chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like my throat was closing up on me; could not breathe and was gasping for air; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Felt like my throat was closing up on me) and DYSPNOEA (could not breathe and was gasping for air) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: depo provera. Past adverse reactions to the above products included No adverse event with depo provera.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Felt like my throat was closing up on me) and DYSPNOEA (could not breathe and was gasping for air). At the time of the report, OROPHARYNGEAL DISCOMFORT (Felt like my throat was closing up on me) and DYSPNOEA (could not breathe and was gasping for air) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No treatment information was provided.  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.
She reports lots of pain in her left arm where she got it; The whole breast on the left side was swollen."; Yesterday she found a "huge lump" in her left breast; I have been having pain in my left armpit; swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Breast implant" (unspecified if ongoing), notes: Patient history: Breast implant (From: Unspecified To: Unspecified). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "She reports lots of pain in her left arm where she got it"; BREAST SWELLING (non-serious), outcome "unknown", described as "The whole breast on the left side was swollen.""; BREAST MASS (non-serious), outcome "unknown", described as "Yesterday she found a "huge lump" in her left breast"; AXILLARY PAIN (non-serious), outcome "unknown", described as "I have been having pain in my left armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional information: LOT number was reported as, could not see, it was small like F or E and then K9895, the label was cut at the bottom, so did not know. Also reported she had appointment with the Gynaecologist, but they did not have any open appointment something like in 2-3 months, so could not wait that long, this was crazy, and this was scary.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Itches all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches all over) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itches all over). At the time of the report, PRURITUS (Itches all over) outcome was unknown.             No concomitant medications were reported.No treatment information was provided.   This case was linked to MOD-2021-089718, MOD-2021-089718 (Patient Link).
A report has been received from a Pharmacist concerning a 42 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 12-Oct-2014. Patient had been administered by expired FLUMIST QUADRIVALENT which started on 12-Oct-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
My son's thigh turned bright red and was extremely swollen.  The area was very hot, itchy and tender to the touch.  Walking was difficult and painful at times for him.
Red at injection site; Itches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: Red at injection site) and pruritus (Verbatim: Itches). The outcome of the injection site erythema and pruritus were not reported.   It was unknown if the reporter considered the injection site erythema and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the injection site erythema and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient got his/her 2nd shot it's red at injection site and itches. anyone else. This report was one of several cases received as part of a line-listing, each containing minimal information.
At about 8 AM on 8/26/04, patient was found having seizure activity, primarily on the right side with repetitive movements of right upper and lower extremities and drooling. She was taken to ER at 9 AM. Gave phenobarbital and stopped the seizure. She was admitted to hospital for work up.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Vaccines were given early, during the 1 month visit. Baby was crying and fussy as per parents after the vaccines. Parents were informed by phone call, from our office, of the early vaccine dosages on the same date of administration, 12/07/2021. Father called us on 12/14/2021 to inform that baby has been fussy and not sleeping well. Father took baby to the ER on that date. Mother called on 12/15/2021 that we didn't get back to her on a call from 12/14/2021, but we did speak with father on that date. Left mother a voicemail. On 12/16/2021 Dr. called and left a voicemail for parents, in order for us to check on baby and to call us back as needed. On 12/21/2021 mother had a concern about fussiness and not sleeping, some leg pain as well. 3-way call was done and Dr. advised mother to bring in baby to our office 12/22/2021 in the morning. Also advised mother to take videos of what mother is concerned about to show the doctor during her office visit.
dizzy; trouble breathing; ears buzzing; little soreness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness (dizzy), Dysponea ( trouble breathing), Tinnittus (ears buzzing) and Vaccination site pain (little soreness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event little soreness, ears buzzing, dizzy and trouble breathing. she also stated that this lasted for 15 minutes, but had not mentioned which event has lated for 15 minutes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Patient received 2 does of Prevnar in 1 year. Received at Family Practice on 1-10-20 and then came to pharmacy and said she wasn't sure/was not previously vaccinated and received again on 10-19-20.
This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on an unspecified date, the patient might have received an improperly stored dose of GARDASIL 9 (lot: M007464, expiry date: 30-JAN-2018) or ROTATEQ (lot: M033338, expiry date: 15-APR-2018) (Incorrect product storage). But she was not sure which of the vaccines the unspecified patient received. The vaccine was exposed to the temperature range of 32°F to 35°F for 8 hours. There was no previous temperature excursion. No adverse events were reported. This is one of the two reports associated with the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001350:
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced a pain on an unspecified arm and cellulitis. The patient sought unspecified medical attention and was given clindamycin as treatment. The outcome of pain on arm and cellulitis was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Client received three vaccinations, minutes later fell to the floor and was observed to be having possible seizure activity.  Monitored by staff for safety and breathing.  pLaced in rescue position and 911 called.  Continued to monitor client until EMS arrived.  Cool cloth to forehead.  Client c/o numbness to nose area after consciousness returned.  Swelling to right cheek also noted.
101.5 fever Friday night, followed by a seizure at 3am.  She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital.  Sudden cardiac arrest.
One day post vax pt experienced an injection site reaction characterized by swelling, red and inflamed area measuring 11 X 7 cm.
Severe muscle pain, swelling at injection site, redness at injection site, fever, reduced mobility in arm.
Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume more than 1.8 ml, but a 0.3 ml dose was still administered
Mom reports started wheezing and coughing on Sunday 08/04/2019, started vomiting today 08/06/2019
Patient is a 29-year-old male with no significant past medical history. Presents emergency room for a syncopal event. Patient was upstairs in this facility receiving a COVID vaccine. A few minutes after receiving the vaccine he began to feel lightheaded, asked for assistance and had a syncopal episode. Patient was eased to the ground there was no trauma. States he has had previous near syncopal events associated with seeing blood or having needles injected into him in the past. He is without complaint. Denies any chest pain or headache prior to event. Denies any previous history of blood clots or other coagulopathies.
DIZZINESS UPON STANDING; SLEEPING 15 HOURS PER DAY; WEAKNESS; SEVERE FATIGUE; PALENESS; This spontaneous report received from a consumer concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included post heart attack, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergy patient was not doing any drug abuse or any illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced paleness. On 11-MAR-2021, the subject experienced sleeping 15 hours per day. On 11-MAR-2021, the subject experienced weakness. On 11-MAR-2021, the subject experienced severe fatigue. On 12-MAR-2021, the subject experienced dizziness upon standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe fatigue, weakness, paleness, dizziness upon standing, and sleeping 15 hours per day. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pt. is a 41 y.o.  male who presented on 12/16/21 for injuries sustained in a pedestrian injured in a traffic accident involving a motor vehicle.   Labs showed alcohol and methamphetamine intoxication.  Per report, patient was crossing the street and the mirror of a motor vehicle hit his head while traveling at 45mph.  He had altered mental status and was unresponsive.  on scene was E1, V1, M4 (6).  upon arrival in ED, required intubation and extubated on 12/18/21.  Patient tested positive for COVID-19.  Patient sustained TBI/SAH/SDH/IVH and multiple facial fractures.  Patient was transferred back to CCU on 12/19/21 due to increased agitation and need for a Precedex. Tested positive for COVID-19 upon admission on 12/16/21.  Patient is homeless.
Left arm red and tender, left wrist swollen with limited motion. Also 3 fingers - 3rd, 4th and 5th fingers left hand were tingling at finger tips and were painful.
One week after the first dose of the vaccine. I had a runny nose and then green congestion. My cheek bones and my head felt like they would explode. I had no energy. I could barely get out of bed. I was in bed for five days with the Sinus Infection. Ten days after the shot I called my doctor and they prescribed an antibiotic Zithromax  which did not seem to help much. The headaches improved gradually and I regained some energy. It took almost two weeks before I felt normal. It has been almost ten weeks and I still have some green discharge. I got my second shot and I had no problems with that. second dose 038B21A
pt recvd flu inject & devel a hot, painful, pruritic area 94 inches in diameter) @ the inject site that resolved in 1 wk;
This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 29-Sep-2015 - unknown stop date, Batch no: U56006, Route of administration: not provided, Dose: 0.5 ml. No additional drugs suspected. On 29-Sep-2015, after starting treatment with AFLURIA the patient experienced Breastfeeding mother received AFLURIA. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious.
None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Onset 1800 3/24 numbness radial side of L arm no weakness, tingling 3/25 0600 radial 8100 L arm 8100 L arm tingle numb, 10000 R side of face numb, 1300 L arm/shoulder numb, 3/26 Facial numbness resolved 3/27 numbness shed to hypersensitive.
still sick from getting the COVID shot/side effects for 3 weeks; covid from a covid shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot) in a 20-year-old male patient 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 ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot). At the time of the report, ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Pencil eraser size erythematous scattered lesions on face, legs, arms and trunk. No central punctae.
Swelling, redness, pain (L) upper arm 5/27 went to Urgent Care-"diagnosed with cellulitis secondary to her body's reaction to vaccine" (per pt.). Received Rx for Clindamycin and Prednisone to treat.
pt recvd vax 22SEP94 & 23SEP94 pt presented in sick call w/either a fever &/or local or systemic rxn;sxs resolved p/several days;
This spontaneous report was received from a non-healthcare professional via Pfizer refers to a 17 years old female patient. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing information was not provided) for prophylaxis. On an unknown date, the patient died. It was unknown if the autopsy was performed. The cause of death was unknown. Reporter considered the event to be related to GARDASIL. Upon internal review, death was determined to be medically significant. This is one of the two reports received from the same reporter.; Reported Cause(s) of Death: unknown cause of death.
Patient received 3rd covid dose. The first two were Moderna. The third was Moderna. Pfizer was used due to Moderna being unavailable in the local market. The wording of the CDC was the 3rd dose was "encouraged" rather than mandated to match the first two doses.   The patient had severe nausea and aches. Encourage patient to reach out to PCP for nausea meds.
On March 17,2021 one day after vaccine woke up to a red, hard, swollen, itchy arm with a light headache. It continue to be like that until March 20,2021.  I also took tylenol to help and iced it.   On March 20 it was a little pink , much better. On March 25,2021 it became hard, hot, swollen, itchy, and a bigger headache and some vomiting.        Sidenote- The vaccine was administered to the middle part of my arm.  Had two professionals say it was to low ,should have been higher on the arm. Taking tylenol and icing.
0920: 10 mins after receiving COVID vaccine, pt began experiencing a tingling tongue; has had a previous reaction to the pneumo-vax. Benadryl po given.  Pt released home once stable.
This spontaneous report as received from a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of MMR II (Lot number, expiry date, route and dose were not reported) as a child. On an unknown date, the patient's titers tested positive after receiving MMR II. The outcome of titers tested positive was unknown. Additional information is not expected.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, one intramuscular dose, for prophylaxis (with either lot # N014464, expiry date: 31-JAN-2020; lot# N020352, expiry date: 10-APR-2020; or N014464, expiry date: 19-DEC-2019). The vaccines underwent a temperature of 47 Fahrenheit degrees (°F) to 77°F (50.7°F), by a time frame of 1 hour 30 minutes, with no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA001401: US-009507513-1801USA008096:
Left arm swelling, redness, headache, fever, chills, left arm stiffness.
Tightness in chest, nauseas, vomiting (6 times), hot, severe weakness, severe chills, eye mucus. Lastest until 09/21/2011 5:00 am
The last week of 12/99, had Christmas family day dinner and afterwards was very ill; headache; fever and blew blood through nose for 2 weeks. Feet were very red and burning for a week. Hot water also turned them very red. Also had a cough and restlessness for 2 weeks. Sore left arm. Prayed to God a lot.
Pt irritable/ soft AF without belge EENT PERRL/RRR sl erythema on site (-) mass or induration.
Red rash around neck upper chest developed 2 days after flu vaccination-no SOB no prob swallowing. Has had a reaction to ZOSTAVAX in past.
Fever of 100.0°. Body aches. Chills. Right sided headache. Right sided neck pain. Arm pain. Fatigue.
Entire upper arm swollen and red rash covering entire arm then later in the afternoon upper arm began itching. Symptoms continued for several weeks and still some symptoms now one month later.
tested positive for COVID-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 after first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19 after first dose). At the time of the report, COVID-19 (tested positive for COVID-19 after first dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Areas of rash on neck, upper chest, hands and arms, smaller rash areas elsewhere. Mild itching at times. Moments of lightheadedness occasionally