chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of the right arm) and extreme headache in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 017B21A) for COVID-19 immunization. Concomitant products included amlodipine for an unknown indication. On Apr 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 6, 2021, patient experienced pain in extremity (soreness of the right arm) and extreme headache. The patient treated with Tylenol (paracetamol), ongoing since an unknown date; 1 dosage form. At the time of the report, pain in extremity (soreness of the right arm) and extreme headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. Patient stated the headache felt like a bad migraine and had to skip work.
DT given 10/15/02-redness, achiness into arm, back, axilla on 10/16 and 10/17. Decreased redness 10/18/02 achiness continued.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving nasal FLUMIST (intranasal). FLUMIST started on 24-Jan-2014. The patient was given expired FLUMIST. No symptoms to report. The patient experienced which started on 24-Jan-2014. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious by the reporter.
Headache, nasal congestion, sinus congestion, post nasal drainage. Patient denies sore throat, worsening cough, fever, chills, body aches, loss of taste, loss of smell, ear pain, nausea, vomiting, diarrhea, shortness of breath, chest pain. starting 11/17/21
Involuntary jerks, convulsion; Full color of face change, really red; temp 99F for a few moments; Looks really painful; A lot of muscular pain; Shivering; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful) and MYALGIA (A lot of muscular pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful), MYALGIA (A lot of muscular pain), CHILLS (Shivering) and NAUSEA (nauseas). At the time of the report, SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful), MYALGIA (A lot of muscular pain), CHILLS (Shivering) and NAUSEA (nauseas) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, Body temperature increased: 99 (High) 99F for a few moments.         Concomitant products were not provided. Treatment medication were not reported. Patient does not have fever, he had 99F for a few moments breathing is fine, but he looks really painful. He's having a lot of muscular pain, like electrical, it comes in waves, it's kind of involuntary. This spontaneous case is concerning of 47 years old male patient with no medical history, who  experienced the unexpected, AESI of Seizures and unexpected  nonserious events of erythema and increased body temperature. The event occurred few hours  after the booster dose of mRNA-1273 vaccine. The outcome of the events were reported unknown. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case is concerning of 47 years old male patient with no medical history, who  experienced the unexpected, AESI of Seizures and unexpected  nonserious events of erythema and increased body temperature. The event occurred few hours  after the booster dose of mRNA-1273 vaccine. The outcome of the events were reported unknown. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-DEC-2015, the patient was vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L025598, expiration date 13-JAN-2017; dose was not reported) and PEDVAXHIB (lot # L030865, expiration date 07-JUN-2018; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6DEC90 upon awakening mom noticed 2 spots & as day progressed rash spots became more prevalent. Appeared to be red splotches of sunburn of various sizes. some size of penny - other, the size of a teacup - not raised but warm to the touch.
C/o pain and redness. Reaction to inj. - to use BENADRYL, MOTRIN.
By the time I arrived home my arm swelled at the injections site, like the size of a baseball!!! It hurt and was painful.  It spread to my armpits and back of neck head and even legs all swollen. Eventually arm swelling went down but under armpits still swollen and very painful, sore. Right arm still sore in general and to touch...this is 6 weeks post shot and still swollen and painful.
Patients mother called. Her some began having symptoms (I believe she said) the day after the vaccine. Fever, feeling under the weather. Began having chest pains and shortness of breath. He was admitted to the hospital 2 days after vaccine. An EKG was performed showing the patient was experiencing mini heart attacks.
Began feeling bad Wednesday during the day and felt really bad Wednesday night. She took 2 ibuprofen Wednesday night and 2 Thursday morning and 2 on Friday morning. She still feels bad and very nauseous. The arm is red below the deltoid down to her elbow and is warm to the touch.
Pts recv vax on unspecified day; Tubersol was intended, post vax pts exp areas of induration & erythema
01/31/2022 a few minutes after the booster I felt dizzy, light headed, and hours later I started having vaginal bleeding and it wasn't time for my menstrual cycle, This lasted a week to 2 weeks. 2 weeks after on 02/19/2022 I had a very large lymph node on my right underarm. It felt like I had 2 lymph nodes. They were out for 3/4 days then it went away. I called the doctor and sent the picture because I thought it was syst. I have an appointment on 03/15/2022 to have another mammogram and to get lab work. The lymph nodes went away and so did my period. I only miss one day of work.
This non-valid spontaneous report was received from a nurse and refers to an unspecified number of patients (reported as several) of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N017701, expiration date 09-JUN-2019 (dose, site and route of administration were not reported), GARDASIL 9 lot # N022952, expiration date 14-JUN-2020 (dose, site and route of administration were not reported), VAQTA lot # R014952, expiration date 09-AUG-2019 (dose, site and route of administration were not reported), PNEUMOVAX 23 (dose, site and route of administration were not reported) and ROTATEQ (dose, site and route of administration were not reported), all for prophylaxis, as well as RECOMBIVAX HB lot # N011851, expiration date 19-DEC-2019 (dose, site and route of administration and indication were not reported). The vaccines were reconstituted with sterile diluent, lot # N021894, expiration date 28-NOV-2019 and lot # M036841, expiration date 17-APR-2019 (no details about storage provided). VARIVAX was stored improperly in temperature of -10 degrees Celsius for 20 hours. The other vaccines were stored improperly in temperature of 9.5 degrees Celsius for 20 hours. Other temperature excursions included improper storage of VARIVAX in temperature of 10 degrees Celsius for 60 hours and GARDASIL 9, RECOMBIVAX HB and VAQTA in temperature of 15.5 degrees Celsius for 60 hours. There were no prior excursion for PNEUMOVAX 23 and ROTATEQ. The temperature was measured with Digital Data Logger. No adverse effects were reported.
pt recvd vax; pt devel t 102; agitation, & loss of appetite w/ 1st dose; pt exp'd minor headache w/ 2nd dose of vax; pt took APAP for tx;
Initial misuse report received from a healthcare professional on 16 October 2013. The cases were received on 21 March 2014 at agency. This case is link with case: 2014SA045132 with same product and same reporter. A 81 years old patient, received FLUZONE INTRADERMAL vaccine (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Vaccine administration error:  Patient should have been given Moderna Bivalent (6m-5Y) since her two primary series doses were Moderna Monovalent, but staff erred by administering Pfizer Bivalent (6m-4y).   Parent had requested Moderna Bivalent.    Follow-up phone call by the pharmacist the next day to parent revealed that the patient is feeling fine, and the only adverse effect was fever of 100.4 during the night.   Pharmacy notified the child's pediatrician of the error by FAX.   In addition to VAERS Reporting, the pharmacy noted the error in the Immunization Registry.   Per CDC guidelines, the dose should not be repeated.
arm pain/swelling; arm pain/swelling; Arm  was sensitive to touch and radiated warmth; Arm  was sensitive to touch and radiated warmth; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2023, the patient received the 1st dose of Shingrix .5 ml. In APR-2023, less than a week after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain/swelling), swelling arm (Verbatim: arm pain/swelling), touch sensitivity increased (Verbatim: Arm  was sensitive to touch and radiated warmth) and feeling of warmth (Verbatim: Arm  was sensitive to touch and radiated warmth). The outcome of the pain in arm was not recovered/not resolved and the outcome of the swelling arm, touch sensitivity increased and feeling of warmth were recovering/resolving.   It was unknown if the reporter considered the pain in arm, swelling arm, touch sensitivity increased and feeling of warmth to be related to Shingrix.     It was unknown if the company considered the pain in arm, swelling arm, touch sensitivity increased and feeling of warmth to be related to Shingrix.   Additional Information: GSK receipt date:13-APR-2023 The nurse reported that the patient was office manager in practice. The patient received a dose of Shingrix and on the day of reporting the patient complaint about arm pain or arm swelling. According to nurse in office the patient's arm was sensitive to touch and radiated warmth. The reporter reported that events appears to be resolving but was still painful. The reporter did not agree to consent for follow up.
mom states p/vax pt has insomnia, is crabby, has bumps mostly on face & about 10 on arms;loss of appetite, dark circles under eyes;rash look like bug bites;leg hurting & less energetic;MD felt rash d/t vax;mom felt was eczema;sudden changes
A report has been received from a Health Professional concerning a 86 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that administered FLUMIST quadrivalent to a 66 year old which started on 27-Oct-2014. The outcome of the event of administered FLUMIST quadrivalent to a 66 year old is unknown. The report was considered to be non-serious.
After getting my second dose on March 16, I was diagnosed with Covid-19 on July 24
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 08-SEP-2015, the patient was inadvertently administered a dose of (Oka/Merck) VARIVAX (route, lot number and expiration date were not provided) and a dose of (Oka/Merck) PROQUAD (route, lot number and expiration date were not provided) was administered to the patient so there was an overdose. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown.  Additional information has been requested.
Patient was seen in the clinic today with complaints of redness and discomfort following her 2nd Covid vaccine. Patient was evaluated with lab work. She has a 9cm linear streaking which appears pink in color of the left upper extremity. Started on cephalexin 500mg QID x 10 days for cellulitis. Encouraged warms pack and elevation.
Fever, chills, headache, body aches and bit of nausea. Took Advil, drank water and rested.  Lasted 36 hours and then passed.
The patient was supposed to receive their second dose of Moderna vaccine but they were instead given a first dose of Pfizer vaccine by mistake.
3 x 2 inch area of erythema left deltoid square shape, slightly warm, decreased sensation in arm, vomited 4 times day after receiving. Treatment Allegra 180mg QD, Lodine 300mg PO BID
Pt developed red raised area on arm where vaccinated. Pt went to urgent care and received cephalexin Rx for cellulitis.
Dizziness; Lupus syndrome; Lose of taste; Lose of memory; Lose of appetite; Not sleeping well; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome) (seriousness criterion medically significant), AGEUSIA (Lose of taste), AMNESIA (Lose of memory), DECREASED APPETITE (Lose of appetite), INSOMNIA (Not sleeping well) and DIZZINESS (Dizziness). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome), AGEUSIA (Lose of taste), AMNESIA (Lose of memory), DECREASED APPETITE (Lose of appetite), INSOMNIA (Not sleeping well) and DIZZINESS (Dizziness) outcome was unknown.            The concomitant medication were not provided. The treatment was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, based on the pathophysiology of systemic lupus erythematous, it is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 02 Jun 2021 included non significant follow up information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.However, based on the pathophysiology of systemic lupus erythematous, it is assessed as unlikely related to mRNA-1273.
HCP called to report that the patient missed his second dose of GARDASIL 9 and will be receiving the second dose late. Limited information available on this case. No additional AE/PQC.; No adverse event; This spontaneous report has been received from a consumer, regarding to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters (ml), administered for prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported). Additionally, it was reported that on 15-OCT-2022, the patient missed his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration).  No additional adverse events were reported in the patient.
Child and mother presented at the clinic for vaccinations with record from out of state.  The record was transcribed onto the clinic vaccination record.  The record was reviewed and child was behind on all immunizations. This RN determined vaccines needed including a HIB and PCV13, incorrectly thinking child was < 60 months old.  Child had had one previous dose of each (HIB and PCV13) at 1 year of age. Error was discovered during the data entry process. Mother of child was notified by phone and told of the error.
Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 22Oct2021, outcome "unknown", described as "Chest pain".  Additional information: The reporter stated that her daughter got the Pfizer vaccine last Thursday and since Friday. Her daughter had chest pain for 5 straight days and she wanted to know if that was an side effect of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site), FATIGUE (Tiredness) and MYALGIA (Muscle on the back and shoulder was achy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LOSARTAN, FLUOXETINE, GABAPENTIN and METOPROLOL for an unknown indication. On 11-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 VACCINATION SITE PAIN (Sore arm at injection site), FATIGUE (Tiredness) and MYALGIA (Muscle on the back and shoulder was achy). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site), FATIGUE (Tiredness) and MYALGIA (Muscle on the back and shoulder was achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. This case was linked to MOD-2021-20769.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 10-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
I'm not 100% whether this started after my first or second shot, but my right shoulder joint feels like it somehow became broken.  It's not broken, but it hurts whenever I move my arm.  It's been a month since I got the first vaccine, and it still hurts, and my left arm, and sometimes my right arm feel a bit numb.  I have also had some weird pains in other places as well, but nothing as pronounced as my shoulder pain.
Side effect; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not reported.
Patient has red shallow up; hot at sigh of injection hot lower left arm. Dr treat w/ antibiotic and Prednisone.