chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever and chills, noted upon awakening on 10/27/2021. Lasted all day and night 10/27-10/28. Epispodes of lightheadedness a few times when I got out of bed, so I stayed in bed all day. Felt nauseous, and fainted on the way to the bathroom at 4AM, 10/28/2021. Woke up immediately upon impact of fall.  Dry heaved for a few minutes. Used ice to treat the body aches from the fall  Please note that I had an influenza vaccine for age 65+ on October 10, 2021. However, I don't know the specific vaccine, so don't know which box to select for question 22. It was administered by a pharmacist at a community event.   Also please note my first two COVID-19 Vaccines were Pfizer
I have had a rash from head to toe. I've been on and off steroids and still having to take antihistamines and famotadine daily- my father has the same rash just worse and so did my cousin- all of which got Moderna vaccine
Information has been received from a consumer concerning his son who on an unspecified date, was vaccinated with 1 dose of MMR II and shortly post vax, the pt developed autistic characteristics, his "normal" development was arrested", "he lost his speech" and has no receptive language. The consumer stated, "I would demand to know what proof you could offer that your product is not responsible for the developmental problems my child is experiencing". Upon internal review, the pt's experiences were considered to be an "Important Medical Event". Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth, Patient age of time  of vaccination, adverse event onset date/time, lot # for vaccine 1, and vaccine administration date/time is not provided."
"PMH, Allergies, Medicaitons Unknown Pt developed facial swelling, itching, rash, anaphylaxis that started ~2hrs post vaccination. Pt reported this reaction when reporting for 2nd dose on 10/12.  Pt declined 2nd dose."
Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 08-Mar-2021, the patient experienced FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.    This case was linked to MOD21-052700 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-052700:Cross Linked no
Costochondrites; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 13:00 (Lot number: Fe3592) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Central sensitization" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fg3182, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 10Sep2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 01Oct2021 20:00, outcome "not recovered", described as "Costochondrites". The event "costochondrites" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of costochondritis.  Additional information: COVID vaccine received at facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: Cymbalta Motrin received as a treatment for adverse event. No COVID prior vaccination. Tested COVID post vaccination. On 04Oct2021 patient had COVID test nasal swab (PCR) type post vaccination and the result of the test was negative. No known allergies.   Follow-up attempts are completed. No further information is expected.
Vaccine given 10/14 7:40 pm. Ate at restaurant after, 10-10:30 pm experienced bladder pain, blurred vision, cough, SOB, hoarseness, throat closing, red eyes, swollen eyelids. body pain, muscle aches. 1 am took 2 BENADRYL. 30 min. later throat was better. 10/15 - pt reports body aches, occasional cough, swollen eyelids. Advised to continue BENADRYL.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
neurological problems; rashes; This spontaneous case was reported by a physician and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological problems) and RASH (rashes) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (neurological problems) and RASH (rashes). At the time of the report, NERVOUS SYSTEM DISORDER (neurological problems) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.
Erythema and swelling of (L) delt area, streak (red) into axilla area. ? cellulitis or secondary hypersensitivity to PNEUMOVAX vaccine. Tx with ROCEPHIN 1 gm IM and KEFLEX PO. Immediate relief - no evidence of swelling by 5/7/12.
This spontaneous report was received from a physician assistant and refers to a 72 year old female patient with allergy to penicillin, valium and codeine. On 11-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml, intramuscular in the left upper extremity for routine vaccination (lot # M038359, expiration date 13-MAY-2018). Concomitant therapies included aspirin (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 12-APR-2017, the patient experienced pain at injection site. On 13-APR-2017, the patient experienced rash at injection site. On an unspecified date in April 2017, upon the physician assistant assessment, the patient's left upper extremity was ecchymotic with additional redness expanding to the left chest, swelling at the injection site, enlarged lymph nodes and fever. The physician assistant requested to perform unspecified blood work but the patient declined at the time of this report and requested to be performed later in a week period. The physician assistant prescribed antibiotic sulfamethoxazole (+) trimethoprim (BACTRIM) (unspecified strength, unspecified lot and unspecified expiration) to be started on 13-APR-2017. The outcome of all adverse events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX23 was not reported. Additional information has been requested.
Rash appeared on 7/15 around 6:00pm had lots of itching, broke out in hives all over itchy, big splotches everywhere. Dx. with urticaria was told to continue with Benadryl and given @ Rx for Steroids.
Flu like symptoms for 3 days...body pain all over not just at the injection site.
Crazy heavy and painful periods since 2nd vaccine. Period did not stop for 25 days.
9JUN92 recvd 1st dose of Engerix-B; pt was pregnant p/1st dose & did not recvd 2nd dose of Engerix-B; 19JUL92 presented to clinic w/ c/o arthralgia, myalgia, profound fatigue & chills; seen by nurse; 25JUL92 spontaneously aborted pregnancy;
Lt. upper thigh 11 1/2 x 11 cm well defined erythema warm/edematous
This spontaneous report has received from a pharmacist referring to a 73 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 06-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N013541, expiration date 23-JAN-2019 (strength was not provided) in the left arm for prophylaxis. The reporter stated that on 07-OCT-2017, the patient reported that she could barely move her left arm, felt sick like she was having the flu and was very tired. Furthermore, it was reported that the patient was instructed to take ibuprofen (unspecified details) as treatment for the events, however it was unknown if the patient actually took the medication. On 08-OCT-2017, the patient stated that she felt fine. Additionally, the patient woke up on 09-OCT-2017 and felt like she was going to pass out but she felt better, and on the same date, the reporter stated that he observed "slight redness around injection site. No laboratory diagnostics or studies were performed. The outcome of vaccination site movement impairment, dizziness, fatigue, influenza and malaise was reported as recovered. The outcome of injection site erythema was unknown. At the time of this report, the causality between the aforementioned events and PNEUMOVAX 23 was not reported.
1 of 6 pts exp inject site react, erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react approx 7 cm long;
S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient alert and oriented, airway patent.  BP 129/88 HR 74 O2 98%  1617 Repeat O2 sat 98% HR 59.  Patient c/o persistent tongue swelling.    A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.
4 hours after receiving my Pfizer COVID vaccination, my chest started to tighten up and I became short of breath. I took some Ibuprofen, but the pain is still there today, and it is hard for me to even walk up the stairs without becoming short of breath or being in pain.
Right arm pit swollen (feels like fluid retention); Lymph nodes tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm pit swollen (feels like fluid retention)) and LYMPH NODE PAIN (Lymph nodes tenderness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right arm pit swollen (feels like fluid retention)) and LYMPH NODE PAIN (Lymph nodes tenderness). At the time of the report, PERIPHERAL SWELLING (Right arm pit swollen (feels like fluid retention)) and LYMPH NODE PAIN (Lymph nodes tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt called and reported being hospitalized. He reported he had a seizure, alter mental status and short-term memory loss.
Pt recv vax on 11/6/98; 5 hr post vax pt exp nausea, fever (102F) & headache; tx=Tylenol; pt imp 11/7/98
Vaccines administered after temperature excursion (46.2 F). Vaccines involved : VAXELIS U7205AA and VAXELIS U7151AA 7.; This spontaneous safety report, with reference number 02272790, was received by a partner on 21-OCT-2022 and forwarded on 24-OCT-2022, from a Health Professional.   This case was considered non-valid due to no patient identifiers were provided (temperature excursion).  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received on 25-NOV-2022 from the physician.  The case is valid as patient identifiers were provided.  It was reported that the patient did not experience any adverse event.  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004325, MCM-004326 and MCM-004327.  Further information is expected.
Patient is a78y.o. year old male who presented to the ED 9/7 with dyspnea x 5d. S/p Pfizer vaccine 3/4, 3/25 Found to be COVID + Admits to cough, hx tracheostomy Afebrile since admission, FiO2 40%. No n/v/d Pt given solumedrol 125mg x 1 in ED, now on 40mg q8h Covid-19 Vaccine (Pfizer) 03/04/2021, 03/25/2021
First night after the vaccine I started feeling feverish and very achey. Flu like symptoms. Extreme. Lasted about 24 hours.  Following day on 4/11 I began to feel very congested in my ears only. Experienced Vertigo and ringing in my ears.  Very uncomfortable, By day 5 I saw my PCP who referred me to ENT.  Saw the ENT on 4/20 and 4/21 for blocked Eustachian tubes. Extremely uncomfortable.  Continued to take decongestants for another week.  Ears eventually cleared.  I work as a flight attendant and do have a history of blocked ears when flying with colds however, this ear blockage occurred after the vaccine and without flying. My ears continued to be sensitive after clearing for a few weeks.  ENT basically said, reaction was due to inflammation which occurred due to the vaccine.  Not necessarily a reaction to the vaccine itself.  Unknown for sure.  His opinion,
This case was reported by a nurse via sales rep and described the occurrence of facial swelling in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, 30 days after receiving BEXSERO, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. The reporter considered the facial swelling to be probably related to BEXSERO. Additions details were provided as follows. The age of vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced facial swelling after vaccination with BEXSERO. The reporter will be on vacation and correspondence contact (practice manager) was reported. This is one of the four cases reported by the same reporter.
sore arm; she got a really big bruise; shoulder and neck was swollen; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CONTUSION (she got a really big bruise), SWELLING (shoulder and neck was swollen) and FATIGUE (exhausted) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PAIN IN EXTREMITY (sore arm), CONTUSION (she got a really big bruise), SWELLING (shoulder and neck was swollen) and FATIGUE (exhausted). At the time of the report, PAIN IN EXTREMITY (sore arm), CONTUSION (she got a really big bruise) and SWELLING (shoulder and neck was swollen) outcome was unknown and FATIGUE (exhausted) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided.   Treatment information was not provided.
The patient is a 57-year-old female with a history of coronary artery disease, hypertension, dyslipidemia and menopause who presents to discuss palpitations. In the beginning of August she had a 2 week period of significant palpitations which has improved since then. About 5 days prior to the initiation of her symptoms she had a vaccination for the shingles virus. She describes the palpitations as a flip-flopping in her chest and associated with symptoms of fatigue. She denies any significant caffeine intake. She did note that with exertion the symptoms improved. She denies any syncopal episodes. Holter monitor worn for 48 hours from September 4, 2012 showed close to 20,000 ventricular ectopic beats with some being in bigeminy and trigeminy. She also had supraventricular beats but only 23 with no significant pauses or runs of SVT.
Headache, Fever, Sore arm at injection site, fatigue, dizziness and foggy head. Narrative:
Shot administered in left deltoid. Could not raise arm for 10 days and still not able to raise arm directly outward from side position without weakness or pain after more than 5 months. Flu like symptoms were experienced for about a month after having the flu shot. Mild aches, lethergy, lung and nasal congestion.
pt recv vax & exp fever of 102 & achy feet;pt recovered from the fever by the following morning;
Grossly swollen legs and feet and ankles BP RISING TO 202/  86 .  i NEVER  HAD THAT LEVEL OF HIGH BP  BEFORE and it still is persisting up until today. highest BP for years was usually in the 130 range or rising a few times into the 150's when greatly stressed
Odd, somewhat metallic taste in mouth. Dry, scratchy throat. Red eyes & yellowish discharge from eyes. Occurred within approximately 4 hrs. after getting shot. Counseled pt. to take OTC BENADRYL. Asked her to follow-up within 24 hrs.
Provider asked me to give a Bivalent Pfizer vaccine to patient. Vaccine was given by protocol.  I checked the selection that said she had not had a previous bivalent vaccine, as I made a mistake and did not see that she had already had a previous one.
INTESTINAL OBSTRUCTION; Information has been downloaded from regulatory authority (US-EMA-20150330-tanvievhp-114818074).  This spontaneous report was received from a healthcare professional refers to a 3 month old female infant patient with milk protein allergy. The patient's historic conditions and concomitant medications were not reported.  On 16-FEB-1999, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) oral solution (lot/batch# 1372E; strength, dose number, anatomical location and expiration date were not reported) for prophylaxis. On 16-MAR-1999, the patient was vaccinated with Hib conj vaccine (CRM197) (HIB-TITER VACCINE) (strength, dose number, anatomical location and expiration date were not reported, lot # 403203A) via intramuscular route for immunisation, polio vaccine (unspecified) (also reported as "POLIO VACCINE "PASTEUR") (indication, strength, dose number, anatomical location, route and expiration date were not reported with lot # N0597), rotavirus G1 G2 G3 G4 reassortant vaccine live (human-rhesus) (ROTA SHIELD) one dose, oral solution (strength, dose number, anatomical location and expiration date were not reported with lot # 4988078) via oral route for immunisation and diphtheria toxoid, pertussis acellular biken vaccine, tetanus toxoid (TRIPEDIA) (strength, dose number, route, anatomical location, expiration date were not reported with lot # 097014D) for prophylaxis. On 11-MAY-1999, the patient experienced intestinal obstruction. The patient was hospitalized for the event on an unknown date in 1999. The outcome of intestinal obstruction was recovered. The relatedness between the suspect therapy and the event was not provided  The Agency considered the event, intestinal obstruction to be medically significant.
Patient reported feeling an involuntary need to sit down immediately upon standing about 12-hours after receiving her first dose of the Pfizer COVID-19 vaccine on 10/05/2021. Patient denied feeling dizzy or faint, denied actual syncope or any sort of loss of consciousness. She said she simply felt the need to sit down after standing. She felt that she recovered by the next morning. This was reported after her second dose of the COVID19 vaccine was administered, despite being screened for symptoms prior.
Platelet count dropped to 57k. Recovering but count is still low.  02/26/2008 MR received from PCP for dates beginning 9/12/2007 to 11/20/2007.  Normal WCC exam on 9/12/07.  Labs 9/15/07 reveal thrombocytopenia.  No bleeding or bruising noted.
Product storage error; redness and swelling at the site of the injections; redness and swelling at the site of the injections; This spontaneous report was received from a physician, concerning  a 4 year old patient of unknown gender.The patient's pertinent medical history included 4 previous vaccinations with DIPHTHERIA VACCINE TOXOID (+) PERTUSSIS VACCINE ACELLULAR (+) TETANUS VACCINE TOXOID (TDAP) and 4 previous vaccinations with polio vaccine. The patient's concurrent conditions were not provided. The patient did not have any prior events with vaccinations and did not have any known allergies or drug reactions.  The patient's concomitant medications included an unspecified multivitamin.   On 29-JUN-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis in the left arm lot #T024284 expiration date 15-JUL-2021 (strength, dose, frequency and route of administration were not provided). That day the patient also was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  also administered for prophylaxis in the right arm, lot #T006167 and expiration date 19-FEB-2022 (strength, dose, frequency and route of administration were not provided) and finally with the first dose diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) also administered in the left arm, lot #C5851AA and expiration date 25-MAR-2023 (strength, dose, frequency, indication and route of administration were not provided).  There was no illness at the time of vaccination and no vaccines were administered within 4 weeks.   The physician reported that the freezer was out of range for a two weeks period and the vaccine was administered on day 5 of a two weeks excursion which was equal to 120 hours that the vaccine was in the excursion.   The temperature excursion was at 24.9 F, no previous temperature excursion was reported.   The physician additionally informed that the temperature excursion resulted due to a malfunctioning of the data logger that was monitoring temperature but was not alerting the temperature excursion.   On an unspecified date, the patient experienced redness and swelling at the  site of the injections, the patient's mother informed the physician who told her that this was an usual post-vaccination reaction.   At the time of reporting the patient recovered from redness and swelling at the site of the injection.   The causal relationship between the vaccination with varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) and the adverse events was not provided by the reporting physician.