chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-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 24-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.   Patient had fever and fatigue.   This case was linked to MOD-2023-747310, MOD-2023-747350 (Patient Link).
Fever and general sickness felt on day after shot, chills in evening, worse fever at night.  Body aches especially in back and chest on the same night.  Second day after shot:  feeling better during day but fever and aches returned at night; aches in upper back, chest, and left hand.
body aches; no appetite; chills; nausea; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), DECREASED APPETITE (no appetite), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (body aches), DECREASED APPETITE (no appetite), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, PAIN (body aches), DECREASED APPETITE (no appetite), NAUSEA (nausea) and HEADACHE (headaches) was resolving and CHILLS (chills) outcome was unknown.        Action taken with mRNA-1273 in response to the events was not Applicable.   Concomitant and treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-069782 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069782:Case for first dose
Rash on forearms noted 2 days later which spread cover torso, went to urgent care given cream and advised to take Benadryl. went back o6 days later and rcvd shot of steriod on 15th.
Inadvertantly gave 2 doses of Pediarix vaccine. 1 dose in each thigh-called GSK (Mfg) and CDC, no life threatening reactions-increase risk for localized react.
Patient had excessive cry from 1 pm to 11 pm. Her right thigh was very red for the same duration. She did not develop a fever.
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself.   A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date, (Oka/Merck) VARIVAX underwent a temperature excursion and on an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX, lot number J014407 expiration date 13-NOV-2015, 0.5 ml, subcutaneous. No concomitant medication reported. No adverse effect report. The certified medical assistant was unable to offer patient identifiers or dates of vaccination, at the time of the report. At the time of the report the action taken with (Oka/Merck) VARIVAX was not reported. Causality was not reported. This case has been linked to Case # 1408USA008060 as same reporter link. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' current conditions and medical history were not reported. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (strength, dose and route of administration were not reported) lot # M029230, expiration date 08-MAY-2018, for prophylaxis. The vaccine was exposed to 9 degree celcius to 25 degree celcius for 35 hours (incorrect product storage). Properly stored sterile diluent (MERCK STERILE DILUENT) was used for reconstitution.There were no reported adverse events. There was no previous temperature excursions. Temperatures were tracked with data logger. There was no product quality complaint(PQC) involved.  Follow-up information was received via medical assistant on 18-AUG-2017. It was reported that one patient was vaccinated with M-M-R II, but did not have that information in front of her. She stated she would fax the patient identifiers and dates of vaccination for that patient. Patient details and narrative updated. This is one of the two cases received from same reporter.; Sender's Comments:  US-009507513-1708USA009300:
Slept poorly, fainted the following morning, sustained a concussion, facial laceration, bruised eye. Admitted to ER, received intravenous fluids, ekg, diagnosed with low blood pressure, mild concussion and received 3 stitches to close laceration above right eye.
This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a female child "older than 10 years" who was vaccinated with GARDASIL. Within 12-15 hours, the patient experienced nausea and vomiting. She recovered on an unspecified date.  This is one of two reports received from the same source. Additional information was not available.
he is having chills on/off; arm sore; little headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 10:15 (Lot number: ER8735, Expiration Date: 31Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure was high" (unspecified if ongoing), notes: Was taking unspecified blood pressure medication and went back to normal. The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "recovered", described as "he is having chills on/off"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "arm sore"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "little headache". Therapeutic measures were taken as a result of chills, pain in extremity, headache.  Additional Information: Caller mentioned that he was having chills on/off after receiving the first dose of the Pfizer COVID-19 vaccine.  Consumer was taking unknown blood pressure medication for  Blood pressure was high for months before. Was put on medication and then it went back to normal and takes every day but as needed. Does not remember the name but thinks it starts with the letter T. Caller states he was calling about Pfizer, took the first Covid vaccine 26 of last month, 26Apr2021. Has been experiencing chills once in a while. One day he would have chills and the next day he would be fine. He was told the chills should not last more than 2 to 3 days. It has been 3 weeks now, back and forth. He needs to seek information before going tomorrow. The first day was ok, the second day it was just sore where he had the shot. After that, it was a little headache and chills and  thought it should be no more than 2 to 3 days. Was not steady, it comes and goes, then he is okay. Arm sore was Went away a couple of days later. Chills: Have been back and forth. Started around the 3rd to 4th day after the shot. He was ok. Happened last night and the day before, he was fine all day. Up until last night and today he was fine as he was talking now. He got confused if it is okay to take the second shot or if he should wait. The chills are about the same. They are tiny chills and are not severe. Has been taking Tylenol as treatment. It was noted on vaccine card that second dose should be 17May2021 to 07Jun2021. History of all previous immunization with the Pfizer vaccine considered as suspect was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was No. AE(s) did not required a visit to Emergency Room/ Physician Office. No prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) was no.   No follow-up attempts are possible. No further information is expected.
4 days after receiving smallpox vaccine, patient developed fever.  Temperature reached a maximum of 104 the following day and was associated with chills, "strong shivering", myalgias, and intermittent headache.  The following day the patient developed sore throat and "swollen lymph nodes" on his neck.  He denied any cough, rhinorrhea, or nasal congestion.  Seen by his primary MD on 3/27.  Diagnosed with Strep throat (rapid Strep test positive).  He was treated with penicillin and was feeling better later that day.
This is a spontaneous report from a contactable nurse (mother).  A 17-year-old female patient received the first dose TRUMENBA (lot number S85201; expiration date: 30Dec2019), via an unspecified route of administration on 19Jul2018 at a single dose for Meningitis B. The patient's medical history and concomitant medications were not reported. The mother stated that she had identical twins 17 year old daughters and were pretty small for their age only like a 100 pounds. It was stated that the mother and her daughter's went to their pediatrician on 19Jul2018 (Thursday) and had the meningococcal group b rlp2086 first shot given to them of the vaccines for the meningitis B. It was mentioned that the patient (one of the reporter's daughter) don't feel well (Jul2018). The patient stated that she had chills and nausea. The mother thought that the patient was going to faint as she was coming down the stairs with thought she going to faint. The patient came on the couch and then she was kinda caught up in bond. The patient was very rigid and very tense and very stiff. The mother then asked if what's going on in the patient's body but can't explain it. The patient described it that it just feel like there's poison running through her body. The mother just freaked out and ended up calling the pediatrician back but didn't hear back from them. The mother then drove to their office and spoke to the nurse. The nurse mentioned that she doesn't think that it was a side effect. The mother then narrated that the patient actually ate a good dinner later and she was starting to feel a little bit better and then she went to bed. The patient then woke up and stated that it was all kind of coming back. The mother then asked what it feels like. The patient then stated that she was like a burning. The patient later elaborated that she woke up with the high fever. The mother didn't check the temperature because she just wanted to bring the patient right over to the pediatrician but she felt warm like probably like 101, 102 so the mother bought her to the doctor's office. The doctor later stated that he mother probably just "chalking up to patient" kind of being like a perfect storm in her body. The patient later stated that like her body was going to start a period or hormones like all this stuff was going on and she said maybe if she wasn't going to start a period she would only have the two symptoms like her twin sister. So the mother kind of left with the feeling like a little more comfortable thinking alright perfect storm in patient body she maybe she would have just have had what her twin sister had if she haven't been starting her periods. The outcome of the adverse events was unknown.
started with a red blotchy rash and urticara, she went to ER and he tongue was swelling on Sunday 4/23/21. Patient ended up in ICU intubated.
Brain fog yet lots of energy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog yet lots of energy) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog yet lots of energy) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog yet lots of energy) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Blood pressure measurement: 168/72 (High) blood pressure 168/72. On 28-Mar-2021, Heart rate: 108 (High) Pulse racing 108.         Treatment information included Tylenol.   This case was linked to MOD21-051879, MOD21-051982, MOD21-051984 (E2B Linked Report). This case was linked to MOD-2021-042782 (Patient Link).; Sender's Comments:  MOD21-051879:MOD-2021-042782 MOD21-051982: MOD21-051984:
This spontaneous report was received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 670699/0814AA, exp. date 02-JUN-2013) (dose and route not reported). It was reported the lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lot of VARVIAX (Merck) exposed to -12C for a period of 328 hours. The excursion date range from 01-SEP-2011 to 05-JUL-2012. All of the stock (quality unknown) of the lot number were administered to an unknown number of patients. Last dose administered on 05-JUL-2012. The reporter stated that she believed that some of the VARVIAX (Merck) should have had stability information to support some of the excursions. Upon review lot # 670699/0814AA exposed to -12C for a period of 328 hours was supported. Temperature excursion did not affect this lot#. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
Arm started to swel; could barely raise his arm, painful; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Arm started to swel) and PAIN IN EXTREMITY (could barely raise his arm, painful) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20N) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SWELLING (Arm started to swel) and PAIN IN EXTREMITY (could barely raise his arm, painful). At the time of the report, SWELLING (Arm started to swel) and PAIN IN EXTREMITY (could barely raise his arm, painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Moderna COVID- 19 Vaccine EUA: After receiving vaccine patient reported scratchy throat. Diphenhydramine 25 mg orally adminsitered and symptom resolved. No new symptoms reported during 40 minute observation period and patient left vaccine clinic stable.
muscle pain, tiredness, headache, shivering, nausea, some mild diarrhea. No treatment as of this time
Patient reported she received vaccine around 1:30pm at Pharmacy, said had no prior flu like symptoms. Said sat for 15 minutes and had no reaction and went home. Said around 11pm that night, patient started having a bad headache and chills.  Said around 2am she started to have rigors that woke her up from her sleep and had a fever around 103 degrees. She stated on Saturday, she was disoriented and had dry heaving, nausea, vomiting and loss of appetite. She stated she felt weak and abnormal gait, stated "it felt like a vertigo attack". She stated she had incontinence 3 separate times after receiving vaccine and stated as soon as she stood up her bladder released.  Said she lost around 7 lbs from Friday to Sunday. She stated her arm was sore for about 48 hours and also had soreness of left breast and swollen lymphnode in armpit. She stated on Sunday her chills started to ease then Monday she started to feel better and her fever broke.
Moderna COVID-19 Vaccine EUA Booster Dose.  About 3 hours after the injection, started with heart flutter and rapid heart beat.  Measured at home, then returned to pharmacy to check vitals with their equipment. Pharmacy is a hub for , with a doctor available by call.  Spoke to pharmacist.  Heart Rate went to 100, blood pressure went to 159/82.  Episode lasted about three hours total,  then subsided.
Narrative: Symptoms:  Rash & UrticariaPruritus Treatment:
little puffy where the redness is; vaccination site warmth; Vaccination site erythema; started to itch a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started to itch a little bit), SKIN SWELLING (little puffy where the redness is), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, ROSUVASTATIN, SULFASALAZINE and CLONAZEPAM for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (started to itch a little bit). On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 03-Feb-2021, the patient experienced SKIN SWELLING (little puffy where the redness is) and VACCINATION SITE WARMTH (vaccination site warmth). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of UNK dosage form and LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PRURITUS (started to itch a little bit), SKIN SWELLING (little puffy where the redness is), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
3 days of SOB, chest pain, fatigue progressively worsening. Treated with Remdesivir, Decadron.
Patient told immunizer she was 65, but she was actually 64 and was given the high dose flu shot instead of regular flu shot. No adverse event reported
Pt was about to sit in a child when he fell to his knees, caught by medical provider and placed in a cot.  Temp 97.8, Resp 24, BP 126/83, P 88, glucose 130  Child transferred to medical clinic where he was monitored, provided fluids-child improved and was released
Mother reports that the day after immunization the patient reported fatigue and was unable to get out of bed.  No headache, no fever, and no other symptoms.  Mother states that patient slept on and off for two days.  No treatment required.  Fatigue/malaise not listed on VIS as side effect.
Extreme Fatigue, Extreme Anxiety, thoughts of Suicide,  and muscle weakness, Still ongoing for over 2 weeks since second dose. No doctor has been seen to address any concerns.
Arm swelled, 3 inch raised red bump that now has turned to a purple bruise- no biggie. Nausea, headache, lethargy and EXPLOSIVE diarrhea...big deal. It?s been 4 days now.
Arm was hard to lift, hot, rash that spread over course of several days but was gone by following Wednesday. Shot was given on Friday.
Having some issues from the vaccine/ Side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Having some issues from the vaccine/ Side effects) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Having some issues from the vaccine/ Side effects). At the time of the report, IMMUNISATION REACTION (Having some issues from the vaccine/ Side effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Reporter did not allow further contact
Patient has a history of Janssen COVID 19 vaccine given 5-18-21 She was due for Monovalent Moderna but was given Bivalent Moderna instead. No signs or symptoms or reactions noted.