chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; persistent headache; soreness at injection site; fatigue; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) dose 1 via an unspecified route of administration (age at vaccination: 27) in Left arm on 17Feb2021 2:00 PM as dose 1, single (at the age of 27 year) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate) ADDERALL, Bupropion SR, (CETIRIZINE HYDROCHLORIDE) ZYRTEC No known allergies. No other vaccine was taken in four weeks. Patient reported that COVID test prior and post vaccination was no. On 18Feb2021 07:00 the patient experienced chills, persistent headache, soreness at injection site, fatigue. Treatment was not received for the events. The clinical outcome of all events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
cellulitis in the leg; bad chills; flu like symptoms; headache; Nausea; high fever; short breathing; A spontaneous report  was received from a consumer, concerning her husband, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.  The patient's medical history was not included. Products known to have been used by the patient were not provided. Prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 041L20) for prophylaxis of COVID-19 infection.  On 04 Feb 2021, after the mRNA-1273 vaccine was given, the patient experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) and PAIN IN EXTREMITY (aches and pains) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (aches and pains). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). On 21-Apr-2021, PAIN IN EXTREMITY (aches and pains) outcome was unknown. At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-082892, MOD21-079885, US-MODERNATX, INC.-MOD-2021-082989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082892: MOD21-079885: US-MODERNATX, INC.-MOD-2021-082989:2st dose
Narrative: Rash on 5/7/21 began to develop erythema at injection site. Since on 5/9/21 the redness has shifted to the r medial arm at bicep area of 7 cm long x 4.5 cm wide. Rom of rue shoulder elbow wrist fingers intact, some lymph node swelling in r axilla, no fever no streaking at injection site.
Headache; Chills; coldness; achy bones; This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 01Mar2021 at 18:00 (at the age of 59-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 60-years-old); as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Concomitant medication included ibuprofen (ADVIL) from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unspecified date in Mar2021, after receiving the first dose, the patient experienced chills, coldness, achy bones for 2 days and headache for 14 days. After the second dose, patient had milder symptoms and for shorter duration. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events achy bones, chills, coldness and headache was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient's mom came into the clinic on 08/13/2018 to pick up his shot records. She reported to me at that time that his left leg was red and swollen at the site. She showed me a picture and it was a large red raised area covering most of his upper thigh. She stated that he started complaining about pain late Friday night into Saturday. She also stated she has been giving him BENADRYL for it as well. She said he is doing better and the swelling has gone down but it is still a little red.
sleeping a lot from exhaustion; sleeping a lot; spending most of each day in bed; This case was reported by a consumer and described the occurrence of bedridden in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of bedridden (1st dose received 6 months back on unknown date. Please refer the case US2020AMR106664).   On 18th June 2020, the patient received the 2nd dose of Shingrix. On 19th June 2020, 1 days after receiving Shingrix, the patient experienced bedridden. On 21st June 2020, the patient experienced exhaustion and somnolence. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bedridden, exhaustion and somnolence were unknown.   It was unknown if the reporter considered the bedridden, exhaustion and somnolence to be related to Shingrix.  Additional case details were reported as follows: Approximately 6 months later after 21st dose on (last Thursday), the patient had booster shot.  The reaction was similar but not quite as bad.  After spending most of each day (starting Friday) in bed, in the late afternoon patient was finally up to getting out of bed. On Sunday, patient was in bed (except for the bathroom) in bed, even sleeping a lot from exhaustion.  This day was the worst of all from the booster shot. The patient was a fairly resilient person, having some very tough.  The patient did not expect to have such an exhausting reaction to the booster shot, even though patient had experienced it with the initial shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106664:same patient (1st dose)
Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 13th January 2023, the patient received the 1st dose of Engerix B. On 13th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: Office staff member reported that a medical assistant administered a dose of Engerix-B vaccine which had an expired. This was the patient's first dose in the series.  At the time of reporting, the dose had not been repeated.  The reporter gave permission for follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Information was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-JUL-2016, the patient was administered a dose of expired, ROTATEQ (lot # K011952, expired on 17-JUN-2016 (dose unknown). No adverse effects reported. Additional information has been requested.
One day post vax, pt experienced a large red area over injection site 11 X 7 cm. From additional information received on 11/16/98, the pt recovered from this experience.
Pt recv vax on 11/21/98; on 11/25/98 pt exp red, painful LA
Father reports that the evening that patient received the vaccine he complained of pain at injection site.  Thigh became edematous and red from the left groin to left knee.  Patient sought medical treatment on 11/03/2003.
Very high fever, 103.8 F.; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 14:00 (Batch/Lot number was not reported) as 2nd dose, single (44 years old at the time of vaccine administration) for covid-19 immunisation. Medical history included herpes. Concomitant medication included valaciclovir hydrochloride (VALTREX) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). Historical vaccine included first dose of BNT162B2 on 15Apr2021 for Covid-19 immunization. The patient experienced very high fever 103.8 degrees Fahrenheit on 07May2021 22:30. The patient was treated with ibuprofen and Tylenol. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection site to middle of arm. Left index finger joint pain. Friday, the joint was just sore. Saturday it was swollen and very painful. Attempted compression and heat therapy unsuccessfully. Sunday pain reduced to soreness. Today pain and soreness from arm and joint have ceased. Index finger joint affected is the one above palm of hand.
Sick as a dog for 5 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog for 5 days after the 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick as a dog for 5 days after the 1st dose). At the time of the report, ILLNESS (Sick as a dog for 5 days after the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  No treatment was reported.
pt recv vax 11MAR98 & mom to hosp 12MAR97 w/pt in arms stated pt seizing;episode started @ approx 1220PM @ home & mom brought pt back to clinic;airway was opened, maintained;pt had circumoral cyanosis w/hyper extended arms & legs;02 given;
Started with leg pain in the left calf. Episodes of dizziness, vertigo, ear pressure, headaches. I now have low ferratin levels and take iron daily. Low vitamin D, fatigue, swollen lymph nodes, heartburn, kidney pain, UTI symptoms, muscle twitches, hands and arms go numb, heart palpitations and Tachycardia, severe anxiety attacks (i believe is due to cortisone levels). I also developed a lump on my right knee which no one can confirm what it is from.
Not sure if related, but she does have autoimmune component.  Patient reports spasms in left buttock and down left leg to foot for one hour.  Over 5 hours post immunization.
administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old female patient who administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event while receiving vaccines DTAP and HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-May-2022, the patient received a 3rd series of 0.5ml dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: uj635aa, expiry: 27-Jan-2023) via intramuscular route in the right thigh for Immunization.  On an unknown date, the patient received a dose of suspect DTAP not produced by Sanofi Pasteur (strength, form, dose, route, lot number, expiry not reported) on an unknown administration site for Prophylactic vaccination.  On 12-May-2022 the patient experienced administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event (product preparation error) (Latency: same day with respect of HIB (PRP/T)  vaccine and unknown for DTAP)  Action taken: not applicable for both the suspects.  Outcome: Unknown   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.
Arm pain began approximately 6 hours after shot; fatigue approximately seven hours after. SEVERE joint pain woke me up approximately 11-12 hours after shot, along with headache. Headache was minimal roughly twelve hours after that (24 hours after shot), SEVERE joint pain, fatigue, and injection site pain lasted about two days.
Patient said she was shopping later on that day and passed out. Didn't feel that way at all right after vaccine for earlier in the day. No signs of allergic rxn, simply fainted then was fine.
Initial report received from a healthcare professional on 9 SEPTEMBER 2012. A 73-year-old male patient, received a dose of FLUZONE HD (lot number: U4489AA) intramuscularly in the left deltoid area on 07 SEPTEMBER 2012. The patient had no illness at the time of vaccination. The patient had cold symptoms three weeks prior vaccination. Concomitant medications were not reported. The patient was receiving yearly flu shots since an unknown duration. On 09 SEPTEMBER 2012, the patient experienced sore throat and congestion. Also he developed hives in the back and lower arms. Laboratory investigations were not reported. As per patient there was no physician intervention. The patient self-treated with BENADRY. On an unspecified date the patient had recovered from the events. List of documents held by sender: none. Follow-up information received from consumer on 17 DECEMBER 2012. The patient continued to take generic BENADRYL and rash lasted for 2 more days. As per reporter it was an allergic reaction. No further treatment was needed.
Patient complained of tingling in both hands (mild) two minutes after vaccination. At 2:30pm, patient complained of tingling in both legs as well. At 2:45pm with ongoing symptoms, patient received diphenhydramine 29mL/72.5mg PO and was monitored by clinic staff for an additional 15min. By 3:00pm, patient noted symptoms had improved and released back to work. Patient was advised to receive 2nd dose in healthcare setting.
Patient complains of having a "blue line" (vein) on her biceps on both arms.
Positive COVID-19 test 6 days after first vaccine shot; Fever; Fatigue; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), COVID-19 (Positive COVID-19 test 6 days after first vaccine shot), PYREXIA (Fever) and FATIGUE (Fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL), ACETYLSALICYLIC ACID (ASPIRIN 1000) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion), PYREXIA (Fever) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced COVID-19 (Positive COVID-19 test 6 days after first vaccine shot). At the time of the report, CONFUSIONAL STATE (Confusion), COVID-19 (Positive COVID-19 test 6 days after first vaccine shot), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       diagnosed with COVID-19 on 23Mar2021, 6 days after vaccination. He is scheduled for the second dose on 14Arp2021. Concomitant medication includes Sleeping aide pill. No treatment information were reported.
The patient is itching, has heaviness in the chest, wheezing, hives, and hot.
Ulcers/ sores inside mouth day after first vaccination in March also lethargic and muscle aches. Same after second vaccination in April with difficulty moving legs. It felt like I was walking through peanut butter, slow and difficult to take steps this subsided after a couple of days. About a week later a second round of ulcers/sores inside mouth.
pain; CHILLS; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), CHILLS (CHILLS) and PYREXIA (little bit of fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Apr-2021, the patient experienced PAIN (pain), CHILLS (CHILLS) and PYREXIA (little bit of fever). At the time of the report, PAIN (pain), CHILLS (CHILLS) and PYREXIA (little bit of fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was provided.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: husband states wife, pt. had hives-Mild
It was like pain in my right side of my chest, it didn't hurt to breathe but it felt like I had inflamed on the right side of my chest. I still feel the same occasionally.
Patient had already received two doses of Ped Moderna 6mo to 4yrs. He received a 3rd dose and should not have since he is not immunocompromised. No adverse reaction happened.
Left arm swelled up at site and was painful; Left arm swelled up at site and was painful; This is a spontaneous case, initially received from other non-health professional via Company (reference number: SEQ19-07425) on 13-Dec-2019, concerning a 78-year-old female patient.   The patient's historical condition included gall bladder removal and lyme disease. The patient's current condition included alpha gall allergy, possible heart murmur and hypothyroidism.   The patient's concomitant medications included Synthroid (levothyroxine sodium), unspecified vitamins and alprazolam, all for an unknown indication.   On 10-Dec-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261983, expiration date: 30-Jun-2020, route of administration: intramuscular and anatomical location: left deltoid] for and influenza prophylaxis.  On the same day, three hours after vaccination, the patient's left arm swelled up at the site and was painful.   On 11-Dec-2019, the patient went to urgent care and received steroid shot. On the same day, the patient recovered.   The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient developed pain in extremity and vaccination site swelling, three hours after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as probably related.; Sender's Comments: The patient developed pain in extremity and vaccination site swelling, three hours after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as probably related.
I'm unsure exactly when the symptoms started, but during her February 25, 2022 annual exam with her pediatrician we reported 2+ weeks of intermittent stomach pain.  We returned to the doctor on March 24, 2022 due to erythema nodosum.  In July 2022 she was officially diagnosed with Crohn's disease.  Note that she received MMR and TDAP during 2/25/22 exam.  Experienced swelling and rash as injection site.
8 days after injection, rash, swelling, intense itching at site.  Rash measures 2.5" x 2.5"  After 2 days itching less intense but continues.  Rash persists.
Fatigue; Chills; Headache; Arm Soreness; ThThis is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Penicillin allergy", notes: Penicillin. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Arm Soreness". Therapeutic measures were not taken as a result of fatigue, chills, headache, pain in extremity.  Additional information: Patient received vaccine dose 1 on Mar2021 at 11:45AM. It was unknown if patient experienced COVID prior vaccination. Patient has not been test COVID post vaccination. Patient didn't take other vaccine in four weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.