chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a dose of YF-VAX via intramuscular route/no AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA233337, 2019SA233344 and 2019SA233345 (same reporter).  This case involves an 49 years old patient (gender not reported) who received a dose of YELLOW FEVER VACCINE - US [YF-VAX] (LOT U6288AB, and expiry date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination as patient received a dose of YF-VAX via intramuscular route.  At the time of reporting, 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 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.  Documents held by sender: none.
This spontaneous report as received from a registered nurse regarding an unknown age and gender patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date not reported), (0.5 ml, intramuscular, single dose). No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced arthralgia, myalgia and injection site swelling after she received PNEUMOVAX 23. It was reported that the symptoms "took a week to resolve" and the patient made a full recovery. No treatment information was reported. The reporting nurse did not assess the causality between arthralgia, myalgia and injection site swelling and PNEUMOVAX 23. Additional information has been requested.
11/6/01 started fever 102F range, severe HA, sore throat Sx all continued into 11/9/01. Lesions started 11/9/01, 11/9/01 3+ erythematous tonsils with petechia strep (-), bronchospasmatic cough with expiratory wheeze, fever resolved 11/10/-11/11/01. 11/9/01 started Acyclovir 600mg.
had them 4 times, After the shot/Suspected Vaccination Failure; had them 4 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had them 4 times, After the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 4 times).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she had shingles four times after the shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pt started with rash that itched and started spreading on 11/4/03. Seen on 11/5/03 at 10:30 AM. Dx with chicken pox per MD.
24 hours post vaccination - low grade fever, joint pain, body aches, nausea, fatigue Day 2 - No symptoms 48 hours post dose - Severe neck pain, headache, low grade fever, nausea, fatigue.  These resolved within 12 hours. Self treatment - Ibuprofen
allergic reaction. Rash, itchy to BLE and BUEs x 2 days with swelling; pt reports mainly in joint areas, getting worse today and spreading; received J&J vaccine on 10MAR21. Rash with redness and itchiness to BUEs/BLEs; no pain; patent airway.  MDM:  Pt does not have anaphylaxis. The temporal relationship to COVID vaccine is suspicious. Will treat as allergic reaction. F/u and return precautions discussed.
At 11am on 2/16, my arm began to get sore.  I took Advil at 4pm and it wasn't so bad.  At about 10pm when I went to bed, I had issues falling asleep because my heart felt like it was pounding through my chest.   That pounding came off and on during the next day.  I woke up twice and my feet were ice cold and my body was very hot.  The second time I woke I thought I would take some tylenol and was extremely dizzy walking to the bathroom.  I was so weak I couldn't open the bottle.  I slept nine hours, very unusual.  I felt very under the weather all day until around 5pm.  I woke up the next morning feeling pretty normal.  The arm pain was completely gone by the 18th.
Flu vaccine given 12/10. Two weeks later (Jan. 2011) I experienced loss of balance, tingling in hands and feet, slurred speech which resulted in ER visit/hospitalization for 1 wk, required physical therapy, speech therapy and occupational therapy, IVIG treatment. Occasional tingling in hands.
miscarriage; Bleeding from uterus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Aug2021 11:00 (Lot number: FC3192) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time:, Date: 07Aug2021, Time: 14:00, Anatomical Site of injection: left site Deltoid, Route of administration: intramuscular, Batch/Lot Number: FA7485), administration date: 07Aug2021, when the patient was 37 years old, for Covid-19 Immunization, reaction(s): "Bleeding from uterus". The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 03Sep2021, outcome "unknown", described as "miscarriage"; UTERINE HAEMORRHAGE (medically significant) with onset 28Aug2021 14:00, outcome "recovered", described as "Bleeding from uterus". The events "miscarriage" and "bleeding from uterus" were evaluated at the physician office visit. Therapeutic measures were taken as a result of uterine haemorrhage.
A non-serious spontaneous report of we gave a dose of expired FLUMIST was received from a health professional concerning a nine-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 02-Jan-2011. On 18-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 10-Jun-2011: The patient did not have any late occurring adverse events.
we had a vaccine event in our pharmacy today, and pt stopped by that table in the front of the store and received the flu hd shot there, then came to the pharmacy asking for a pneuomonia vaccine, our hand held programmer showed pt was pending both vaccines and he was inadvertently given the flu hd vaccine again.
Patient received COVID booster on 11/19, unknown type (I do know that the original series was Pfizer).  The following day she was admitted with a myocardial infarction and severe anemia requiring blood transfusion.  She has well-established multi-vessel CAD prior to this admission, as well as chronic anemia.  At most, the vaccine was only a contributing factor or trigger to something for which she had been liable for years.
10 DAYS AFTER INJECTION ARM BELOW INJECTION SITE STARTED TO ITCH AND WAS BRIGHT RED. APPLIED LOTION AND ITCH STOPPED BUT REDNESS CONTINUES. NO PAIN BUT TENDERNESS.
large painful boils and lumps in my armpits and under breasts; large painful boils and lumps in my armpits and under breasts; large painful boils and lumps in my armpits and under breasts; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 16:00 (Lot number: FJ1620) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number: EW0176, administration time: 04:00PM, location: Left arm,), administration date: 27Apr2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, lot number: ER8737, administration time: 02:00PM, location: Left arm), administration date: 06Apr2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "dose number=3"; FURUNCLE (non-serious), AXILLARY MASS (non-serious), BREAST MASS (non-serious) all with onset 13Dec2021 12:00, outcome "not recovered" and all described as "large painful boils and lumps in my armpits and under breasts".  Additional information: After 3 dose (booster) patient have been experiencing large painful boils and lumps in her armpits and under breasts. Patient has not suffered from covid prior vaccination and has not been tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
I just want to know if I could take an extra strength of Tylenol for my headache.; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I just want to know if I could take an extra strength of Tylenol for my headache.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Yesterday (3/18/21) he received the second dose of Moderna COVID-19 vaccine. This morning he feels achy all over. On morning temperature screening in the respiratory clinic, his temperature was 99.2
severe asthma attack, no fever, sinus infection. pt treated with iv decadron followed by po taper of prednisone
patient given Moderna booster dose instead of Pfizer (5-11y/o).  I reported to my local County Health Department and state database.  Called Moderna and received information in a few days recommending a second dose of Pfizer (5-12y/o) 28 days from this vaccine.  Mom   called pediatrician and they reassured her kids would be ok.
High Fever; Inflamed lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High Fever) and LYMPHADENITIS (Inflamed lymph nodes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011G21A, 013120A and 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    No Medical History information was reported.   In 2004, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 mcg (125 mcg,1 in 1 D). In 2005, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 112 mcg (112 mcg,1 in 1 D). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 88 mcg for three days and 100 mcg for four days (88 mcg,1 in 1 D). On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 100 mcg (100 mcg,1 in 1 D). In December 2021, the patient experienced PYREXIA (High Fever) and LYMPHADENITIS (Inflamed lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In December 2021, PYREXIA (High Fever) and LYMPHADENITIS (Inflamed lymph nodes) had resolved.            No concomitant medications were reported.  The reporter's causality for the events of high fever onset in December 2021, inflamed lymph nodes with Synthroid (levothyroxine) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-621238, MOD-2022-630556 (Patient Link).
Woke up feeling achy, chills,  Feverish Low grade fever Estimated date of delivery 08/25/2021
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot # M016238 and expiry date 07-DEC-2017) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013520: US-009507513-1612USA013519: US-009507513-1612USA010663: US-009507513-1612USA013517.
Mom of client called office at about 12:30 pm on 5-29-15 and stated her sons arm way swollen and red arm warm. Client presented if office and nurse assessed. Arm was swollen from top of shoulder to elbow. Red, tight and hot. RN called local PA, to make appointment to be seen right away. Client did not have a fever. Was treated at medical clinic.
pain in her pubic area; wobbly on her legs; body temperature of 100.4 deg. F; A spontaneous report was received from a consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain on her pubic area, body temp. of 100.4 deg. f, wobbly on her legs.  The patient's medical history was not provided. Concomitant medications reported were Pravastatin for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) pain on her pubic area, body temp. of 100.4 deg. f, wobbly on her legs.  Treatment details included No  taken, but patient plans to see HCP tomorrow.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain on her pubic area, body temp, of 100, 4 deg, f, wobbly on her legs was unknown.
About 2-3 days after I got my vaccination I had a welt on my left top of shoulder to elbow to side to side of my arm for about 3 weeks and was itchy and larger.  I called my doctor at 7am on the 15th and they scheduled a teleconference at 5pm that afternoon. My doctor was unsure and noted it but didn't treat it. I didn't have any other symptoms so he didn't treat me with anything.  It did eventually resolve
I had fever, chills, muscle aches, joint pain, headaches and lymph nodes swelling on the left side.
Angioedema TINGLING SENSATION LEFT LOWER JAW AND SWELLING OF LEFT LOWER JAW AND BACK OF LEFT EARLOBE Narrative: 3 HOURS AFTER GETTING THE FIRST DOSE OF PFIZER, STARTED FEELING SWELLING OF BACK OF LEFT EARLOBE, AND LEFT LOWER JAW. THEN FELT TINGLING SENSATION ON LEFT LOWER JAW TOOK BENADRYL 25 MG X 1 DAY 3X ADAY ONLY. SWELLING DID NOT SUBSIDE BUT DID NOT GET WORSE. AFTER 3 DAYS DISAPPEARED. ALSO FELT LETHARGIC DAY 1 OF VACCINE. SHE WAS ADVISED NOT TO TAKE THE SECOND DOSE OF PFIZER 21 DAYS AFTER. SHE WILL AWAIT THE CALL FROM HER PCP AND IT HAS BEEN MORE THAN 2 MONTHS NOW AFTER FIRST VACCINE WAS GIVEN
Patient presents with rash. No history of fever, sore throat, and cough. The rash is involving the upper extremity. The character is described as pruritic, red and warm. Had Tdap 3 days ago. Starting next day arm was red, swollen, itchy, slightly improved today. No medication given, no fever.
ADMINISTERED COVID19 PFIZER BOOSTER WITHOUT CONSENT FROM FAMILY/RESPONSIBLE PARTY
Initial report received from nurse on 03 Dec 2009: This patient with a medical history of early stage Parkinson's disease, received FLUVIRIN H1N1 lot number 960355P, 0.5 ml intramuscular on 12 Nov 2009. On 01 Dec 2009, the patient experienced impaired mobility of her arm and shoulder. The patient sought treatment for the events. The patient's neurologist ordered some tests. The outcome of the event was reported to be continuing.
Pain in the hand; Started seeing blurred or black; sweated a lot; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the hand), VISION BLURRED (Started seeing blurred or black), HYPERHIDROSIS (sweated a lot) and DIZZINESS (Felt dizzy) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the hand). an unknown date, the patient experienced VISION BLURRED (Started seeing blurred or black), HYPERHIDROSIS (sweated a lot) and DIZZINESS (Felt dizzy). At the time of the report, PAIN IN EXTREMITY (Pain in the hand) had not resolved and VISION BLURRED (Started seeing blurred or black), HYPERHIDROSIS (sweated a lot) and DIZZINESS (Felt dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Blood pressure fell.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. It was reported that Patient was treated with Water and events got improved.
ATTACHED IS ER PHYSICIAN DOCUMENT :      reported approximately 15 minutes after the vaccine was administered patient had a seizure.  Mom did not witness the seizure there is no discrete record of what occurred though mom believes that it was one of her, "silent seizures."  Mom states that child has not recovered from her postictal period as she normally would have and patient agrees she feels that she is still more lightheaded fatigued and confused than she normally is.  Mom is concerned that she may have had multiple silent seizures since she has been home
stiffness in arm; soreness in arm; knot in arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of limbs stiffness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 18-SEP-2023, the patient received RSV vaccine. In SEP-2023, less than a week after receiving RSV vaccine, the patient experienced limbs stiffness (Verbatim: stiffness in arm), pain in arm (Verbatim: soreness in arm) and local swelling (Verbatim: knot in arm).  The outcome of the limbs stiffness and pain in arm were not resolved and the outcome of the local swelling was resolving.   It was unknown if the reporter considered the limbs stiffness, pain in arm and local swelling to be related to RSV vaccine.     It was unknown if the company considered the limbs stiffness, pain in arm and local swelling to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 22-SEP-2023 This case was reported by a patient via interactive digital media. The patient took the vaccine on Monday, got a big fat knot on arm. On the day of reporting the patient stated that the knot was small but still had stiffness and soreness in arm. The follow-up could not be possible as no contact details were available.
Symptoms started 1 week after vaccination, at night while i was sleeping I woke up experiencing  full body tingling and numbness, hot  pins and needles all over body.  went to hospital they said seemed nerve related sent me home.  next day saw neurologist, symptoms at this time only lower legs and feet peripheral neuropathy (numbness and tingling sensation) this feeling in my legs and feet lasted for about 3.5 weeks until went away on September 19, 2021.
Large area of erythema from vaccines. 5" x3 " on left arm. Cool packs applied and Benadryl given. No fever or s/s of infection.
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Symptoms began about 2 days after vaccine administration.  She experienced significant weakness, numbness, and tingling to her left arm.  It then progressed to her entire body.
Child given TDAP/MCV at 11:00 a. Child already had both vaccines 9-14-10 - No issues at time of event. The shots were not entered into records so it looked as though did not have them.
Redness, swelling from shoulder to wrist, spotting, feverish arm. Treated at hospital.
fever PM of 23APR97 103 ax, malaise, no appetite-bones hurt;taking fluids, refused chewable APAP because my teeth hurt;temp @ 12PM 24APR 101 ax;APAP elixir recommended, if sx intensify or become worse;