chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm sore from 1:00pm on 2/27 until 8:00 on 3/2. Chills off and on from 12:10am - 8:00am on 2/28. On 2/28 felt tired and just lousy. No fever, not achy, no nausea or vomiting. Felt 100% better by 8-00pm same day.
Information has been received from a health professional concerning a female who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). This was a revaccination with pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included a dose of influenza virus vaccine (Unspecified). Subsequently the pt developed local redness, swelling, and pain. The pt went to the ER, but was not admitted to the hospital. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
lyophilized powder vial component reconstituted with sterile diluent; inappropriate dose of vaccine administration; Expired vaccine used; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA643A, expiry date 30th January 2022) for prophylaxis.   On 5th August 2022, the patient received Menveo. On 5th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and expired vaccine used. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and expired vaccine used were unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter comment: The nurse reported that a patient received the contents of the Mena lyophilized powder vial component reconstituted with sterile diluent. The reporter consented to follow up. Additional supportive information: The patient was administered with Menveo reconstituted with sterile diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administration. The patient was administered an expired dose of Menveo, which led to expired vaccine used.
PATIENT RECEIVED DOSE #2 SHINGRIX THE EVENING OF 6/17/20.  LATER THAT EVENING THE PATIENT REPORTED HAVING DINNER AND THEN FEELING SO TIRED THAT HE WENT TO SLEEP FOR 3 HOURS.  THE PATIENT DEVELOPED BODY ACHES IN THE MORNING (6/18) BUT STILL REPORTED TO WORK.  HIS TEMPERATURE WAS TAKEN AT WORK AND HE WAS AFEBRILE.   HE REPORTS SHOULDER SORENESS AND A TINGLING SENSATION IN HIS HANDS.  HE STATED THAT HE HAS HAD "STRANGE" REACTIONS TO VACCINES AND MEDICATIONS (IBUPROFEN) IN THE PAST.  PATIENT CONCERNED THAT THESE SYMPTOMS COULD BE COVID RELATED BUT DOES NOT REPORT ANY OTHER SYMPTOMS ASSOCIATE WITH COVID.  ON 6/18/20 AT 10:30 AM WHEN THE PATIENT CALLED THE PHARMACY TO REPORT THIS ADVERSE EVENT, HIS FATIGUE AND BODY ACHES HAD SIGNIFICANTLY SUBSIDED, BUT NOT COMPLETELY.  WILL FOLLOWUP WITH PATIENT VIA PHONE CALL TOMORROW 6/19/20.
chills, fever, shortness of breath, headache, vomiting, nausea, chest and rib pain when coughing, sweating
Severe chills for 2 hours; broke out into a fever; very tired for two days.
3/26 within minutes itching on the injection arm. took benadryl.  3/26 9 pm clammy,  joint pain, body aches.  3/27 fever and  hot and cold, joint pain, each joint swelled and stabbing feeling in each joint. Face swelling, hands and legs swelling severe fatigue.  Stayed home/ quarentined home by NYS for 14 days.  Swelling, joint pain, loss of smell 3/28 loss of taste 3/28 , fever , body aches.  went to allergist -   Dr office- in april 2020 not allergic reaction- covid blood test not positive no negative inconclusive. Never positive with nasal test or blood work.  When to PCP 4/24/2021  and still had face swelling joint pain, hand swelling, difficulty walking,  severe fatigue referral to ra md dr 5/27/2021 , +dry eyes and mouth has allergies,+raynauds symptoms developed recently
Covid19 breakthrough.  1st vaccine received on 03/25/2021.  65 y/o PMH HTN, COPD, Hepatitis C, Asthma, DM, Prostate CA presents to ED with hx of positive Covid test on 01/13/2022 and worsening symptoms of generalized weakness, fatigue, cough and fevers.  Pt had to increase home O2 usage from nighttime only to around the clock.  Upon arrival, O2 sats 80's, placed on 15L NRB/15L high flow.  CXR-multifocal airspace dz.  low grade temps. Treated with IV Steroids/ IV AbX and Tocilizumb.
Loss of function  in left arm. Initially unable to use my left arm in a functional manner. Compromised gym activities missed work and weight restricted.  Treatment by urgent care and Orthopedist along with physical therapy.
Redness and soreness around injection site, swelling, bruising to the elbow.  Patient is currently on Plavix.  Headache to the left side of the head by ear behind left eye.  Reaction lasted several days.
Experienced Aura. Was daily initially and tapered off over the course of a month. Then in January an Abdominal/Pelvic CT (dr ordered) and a Cerebral CTA (in ER) revealed the following: 3 x 2 mm medially-directed saccular aneurysm arising from the cavernous right internal carotid artery;1 cm left renal artery aneurysm; Right colonic submucosal fat sack; Tiny fat-containing umbilical and supraumbilical hernias
a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via consumer via phone via Medical Information number: 00775126.    This case is linked to cases 2021SA311330, 2021SA314182, 2021SA312255 and 2021SA312326 (same reporter).  This case involved 2 year-4-month-old female patient who was administered a 1 ml dose of IPV (VERO) [IPOL] vaccine (overdose).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 1ml total dose of suspect IPV (VERO) (lot: U1A452M and expiry date: 20-Feb-2023) frequency: once, strength: standard via unknown route in unknown administration site for prophylactic vaccination (overdose).  It was a case of actual medication error due to overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.
swelling @ site w/urticaria; seen by allergist who recommended desensitizing;
Vaccine about 5 PM 10-27-09. 10-27-09 Abdominal pains 8 PM. Fever 103 middle of the night. Fever continues tx with TYLENOL and ibuprofen.
about one hour after getting the shot, i had trouble breatheg, sharp pains in my chest and my heart was pounding. i could not move, ilive alone and thought i was going to die.about an hour went by and i was able to get up and i was stll laboring to breath still with sharp pains. luckily i woke up the next day. i contacted my doctors office to be seen to find out what went wrong and concerned about getting the second shot which would have been on 08/25/2021 i was denied an appointment by intake. they said discomfort was normal and to get the second shot. i caaled repeatedly trying to get an appointment to do a test or somthingbefore i got the second shot and kept getting denied. i even went to the doctors office without an appointment the day before i was supposed to get the second shot and was not allowed to talk to a nurse or my doctor, so i never got the second shot, i was able to talk to the manager but she offered no appointment and also recommended i just take the second shot. that doctor is no longer my doctor. i just found out that their is a way to report these affects.
pt developed dizziness immediately following vaccine administration. patient gently moved himself to the floor. Pt never lost consciousness, awake alert. BP 145/85 Pulse of 41. (patient is a runner and this is his baseline) No other symptoms. Pt recovered fully within 10 minutes and at 30 minutes was fine. (History of previous vaso-vagal reactions and he warned the vaccine administration staff before receiving injection.
ARM REACTIONS; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (ms). The patient experienced bad arm reactions when treated with influenza vaccine, and pneumococcal vaccine for prophylactic vaccination.  The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm reactions. The action taken with covid-19 vaccine was not applicable. The outcome of arm reactions was not reported. This report was non-serious.
covid vaccine breakthrough case  dose 1 Moderna 2/12/21  025J20A dose 2 Moderna 3/12/21  006M20A
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been received nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 25-OCT-2014. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A which started on 08-DEC-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning her currently 23 year old son with pertinent medical history or allergies who on 15-MAY-1992, at the age of 5 year old, was vaccinated intramuscularly with the first 0.25ml dose of RECOMBIVAX HB (lot# 602638/0310V). On 24-OCT-1992, the patient was vaccinated intramuscularly with the second 0.25ml dose of RECOMBIVAX HB (lot # 604946/1163V). On 24-FEB-1993, the patient was vaccinated intramuscularly with the third 0.25ml dose of RECOMBIVAX HB (lot # 606130/1517V). There was no concomitant medication. The physician mentioned that the patient had negative titers after received 3 dose series of RECOMBIVAX HB. On 19-MAY-2010, the patient was vaccinated intramuscularly with the fourth dose of RECOMBIVAX HB (lot # not reported) because of negative titer. The patient still had negative titers. Additional information has been requested. This is an amended report. The codes of negative titers were changed from antibody test negative to Anti-HBs antibody negative.
That evening I had a sore arm starting about 10PM - and then it was really sore the next day. The next day around 2:00 pm, I had chills with no fever; I had muscle and joint soreness and body aches; I started getting a headache; I was super tired. It was a low grade headache the rest of the day.  (I had to take a nap and rest - couldn't do my normal activities on the worst day of the symptoms.)  The day after that my arm was still sore; persistent headache behind my eyes only that lasted all day. The symptoms were gone. The day after that one then all of the symptoms were gone except for the sore arm (lasted in soreness a full day longer than first vaccine). My birthday is  on 24th  of - not on the fourth as listed on the report for vaccine dose 1 .
Chills, Pain all over the body, Palpitations, loss of appetite.insomnia. Today May 10, finally feeling better. Took Tylenol (1000 MG) as of Saturday night.
Hives.  First started with extremely itchy palms (both hands), spreading to forearms, then hives developed on trunk and backs of thighs.   Symptoms improved after taking benadryl, but returned about 5 hours later.
Mom noticed rash with lesions and fever of 103 deg. F. on 04/27/2002. Seen in clinic on 04/29/2002 with 98 vesicular lesions on lower lip, scalp, trunk and extremities. Diagnosed varicella. Plan to give Tylenol, Benadryl and Calamine. A follow up report received 5/30/2002 adds: Less than 100 lesions observed on child.
on the 2nd i had the shot in the left upper arm .. two days later i woke up to violently upchucking pure water after that i when to hospital and was admited i was told after a ekg that i was haveing a  heart attack after that  have no recolectiom of anything i wake up to a doc telling ,e it was a bad heart attack and  had delovped about 5 blod clots in left lung and microcaditis i have been trying since then for a doc to talk to me but so far i been avoided
experienced nausea / started the next day; chills /started the next day; drowsiness/ started the next day; sore arm / started the next day; dizziness that started the next day; accidentally received a third dose / on Friday 12/11/2020; This case was reported by a consumer and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 27th May 2022) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (1st dose received on 12th December 2019, reference case US2020AMR248211) and shingrix with an associated reaction of pain in extremity (2nd dose received on 11th February 2020, reference case US2020AMR248212).   On 11th December 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 11th December 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 12th December 2020, the patient experienced nausea, chills, drowsiness, pain in arm and dizziness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, chills, drowsiness, pain in arm and dizziness were recovering/resolving and the outcome of the extra dose administered was unknown.   The reporter considered the nausea, chills, drowsiness, pain in arm and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient accidentally received a third dose of Shingrix, which led to extra dose administered. The patient experienced nausea, chills, drowsiness, sore arm and dizziness that started the next day from vaccination.  The patient mentioned that all of these side effects were resolving at the time of reporting and she was started to feel better. The reporter asked if there are any special instructions since she did receive a third dose.  The reporter was provided with phone number to medical information and advised her to have her health care professional call for further information. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR248212:Same reporter US-GLAXOSMITHKLINE-US2020AMR248211:Same reporter
7 days after receiving vaccination pt broke out in a rash on abdomen-on 8th day rash worsened, got redder and spread all over trunk, down legs and up back neck. Pt acted like rash itched mom stated. Pt very fussy couldn't sleep and a decrease in appetite for 2 days was noted. Rash still 2/20/06.
During checkout after appt, patient leaned against the wall and slumped down, with approx 5-10 seconds of shaking. She was assisted to the floor, where she was unresponsive for approximately 1 minute. Upon regaining consciousness, she was tearful and rather quiet. She was allowed to rest on the floor an additional 2 minutes, then returned to the exam room, where she was observed for another 20 minutes, after which time she was alert and oriented, with stable vital signs, taking PO well.
Periodic dizzyness, unbalanced, easy exhaustion, sporadic high and low heart rate, easily short of breath, extremity weakness, near blackouts if I overexert of move quick, muscle aches, joint aches.  All symptoms have been experienced since the second vaccine.
4/21/09 Headache, itching, rash, chest discomfort, tongue swelling, difficulty breathing.  8/14/09 MR received from pcp for DOS 3/12/09. HPV#1 given 0229X.  8/24/09 ER records received DOS 4/21/09 - 4/22/09. Assessment: Cephalgia, hypertension. Presents with headache associated with photophobia, nausea. Anxiety. Hypertensive. Obese. Flushed.
syncope reaction, head drooped backwards, eyes rolls in back of head, arm and leg twitched
Patient given Hepatitis A #2 and HPV #3 on 3-28-08.  Patient had positive pregnancy test 4-7-08.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 19th July 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient thought he/she have fever after getting the Shingrix vaccine.
Large red knot with bruising and heat noted. Still watching at home low grade temp temp baby crying and c/o pain to site.
Adverse Events: Severe back pain, nausea, dizziness lasting about 2 days from onset.
Nine days after receiving the 1st MMR vaccination our daughter developed a fever (highest recorded was 101.3), had minor vomiting (4 episodes total), and a rash presented itself on her abdomen, back, neck, tempal area, and scalp.  The rash appears as small pinkish/reddish dots that are slightly raised.  Our daughter also started to itch her scalp.
The diluent used to mix the vaccine was "sterile water" instead of NaCl0.9%. The patient reported no injection site reaction or adverse event of any kind. Per Pfizer the patient does NOT to be revaccinated at this time as studies are ongoing.
This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a 12-year-old male patient who received MENVEO (batch number M16077, expiry date March 2018). On 12th January 2017, the patient received MENVEO .5 ml. On 12th January 2017, less than a day after receiving MENVEO, the patient experienced injection site pain and numbness. On an unknown date, the outcome of the injection site pain and numbness were unknown. It was unknown if the reporter considered the injection site pain and numbness to be related to MENVEO. Additional details were provided as follows: The patient received a dose of MENVEO in his left deltoid and experienced sharp pain at site. No other information was reported.
tired; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ATENOLOL for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient received Prevnar-13 on Thursday 15Apr2021
Facial rash which was hive like in appearance appeared in face in butterfly like pattern in 5-7 minutes after vaccine given. No resp symptoms, rash after observing 30 min.
This am 1/28/21 resident started with diarrhea. It has been about 60 hours since injection.
feeling a little under the weather with a sore throat and sinus issues.; feeling a little under the weather with a sore throat and sinus issues.; back pains; muscles were real tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Heart blockages" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: BACK PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "back pains"; MUSCLE TIGHTNESS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "muscles were real tight"; OROPHARYNGEAL PAIN (non-serious), SINUS DISORDER (non-serious), outcome "unknown" and all described as "feeling a little under the weather with a sore throat and sinus issues.". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: The female patient who received her 1st dose of the vaccine on 16Apr2021. During the 1st week after her shot, she experienced some back pains, feeling that her muscles were real tight. She cannot distinguish if this was really from the vaccine as she had conditions like diabetes and heart blockages. Because of this, she was on antidiabetic medications, blood-thinners, and anti-acid reflux medications. She mentioned that she felt better by the 2nd week. She was asking if she can take her 2nd dose of the vaccine today because she was feeling a little under the weather with a sore throat and sinus issues. She was gargled and took Tylenol last night and it made her feel a little better. She told that she was on cholesterol medication. She had back pains for about a week after the vaccine. Then it went away and she was just sore. She could not tell if it was the shot or just something she did. Her back was really sore. Her back ached. The back being sore and ached only lasted about 3-4 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I, as the patient, experienced mild to moderate pain at the site of the injection in my right arm.  I also had a low grade fever for a day or two ranging from 99.7 to 100.7 and some mild gastrointestinal discomfort, i.e., a bit of an upset stomach but not really bad nausea.  I took Pepto Bismol and also ate a bland diet for a couple of days.  To control the fever, I used Extra Strength Tylenol in the dose recommended on the label of the bottle of Tylenol.  These were mild, adverse symptoms commonly associated with this particular vaccine and all negative symptoms have now disappeared within two days of receiving the vaccine.  I am reporting this mild, adverse event in the interests of giving the Dept. of Health and Human Services more information about the various vaccines that are out there in the interests of assisting the federal government to assist the pharmaceutical companies and the medical profession to continue to monitor how various people react to these efforts to be proactive in avoiding disease while also creating better vaccines with fewer adverse reactions, either of a severe or even a mild nature.  Thank you for the opportunity to share this information which I hope, along with all of the other information you all are collecting thru this web site, can be used to benefit the general population.  Take care.
PT EXPERIENCED PAIN AT THE INJECTION SITE FOR SEVERAL HOURS FOLLOWING. THE MORNING AFTER, SHE NOTICED TWO LARGE RED, RAISED BRUISES NEAR THE SITE. 24 HOURS LATER THE AREAS WERE SWOLLEN AND CONTAINED BOILS. SHE VISITED THE ER, HER PCP AND A DERMATOLOGIST. SHE WAS GIVEN ANTIBIOTICS, A STEROID CREAM AND THE BOILS WERE LANCED ON 12/8/2021.
Swelling at injection site. As well as bruising applied pressure to area to stop bleeding then applied ice to area for over 20 minutes.