chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; achy joints; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm) and joint pain (Verbatim: achy joints).  The outcome of the pain in arm and joint pain were resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm and joint pain to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and joint pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2023 The patient got RSV vaccine and for 3 days had a sore arm and achy joints.
Patient's arm became red and swollen. She used BENADRYL which resolved these issues. However, she has since developed hives which go unresolved with BENADRYL and hydrocortisone cream. Patient told to call MD immediately.
pt recv vax & c/o both arm burning no itching mom states they were swollen & had tiny red raised dots on arms & chest;no fever or other s&s;mom took pt to ER;
Part of the dose leaked out through the connection of the needle to the syringe; Part of the dose leaked out through the connection of the needle to the syringe; A spontaneous report was received from a healthcare professional (pharmacist) concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced the event part of the dose leaked out through the connection of the needle to the syringe (syringe issue) (underdose).  The patient's medical history was not provided. No Relevant concomitant medications was provided.  On unknown date, patient received their second of two planned dose of mRNA-1273 (Lot/Batch: unknown) vaccine for prophylaxis of COVID-19 infection.  On an undisclosed date, patient experienced the event part of the dose leaked out through the connection of the needle to the syringe. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of events experienced for event part of the dose leaked out through the connection of the needle to the syringe was resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
This spontaneous report was received from a male consumer, referring to her 226 days old (reported also as 32 weeks + 2 days old) son. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first and second dose of ROTATEQ (strength, dose, lot # and expiration date were not reported). It was reported that the patient completed 32 weeks + 2 days and he still did not take the third dose of ROTATEQ and asked if he/she could give it to him and if it was effective or not. No concomitant therapies were reported. Additional information has been requested.
Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a female patient of an unknown age who received mRNA-1273 BIVALENT (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 fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient wanted to check the lot number of the booster dose patient received to make sure that patient had in fact received the Moderna COVID-19 vaccine, bivalent. Patient not had any reaction with that vaccine and patient was not sure why. Patient had 2 full shots and 2 booster shots of the Moderna previously. Patient was expecting to be in bed, sick after receiving the 3rd booster shot. Patient went to a different pharmacy than usual and patient was curious whether patient received the bivalent booster or not.  No treatment information was reported.   This case was linked to MOD-2022-644031, MOD-2022-644029 (Patient Link).   Reporter did not allow further contact
Pt had outbreak of zoster. Reaction occured 7 days after smallpox vaccination.
2 vaccines were given 8 days too early. Not found until 2 months later during billing.
Pt reported her chest hurt, dizziness, chest tightness, heart racing, anxious, shaky. Shaky voice, inc. RR, elevated BP & HR, O2 Sat 99%, diaphoretic. vs monitored, pt laid down, practiced pursed lip breathing.  22 min after symptoms  reported, pt began to improve.  c/w vasovagal response.  pt d/c feeling well/stable  condition 1hr after symptoms first reported.
104.2 degree F fever.  Abated with time, APAP and Ibuprofen.
Narrative:  COVID infection following COVID vaccine series 03/31, Pfizer, dose #1 04/21, Pfizer, dose #2 12/20 SARS-COV-2 Variant Sequencing; pending 12/20 COVID swab, result: detected 12/17 pt cc: chills, cough, fatigue, fever, headache, rhinorrhea, sore throat exposure: unknown clinically resolved
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 71-year-old male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 1st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st September 2018, less than a day after receiving SHINGRIX, the patient experienced shivering and joint pain. On an unknown date, the outcome of the shivering and joint pain were not recovered/not resolved. It was unknown if the reporter considered the shivering and joint pain to be related to SHINGRIX. Additional information was reported as follows: On 1st September 2018, the same day after vaccination with SHINGRIX, the patient experienced shivering and joint pain from the hip down which occurred more specifically at the left leg. Till the time of reporting the patient was still experiencing the events. The reporter was unable to provide further additional information.
The second dose caused the reaction, the first being exactly 3 wks earlier.  No major problem to that dose. (Had  arm pain and mild chills and fatigue).  The day after dose two above noted fullness and discomfort in feet, On the second day after, had  early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize.  However, progressed and at 9am on the third day after vaccine started prednisone 40mg.  At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
03/21/2005- c/o dizziness during aerobics class, nausea. Continued to c/o vertigo with any movement. Denies fever, aches, vomiting or diarrhea. 03/22/2005- Appt with PMD, diagnosis: viral inflammation in ears, or reaction to vaccine. 03/23/2005 calls to report continued veritgo, better if she lies still in bed. Must steady herself on somehting when walking.
A report has been received from a Health Professional concerning a 1 year old, male subject, height: 32.0 inches; weight: 21.6 pounds, who had been receiving FLUMIST Quadrivalent (intranasal), 0.1 ml in each nostril/one time administration. FLUMIST Quadrivalent started on 12-Oct-2015. Patient stated that on 12-Oct-2015, an 18 months old child was administered FLUMIST, 0.1 ml in each nostril/one time administration, intranasally by an inexperienced nurse who did not read the indications. The outcome of the event of 18 month old child was administered FLUMIST was unknown and the outcome of the event of intentional product misuse was unknown. The reporter's description of the event(s) was as follows: allergy to amoxicillin (rash). The report was considered to be non-serious.
redness & warmth @ site, cont crying for 8-12 hrs, congested nose; No other vax; next day fine;
Received Vaccine on Friday Morning. 2/5/21.  on Sat Morning 2/6/21 12N developed blisters on all tops of toes on both feet.  Very painful.  Soaked feet and elevated Sat & Sunday  Called Monday morning saw Primary care Dr. on Tuesday they referred me to a Dermatologist.   also under advise of my Son Dr. who I sent pictures to on SAt & Sunday/ Dr has spoke to the Dermatology Dept  and has been checking on information about this.  I was also advised to report this to you and Moderna.  on 2/9/21  prescribed Prednisone, Doxecyline and 81mg Baby aspirin a day.  Cultured blisters. Return to see her Monday Feb 15th
pain; inflammation; sick to stomach; yellow in center; hard to move arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix (intramuscular). On 29th May 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation, upset stomach, injection site discoloration and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: It was reported that right away after vaccination the patient developed pain and inflammation in her arm and was sick to her stomach.  The inflamed area looked yellow in the center and she had difficulty moving her arm. The reporter had consented to follow up.
Vasovagal episode within 10 minutes of vaccination. Reported lightheadedness, palpitations BP= 74/40; HR=39. Pt Managed by healthcare workers with IV fluids and bedrest for 20 minutes. Symptoms resolved. Refused transport to ER.
Injection to left arm next day elbow pain  with soft, nontender swelling to LEFT elbow, brucites noted on xray also normal injection reactions that are expected, tender to site of administration otherwise no fever or other problems. Symptoms improving wihtout complications
Within 24 hours of administration of PNEUMOVAX 23 Pt's arm became swollen and red, with edema extending into axilla.
On 7/24/01, phone call from mom, reports Daycare states child had raised red spots on chest, back, arms and legs. She had given him some Benadryl in the AM for stuffy nose and reports history of allergy to cats. On 7/25/01, phone call to mom; she reports child had 101F temperature and clear diarrhea last night and still has rash. She called PMD and he Rx'd Benadryl, Tylenol and fluids.
1134 patient complains of feeling hot and flush in the face, patient has a history of hypertension, COPD. vital signs checked 98.3, 80, 20, 162/84 spo2 97% on room air. patient c/o being anxious about receiving shot. 1145 patient continues to voice being nervous of shot. at this time, stating some relief from "hot feeling" in the face. offered a cool compress, patient accepted. patient education provided for post symptoms in the next 24 hours. patient educated on guillain barre syndrome and symptoms to monitor for. denies shortness of breath, fatigue, headache, weakness, denies sore arm, denies body aches. Patient stated it has been 6 months since he followed up with his primary care physician in regards to hypertension and current medications. advised patient he needed to follow up with his PCP as needed. 1155 patient states feeling better, and released with friend at this time, advised if symptoms return or worsen to go to nearest ER for treatment.
6/20/13 mom called and reports has bumps all over and blisters on rt leg where she got her vaccines 2 days ago. Mom instructed to bring child into clinic. Did not come in. Rescheduled to 6/21/13. 6/21/13 appt canceled. 6/24/13 spoke with mom and states bumps went away the next day and no problem now.
Chest pains.  Went to local accurate care clinic.  EKG was performed.  Doctor recommended going to local Emergency Room for further testing due to abnormal results.  Admitted to Emergency for blood work and additional testing.  ER doctors stated some results appear to be from a heart attack, while blood work does not.  Was monitored for one hour later and released.  Chest pains continued for additional two days.
Is there any shedding; This case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was not recovered/not resolved.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient asked if there was shedding with shingrix vaccine. The patient asked if the patient could infect/affect others after taking Shingrix.
Pain, swelling, and redness of the right arm. Fatigue, muscle pain, joint pain, chills, nausea, and weakness. The pain started yesterday afternoon, The swelling got pretty bad in the evening and also that arm is really warm to the touch. The rest of the symptoms I noticed as soon as I woke up this morning.
1/16/07 6 pm sore arm left deltoid. 1/17/06 early morning-redness, soreness left deltoid felt tired all day. 1/18/07 early morning-felt sweating, cold, chills. Notice 3 red spots 1- 1 1/2 inch and the other 2- 1inx1in. Warm to touch and tender under arm in arm. 1/19/07 arm feels better left arm is sore.
hives all over the body; pretty heavy rash; itching (rash); rash hot to touch; rash swollen; severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body), DIARRHOEA (severe diarrhea), RASH (pretty heavy rash), RASH PRURITIC (itching (rash)) and VACCINATION SITE WARMTH (rash hot to touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). On 12-Mar-2021, the patient experienced RASH (pretty heavy rash), RASH PRURITIC (itching (rash)), VACCINATION SITE WARMTH (rash hot to touch) and SWELLING (rash swollen). On 17-Mar-2021, the patient experienced URTICARIA (hives all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 17-Mar-2021, RASH (pretty heavy rash), RASH PRURITIC (itching (rash)), VACCINATION SITE WARMTH (rash hot to touch) and SWELLING (rash swollen) had resolved. At the time of the report, URTICARIA (hives all over the body) had not resolved and DIARRHOEA (severe diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Swelling, redness, fever for 2 days p/vax; area of redness was 11cm in size;
SORENESS AND BRUISING LOCALLY, EXTREME LETHARGY AND WEAKNESS, PT VISITED DR ON 10/15/2012 GIVEN ANTIBIOTIC SAMPLES AND ANTIHISTAMINE.
Pt devel hives immediately @ inject sites & upper trunk et arms; breath sounds clear throughout; pt taken to ER given DPH;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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 and expiry: Unknown) dose was not reported, 1 total administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient got the corona virus after the vaccine and the only reason patient know was because patient thought that patient caught the sniffles from patient's grandchild (suspected covid-19 infection). Patient's symptoms had been mild 102 fever for one night then feeling normal most of the day until 16:00. Patient did get tired early. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 fever. Patient was 7 days in and patient feels that patient has been 95 % back to normal but not taste. Lost taste on day 4. Patient had zero initial side effects after vaccination, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192284; Sender's Comments: V0: 20210908721-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine; so worries she didn't' get the full dose of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine) and ACCIDENTAL UNDERDOSE (so worries she didn't' get the full dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine) and ACCIDENTAL UNDERDOSE (so worries she didn't' get the full dose of the vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (full syringe was not properly injected, so worries she didn't' get the full dose of the vaccine) and ACCIDENTAL UNDERDOSE (so worries she didn't' get the full dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a health care provider, therefore having high risk due to potential exposures. Patient was not immunocompromised. No concomitant medications were reported.  Treatment information was not provided.  This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious events of product administration error and accidental underdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious events of product administration error and accidental underdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Initial misuse report received from a healthcare professional on 28 October 2013. The case were received on 21 March 2014 at the agency. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received DTAP/IPV only. The Acthib was not given. No adverse event was reported. List of documents held by sender: none.
Received shot in (R) arm. Arm has been sore event sent shot. Taken 2 steroid pack. Now taking indomethacin going to specialist December. As well as using eat.
left arm still tender where shot was given; left arm still tender where shot was given and slightly red and itchy; left arm still tender where shot was given and slightly red and itchy; headache; Body aches; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267), second dose via intramuscular, administered in left arm on 24Feb2021 at 10:00 (at the age of 75-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation at hospital. No relevant medical history was reported. The patient's concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318), first dose via intramuscular, administered in left arm on 04Feb2021 at 16:00 (at the age of 75-year-old) as dose 1, 0.3 ml single for COVID-19 immunisation at hospital. On 25Feb2021, the patient experienced headache, body aches, chills, on 28Feb2021, the patient experienced left arm still tender where shot was given and slightly red and itchy. It was reported that the patient had headache, body aches and chills day after 2nd shot on 24Feb2021. Took 2 Advil and took 2 hours nap. Third day after shot, got headache and body aches in late afternoon after working, took 2 Advil and rested, went away. On 28Feb2021, left arm still tender where shot was given and slightly red and itchy, otherwise okay. The patient underwent lab tests and procedures which included urine analysis: UTI in Jan2021 cleared up. Therapeutic measures were taken as a result of headache, body aches, chills. The outcome of the events headache and body aches was reported as resolved in Feb2021. The outcome of the other events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Pediarix and Engerix given on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number FB9RH) for prophylaxis.   On 13-FEB-2023, the patient received Pediarix and Engerix B. On 13-FEB-2023, an unknown time after receiving Pediarix and Engerix B, the patient experienced accidental overdose (Verbatim: Pediarix and Engerix given on the same day). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was a medical assistant. The reporter consented to follow up. The patient received Engerix B and Pediarix on same day, which led to overdose.