chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stress; swelling of the injection site; Redness and inflammation is growing (right) arm to elbow; Right arm to elbow is hot to the touch; Redness and inflammation is growing (right) arm to elbow; Itching of right arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (Redness and inflammation is growing (right) arm to elbow), VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), STRESS (Stress), INJECTION SITE SWELLING (swelling of the injection site) and ERYTHEMA (Redness and inflammation is growing (right) arm to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLAMMATION (Redness and inflammation is growing (right) arm to elbow) and PRURITUS (Itching of right arm). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), INJECTION SITE SWELLING (swelling of the injection site) and ERYTHEMA (Redness and inflammation is growing (right) arm to elbow). On an unknown date, the patient experienced STRESS (Stress). At the time of the report, INFLAMMATION (Redness and inflammation is growing (right) arm to elbow), VACCINATION SITE WARMTH (Right arm to elbow is hot to the touch), STRESS (Stress), INJECTION SITE SWELLING (swelling of the injection site), ERYTHEMA (Redness and inflammation is growing (right) arm to elbow) and PRURITUS (Itching of right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: No specific follow-up information recorded.
Fatigue; Very sore arm at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Very sore arm at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Very sore arm at the injection site). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Very sore arm at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2022-500058 (Patient Link).
After 2 days of the common AEs of painful arm, fatigue, low fever, I developed a painful tongue, which has been persisting.
Red, swollen, right outer thigh. (Localized). No fever accompanied. Hydroxyzine 10mg/5mL (3.5 mL every 6 hours). Prednisolone 15mg/5mL (10mL x 5 days).
Child crying and fussy non-stop since day after vaccination.  Date of vaccination 11-3-05.  Afebrile.  No redness or swelling at injection site.  No malaise.  Treated with Advil prn.
Bilateral axillary lymphadenopathy x 9 days, left cervical lymphadenopathy and left facial swelling x 3 days
just made me really tired; I had aches and pains afterwards for a day or two/whole body was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing); "real bad anxiety problems" (unspecified if ongoing); "panic attack" (unspecified if ongoing), notes: Patient is brought to the ER every time when having a bad panic attack. The patient's concomitant medications were not reported. Past drug history included: Xanax for PTSD, reaction(s): "did not have side effects"; Xanax for anxiety, reaction(s): "did not have side effects"; Chantix, reaction(s): "really vivid dreams about batman". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "just made me really tired"; PAIN (non-serious), outcome "recovered", described as "I had aches and pains afterwards for a day or two/whole body was sore ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme pain in arm, hard to breathe, heart was pounding - felt like a heart attack, weak.  Called daughter - EKG was done, dr exam in urgent care!  Could not lift arm for over week - took MOTRIN.
Headache, Myalgia, & Fever Narrative: dose 1: sore arm dose 2: 1/21 10 AM 1018 F. Severe headache, myalgias, RUQ abdominal discomfort. 1/22 Body aches low grade fever in AM;cough. No fever by 1400, took Ibuprofen at 6 AM. 1/23 soa;1/24/ha
pt completed Engerix-B series (12JUL90, 16AUG90, 25JAN91);titers tested w/in last month (?APR92) & were found to be neg;
This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox and shingles. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient received SHINGRIX vaccination 48 hours before the reporting date. Other than a very slight soreness at the injection site the patient had no side effects. All of the readings the patient had seen that most people have some nasty side effects. The patient asked that she was just lucky or her immune system was wonky. This case had been linked with case US2018GSK169316, reported by same reporter.
Patient tested positive for COVID after he completed the Pfizer vaccine series > 14 days prior to this
HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
No adverse event, patient was under the recommended age of 65 for receiving the HD fluzone vaccine.
Sore arm; headache; chills; low grade fever; fatigue; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL3247), on 11Feb2021 10:45 AM at Left arm, as single dose for covid-19 immunisation. The patient had received first dose on 0Jan2021. the patients' medical history included hypothyroidism and no known allergies were reported. The concomitant medications included Levoxyl. on 11Feb2021, 05:00 PM, the patient experienced Sore arm, headache, chills, low grade fever, fatigue. the patient was treated with Acetaminophen, ibuprofen (OTC). the outcome of event was Recovering.  No follow up attempts are possible. No further information is expected.
Came to HD and reports that today is day 11 after receiving her first dose of Moderna Covid 19 Vaccine and she states that the site of the injection which is the LD is red and hot to touch. Denies other symptoms.
I woke in the middle of the night with extreme, extreme,extreme vertigo with vomitting over the next three days. No other symptoms.  It has been off and on since the vaccine. On the 27th of December, I did a virtual visit with the UTC.
On 06Oct2021, had after the 2nd shot of the vaccine she got strep throat again which is not resolved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:30 (Lot number: 301358A) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose , Vaccine on 12Sep2021, lot 301308A, first shot of the vaccine she was getting strep throat), administration date: 12Sep2021, when the patient was 23 years old, for COVID-19 immunization, reaction(s): "strep throat". The following information was reported: PHARYNGITIS STREPTOCOCCAL (non-serious) with onset 06Oct2021, outcome "not recovered", described as "On 06Oct2021, had after the 2nd shot of the vaccine she got strep throat again which is not resolved". Therapeutic measures were taken as a result of pharyngitis streptococcal.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224489 similar report from same reporter
I first felt queezy, chills, and muscle restlessness while I was sleeping and it woke me up at 4:30 am.  I could not go back to sleep mostly due to my muscles in my legs being restless and constantly make me toss and turn.  After taking some night-time flu medicine I was able to fall back asleep.  By the afternoon on the day after the shot I had a fever of a 101 for over 24 hours.  Severe headache to the point of not being able to keep my eyes open.  Delirium from fever and chills  with other flu like symptoms such as severe fatigue and body aches. I was unable to stand and felt like my equilibrium was off. By the third day after my vaccine I was still tired but mostly felt hot with no fever and sweat uncontrollably.  It took  until Monday which was 5 days from my shot to feel like myself again.  Tylenol really did not help my headaches but would reduce my fever. Ibuprofen helped reduce my headaches on Friday but only by Saturday did they finally. subside.
my right arm had tingling effect feeling, I have to rub rub until it get away; was really wired I couldn't get the sleep; had a little fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot# EW0150), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "my right arm had tingling effect feeling, I have to rub rub until it get away"; INSOMNIA (non-serious), outcome "unknown", described as "was really wired I couldn't get the sleep"; FATIGUE (non-serious), outcome "unknown", described as "had a little fatigue". Therapeutic measures were taken as a result of paraesthesia, insomnia, fatigue.  Additional information: The patient put some oil on her arm; Just Tylenol. The patient tried to sleep but she didn't sleep because it was bothering her so much. No Investigation Assessment.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US018199 is an initial spontaneous report received from a nurse on 10 Sep 2014. This report refers to a 17 years old male patient. He had no known allergies to any vaccines and never had syncope with vaccines in the past. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 Sep 2014. It was reported that on the same day he experienced syncope for less than one minute after MENVEO administration. The nurse reported that he was not anxious and did not experience pain. When he woke up, his blood pressure and heart rate were within the normal limits. He was not cyanotic during the syncope and did not experience jerking movements. When he woke up he was grinning, very relaxed and not disoriented. He was not hospitalized, but the physician kept the patient lying on the table for some time before he was allowed to leave. The event outcome was reported as complete recovery on 04 Sep 2014. The seriousness and causality was not reported.
flu; Initial information was received on 06-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves a patient of (unknown demographics) who experienced flu (influenza) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (one week) following the administration of INFLUENZA VACCINE.  It was reported "Over 36 years ago I received a flu shot. One week later I got the flu. I haven't had another flu shot since then and have never had the flu since then either."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event (influenza).  On an unknown date, the patient recovered from the event (influenza).  There will be no information available on the batch number for this case.
After taking one dose of oral Typhoid within a few hours she complained of a severe headache. She took something for the headache, but it offered no relief. Instructed to stop taking it had symptom cleared. had taken the oral in 1999.
On December 23, 2022 I  tested positive for Covid-19.  I experienced a breakthrough cases and a VAERS employee telephoned me on December 27, 2022 and told me to report it on this website.   A nurse in my doctor's office prescribed Paxlovid and a prescription nasal spray which I used.  I am experiencing mild symptoms which largely ended after 48 hours.  Main symptom was a dry throat, particularly upon waking in morning.  On December 24, I experienced some brain fog.  My energy level improved after 48 hours.
Information has been received from a consumer concerning a 66 year old female who on 13-SEP-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) (Lot # 65820/0883U). There was no concomitant medication. On 01-OCT-2007 the patient developed a large edematous welt with a central blister at the injection site. One week later, on approximately 08 OCT 2007, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint; Additional information is not expected.
arm little sore and itching around her arm.; arm little sore and itching around her arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 77; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient mentioned that she received the second dose of the covid vaccine last Tuesday and got no symptoms, so she wanted to know if this is working. Later, on an unspecified date, the patient experienced arm little sore and itching around her arm. Patient wanted to know if she could take Benadryl for the itching around her arm. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Cranial and spinal SAH hematoma  at roughly same time as heart attack.  Cause of hematoma was unknown.  Potentially a side effect of elliquis; but her cardiologist does not believe ellipsis was the cause.  Heart attack at similar time due to blood clot and blocked artery and possibly reaction of body  to hematoma.   We do not have any hard data that either are related to the vaccine; but are reporting  them under the advice of a doctor to give information for science.
Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-250486 (Patient Link).
lethargy,nausea,abdominal cramps,headache,body aches,emesis,diarrhea.
pain, 4/10; Suspected vaccination failure; breakthrough herpes zoster, shingles; vesicular rash on buttocks; burning; itching; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml and the 1st dose of Shingrix .5 ml. In December 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced vesicular rash, burning sensation, pruritus and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the vesicular rash, burning sensation and pruritus were recovered/resolved.   The reporter considered the vaccination failure, shingles, vesicular rash, burning sensation, pruritus and pain to be unrelated to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported a case of breakthrough herpes zoster disease in December 2021 (exact date was unknown).  The patient completed the 2-dose series of Shingrix, received on left arm, when it first became available, in 2018 (exact dates unknown). The reporter stated that, herpes zoster was diagnosed based on visual presentation (not polymerase chain reaction- PCR) 3 days after symptom initiation. It presented as a vesicular rash on the buttocks 3x3 cm, other symptoms included burning and itching which resolved after 1 week. The vesicles crusted over after 2 weeks. The patient stated the pain was not painful, rated as a 4/10. No antivirals, no pain medicines were taken, and no further care was provided. The reporter described it as a very minor case of shingles. The reporter acknowledged the vaccine efficacy and attributed the episode as a breakthrough case brought on by other stresses occurring at the same time. The reporter did not think the herpes zoster episode was caused by Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow up.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.   Reporter did not allow further contact
Information has been received from a consumer concerning her 26 week old daughter with asthma who on 17MAR2004 was vaccinated with hepatitis B virus vaccine rHBsAg+Hib conj vaccine. Concomitant medication included budesonide. Subsequently, "later that same day", the patient developed "swelling, heat and small marking at the injection site." Medical attention was sought. The patient was treated with Tylenol and cold compress. It was reported hat "patient still exhibits small marking at the site of injection." The patient's other symptoms subsided within several weeks. No product quality complaint involved. It was also reported that the patient's sibling had a similar reaction (WAES0405USA01949). This is an amended report. The lot number has been added.  Additional information has been requested.
The patient is a 59 year(s) old Female. She was evaluated in the ED for abdominal pain of 3 days duration. The pain (started on the 11th day of vaccination) was acute in onset and was radiating to the back. Pain was worse with lying down and with movement. She denied nausea, vomiting, diarrhea, constipation, fever, chills, dysuria, or frequency. Abdominal Examination revealed epigastric and RUQ tenderness.    Treatment: famotidine Injectable, ketorolac Injectable, and sodium chloride 0.9% Bolus.   Outcome: Patient continues to have intermittent abdominal pain which is managed with oral NSAIDs as needed.