chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has a cough. The hospital gave her a bunch of medicine Lovonox for blood clot. Patient is fully vaccinated. She was hospitalized due to COVID-19.
SEVERE HEADACHE THAT WAKES HIM UP; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced severe headache that wakes him up. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe headache that wakes him up. This report was non-serious.
My first Covid-19 vaccination was on February 2, 2021. I had little or no side effects with pain at  the exception of pain at the injection site, and minor body aches for two days.  My second Covid-19 vaccination was on March 5, 2021. I experienced a terrible headache, nausea, bodyaches, slight fever, and chills. These symptoms lasted for 3-4 days.  A couple days later I began to hear a hissing sound in my right ear. There is nothing I can do to eliminate  it, and it continues today.  Sometimes it?s soft, and sometimes it?s very loud, but always constant. I reported it to my family doctor on March 23, 2021.
This spontaneous report was received from registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 31-JUL-2015 (also reported as 30-JUL-2015 by the same reporter), the patient was vaccinated with a incorrect storage of VAQTA, lot # J003719, expiration date: 27-SEP-2015, (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Malaise, suspected fever, headache, body ache, chills, diarrhea, drowsiness
Information has been received from a physician and a healthcare professional, concerning a patient (age and gender not specified), who on 19-JUN-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 20-JUN-2007 the patient developed a fever (value not specified). On 21-JUN-2007, the fever was 101 degrees and the patient also developed a local reaction of swelling and erythema. Treatment for the fever included acetaminophen (TYLENOL), and erythromycin was also prescribed. The patient recovered after an unknown duration of time. The physician considered the injection site reaction to be serious as other important medical events. Additional information is not expected.
It's started with itchy sensation all over my body right after the Flu shot,  the nurse give me Benadryl for my itchy, now I have itchy body and muscle ache, I'm still taking the Benadryl for the itchy and Advil for the muscle pain.
Slight headache; Muscle aches; Fatigued/Tired; Headache; Sore throat; Nasal cold-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Nasal cold-like symptoms), HEADACHE (Slight headache), MYALGIA (Muscle aches) and FATIGUE (Fatigued/Tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Slight headache) and MYALGIA (Muscle aches). In April 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Nasal cold-like symptoms), FATIGUE (Fatigued/Tired) and HEADACHE (Headache). In April 2021, HEADACHE (Slight headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigued/Tired) and HEADACHE (Headache) outcome was unknown and NASOPHARYNGITIS (Nasal cold-like symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: (Negative) Patient checked for COVID infection which came as negative..         No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-049494 (Patient Link).
Bad sore neck on the left side; exact side that she had the vaccine arm, she had on the left side; she can hardly move her neck; Flu like symptoms; Chills really bad; real shaky; Chills really bad; real shaky; This is a spontaneous report from a contactable consumer (parent). A 16-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 16-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 08Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On 09Sep2021 at 03:30, the patient experienced flu like symptoms, chills really bad; real shaky, on 10Sep2021, the patient experienced bad sore neck on the left side; exact side that she had the vaccine arm, she had on the left side; she can hardly move her neck. The outcomes of events (Flu like symptoms, Bad sore neck on the left side; exact side that she had the vaccine arm, she had on the left side; she can hardly move her neck) were unknown and the outcomes of events (Chills really bad; real shaky) were recovered on an unspecified date in Sep2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
The patient started having Bells Palsy symptoms, diagnosed by the doctor, two days after receiving the immunization. He went to Dr. and they prescribed prednisone. The patient has recovered fully.
I had a funny feeling in my throat, and severe fever, and chills, and body aches for 3 days. 20 Oct 2021 developed a deep cough for 3 days. 23 Oct 2021 it started go away. 20 Oct 2021 lost taste and smell. 22 or 23 oct 2021, regained them both.
Horrible issues the last four months. 1. Early period /cycle is off 2. Gastrointestinal issues  3. Nerve pain 4. Muscle spasms and twitches  5. Thyroid went out of control 6. Went to ER with shortness of breath and chest pains
Large amount of swelling left arm lasted for 1 week, swollen up to her neck.  Some weakness of left arm.  Persistent generalized fatigue at time of exam.
pt recv vax 26NOV97 & that evening exp aching of the back of neck;the next day the rt side of neck was sore & rt shoulder was painful;treated self w/medrol dosepak, SOMA, hydrocodone w/APAP & hot compresses;pain persisted as of 29NOV97;
I was positive for COVID-19 on 30DEC2022, I was out of state and had to call my doctors office. I spoke to the doctor over the phone, they prescribed PAXLOVID. I did not have a fever, really bad runny nose, achy feeling through my body just like the flu. I took PAXLOVID and started feeling better a while after not right away, I don't know if I had a rebound but I didn't retake the test.
Mother noticed 3/10/04 in evening son's right upper arm was swollen and red and hot to touch. No fever. Child did not say it hurt or was sore, although mom noticed him rubbing arm. Temperature at clinic 3/12/04 95.9 (in clinic for PPD). Mom gave Motrin for comfort. Child states arm is itchy.
Mom reports at 1 PM today noticed swelling and red area on left thigh. Shot given about 3:15 PM 7/21/03. Child healthy on exam yesterday. He had 1 1/2cm post occipital node with 2 tiny insect bites in both q neck. Today left thigh 5 x 9 raised hot swollen area, nontender perfusin normal pulse 2+. No treatment just cold compresses and return tomorrow.
Information has been received from a registered nurse (R.N.) concerning an 83 year old male who on 14-MAY-2008 was vaccinated with ZOSTAVAX 0.65ml via subcutaneous route. Site of injection was not reported. Subsequently the patient was not feeling well. On 24-MAY-2008 the patient called the office and reported that he also gained about seven pounds. The physician diagnosed with worsening "mitral regurgitation". The patient was put on LASIX 40 mg and potassium 10 milliequivalents. On 02-JUN-2008, the patient was feeling better. He also lost seven pounds. The patient saw a cardiologist and was put on the short course of MEDROL and reduced the CARDURA dose  from 8 mg to 4 mg. On 03-JUN-2008 the patient called into the office stating that he felt much better. Follow up information was received from a physician reported that on 27-MAY-2008 the 83 year old white male went to see a cardiologist and reported that he felt bad after received ZOSTAVAX and had dyspnea and weight gain. At the same day, echo was performed and the result indicated "worsening mitral regurgitation". The patient was put on LASIX and potassium. The patient was referred to a cardiologist. On 02-JUN-2008 the patient felt some improvement and lost seven pounds. Blood work and chest X-ray were done and the results showed that the patient had pleural effusions (small). On 20-JUN-2008 the patient felt better but continued to have pleuritic type discomfort, the patient was put on MEDROL DOSEPAK. On 22-JUN-2008 the patient called to say he felt much better. Dyspnea, worsening mitral regurgitation, pleural effusions and pleuritic type discomfort were considered to be other important medical event. Additional information is not expected.
Cough      "I have a very bad cough, I'm coughing up my insides."       History provided by:  Patient Language interpreter used: No   Cough Cough characteristics:  Dry and non-productive Severity:  Mild Onset quality:  Gradual Duration:  2 days Timing:  Constant Progression:  Unchanged Chronicity:  New Smoker: no   Context: sick contacts   Relieved by:  Nothing Worsened by:  Nothing Ineffective treatments:  None tried Associated symptoms: fever, myalgias and sore throat   Associated symptoms: no chest pain, no chills, no eye discharge, no headaches, no rash and no shortness of breath       Review of Systems  Constitutional: Positive for fever. Negative for chills.  HENT: Positive for sore throat.   Eyes: Negative for discharge.  Respiratory: Positive for cough. Negative for shortness of breath and stridor.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Endocrine: Negative for polydipsia.  Genitourinary: Negative for flank pain and hematuria.  Musculoskeletal: Positive for myalgias.  Skin: Negative for rash.  Neurological: Negative for seizures and headaches.  Psychiatric/Behavioral: Negative for suicidal ideas.
Developed hives several hours after 2nd vaccine treated with Benadryl (orally) improved 2-3 days. Following 3rd vaccine developed hives again. I have been treated with steroids. Medrol Dos-pack times 2 Prednisone, Benadryl, and Zyrtec. Still not improved.
Got shots years ago, shingles 6-7 months ago/suspected vaccination failure; Shingles; Rash; Redness; Itching; Severe pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, erythema, pruritus and pain. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, erythema, pruritus and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, erythema, pruritus and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176058   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The patient was over 70 years of age now.  The patient's husband reported that the patient got shingrix injections several years ago and 6 to 7 months ago the patient got shingles. The caller reported that the patient still had shingles and further described her shingles symptoms by saying she still had the rash, redness, itching and severe pain.  The caller said the patient received nerve block injections for the shingles which helped her a little bit.  The caller also reported that the patient received lidocaine for the pain from the shingles.  The caller said the lidocaine was not helping the patient. The caller did not knew the exact year when the patient received Shingrix. The caller declined to give the patient's date of birth. Did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR176058, reported by same reporter for different product.; Sender's Comments:  US-GSK-US2022AMR176058:same patient
Dose administered after 30-day Use By Date; Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 10:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported. The vial was initially stored in the refrigerator on 18-JAN-2022 No vials undergo any temperature excursions. It was reported that the expiration date was verified with the CDC website and confirmed that it was not expired. No unusual adverse effects were noted.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Followup received: Added booster dose administration time and anatomical location, new event (product storage error). Updated inarrative supplement.
Vaccine given in upper left arm - arm became sore as in a sore muscle - slight fever - aches - fatigue - arm became very red and hot - this spread across the front of upper arm Symptoms lasted for 2 to 3 days with the exception of the redness and heat in arm.  Heat in arm lasted several more days. Redness lasted for several weeks and in fact the skin in that area still looks like a slight sunburn.  (Vaccine given on 02/10/20 and today is 03/06/20).  This was the 2nd vaccine for shingles. The 1st given in November with no side effects.
Pain in testicles, especially when walking. The pain is more frequent in the left testicle.
20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied with perspiration, flushing, myalgia and malaise. Tachycardia resolved, other symptoms persisted for 12+ hours.
10 minutes after shot given donor became sweaty with slight dizziness. Donor layed on bed  with legs elevated- cool cloth and juice given 10 minutes after onset symptoms resolved.
patient who was scheduled to receive FLUZONE HIGH-DOSE QUADRAVALENT was immunized with FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and non-healthcare professional via Regulatory authority (reference number -00794873).  This case involves a 65-year-old male patient who was accidentally vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of FLUZONE HIGH-DOSE QUADRAVALENT with no adverse event (Wrong product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 01-Oct-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (oral solution, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (Wrong product administered).  There were no laboratory data/results available.  It was case of an actual medication error due to wrong vaccine administered (latency was on same day).  It was reported "the patient is asking to be vaccinated with the High-dose, the nurse was told by the pharmacy that an additional flu vaccine can be given, she is seeking clarity she stated that the patient is very entitled and wants to know how long he must wait until he can get the high-dose vaccine."  At the time of report, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information available on batch number for this case.
24-36 hours after first dose I developed a raised, rash that was red and some areas raised but flesh color, and itchy.  The rash was up and down both arms, neck, small area on abdomen and upper legs.  No other symptoms involved.
fever; pain in the arm; pain in her armpit/she believes this could be a lymph node; pain in her armpit/she believes this could be a lymph node; she also had some bulging that feels hard when touched; she also had some bulging that feels hard when touched; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown) via unspecified route of administration on 28Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced fever and pain in the arm. Patient took Ibuprofen which diminished the pain and fever, yesterday night she started to develop pain in her armpit to the extend of not being able to lower her arm totally this pain remained even after taking Ibuprofen, she believed this could be a lymph node, she felt the pain on her arm and hand but mostly in the arm pit in the breast side, she also had some bulging that felt hard when touched. She wants to know if these were reported side effects. The treatment received for fever, pain in the arm was ibuprofen. The outcome of fever, pain in the arm was recovered on an unspecified date in Mar2021, pain in her armpit was not recovered while outcome of she believes this could be a lymph node, bulging that feels hard when touched was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
REDNESS AND WARMTH AT INJECTION SITE AND ITCHING AT SITE. VITAL SIGNS TAKEN AND CLIENT OBSERVED FEW MINUTES THEN BENADRYL 50 MG GIVEN IM.
Headache, myalgias, acid reflux, watery diarrhea, fever, shivers, lasted 5 days.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756537A, A0756539 - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 10-FEB-2015, the patient who was in the office to receive (Oka/Merck) ZOSTAVAX was inadvertently vaccinated with (Oka/Merck) VARIVAX, (lot number unspecified) 0.5 ml, subcutaneous. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. Additional information has been requested.