chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received shot around 10:00 am. Around 1:45 pm woke up from nap screaming. Couldn't be comforted. Administered Pedia Care Acetaminophen for pain. Didn't work. Had golf ball sized knot where the injection was administered. Purple circle are site about an inch in diameter. Red patch, hot to the touch, about 4 inches in diameter.
left breast so sore; pain; she had in left arm and they were so so sore; left arm and left side of her body are so sore; the lymph nodes went crazy and they were so so sore; It's really really really tender/it sure hurt; Under the armpit it was almost as big as a golf ball,it sure hurt,now it's the size of a marble; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (left breast so sore), PAIN (pain), VACCINATION SITE PAIN (she had in left arm and they were so so sore), MYALGIA (left arm and left side of her body are so sore) and LYMPHADENOPATHY (the lymph nodes went crazy and they were so so sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M202 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included FUROSEMIDE (LASIX M) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (left breast so sore), PAIN (pain), VACCINATION SITE PAIN (she had in left arm and they were so so sore), MYALGIA (left arm and left side of her body are so sore), LYMPHADENOPATHY (the lymph nodes went crazy and they were so so sore), LYMPH NODE PAIN (It's really really really tender/it sure hurt) and LYMPHADENOPATHY (Under the armpit it was almost as big as a golf ball,it sure hurt,now it's the size of a marble). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BREAST PAIN (left breast so sore), PAIN (pain), VACCINATION SITE PAIN (she had in left arm and they were so so sore), MYALGIA (left arm and left side of her body are so sore), LYMPHADENOPATHY (the lymph nodes went crazy and they were so so sore), LYMPH NODE PAIN (It's really really really tender/it sure hurt) and LYMPHADENOPATHY (Under the armpit it was almost as big as a golf ball,it sure hurt,now it's the size of a marble) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also include blood pressure medication and diabetic. Patient had mammogram and an ultrasound (Results not provided.)and it brought back the pain and everything. They thought she had a cyst under her breast but it was her lymph node. Cancer doctor told her to not wear a bra.   This case was linked to MOD-2021-022641 (Patient Link).
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 1172 hours with the highest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the second time was 88 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the third time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the fourth time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Pt developed rash on both arms. Feels warm but not sure if feverish. Took BENADEYL and feel better.
Racing heart  Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8 times over 3 days
sz episodes 13JAN94 consisted 10 to 15 mins episode of arching back & was unresponsive; tonic during this but no clonus; good color throughout the epidose rt temp was 100; no prior hx of any sz activity;
Pt. states (5 to 6weeks pregnant/no prenatal) 06/28/2021 received 1st Moderna shot after 30mins  wait, vision bouncy/blurry, BP 160/80,  nauseous, disorientation.  Informed to file a report by employer.
Pt was reported to have flushing of face without rash. Patient c/o generalized itchiness which has improved. Vital signs 144/88 HR 79, Sat 100% RA.
men that received moderna began to lactate; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GALACTORRHOEA (men that received moderna began to lactate) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GALACTORRHOEA (men that received moderna began to lactate). At the time of the report, GALACTORRHOEA (men that received moderna began to lactate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided by the reporter.
pt reports thick feeling and tongue itching about 15 minutes after injections.  Benadryl 50 mg given.
This is a spontaneous report from a contactable nurse reporting on behalf of her daughter, received via a sales representative. A female patient of unspecified age (reported only as 19) received TRUMENBA on an unknown date, at single dose, for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness, irritation and she did not feel good and said it was the ''worse shot she ever received''. Events outcome was unknown.
Numbness of hands and limbs; tickling sensation on head. Alterations in menstrual cycle and profuse bleeding; cramping (not previously presented).
This spontaneous report as received from a healthcare worker/certified medical assistant refers to 3 patients of unknown demographics. The patients were vaccinated with improperly stored VAQTA (lot # L023232, expiry date: 25-FEB-2017) that was exposed to the following conditions: Temperature of 47.3f for 1 hour and 24 minutes. There was no previous temperature excursion. The temperature excursion was because of a data logger. It was confirmed that the improperly stored vaccines was administered to the patients. No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Experienced "covid arm."  Area around the injection site approximately 4 inches long by 3 inches high became red, warm, very itchy, and slightly swollen about 8-10 days post injection.  It remained remained that way for about 10-14 days until reactions resolved.
17NOV95 3cm area of erythema in the rt lateral knee area/side;it has some raised papules scattered throughout it which area approx 2mm in diameter
The first abnormal effect I experienced was numbness in my inner upper lip. This was intermittent and lasted roughly 24-48 hours after vaccine administration. Then on 3/25, I had muscle cramping/soreness in my lower leg muscles (calves). The next day (3/26), the muscle soreness continued, and my lower leg muscles began to feel tight when walking. On 3/27, I woke up with numbness and tingling in my right 5th digit, which then spread to all my fingers and toes.  That morning, the muscle soreness had also spread into my thighs and bilateral upper extremities. I also noted mild swelling in my hands and feet and could not put my rings on or wear socks or shoes. By that evening, walking became more difficult as the muscle soreness had now turned into muscle weakness. This prompted me to go the ER for evaluation. A CT scan of my head and lab work was done. I was given IV fluids and sent home with instructions to return to the ER the following day for a MRI of my brain. Overnight, the weakness and swelling in my hands and feet progressed . I became unable to walk, go to the bathroom, or feed my self without assistance. The numbness and tingling I first experienced in my inner upper lip returned, and these symptoms were also now noted in the rest of my face as well. I also began having muscle soreness in my neck, my jaw felt sore when chewing food, and I began seeing some floaters. I returned to the ER the morning of 3/28.  They did more blood work, imaging, as well as a lumbar puncture, and I was admitted to hospital. Once admitted, the hospitalist consulted with another hospital and recommended transfer by EMS there where I was admitted under a neurologist's care. When I arrived at that hospital, I began to feel somewhat better as the soreness and swelling appeared to be improving, and I could walk without assistance. They did a full neurological workup and kept me overnight for observation. Overnight, I did experience a mild headache that was relieved with Tylenol and rest.  I woke up the next morning  (3/29) with nausea and did have a few episodes of vomiting that turned into dry heaving and was given Zofran with relief. The swelling in my hand went down enough that I was able to make a fist and grasp objects with my fingers again. After the neurologist reviewed my labs and work up the morning of 3/29, I was allowed to return home to await final test results as all my tests were looking normal, my symptoms were continuing to improve, and PT had cleared me to be able to return home. Upon discharge, I was instructed  to not get my 2nd COVID vaccination as it was possible that my symptoms were an adverse reaction to the COVID vaccination as no  other diagnosis was found with testing. I was instructed to follow up with my PCP in one week. Since returning home, I have continued to be very easily fatigued and have had some headaches, nausea, and dizziness. I continue to feel weak when walking and have some muscle stiffness when first waking from sleep. I also continue to have some intermittent episodes of numbness and tingling.
Onset of symptoms 7/15/08 of severe intense headache, N/V, fatigue, lump in Lt axilla-tender to touch and swollen afebrile. Treated with IBUPROFEN and ice pack to site.
Second dose scheduled beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled beyond 42 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled beyond 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled beyond 42 days) 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 medications were not  mentioned. Treatment medications were not mentioned
10 ' after vaccine, developed roof mouth tingling , dizziness , tachycardia and Left arm tingling .
2/17/21 9:00 pm - Mild sore arm 2/18/21 2:35 am - Very sore arm, no fever, fatigue, feel badly. Took 2 Tylenol 2/18/21 5:10 am - Very sore arm, 99.7 fever,  fatigue, feel badly 2/18/21 6:40 am - Very sore arm, 100.8 fever,  fatigue, feel badly 2/18/21 8:35 am - Very sore arm, 99.1 fever, fatigue, feel badly, bedridden. Took 2 Tylenol 2/18/21 12:30 pm - Sore arm, 100.2 fever, fatigue, feel badly, bedridden. 2/18/21 4:15 pm - Sore arm, 101.2 fever, fatigue, feel badly, bedridden. Took 2 Tylenol. 2/18/21 10:20 pm - Sore arm, 99.6 fever, fatigue, feel badly, bedridden. Took 2 Tylenol. 2/19/21 7:40 am - Sore arm, no fever, some fatigue 2/19/21 2:15 pm - Sore arm, 100.2 fever (again!), fatigue, back to bed. Took 2 Tylenol. 2/20/21 8:00 am - Sore arm. Found 3" diameter red spot on my right arm just below injection site. First noticed today. No fever, no fatigue.
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from contactable consumer.  This consumer reported for 37 patients. This report is for 30th patient of 37 patients.  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unknown route, on 15Jan2021 (Lot number EL3249) at single dose and the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unknown route, on 05Feb2021 (Lot number EN5318) at single dose, for COVID-19 immunisation. Relevant medical history included ongoing asthma. No relevant concomitant medications were provided. Patient's body mass index (BMI) is 44.6. The patient tested positive for COVID virus, after being fully vaccinated. The clinical course reported as follows, the reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the lot # or expiration date, however was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Caller reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller stated, reclarified later in report, she has 37 patients with partial identifiers. Caller stated she cannot provide some identifying details and that she would need to check with her legal department first. Caller provides the details she was allowed to identify. Caller stated unknown or could not provide to other questions. On 06Aug2021, antigen Covid test was done and resulted positive. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
pt rec'd grey cap pfizer vaccine after it was stored in freezer for 22 days- pt doesnt not want replacement dose
Upper arm down to the elbow was red; Upper arm down to the elbow was red,hot rash; Upper arm down to the elbow was red,hot rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper arm down to the elbow was red,), BURNING SENSATION (Upper arm down to the elbow was red,hot) and RASH (Upper arm down to the elbow was red,hot rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Osteopenia and Colon cancer stage II. Concurrent medical conditions included Hiatal hernia, Hypothyroidism, Blood pressure high, Triglycerides high and Heartburn.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA (upper arm down to the elbow was red,), BURNING SENSATION (Upper arm down to the elbow was red,hot) and RASH (Upper arm down to the elbow was red,hot rash). At the time of the report, ERYTHEMA (upper arm down to the elbow was red,), BURNING SENSATION (Upper arm down to the elbow was red,hot) and RASH (Upper arm down to the elbow was red,hot rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Sore throat. Stiffness of muscles: 8 out of 10 level of pain that lasted four days. Pain only occurred when moved: if kept still no pain. Pain was like every muscle had been ripped or pulled. Which muscles had extreme pain: legs, stomach, back, arms. Extreme pain finally subsided 10/01/2009, replaced with weakness in arms, struggle to write and lift objects, and constant fatigue. Went to the doctors on 09/28/2009 and reported extreme pain: tested for N1H1: results reported negative on 09/29/2009. I believe that this has been an allergic reaction to the flu shot.
Patient said that at the time the vaccines were given, he felt fine. The next day he felt terrible his arms and neck hurt and he had a low blood pressure of 93/50 and went to the ER. He did not have any follow up and fell fine now.
pt recv vax & exp unspecified reaction;it was reported that pt had been sent to an allergist;
Arm painful at time of injection due to increased physical activity. Within 3 days other arm pain left arm resolved. Right arm continued to get worse. The pain at onset then started causing problem with joint (elbow). Unable to straighten at times. Has weakness, tingling in fingers of right hand at times.
Patient fainted and fell on the floor, as soon as he left  the room to wait in the observation area for 15 minutes. He was conscious and oriented, We called 911, they took care of him and got him out of the store. He didn't go to the hospital, and said that he felt much better as soon as they gave him water.
RECEIVED FLU SHOT ON 10/9/08 AND WOKE UP WITH LEFT ARM SWOLLEN AND RED 2 DAYS LATER. REDNESS EXTENDED DOWN TO THE ELBOW, ITCHING. NO PAIN WITH TOUCH. ADVISED ICE PACKS AND BENADRYL.
Left deltoid 5 1/2 cm wide to 4 1/2 cm long red, raised knot.  Itching.  Mom described 0 pain.  (Warm to touch).  Mom informed to apply warm compresses.
Patient received an expired dose of daptacel, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who received an expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5307AAand expiry date: 23-Oct-2019) from  on 04-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HIB VACCINE (HIB) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  Patient and family waited a 15-minute post vaccination observation period, and the family reported no adverse events as of that time.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Hallucinations, Headache, Myalgia, Arthralgia & Fever Narrative:
22 hours after after vaccine was given- child felt dizzy and said heart was fluttering. She also experienced flu like symptoms: aching bones, tired, sleepiness, lack of appetite, raised red (warm) patch size of baseball at site of injection.
Severe chest pain for 2 hours. (If I hadn't gotten the vaccine the day before, I would have thought I was having a heart attack.)  Also had fever, chills, abdominal pain and vomiting, muscle aches and low energy level.  Lasted 2 days.
A spontaneous report has been received from a Health Professional concerning a patient of unknown age and gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started during Oct-2014. Patient received FLUMIST quadrivalent after vaccine taken outdoors on excursions, exposed to a wide range of temperature change during Oct-2014. The outcome of the event of 5 patients received FLUMIST quadrivalent after vaccine taken outdoors on excursions, exposed to a wide range of temperature change is unknown. The report was considered to be non-serious by the company physician.
injection site pain; low grade fever; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included evolocumab.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain), low grade fever (Verbatim: low grade fever) and general body pain (Verbatim: body aches). The outcome of the injection site pain, low grade fever and general body pain were resolved (duration 5 days).   It was unknown if the reporter considered the injection site pain, low grade fever and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, low grade fever and general body pain to be related to Shingrix.   Additional Information: GSK receipt date 28 Jun 2023 The reporter was the patient.   The patient stated she had her first dose of Shingrix two years ago (incomplete series) and she had body aches, injection site pain, and low grade fever that lasted 5 days.  Due to her adverse reactions she did not know if she would have the 2nd dose of Shingrix. The reporter consented to follow up.
tiredness; joint ache; muscle ache; headache; Pain; hair ache / scalp hurts; Stiffness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy.   On 12th March 2019, the patient received the 1st dose of Shingrix. On 13th March 2019, 1 days after receiving Shingrix, the patient experienced tiredness, joint pain, muscle pain, headache, ear pain, scalp pain and stiff joint. The patient was treated with paracetamol (Tylenol). On 15th March 2019, the outcome of the tiredness, joint pain, muscle pain, headache, ear pain, scalp pain and stiff joint were recovered/resolved.   It was unknown if the reporter considered the tiredness, joint pain, muscle pain, headache, ear pain, scalp pain and stiff joint to be related to Shingrix.  Additional information received were as follows: The patient received 1st dose of Shingrix on left arm. The day after vaccination, the patient experienced tiredness, joint pain with stiffness and soreness muscle ache, headache, hair ache, ear hurts, and scalp hurts which resolved after 2 days. For tolerance to 2nd dose of Shingrix, refer linked case US2019AMR140172.