chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Head ache; Muscle ache; Malaise; Fever; Chills; Swollen lymph nodes; Runny nose; Sore throat; Coughing up greenish/brown phlegm; Sinus congestion; URI; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration, on 17Mar2021, at 11:00, (at the age of 45 years), on left arm, as a single dose for COVID-19 immunisation. Medical history included Crohns, colitis and allergy to gabapentin, Lyrica and pecans. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration, on 24Feb2021, at 11:00, on left arm, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, at 03:00, the patient experienced head ache, muscle ache, malaise, fever, chills, swollen lymph nodes, runny nose, sinus congestion, sore throat, and cough. These have turned into an upper respiratory tract infection. The patient had sinus phlegm that was green/brown. It had now started to set up in the patients chest and the patient was coughing up greenish/brown phlegm. The treatment received as a result of events included unspecified antibiotics and the events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of head ache, muscle ache, malaise, fever, chills, swollen lymph nodes, runny nose, sinus congestion, sore throat, upper respiratory track infection, and cough were recovering.   No follow-up attempts are needed. No further information is expected.
The Pfizer vaccine was kept in the refrigerator past the date of removal/expiration. The patient was notified about the expired dose given, had no signs of an actual adverse reaction to the vaccine, and did not want to receive an additional booster. The patient requested anitbody testing to see efficacy of the vaccine given.
Approximately 1 hr after receiving flu vaccine pt reported tingling of lips, "heavy" chest, fatigue, BP 159/96 HR 82 resp 18, chest clear, coherent, speaking, using cell phone.
Pain in left arm at injection site.  It still hurts at the site and feels like the muscle is sore
This spontaneous report as received from a female patient of unknown age reporting on herself. The patient's pertinent medical history included high blood pressure, no drug reactions or allergies. In early October 2015, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly (dose, site of administration, lot#, expiry date were not reported). On the same day, patient was vaccinated with an unspecified influenza virus vaccine (manufacturer unknown) reported as "flu" vaccine (dose, site and route of administration, lot#, expiry date were not reported). The other patient's concomitant medications included unspecified blood pressure medications. On an unknown date in 2015, after receiving PNEUMOVAX 23, the patient experienced rash. The patient was prescribed unspecified medications for treatment of her rash by her family physician. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered/not resolved (reported as "she is still experiencing a rash"). The patient sought medical attention by contacting a physician. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporter did not wish a further contact.
The patient reported swelling, itchy arm/hands, the day after. Seven days out patient is reporting itchiness on site along with headache, nausea, and vomiting.
65 y/o female/employee who presented today due to two 1cm eythematous macule in  thr right shoulder/deltoid/axillary area.It appeared last night afte injection  of pneumovax in the area. The lesion is not around yhe injection area.It is  itchy with mild tenderenss. No other lesions in other par of the body.no  headcahe, dizzines, shortness of breath, chest pain or abdominal pain.                        A/P 1.erythema, S/P pneumovax injection, right deltoid, possible local reaction from  the injection site - apply warm compress - if itchy apply hydrocortisone cream. - re-assurance
Severe swelling, induration moderate pain, hives, redness 9cm x 6cm (Seen at Urgent Care before visit here).
very tired; no appetite yesterday; Fever; ARM WAS LITTLE SWOLLEN; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (very tired), DECREASED APPETITE (no appetite yesterday), LIMB INJURY (SORE ARM) and PERIPHERAL SWELLING (ARM WAS LITTLE SWOLLEN) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and LATANOPROST for an unknown indication.   On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 14-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 14-Feb-2021, the patient experienced LIMB INJURY (SORE ARM). On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (ARM WAS LITTLE SWOLLEN). On 15-Mar-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced FATIGUE (very tired) and DECREASED APPETITE (no appetite yesterday). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (very tired), DECREASED APPETITE (no appetite yesterday), LIMB INJURY (SORE ARM) and PERIPHERAL SWELLING (ARM WAS LITTLE SWOLLEN) outcome was unknown. Not Provided
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of oral ROTATEQ lot # K001831, expiration date 21-OCT-2015, by oral route (dose and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Tetanus/ Diphtheria/ Pertussis vaccine administered on 10-22-07 in left deltoid area at 11:00. At 1406, emp return to clinic c/o itchy feeling all over redness noted to skin in chest area and above left deltoid vaccine site. Doctor administered 0.3 ml of 1:1000 Epinephrine subcutaneous via left upper arm. Emp sent home via her grandmother at 1503 after full recovery.
severe trembles; losing all his dependency and needs other to care for him; not able to drive; headache; teeth chatters; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe trembles), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (losing all his dependency and needs other to care for him), IMPAIRED DRIVING ABILITY (not able to drive), HEADACHE (headache) and CHILLS (teeth chatters) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (severe trembles), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (losing all his dependency and needs other to care for him), IMPAIRED DRIVING ABILITY (not able to drive), HEADACHE (headache) and CHILLS (teeth chatters). At the time of the report, TREMOR (severe trembles), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (losing all his dependency and needs other to care for him), IMPAIRED DRIVING ABILITY (not able to drive), HEADACHE (headache) and CHILLS (teeth chatters) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Breakthrough COVID-19 infection. Pt received Pfizer on 2/21/21 and 3/14/21.
immun given on Wednesday & by Thursday had rash that could see & feel, small, fine, bumps over entire body that itches;mom concerned because pt had stevens johnson synd around age 7;rash lasted for about 5 days;
Pt received FLUVIRIN IM and PNEUMOVAX IM in same arm per patient request; so CDC protocol was followed with 1 inch apart and 3 hrs apart and pt's arm started to swell and hurt later that evening and went to hospital ER and admitted for cellulitis in arm.
Muscle aches, fatigue, low grade fever, headache all subsided within 2 days of administration.
excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-383439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant Follow up contains patient  and suspect details
Patient started having bilateral arm weakness on 6/13. She was evaluated in emergency room and found to have markedly elevated CPK to >7000 and mildly elevated AST (195) and ALT (70),  and was diagnosed with rhabdomyolysis and admitted to hospital where she was treated with IV fluids. Her CPK peaked at 11,400. She improved on IV fluids and was discharged home on 6/16. On follow up visit in clinic on 6/19 her CPK had improved to 1151, her liver enzymes were trending down and her symptoms were completely resolved. Hospitalist felt rhabdomyolysis was due to activity as patient had been training for a  black belt, but parents report no recent change in training schedule or intensity and concerned that this may be effect of vaccine given timing of onset of symptoms
Nausea first day Next morning chills and fever 103.4 Incoherent Couldn?t function, like pull self out of chair Nausea  Wet chair Inflammation in lungs after  being checked at hospital
Patient admitted to Hospital 5/30/22 with progressed shortness of breath and weakness with bilateral lower leg edema. Vital signs Stable. O2 Sat at 96% on 2L of O2. COVID +. noted ground glass opacities bilaterally throughout lung fields. Patient given Ceftriaxone and Lasix and started on RPBC transfusion. Patient is fully vaccinated with Moderna and 2 Pfizer boosters. last Pfizer booster dose 5/16/2022. no additional information on outcome known. please contact  Hospital for any additional details.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. On 9th November 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, she did not feel well after receiving SHINGRIX. The patient did not elaborate or specify which event she experienced other than not feeling well. The caller disconnected the call when informed her that, could not provide medical advice or treatment regimen for any side effect.
Immediate strong soreness at injection site; sore enough that I spoke to the nurse doing the 15-minute watch. She told me to monitor it and that soreness was a common result. My arm was sore but I also have some tingling and numbness in my left arm and hands. It is uncomfortable and worrying but does not seem to affect my activities at this point. That being said it has worsened over the period between now and the injection.   My only side effect from the first injection was soreness the day after the injection, which subsided within two days with no lasting effects.
Pain and swelling at injection site which continued to worsen.  On 19 Nov 09 patient noted marked swelling, erythema, and induration at injection site, increased pain in arm and hand and difficult ROM.  Patient has had 6 previous anthrax shots without problem; first booster caused increased swelling and redness, but nothing like this reaction.  Patient given acetaminophen.  On 20 Nov 09, swelling slightly greater, unchanged erythema and induration, but much better ROM and less pain in hand/fingers.  Patient given Allegra and Prednisone and designated as medically exempt from further anthrax injections.
Pt received Moderna injection on 3/21/2021 without any side effects.  The second injection was administered on 4/24/2021.  The following day he developed a pruritic rash on his medial right elbow.  The rash has since spread over his torso and extremities.  It is extremely pruritic and is still present today and not responsive to antihistamine therapy.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA310640 (same patient). This case involves 19 years old patient (gender not reported) who was vaccinated with 0.5 ml expired dose of MENACTRA (Batch number: 05712AA, expiration date: 11 Oct 2018, dose, route and site of administration was not reported) on 07 Nov 2018. The patient's medical history was not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; ADACEL for Immunisation; and VARICELLA VACCINE for Immunisation. It was an actual medication error due to expired product administered. It was unknown if patient had adverse event. 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. List of documents held by sender: none.
Information has been received from a 24 year old female registered nurse with no drug reactions/allergies and no reported medical history who on 01-FEB-2007 was vaccinated with the first dose of GARDASIL intramuscularly. Concomitant therapy included ORTHO TRI-CYCLEN LO. On 27-FEB-2007 the patient had a complete blood count with differential and her white blood cell count was low. Another CBC with differential was taken on 19-MAR-2007 (results pending). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a registered nurse and a 24 year old female registered nurse with no drug reactions/allergies and reported medical history who on 01-FEB-2007 at 9:15 am, was vaccinated IM in the right deltoid muscle witha first dose of GARDASIL vaccine (lot # 654702/0011U). Concomitant therapy included ORTHO-TRI-CYCLEN LO). On 27-FEB-2007 the patient had a complete blood count with differential and her white blood cell count 3.6. On 15-MAR-2007 and her white blood cell count 3.5. On 27-MAR-2007 her white blood cell count 4.3. On 27-MAR-2007, the patient recovered from low white cell count. Patient stated she had a virus at the time of the first lab draw of 27-FEB-2007. No further information is available.
Made me sick never having another.; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp from social media.  This case involves a patient (unknown demography) who was sick and never having another (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickness (malaise), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that the patient was sick after the vaccination so he/she never had another dose.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Chills, fatigue, and body aches one day after shot lasting 15 hours. Migraine headache starting 48 hours after shot lasting 5 days.
Only  liquid conjugate given; Only  liquid conjugate given; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA758A, expiry date 31st October 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: A health care professional (HCP) did not answered if follow-up was ok, email was above if follow-up needed. Additional Supportive Information:  The patient was administered only the liquid conjugate portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old male patient who received SHINGRIX (batch number M224F, expiry date 8th February 2021) for prophylaxis. The patient's past medical history included migraine.  On 10th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. In 2018, the patient experienced severe headache which lasted for 12 hours. The patient sat in a dark room, had a caffeinated beverage and took Tylenol, and the headache resolved. The healthcare professional reported that the patient also had a history of migraines, but the headache he experienced was described by the patient as a different kind of headache.
Immediate reaction at injection site with itching and redness; resolved quickly with icing.  followed over 12 hours later with itchy, red and splotchy rash on hips and down right leg that resolved over the course of a day.
her sister's face swelled; This is a spontaneous report from a contactable consumer. This consumer reported for similar events for 2 patients. This is 2 of 2 reports. This consumer reported for female patient (reporter sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Reason for no lot number: Caller unwilling to complete the report. Medical history included connective tissue disorder (her sister have Ehlers Danlos, which is a connective tissue disorder. It is genetic but it also impacts one part of the immune system. Neither of them have been diagnosed with this additional part because they do not think it is useful to go for a million tests for something that they are then not going to treat them any differently. Caller adds that this goes with mast cell activation disorder and a lot of people with Ehlers Danlos have mast cell activation disorder. It causes a lot of allergic reactions to a lot of things. Her sister, for instance, takes a ton of antihistamines and a lot of stuff and she takes it to prevent outbursts of hives.) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Caller mentions that patient (her sister) also had a similar experience with the COVID-19 Vaccine. Report 2 was caller talking about her sister. Her sister had the same reaction to the COVID-19 Vaccine and patient have the same conditions. Caller adds that patient reaction was different in that face swelled. She did not have details or dates or anything but her sister sent caller a picture of her face. Caller adds both her and her sister are fine. The outcome of the event was recovered on 2021.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.