chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they were not suitable for use/no AE; they were not suitable for use/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed or not.  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 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.
Left arm had pain occasionally 3 times and not continuously, and pain felt like nerve pain which only lasted for a day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Left arm had pain occasionally 3 times and not continuously, and pain felt like nerve pain which only lasted for a day) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 in December 2020. Previously administered products included for an unreported indication: VACCINES (Patient also received Shingles vaccines 15 days before receiving COVID-19 vaccine.) in February 2021.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm had pain occasionally 3 times and not continuously, and pain felt like nerve pain which only lasted for a day). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 11-Mar-2021, PAIN IN EXTREMITY (Left arm had pain occasionally 3 times and not continuously, and pain felt like nerve pain which only lasted for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment drug us was not provided by the reporter
This concerns the second dose, but effects were the same after the  first. Pain and redness at injection site. Pain initiated if area touched. Headache, effectively controlled by Tylenol. "Funny" feeling in head for several hours....felt like a mix of light headedness and dizziness, but not like either by itself. Red areas about 3-4" above injection site as well as around navel and band across chest under breasts.  Following the first vaccination, the "events" subsided in a couple of days, except for the red areas which lasted a week or so. None of the effects prohibited me from normal activities.
Continual stiff neck, soreness of neck, shoulder and upper back.  Soreness in major joints and muscular areas, such as arms and legs.
Patient reported redness at injection site. Patient consulted with PCP and was prescribed oral antibiotics.
Information has been received on 09-JUL-2018 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 15-SEP-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, 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.
besides a sore arm , back muscle soreness and canker soar in my  mouth and cold sore on my lower right lip
The day after his second dose, he felt malaise, severe headache.  His left side of the face developed numbness, he had hearing loss, and worsening tinnitus.  He has existing tinnitus and hearing issues and was objectively evaluated by audiology within 2 days, and found to have found significant worsening.  It began slowly resolving over a few days to weeks.  It is still being evaluated for potential other causes such as intracranial tumor or cochlear stroke.
Immediately s/p vaccination, pt c/o dizziness. Put to lie supine on exam table, after 15 mins dizziness resolved.
Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 83 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering".  Additional Information: The patient believes that fatigue was after the third vaccination but it wasn't constant, one day this week, one day next month. End Date: Might happen this month then not happen again until next month. However, it was clarified it is ongoing but has improved as it used to be every other day, then every other week, and now by month.
Sweating, lightheaded, flushed cheeks, general feeling of malaise.  No fever.  Rest and fluids administered for two days and patient appears to have fully recovered.
I had very bad headache, nausea, vomiting. I felt like my left side was weaker than my right side, I thought I was having a stroke. I went to the emergency room to rule out that I was not having a stroke. They did a CBC, CT Scan with and without contrast, blood work. Everything came back normal. They gave me IV fluids, some pain medication.
Time to onset: 6 hours. Patient developed full body hives, severe congestion, lip, tongue, throat, and eye swelling. Wheezing. Difficulty swallowing. Treated with Claritin 20 mg po, Benadryl 25 mg po, albuterol inhaler 2 puffs, prednisone 50 mg po, and Asmanex 2 puffs. Within 1 hour hives and lip swelling began to resolve. 1 hr after taking prednisone, tongue and eye swelling resolving.  As of 740 am on 5/19/21, hives resolved. Only continuing sx was mild throat swelling sensation.
48 hours after vaccination, I experienced majority of side effects, fever, chills fatigue, headache, sniffles, sore arm where shot administered,etc. side effects only lasted 48 hours except for arm, it was sore 3 days.
chills; headache; achiness; fever; vomited; tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (achiness) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Talwin, Lisinopril).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). On 25-Feb-2021, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (achiness), PYREXIA (fever) and VOMITING (vomited). At the time of the report, CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (achiness), PYREXIA (fever) and VOMITING (vomited) outcome was unknown.            there are no concomitant medication mentioned :no medical history mentioned , no lab data mentioned. Patient treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received and contains no new information (declined further contact)
Dx Cough  ? Headache ? Sore Throat ? Fatigue   Upper respiratory tract infection, unspecified type  Loss of taste
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
The pt developed shingles (blistered rash) on left upper arm. Same location vaccine administered in.
No adverse event; The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (patient received the primary series and the first booster dose with Pfizer Covid-19 vaccine .). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 17-Feb-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older).    No concomitant medications were reported. The patient is doing well and did not complain of any other Adverse Reactions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2023: Live-Significant Follow up received- Narrative and Reporter name was updated.
Red rash from top of deltoid to elbow on outer surface of arm, started 6 weeks after vaccine and has persisted several days. Possible fever.
R09.02 HYPOXIA 4/26/2023 BACTERIAL PNEUMONIA
I had 8 days of severe body aches and weakness. I took Tylenol which gave some relief, but not complete relief.
Diagnosed with Covid After 1st shot; Weakness; dizziness; bodyache; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid After 1st shot), ASTHENIA (Weakness), DIZZINESS (dizziness), MYALGIA (bodyache) and HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (dizziness), MYALGIA (bodyache) and HEADACHE (headache). On 04-Jun-2021, the patient experienced COVID-19 (Diagnosed with Covid After 1st shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. At the time of the report, COVID-19 (Diagnosed with Covid After 1st shot), ASTHENIA (Weakness), DIZZINESS (dizziness), MYALGIA (bodyache) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, SARS-CoV-2 test: positive (Positive) diagnosed with Covid after 1st shot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added lab data, treatment medication and patient anatomical section.
Rash over entire body, took BENADRYL q6h for 2 days. Rash resolved after 48 hrs.
Per mom patient developed a rash all over body from the neck down on2/3 @1
Initial unsolicited report received from a Physician on 17-MAY-2018. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as last fall, September-October) at a pharmacy. Patient's medical history and concomitant medication were not reported. On an unknown date, within one to two-hour post vaccination, patient developed anaphylactic reaction. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: anaphylactic reaction. Documents held by sender: none.; Sender's Comments: This is poorly documented case which involves a female patient who received FLUZONE HD vaccine and experienced anaphylactic reaction one- two hours after vaccination. Time to onset is compatible with the role of vaccine and the diagnosis. Anaphylactic reaction is an expected event following FLUZONE HD administration. However, additional information, including patient's medical history, allergic history, medical condition at the time of vaccination and immunization history (tolerance to previous vaccination) are needed for further assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Ventricular tachycardia; Heart trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose:1), for Covid-19 immunization. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), outcome "unknown", described as "Ventricular tachycardia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart trouble". Caller stated she spoke to a representative earlier wherein she reported that after getting the 2nd dose of Comirnaty, she developed ventricular tachycardia. Caller added that no doctor can say if it was or it wasn't from Comirnaty but she said she did have heart trouble after the 2nd dose. Caller said she was curious if had this been reported and said that she doubted that she was the only one who experienced this. She mentioned she had all 3 doses although she was very leery to take the booster dose. Caller added this was just something she wanted to report as she's never had heart trouble and this started after the 2nd dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt without h/o hematologic disease.  Admitted to hospital <2 weeks after vaccination with acute severe thrombocytopenia (platelets 17) without otherwise normal CBC/diff.  No symptoms other then bruising and minor bleeding (epistaxis). Pt treated as ITP with oral dexamethasone bolus (40mg PO qd x 4).  Immediate improvement of thrombocytopenia.   February 11, 2021 06:10 94 L  10 3/cumm  February 10, 2021 06:50 36 L  10 3/cumm  February 9, 2021 13:55 17 CL  10 3/cumm   Will be discharged on to complete steroids on 2/12 and then labs/CBC will be monitored every few days as outpt. Pt to continue to hold BASA until at least confirm stability of platelets off Rx.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 17:45 as dose 4 (booster), single (Lot number: GJ3275) at the age of 50 years, in left arm 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's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen; Methotrexate, reaction(s): "Known allergies: Methotrexate", notes: Known allergies: Methotrexate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: I originally started testing negative on day 8-11; Negative, notes: I originally started testing negative on day 8-11; Negative, notes: I originally started testing negative on day 8-11; Negative, notes: I originally started testing negative on day 8-11; Positive, notes: Tested on day 13 from original positive test and tested Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral Paxlovid for COVID 19 Treatment from 29Dec2022 to 03Jan2023.
I did  not have a reaction until I got home on Jan 4th, 2021. I had a headache for a solid 2 weeks. Lost my vision right eye on Feb 1st with extreme vertigo ended up in the hospital. After a few tests they found a heart defect ASD. Never in my life have I been told I have had a heart condition. I am correlating it to the vaccination because for the 4 solid weeks before I ended up in hospital I was so sick.
15 days after first shot (April 10), experienced migraine with aura, had 4 of the same episodes in the same week, also including vertigo, nausea, fatigue. Also began menstruating in this month two weeks early, with an unusual flow.
pt c/o itching on bilateral legs, taken to close observation area where she began to c/o SOB. Epi given IMx1 and pt transferred to ED
Felt like she was having a seizure, her head kept moving back and forth; Tremendous amount of mucous in her naval cavity; Didn't feel good; Got really hot; A spontaneous report was received from a consumer who was a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity.    The patient's medical history included vagus nerve problems. No relevant concomitant medications were provided.   On 02 Jan 2021, at 11: 30 am, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19.  On 02 Jan 2021, about 8:30 pm, the patient stated she got really hot and didn't feel good. She mentioned she had a history of vagus nerve problems, and this reminded her of that experience when she felt like she would pass out. The patient said she felt like she was having a seizure and her head kept moving back and forth. She mentioned having a tremendous amount of mucus in her nasal cavity. She stated she still didn't feel like herself at the time.   On 19 Jan 2021 the patient stated she felt a bit better.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity, were resolving.; Reporter's Comments: This case concerns a 76-year-old, female patient with medical history of vagus nerve problems, who experienced serious, unexpected event of seizure like phenomenon and non serious, unexpected event of hot flush, malaise and mucus discharge. The event occurred 9 hours after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
He was waiting for 15 minutes after the vaccine.  He was starting to feel warm and had a metallic taste in his mouth.  He also felt nauseous and lightheaded.