chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt brought to ED, cardiac arrest; EMS was called to pick up pt due to SOB and respiratory distress; pt arrested when EMS arrived; history of COVID; pt passed away in the ED
left supraclavicular and axillary lymphadenopathy on ipsilateral side of injection, normal labs, resolved over next month
Fever; Chills; Headache; This is a spontaneous report received from a contactable consumer (patient) via a Regulatory Authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 09Mar2021 (Batch/lot number not reported), as dose number unknown, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Mar2021, after the vaccination, the patient experienced fever, chills and headache. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
temp to 104 during noc, fussy, unconsolable, dec appetite f/u @ clinic next day temp 100.4 R;alert, hoarse, lungs clear, immun site negative;
This case was reported by a physician via call center representative and described the occurrence of generalised muscle aches in a 55-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 29th January 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th January 2018, 4 hrs after receiving SHINGRIX, the patient experienced generalised muscle aches, chills, tremor and general body pain. On 29th January 2018, the outcome of the generalised muscle aches, chills, tremor and general body pain were recovered/resolved. The reporter considered the generalised muscle aches, chills, tremor and general body pain to be related to SHINGRIX. Additional information was received as follows: Concomitant medication included Vitamins. The physician reported that the patient experienced a side effect such as body ache, shakes and chills after a dose of SHINGRIX. Less than a year after receiving SHINGRIX, the patient experienced tremor. The events did resolve but the patient did not provide how long it took for them to subside. This case was linked with case US2018GSK077833, reported by the same reporter.
I started getting symptoms of headache, nasal drainage, fever, and sore throat. Then my fever progressed to 101-102 and a cough. I took an at home COVID-19 test and took a PCR COVID-19 test which were positive. I received Paxlovid which I had an allergic reaction to and experienced a rash and hives all over my body. I called my PCP and was told to go to an urgent care. While at urgent care I was given Benadryl and was told not to take Paxlovid. I still have lingering effects of cough, sore throat, headache, tiredness, brain fog, and body aches.
Rhinorrhea/ Runny Nose; Pain/ Generalized Aching. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a consumer regarding a 35 year old female patient who experienced runny nose and became achy. At 35 years of age, the patient received a dose on 13-Dec-2003. The patient experienced runny nose (rhinorrhea) on 13-Dec-2003 and became achy (pain) on 16-Dec-2003. No additional information was available at the time of this report.
3 days after receiving the vaccine I had a seizure. I went to the hospital and they refused to listen to anything negative regarding the vaccine. The hospital was of no remedy to me. One doctor even boldly claimed that she wasn?t there so they can?t necessarily say I had a seizure. I received no medications and left the hospital with no CT scan.
sore throat; dizziness; weakness; achy joint; vomiting; chills; flashing; continuation of movement of light - like watching film and advancing it, (there are) different frames in there; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (flashing), VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness) and ASTHENIA (weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PHOTOPSIA (flashing) and VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there). On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), ASTHENIA (weakness), ARTHRALGIA (achy joint), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PHOTOPSIA (flashing), VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), ASTHENIA (weakness), ARTHRALGIA (achy joint), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Fine 1-2 mm size rash blanches on pressure/ maculapapular type of rash
This case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received SHINGRIX. On 10th February 2018, the patient received SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were not recovered/not resolved. The reporter considered the hives and rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient had not received other vaccines within the last 4 weeks before reporting and took no other medication. The patient was administered SHINGRIX in the right arm. She did not know the lot number of the vaccine. The patient stated she normally wears long sleeves so she was not aware of the hives. The night before reporting date, the patient wore a short sleeve shirt and her daughter told her about the rash on her arm. The patient said it did not bother her, there was no pain or itching. The patient took pictures of it if it could be reported. The patient did not provide the name of her physician as the physician did not prescribe the vaccine.
I have had  fatigue and chills and occasional headache since 1/24/21.
Sore arm; Bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Bad headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Bad headaches). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and HEADACHE (Bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant FU received on 28-Jul-2021, Sore arm event outcome updated.
I started to feel unwell on weekend before I had the symptoms of a cold for a couple of days. I had a stuffy nose for two days mild cold however now I am now having long issues with asthma and migraines after being diagnosis with COVID Positive 02/15/2022. I have just seen a doctor for a six month checkup and he put me on Singulair and that helped with lungs and I was put on prednisone for migraines and the lungs. I am scheduled to see a neurologist in May 2022. I am recovered from COVID but not the side effects of COVID symptoms breathing, lungs, and asthma. No physical exercise and this cause issue with lung filling up, and pain.
erythema multiforme reactions; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (erythema multiforme reactions) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA MULTIFORME (erythema multiforme reactions) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (erythema multiforme reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA MULTIFORME (erythema multiforme reactions) to be related.    Treatment and concomitant medications were not reported  Company Comment - This regulatory authority case concerns a 53 year old female patient with no relevant medical history, who experienced the serious unexpected event of erythema multiforme. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-475693 (Patient Link).; Sender's Comments: This regulatory authority case concerns a 53 year old female patient with no relevant medical history, who experienced the serious unexpected event of erythema multiforme. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Mother states the child began a fever of 104 on Friday 9/15/17 with rash on face. C/O headache, watery eyes. This lasted until 9/17/17 but the rash was still present as of 9/19/17. Mother called pediatrician.
headache, sore throat, cough, body aches  starting 10/26/21
Patient got shot on 10/5/17. She woke up 10/8/17 with a red area around the injection site. She was told to mark the area and ice. The area decreased until today 10/15/17. It has spread larger beyond the marked area. It is about 4 1/2 inch long and 2 1/2 inch wide red area.(just red no rash). I told her to ice again and get ahold of her doctor.
Pt received a Moderna Bivalent on Sept 12, then received a second Pfizer Bivalent on Sept 27. He meant to ask for a flu shot but accidently asked for a Covid Booster. He had already received a Moderna Bivalent Booster at another pharmacy.
Pt calling it "covid arm" - significant swelling about 6-9 inches below site of vaccination that has turned red and expanded to a 5 inch by 5 inch itchy, red rash. She has treated with benadryl cream.
My mother had a minor stroke the week of March15th she went to the ER on March 16th but since an MRI was not performed they missed the stoke.  10 days later on Friday March 26th she had a larger Ischemic stroke and was hospitalized.  She was moved to acute rehab when they found a blood clot in her leg on April 12th.  By the end of the month she became non verbal and catatonic so she was moved back to Hospital on May 3rd, 2021.  She was so agitated they couldn't even give her a MRI to verify if she indeed she had another stroke.  On May 28th she was moved to sub acute rehab and failed to thrive or respond to rehabilitation treatment.  She died on June 21, 2021 just 4 months after her second Pfizer shot.
She received vaccine at 12pm. Started with headache at 12:16pm. Vitals 106/68, 72. Pain 3-4/10. At 1230pm, pain increased 5-6/10. OK by Dr to take personal medication (she has rx of baclofen for tension headaches). F/u with pcp if pain persists, and she was discharged.
Patient reports that arm has been so sore for the last three days that it is barely moveable. He also reports dry cough, mild headache and extreme fatigue.
quadracel dose given at 8 years old and 9 months with no reported adverse event; Initial information was received on 28-Nov-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 8 years old female patient who had quadracel dose given at 8 years old and 9 months with no reported adverse event after receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), rubella vaccine LIVE (WISTAR RA 27/3), VARICELLA zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection at dose of 0.5 ml frequency: total (lot C5970AA and expiry date: 02-Feb-2024) via intramuscular route in the left thigh for Immunization (Immunisation).  On an unknown date the patient had a non-serious event of quadracel dose given at 8 years old and 9 months with no reported adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
feeling sick to her stomach this morning; arm hurt all night long; This spontaneous report was received from a consumer concerning herself, a 68-year-old female patient. The patient had a pneumonia vaccine one year ago (did not know what it was) but had no side effects from the vaccine. The patient had no medical history. The concurrent condition included seasonal allergy. The concomitant therapy included allergy pill (unsure the name).  On 18-AUG-2022, the patient received a pneumonia shot (pneumonia vaccine) with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prevent pneumonia (dose, strength, lot #, expiry date, and route of administration were not provided) at her doctor's office. The doctor would not tell her what it was just said it was a pneumonia shot and she was supposed to get it.   The patient stated that her arm hurt all night long (pain in extremity) on 18-AUG-2022. On 19-AUG-2022, the patient was pretty sick this morning. The patient felt sick to her stomach this morning (abdominal discomfort), and her arm still hurts this morning. The patient was not sure if the nurse did not know what she was doing or if the vaccine was too close together but she never had a reaction before. The patient did give permission to contact her healthcare provider. At the time of this reported, the patient had not recovered from pain in extremity and abdominal discomfort. The patient had no treatment for events.  The causal relationship between pain in extremity, abdominal discomfort and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Received Varicella vaccine on 7-31-07 returned to clinic 8-2-07 measured 30mm x 40mm at site of injection.
Pt  with chest tightness  after vaccine with throat itching and fullness. Gave Benadryl IM wth symptoms not getting better with pt looking pale . Gave Epinephrine IM  with 911 called . Anaphylaxis like reaction
stomach and colon pain, headache, weakness, a-fib, short of breath, loss of taste. All symptoms occurred subsequent to suspected COVID 2/15/2020 (was not tested at the time because there wasn't much COVID in Utah where I lived at that early date). Symptoms continued for a year, was getting better the last couple of weeks before the 2nd COVID shot and then relapsed (including had regained sense of taste for 2 weeks. then lost it again after the shot).
Heavier menstruation; Cycle came early; period color darker than normal; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 at 17:00 (at the age of 43-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history of the patient was not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 22Jul2021 at 14:00, the patient experienced heavier menstruation, cycle came early, period color darker than normal and it happened with second dose as well. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavier menstruation, cycle came early and period color darker than normal was recovered on an unknown date in 2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
pt recv vax 25NOV92 & 5JAN93 pt devel Bell's palsy;subsequently the palsy resolved;no further details were provided;
Stared with c/o painful legs increased by 7:00 PM both legs swollen, red with severe eczema on both thighs size of lime. Started Benadryl and Cutivate cream LA.  08/24/2011 legs still swollen, but less redden. Ct. meds.  Referring to Allergist per Dr.
headache; Chills; very tired; very swollen lymph node; This case was reported by a consumer and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 3rd June 2020, 2 days after receiving Shingrix, the patient experienced headache, chills and tiredness. In June 2020, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes, headache, chills and tiredness were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, headache, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had very swollen lymph node on my underarm on the same side as the injection.  The patient felt very tired, headache and chills. The reporter asked could this be a side effect of the injection.
Information has been received from a physician concerning a patient who on an unspecified date was orally vaccinated with a dose of ROTATEQ. The physician reported that the ROTATEQ was administered off label by giving it later than 32 weeks. There was no adverse event reported. It was noted that this was brought up because the vaccine was not covered by insurance since it was given off label. Additional information has been requested.
Initial misuse report received from a healthcare professional on 02 January 2014. A 17-month-old patient had forth dose of had ADACEL instead of DAPTACEL. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Rash-red, raised, warm and tender to touch. Assessed as cellulitis. Prescribed KEFLEX 500 mg capsules (40).
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 02-year-old male patient. On 17-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
PATIENT CALLED LCHD ON 1/6/21 TO REPORT REDNESS AND HEAT TO INJECTION SITE AT THIS TIME. PATIENT STATES THAT SHE TOOK BENADRYL AND WAS LIGHTENING UP IN COLOR.
Had MMR vaccine on 12-9. 12-15 had a 102.5 fever, runny nose, congestion, tearing eyes, cough. 12-18 woke up with a rash more brownish/reddish in nature, extremely whining, constantly had to be held, acted like he was in pain. Didn't sleep well for 5 days.  Then on Dec. 27 had congestion still, runny nose, fever again, croupy, friday morning Dec. 28 started breaking out in a rash.  Woke up friday rash had spread over his entire trunk region, face and slight on upper extremeties, red and raised.  5 days post rash took him to the doctors because they were closed for the new years holiday. the rash had spread to his extremeties and was almost gone on his stomach region.  He was congested, conjuctivitis, croupy, fever, runny nose.  The doctor said it could be atypical measles but he had never seen measles before but it looked similar to the picture.  Said he couldn't test it because he was vaccinated and it would be positive anyways.  He had the rash on his extremities for almost 2 1/2 weeks.  He had an ear infection. I spoke with National Vaccine and they said that I should report it.