chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 91 year old female patient with hypertension, high cholesterol, meniere's disease, iron deficiency, hypothyroidism and drug hypersensitivity to PRAVACHOL and a history of basal cell carcinoma, anaemia and dry eyes who on 03-FEB-2004 was vaccinated intramuscularly with her first dose PNEUMOVAX 23 (Lot # 665270/1398Y). Concomitant therapy included CENTRUM SILVER, hydrochlorothiazide (manufacturer unspecified), NORVASC, iron (unspecified) and vitamin D (unspecified). It was reported that the patient who received the second dose of PNEUMOVAX 23 developed swelling, pain and redness at the injection site in the right arm. No diagnostic tests were performed. At the time of the report the patient had not recovered. The patient sought medical attention by a phone call. Follow up information received from a physician indicated that the patient was a retired female who on 20-JAN-2010 was vaccinated intramuscularly with a second dose of PNEUMOVAX 23 (lot # 665270/1398Y). The patient developed right arm swelling within hours of injection. According with the reporter this never happened before. The patient recovered from right arm swelling on 21-JAN-2010. The outcome of pain and redness at the injection site were not reported. This is one of several reports received from the same source. Additional information has been requested.
Fast heartbeat at bedtime. I received the vaccination at 12:40pm, but heart palpitations started at bedtime, around 11: 00pm on same day of vaccination, March 21, 2021.
terrible itching and burning all over body and head that are still there. Received one steroid shot and taken many antihistamines and really no help.
She reported severe nausea and a sense of a racing heart, her husband reported similar symptoms (see report #134759).
losing more hair; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hair loss.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had noticed that she was losing more hair after receiving the Shingrix vaccine. The reporter was unwilling to provide any additional details.
Fatigue 24 hrs after vaccination; Swelling and redness at injection site 36 hrs after vaccination; Swelling and redness at injection site 36 hrs after vaccination; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient started to receive started to receive BNT162B2 (Solution for injection, lot number: Eh9899 and expiry date was unknown), via an unspecified route of administration on 17Dec2020 15:00 at single dose in the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergies to sulfa drugs and diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 18Dec2020 18:30, the patient experienced fatigue 24 hrs after vaccination and swelling and redness at injection site 36 hrs after vaccination. No treatment received for all the events. The outcome of the events was unknown.  The following information on the batch number has been requested.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received and added age group.
This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA, HEADACHE and CHILLS in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA, HEADACHE and CHILLS. The patient was treated with ACETAMINOPHEN ongoing from 06-Feb-2021 at an unspecified dose and frequency. On 07-Feb-2021, MYALGIA and CHILLS had resolved. On 09-Feb-2021, HEADACHE had resolved.        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.   Concomitants included medication for diabetes, hypertension medication, not specified.  No treatment medications were reported.   This case was linked to MOD-2021-031189 (Patient Link).
I started feeling weak and fatigued on the afternoon of 1/21/2022. I also had a scratchy throat. By the time 1/23/2022 arrived, I still felt unwell and had a sore throat, so I decided to take an at-home COVID-19 test, the result was positive and I had a breakthrough case. I contacted my PCP through the patient portal to inform him of the test results. He prescribed me molnupiravir and advised me to also take vitamin C, vitamin D, and zinc. I isolated for 10 days, though I bounced back pretty quickly and felt fine by 1/26/2022.
These side effects only started from Shot #2 - 100.5 fever started almost 24 hours later,  itching my left wrist and right thumb(assuming poison ivy), softball size lump under left arm where I received the shot.  Fever lasted 3 days, lump lasted at least 4-5 days before slowly going back down.  Extreme tiredness for almost a week+, no interest in doing anything for over a week.  Noticed itchy rash upper thigh.  Searched other side effects.  Appeared to not be poison ivy but "shingles".  Went to the doctor to confirm shingles and immediately went on Valacyclovir HCL 1 Gram tablet every 8 hours for 7 days.  Rash on upper thigh still quite visible, hoping that goes away.  Hand and wrist 100% cleared up.
Upper respiratory issues; COPD; Asthma; Has issues now with his health, the allergies and different things now that are kicking in on him; Has issues now with his health, the allergies and different things now that are kicking in on him; This is a spontaneous report from a contactable consumer reporting for husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6202; Expiration date was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for Covid-19 immunization. Medical history included chronic obstructive pulmonary disease, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced upper respiratory issues, COPD, asthma, had issues with his health, the allergies and different things now that were kicking in on him on Mar2021. Reporter stated patient had his first Pfizer shot was 9 days ago. At the time of this report, he was having some issues with (incomplete sentence), he had upper respiratory issues. He was due to take his next shot, reporter thought it was on 21 or 22nd. If patient wanted to take Prednisone as an antibiotic, reporter asked if he could still get the second dose. Patient had not taken it yet. He did not know if he can, and reporter asked what would happen if he did not get the second shot. When paraphrased about the concern, reporter stated patient had COPD and asthma (further not clarified if consumer had COPD and Asthma prior taking the COVID-19 Vaccine or not, hence captured as event). Reporter added patient did not have any problem with the shot. It was just he had issues then with his health, the allergies and different things now that were kicking in on him. Reporter stated that it was not with the shot, and do not think to be. Reporter was informed about Pfizer Medical Information and telephone # was shared. Reporter was unwilling to share further information, hence, product details (NDC, UPC) and other details were unknown. Limited information was available over the call. Clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Felt weak; Can't lift left arm; Feels like he's drunk; Muscles were sore; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), HYPOKINESIA (Can't lift left arm), FEELING DRUNK (Feels like he's drunk) and MYALGIA (Muscles were sore) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B71A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Felt weak), HYPOKINESIA (Can't lift left arm), FEELING DRUNK (Feels like he's drunk) and MYALGIA (Muscles were sore). At the time of the report, ASTHENIA (Felt weak), HYPOKINESIA (Can't lift left arm), FEELING DRUNK (Feels like he's drunk) and MYALGIA (Muscles were sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.
wheezes @ 345PM, SOB @ 345PM, n/v, cramps @ 130PM; hosp overnoc;
Started with 99.4 temperature, chills, shortness of breath, aches and pains, called doctor got a prescription for an antibiotic, amoxicillin 500mg, weakness has gotten worse and so has the shortness of breath on a daily basis, is progressive with weakness and shortness of breath.
Pt stated she has been having arm pain after getting flu shot. She can't lift or move her arm (left arm).
Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine accompanied by painful sensory neuropathy. Covid test on 2/12/21 negative. Pain and rash persisted and worsened. I saw my primary doctor on 2/19/21 because my rheumatologist had left her practice. He checked my circulation and prescribed prednisone course to be taken if problem worsened. I waited another week because I am reluctant to take prednisone and was then advised by my friend who is a rheumatologist that I should go ahead with the steroid. This rash resembled the "Covid toes " phenomenon that has been reported in response to the actual Covid 19 viral infection and the neuropathic pain in my feet was very uncomfortable. I started prednisone course 40 mg QD on 2/26/21 with some improvement so far after one day.
both of her legs swelled up; heavy legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 12Jun2021, outcome "unknown", described as "both of her legs swelled up"; LIMB DISCOMFORT (non-serious) with onset Jun2021, outcome "not recovered", described as "heavy legs". The event "both of her legs swelled up" required physician office visit.  Additional information: Patient was vaccinated with Pfizer COVID vaccine on 12Jul2021. About 1 hour later, both of the legs swelled up and was consulted with doctor. After week of rest, patient went back for running with very heavy legs and these heavy legs have not gone away. Reporter stated that it was a reaction to the vaccine and possibly COVID as well. Reporter also stated that she wants patient's leg back as she is so young. Reporter asked whether anyone else had the problem and any solution   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever; little bit of sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "Fever"; OROPHARYNGEAL PAIN (non-serious) with onset 08Oct2021, outcome "unknown", described as "little bit of sore throat".  Additional information: The dates, seriousness for fever and little bit of sore throat was unspecified. RA number and expiry date of Booster Vaccine was Unknown. Concern stated she got the booster yesterday and unfortunately she is having fever right now and she is asking if she is allowed to be with other people as she is having this fever and a little bit of sore throat too not really bad. It was stated that talking about the Pfizer booster vaccine. She was informed that Pfizer Medical Information is the concerned department to answer the question and offered the number. Consumer was again informed about the role of Pfizer and informed about filling of safety report, She don't see an expiration date. She already had 2 shots, the booster shot and she stated that she have to hear everything about the first shot.   No follow-up attempts are possible. No further information is expected.
pt reports arm pain since 2/6/99 & 2/8/99 reports swelling of arm, hives on arm only, itching & redness & then on 2/9/99 c/o scratching of throat & problems swallowing;pt saw MD 2/9/99 given motrin & is having no problems today;
These may be symptoms of the vaccine- and I'm not sure this is necessarily considered an AE (I am filling this form myself)- but I believed it to be relevant data: -Severe Nausea -Fever of 101 F -Severe chills/shivering -Extreme Fatigue: muscle stiffness/soreness left me bed ridden for 16-24 hours and time off work -High resting heart rate (normally 45-55- RHR of 68 on night after vaccine) -Soreness in arm
Polymyalgia developing from arm into shoulder, trunk, now all extremities. Pain/soreness in all muscles, 7 weeks after first dose.
Client received Covid 19 Moderna vaccination then received her flu vaccination Flucelvax Quadrivalent immediately after.  She complained of feeling dizzy immediately after the flu vaccination.  She was placed in a supine postion with her feet up and reported relief.  VS stable throughout.  4:15 PM HR 68, RR 18, BP 130/70, 4:20 HR72 RR 16, BP 132/80, 4:45PM HR 60, RR 16, BP 124/76. 4:45 PM client was placed in a sitting position with no symptoms.  Husband was present.  5:50 PM discharged with husband.  Denies any further dizziness.  Husband drove her home.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years 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's relevant medical history included: "Birth Control" (unspecified if ongoing). Concomitant medication(s) included: OCELLA taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Antiviral details, Paxlovid for COVID 19 Treatment, from 13Jun2022 to 18Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Today, 9 days later I have pain in arm, and numbness in my hands on the side where I got my shot. Neck pain and leg pain on the side that I got the shot. Joint pain on the side where I got my shot.. Slight Cough.
Headache, Fever, CoughWheeze, HA, fever and chills Narrative:
BODY ACHE; BRAIN FOG; FELT LIKE A MILD BODY COLD; CHILLS; MILD FEVER; NAUSEA; HEADACHE; SORENESS AT THE SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 patient experienced body ache, brain fog, felt like a mild body cold, chills, mild fever, nausea, headache, and soreness at the site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like a mild body cold, and mild fever, and the outcome of soreness at the site, chills, body ache, nausea, brain fog and headache was not reported. This report was non-serious.
entire body was racing/felt jittery; pulse shot up to 208 bpm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 at 12:30 as dose 3 (booster), single (Lot number: EWD168) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma". The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "known allergies Ceftin"; Cipro, reaction(s): "known allergies Cipro"; Levoquin, reaction(s): "known allergies Levoquin". Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 06Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Covid Positive", "Covid Positive"; BNT162b2 (Dose 1, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 16Jan2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "Covid Positive", "Covid Positive". The following information was reported: HEART RATE INCREASED (medically significant) with onset 04Nov2022 at 20:00, outcome "not recovered", described as "pulse shot up to 208 bpm"; FEELING JITTERY (non-serious), outcome "recovering", described as "entire body was racing/felt jittery". The event "pulse shot up to 208 bpm" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (04Nov2022) 208, notes: bpm. Therapeutic measures were taken as a result of heart rate increased and included treatment with diltiazem hydrochloride (CARTIA XT) 240 in the morning and 120 in the evening, apixaban (ELIQUIS) 5 mg, twice a day, digoxin 0.125mg at night. She cannot take a beta blocker due to her asthma. The patient personally believe this all had to do with her booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300007504 same patient, different dose and event;
Information has been received from a health professional who was informed by a physician's office concerning a 13 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
Child received his school immunizations DTaP, IPV and MMR. Within 8 hours he was running a high temp. Developed croup within 24 hours. Took to ER on 8/25/03. Diagnosed with pneumonia. Child not hospitalized. Rx with antibiotics.
Rt quarter size red, raised area no blister, slight itching, no soreness no SOB and no ER visit
syringe was not attached well to the needle and when the nurse she went to inject the patient did not get a full dose, no AE; syringe was not attached well to the needle and when the nurse she went to inject the patient did not get a full dose, no AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 1 years old female patient who received 0.25 mL to 2 mL of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U704DA  and expiration date: 30-Jun-2021, unknown route, administration site) for prophylactic vaccination. While administering, the syringe was not attached well to the needle and when the nurse she went to inject the patient did not get a full dose and when the shot was being administered the needle came off and the medicine went everywhere on 02-Oct-2020 (PT: underdose, syringe issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) ; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe issue (same day latency).  No adverse event reported at the time of reporting.  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.