chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days after injection left arm and shoulder hurt. I could not lift any weight and had limited range of mobility. One week after vaccine I reported to my PCP who examined me and said I was fine. One week later I reported to my PCP again who again told me I was fine. Two weeks later after arm and shoulder did not improve I saw another doctor who agreed the injection was too high and too deep and sent me to physical therapy. The pharmacy tech injected too high on my arm and went very deep inside. I have been in physical therapy for 5 weeks and there has been improvement with range and weight being put on joint. Physical therapist is unsure if physical therapy will fix it. New doctor is checking on steroid injections to ease pain.  The pain one week after injection was a 8/10. Now it rates 5/10.  It seems to be getting better but I still can't use my arm and shoulder like I could before the vaccine.
This case was reported by a healthcare professional and described the occurrence of injection site rash in a 21 year old female subject who was vaccinated with FluLaval for prophylaxis. Medical history included non-smoker and non-drinker. On 13 November 2006 the subject received a dose of FluLaval in an unspecified arm. The healthcare professional noted that at the site of the FluLaval injection, on 13 November 2006, less than one day after vaccination with FluLaval, the subject experienced "a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site." The events resolved on 14 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
Patient had groundglass opacity noted on her CAT scan negative for Covid per PCR test tachypneic on exertion
7:30 AM-Patient woke up, ate 6 oz of Similac Advanced formula, and fell asleep on my chest. 8:45 AM- his body went rigid, he started having continuous shaking in his arms and legs, his back arched, and his eyes were open, but pupils were rolled back in his head. 8:47 AM-seizure ended, patient was not able to focus on anything and was very sleepy.  He had four more seizures about two hours apart, and was hospitlized for 3 days.  He is now taking Keppra twice a day.
Erythema multiforme- minor causes to target lesion over the face, torso, extremities but no mucosal involvement. Patient was interactive and appropriate during exam. Information from Follow-up report states: Dr called Pediatric Partners and stated that patient received a flu vaccine on November 8,2005 and had an adverse reaction to the vaccination. She was seen and treated in the office by DR and he is now requesting the lot number, expiration date, manufactuer of vaccine, and route of the influenza vaccine.
protected with the deviation in vaccination schedule; she was bitten on the hand by a cat; Initial information received on 07-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced protected with the deviation in vaccination schedule and she was bitten on the hand by a cat while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TETANUS VACCINE (TETANUS VACCINE) for Cat bite.  On 05-Jan-2022, the patient received a  dose of suspect RABIES (HDC) VACCINE (lot number , Strength, formulation and expiry date was unknown) via unknown route in unknown administration site for immunization.  On 05-JAN-2022 the patient developed a non-serious event "protected with the deviation in vaccination schedule" (inappropriate schedule of product administration) following the administration of RABIES (HDC) VACCINE.  On 31-DEC-2021 the patient developed a non-serious  event "she was bitten on the hand by a cat "(animal bite) following the administration of RABIES (HDC) VACCINE.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the events (protected with the deviation in vaccination schedule, she was bitten on the hand by a cat).  At time of reporting, the outcome was Unknown for the event protected with the deviation in vaccination schedule and was Unknown for the event she was bitten on the hand by a cat.     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.
Tightness in throat and change of voice (inability to project voice); tightness in chest; disrupted sleep patterns, jolted awake essentially every 2-3 hours every night with increased respiration rate, heart rate and lower than normal O2 levels. This has continued for 20 days.
Developed moderately severe rash with itching at and below injection site. Area is slightly warm and moderately swollen, with red rash covering majority of upper arm.
Miscarriage: I was due at the end of the year. Miscarried after 2nd shot.
Patient received Pfizer dose 1 today. Reports burning in chest  at 11:29am and dizziness 5 minutes after getting vaccinated. Patient describes burning in chest as acid reflux. Offered medication, water, ice pack and crackers. Patient declined. Patient declined laying down. Patient had her 2 young children with her.   VS: 11:41am 120/62 99 84 At 11:48am dizziness subsided.  Discharged 11:55am. Advised to monitor burning in chest and contact primary with questions/concerns. Advised to take medications at home if needed. Patient agreed.
Participant was put in hospital after testing positive for Covid. He is still on ventilator and oxygen. Participant is confused and is on dialysis. He is in ICU but will be moved to a long care treatment facility today 03/4/2022. Had lots of chest xrays, Ct scans. Labs were done.
cold sweats; diarrhea; nauseous; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), COLD SWEAT (cold sweats), DIARRHOEA (diarrhea) and NAUSEA (nauseous) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 13-Feb-2021, the patient experienced NAUSEA (nauseous). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 22-Feb-2021, the patient experienced COLD SWEAT (cold sweats). On 13-Feb-2021, NAUSEA (nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm), COLD SWEAT (cold sweats) and DIARRHOEA (diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not provided.  concomitant details not provided.
itching and redness (welt) at site of vaccine administration starting one week after getting first vaccine dose; still active at time of this reporting
No adverse effects; administration of expired ROTATEQ vaccine.; This spontaneous report was received from an office manager referring to a 2-month-old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 05-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 ml/once, lot # 1707469, expiration date: 31-MAR-2022; strength was not reported) orally for prophylaxis (expired product administered). No adverse effects were reported at that time.
Information has been received from a physician concerning a 16 year old female who on 12-JAN-2009 was vaccinated with the second dose of GARDASIL (Lot # not reported). After receiving the second dose of GARDASIL, the patient broke out in a rash and hives on her legs, and she also had swelling and hives at the injection site. The outcome of adverse event was unknown. It was reported that the patient sought medical attention: called the physician. Additional information has been received from the medical assistant who was inquiring if the patient should received her third dose of GARDASIL. Additional information has been requested.
A third dose of the Shingrix vaccination was administered to the patient, no reactions have been reported thus far. The patient and the provider were contacted about the incident.
Heart started racing; She had tachycardia; Her appetite is down; Sweating palms; nausea; Headache; Fever; Chills for 2 days; This spontaneous case was reported by a physician assistant and describes the occurrence of PALPITATIONS (Heart started racing), TACHYCARDIA (She had tachycardia), DECREASED APPETITE (Her appetite is down), HYPERHIDROSIS (Sweating palms) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FEXOFENADINE, MELATONIN and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills for 2 days). On 30-Jan-2021, the patient experienced PALPITATIONS (Heart started racing), TACHYCARDIA (She had tachycardia), DECREASED APPETITE (Her appetite is down), HYPERHIDROSIS (Sweating palms) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) on 28-Jan-2021 for Chills, Fever and Headache, at an unspecified dose and frequency. On 30-Jan-2021, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills for 2 days) had resolved. At the time of the report, PALPITATIONS (Heart started racing), TACHYCARDIA (She had tachycardia), DECREASED APPETITE (Her appetite is down), HYPERHIDROSIS (Sweating palms) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Blood potassium: low (Low) Low. On 30-Jan-2021, Blood sodium: low (Low) Low.     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.   Additional concomitant medication included unspecified birth control.   Reporter did not allow further contact
burning feeling in my arm; Felt like a thickness like my arm was full down to fingers; lump that formed at the injection site; she had a mild headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (burning feeling in my arm), PERIPHERAL SWELLING (Felt like a thickness like my arm was full down to fingers), INJECTION SITE MASS (lump that formed at the injection site) and HEADACHE (she had a mild headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (burning feeling in my arm), PERIPHERAL SWELLING (Felt like a thickness like my arm was full down to fingers), INJECTION SITE MASS (lump that formed at the injection site) and HEADACHE (she had a mild headache). At the time of the report, INJECTION SITE PAIN (burning feeling in my arm), PERIPHERAL SWELLING (Felt like a thickness like my arm was full down to fingers), INJECTION SITE MASS (lump that formed at the injection site) and HEADACHE (she had a mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Patient reports that his throat feels like it is closing and his eyes are itchy.  The reaction is similar to a reaction he had when he ate shrimp, which he is allergic to. This started roughly 3 hours after his vaccine was given.  Patient was instructed to seek immediate medical attention, either at the ER or a clinic.  If this was not available to him, then we instructed him to go to a pharmacy to purchase Benadryl and take 25mg immediately.
Got second dose after 55 days after first one; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose after 55 days after first one) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose after 55 days after first one). On 14-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose after 55 days after first one) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.
After 2nd Pfizer vaccine, Pt. noticed (R) sided arm discomfort @ injection site. Completed 15 minute observation period & departed vaccine site to her car. Returned for eval due to persistent discomfort. Discomfort had migrated to (R) upper chest over about 5-10 mins after vaccine receipt. Discomfort reported 3/10. VSS. Pt. denied dyspnea, urticaria, facial edema, or substernal chest discomfort. No signs of rash, erythema at injection site.  Pt. appeared in NAD. . Due to c/o chest discomfort, ER eval recommended w/ambulance transport. Pt. declined. Pt. alone. Signed out AMA. Appeared NAD on departure.  Advised to seek med attn if sxs persist or 911 if worse.
Fever, aches, lethargy; Fever, aches, lethargy; Fever, aches, lethargy; other vaccine same date product=GSK; other vaccine same date product=GSK; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Nov2022, outcome "unknown" and all described as "other vaccine same date product=GSK"; PYREXIA (non-serious), PAIN (non-serious), LETHARGY (non-serious) all with onset 02Nov2022, outcome "recovering" and all described as "Fever, aches, lethargy". Therapeutic measures were not taken as a result of pyrexia, pain, lethargy.  Additional information: Location of injection for vaccine received same date: GSK - left arm. The patient was not diagnosed with COVID-10 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.
Patient developed left arm pain with radiation to midsternal area. Also, she had pain on deep inspiration.
Funny feeling in her lips; felt funny; Funny feeling in her lips; felt funny; This is a spontaneous report from a contactable consumer or other non health care professional (patient) reported in response to Non-health care professional letter sent in cross referenced case. An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 27Jan2021 (at the age of 85-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced same reaction as first shot: funny feeling in her lips; felt funny. Patient took benadryl as treatment for the events. Symptoms disappeared in about 5 min, fine afterwards. The outcome of evens was resolved on an unspecified date in 2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Approximately 1 hour after receiving the  vaccine I developed tachycardia  that ranged between 130 and 95, this lasted from  01/08/2021 until 01/09 ~10 AM.  On 01/08  ~5 PM I began to develop  a fever that reached a peak of 102.4 at 4am (01/09), despite taking 1000 mg of acetaminophen every 6 hours. Last fever recorded 01/09 ~9PM of 99.5 (while still taking 1000 mg of acetaminophen every 6 hours).  Additional symptoms have been severe nausea, dizziness, lightheadedness, bilateral lower back pain with some mild bruising to the kidney region, difficulty breathing,  chest pressure, shortness of breath along with a cough upon exertion (developed ~6 PM 01/08), which is still present today (01/10 1:25 PM), and an erythematous rash that covers the anterior side of the right forearm, from wrist to elbow (first noticed on 01/10 ~11 AM).
10/4 at 8p-small, discreet rash first on face-hours later on neck-hrs later on legs. On 10/5 afternoon rash (small, red, rough) all over body: T 101 deg F. Tx Tylenol/Calamine fluctuates-low or during day and normal at night. Sun and Mon. no other s/s. Normal behavior/playing. As of 10/11, rash is slowly resolving; fewer spots now lighter.
Fever of 102.2, Nausea, Vomiting, Chills, Fatigue, Muscle Aches. Eventually went away after 24 hours.
Intussusception 5-6 days after vaccines. Seen in ER with bloody stools, intussusception seen on ultrasound, sucessfully reduced with air enema
stiff feet/ ankles/ wrists; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 28Apr2021, outcome "unknown", described as "stiff feet/ ankles/ wrists". Therapeutic measures were taken as a result of musculoskeletal stiffness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got the flu shot at around 11:15 AM on 11/12/2019. After a few hours (around 4PM), she called back and reported that she experienced allergic reactions to the vaccine such as hives, wheezing and swelling. She then took Benadryl and the hives almost disappeared. Patient was told by the reporter (pharmacist) to keep monitoring it and contact to healthcare professional right away if it worsens or does not get better soon. She agreed to follow instructions.
The patient presented to the pharmacy on 10/23/15. He said he felt fine after his shot on 9/30/15, but he woke up in the middle of the night that night and felt "numb" down his arm where he received his shot, and also his back. He said he didn't experience any pain, just a strange numbness that he has never experienced before. When he woke up the following morning, the numbness was gone and he stated he did not experience it again.
8 cm x 4 cm erythematous area at inject site, then 8 cm x 4 cm erythematous area medial to the inject site (2 identical areas) warm to touch.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: they tested me for COVID; Positive, notes: then I had COVID again.  Additional information: Patient stated that I was sick and then every time I tested to see if I could get everything worked out, I, I, they tested me for COVID. I got sick twice, but I didn't know. I got sick 3 or 4 times but anyway. Then I had COVID again. While discussing Pfizer, the patient stated, "You're the ones that gave me my shot for the COVID and whatever."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Other- patient had blueness in one hand, states she had problems breathing, and vomiting, epipen was given and paramedics were called, she was taken to the hospital, not believed to be anaphylaxis
This spontaneous case, initially received on 12-Dec-2017 from other non-health professional, concerns a female patient (non-pregnant) of an unspecified age. On an unspecific date, the patient was administered with INN flu vaccine seasonal (dose, route of administration, anatomical location, manufacturer, trade name, batch number and expiry date: not reported). On an unspecific date, the patient was also administered with non-company suspect product ILLARIS (dose: 150 mg/ml SDV injection, every 8 weeks, route of administration: subcutaneous (reported as injected under the skin), anatomical location, batch number and expiry date: not reported) for tumour necrosis factor receptor-associated periodic syndrome (TRAPS). On an unspecified date, after the vaccination, the patient felt unwell, had mild cough and general sluggish feeling. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious and considered the causality of the events related to the suspect vaccine.