chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; headache; felt lethargic; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and LETHARGY (felt lethargic) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, SIMVASTATIN, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In June 2023, the patient experienced PYREXIA (fever), HEADACHE (headache) and LETHARGY (felt lethargic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), HEADACHE (headache) and LETHARGY (felt lethargic) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine The patient had COVID-19 diagnosis. The patient had received the 1st dose of COVID-19 Vaccine on 12-JAN-2021, 2nd dose on 11-FEB-2021, 3rd dose on 18-AUG-2021 and the 4th dose on 05-APR-2022. The patient experienced these same symptoms with 1st dose which lasted for 3 or 4 days, and with last dose symptoms occurred approximately 1 week after the injection as the patient  had a delayed reaction, and symptoms were still ongoing.   This case was linked to US-MODERNATX, INC.-MOD-2023-728880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728880:(Monovalent Case)
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-DEC-2009, the patient was vaccinated at a hospital by a registered nurse with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2014, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
two doses of PENTACEL were administered, only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 patients who were administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ876AA) (with an unknown strength, dosage and expiry date) via unknown route in unknown administration site for Immunization, only the HIB portion given, and it was thought to be reconstituted with sterile water with no reported adverse event (product preparation error) (latency- same day).  Reportedly, Caller reporting two doses of PENTACEL were administered, only the HIB portion given, and it was thought to be reconstituted with sterile water. Caller reporting, they had 2 extra doses of the DTAP/IPV, which led them to believe 2 patients were given only the HIB. Caller reporting, they are unsure which patients affected, they have narrowed it down to 4, meaning 2 of the 4 receiving only HIB/sterile water and the other 2 patients received the full dose of PENTACEL. caller that the two patients who received the doses with HIB reconstituted with sterile water would not be counted as a valid dose. Caller then asked if they need to be repeated.  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 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.
Swelling, hot, hard, painful, headache, elevated blood pressure, onset 2:10 pm 11/6/14. ER visit. Ice and pain med 1 tab NORCO 5/325, methylprednisolone 125mg IM.
Approximately 12hours post-injection, onset of general muscle aches, nausea, slight fever.  Took 2 500mg tylenol Q8H.  AEs resolved on their on about 30hours post-injection.
Patient was consented for the flu vaccine, but tdap vaccine was given by mistake on 11/4/21.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose1, 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's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
03-16-17- Dad called to say child's left arm is pink, swollen and warm to touch. No pain -child is using arm. Afebrile. Advised to use cool moist compress. 3-18-17- Dad called to say arm is still swollen, pink and warm to touch. Area is from shoulder to elbow. Afebrile - playing and using arm. T.C. to medical Dr. Dad to take to clinic if not better by tomorrow. 3-18-17 9:30AM -Dad called to let me know child's arm is much improved and doesn't need to see a Doctor.
Pt vaccinated with Fluogen/Engerix developed puffy below eyes, blotchy patches on shoulder & legs, felt like fever, stiff neck started morning after & lasted 1 wk red color around neck
A report was received from a health care professional on 12/18/03 concerning a 42 year old female vaccinee who received expired Fluvirin on approximately 10/20/03. On approximately 10/20/03 the vaccinee received expired vaccine. The vaccinee did not experience any adverse effects as a result. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending. All information received.
This spontaneous report was received from a nurse practitioner referring to a patient of 4 months old of an unknown gender. The patient's relevant medical history and past drug history were unknown. On 14-APR-2010, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot # were unspecified). On 16-JUN-2010, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route and lot # were unspecified). On 09-AUG-2010, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot # were unspecified). Concomitant medication were not reported. The reporter stated that the patient's dates of vaccination with RECOMBIVAX HB was not correct. No adverse experience reported. Additional information has been requested.
"Red, warm and lumpy x 1 week" Now lumpy and bruised x 1 wk", bruising, harden areas and slight tenderness observed.
patient reported groin and armpit lymphodema beginning 3 days after immunization and remaining present 38 days post vaccination. Patient went to primary care doctor who assessed and informed him it was probably an immune response to the recent vaccination. Lymphodema improved with no lingering symptoms
No adverse event; pt received an 2 day expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (pt received an 2 day expired dose).    No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
This spontaneous report as received from Licensed Practical Nurse regarding a 4 month old patient. The patient's medical history and concurrent conditions were not reported. On 11-APR-2016, the patient was inadvertently administered with an expired dose of ROTATEQ (lot # K006455, expiry date 10-FEB-2016) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Low grade fever for 24hrs? still active: Full body muscle aches(primarily lower back, neck, and shoulders), pain at injection site, fatigue...
chills, muscle aches, runny nose, sore throat, headache,, cough, sweats
I have lost at least 25% of my hair. I have never experienced this type of hair loss before the shot, and am not under any major stress. I had my last shot about one year ago, and have noticed a lot of shedding of my hair since then. It is just now to the point that other people are noticing how wide my part is getting. Not to mention the fact that I have had other strange symptoms.  Sometime after my second shot, I ended up in the hospital with what the doctors called a "panic attack".  I have no previous history of panic attacks and was not under any real stress at the time.  Furthermore, I have had extreme headaches, near fainting spells with partial loss of vision for a few hours at a time.  To add to that, I have developed immunity deficiencies. Before this vaccine, I was perfectly healthy.  Now, I have spent hundreds and hundreds of dollars trying to figure out what is wrong with me.  This is physically and emotionally damaging, and I hope no one else has to experience this.  2/11/09 Received ER medical records of 8/23/2007. FINAL DX: panic attack; possible med side effect Records reveal patient experienced shakiness, difficulty swallowing with sudden onset after taking bactrim for facial infection.  Felt facial swelling.  Tx w/antihistamine, improved & d/c to home.  3/10/2009 Received PCP medical records of 1/29/08-1/14/2009. FINAL DX: Records reveal patient experienced: asthma, sinus HA, chest congestion, cough, fever, body aches, URI, asthma exacerbation, BCP use, tension & difficulty relaxing, weight loss, feeling cold, anxiety, fatigue, conjunctivitis, HA w/temporary left lateral vision loss 11/08, alopecia 12/08.  Tx w/meds.
rash 3 inches long, 2 inches wide and blotchy; small rash on the patient arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (rash 3 inches long, 2 inches wide and blotchy) and VACCINATION SITE RASH (small rash on the patient arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (small rash on the patient arm). On 17-Mar-2021, the patient experienced RASH MACULAR (rash 3 inches long, 2 inches wide and blotchy). In March 2021, VACCINATION SITE RASH (small rash on the patient arm) had resolved. At the time of the report, RASH MACULAR (rash 3 inches long, 2 inches wide and blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient was prescribed with an unspecified steroid and antibiotic cream.
Pt. c/o pain and redness to (Lt) deltoid. Pt. seen 9-11-12 rec. injection. Dx: cellulitis -> pt seen again 9-13-12.
Some hardness; Muscle is a little bit hotter; Temperature inflammation around the area; Red spot bigger and bigger; Itchiness; Pain at bit lower at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Some hardness), VACCINATION SITE WARMTH (Muscle is a little bit hotter), INFLAMMATION (Temperature inflammation around the area), ERYTHEMA (Red spot bigger and bigger) and PRURITUS (Itchiness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Some hardness), VACCINATION SITE WARMTH (Muscle is a little bit hotter), INFLAMMATION (Temperature inflammation around the area), ERYTHEMA (Red spot bigger and bigger), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at bit lower at the injection site). At the time of the report, VACCINATION SITE INDURATION (Some hardness), VACCINATION SITE WARMTH (Muscle is a little bit hotter), INFLAMMATION (Temperature inflammation around the area), ERYTHEMA (Red spot bigger and bigger), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at bit lower at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The treatment information was provided as painkiller.
Patient reported back to us that she had swelling and redness at the injection site. She had some slight pain as well.
SADDLE PULMONARY EMBOLISM ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT, UNSPECIFIED VEIN ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXEMIA
Per MCIR, patient received three doses of Pfizer COVID-19 vaccines on 3/5/2021, 3/26/2021, and 10/22/2021 and was subsequently diagnosed to have COVID-19 at our hospital on 1/6/2022
Patient reported reaction at site of injection which was hot to the touch and could not be relieve with icing. Patient experienced pain and refuses to schedule 2nd dose. Her symptoms resolved after two weeks.
Area of injection site is red approximately 1 inch diameter. 3 inches distal to injection site there are red, warm, firm raised areas.
Patient developed dizziness, severe right arm pain and heaviness, hyperventilation, severe shivering, diffuse "pain", nausea, and altered level of consciousness over the course of 20 minutes post-vaccination. Was unable to lift/use right arm and any movement/palpation of right arm caused shivering/tremors and pain.  Vital signs including BP, HR, temp, and Oxygen sat remained stable throughout.  After 20 minutes pt became very fatigued and was difficult to arouse intermittently therefore 911 was called and paramedics arrived, VS remained stable, blood glucose 95, IV started, pt was given Benadryl IV and transported to ED for ongoing evaluation and observation.  Per parent, within 45 minutes of arrival in ED pt had fully recovered, symptoms had resolved completely including pain, and pt was discharged home with diagnosis of "panic attack"
Received DTaP in deltoid IM on right arm and MMR SQ in posterior right arm. Developed erythema, increased skin warmth and moderate swelling over deltoid region of right arm around 5cm starting on 5/1/04. No temperature or irritability. Does not extend to site of MMR vaccination.
I was 33-34 weeks at the time of vaccination. With the exception of fatigue, I was fine up until about 2 weeks later. I was basically burning the candle at both ends and I had a low-grade fever that was increasing and chills, so I contacted my midwife and was instructed to take Tylenol. I was fine afterwards. I'm not sure if it's related. It couldn't been the fact that I was moving during this time.
10/26/07 - Patient reports left arm "aches awful" where "flu shot was given 10 days ago."  No home intervention for pain.  No redness, swelling or discharge.  Advised ice and Tylenol as needed.  Seen by M.D. 11/1/07 for persistent pain.
The evening after vaccine administration, pt felt feverish, total body aches, pain at injection site on (L) upper arm. Also sinus congestion, cough - still having these symptoms 8 days later. 15 weeks pregnant.
Anxiety, dizziness, respiratory distress. BP 194/94 (pulse 96), 162/95 (pulse 74).
I received the j&j vaccine on 3.7.21 and I currently have symptomatic covid.  had to get albuterol, steroids, cough suppressant etc and feel pretty bad.  I wanted to be sure to report.
This spontaneous report as received from a pharmacy student refers to a female patient of unknown age. On 01-DEC-2012 the patient was vaccinated with ZOSTAVAX vial for vaccination (form, dose, frequency and route unknown). No other co-suspects were reported. No concomitant medications were reported. The pharmacy student reported that a patient developed shingles a few days after receiving ZOSTAVAX (exact date unspecified). At the time of report the outcome was unknown. Additional information has been requested.
SWEATING; CHILLS; NAUSEOUS; FATIGUE; HEADACHE; CRAMPS IN LEGS; ACHINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021, the subject experienced cramps in legs. On 18-MAR-2021, the subject experienced achiness. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced nauseous. On 18-MAR-2021, the subject experienced fatigue. On 18-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps in legs, achiness, chills, nauseous, fatigue, and headache on MAR-2021, and sweating on 19-MAR-2021. This report was non-serious.
Tested (+) for Covid; Tested (+) for Covid; This is a spontaneous report from a contactable other hcp. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: El3247, Expiration date: Unknown), intramuscular, administered in left arm on 11Feb2021 06:45 (at the age of 50-years-old) as dose 2, single and first dose via intramuscular, administered in left arm on Jan2021 04:45 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. It was unknown that, other vaccine was administered in four weeks. It was unknown that, other cations were given in two weeks. The patient did not have Covid prior vaccination. It was unknown that, if Covid tested post vaccination. Known allergies was reported as unknown. The patient's medical history and concomitant medications were not reported. On 02Aug2021, the patient tested positive for covid. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. No treatment was received for the event. The outcome of the event was recovering. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and Vaccination failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the drug is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, as appropriate.
10-12 hours after the vaccination  very severe arthritis pain in shoulders and neck, fatigue, chills (no fever). Treated with tylenol and topical voltaren. Pain scale 9+