chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 2JAN96 1030MA & 15mins later pt c/o flushing, palpitations & anxiety;also has pruritic hives;no facial edema or edema to throat or mouth;no wheeze; saw MD in ER who gave DPH;by 11AM sxs no longer present x/hives
pain at the injection site; it bothers me from time to time; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2021, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and emotional distress. On an unknown date, the outcome of the injection site pain and emotional distress were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and emotional distress to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported, however it could be 66 or 67 years. The patient received shingles shot 10 days ago from the reporting date and he/she was still getting a pain at the injection site. The reporter mentioned that nothing was  too bad, but it bothers him/her from time to time and asked if he/she should be concerned. The follow-up would not possible as no contact details were available.
I was 8 Weeks Pregnant when I went to the Doctor and they suggested that I get the H1N1 Shot to protect my baby I thought everything was fine a couples of weeks later I started to spot bleed followed by heavy bleeding Iwent to the hospital to find out that I had lost my child I was so angry I thought something was wrong with me I truly believe that this shot was the cause of me losing my baby..I never had any problems before this would have been my third child some one please help us this shot is dangerous...
c/o uncontrollable screaming x 4 hrs p/shots given 7JUL93;
it occurred with four different patients, they received 0.3ML of the vaccine undiluted; it occurred with four different patients, they received 0.3ML of the vaccine undiluted; This is a spontaneous report received from a contactable other hcp or pharmacist reporting same event(s) under the same suspect product(s) for 4 patients. A 88-years-old patient of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Aug2021 (at the age of 88 years old) as Dose 1, 0.3 ML Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced it occurred with four different patients, they received 0.3ml of the vaccine undiluted on 27Aug2021. Reporter wanted to call to get information on whether the patient needs to be re-vaccinated or not.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101136408 same reporter/ vaccine/ AE, different patients;US-PFIZER INC-202101136407 Same reporter/ vaccine/ AE, different patients;US-PFIZER INC-202101136409 same reporter/ vaccine/ AE, different patients;US-PFIZER INC-202101169375 Pfizer
Severe, prolonged systemic reaction:  1st dose of vaccine: 2 days later, had low grade fever, malaise, nausea (for 2 days).  Second dose:  2 days post vaccine, had fever >100F, malaise, night sweats, LH, dizziness, nausea.  This lasted almost 2 weeks.  Did not get any subsequent anthrax.  Did NOT have rash, hives, SOB, joint pains.
TINGLING IN ARM; SORENESS IN THE ARM; MUSCLE SORENESS; This spontaneous report received from a patient concerned a 47 year old male. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced tingling in arm. On 11-APR-2021, the subject experienced soreness in the arm. On 11-APR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in the arm, tingling in arm and muscle soreness was not reported. This report was non-serious.
Patient was administered influenza vaccine during an off-site flu clinic. Patient had complaints of itching at site of injection, itching of lips, slight dizziness and mild chest discomfort. Administered BENADRYL 25mg 1 tab PO.
CLIENT SAID SHE WAS FEELING NAUSOUS AND LIGHTHEADED AT 5:25PM, SHE LAID FLAT ON A MAT. SHE SAID IT HELPED HER A LITTLE. AT ABOUT 6:00PM SHE ASKED FOR A SIP OF WATER BECAUSE HER THROAT WAS HURTING. THE CLIENT WAS ASKED IF SHE HAD TROUBLE BREATHING SHE SAID JUST A LITTLE. HER VITALS WERE NORMAL, 20 MINUTES LATER THERE WAS NO CHANGE. SHE SAID IT WAS ABOUT THE SAME. CLIENT HAD ITCHING OF HER MOUTH IT WAS DECIDED SHE GO TO EMERGENCY. THE MOTHER DECIDED TO TAKE HER TO THE HOSPITAL NO MEDICINE WAS GIVEN. THE NEXT DAY THE CLIENTS MOTHER CALLED AND SPOKE WITH THE MANAGER OF THE CLINIC AND STATED THAT CLIENT WAS GIVEN SOME MEDICATION BY THE EMERGENCY ROOM  FOR THE NAUSEA AND FOR PAIN AND WAS RESTING AT HOME.
I started noticing continuous ringing in my ears in December 2021. Mentioned this during a doctor's visit in April 2022 and it was recommended I have an audiogram. Had audiogram with Dr May 3, 2022. By that time I had figured out that the ringing started after my Moderna booster (3rd shot). I'm not sure the ringing was caused by the shot, but Dr did say it was certainly possible. I want to share my history with this in case there are others who have had the same thing happen. Since then, I have had a fourth shot, had Covid, and had a fifth shot and the ringing is slowly getting louder.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 24-month-old female subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, FLUMIST which expired on 26-Dec-2008 was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 01-Apr-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
This case was reported in a literature article and described the occurrence of anaphylaxis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and other: Serious per reporter. The subject was treated with epinephrine. The outcome of anaphylaxis was unknown. It was unknown if the investigator considered the anaphylaxis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of anaphylaxis in a patient of aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention  (CDC)  and  the Food  and  Drug  Administration (FDA)-to summarize reports following immunization with MENVEO. The patient had a history of anaphylaxis immediately following receipt of an unknown vaccine 6 years earlier. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and measles, mumps and rubella (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and human papillomavirus (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, 24 hours or more after the vaccination, the patient developed anaphylaxis. The case met the definition of Brighton level 2. This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). The patient was treated with epinephrine. The outcome of the event was not reported. The authors did not comment on the relationship between the event of anaphylaxis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cased in the same literature article.
a blood that came out of the injection site/ bled a little; This is a spontaneous report received from a contactable consumer (Patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that on his first dose he saw that there was a blood that came out of the injection site. On his second dose, he unsure if he got the vaccine as he didn't see a blood come out. He didn't feel anything in his arms. Patient went to take the second vaccine today, but he doesn't know if he got it or not. He got the first one and it bled a little, but with the second one he felt nothing. Did they give it to him. Patient was unsure if he got the second dose vaccine. The outcome of the event was unknown.   Information about batch/Lot number has been requested.
itchy rash; a large hot itchy rash purple and red; large hot itchy rash purple and red; large hot itchy rash purple and red; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (itchy rash), SKIN DISCOLOURATION (a large hot itchy rash purple and red), SKIN WARM (large hot itchy rash purple and red) and RASH ERYTHEMATOUS (large hot itchy rash purple and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH PRURITIC (itchy rash), SKIN DISCOLOURATION (a large hot itchy rash purple and red), SKIN WARM (large hot itchy rash purple and red) and RASH ERYTHEMATOUS (large hot itchy rash purple and red). At the time of the report, RASH PRURITIC (itchy rash), SKIN DISCOLOURATION (a large hot itchy rash purple and red), SKIN WARM (large hot itchy rash purple and red) and RASH ERYTHEMATOUS (large hot itchy rash purple and red) outcome was unknown. Not Provided      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 relevant concomitant medications were reported. No treatment information was provided.
? 1/11/2022 afternoon: I got the J&J Covid-19 vaccine shot. Soon my left arm where the shot was received got numb. At night: worse ear ringing, slight headache, sore and painful left arm. ? 1/12/2022: worse ear ringing, low fever, numb (left foot+left leg+left part of neck), numb and sore and painful left arm, tired, do not feel well, headache. Took a sick day. ? 1/13/2022: very sleepy, worse ear ringing, low fever, numb (left foot+left leg+left part of neck), numb and sore and painful left arm, slight headache, right arm starts to hurt and to be numb, right leg starts to be numb ? 1/14/2022: numb (left foot+left leg+left part of neck), numb and sore and painful left arm, numb right arm and right leg ? 2/2022: a lump developed under the skin on my right side of face. In general, more tired than before shot. ? 3/24/2022, in general (slight) numb left arm and left leg and worse ear ringing and being more tired have been occurring since the shot. For several days last week for some time I also got severe headache and pain on left side of head and left part of neck. My left arm hurts today. The lump on my right side of face is still there. ? 3/27/2022 my left arm is painful more frequent today. For sometimes today, I feel somewhat chest pain, more frequent around 10:50 PM. Since I got the shot, occasionally my chest has been discomfortable/a little painful. I also found another lump under my skin on my left side of face close to chin. ? 3/30/3022 since around the week of March 14, one area of my left foot big toe is painful when touched. The area close to the little toe on left foot and area behind the ankle on my left foot start to hurt a little. Last night, my right eye felt painful for short time. This morning when I woke up, my left face felt a little numb. My chest felt a little tight.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            Concomitant medication list was not provided.  Treatment information was not provided.  Company Comment: This spontaneous case concerns an unknown-years-old male patient, with no medical history reported who experienced the unexpected AESI of Covid-19 unknown days after 3rd. dose of mRNA-1273 vaccine. The patient received three doses of moderna vaccine. At the time of the report, COVID-19 (COVID-19) was resolving.    The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an unknown-years-old male patient, with no medical history reported who experienced the unexpected AESI of Covid-19 unknown days after 3rd. dose of mRNA-1273 vaccine. The patient received three doses of moderna vaccine. At the time of the report, COVID-19 (COVID-19) was resolving.    The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
pt recvd vax & 830PM on 20APR93 exp gen'l grand mal sz 4-5 mins; mom took pt to ER where was adm;
Psoriasis flare-up; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. On unknown dates, the patient experienced had non-serious fatigue and psoriasis flare up with SKYRIZI (RISANKIZUMAB).  The patient had psoriasis flare up once a year. He took covid vaccine and was fatigued for about one week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of fatigue and psoriasis flare up with SKYRIZI (RISANKIZUMAB) was no reasonable possibility. No treatment medications information were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Vomiting, weakness, low temperatures, multiple incidents of vasovagal syncope, 1 resulting in a fall
"Patient is a 50 year old male who initiates telemedicine visit today for what he believes are side effects from his second coronavirus vaccine that he received yesterday about 2:30 PM. Patient states he noticed a mild symptoms during the middle of the night but really noted them this morning after waking up. Thanks and state symptoms include fever, chills, body aches and a little bit of diarrhea. Patient states he had the same symptoms after the first dose of the vaccine but to a much lesser degree."
Patient was given a vaccine that was 5 days past expiration date. Contacted GlaxoSmithKline whom stated vaccine is considered invalid, and will need a repeat after 28 days. Patient was notified, as well as MCIR.
Severe migraines for two weeks which persist for night and day.did not go away after many forms of opioids; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 08:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. The patient previously took metronidazole (FLAGYL [METRONIDAZOLE]) and experienced allergies. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 08:00 in the left arm for covid-19 immunization. On 28Apr2021 17:00, the patient experienced severe migraines for two weeks which persist for night and day. This did not go away after many forms of opioids were taken, only subsided after steroids. The patient never had a history of headaches or migraines. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with opioids, muscle relaxers, and steroids. The outcome of the event was recovering.  Information on the batch/lot number has been requested.
1.FEVER AND ABDOMINAL PAIN WITHIN 18 HOURS- MOTRIN, CHARCOAL CAPSULE 2.PAIN FROM RIGHT SHOULDER TO ELBOW AND ARMPIT AND BACK RADIATING FROM CHEST WITHIN 24 HOURS 3.WHEEZING, LIGHT HEADEDNESS, NAUSEA, LOOSE BOWELS WITHIN 24 HOURS- ALBUTEROL INHALER, REST 4. CHEST PAIN, IRREGULAR HEARTBEAT, ATRIAL FIBRILLATION-WITHIN 48 HOURS- WENT TO ER- TOLD TO REST
Shingles appeared in the same location I had 7 years ago, in spite of the vaccination received 8/17/2011.  Itching, jaw pain, headache.  Went to urgent care clinic and received anti-viral prescription.
PATIENT CAME TO PHARMACY WITH HIS MOTHER. A FEW SECONDS AFTER THE IMMUNIZATION THE PATIENT FAINTED, HE WAS PALE  AND SWEATING. PATIENT WAS PLACED ON THE FLOOR AND STARTED RECOVERING IN ABOUT 5 TO 10 SECONDS. HIS BLOOD PRESSURE  WAS 102/55 . PATIENT  WAS PLACED ON A CHAIR ONCE HE STARTED ANSWERING QUESTIONS PROPERLY. RESCUE ARRIVED TO THE STORE AND PATIENT WAS EVALUATED, PATIENT BLOOD PRESSURE WAS BETTER  102/80 AT 3:57PM. PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL.
Pyrexia/Fever; Paryngolaryngeal pain/ Throat sore; Pain/Generalized aching. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 23 year old male patient who experienced fever of 102 degrees, sore throat and body aches. At 23 years of age, the patient received the first dose on 18-Dec-2003. The patient received flumist on 18-DEC-2003 and did not experience any symptoms immediately following administration of the vaccine. On 18-Jan-2004 the patient experienced fever of 102 degrees (pyrexia), sore throat (pharyngolaryngeal pain) and body aches (pain). He was treated with Tylenol but low-grade fever, sore throat and body aches persisted as of 22-Jan-2004.
pt recv vax 28FEB97 & 18DEC97 pt exp more than 35 lesions over entire body & inside mouth;pt was covered w/chickenpox & had lesions inside ear canal, hair, genitals, eye lids, buttocks, extremities & trunk;exp sl fever, sore throat & h/a;
Pt recvd measles vax on 7FEB91 & devel severe h/a & double vision; Pt was seen by a neuro-opthalmologist who noted monocular & binocular diplopia & scheduled pt for a CAT Scan & MRI;
While working with the clinic it was determined that our vaccines were out of the temperature recommendations for a brief period of time before vaccination.
Received a invalid dose of 0.3 ml; A spontaneous report, was received from a consumer (patient's sister), concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received an invalid dose of 0.3 ml (underdose).   The patient's medical history was not provided. Concomitant mediation was not reported.    On 15 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The patient's sister received a call from the pharmacy, and it was reported that the patient received Moderna COVID-19 Vaccine on 15 Feb 2021. The patient's sister reported that the lady giving the dose was not used to give Moderna Covid-19 Vaccine and administered a 0.3 ml dose to the patient instead of the 0.5 ml dose. Treatment information was not provided.    Action taken with second dose of mRNA-1273 in response to the event was unknown.  The event, received an invalid dose of 0.3 ml, was considered recovered/resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose administered to a male patient for mRNA-1273, (lot # not reported) with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015236:Lnked case- Sister case