chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ilost sense of smell yesterday, 3rd of December,lost sense of smell; cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Ilost sense of smell yesterday, 3rd of December,lost sense of smell) and ORAL HERPES (cold sore on lip) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 041L20A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Fracture of spine. Concurrent medical conditions included Blood pressure high. Concomitant products included ENALAPRIL and CHLORTALIDONE (CHLORTHALIDONE) for Blood pressure management, POTASSIUM CHLORIDE and GABAPENTIN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANOSMIA (Ilost sense of smell yesterday, 3rd of December,lost sense of smell). In December 2021, the patient experienced ORAL HERPES (cold sore on lip). At the time of the report, ANOSMIA (Ilost sense of smell yesterday, 3rd of December,lost sense of smell) and ORAL HERPES (cold sore on lip) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) Rapid Covid-19 test negative.         Concomitant medication also include some supplements and a muscle relaxant medication because she fractured her spine, she did not remember the name but, said that it was like blexaril.  No treatment information was reported.  This case concerns a 64-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, Anosmia. The event occurred approximately 2 weeks after receiving the third dose of mRNA-1273 Vaccine while the rest of the events occurred on an unknown interval. The rechallenge was not applicable since event only happened on the third dose. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 64-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, Anosmia. The event occurred approximately 2 weeks after receiving the third dose of mRNA-1273 Vaccine while the rest of the events occurred on an unknown interval. The rechallenge was not applicable since event only happened on the third dose. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Random Eye Twitch in Right Eye (ongoing, every couple of days; beginning to become less often; didn't have eye twitch before); Tinnitus in Left Ear (3-5 times so far)
Headache, Diarrhea, Nausea Vomiting, Chills Narrative:
Extreme fatigue, severe malaise, body aches, feeling of impending doom, shortness of breath, high heart rate, high blood pressure.
pain; inflammation,; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain and inflammation. She was concerned about taking Advil and/or Tylenol after her surgery on Monday. She has not taken those medications yet, however, she asked if taking them for any pain or inflammation, could that interfere with the immunization process of her vaccination. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Constant sneezing and irritation of right nostril, with slight runny nose, for approximately 10 days less than 90 days from second dose of Moderna.
TETANUS SHOT WAS GIVEN ON LEFT ARM, UPPER LEFT SIDE OF PATIENT'S LIP STARTED TO SWELL.BY 10 PM HIS ENTIRE UPPER LIP WAS SWOLLEN AND NUMB.THIS MORNING IT SEEMS LIKE ITS GOING DOWN. ORDERED TO TAKE BENADRYL
Blurred vision all of a sudden.  Headache, Dizziness when bending down. All of a sudden loss of balance.  Soreness at the injection site.
Pt had previously received the Johnson and Johnson vaccine and then came back for an un-needed second dose and received a dose of Moderna.  no adverse effects noted and no treatment needed
Symptom of poor memory in creased greatly and arthritis pain greatly increased. Pain in arm not until day 15
pt recvd vax; devel rash beginning on torso 13 days after vax;rash spread to face & extremities; rash looked like measles rash & was not itchy;
Nurse administering vaccine reported error in administration. Patient was administered Janssen vaccine instead of Pfizer covid-19 vaccine 2nd dose. Patient has not presented adverse effects thus far, but counseled on going to the nearest emergency room in case of serious adverse event. She was told to document any symptoms should they happen. She was concerned as she is a lactating mother and was getting the Pfizer vaccine recommended by her doctor so that her child could develop antibodies.
Information has been received from a nurse practitioner concerning a 64 year old female with environmental allergy, asthma, hypertension, diverticulosis and goiter who on 30-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot number 659409/0409X) subcutaneously (injection site not reported). Concomitant therapy included LISINOPRIL (manufacture unknown), (ALLERGA), (PULMICORT), (XOPENEX), (EVISTA) and (VAGIFEM). On 14-JUN-2008 the patient developed 3 lesions (1 vesicular). The lesions were itchy and located on the right shoulder, the ventral side of the left forearm and the lateral side of the left upper arm. Unspecified medical attention was sought. At the time of reporting, the patient was recovering from the lesions. Additional information has been requested.
Starting the morning of 10/14/2021, or 5 days from the shot, I woke up with tunnel vision in both eyes, although much more pronounced in my left eye.  My upper left lip was also twitching.  I've never experienced anything like this before.  Both of these symptoms lasted for nearly 1.5 days until subsiding.  I went to a urgent care facility the evening of 10/15/2021, but by the time I got there the sumptoms were gone.  I was examined by a doctor on site, and he consulted with an opthamologist and they believed everything seemed to be back to normal.  I then saw an opthamologist, Dr., on 10/18/21.  He conducted an exam and everything appeared normal and he thought I was experiencing probably migraine equivalent.  An MRI was ordered and completed on 11/21/2021 and the results were negative for anything neurological.
pt recv vax 24JUL97 & on 9AUG97 pt devel an inj site rash & wheezing & SOB that was dx as acute bronchitis;tx w/albuterol inhalers;
Patient told the nurse after he received his vaccine it was his second one. School nurse notified, contacted the mother and mom confirmed patient had the first covid 19 vaccine on 11.13.21.  Patient is feeling fine
Fever for two days. Redness (started two inches and expanded to 5 inches before fading 7 days later) Pain and swelling of the arm around the site
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Quite weak) and MOBILITY DECREASED (Has difficulty getting up and moving around) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Dementia. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ASTHENIA (Quite weak) and MOBILITY DECREASED (Has difficulty getting up and moving around). At the time of the report, ASTHENIA (Quite weak) and MOBILITY DECREASED (Has difficulty getting up and moving around) was resolving. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received on 24-Nov-2021, event outcome updated.
5/14/05 Child woke up with a few chicken pox lesions; more broke out 5/15/06. Seen by this office 5/16/05 for confirmation. Child looks well. No other symptoms. Has 20-30 varicella lesions.
worsened diffused pain; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 (Lot number: ES0153) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mixed connective tissue disease", start date: 2017 (ongoing), notes: Pertinent details: ongoing diffused joint and muscle pain; "HTN", start date: 2017 (ongoing); "Hyperthyroidism", start date: 2012 (ongoing), notes: Pertinent details: Thyroid surgery; "Anxiety", start date: 2012 (ongoing); "Hyperlipidemia", start date: 2012 (ongoing); "Allergies: PCN [Penicillins]" (unspecified if ongoing), notes: Allergies: PCN [Penicillins] - (reactions not documented); "Allergies: Seafood" (unspecified if ongoing), notes: Allergies: Seafood - (reactions not documented); "Allergies: Sulfa drugs" (unspecified if ongoing), notes: Allergies: Sulfa drugs (reactions not documented); "Allergies: Adhesive Tape" (unspecified if ongoing); "Allergies: Adhesive Tape - Rash" (unspecified if ongoing); "congestion" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "pain" (unspecified if ongoing); "sleep" (unspecified if ongoing); "nausea" (unspecified if ongoing); "vomiting" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE]; CELEBREX; KLONOPIN taken for anxiety; COLACE; VIVELLE-DOT; LUNESTA; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; ATARAX [HYDROXYZINE HYDROCHLORIDE] taken for nasal congestion; SYNTHROID; LIDODERM; TOPROL XL; MILK THISTLE; BENICAR; LOVAZA taken for dry eye; PRILOSEC [OMEPRAZOLE]; OXAYDO taken for pain; COMPAZINE [PROCHLORPERAZINE MALEATE] taken for nausea, vomiting; AMBIEN CR taken for sleep disorder. Past drug history included: Aspirin, reaction(s): "Allergies: Aspirin [Dihydroxyaluminum Aminoacetate]", notes: Allergies: Aspirin [Dihydroxyaluminum Aminoacetate] - Hives; Aspirin, reaction(s): "Allergies: Hives", notes: Allergies: Aspirin [Dihydroxyaluminum Aminoacetate] - Hives; Gabapentin, reaction(s): "Allergies"; Trazodone, reaction(s): "Allergies"; Wellbutrin, reaction(s): "Allergies". Vaccination history included: Prevnar 13 (Allergies: Prevnar 13 (Pneumococcal 13-VAL CONJ Vacc] - Rash), reaction(s): "Allergies: Prevnar 13 (Pneumococcal 13-VAL CONJ Vacc] - Rash", "Allergies: Prevnar 13 (Pneumococcal 13-VAL CONJ Vacc] - Rash". The following information was reported: PAIN (non-serious) with onset 03Apr2021, outcome "recovering", described as "worsened diffused pain". The event "worsened diffused pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain.  Additional Information: The patient also received bnt162b2 (BNT162B2), administered on Left Arm, administration date 23Apr2021 (Lot number: EW0172) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient has no prior vaccination within 4 weeks. The patient received prednisone as treatment for adverse event.   No follow-up attempts are possible. No further information is expected.
10-year-old patient was inadvertently administered fluzone high-dose QIV with no reported adverse event; The 10-year-old patient was inadvertently administered Fluzone High-Dose QIV with no reported adverse event; Initial information was received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 years old male patient who had inadvertently administered fluzone high-dose qiv with no reported adverse event after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for COVID-19 immunization.  On 15-Nov-2022, the patient received 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot: UJ895AC) (frequency: total) (expiry date, strength was unknown) via intramuscular route in the left deltoid for Immunisation.  On 15-Nov-2022 the patient had a non-serious event 10-year-old patient was inadvertently administered fluzone high-dose qiv with no reported adverse event (product use issue) and (Accidental exposure to product) (latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 14 hours after the second dose of Pfizer patient woke up with a headache, dizziness, nauseous, and extremely diaphoretic. Patient sat on the edge of the bathtub due to the nausea and dizziness and had a blackout resulting in falling onto the tile floor head first. Patient was unconscious for approximately 8 min and was found by a family member.  Patient currently has a black eye accompanied by neck pain from the fall. Patient has no memory of the fall. Patient is young with no prior health history. Patient did not seek medical help on the date of the incidence because she was unsure that they would be able to find the cause.
Fever; Chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA and CHILLS in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HUMIRA for Rheumatoid arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA and CHILLS. At the time of the report, PYREXIA and CHILLS had resolved.        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 concomitant product use was provided by the reporter.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-May-2021 and contains no new information.
pt recv vax 26FEB97 & on 27FEB97 pt exp a nickel-sized swollen area around the inj site (it was not specified which vaccine inj site);
Right arm pain, fatigue, lightheaded for several hours following vaccine. Also muscle pain, chills that night. Symptoms lasted a week (see below). Still with arm pain as of 6-26-18. All symptoms resolved by 5 days.
Plunger of syringe was stuck and would not allow injection into the left arm.  Patient received the vaccine in the right arm with a replacement vaccine.
morning sugar was reported to be 600mg/dL; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (morning sugar was reported to be 600mg/dL) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (morning sugar was reported to be 600mg/dL). At the time of the report, BLOOD GLUCOSE INCREASED (morning sugar was reported to be 600mg/dL) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Glycosylated haemoglobin increased: 9.5 % (High) while normally it stays around 8%.. On 19-Apr-2021, Blood glucose: 600 mg/dl (High) increased.         No treatment and concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081236:1st dose of vaccine
Received 2nd does of Moderna Covid-19 vaccine on2/26/21 in my left deltoid area. 18 hours later developed an indurated, red, itchy, and very tender area 6cm by 14 cm in the same area. Exactly as shown and described as the  "Covid Arm" on several websites. Induration and rash remained constant for 3 days, then slowly regressed, until completely gone on 3/4/21.  Had no reaction to the 1st dose of Moderna vaccination.
On 9/24/2023 around 9am, my daughter woke up with sharp and intense lower abdominal pain.  She went to the emergency room.  Her pain level was at a 10/10.  They gave her tylenol.  They checked for UTI, appendicitis, twisted ovaries, and checked her uterus.  There was nothing wrong with any of it. Her pain level decreased by 10:30am. She was in some pain until 3pm.
Headache, Myalgia, NauseaVomiting, Palpitations, Fatigue Narrative:
I developed tinnitus which is extremely annoying one week after my second dose of Pfizer Covid-19 vaccine.  My ear doctor said there is nothing I can do to get rid of this condition.  It hit exactly one week after my second shot.  It persists.  It interferes with my sleep and with my thinking and with my activities of daily life.  It's quite terrible.
Pt. C/O tingling of the left hand  including the palmer surface, full ROM no motor weakness. No respiratory issues, no other complaints
8 days post vaccine patient reports swelling to deltoid along w/ welts and redness. Day 9 swelling improved, redness persisting. Not problematic otherwise. Presentation consistent with "COVID arm" like presentation via virtual visit
Left arm severe swelling, lymphoedema and bruising below injection site. Unable to move arm. Swelling not coming down after2 days.
- Instantaneous sharp pain throughout the shoulder region (not experienced during initial vaccination shot, 3 weeks earlier in same shoulder). - Subsequent loss of use of left arm for 2-plus days (any motion caused inflammation to spike in shoulder, centered on one muscle but radiating throughout). - No treatment other than limitation on use of arm, very gradual reintroduction of usability. - Gradual recovery over several weeks. Now 18 days out from second shot, about 98% recovered from shoulder injury.
ADACEL administered to patient under 10 years of age, instead of the intended DAPTACEL.; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old female patient and it was reported that adacel administered to patient under 10 years of age, instead of the intended daptacel, after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 17-Aug-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C5854AA, expiration: 14-Apr-2023 via intramuscular route in the Right Vastus Lateralis(Right thigh) as Immunization. Meant to be 4th DTaP, but 1st Tdap.  On 17-AUG-2022 adacel administered to patient under 10 years of age, instead of the intended daptacel (wrong product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Narrative: -Last Covid vaccination completed 4/20/21. Post vaccination had regional tenderness in triceps. 2x days later started to experienced pins/needles on tips of fingers of left hand ( vaccine completed in left arm), has not gotten worse since then but also not better. Described as constant, no known exacerbating or alleviating. Does lay on that arm when sleeping occasionally with no exacerbation, able to sleep (other than insomnia). No numbness. Right hand dominant. Concern that this doesn't feel quite right and is mostly annoying. While  on phone, confirms that raising over head, causes sx of neuropathy to increase up forearm. Also Saturday night ride are increases sx of neuropathy up to elbow. Obtaining LUE with doppler to r/o thoracic outlet syndrome, look for potential causes of brachial plexux compression.
Severe bone pain throughout spine, hips, and femurs for 36 hrs Severe headache for 36 hrs that faded and persists as mild headache now
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083: