chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT MENTIONED THAT SHE EXPERIENCED SEVERE ALLERGIC REACTIONS TO ANOTHER UNSPECIFIED MEDICATION, SOMETIME AFTER HAVING RECEIVED FLUMIST WHICH WAS BEFORE 2016; PATIENT REPORTS THAT SHE IS ALLERGIC TO POLYETHYLENEGLYCOL AND HAS HAD TO GO TO THE ER TWICE FOR REACTIONS, SPECIFIC START DATES UNKNOWN; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) 1 df once/single administration, via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016 (preferred term: Drug hypersensitivity). On an unknown date, the patient experienced patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown (preferred term: Polymers allergy).     The outcome of the event(s) of patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016 and patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown was unknown.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown and patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016.  The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown and patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 24-Oct-2023: Unticked the Include in E2B box in ALL files. Narrative updated.
Cold sensation over entire body; Body Aches; sever headache; swollen lymph node under left arm/next morning still had swollen lymph node and redish bruising under arm in armpit; fatigue; redish bruising; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 18Apr2021 16:45 (Age at Vaccination 28-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included Allergies to medications, food, or other products:percoset, vicodin, alieve, codine, zythromax, osmopret, bactrim, ceftriaxone, bee stings. Concomitant medications included spironolactone; doxycycline; norethindrone taken for an unspecified indication, start and stop date were not reported. The patient experienced cold sensation over entire body, body aches , sever headache, swollen lymph node under left arm/next morning still had swollen lymph node and redish bruising under arm in armpit , fatigue, redish bruising on 18Apr2021 16:45. No treatment were provided for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021 hcp became aware of the events. The patient was not tested covid prior or post vaccination. The clinical outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Immediately after receiving the vaccine, started feeling hot inside the stomach, the whole body also started feeling very hot. Having difficulty breathing/shortness of breath/heart pounding fast and hard. Face, hands and feet started feeling numb/tingling. Heart rate was 140. Blood pressure was normal. Was hyperventilating, total feeling of panic. This experience occurred a 2nd time just before leaving the office. Once home the above experience happen a 3rd time and the paramedic was called to the home. Could not speak due to difficulty breathing/unable to move the body oxygen was administered. Was a having a panic attack.
EXTREME ITCHING: 1. UPPER + LOWER BACK 2. LEFT LEG 3. INTERNAL TREMERS (WHOLE BODY) 4. BROKE OUT IN A RASH (WHOLE BODY) LAST MEDICATION TAKEN ON 11-28-2019 AT FIRST I DIDN'T THINK MUCH OF THE ITHCING, BUT GOT STEADILY WORSE TRIED BENADRYL ON MY OWN, DID NOTHING THINGS GOT WORSE, I DECIDED IT WAS TIME TO SEE A DOCTOR. WENT TO WALK IN TYPE CLINIC. WAS PRESCRIBED: 1. HYDROXYZINE (ATATAX) 2. METHYLPREDNISOLONE (MEDROL DOSEPACK) 3. INJECTION OF CORTAZONE AT THE CLINIC THINGS STARTED GETTING BETTER AFTER ABOUT A WEEK THIS WAS PRETTY BAD. I HOPE YOU CHECK THIS OUT, SO NO ONE ELSE GOES THREW THIS, IF POSSIBLE
C/o dyspnea and "throat feeling like swelling"; Increased BP 180/100 when returning with symptoms but 100/60 before with physical; O2 sat 98-100%, BP readings 150/100, 150/94 140/94. 146/102 - told to follow up Monday and no football until recheck but didn't keep appt 8-12-13.
feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling unwell). At the time of the report, MALAISE (feeling unwell) outcome was unknown.            No medical history was provided by the reporter
On sat 5/11/19 had flu like symptoms, devleopment of notable blister over site of injection and fine papular rash on ipsilateral side of her body. All symptoms are resolving and left with scabbed blister 1in diameter over site of injection. No redness, swelling, pain or concerning drainage to suggest infection. Itchy, using top hydrocortisone. Discussed monitoring for signs of infection, expect to continue to improve.    Reaction does not sounds like IgE mediated allergy. Tolerated shingrix #1 without side effects.
she cannot move her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown  ,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "she cannot move her arm.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Infection; Swelling; The site had a "small rash"; This case was reported by a pharmacist via call center representative and described the occurrence of infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 1 day after receiving Shingrix, the patient experienced infection, swelling and injection site rash. The patient was treated with antibiotics nos, (Antibiotic (Details Unknown)). On an unknown date, the outcome of the infection, swelling and injection site rash were unknown.   It was unknown if the reporter considered the infection, swelling and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that the patient developed swelling. The patient sought treatment at urgent care and was diagnosed with an infection for which she was prescribed antibiotics. The patient also had small rash at the injection site. The reporter consented to follow up.
PATIENT APPAREDTO BE DIAPHORETIC AND HAD AN EPISODE OF LOC FOR ONE SECOND
Rash around the shot area; rash is itchy; hives all over the body; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Rash around the shot area), RASH PRURITIC (rash is itchy) and URTICARIA (hives all over the body) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash around the shot area), RASH PRURITIC (rash is itchy) and URTICARIA (hives all over the body). At the time of the report, VACCINATION SITE RASH (Rash around the shot area), RASH PRURITIC (rash is itchy) and URTICARIA (hives all over the body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Nonsignificant follow up appended on 13-APR-2021 with No new information
Local reaction with swelling/redness pain nausea/vomiting/low grade temp started 2 days later unclear if related. ZOFRAN given for symptomatic relief.
pt recv vax 30OCT96 & pt exp numbness in the fingers & arthralgia in the lt shoulder;numbness in the fingers resolved as of 2NOV96 -arthralgia persists 12DEC96;painful abduction;while sleeping pain awakens the pt;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 25-JUL-2014, the patient was administered an expired dose of VARIVAX (merck) injection 0.5 ml, subcutaneously (lot # H013398, expiry date: 10-JUL-2014; indication unspecified). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
CLIENT HAD FEELINGS OF DIZZINESS, HEADACHE, EARS RINGING.  HE TRIED PUTTING HIS HEAD BETWEEN HIS LEGS FOR ABOUT 5 MINUTES, SYMPTOMS BEGAN TO SUBSIDE AND RETURNED ABOUT A MINUTE LATER.  NURSE HELPED CLIENT TO A BED, ON THE WAY HE HAD A SYNCOPAL EPISODE THAT LASTED A COUPLE SECONDS.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Previously administered products included zoster vaccine (received at the age of 55 years without any adverse events) and pneumonia vaccine (received in May 2018). Concomitant products included Metoprolol. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd May 2018, 8 hrs after receiving SHINGRIX, the patient experienced fever, headache, chills and heart rate increased. On 22nd May 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the headache and heart rate increased were recovered/resolved. The reporter considered the fever, headache, chills and heart rate increased to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on right arm. The fever resolved after 2 hours. The chills resolved after 3 hours. The slight fast heart beat did not last long at all.
Real bad chills; Nausea; Weakness; shaking; get real cold; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 08Feb2021 (at the age of 69-year) as dose 1, single for COVID-19 immunisation (didn't want to catch it. Was up in age thought she needed it). Medical history included eye surgery three weeks ago from "yesterday" to an unknown date. There were no concomitant medications. The vaccine was not administered at facility. Investigation assessment was not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had first COVID-19 Vaccine on Monday (08Feb2021). Did alright until early "this" morning. Wanted to know if it was natural for this to happen. Was having real bad chills, nausea, and feeling weak. She was started to experience nausea, real bad chills, and weakness around 09:00-10:00 this morning. She was started get real cold and put a heating pad in her bed. She was shaking. Was alright until she took the shot. Assuming it was side effects of the shot. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
adult patient was given a pediatric dose of Engerix-B.; adult patient was given a pediatric dose of Engerix-B.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 56-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 4ZN3H, expiry date 28-MAR-2025) for prophylaxis.   On 25-JUL-2023, the patient received Engerix B 10 mcg. On 25-JUL-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: adult patient was given a pediatric dose of Engerix-B.) and adult use of a child product (Verbatim: adult patient was given a pediatric dose of Engerix-B.). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: Receipt date: 10-AUG-2023 The nurse reported an adult patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
pt recv vax 14MAR97 &  a few hr post vax pt exp inconsolable crying that persisted for 3 or 4hr;
03:40 pm..Numbness in right cheek into lower jaw.  similar to when you are coming out of novicane from dental appt. Lasted about 15 minutes but subtle feeling for 24 hours.    Friday morning: reaction to my BP meds of heavy head, weak hands that other meds caused me in past.   Never had previously.  Been on this med brand for over 3 years.   The symptoms passed after 5 hours when med wore off.  My BP seems lower than before shot. So reduced med to half dose 2x day and full dose once a day.   Seems to have helped reduce symptoms, but they reappear less intense now.  Also have heartburn and much more gas than ever had in past.
VACCINE WAS ADMINISTERED ON 3/21/23 AFTER EXPIRATION DATE (2/24/23).
Moderna booster dose (dose #3) given was expired.  Patient was contacted and advised to obtain a new booster dose.
12 x 13 cm area of redness, swelling and itching @ site of 2 vaccines. Has spread to current  size today. No other symptoms have developed.
hives; itching; felt awful; Initial information regarding an unsolicited valid non-serious case was received from a Registered Pharmacist via Medical Information (Reference number- 00442525) and transmitted to Sanofi on 22-Jan-2021.  This case involves 87 year old male patient who had hives (urticaria), itching (pruritus) and felt awful (feeling abnormal), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date in 2013, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  Registered Pharmacist stated a patient reported having a reaction after being given the vaccine.  On an unknown date, the patient developed a non-serious hives (urticaria), itching (pruritus) and felt awful (feeling abnormal) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Warm transferred Registered Pharmacist to health care professional.   Pharmacist states she searched in the daily medicine site for the package insert but could not find it.  Would like to know the ingredients as the consumer had a reaction and wants to make sure there is not the same ingredients in the COVID vaccine although she has tried to reassure him he wants to see it on paper.   Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Registered Pharmacist stated no additional information was given by the patient.   There will be no information available on the batch number for this case.
swelling in the face only. swelling began immediately after vaccines were administered. Patient was given epinephrine 1:1000 & benadryl 15mg. e.m.s was called
Increased reactions to existing allergies. The skin around my eyes became very inflamed and my skin has been non-stop itchy for 24 hrs. all over my body. My skin gets hives as well.  I have never had allergic reactions like this in the past to any of my allergens.  Normally,  I would take Allegra and this would help my allergies (I have done this for years). Now even Allegra doesn't help anymore all of a sudden.  My allergist told me to increase my dosage of Allegra and start taking Pepsid to help control the itching.
The day after the vaccine I was in a lot of pain. It started overnight my Lymph nodes were very swollen and my neck was stiff. As the day went on I started to get more bumps on my head and other places. The bumps were severely painful and I could barely move my head without flinching. I went to the ER and the doctor said it was a normal reaction with my Lymph Nodes. I actually had the Shingles and had to return to the ER again. The second time at the the ER it was identified immediately. The rash was mostly on my head with a few on my torso which cleared up sooner. It has been 31 days and I still have episodes of severe pain once or or twice daily and don't last as long. The pain is a level 10 when it is severe. It is at a level five when it is not spiking.  I have not had any problems with my pregnancy so far and I am twenty eight weeks.  Due Date 07/17/2021 Pregnancy-second pregnancy
Now back down 99.5 today; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Now back down 99.5 today) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Now back down 99.5 today). At the time of the report, PYREXIA (Now back down 99.5 today) was resolving.            Relevant concomitant medications were not reported.  It was reported that patient's body temperature back down 99.5 at the time report and there was no real cough. Patient received 2 shots of Moderna COVID-19 vaccine and booster from Pfizer. It was also reported that the patient was feeling really fortunate at the time of report.  Treatment information was not 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.
Pateint reports feeling tightness in throat  she did take Benadryl, was talking in full complete sentences Denies hives, denies swelling on mouth or SOB SHe called 911 no epi provided
CoughWheeze sneezing , congestion, runny nose, fatique Narrative:
Information has been received from a 26 year old female patient consumer reporting on herself for GARDASIL, a Pregnancy Registry product, who on 23-SEP-2011, was vaccinated with a first dose of GARDASIL (lot number, dose and route not reported. The consumer reported that she became pregnant one month after the initial dose of vaccine in the administration series. No adverse effect was reported. Additional information has been requested.
Administered patient acquired MMR (acquired from Pharmacy) to left thigh on 3/19/2019. On 3/21/2019 received notification that the patient spiked a 104F temperature and suffered a seizure. Patient was transported by ambulance to the local emergency room for evaluation. Patient was evaluated and discharged with diagnosis of fever seizure.
Bloating; Abdominal pain; Chronic diarrhea/ every time eats she gets diarrhea 45 min after; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Chronic diarrhea/ every time eats she gets diarrhea 45 min after) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, received 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 ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Chronic diarrhea/ every time eats she gets diarrhea 45 min after). At the time of the report, ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Chronic diarrhea/ every time eats she gets diarrhea 45 min after) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details included pills to relax bowels.
subacromial bursitis of left shoulder. Given steroid injection and Meloxicam with improvement.
I had a slight fever, then sub fever then a fever, 96.7, 99.5 then 101.2  I had chills and sweats , muscle aches and fatique. I rested for two days and had a liquid diet for.  The fever broke on the second day, still weak and fatiqued second day and then no problems after that. I had a normal fever and my taste returned. So it lasted for two days. I got sick on 25th and 26th of March.