chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given expired dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (HTN), Hyperlipidemia (HLD), Type 2 diabetes mellitus (T2 DM), Irritable bowel syndrome (IBS) and Penicillin allergy (Penicillins).    On 23-Mar-2022 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It reported that the patient has not experienced an adverse event to the knowledge of clinical staff, as per HCP the vial didn't undergo any temperature excursions, vaccination site reported as deltoid.  No treatment medications were reported.   This case was linked to MOD-2022-543908 (Patient Link).
C/o red, slightly raised area at site of flu shot injection. Throbs. Slight warm. Tx. Ice, ibuprofen.
10-18-2017 Mother said "There's a red spot slightly next to the spot where vaccine was administered. It's on his right leg which only had 1 shot. It feels slightly warmer than the rest of his leg and hard."  10-19-2017 Mother said "It looks less red still feels just a bit hard but looks better." No medications given.
Patient started having redness by the next day and it slowly increased in size and became a raised spot on the arm where the vaccine was given. The spot is warm to the touch.
Myalgia, Arthralgia & Fever Narrative:  Fever 101, body aches day after injection, felt bad for several days
Nausea, stomach pain, full body muscular pain, headache, 99.7 temperature.
Information has been received from a pharmacist concerning a 42 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 about a month ago (approximately March 2010). On an unspecified date, the patient saw the pharmacist and mentioned that she had pain at the injection site which spread to her underarm and breast area. The pharmacist noticed that the patient had a heat rash around the injection site. At the time of this report, the patient's status was unknown. Additional information has been requested.
pt recv vax 24MAY96 10-11AM & mom reported pt having shaking spell, t102 in ER;pt taken to ER dx febrile sz w/vax;given APAP;mom will call w/further problems;devel rash consistent w/roseola 27MAY96
Monday: Low grade fever, chills, severe body aches - started ~ 1:30am, chills broke by 6am Low grade fever, body aches - continued from ~6am through 12pm Severe headache and loss of appetite - started ~ 10am through evening Took Tylenol at ~2pm; headache and body aches decreased by 5pm; very slight increase in appetite Took second Tylenol at ~7:30pm; headache and body aches subsided Tuesday:  Woke up 4:30am feeling lethargic with slight headache, appetite slightly increased but not near normal
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: En6208), on 07Apr2021 as dose 2, single (Lot number: Er8727), on 07Nov2021 as dose 3 (booster), single (Lot number: 3203bd) and on 25May2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ABILIFY, start date: 02Feb2021; LAMOTRIGINE; PRIMIDONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Resumption of symptoms rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical information: The patient had received other medication within 2 weeks of vaccine administration. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid started on 23Aug2022 and stooped on 28Aug2022.
Eczema flare up; Skin itches between thighs, stomach, hands, neck; Eczema flare up; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm right on 13May2021 at 16:15 as dose 1, single (age at vaccination 34 years) for covid-19 immunisation. Medical history included eczema and asthma since an unknown date. The patient did not have any known allergies. Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13May2021 at 16:15 the patient experienced eczema flare up and skin itch between thighs, stomach, hands, neck. The patient did not receive any therapeutic treatment for the events. The events were reported as non serious. The outcome of the events was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Subsequent to receiving three doses of Engerix B, the pt was found to be a non-responder. The pt received her fourth and fifth doses of Engerix B and was again found to be a non-responder. As of 08/09/2000, the outcome of the event is unknown.
Initial unsolicited report received from a Consumer on 19-JAN-2015. A male patient (age was not reported), whose medical history and concomitant medications were not reported had received a dose of FLUZONE (dose details, batch number, route and site of administration was not reported) on 18-SEP-2014. On 18-SEP-2014, the patient experienced soreness, redness and hot to touch area at injection site. It was reported that over next 2 days he also had "stomach symptoms", weakness and continued muscle soreness of arm. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient recovered from the events of stomach symptoms and weakness on an unspecified date and continued to have left arm pain and limited use of arm due to pain. The patient required ER or doctor visit. Documents held by sender: none.  Follow up information received from a consumer on 23 FEBRUARY 2015: Patient reported that in spite of his warning to pharmacist that he injection was being injected in patient's upper right arm too high, the pharmacist went ahead and did so, the needle going into reach the shoulder joint, and or pieces of connective tissue. It was immediately painful and remained so to the day of reporting, six months later the arm was till hurting daily in that area and its motion was limited. Pharmacy is to blame. At the time of report patient had not recovered from the event "arm hurts daily in that area" and "it's motion is limiting". List of Documents held by sender: none. Follow-up information received from a non-healthcare professional (consumer) on 30 APRIL 2015. It was reported that wrong injection technique of the pharmacist caused adverse events (muscle soreness of arm, mobility decreased, soreness, redness, hot to touch area at injection site) to the patient.
left arm tingling, dizziness, lightheadedness, nausea, tachycardia, hypertension
This spontaneous report as received from a pharmacist refers to a currently 74 year old female patient. On an unknown date (reported as over 2 years ago) the patient was vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date the patient experienced rash on her legs and groin that has persisted. The reporter stated that the patient also experienced rash that had blisters with fluid in them. The rash was appearing to be spots on the patient's legs and the patient reported that near her groin the lesions were still vesicular. The patient consulted her healthcare provided and the patient had used clobetasol and PROTOPIC topically. The outcome of events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
CLIENT REC'D FLU SHOT INJECTION LEFT DELTOID ON 10/18/2011. NOTICED REDNESS AND INFLAMMATION LEFT DELTOID AND UPPER LEFT ARM 10/19/2011. AREA IS WARM TO TOUCH, RED, AND BURNING SENSATION. SWELLING NOTED AT AREA OF INFLAMMATION. AREA AFFECTED IS APP 10 CM X 7 CM. NO SOB OR OTHER ANAPHYLACTIC REACTION NOTED.
Information has been received from a consumer concerning his male nephew who was vaccinated with a dose of MMR II (dose, route and lot # not reported) when he was 14 or 15 month old. Within a week or two after receiving the vaccine, the child's behavior changed drastically (unspecified changes). In order to find out what was wrong with the child, the parents took him to multiple physicians for "over three months". Eventually, the child was diagnosed with autism. The patient did not recover. Autism was considered to be disabling by the reporter. No further information is available.
This spontaneous report was received from a registered nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that on an unspecified dates, the patient received two doses of GARDASIL (route, dosage, lot # and expiration date were not reported), and afterwards on 17-AUG-2015, the patient was vaccinated with GARDASIL 9 (route, dosage, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
p/ pt recv vax approx 3 yrs later pt devel a rash w/approx 10 lesions on back. MD dx w/chickenpox.
Swelling and itchiness at injection site 7 days after injection. Have only had 1 shot.
FEVER; INCREASED HEART RATE; CHEST PRESSURE AND CHEST PAIN; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and inflammation of the sternum.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for inflammation of the sternum, and propranolol for inflammation of the sternum. On 15-MAR-2021, the subject experienced increased heart rate. On 15-MAR-2021, the subject experienced chest pressure and chest pain. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and fever on 16-MAR-2021, and had not recovered from chest pressure and chest pain. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
This spontaneous report as received from nurse refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients was received improperly stored RECOMBIVAX HB (lot# K018180 and expiry date: 17-SEP-2016; lot# K022265 and expiry date: 22-DEC-2016; lot# 1004754 and expiry date: 10-NOV-2016). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sharp chest pain (left side), dull pain in back near shoulder blade (left side), left arm dull pain and sharp pain. Lasted about 3 or 4 hours. The pain woke me up from sleep. I waited to see if it would get better and finally fell asleep. I did not seek medical attention.
8 days after the vaccine, I developed a blotchy red rash that trailed down my arm from the injection site. The injection site was red, swollen and painful to touch. Mild itchiness noted on that arm. Otherwise, I was fine. Just seemed strange so long after the vaccination. It improved without intervention and was gone within 2-3 days. I did not seek professional help because I read that this reaction was noted with the Moderna vaccine and that it was just considered a mounting immune response and no cause for concern.  However, I still thought I should report it. I have since received the second dose of vaccine on 2/19/21. I had moderate side effects starting on 2/20/21 (lasting 15 hours) of fatigue, chills, body aches, joint pain, headache, generalized body swelling, swelling and pain at injection site and brain fog. I didn?t experience a rash (yet- the vaccine was only 3 days ago). Will update if that changes.
Patient was vaccinated on 2/24/21. On evening of 2/25/21, patient began to experience balance problems. On 2/26/21, patient began to experience tingling and weakness in lower extremities. On 2/27/21, patient required walker to ambulate.
Patient passed out, had cramps, nausea, dehydration, myalgia, no fever, no localized reaction. Patient had both seasonal influenza and H1N1 injection that day, as well as started menses.
lost feeling in face; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and HYPOAESTHESIA (lost feeling in face) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and HYPOAESTHESIA (lost feeling in face). At the time of the report, PYREXIA (fever), HEADACHE (headache), CHILLS (chills) and HYPOAESTHESIA (lost feeling in face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment details include, ibuprofen.
About 6 hours after being vaccinated I started having ringing in my ears. I actually lost hearing in my left ear for about 12 hours. It is still kind of muffled at this time and the ringing continues. I am still dealing with this at this time.
Headache; joint pain; armpit pain; exhaustion; arm pain; diarrhea; every part of my body hurt to touch, extremely achey and muscle pain; every part of my body hurt to touch, extremely achey and muscle pain; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 16:45 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA; WELLBUTRIN; ADDERALL; CRESTOR. Past drug history included: Prilocaine, reaction(s): "Known allergies: Prilocaine". Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: Unknown (unable to locate or read the details), administered at left arm), administration date: 13Apr2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown (unable to locate or read the details), administered at left arm), administration date: 23Mar2021, when the patient was 52 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 16:45, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "joint pain"; AXILLARY PAIN (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "armpit pain"; FATIGUE (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "exhaustion"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "arm pain"; DIARRHOEA (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "diarrhea"; MYALGIA (non-serious), PAIN (non-serious) all with onset 23Nov2021 07:00, outcome "recovering" and all described as "every part of my body hurt to touch, extremely achey and muscle pain". Therapeutic measures were not taken as a result of headache, arthralgia, axillary pain, fatigue, pain in extremity, diarrhoea, myalgia, pain. Additional information: Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID, prior to vaccination and had not been tested for COVID-19, post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
8 days after vaccination developed indurated warm red area over the site of injection approximately 2 in x 5 in, along with mild fatigue and low-grade temperature 99.5'F.
COVID-19 pneumonia; A spontaneous report was received from a nurse concerning a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Covid-19 pneumonia.  The patient's medical history was not provided. Concomitant medications were not reported.  On 20 Jan 2021, six days prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced symptoms of Covid-19 pneumonia. The reporter stated, the was patient tested positive for Covid-19 on 04 Feb 2021 and currently recovering from pneumonia.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, Covid-19 pneumonia, was considered resolving.; Reporter's Comments: This case concerns a male subject of unknown age who experienced a serious unexpected event of COVID-19 pneumonia. Event onset on 26Jan21, 6 days after first dose of mRNA-1273 on 20Jan21. SARS-CoV-2 test positive on 04Feb21. Treatment not reported. Event resolving. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
About a month after receiving the vaccine, I began having pain in the middle/side of my back at about 8:00 PM. The pain continued the next day, so I went to urgent care. The thought was that I might have overworked my back, but the D-Dimer came back elevated, so they sent me to Hospital to get a CAT Scan. The CAT-Scan revealed that I had a very small blood clot in the right lower lobe of my lungs.  I had not been traveling such that my movement had been constrained which might give rise to deep-vein thrombosis.  The emergency room performed an ultrasound of both legs, and could not find any indication of deep-vein thrombosis or any other impetus for the blood clot.  As there was no vector found for the blood clot, I assume that the clot was caused by the vaccine as I have not had any problems with clotting prior to this instance.
ADACEL: Given 1 wk ago in her (R) shoulder with persisting pain itch and ache. Exam with mild erythema and tenderness but good ROM of shoulder.
6 inches circle around the injection site; big hard lump; itchy; much more tired; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (6 inches circle around the injection site) and VACCINATION SITE INDURATION (big hard lump) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN, EZETIMIBE and HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ) for an unknown indication.    On 13-Jan-2021, 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 DISCOLOURATION (6 inches circle around the injection site) and VACCINATION SITE INDURATION (big hard lump). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOLOURATION (6 inches circle around the injection site) had not resolved and VACCINATION SITE INDURATION (big hard lump) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This case concerns a 77-year-old female who had a non-serious unexpected event of injection site mass and non-serious expected events of vaccination site pruritus, injection site discoloration, and fatigue.  The events occurred about one week after the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a male with no known pertinent medical history who on 26-JUN-2008 was vaccinated with a first dose of VARIVAX (Merck) 0.5 ml SQ. There was no concomitant medication. The patient developed a rash after he received the vaccine on an unspecified date. The patient sought medical attention by calling the nurse. Additional information has been requested.
Seizures, tremors, vomiting, loss of appetite, shaking, vomiting, insomnia, migraine, palpitations, dizziness, vertigo, joint pain, weakness, numbness on one side, anxiety, depression, hair loss, rapid weight loss.
achy pain above right ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (achy pain above right ear) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027120A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced EAR PAIN (achy pain above right ear). At the time of the report, EAR PAIN (achy pain above right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
After getting flu shot, I had upper arm pain that radiated to my neck and shoulder. I endured the pain for more than two months. The pain had greatly reduced my energy level and inhibited my mood and movement. I had to seek medical treatment multiple times to alleviate the pain I suffered.