chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Fever, injection site pain, under left lymph node swelling, Told to follow up with primary care physician if further promblems  Narrative:
Night chills, weakness, runny nose, coughing, sneezing, body aches, no taste and smell and peeing on myself.  This started on Wednesday ( Dec. 21, 2022) through Tuesday(December 27, 2022).  I finally started tasting my food on January 3, 2023.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This is a spontaneous report from a contactable medical assistant and from a health care professional reporting on behalf of a physician  via a Pfizer  sales representative. A 17-year-old female patient of an unspecified ethnicity received 0.5 ml single dose of TRUMENBA, Batch/Lot # M37315, Exp date APR2017, intramuscular in Left Deltoid on 08MAR2016 at 3:51 PM. Medical history included headache, nausea and dizzy on off lately. Concomitant Drug includes: JUNEL for birth control and multivitamins. The patient had a bad local reaction on her arm, skin rash, described as itchy. It has been located on the left arm on 09MAR2016. The patient was visited on 10MAR2016. No fever, chills, sore throat, cough or difficulty breathing. No hoarseness, lump in throat or enlarged lymph nodes. All systems otherwise negative expect as recorded above. The rash was macular, urticarial and erythematous. There was warmth. Clinical diagnosis was Localized allergic reaction with skin rash secondary to intramuscular vaccine. The patient had no history of heart disease, lung disease, hypertension or hyperlipidemia. No history of neurological disease, GI disease or diabetes mellitus. Social history: Never smoker, No alcohol use or drug use. Rash and symptoms improved with BENADRYL 25 mg 2DF orally every 4 hours as needed for itching and recovered on an unknown date. The physician assessed the adverse reaction as related to TRUMENBA and commented as follows: The patient had the headache before the product was given. Follow up 11APR2016: New information from a contactable health care professional included vaccination date, onset date and event description, medical history and concomitant medications. Follow up 19-MAY-2016: Follow-up attempts are completed. No further information is expected.
Red scar at the site where the needle penetrated the skin. Around the area is discolored, it looks like a bruise. It appeared after (the same days as the) vaccine was administered.
6/18/02 immunizations given. 06/19/01 noted hives that am. 06/20/02 mother brought child to HD to see child and show where residual "hives" were scattered to lower legs bilaterally. Mother treated child with Benadryl as prescribed by pharmacist (06/19/02). Doctor notified of reaction pt advised that his clinic plans to start giving immunization by the end of the month (July). MD prefers next immunizations be given at MD office.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was vaccinated with a first dose of GARDASIL. Then on 09-DEC-2014, the patient was vaccinated with a second dose of GARDASIL (doses, route, lot # and expiration date were not provided). On 25-FEB-2015, the patient was vaccinated with a third dose of GARDASIL which was considered an inappropriate schedule of drug administration. No adverse symptoms reported. Additional information has been requested.
shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient (pt) of unknown age . There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. In or around 2016,the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving the zoster vaccine live (ZOSTAVAX) the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Further, as a tragic consequence of vaccination with zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling.
2x3cm indurated in area of inj;no drainage @ site of inj on 21OCT95;On 23OCT95-flat & not red
Information has been received from a nurse via a field representative referring to 2 unspecified patients. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (dose, route and application site were not reported). It was not specified whether this was the first or second dose of PROQUAD (Merck). The nurse reported that the patients presented with injection site reactions ten days after receiving PROQUAD (Merck) injections. The patients had cellulitis and hematoma at the injection site. The nurse had started to collect information with the lot numbers, but found no pattern with the adverse reactions. The lot number information was not provided as of the date of this report. No medical attention was sought. No treatment was given. The outcome of events was unknown. The causality was not reported. Additional information has been requested.
Rash on arms, legs, buttocks on this occasion and when readminstered 14 February 2011
Pt given VZV vaccine in Lt arm - 4 day later rash on arm c/w chicken pox. Mom knew that rash was possible side effect of vaccine.
1ST DOSE MODERNA VACCINE GIVEN TO 13 YEAR OLD MALE ON 8/3/2021.  NO NEGATIVE OUTCOME TO PATIENT AS PER GRANDMOTHER. NOTICED THE ERROR ON 8/17/2021 WHEN SUBMITTING VACCINE FORM. CALL PLACED TO GRANDMOTHER NOTIFIED AND SHE REPORTS THE CHILD IS FINE AND NO ISSUES AFTER THE VACCCINE.  SHE REPORTED THAT HER GRANDSON'S FRIENDS ALSO RECEIVED THIS VACCINE AT ANOTHER CLINIC AND THERE WAS HER PREFERRED VACCINE.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored ROTATEQ lot # L035508 with expiry date: 12-JUL-2017, M019691 with Expiry date: 02-NOV-2017 and M014318 with Expiry date: 30-SEP-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Facial and body spasm. Patient was having facial spasms 3x in a row and about 1 hr apart on Sunday. Monday still having them. Tuesday 1x about every 4 hours. Wed same. Thursday same.
the first dose of Shingrix back on 9/25/2019 and the second dose on 9/14/2023 and the physician recommended a third dose to this patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number FY793, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th Sep 2019).   On 14-SEP-2023, the patient received the 2nd dose of Shingrix. On 14-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the first dose of Shingrix back on 9/25/2019 and the second dose on 9/14/2023 and the physician recommended a third dose to this patient.).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date 27 Sep 2023 A pharmacist mentioned that a patient received the first dose of Shingrix back on 25th September 2019 and the second dose on 14th September 2019  and the physician recommended a third dose to this patient. The pharmacist asked if the patient needed a third dose or needed to restart the series. The patient received 2nd dose late than recommended interval which led to lengthening of vaccination schedule.
At 4 o?clock the day of my shot I became extremely exhausted. I have been through chemo and it was that type of exhaustion.  Then the headache and nausea started. I woke up Saturday morning running a low-grade fever, by lunch it was 102.7.   Around that time diarrhea started.  Friday night until 915 Sunday morning, I would be awake for an hour and a half or two hours, then sleep for the same around the clock.   I had every symptom on the nonemergency list except for injection site problems and vomiting.   The fever broke Sunday afternoon, but I still felt terrible. I barely made it through work on Monday. I started feeling a little better throughout the week. But a week later I still have nausea and diarrhea no matter what I eat.  Also still more tired than usual.    I had Covid back in November, and I heard that the vaccine side effects could be worse, but I sure wasn?t expecting all of this!
My mentral cycle is 8 days late as of today. My cycle is regular and this is a new occurance.
Migraine headache shortly after vaccine administration. D5 after vaccine recurrent migraine. D10 got menstruakl cramping and onset of menses than continued through D13. In addition have had night sweats , headaches, mild cramping and bloating during, and since menstruating. Prior to this experience, my last menses was in December 2020 when I stopped taking the birth control pill. It took about a month after stopping the pill that my migraines (used to get them 3-4x/mo) and night sweats (that mostly occurred during menses) stopped so this experience has been concerning and disconcerting. It feels like this vaccine negatively affected my hormones.
Sore arm 2-3 days.  Day after 1st vaccine tight in middle and to left side of chest.  Brief racing heart feeling (maybe couple of times).
Sore throat, Headache, Malaise, Submadibular and Anterior Cervical Lymphadenopathy, body aches, increasing temperature. Took motrin. by 3AM on the 10th temp was 100.6 F oral, remained above 99 F oral until 11 Nov; recieved solumedrol shot at 6:15 pm 11 Nov at MC along with oral prednisone, tessalon, mucinex D, 1:1:1 benydryl/malox/lidocaine mouthwash and codiene for "viral URI" because lymphadenopathy became so bad that swallowing liquids was very difficult.  I have a similar "viral" infection every year that I get a flu vaccine. Symptoms ongoing.
feeling Achy; Nausea; Vomiting; feeling Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 30th November 2020) for prophylaxis.   On 5th November 2019 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, 16 hrs after receiving Shingrix, the patient experienced pain, nausea, vomiting and tiredness. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ondansetron (Zofran). On 6th November 2019, the outcome of the vomiting was recovering/resolving. On 8th November 2019, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the nausea and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the pain, nausea, vomiting and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and on 6th November 2019 at 8 AM feeling tired, achy, nauseous and then vomiting every hour until 1 pm.  The caller reported that going to emergency room for intravenous (IV) fluids and antinausea medicine. The caller reported feeling better, nausea no longer severe and only taking Zofran once. The caller reported no vomiting. At the time of reporting the patient wakes up in the middle of the night feeling mildly nauseous and a little tired. The caller reports not feeling achy. Emergency room visit required. The caller declined to provide full name and phone number due to uncertainty of protected information.If she receives a HIPAA letter via mail rather than me providing verbal HIPAA consent she may provide full name and phone number.  The reporter agreed to provide address for follow up letter.  The reporter did not consent to health care professional to follow up. The patient was considering not receiving 2nd dose due to wretched side effects.
coughing up thick brown/reddish phlegm; everything tasted like salt; not well; Headache; Arm really sore; Metallic Taste in Mouth; Lost appetite; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm) and DYSGEUSIA (everything tasted like salt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), MALAISE (not well) and HEADACHE (Headache). On 19-Jan-2021, the patient experienced PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm) and DYSGEUSIA (everything tasted like salt). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qd and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Arm really sore), DYSGEUSIA (Metallic Taste in Mouth), DECREASED APPETITE (Lost appetite), PRODUCTIVE COUGH (coughing up thick brown/reddish phlegm), DYSGEUSIA (everything tasted like salt), MALAISE (not well) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Fallow up received and treatment medication Zithromax and new events were added On 05-Aug-2021: Follow up  received and reporter address were updated.
significant rash to bodies worse in arms and feet swelling to site significant headache fatigue -general malaise
Pt. given DTAP on 8/3/10 to (L) thigh. Pts mom noticed the same evening, leg was red, swollen. She called advise line they instructed mom to apply ice & giveTYLENOL for fever/pain. Mom called office 8/5/10 stating (L) leg more swollen/hard/hot to touch & with vesicular rash.
Mother called reported redness and swelling (L) arm back of (L) arm from armpit to elbow large amt of swelling and redness with hard nodule at varicella injection site to (L) posterior arm.
Received 3 injections - experienced fever, chills, dizziness that night. Also very red, hot (R) arm requiring dr's visit on 9/16 though no treatment rendered. Dx "toxic" reaction to shots. Painful to touch, hard to move arm in general. Redness spread from baseball sized 9/15 - patchy redness all over 9/16. Dr took pictures of arm.
what he has experienced just gives a pause to whether or not he wants to continue with the vaccination; experienced flu, body hurt, fatigue and felt foggy/flu like symptoms; experienced flu, body hurt, fatigue and felt foggy/flu like symptoms; experienced flu, body hurt, fatigue and felt foggy; experienced flu, body hurt, fatigue and felt foggy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient in his 60's received bnt162b2 (BNT162B2), administration date 23Apr2021 (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: INFLUENZA (non-serious), PAIN (non-serious) all with onset 03May2021, outcome "unknown" and all described as "experienced flu, body hurt, fatigue and felt foggy/flu like symptoms"; FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 03May2021, outcome "unknown" and all described as "experienced flu, body hurt, fatigue and felt foggy"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "what he has experienced just gives a pause to whether or not he wants to continue with the vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated her husband on 23Apr2021, a Friday, got his fist dose of the Pfizer COVID vaccine. He had no reactions or symptoms, everything was fine and he was feeling fine. Then oddly enough, they didn't think about it at first but a little over a week later on 03May2021, Monday, he started getting flu like symptoms. They have been pretty diligent for the last year with social distancing, they have taken care of themselves, they wear their masks, they have been very vigilant and have been very healthy and they continued to practice these same things even though they had their first dose of the COVID vaccine. They are never sick from work but when her husband had flu like symptoms he had stayed out of work because he felt like he had the flu. But to make a long story short her husband went to the doctor and he got a COVID test and the doctor said that her husband didn't have COVID. Reporter stated the 2nd dose will be on 14May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Enlargement of lymph nodes on both sides / in his chest also; Lymph nodes turned fire red; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 56-year-old patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis.   On 19th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and localized erythema. On an unknown date, the outcome of the enlargement of lymph nodes and localized erythema were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm intramuscularly and approximately seven days after experienced an enlargement of lymph nodes on both sides and lymph nodes turned fire red.  Also the patient experienced swollen lymph node in his chest. The reaction got subsided after about a week. The reporter consented permission to follow up with health care professional.
Patient complained of lightheadedness, taken to medical privacy room was offered small snack and bottle of water. Patient and RN conversed for 15 minutes before patient complained of nausea and began to vomit. Patient vomited 2 more times and was assessed by pharmacist.  RN and RP discussed with patient plan to go to ED for antiemetic and patient declined. Patient requested to laydown for a few minutes to see if she would feel better.  After 15 minutes patient stated she felt better but upon rising patient became nauseous and began vomiting. RN suggested patient go to ED and patient agreed. No medical treatments were given. Patient was taken to ED and seen by provider.  Patient declined to be fully evaluated and was released from ED. Patient was stable upon dismissal from ED and was able to drive home.
HEADACHE; HIGH BODY TEMPERATURE; CHILLS; This spontaneous report received from a consumer concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included undergoing cancer treatment, controlled hypertension, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 12-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced high body temperature. On 12-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 103 (unit unspecified), around 101.8 (unit unspecified). On 13-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-MAR-2021, and had not recovered from high body temperature, and headache. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Fever and chills, debilitating headache, weakness and muscle aches, joint pain, nausea, and fatigue. Local swelling and pain at injection site.  Also felt unusually anxious, though unsure if that was directly due to the vaccine or to the inability to sleep for a number of days because of the feverish chills. Acute symptoms lasted for 48 hours, and prohibited me from being able to work from home.   I still have what feels like a lingering sinus headache (with no actual sinus symptoms) as well as some fatigue. Lingering headache is not debilitating, but it is irritating. Feels a bit like a sensation of pressure in my forehead.
Worsening shortness of breath since the vaccination; collapsed in bathroom on day 10 post-vaccination