chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the COVID arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the COVID arm (left arm)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the COVID arm (left arm)). At the time of the report, INJECTION SITE ERYTHEMA (Redness at the COVID arm (left arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10-MAY-2021 and contains No New Information
Immediately following the injection, I got chills that evening. Warm to the touch; red; like a rash and soreness and it was also very itchy - on my left arm - everything happened below the injection site.  These symptoms on the arm lasted about four days. I used allergy OTC med and put an ice-pack on my arm and those helped relieve the symptoms. I didn't have a doctor appt but just talked to a nurse - I went to her on the 19th - at the school.
started feel like sleepy after receiving the vaccine; cough, inflamed, diarrhea; cough, inflamed, diarrhea; cough, inflamed, diarrhea; woke up with a rash on the chest, it's itchy; running nose, weakness, cough, and a red rash; running nose, weakness, cough, and a red rash; running nose, weakness, cough, and a red rash; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (started feel like sleepy after receiving the vaccine), COUGH (cough, inflamed, diarrhea), INFLAMMATION (cough, inflamed, diarrhea), DIARRHOEA (cough, inflamed, diarrhea) and RASH PRURITIC (woke up with a rash on the chest, it's itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D2 for an unknown indication.    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 SOMNOLENCE (started feel like sleepy after receiving the vaccine), COUGH (cough, inflamed, diarrhea), INFLAMMATION (cough, inflamed, diarrhea), DIARRHOEA (cough, inflamed, diarrhea), RASH PRURITIC (woke up with a rash on the chest, it's itchy), RHINORRHOEA (running nose, weakness, cough, and a red rash), ASTHENIA (running nose, weakness, cough, and a red rash) and RASH ERYTHEMATOUS (running nose, weakness, cough, and a red rash). At the time of the report, SOMNOLENCE (started feel like sleepy after receiving the vaccine), COUGH (cough, inflamed, diarrhea), INFLAMMATION (cough, inflamed, diarrhea), DIARRHOEA (cough, inflamed, diarrhea), RASH PRURITIC (woke up with a rash on the chest, it's itchy), RHINORRHOEA (running nose, weakness, cough, and a red rash), ASTHENIA (running nose, weakness, cough, and a red rash) and RASH ERYTHEMATOUS (running nose, weakness, cough, and a red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided
liquid portion of PENTACEL being given without the Hib portion, with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who was administered liquid portion of pentacel being given without the hib portion, with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 14-Jul-2022, the patient received a 2nd or 3rd  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ590AAA  at a dose of 0.5ml once via intramuscular route in the left thigh for immunization.  On 14-Jul-2022(latency: same day), the patient developed a non-serious event of liquid portion of pentacel being given without the hib portion, with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event   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.; Sender's Comments:  01213243:
One week after vaccine I experienced redness and swelling in my breast. Then two days after that I started having tingling and "creepy crawling" feelings in my legs. I also experiences buzzing in my head and severe anxiety. I am still experiencing severe anxiety and the "creepy crawly" feelings in my legs. Doctor diagnosed as possible Guillain Barre
Pain in lower back on both sides of spine.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 at 14:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, double mastectomy on an unknown date in 2013, chemotherapy on an unknown date in 2014, skin cancer, latex allergy, food allergy to mushrooms, shellfish allergy and milk allergy (aged cheeses). 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. Concomitant medications included anastrozole (ARIMIDEX), vitamin d nos (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and nicotinamide (MANUFACTURER UNKNOWN), all from an unknown date, for unknown indication and unknown if ongoing. The patient previously took cefalexin (KEFLEX) for an unknown indication, on an unknown date and experienced drug allergy. On 27Feb2021 at 15:00, the patient experienced pain in lower back on both sides of spine. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in lower back on both sides of spine was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
few people come back for the 2nd shot; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a unspecified number of patients who received Hepatitis B vaccine for prophylaxis.   Previously administered products included HEPATITIS B VACCINE (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report The reporter said that, the pharmacist who administered the shots to her mentioned that, very few people (patients) come back for the 2nd shot and till the time of reporting, the patients did not receive 2nd dose, which led to incomplete course of vaccination The reporter did not want to provide her mailing address. The reporter provided limited information. The case had been linked with US2021AMR225939, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR225939:same reporter
extreme headache. Her whole head feels very traumatic in her forehead and in back of head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headache. Her whole head feels very traumatic in her forehead and in back of head) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F23A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Allergy to metals and Food allergy (Dairy products). Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced HEADACHE (extreme headache. Her whole head feels very traumatic in her forehead and in back of head). At the time of the report, HEADACHE (extreme headache. Her whole head feels very traumatic in her forehead and in back of head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.  Patient race was reported as black.  dose was given on 30-OCT-2021 12 PM.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant follow up was received and included vaccine facility information, contact address of health care professional, patient demographics (height, weight, race, and ethnicity), allergic and medical  history and concomitant medication.
Pt had vasovagal reaction with fainting. Following this episode was evaluated in ED - nl EKG. Developed significant migraine-like headache and back pain. Seen in clinic next day. Improved after Toradol.
Patient received second dose too early.  His first dose was received on 5/23/2022.  Patient was no experiencing any side effect while in the pharmacy.
Headaches, fever, swelling, redness, muscle aches, nauseated for 2 weeks after second shingrix vaccination
PRESENTED ON 13 JUNE 2003 WITH COMPLAINT OF RED, SWOLLEN RIGHT EYE X 3 DAYS.  EXTERNAL EXAM SHOWED CONJUNCTIVAL CHEMOSIS OF THE RIGHT EYE, A MILD KERATITIS OF THE RIGHT EYE AND (+) PREAURICULAR AND SUBMANDIBULAR NODES ON THE RIGHT SIDE.  HE WAS TREATED WITH POLYTRIM GTTS QID OD, VOLTAREN GTTS QID OD, ARTIFICIAL TEARS PRN OD, LACRILUBE UNG QHS OD AND VIROPTIC GTTS 5 X'S/DAY OD.  AT F/U ON 14 AND 16 JUNE 2003 THERE WAS IMPROVEMENT IN THE SYMPTOMS AND CHEMOSIS.  THERE IS NOW A KERATITIS INFERIORLY IN THE RIGHT EYE MOST LIKELY DUE TO THE VIROPTIC GTTS.  HE WILL BE FOLLOWED ON A DAILY BASIS.
This spontaneous report was received from a physician referring to his 16 year old male patient son. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-JUN-2018 (reported as "two days ago"), the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date, the physician stated that the patient had a huge 15 cm localized site reaction, red, swollen, sore, and with fever. At the time of the report, the outcome of  localized site reaction, red, swollen, sore, and with fever, was unknown. The physician did not mention the causality assessment between the events and GARDASIL 9 vaccination.
Short of breath in recent weeks, heart rate on June 9,2021 was up to 135 resting rate, abnormal heart rhythms (extreme fast or slow beating)
This case was reported by a physician via a sales representative and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event described as a sensitivity reaction. At the time of reporting the outcome of the event was unspecified. The sales representative stated that she was at a large convention on 30 September 2008 and was approached by a physician that reported his hospital had suspended administration of FLUARIX due to 6 subjects developing adverse events after receiving the FLUARIX. No details of the report are available and the sales representative heard the report third hand. Linked cases include: A0753365A, A0753367A, A0753368A, A0753369A and A0753371A.
Patient reports she received the shingles vaccine a few days ago and had a reaction to it. she states she has loose bowel movements and felt very fatigued.; Patient reports she received the shingles vaccine a few days ago and had a reaction to it. she states she has loose bowel movements and felt very fatigued.; Patient reports she received the shingles vaccine a few days ago and had a reaction to it. she states she has loose bowel movements and felt very fatigued.; This spontaneous report was received from a consumer through Agency via pharmacy refers to a female patient of approximately 83 years old. The patient's concurrent condition and medical history were unknown. The patient's concomitant therapy included rivaroxaban (XARELTO). On an unknown date in 2019 (reported as a few days ago), the patient was vaccinated with varicella virus vaccine live (oka/merck) (Manufacturer Unknown) (dose, frequency, anatomical location, lot # and expiration date unknown) for prophylaxis. On an unknown date in 2019, the patient had reaction to it (vaccination complication). The patient also stated that she experienced loose bowel movements (diarrhea) and felt very fatigued. The outcome of vaccination complication, diarrhea and fatigue was reported as unknown (It was also reported that the patient was finally feeling better on 17-OCT-2019). The causal relationship of the events with varicella virus vaccine live (oka/merck) (Manufacturer Unknown) was not provided.
Left arm pain; viral cellulitis. ? bacterial secondary infection. Fever 105. Altered mental status.
Fever that started at around 9 PM, about 12 hours after injection. It reached 101.6 degrees Farhenheit. Body aches started shortly after the fever along with chills. About an hour or two into the fever I got a headache and also felt slightly nauseous. About 5 hours after side effects appeared I was able to fall asleep after taking some Tylenol PM. Woke up around 8 or 9 am with most of the side effects gone except for body aches. My body was sore for the rest of the day but now all side effects are gone.
injection site swelling; itching at the injection site; a little rash on the injection site; induration at the injection site; looked bruised at the injection site; tenderness; pain at the injection site; tenderness at the injection site; redness at the injection site; more than usual bleeding at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site), INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness) and INJECTION SITE PRURITUS (itching at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site). On 23-Jan-2021, the patient experienced INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness), INJECTION SITE PAIN (pain at the injection site), INJECTION SITE PAIN (tenderness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE RASH (a little rash on the injection site). On 31-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site swelling). On 27-Jan-2021, INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness), INJECTION SITE PAIN (pain at the injection site), INJECTION SITE PAIN (tenderness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site), INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (a little rash on the injection site) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown. Not Provided      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.   Patient had the flu shot at the beginning of December (no specific date provided) and that her arm kind of hurt ever since. No Concomitant medications were provided by the reporter. No Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: injection site swelling AE updated.
A day after my vaccines I noticed my heart racing while I was standing in a bookstore, it got up to 160 BPM according to my watch. As soon as I got up and walked around again my heart rate shot back up. Any time I get up and move around my heart rate rises quickly, it has been doing so since I've gotten the vaccine.
Fatigue, body aches, chills, cough, sore throat, headache.
My son received the MMR vaccine on 04/27/2019 and was perfectly fine and healthy up until this point. On 04/29/2019 my son began to throw up and showed signs of exhaustion. A few hours later he was diagnosed with intussusception.
At the time of the injection, I felt coldness run from my left shoulder into my left ear/ear lobe. Later that evening, I started feeling paresthesia in my left ear. Over the course of two weeks, I have had gradual worsening paresthesia in my left anterolateral neck, jaw, cheek bone, forehead and left skull. I am also starting to taste metallic like pennies in my mouth.
Returned 3-4 hrs post receiving Hib and PCV in R thigh with redness and swelling from upper thigh to knee. Painful with movement but full ROM-instructed to give bath, and warm compresses and Tylenol. F/up phone call in am
62y.o. female with history of cerebral palsy who presented on 8/13/2022 with abdominal pain, N/D for 2 days.  Findings on imaging consistent with SBO.  Pt underwent procedure listed above which they tolerated well without complication, see operative report for full details.  Patient recovered well. Hospital course significant for delerium, post op care.  On POD#6, pain controlled, pt tolerating diet, voiding and ambulating independently, ready for discharge to facility.
pt reported have amnesia and not clear thoughts 24 hours after receiving 2nd Pfizer dose
This spontaneous report was received from a Registered Nurse via a company representative, referring to a 17 year old patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On an unknown date, the patient was vaccinated with an adult dose of VAQTA injection, 50/1.0 U/ml (dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis. No adverse effects were reported.
The patient develeoped swelling at the site of administration and itching.  Itching resolved with Benadryl prn.  For the residual swelling, the patient had the option of using Motrin prn.
The pt developed redness and swelling at the injection site 24 hours post vax. The pt complained of itching, site redness and hot. Advised mother to apply compresses. Given Tylenol and Benadryl. Pt to see MD. Also advised to take child to ER if any trouble breathing.
Pt was accessed in clinic for pain in arm and swelling. No actions were taken since pain can be treated with TYLENOL or ADVIL and swelling will go down, pt is aware to contact the clinic or go to the ED if arm gets worse. PCP is aware of the event.
Spreading rash that is very itchy.  Started on back.  Now on entire back, upper chest, right arm, neck, scalp and upper legs.  Topical steroid cream made some improvement but continued to spread.
Client became pale and fainty and he complaint of a headache. Immediately, he was placed on an examination table for twenty minutes in a supine position B/P 90/60 P 78 regular, Res 20. He was given a cup of water and father given him a sandwich. He laid on the examine table until he felt better and skin color became back to normal. Resume other immunizations
within two hours of receiving the vaccine I experienced: sore arm, crushing exhaustion, facial numbness and tinnitus. The sore arm and exhastion went away after 2-4 days. The facial numbness decreased (but has not gone away) and the tinnitus has increased over time to the point where now it is very difficult to sleep because of the noise.
pt recv vax 13AUG98 & 630PM same evening felt sick-aching, chills, weakness, pain lt  site, neck, face, jaw, w/muscle spasms & fatigue LUE, swelling lt axilla w/pain when raising arm, redness,knot @ site;
Sore throat; Loss of appetite; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) in a 75-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) had resolved.            No relevant concomitant medication were provided. No treatment information was provided.   This case was linked to MOD-2021-024134 (Patient Link).
Within 12 hours, I started to feel achy, and soon after I felt the chills, and had a small fever.  The achiness and fever continued for 36 hours before the symptoms stopped.
sl fever, h/a, complete weakness in bed 1 wk went to MD had a mild bacterial infect in blood had a kidney transplant; flu shot given 14OCT92;
24 hr post vaccine--felt tired with nausea & vomiting 48 hr post vaccine--temp 100 with headache 72 hr post vaccine--headache worse, generalized muscle aches 96 hr post vaccine--headache same, felt spine was enlarging, went to E.R., labs (CBC) done, sent home 7 days later--fully recovered