day of) body aches and headaches   47 hours after vaccine heart palpitations requiring an emergency department visit
approx 7min p/vax pt appeared ashen, BP 80/50, pulse 72, sl diff breathing but lungs clear, resp 24;911 called c/o feeling like was going to die;epig given;pt feeling itchy & weakness;inc tightness in chest, diaphoresis, dec breath so
Severe dizziness, chills causing entire body to tremble, overly groggy, unable to carry on a conversation.
PATIENT FAINTED CONSENT AND RELEASE FORM INDICATED NO PAST HISTORY OF FAINTING.
tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2DA and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient developed tinnitus, it started about July or August.   This case was linked to MOD-2021-067759 (Patient Link).
The next day after the vaccination the right side of my neck was hurting so I took motrin, ice packed it and perform stretches to help with the pain and after about 5 days it finally subsided.
Extreme pain on injection and post injection.  Loss of range of motion to right arm, persistent dull pain at rest and with movement of shoulder.
2 MO received Engerix-B (1ml); 2 MO received Engerix-B (1ml); This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 2-month-old female patient who received HBV (Engerix B) (batch number 9255P, expiry date 15th February 2024) for prophylaxis.   On 1st December 2022, the patient received Engerix B 1 ml. On 1st December 2022, unknown after receiving Engerix B, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.      Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The physician reported that the patient administered 1 dose of Engerix B 1 ml instead of 0.5 ml to the patient. The reporter asked for safety information. The reporter consented to follow up. Additional supportive information: 1 ml of dose was intended for use in patients 16 years of age and above however patient was 2 months old and was administered 1 ml of dose of Engerix B which led to overdose and adult product administered by child.
On 5/29/15, pt called office reporting extreme pain in the shoulder upper at the site of her PNEUMOVAX injection administered the day before. She had decreased ROM secondary to pain which she described as an ache at 10/10. She denied redness or heat, but did describe some slight swelling at the site. She had already applied heat and was encouraged to apply cool compresses and take OTC analgesic. She was offered an appointment for further assessment and opted to see how she progressed over the course of the next several days, but did say she would go to Urgent Care or Emergency Room for worsening S and S. Follow up call after weekend indicated the pt was having some relief and getting better with pain and decreased ROM.
13 month old with rash to face, trunk and fever.  Given Veadryl, Motrin, Tylenol
Evening of injection severe itching, big red rash below where shot given, swollen, pain of lifting arm.  continued thru 10/10/20.  Took Benadryl and used Cortisol save
Pt diagnosed with Guillian Barre syndrome.  Also had live atten influenza vaccine, typhoid administered then anthrax 10 days later. c/o fever shortly after vacines then developed progressive tingling and weakness in extremities.  May have been a combination of the 2 vaccines given together?.
This is a spontaneous report from a contactable nurse reporting for her daughter via a Pfizer sales representative. A 18-year-old female patient received third dose of TRUMENBA (Batch/Lot# M13066 and expiration date 30Sep2016) intramuscular in left arm on 25Feb2016, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient had received the first dose on unknown date, the second dose, on unknown date, after two months and the third dose after 4 months. The patient experienced swelling on her left arm with the circumference of the size of baseball, she had itching all over her body especially at the injection site, injection site was very warm to touch for several days, there was muscle tenderness, the patient woke during night, very sore arm and redness, all on 25Feb2016, with outcome of recovered. Follow up (17May2016): Additional information from a contactable nurse includes age of the patient, route of administration of the vaccine, anatomical location and date of vaccination, nocturnal awakening, pain in arm and redness added as adverse events.
IMMEDIATE FEELING OF HEAVINESS/HEADACHE/LIGHT HEAD VACCINATOR OBSERVED FOR 45 MINUTES/NURSING ASKED TO ASSESS/TAKE BP
This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the 9-year-old son). The other 3 patient are captured in case numbers 2012-09093, 09095, and 09096. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient and her husband. This case involves a 9-year-old male patient who had received a PERTUSSIS VACCINE (manufacturer, date, route, site of administration not reported) and later developed whooping cough. The patient's 4-year-old brother was the first in the family to develop a cough. Because the patient's sister was undergoing chemotherapy, the patient went away for a family vacation with his mother and 2 brothers to avoid the risk of his sister getting sick. All of them quickly came down with nagging coughs that couldn't go away and seemed to be getting worse. After approximately 2 weeks, the 4-year-old brother experienced a cough where he was gasping for breathing during coughs, and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The 4-year-old brother was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient and his mother were reported to have a lesser, but still nasty, cough while the 7-year-old brother was doing great. The patient and his 7-year-old brother were up-to-date on their vaccines; although the mother had not received the recommended booster shot for pertussis. Outcome was not recovered. Documents held by sender: None.
9 lymph nodules inflamed on the neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (9 lymph nodules inflamed on the neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Nodule (The patient said that had a nodule like lipoma 2 years ago) since 2019. Concomitant products included LEVOTHYROXINE, METFORMIN and ROSUVASTATIN for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (9 lymph nodules inflamed on the neck). At the time of the report, LYMPHADENOPATHY (9 lymph nodules inflamed on the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Ultrasound scan: 9 lymph nodules inflamed (abnormal) 9 lymph nodules inflamed on the neck.         No treatment information was reported.  The patient received both doses of the Moderna COVID-19 Vaccine between march and April (date not available).
4/28/10 2PM vaccine administered. On 4/29/10 around 9AM - Pain in right side of body, including arm and leg. At 4PM noticed could not move her arm. Went to Emergency Room. Stated B/P elevated. Pulse increased. States was told may have been allergic reaction to vaccine.