chrisvoncsefalvay/vaers-outcomes huggingface dataset:
generalized body pain from head to toe; This spontaneous case was reported by a patient and describes the occurrence of PAIN (generalized body pain from head to toe) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Idiopathic intracranial hypertension.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (generalized body pain from head to toe). The patient was treated with TRAMADOL for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (generalized body pain from head to toe) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: 1/1280 and 141.     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.   The 2nd dose lot number was 032L20A and it was administered on 19-Feb-2021. The 3rd dose lot number was 058F21A and it was administered on 05-Nov-2021. No concomitant medication was reported. Patient's rheumatologist was working on her autoimmune problem. Her results were high for example her ANA was 1/1280 and her anti-centromere b was 141. She started having side effect 4 days after the first dose. She went to the doctor. They gave her medication and told her it may go away. After the second dose the pain never went away. The pain was there 24/7.
shots on 12/30/19, ER visit on 01/03/2020 due to coughing to the point of choking and snotty, 01/05/2020 started having seizures with high fever rushed by ems to hospital. Also since seizures has had a on and off again eye twitch mainly right eye.
Anaphylaxis post adm. of MMR vaccine. Wheezing, periorbital edema. Epinephrine, Benadryl, decadron IM, albuteral inhalations.
RUE erythema, edema, warmth.  Using Tylenol & cool compresses with good results - decreased sxs over weekend.
1 hour afterwards started having right leg pain, 1 day later became left leg pain. 2 days afterwards still walking with stiff left leg, though seems to be improving. Described legs as feeling numb, though normal sensation. Developed congestion after the vaccine as well. No swelling, redness, fevers.
HPV vaccine was given to patient who was too young. No adverse effects were reported as of 9/22/23 at 15:30.
Low grade temp 101.2 on 4-2-2021 elevate pulse and resp gave tylenol soreness of injectioion site right arm . Saturday 4 am didn;t sleep at all  continue with heart rate temp and pulse, 102.8 temp chills epeni given in left thigh tylenol given labor breathing rdness in face no hives. as of 7am 4-3-2021 symptoms same  temp 101.1 heart and resp rate lower.will continue to access vital signs and given tynleol if symptoms get worse will contact pcp. Sunday 4-4-2021 appear to feel better 100.8 heart rate 100 eyes red
A non-serious spontaneous report of Influenza Type A manifested by fever, cough and nasal congestion has been received from a consumer concerning her male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The medical history includes patient did not have any concurrent illness nor did she receive any other vaccines within 30 days of receiving FLUMIST. No concomitant medications have been reported for this patient. On 11-Sep-2010, the patient received FLUMIST. On an unknown date, the patient experienced fever, cough and nasal congestion and went to ER. He was tested positive for Influenza Type A. The event Influenza Type A manifested by fever, cough and nasal congestion resolved without treatment. Additional information was received on 25-Apr-2011 and incorporated into the narrative: The outcome of adverse event was resolved and medical history.
Sore throat, head ache on the 8/8/21.   8/10/21 lost taste and smell.  Difficulty breathing, fevers night sweats, fatigue, shortness of breathe. 8/14/21 numb/tingly arms. 8/17/22 chest pain.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographics details for each patient were provided. This report referred to an 11-year old male patient with polycystic kidney, who had no known drug allergy and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 25-FEB-2014 at 12:10 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not return call. No adverse event was reported for the patient. The outcome was reported as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Approximately 2 weeks after first Moderna injection, I experienced aching in my hips and knees...unsure if in joints or muscles or possibly both.   I increased the dosage of Aleve from 1 every other day to 2 every day.   Now 3 weeks after the 2nd Moderna shot,  the muscle or joint aches are still debilitating to my movements like standing or walking.
Injection site wheal, papule, urticaria - Information has been received from a registered nurse concerning a white 15 month old female with no known drug allergies who on 23 Mar 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vacine live second generation lot 637382/1509k.  on 23 mar 2001, the child was also vaccinated with streptococcus phenuomia vaccine prevnar lot 472-332 and diphtheria toxid (+) haemophilus b conjugate vaccine (+) pertussia vaccine (+) tetanus toxoid trihibit lot us554aa and u031411.  Within 10-15 minutes of receiving the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation in her left subcutaneous area over the deltoid, the child developed a large erythamatous plaque with a contral wheal that was distinct from the actual injection site.  She later developed a small hive on her vace and she had a few erythematous papules on her chest.  the child was given diphenydramine benadryl 3/4 tsp and ice.  She was observed for 30 -45 minutes in the clinic.  Her lungs were clear, she remained active, no further lesions immerged, she was instructed to repeat diphenhydramine dose every 6 hours while awake on 23 mar 2001 and then discontinue, she recovered from the events, no further details were provided.  The patient sister waes 01033066 had a similar experience.
Fever 102.2 lasting about 18 hours; Severe headache lasting about 24 hours; Nausea with vomiting lasting about 10 hours; Ringing in ears still occurring; Tiredness lasting 24 hours
A consumer report has been received. The report concerns a 14 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 10-Dec-2013. The patient experienced headache and sore throat which started on 10-Dec-2013. The outcome of the event of headache and sore throat is unknown. The report was considered to be non-serious.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.   They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions.  No treatment information was provided.
2:15 PM 1/28/10 Elementary called with c/o that child very hyperactive, had become weak and lethargic. Inst them to call 911 when breathing slowed. Pt taken to local ER. Spoke with someone 01/29/10 9:30 AM, she reported child's Potassium low. Given Potassium at hospital, she is fine now.
Muscle aches; Shivering; Pain at the injection site; Tired; Diarrhea; Headaches; muscle fatigue; aching; This case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, 2 days after receiving Shingrix, the patient experienced muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain were unknown.   It was unknown if the reporter considered the muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st shingrix vaccine 2 days ago, and pretty much had all of the side effects. The patient had severe muscle aches, shivering and pain at the injection site, headache muscle ache so severe. The patient was putting ice pack everywhere. On 26th September 2019, the patient feel tired and had diarrhea all day. Th patient bother getting the second vaccine 2 months. The patient stated that am young, very healthy, exercise regularly and take no medications for any underlying issues. The patient had no choice but to be in bed. The muscle fatigue and aching was pretty intense and patient took Motrin and Tylenol around the clock so would had any benefits at all in just having this vaccine or must had both.
Mother called and reported her child received vaccine at local health department around 3pm. Child had a little bit of fever after shot; was given Tylenol. Went to sleep and woke up at 9pm "staring in another world", hands shaking, fingers crippled, not responding to her asking if he was o.k. Took him to the ER fo tx. Child had seizure in past, mother state this was not like seizures had in the past. Child was also sweating a lot complained of stomach hurting in past, prior to receiving shot and had been to the ER.
The upper arm started to become red and blotchy around the site of the injection, then the reaction started spreading.  She took Benadryl, the redness continued to spread, warm to touch and appears to have streaks, although she has been scratching at it, it is painful moreso than itches.  Temperature was 98.0, does not feel feverish. Dr diagnosed an allergic reaction. Persisted for one week with swelling and numbness. She was prescribed prednisone.
Chills (no fever), myalgia, arthralgia, fatigue, malaise, headache, right arm soreness. No treatment given except rest. Lasted ~24 hours.
11/17/21: BODY ACHES, FEVER, NASAL CONGESTION, CHEST CONGESTION, COUGH, CHANGE IN TASTE, RUNNY NOSE, SINUS DRAINAGE
Severe tinnitus beginning 18 hours after the 2nd vaccine. The tinnitus has not subsided very much as of the date of this report. About 18 hours after the second shot I started getting a very severe headache. The absolute worst of my life and debilitating. I did not have a high fever, but had some chills and fatigue. No nausea. I expected the ringing to return to my "normal" levels pre-vaccine, which is a level that is not usually noticeable unless I focus on it. Now my ears are ringing loudly and the sound is ever present. I am worried this will be a chronic condition.
Sore in injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore in injection site) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3992HA91) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, COLCHICINE, MAGNESIUM, RHODIOLA ROSEA ROOT, THIAMINE HYDROCHLORIDE (RHODIOLA ROSEA [MAGNESIUM;RHODIOLA ROSEA ROOT;THIAMINE HYDROCHLORIDE]), SYNTOL and PROBIOTICS NOS for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore in injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore in injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products included kidney cleans, super enzyme for an unknown indication  Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
April 3-7 (days 10 thru 20 after vaccination) experienced nausea, vomiting, muscle aches, headache, malaise and fatigue.  Did not see MD. Missed 3 days of work.
I'm going over circles and circles; I'm getting a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I'm going over circles and circles; I'm getting a headache".   Additional information: Patient stated her 2nd dose was scheduled to the 01Apr2021 However she was unable to, so she now scheduled her 2nd dose for tomorrow on 08Apr2021. So she over now 21 days period. The patient was asking if it was ok because it was more than 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8 days into the shot (1/12) my left arm started feeling sensitive again, as it did when I got the injection. Two days later (1/14) I noticed three red spots surrounding the injection site ranging in size of 1/2 inch to 1.5 inches. My arm was tender to the touch, and the red spots joined on the second day (1/15) then slowly went away by 1/17. Since 1/12 I have felt tired.
Pt devel transient elevations of liver function tests following 1st dose of Hep B vax; elevated liver function tests recurred following 2nd & 3rd doses as well; No further details were provided;
Pt developed big red blotches on buttocks on D.O.S. at 7:30 pm. On 3/24/10 rash was gone from buttocks, but reappeared on legs at 3:00 pm.
(1) Pt. had a fever of 103.5 degrees the morning following day vaccines rec. Pt. self medicated with TYLENOL - fever resolved same day. (2) Redness & swelling x 3 days at PNEUMOVAX inj. site.
States she developed a vesicle type rash on 6-13-08 - saw M.D. on 6-16-08 NAD <20 areas. None at site of injection. Only other symptom was general malaise. Info given to me by nurse
pt recvd vax & was screaming spell x 15min; suddenly became limp & blue x approx 20 sec; pt as unresponsive & leg was very swollen;
Face started swelling and turning red and developed rash over abdomen. Took child to ER and was given steroids. Took child to her doctor the next day and symptoms were completely resolved.
tingle in arm; pain from her collar bone to the tip of her fingers; shoulder blade was painful and if felt like arthritis; sweat on her forehead; felt feverish; blood pressure was 135/90; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead) and PYREXIA (felt feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) for an unknown indication.   On 10-Feb-2021, the patient received first 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 an unknown date, the patient experienced PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead), PYREXIA (felt feverish) and BLOOD PRESSURE ABNORMAL (blood pressure was 135/90). At the time of the report, PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead), PYREXIA (felt feverish) and BLOOD PRESSURE ABNORMAL (blood pressure was 135/90) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 135/90 135/90  Patient states he blood pressure is usually low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used a heating pad to help alleviate the pain.
Patient received nasal vaccine during pregnancy.  11/23/09:  Prenatal records received for dates of service 9/28/09 to 11/10/09. Gravida 4, Para 2, LMP 8/10/09, EDC 5/11/10 was immunized with LAIV.
I developed several red inflamed spots on my right upper chest and back of my neck. The largest was about 2?x2? and looked a lot like pictures of shingles I have seen.  The most of the spots have diminished considerably, but the one on the back of my neck is still red. It was the last one to appear
Tingling/strong tingling in the arms, legs, and around mouth; Short breath; Fast heartbeat during midnight or early morning; it weakened her up; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 16:30 (Age at vaccination: 62-year-old) as single dose, for covid-19 immunization. Medical history included thyroid replace medicine from an unknown date and unknown if ongoing. Concomitant medication included ergocalciferol (VIT D), levothyroxine sodium (LEVOTHYROXINE SODIUM), calcium (CALCIUM) and unspecified medications all taken for an unspecified indication, start and stop date were not reported. and It was reported that a few minutes after the first dose she felt some tingling and the next day it was rather severe and it weakened her up, this never happened before, she went to ER and everything seemed okay. After the second dose, she developed muscle weakness and severe tingling, she is not sure if it is related to the vaccine, but she has felt this almost every other day, she was weak because of the tingling, it is limiting and has been there for some time, on the face. The tingling increased at night. She went again to ER the day before yesterday, the doctor found everything was normal except the potassium, which was at 3.4 (limit 3.5) and she thinks it may not be related. After that, she started taking potassium supply tablets but they did not help. Patient wanted to know how many days after the vaccine was the fatigue reported. Upon date 01Mar2021 it was reported that patent stated, Muscle weakness, muscle tingling on face and my arms, sometimes face, most of the time it was limbs. She want to get some advice on what is going on there. Also reported after the vaccination, she feel muscle weakness. Upon date 13Mar2021 it was reported that wake-up by strong tingling in the arms, legs, and around mouth with short breath and fast heartbeat during midnight or early morning, and the tingling last during the day. First event occurred the night after 1st dose; then after the 2nd dose, the episodes occurred almost every other day (sometimes, every day). Occasionally there was strong muscle ache in the arms and legs. She was still having those symptoms. She could not sleep for most of the nights due to these episodes. she can not live normally since the vaccination. Patient was not tested for covid post vaccination. Adverse event resulted in physician office visit or ER visit. Outcomes for the event was reported as not resolved.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238818 same reporter/patient/drug, different events/vaccine dose