chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning in chest; weakness; shaky; fever; chills; achy; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (achy), HEADACHE (headache) and CHEST PAIN (burning in chest) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD and COVID-19 (She did have Covid-19 last May).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (achy) and HEADACHE (headache). On 05-Mar-2021, the patient experienced CHEST PAIN (burning in chest), ASTHENIA (weakness) and NERVOUSNESS (shaky). On 27-Feb-2021, PYREXIA (fever), CHILLS (chills), PAIN (achy) and HEADACHE (headache) had resolved. At the time of the report, CHEST PAIN (burning in chest), ASTHENIA (weakness) and NERVOUSNESS (shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) came back clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Syncope, fell from standing. I do not have many details as I am reporting second hand. Paramedics were called and provided support. Pt did report that he had not eaten since the previous day.
mild headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: MOD22-025425 (Moderna).  A male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 12Oct2021 as dose 3 (booster), single (Lot number: EW0186) for COVID-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing); "Digestion" (unspecified if ongoing). Concomitant medications included: LOSARTAN taken for blood pressure; SIMVASTATIN taken for cholesterol; SERTRALINE taken for antidepressant; OMEPRAZOLE taken for digestion; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Lot number: EN6201), administration date: 10Feb2021, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Lot number: EN6198), administration date: 03Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "mild headache".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200076049 same patient/event, different dose number;
Feeling tiredness; Injection site pain; Muscle pain all over the body; Soreness all over; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old patient of an unspecified gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified), via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, 14 hours post vaccination the patient started feeling tiredness, injection site pain, muscle pain all over the body. The patient then went to bed woke up in the morning with initial feeling of soreness all over but it quickly disappeared, and the patient felt normal and also ecstatic. The outcome of the event was reported recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
tingling in the body; felt heaviness in the arms; involuntary movements; left knee was swollen; she felt heaviness also in her leg; Severe headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypoglycaemia" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known_allergies: Penicilina, Nansev. Concomitant medication(s) included: CLARITIN ALLERGIC; FLONASE ALLERGY RELIEF. The following information was reported: DYSKINESIA (non-serious) with onset Mar2021, outcome "not recovered", described as "involuntary movements"; JOINT SWELLING (non-serious) with onset Mar2021, outcome "not recovered", described as "left knee was swollen"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "she felt heaviness also in her leg"; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe headaches"; PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "tingling in the body"; LIMB DISCOMFORT (non-serious) with onset 17Mar2021, outcome "not recovered", described as "felt heaviness in the arms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyskinesia, joint swelling, limb discomfort, headache, paraesthesia, limb discomfort. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included :Claritin, Flonasec. Treatment received for the adverse event included: Ibuprofeno, vitamina B 12. On the first day she involuntary movements (twitches) in her left side, her left knee was swollen and she felt heaviness also in her leg. Severe headaches (for 2 weeks). On 17Mar began tingling in the body and did not feel legs and felt heaviness in the arms. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. known allergies included: Penicillin, Nansev  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
no additional AE; patient received the second dose of MMR II 7 months after the first dose; patient received the second dose of MMR II 7 months after the first dose; This spontaneous report was received from an office manager and refers to a 16-month-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date in January 2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 11-AUG-2020, also reported as 7 months after the first dose, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration, Inappropriate schedule of vaccine administered). No adverse events were reported.
Hypoglycemic crash; Feet cramping; Sweating; Feeling cold; Arm soreness; Brain fog; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOGLYCAEMIA (Hypoglycemic crash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and VACCINATION SITE PAIN (Arm soreness). On 21-Mar-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic crash) (seriousness criterion hospitalization), MUSCLE SPASMS (Feet cramping), HYPERHIDROSIS (Sweating) and FEELING COLD (Feeling cold). The patient was hospitalized on 21-Mar-2021 due to HYPOGLYCAEMIA. At the time of the report, HYPOGLYCAEMIA (Hypoglycemic crash), MUSCLE SPASMS (Feet cramping), FEELING ABNORMAL (Brain fog), HYPERHIDROSIS (Sweating), FEELING COLD (Feeling cold) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
p/vax pt devel fever & swelling at inj site; seen in ER;
COVID 19 Treatment; COVID 19 Treatment; Exposure during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 40 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Dec2022. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Exposure during pregnancy". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was unknown if patient received other medication in two weeks. Patient received Paxlovid from 09Dec2022 to 14Dec2022 for COVID-19 treatment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event and BNT162B2.
5 days of non activeness, bed rest, mini seizures going in and out of consciousness, fever of 104. Gave Tylenol and Motrin and fever would go down for an hour or so but would remain bed ridden and then would spike back up again. Called Doctor and they said it was "normal". This was not normal for patient, visited Dr about a week later, they said he "just had a cold" and to keep giving him Tylenol and Motrin.
Patient had extreme soreness that began at the site of injection of the deltoid of her arm, extend down her arm to her wrist, over her shoulder, down her back, and along her ribcage.  She is in terrible pain and cannot reach her arm up over her head.  It is not getting better even though she has taken some naproxen to help with the inflammation. The pain is starting to interfere with her working her job.
by 12noon, t101.5 R, appeared drowsy, jerking; transported to ER;wheezing discoloration around mouth enroute;
pt recv vax 8APR97 & 29APR97 lab eval revealed a failure to seroconvert;29APR97 pt devel a rash & was dx w/vaccination-induced chickenpox;
PAINFUL DURING THE VACCINATION.  AT THE SITE OF THE INJECTION MY ARM WAS VERY SORE AND WORSEN FROM MARCH 9- MARCH 11TH  PAINFUL WITHOUT TOUCH AND WAS SWOLLEN. MARCH 11TH- PM - LESS PAIN AND MY SWOLLEN SITE WAS REDUCED.
Reaction to the vaccine; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine) and RASH (Rash) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the vaccine) and RASH (Rash). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Pt had exam & vaccines; went home and took a nap.He woke up after 2 hrs w/ axillary temp of 104.5, crying unconsolably, & would not feed.
1/14/02 approx. 7pm, mother stated child indicated to her that his arm is growing. On 1/15/03 when she checked his left arm she noted that it was swollen, hard and red. 1/15/03 731pm child was seen in the ER. Dx ? allergic reaction vs cellulitis L deltoid. Tx: Benadryl 12.5mg and EES 200mg PO. CBC drawn. Child was admitted with diagnosis cellulitis left arm. No fever. Medication: Cefotaxine 500mg IV q 6 hrs.
I95.9 HYPOTENSION 7/22/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED. I95.9 HYPOTENSION 7/22/2021 ANAL DISEASE
pt sibling  recv vax 5SEP97 & 7OCT97 pt devel red bumps that extended to extremities & were heaviest on face;few lesions appeared on trunk, arms, & legs;10OCT97 seen by MD 25 lesions w/mult papules scattered;T100.2; 02/11/2010 Information has been received concernign a 20 weeks old male patient whose sibling was vaccinated on 05-SEP-1997 with VARIVAX. There was no concomitant medicationl On 07-OCT-1997 the patient developed "red bumps that extended to his extremities and were heaviest on his face". "A few" lesions also appeard on his trunk, arms and legs. On 10-OCT-1997 he was seen by a physician who noticed 25 lesions "with multiple papules scattered on his face, scalp, chest, abdomen, back and extremities". The patient also experienced a fever of 100.2 P rectually, but the infant was "otherwise fairly active and happy". Polymerase chain reaction analysis, obtained from a vesicle on his upper extremity, revealed VARIVAX/adequate specimen, vaccine strain. The patient's mother reported that the patient "bathed with the vaccinated sibling" who had a similar experience (WAES 97101013 and 97120340). Subsequently the patient's experiences were reported in a published literature article. The patient developed varicella after exposure to his sibling who was vaccinated with VARIVAX.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration), INFLUENZA LIKE ILLNESS (She felt like she had the flu), INJECTION SITE ERYTHEMA (She had redness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bariatric surgery. Concurrent medical conditions included Hypertension, Obesity, Diabetes and Drug allergy (clinoril). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), LABETALOL, MELOXICAM (MOBIC) and OMEPRAZOLE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (She had redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE PAIN (pain at the injection site). On 16-Jan-2021, the patient experienced PAIN (body ache), INFLUENZA LIKE ILLNESS (She felt like she had the flu), HEADACHE (bad headache) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body ache), BACK PAIN (had stabbing pains on upper back, not on inspiration or expiration), INFLUENZA LIKE ILLNESS (She felt like she had the flu), INJECTION SITE ERYTHEMA (She had redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE PAIN (pain at the injection site), HEADACHE (bad headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: No new information
Swelling and erythema of the right forearm after second COVID-19 vaccine along with shoulder pain. Symptoms started on 3/14/21.Pt was admitted to the OBS Unit  and subsequently diagnosed with  Right Upper Extremity Cellulitis.Tx in hospital was Rocephin IV for failed po Keflex tx. and subsequently discharged home on Doxycycline 100mg po BID x10 days .Pt. was also in the ED on 3/17/21 for same c/o and discharged on po Keflex.
The first dose was normal and no side effects but the second one was a different story. I got a fever and it was an unbearable headache. I took a tylenol and short after everything was back to normal. The pain was in the middle of my head.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included INFLUENZA VACCINE for an unknown indication. On 7th October 2018, the patient received the 2nd dose of SHINGRIX and INFLUENZA VACCINE. On 7th October 2018, less than a day after receiving SHINGRIX and 1 day after receiving SHINGRIX and INFLUENZA VACCINE, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were unknown. It was unknown if the reporter considered the fever, pain and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but he was above 65 year old The patient got SHINGRIX concomitantly with high dose of Flu shot.  Both shots were given in the same arm. The patient experienced pain, fever, chills until the next day. The reporter said thought it was due to the high dose flu. The reporter did not agree to follow up from GlaxoSmithKline.
Chest pain; Shortness of breath; Chills; Ache every part of the body even if she was touch she would shout of pain; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), CHILLS (Chills), MYALGIA (Ache every part of the body even if she was touch she would shout of pain) and HEADACHE (Severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMIN D NOS for an unknown indication.    On 18-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 CHILLS (Chills), MYALGIA (Ache every part of the body even if she was touch she would shout of pain) and HEADACHE (Severe headache). On 25-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), CHILLS (Chills), MYALGIA (Ache every part of the body even if she was touch she would shout of pain) and HEADACHE (Severe headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Additional concomitant medication included unspecified medicines for high blood pressure (every day) and for stomach. On an unspecified day, the patient felt ok but not 100% well. Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
serious neurological injuries; skin infection; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 12-OCT-2015 (at approximately 59 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: skin infection and serious neurological injuries. The outcome of the events was unknown.   The lawyer considered the event serious neurological injuries to be medically significant.
Medication error. Combination Vaxelis was administered instead of the ordered DTaP, resulting in extraneous dose of Hep B, out of schedule IPV and duplicate HIB vaccine. No reactions noted a tthe time of service. No report from parent/guardian of adverse reaction. Parent was notified by provider.
1 day post vax, temp of 103.6. L deltoid swollen w/ red rash and painful.