chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt something strange in the teeth,like it was loose; felt some malaise in the mouth,felt a lot the food in his mouth; he regained the sensitivity there; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL DISCOMFORT (felt something strange in the teeth,like it was loose), ORAL DISCOMFORT (felt some malaise in the mouth,felt a lot the food in his mouth), HYPERAESTHESIA TEETH (he regained the sensitivity there) and PAIN IN EXTREMITY (pain in arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 027C21A) for COVID-19 vaccination.     The patient's past medical history included Tumor excision (About 10 years ago he had an operation where he lost part of the face and has metal instead because of a tumor he had; so he had no sensibility in that part).   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced DENTAL DISCOMFORT (felt something strange in the teeth,like it was loose), ORAL DISCOMFORT (felt some malaise in the mouth,felt a lot the food in his mouth), HYPERAESTHESIA TEETH (he regained the sensitivity there) and PAIN IN EXTREMITY (pain in arm). On 17-Jun-2021, DENTAL DISCOMFORT (felt something strange in the teeth,like it was loose) and ORAL DISCOMFORT (felt some malaise in the mouth,felt a lot the food in his mouth) had resolved. At the time of the report, HYPERAESTHESIA TEETH (he regained the sensitivity there) and PAIN IN EXTREMITY (pain in arm) outcome was unknown.            No concomitant medications were reported  No treatment information was reported
No additional AE; an expired MMR II was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 27-APR-2023, the patient was vaccinated with 1 dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot#: u007685, expiration date: 09-MAR-2023; strength, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). The diluent was not expired. No additional adverse events (AE) were reported (no adverse event).
I have had my menstrual cycle for over 5 weeks.  This has never happened before.
10 year old patient was given FluBlok, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 year old patient (unknown gender) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  At the time of report no adverse event was reported.  Reporter called to ask if there were any warnings against giving FLUBLOK to patient under 18.  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.  There will be no information available on the batch number for this case.
17 y/o received the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o received the Moderna vaccine) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 Drug was reported
Initial report received from a health care provider on 12 October 2009. A female patient (age not reported) was vaccinated with FLUZONE (Sanofi Pasteur, Lot # U3173BA) via an intramuscular injection to the left deltoid on 13 September 2009. Post vaccination, the patient reported discomfort at the injection site and difficulty lifting the left arm. One month later, the patient continues to experience these symptoms. The patient also stated that the site of vaccination may have been a little higher on the arm than the deltoid (more toward shoulder area). The patient reported no known allergies. No further information is expected. List of documents held by sender: none.
Reporting an error, not an adverse event.  Pediatric patient's guardian requested Moderna COVID vaccine for 5 year old child, but patient was erroneously given Pfizer COVID Vaccine indicated for 6 month to 4 year olds. The Pfizer vaccine information (which was actually administered to the patient) was recorded on the patient's COVID Vaccine card and the guardian noticed the discrepancy during the post-immunization observation period and brought it to the attention of the vaccine clinic staff. Contributing factors identified is multiple various vaccine preparations with various age ranges and doses, as well as busy clinic with distractions.  Of note, in addition to the brand discrepancy, the Pfizer vaccine given is of a lower dosage than is indicated for a 5 year old child. The Pfizer 6 month-4 year vaccine that was administered contains 3 mcg/0.2 mL, whereas the Pfizer vaccine indicated for children 5 to 11 years contains 10 mcg/0.2 mL. Being reviewed by local expert to determine if a make-up vaccine dose is indicated.
Disorientation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jun2023 at 10:00 as dose 1, single (Lot number: Glo446) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hip replacement" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies : tree nuts" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Tetanus, for Immunization, reaction(s): "Known allergies: Tetanus". The following information was reported: DISORIENTATION (non-serious) with onset 13Jun2023 at 08:00, outcome "recovering". Therapeutic measures were not taken as a result of disorientation.  Additional information: no other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
fever,chills ,vomiting,nausea,.fast heartbeat. In bed  for3 days
Immediate swelling,    sweating.   The worst of the swelling subsided within 15 minutes, although it remains painful.  No anaphylactic symptoms at all.  Sweating was probably due to anxiety over event.
Temperature increased to 104F, was fussy, had bulging fontanel and was vomiting. Treated 2 days with IV Rocephin. Pt's recovery to be determined.
Mother called to office x1 week after imms given with concerns of rash to (L) leg. She reported temp 101.2 following imms admin. Relieved with dose of TYLENOL. Redness and raised area to bilat aspects of thighs. As of 3/4 on exam noted fine slightly erythematous papular rash - left leg greater than Rt. Impression maybe secondary to imms but cannot rule out eczema as well.
product=COVID 19 Treatment, brand=Paxlovid/vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=25/Nov/2021; product=COVID 19 Treatment, brand=Paxlovid/vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=25/Nov/2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm 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 was not reported. Concomitant medication(s) included: TYLENOL, start date: 19Apr2022, stop date: 29Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=25/Nov/2021". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing full course of Paxlovid Covid symptoms returned 5 days later  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and DRUG INEFFECTIVE, COVID-19 cannot be completely excluded.
Patient was given an adult dose of Pfizer at our Covid Vaccine Clinic on 11/19/2021. Patient is 11 years of age and it was not caught at the time of check-in or vaccination. Patient was given the adult dose of Pfizer and completed the 15 min observation time without any side effects or symptoms. Patient was called by provider to inform them of the incident and follow up over phone was completed.
4/28/21 (first day after)  headache and achey 4/29/21 (second day) Severe Swollen tongue, I took two 25mg benadryl  and swelling subsided after 2.5 hours,   4/30/21 (third day) swollen tongue for 1.5 hours, took two 25mg benadryl, and after that subsided, my throat got swollen and neck/glands swollen, ....I took two more 25mg benadryl  5/1/21 f(ourth day after vaccine - today) tongue again began to swell (not as severely) and slight swelling around lips and took two 25mg benadryl which does help
This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of SHINGRIX and experienced unspecified adverse effects. The patient declined to participate in filing this adverse event. No further specifics were captured. No further adverse event information was provided.
report of mild h/a 9 day duration post 1st vax;report of severe h/a 4 days duration post second vax;saw civilian MD given Ibuprofen;@ 9 days post vax had hives, bilat upper extremity, chest & back;mild pruritus;no SOB/resp sx, given med;
It started with flu like symptoms, sinus drainage, post nasal drip, then it progressed into a sore throat. 24 hours later, I had body aches, headache, a cough that became productive later on. On 12/24/2022 at about 08:00PM, I had the tele-visit and he prescribed TAMIFLU. At that point in time, the symptoms were starting to abate on 12/25/2022. I took the 10 day course of TAMIFLU anyway. The symptoms slowly declined over a week. The sore throat and headache were gone by 12/28/2022. I continued to have the cough and symptoms with post nasal drip. I will go into a coughing fit every now and then to now. With strenuous exercise, I have noticed a change in my lungs. Seems to feel a bit different, but it is not debilitating. It's hard to describe.
Sore arm at site of injection - same day Sore and swollen armpit - next day Still have soreness and swelling 2 days later
This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of ROTATEQ, orally (dose, lot#, expiration date were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse reactions. Patient received Johnson & Johnson vaccine at 0.3mL dose vs 0.3mL Pfizer as requested.
Progressive  joint pain, numbness and tingling and swelling in bilateral hands. unable to bend fingers due to stiffness and pain. weak grips bilaterally. knee  amd ankle weakness and bilateral foot swelling. upon presentation to ER d Dimer elevated to 1100. negative for DVTs in all 4 extremities. currently awaiting primary doctor appointment to follow up.  Condition progressing with additional muscle pain at this time.
Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015 the patient was vaccinated with one dose of improperly stored PROQUAD (lot # L002420, expiration date 23-JUL-2016; strength and route not reported). No adverse effects were reported. Additional information has been requested.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267231; 2019SA267232, 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left arm on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
Fever, chills, chest pain, muscle aches, severe headache, nausea, loss of energy. All symptoms lasted for 3-4 hours with chest pain, muscle aches, headache, and loss of energy continuing into the next day.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and MYALGIA (Muscles aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN and ORPHENADRINE CITRATE, PARACETAMOL (ANAREX [ORPHENADRINE CITRATE;PARACETAMOL]) for an unknown indication. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headaches) and MYALGIA (Muscles aches). At the time of the report, HEADACHE (Headaches) and MYALGIA (Muscles aches) outcome was unknown. Not Provided. Treatment information not provided; This case was linked to MOD21-027282.
Patient called pharmacy on 01/12/18 reporting a rash on the arm which she sent a picture. Red rash with 5 inch margins. Patient stated that it was showing a little red starting 30 minutes after shot but did not contact us until 2 days later. We sent patient to urgent care and they prescribed ranitidine, and certerizine for reaction. Pharmacy gave her benadryl to take 50mg dose at night and will be contacting her on Monday.
Throat irritation; Rash on several parts of her body; Extreme stomach Cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Extreme stomach Cramps), DIARRHOEA (Diarrhea), THROAT IRRITATION (Throat irritation) and RASH (Rash on several parts of her body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included SEMAGLUTIDE (RYBELSUS), METFORMIN and LEVOTHYROXINE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Extreme stomach Cramps) and DIARRHOEA (Diarrhea). On 15-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation) and RASH (Rash on several parts of her body). At the time of the report, ABDOMINAL PAIN UPPER (Extreme stomach Cramps), DIARRHOEA (Diarrhea), THROAT IRRITATION (Throat irritation) and RASH (Rash on several parts of her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Pt presented to ED 1/4/2022 with 2 day h/o nausea, vomiting, fatigue, tachycardia. Initially tested negative for COVID on 1/4. Repeat testing 1/12/22 positive. Pt required supplemental oxygen throughout admission. Home requirement unknown.
ARM PAIN, JAW PAIN, A LITTLE WOOZY, BUT THATS IT
This spontaneous report was received from a medical asistant and refers to a 6-year-old (repoted also as 7 year-old), female patient. There was no information about the patient's concomitant therapies or medical history provided. The patient did not have any illnesses at the time of vaccination. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (strength, dose, route of administration lot# and expiration date were not reported). On 07-OCT-2015 at 14:00 (reported also as 2 pm), the patient was vaccinated with an improperly stored second dose of VARIVAX lot # L013068, subcutaneously in the left arm for prophylaxis (dose and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1611USA008278: US-009507513-1702USA004109: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105:
I was extra tired; couldn't get out of bed; Achiness, muscle and joint pain; Achiness, muscle and joint pain; Achiness, muscle and joint pain; Light headedness; Feverish; Rapid heart rate if lifting some things, my body responded if it was very strenuous; This is a spontaneous report received from a contactable consumer (patient).  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder on 10Apr2021 13:51 (Lot Number: EP7533) as single dose for COVID-19 immunisation.  Medical history included Allergy. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for Allergy, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 20Mar2021 (at age of 63 year-old) for COVID-19 immunisation and experienced extra tired for few days. The patient  stated,  it was in the wee hour of Sunday (11Apr2021) morning, between 1 and 2 AM, The patient  had a lot of achiness, muscle and joint pain. The patient  was so tired and  just couldn't get out of bed taking a Tylenol or an Advil (treatment) but that's where started and the patient did have during Sunday  (11Apr2021) had light headedness. The patient stated maybe a little feverish occasionally but the main thing was the lightheadedness, the rapid heart rate if the patient  just did some basic lifting of things, her body responded as if it was very strenuous when it really wasn't, the main thing was achy joint and muscles and light headedness but the patient had no respiratory issues, no sore throat. When probed for any treatment for the event, The patient stated, "I took an Advil, I don't usually take Advil, but I did take Advil, Sunday morning and afternoon and just before going to bed which was like 11 o'clock but I had taken a 2 hour nap in the afternoon, so I took a few Advil now, today I am much improved, I mean I may have a little ache here or there but I at this moment do not feel the need for any more Advil or anything for that matter." Therapeutic measures were taken as a result of achiness, muscle and joint pain, achiness, light headedness, feverish. The outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.