chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site aches; it feels leg no temperature to touch/Sometimes it feels (word not legible)/ hot; Radiating pain/tingling down arm into hand and fingers.; Radiating pain/tingling down arm into hand and fingers.; a small swelling appeared on arm below injections site- now a hard bump had replaced it; The initial case was missing the following minimum criteria: [No Adverse Effect]. Upon receipt of follow-up information on (15Feb2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EN9581) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pain in arm" (unspecified if ongoing), notes: Tylenol (intent: treatment) for the pain in my arm. The patient's family history included: "ILD-Interstitial lung disease" (ongoing), notes: Family Medical History relevant to adverse events (AEs): ILD- Interstitial lung disease. Concomitant medication(s) included: VENLAFAXINE HYDROCHLORIDE; VITAMIN D [COLECALCIFEROL]; BABY ASPIRIN; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site aches"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "it feels leg no temperature to touch/Sometimes it feels (word not legible)/ hot"; PAIN (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "Radiating pain/tingling down arm into hand and fingers."; SWELLING (non-serious), outcome "unknown", described as "a small swelling appeared on arm below injections site- now a hard bump had replaced it".  Additional information: For fast 2 years injection site aches. Sometimes it feels (word not legible)/ hot. No temperature to touch. Radiating pain/tingling down arm and into hand and fingers. At one point, a small swelling appeared on arm below injection site. Now a hard lump has replaced it.
swelling (size of a dime), redness, and warmth at the site of vaccination and surrounding area/shoulder, total area approx 3 inches
pt recv vax & devel pain @ the inj site;pain persisted for several days & resolved;
Local reaction of left shoulder. 2 inches red and swelling in 24 hours. Dry mouth with swallow problem next day. Pt went to ER and given Prednisone/BENADRYL and PEPCID.
Local irritation to injection site. Mild redness visible no c/o itchiness. BENADRYL gel applied topically. Patient released at 2:10 with decreased redness. No further treatment required. Follow up next day rash had vanished within one hour post injection as per patient. She reported to work.
MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; FEELING UNWELL; FATIGUE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a patient concerned a 32 year old female. The patient was enrolled in a non-company sponsored study regulatory authority: COVID 19 Vaccines regulatory authority Registry number: C00103). The patient's weight was 90.7 kilograms, and height was not reported.  The patient's concurrent conditions included anxiety, asthma, depression, and polycystic ovarian syndrome. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prevention covid-19 (covid-19 immunisation). Concomitant medications included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide.  On MAR-2021, the patient experienced maternal exposure during pregnancy. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced muscle pain. On MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, feeling unwell, muscle pain, sore arm, maternal exposure during pregnancy and nausea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, feeling unwell, fatigue, muscle pain, and nausea was related.  This report was non-serious.
Fever ARM PAIN, FATIGUE, MALAISE, BODY ACHES Narrative:  Other Relevant History:
GOTTEN COVID AND WORSE; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient experienced gotten covid and worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gotten covid and worse. This report was non-serious. This case was associated with product quality complaint: 90000263901
No adverse event; patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7643e) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.) 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 (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.).    Concomitant product use was not provided by the reporter.  It was reported that this was patient's first bivalent dose. The patient received 2 doses of monovalent spikevax in the past.  Treatment information was not provided.
Had been an amoxicillin x 1 week & then had 2 vaccines at 5:05 pm. Mother reports that rash began around 6:30 pm & pt was taken to ER. She was given BENADRYL.
This spontaneous report as received from a Certified medical Assistant refers to a multiple unspecified patients of unknown ages and genders. The patient's medical histories and concurrent conditions were not reported. On an unknown date between 01-JUL-2016 and 14-JUL-2016 the patients were vaccinated with improperly stored dosses of ROTATEQ orally (lot number, expiration date, dose and frequency were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Case previously recorded as MA2009-4084. Initial case report received from a nurse via MedCom on 09 NOV 2009. A patient 2-year-old female was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 1009225PA) once i.m. on 09 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007868.
At 12 hrs after injection vomiting and severe chills for an hour.  15 hrs after injection severe body aches for an hour.  18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.
Large area of superficial redness at site of injection. No induration, no signs of infection. Benadryl and Tylenol as needed.
This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of neck, dizziness, difficulty swallowing. This persisted until 3/17. I had a similar reaction to the first dose. 3/15: Rash on face and neck. 3/16 Rash spread to chest and upper arms. 3/17 face swollen; headache, scratchy throat.  3/18: Symptoms subside by end of day, although skin still a little blotchy. I did tell the person who gave me the injection about my reaction to the first dose and she looked for the rapid response team to watch me, but she didn't find them. I suggest a sign in the waiting area indicating which symptoms are of concern (hard to distinguish immune response from allergy and/or anxiety attack.
numbing on right side of the body; Pins and needles sensation; Nerve pain all over body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): ACL21-10245.  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Thyroid, reaction(s): "heart rate irregular", notes: 120mg tablets(lot : UNK ; exp : 09/2021); Thyroid, reaction(s): "constipation"; Benadryl, reaction(s): "allergies"; Thyroid, reaction(s): "difficulty sleeping"; Trovan, reaction(s): "allergies". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing on right side of the body"; PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles sensation"; NEURALGIA (non-serious), outcome "unknown", described as "Nerve pain all over body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient takes the following concomitants medications (therapy dates : UNK). the consumer advised that Cytomel cause " horrible side effect" so she was switched to nature Throid (Strength, dose, frequency :UNK). On an unknown date, Nature Throid "quit working" and she was switched to armour Thyroid (Strength, dose, frequency :UNK). Approximately six years ago, she was switched to NP thyroid 120mg tablets, one half tablet by mouth in the morning and one quarter tablet by mouth in the morning. At the time, her labs were normal, and she didn't want to "over do it". In 2021, after picking up new fill of the suspect medication she began to experience an irregular heart rate, difficulty sleeping(insomnia), and constipation. In Feb2021, she complete lab work with her physician (results : TSH: 2.5, T3 low normal, and T4 low normal). In Apr2021, she received another fill of the suspect medication and her heart rate irregular, and constipation resolved. No treatment was reported. at the time of this report, she continuous to take the suspect. The outcome of her insomnia is ongoing and the outcome of her heart rate irregular, and constipation remain resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, NauseaVomiting, Localized pain, swelling; fatigue Narrative:
Patient passed away 4/12/2021 suddenly, found by family on couch. Was having shortness of breath day before. Per mom, patient had been laughing and talking the morning before patient passed away.
I got Covid in June and tested positive on June 20, 2022 I experienced fever, chills, severe headache, sore throat, hoarse voice and fatigue.   Symptoms lasted about a week and fatigue continued for 2-3 weeks afterwards.
The pt experienced a fever of 101 orally, 24 hours post vax, 5-8 cm erythema, induration, itching and pain over left deltoid. Symptoms have resolved by day 15.
Throat tightness. Facial swelling. Pt stated she took some steroids that she already had at home that were left over from a previous prescription.
1045am  Patient reported not feeling well to mom from School 1115am Mom gave Ibuprofen 600mg  Temp was 99.0 and she also reported a headache 1215pm MOM spoke to FNP and reported fever 101 and headache 2:26pm  mom report fever 100.5
approx 15min p/vax pt nauseated w/abd cramping which progressed to vomiting throughout the noc;also shoulder pain & inc thirst;also t101;instructed to keep well hydrated;T101;sl diarrhea;
2-3" raised red, raised rash at injection site; 2-3" raised red, raised rash at injection site; Itchy injection site; sore injection site/arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site/arm), VACCINATION SITE RASH (2-3" raised red, raised rash at injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE ERYTHEMA (2-3" raised red, raised rash at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K2VA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site/arm). On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (2-3" raised red, raised rash at injection site) and VACCINATION SITE PRURITUS (Itchy injection site). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (2-3" raised red, raised rash at injection site). On 11-Jan-2021, VACCINATION SITE PAIN (sore injection site/arm) had resolved. At the time of the report, VACCINATION SITE RASH (2-3" raised red, raised rash at injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE ERYTHEMA (2-3" raised red, raised rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.
pt recvd Engerix-B & 15 mins p/inject devel sl dizziness, nausea, h/a, blurred vision & BP was 100/70; seen in ER & released;
Pt complained of thirst after receiving vaccines, fainted , clammy, pupils dilated, double vision, After about 15 min. pt recovered.
Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced COVID-19 (Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 08-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 10-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient was taking any other medications or products within two weeks of starting COVID-19 treatment with Paxlovid. COMPANY COMMENT: This is an spontaneous case concerning a  53-years-old male patient with   no medical history who experienced the unexpected AESI event   of COVID-19 166 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  53-years-old male patient with   no medical history who experienced the unexpected AESI event   of COVID-19 166 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient was vaccinated on 3/2/21 and 3/23/21, so was fully vaccinated when testing positive for COVID-19 on 9/26/21.
Felt what may have been heart palpitations for the first time in my life tonight. Felt twice for just one beat each time like my heart was beating much harder/heavier
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid/Pfizer from 23May2023 (lot number: 2707499) for Treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid-19 cannot be ruled out.
6/26/05 noticed rash over entire body.  6/28/05 rash worse, went to drs place on prednisone - rash better, pt also has sore throat.
got double dosed with PENTACEL within seven day period / no AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00774812).  This case involves an 11-month-old (unknown gender) patient who received double dosed of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (extra dose administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported "Caller has a patient who was double dosed with PENTACEL within a seven day period; patient is 11mons old and has had a double lung transplant; caller would like to know what signs of AE to look out"  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was Not Applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-052928, US-MODERNATX, INC.-MOD-2021-052937, US-MODERNATX, INC.-MOD-2021-071492, US-MODERNATX, INC.-MOD-2021-053066 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information was received from the initial reporter: The reporter mail ID was added; Sender's Comments: US-MODERNATX, INC.-MOD-2021-052928:Crosslinked case; US-MODERNATX, INC.-MOD-2021-052937:Crosslinked case; US-MODERNATX, INC.-MOD-2021-071492:Crosslinked case US-MODERNATX, INC.-MOD-2021-053066:
After giving the vaccines, the patient stood up and went to stand next to father. 3 minutes passed by and he felt dizzy and started to kneel down. He fainted and landed on his back. He hit the back of his head. After less than 1 minute he woke up. Parents stated he was fasting.
Information has been received from a physician concerning an "around 12 year old" female with unknown allergies and unknown medical history who on an unspecified date was vaccinated with a dose of GARDASIL (dose number, vaccination date not reported). Subsequently, on an unspecified date after vaccination the patient had a positive papsmear test. Unspecified medical attention was sought. At the time of report, the patient's status was unknown. Additional information has been requested.