chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  Follow up to be done by Physician or delegee will include specific description of next steps for obtaining dose 2.
Sudden onset abdo pain 6SEP91 doubling pt over, t<103 @ hosp ER; pt admitted & started on ATB IV; c/o severe h/a & fever 103.4; dx pancreatitis; crying, hungry but didn't have an appetite, limping, chilled, difficulty getting comfortable;
Pt reported same night after receiving vaccine, around 7pm, she noted itchy red irregular shaped rashes on both lower extremities from the hips down to her ankles. She reported the rash would come and go throughout the day and night and they would continue to show up in different locations as raised irregular shapes. Pt was seen in clinic yesterday with symptoms present and MD requested VAERS form be completed for possible allergic reaction to vaccine.
GROGGY; HEADACHE PRETTY MUCH THROUGHOUT THE DAY; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 45 year old male. 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 not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced groggy. On 26-MAR-2021, the subject experienced headache pretty much throughout the day. On 26-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from groggy, headache pretty much throughout the day, and soreness at injection site. This report was non-serious.
large swollen and red area ( from where the shot was given in the upper arm down to my elbow approximately half way around the arm) that became warm to the touch a day later. My arm is still red to a lesser extent but still itches occasionally.
Shortness of breath and chest pain. The shortness of breath resolved fairly quickly, but the chest pain is still ongoing.
Muscle aches, joint aches, numbness/tingling on left side of face & watery stools.
Pain at injection site; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comment: The patient's wife reported this case. The patient received dose of Shingrix vaccine into left arm and experienced pain at injection site and fatigue. The reporter did not consent to follow-up. This is one of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022086533:Same Reporter
GOT COVID; This spontaneous report received from a patient 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious.
migraine headache; Appetite lost; Dizziness; itching; Numb face; tingling; Joint ache; Muscle ache; Vomiting; Fatigue; chills; fever; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache), DECREASED APPETITE (Appetite lost), DIZZINESS (Dizziness), PRURITUS (itching) and HYPOAESTHESIA (Numb face) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (sulfa, gluten, azithromycin,), Food allergy (corn) and Hypothyroidism.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm). On 15-Apr-2021, the patient experienced MIGRAINE (migraine headache), DECREASED APPETITE (Appetite lost), DIZZINESS (Dizziness), PRURITUS (itching), HYPOAESTHESIA (Numb face), PARAESTHESIA (tingling), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache), VOMITING (Vomiting), FATIGUE (Fatigue), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine headache), DECREASED APPETITE (Appetite lost), DIZZINESS (Dizziness), VACCINATION SITE PAIN (pain in arm), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and PYREXIA (fever) had not resolved and PRURITUS (itching), HYPOAESTHESIA (Numb face), PARAESTHESIA (tingling) and VOMITING (Vomiting) had resolved.            Other concomitant medications include hypothyroidism medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-080118, US-MODERNATX, INC.-MOD-2021-080159 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080118:Husband's case crosslinked US-MODERNATX, INC.-MOD-2021-080159:
Stiff arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiff arm".  Additional information: Report was not related to a study or programme. Caller was self-reported on adverse events he experienced following the Covid-19 vaccine.  the patient, that reported that he had been experiencing a stiff arm since receiving the Pfizer Covid-19 vaccine. Caller was unable to provide full patient details, patient HCP information, product details, patient history, or investigations. Caller reported that he did not know any personal information about the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm had swelling, redness, heat and pain. This has lasted for two (2) weeks and 2 days. Visited the doctor 01/12/2011 and treatment was medication for pain, inflation and infection.
1/7/2019 pt reports pain at injection site, lethargic and twitching in left index finger. Became increasingly tired and felt foggy and that her body had been invaded. 1/11/2019 She reports muscle spasms in arms and legs and jerking. 1/12/2019 jaw was twitching and continued spasms.  Saw doctor on 1/14/2019 and he ordered MRI and referred her to a neurologist. Continued to have spasms off and on from 1/15/2019-1/23/2019. MRI on 1/21/2019 was normal and B12 level was normal per doctor's office.
On 03/07/2005 Pt received immunizations. Grandmother complained of infant with fever and  diarrhea that started day of immunizations.
Patient was bleeding after shot was administered. As I started to clean it up she stated she felt nauseous and laid her head on her knees and fell forward. She hit her chin on the ground. I kept her talking while the tech called 911. She lost consciousness for a split second and came right back. She stated she still nauseous and was sweating.
no other AE occurred; Received PROQUAD at an age outside of the recommendation in the Prescribing lnformation; received a dose of PROQUAD, but the patient was supposed to receive a dose of MMRII.; patient received a dose of VARIVAX last week; This spontaneous report was received from a medical assistant and refers to a 27-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, concentration, exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in October 2021 (reported as "last week"), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, concentration, exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 21-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dose, lot # t0032150, expiation date reported as 20-MAR-2022 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age) (wrong vaccine administered). No adverse event was reported (no adverse event). Lot Number t0032150 is not valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and does not match any Company product.
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 11-JUN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # M027886 with expiration date 03-JUN-2018, subcutaneous for prophylaxis (dose was not reported). At the time of this report, there were no known adverse effects. No product quality complaint was involved.
Fever (high) and maculopapular rash (cephalocaudal distribution). No Koplik  spots. No conjunctival infection. Most likely measles. Will do titers when he recovers.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A 66-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 26, 2021, single dose, for COVID-19 immunisation. Medical history included cancer (unspecified if ongoing) and cardiac ablation (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), on Mar 4, 2021, for COVID-19 immunisation (reaction/s: tiredness, leg ache and diarrhea. Patient had a flu shot in 2019; and experienced reaction(s): whole arm started hurting down to my wrist. The patient reported pain in extremity/leg ache, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
About 4 hours after the vaccine during dinner felt tired. Around 11, midnight I felt achy, body hurts, I  had chills, and developed cough and shortness of breath. By Thursday I felt horrible and now I can not even taste or smell anything. My body aches are gone I feel somewhat better.  No shortness of breathe and no cough, still fatigued. Took Ibuprofen and Tylenol on Thursday Friday and Saturday. Was tested for COVID on 12/18 - tested positive.
COVID 19 Treatment; COVID 19 Treatment; dose 1, 2, and 3: Moderna, dose 4: Pfizer BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 25Mar2021 as dose 1, single (Lot number: 002B21A), in left arm, on 30Apr2021 as dose 2, single (Lot number: 017C21A), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PST" (unspecified if ongoing); "LCIS" (unspecified if ongoing). Concomitant medication(s) included: RALOXIFENE (EXELAN), start date: 01Dec2020, stop date: 06Nov2022. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin", notes: known allergies: Macrodontia. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03May2022, outcome "not recovered", described as "dose 1, 2, and 3: Moderna, dose 4: Pfizer BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Nov2022) Positive, notes: positive with AG home test; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Patient developed hives on neck, stomach, back and chest about 20 mins after vaccinations.  She also reported her arm thrombing after vaccination.  Patient took a benadryl at home and went to urgent care for treatment.  At urgent care, she was given a steroid shot and prescribed an oral steroid and an epi-pen.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-395969, MOD-2021-395983, MOD-2021-395969 (Patient Link).
pt recv vax in lt arm;arm began to swell w/in 10min of vax; watch & ring became tight;arm became mottled, nail beds became sl purple, arm felt numb w/in 30min;13FEB97 dec pain & discomfort;able to lift inc amounts;
Feeling of throat closure and chest tightness (SOB).  Later that day patient developed fever, chills, body aches.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
20 month old has received 3 Fluzone Quad vaccination, no AE; Initial information received on 28-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 month old female patient who received 0.5 ml third dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6695MA, Exp. Date 30-Jun-2020) via unknown route in the left thigh on 27-Jan-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered.  It was reported that 20 month old has received three Fluzone Quad vaccinations, this season.  At the time of report, 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 holders 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.
Right upper arm where two of the injections were given stay sore; along with pain on occasion traveling down my arm into my right thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Right upper arm where two of the injections were given stay sore"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "along with pain on occasion traveling down my arm into my right thumb". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: It was reported that the patient have had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 and 26Jan2021. Then two Pfizer boosters on 20Aug2021 and 01Oct2022. Her right upper arm where two of the injections were given stay sore along with pain on occasion traveling down my arm into my right thumb. That had been ongoing for quite awhile and thought it was her side sleeping but bought a spinal alignment pillow and it still persisted. The pain was not severe but was there.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Initial report received from a parent (who is also a PA) on 22 February 2008.  An 18 year old, male patient (with a history of intermittent lymphadenopathy) developed large lymph nodes during the summer of 2007, after he had received MENACTRA (lot number, route and site of administration not reported) in November 2006.  The symptoms have persisted until the time of the report.  The patient has undergone an extensive work-up with allergists and infectious disease specialist doctors.  The node biopsies and all other tests have been negative.  They've ruled out benign hyperplastic lymph node conditions.  The mother has been told he does have a predominant T cell response.  It was unknown if patient was on any medications or had any illness at the time of vaccination.
Fever and cough. Fever began 1 day after receiving the H1n1 flu mist. it lasted 4 days. highest point being on day two, registering 103.6 under the arm (104.6 if you add a degree to that). Cough is still ongoing.
About 15 minutes after receiving the injection my nose started to itch a little.  It was so minor I was not concerned.  By 40 minutes after the injection when at home I was itching significantly all over my body.  My tongue was red, sore, and swollen.  My mouth and throat were red and sore.  I was having some trouble swallowing and hoarse.  I developed a cough.  I felt very tired and my hands, feet and face were swollen.  Maybe about 50 minutes after the injection, my chest was feeling tight like the start of asthma.  I used a Breo ellipta (100mcg fluticasone furoate and vilanterol 25 mcg inhalation powder.) Maybe 30 minutes later I was breathing better.  As the other symptoms worsened I took benedryl by mouth.I had an epipen, but I did not use it.  I awakened in the night and my joints (hands, knees, feet) were very sore and swollen.  I had a mild headache and lower back ache.  The other symptoms persisted except for the trouble breathing.  The  symptoms have, except the trouble breathing,  continued throughout the day after the vaccination but milder. However the fatigue and joint pain and swollen hands, feet, and face are still moderate.  I am considering taking another benedryl. I sent a non-urgent message today (the day after the vaccination) to my doctor describing what happened and what I did.  We had discussed precautions prior to the vaccinations because of my allergies.
This spontaneous report as received from a physician refers to a 16 week old patient of unknown gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On an unknown date, the patient was in the office and was possibly going to receiving orally the first dose from the series of ROTATEQ (dose, lot# and expiry date were not reported). During the phone call, the physician reported that the patient had not yet received the first dose of ROTATEQ. No adverse effects were reported. Additional information has been requested.
Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal saturation 97% on room air. Dyspnea  with exertion with normal sinus rhythm rate in 80s. Cheat tightness.