chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in mouth and teeth; mouth is very sensitive; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Soreness in mouth and teeth) and ORAL PAIN (mouth is very sensitive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Soreness in mouth and teeth) and ORAL PAIN (mouth is very sensitive). At the time of the report, ORAL PAIN (Soreness in mouth and teeth) and ORAL PAIN (mouth is very sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Patient checked No to "Has the person to be vaccinated ever received a COVID-19 vaccine?", so patient was given the Janssen Vaccine he requested. When Patients data was entered into LINKS, it was found that he had received a first dose of Moderna on January 12th, 2021.
dizziness, vertigo, persistent headaches more prominent on left side, tingling pain in left side of face, down left side of neck and back, some shooting pains down left arm, nausea, feeling consistently off balance and slightly nauseous
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 11-Dec-2011. On 13-Dec-2011, the patient received expired FLUMIST. 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 19-Mar-2012. The patient did not experience any adverse events.
moderate soreness at injection site; swelling and soreness of infraclavicular lymph node; swelling and soreness of infraclavicular lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9262) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "swelling and soreness of infraclavicular lymph node".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199952 same patient, similar events with different dose;US-PFIZER INC-202300243142 same patient, similar events with different dose;US-PFIZER INC-202300243143 same patient, similar events with different dose;US-PFIZER INC-202300243144 same patient, similar events with different dose;US-PFIZER INC-202300243141 same patient, similar events with different dose;
Had both doses and 6 months later tested positive for covid virus; Had both doses and 6 months later tested positive for covid virus; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGL: on an unspecified date DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was reported that INT withheld swap from withheld had both doses and 6 months she tested positive for COVID virus and she thought she had delta variant. She wanted to get the booster but wanted to be ensured that would be better that the other 2 she got. The patient also reported that the governor in withheld got the covid virus and he got the infusion and why did not she get the infusion. She had to suffer with her illness no one told her about the infusion. Asking if we are working on a better booster. The patient was told she would have to wait 90 days to get the booster because she tested positive. The patient underwent lab tests which included Covid virus test: positive. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
36 hours after vaccination I had congestion and dizziness, headache and fatigue. My doctor advice that it could take up to 6 months to resolve,  Adverse even is that both lungs are inflame and when I do activities I come down with respiratory symptoms as well, I saw my provider mid September my, Family Practice and he did breathing test on my lungs and that was their conclusion. At some point I had X-ray to check if I had pneumonia and it was not. My breathing is improving but is not back to normal yet.
had both shots and still ended up getting it/suspected vaccination failure; getting it on the right side of my face; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and still ended up getting them on the right side of his/her face.  The patient want his/her money back. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Left arm lymphadenopathy; 48 hours swelling visual; Pain with movement; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 1, ), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Left arm lymphadenopathy"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "48 hours swelling visual"; PAIN (non-serious), outcome "unknown", described as "Pain with movement".  Additional information:No concomitant meds or vaccines were reported. No underlying conditions. No similar reaction with past vaccines noted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a lingering headache; chills; fever; slight tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lingering headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (slight tiredness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced HEADACHE (a lingering headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (slight tiredness). At the time of the report, HEADACHE (a lingering headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (slight tiredness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-438760, MOD-2022-438857 (Patient Link).
PT HAD CONFUSION ANS VISION ISSUES. HAD CT AND MRI CONSULTED RETINA SPECIALIST.  GAVE INFO AT PHARMACY ON 6/7/2019. CONFUSION RESOLVED AND STILL CONSULTING RETINA SPECIALIST
Client complaints of feeling hot. Client was brought to observation area via wheelchair. Vital signs stable. Client was offered, water icepack and mint. Client reported feeling better. Encouraged client to report at the next vaccine appointment.
Immediate dizziness and nausea  Soreness in arm after 12 hours Tongue swelling and tongue has white spots on sides of tongue 48 hours after
Pt developed fever and had left arm twitching in the evening of 8/1/2010.  He was admitted to the hospital the next day to r/o partial complex seizure with fever.  Initial blood cx positive but was determined to be a contaminant.  He was discharged from hospital on 8/7/2010.  He had no seizure -like events in hospital and appeared well the entire time.  MRI and EEG were normal.  Repeat Blood cx negative and he defervesced.
Pain at the injection site; This is a spontaneous report from a contactable Other Health Professional (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site after Covid 19 vaccine on an unspecified date with outcome of unknown. Information on the Batch/Lot number has been requested.
My left arm/shoulder muscle had swelled with a very painful lump about 4 in. by 3 in. within 4 hours. At that time I also began having a low-grade fever. Six hours after vaccination I could not move my left arm or touch my shoulder without extreme pain. The following day those symptoms continued and added some episodes of dizziness, mild nausea, fatigue, thirst, short term memory problems, and joint and muscle pain. My fever peaked at 100.6 about 24 hours after the injections. The listed symptoms peaked about 24 hours after the injections. All gradually subsided and disappeared except the fatigue and short term memory problems which have continued until now (but are better), about 44 hours after injection.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 22 of 40 adult patients described by the reporter.  No concomitant product was reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacy intern reported that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:master case
p/vax pt seen by Md for perirectal abscess, placed on ATB;saw MD on 7/9/99 for mult abscess;hosp on that date;determined that infect had spread to heart, hosp;IV ATB for 5wk;dx cellulitis, endocarditis, perirectal abscess;
Lightheadedness (initially and lasting for about 1 hour), palpitations (still ongoing since vaccination), chest pain (off and on since vaccination), arm pain at injection site (occured some hours after injection and resolved in less than one day), pain with breathing (upon exertion some hours after vaccination, resolved by the next day)
mild form of reactive arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: ARTHRITIS REACTIVE (medically significant), outcome "recovered", described as "mild form of reactive arthritis". Clinical course: During report caller stated that her dad got the Pfizer Covid 19 vaccine and the booster and got Covid. Also had a mild form of reactive arthritis and that went away. Reporter stated that many people have died from heart attack or stroke, and they are kids with no health problems prior.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224810 similar report from same reporter;
My Head itches all the time and when I brush my hair it hurts my scalp.; My Head itches all the time and when I brush my hair it hurts my scalp.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EC8734, Expiry date: not reported, age at vaccination: 56-year-old), via an unspecified route of administration, administered in Arm Left on 28Mar2021 as dose 2, single for covid-19 immunisation administered in Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (dose 1, Lot number ER8734, in Arm left on an unknown date at 03:15 PM) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 since the vaccination. On an unknown date in Jun2021, the patient's head itches all the time and when she brush her hair it hurts her scalp. No treatment was received for the events. The outcome of events was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
On April 3rd after his second shot he felt headache and "fuzzy headed"  continued to get worse until he suffered severe memory loss.  Could not remember how to lock the front door or put on a seat belt.  Went to Doctor who sent him immediately for a head scan.  The scan showed a very large brain bleed and he was taken to the ED and they began reversal procedures to the Coumadin with platelets and injection of "K". He had brain surgery on April 23, Burr holes to relieve pressure.  Returned home on April 26.  On May 10th he was reading the paper and suddenly could not speak and did not have use of his arms or legs.  Called 911 and he was rushed to the ED.  They did a head scan and found that his brain had an additional bleed.  He had brain surgery again on May 12th, Craniotomy. Returned home on May 16th and is still recovering.
administered Adacel that were exposed to temperature excursions and not acceptable for use; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157613, 2019SA157599, 2019SA157614 and 2019SA157615.  This case involves a 12 years old female patient who received 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5585AA and Exp. Date 06-Mar-2021 via intramuscular route in the left deltoid on 29-May-2019 that was exposed to temperature excursions and not acceptable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of reporting, no adverse reaction 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.  List of documents held by sender: none.
after 8 days without a period/she had regular menses until her covid vaccine; Dose1 and Dose2 on 05Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: ER8727) as dose 2, single and administered in arm right, administration date 05Mar2021 17:45 (Lot number: EX6199) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergy: walnuts" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Toradol for drug allergy. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Mar2021, outcome "unknown", described as "Dose1 and Dose2 on 05Mar2021"; MENSTRUAL DISORDER (non-serious) with onset 28Apr2021, outcome "not recovered", described as "after 8 days without a period/she had regular menses until her covid vaccine". The event "after 8 days without a period/she had regular menses until her covid vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient took Prenatal vitamins as Other medications in two weeks. She was on her period at the time of second shot. Her period that began the following month lasted from 28Apr2021- 08Jun2021 after 8 days without a period, it began again on 17Jun2021 and is still currently going. No prior Covid vaccinations. Patient did not tested positive post vaccination. Patient told that she had regular menses until her covid vaccine. No other information, she was only seen 1 time in the office.  No follow-up attempts are possible. No further information is expected.
No other AE; The caller said the patient had a titer drawn (date unknown) and she needed a dose of MMRII, but the patient inadvertently received PROQUAD; 37-year-old patient; This spontaneous report was received from the Medical Assistant, and refers to a 37-year-old female patient.  Her medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin, subcutaneous injection, 0.5 milliliter, lot #u039255, expiration date: 09-JUN-2023, administered for viral titre decreased (strength, and route of administration were not provided); inadvertently, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product administered to patient of inappropriate age, wrong product administered). No other adverse event occurred.
1 day following vax pt exp itching of neck; resolved w/Seldane treatment;
5am 3/19/21 woke with a headache, severe chills and fatigue,at 12pm fever of 101.5 chills unable to stay awake no energy lasted 18 hours. Injection s iteswellibg hot and pain. Swelling and pain for 8 days at injection site.
Per ER note 10/11/12 3:36PM "had office visit and got a flu shot, felt OK until going to bed at 8 or 9PM, at which time he felt discomfort in the anterior chest". Workup unremarkable, inc CXR (-), neg troponin, EKG (-). D/C Dx: Non-cardiac chest pain.
skin infection; Itchiness; Hotness; Stiff shoulders; Swelling; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), METFORMIN, LISDEXAMFETAMINE MESILATE (VYVANSE), COLECALCIFEROL (VIT D [COLECALCIFEROL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), TIOTROPIUM BROMIDE (SPIRIVA) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced SKIN INFECTION (skin infection). The patient was treated with DICLOFENAC at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache), NAUSEA (Nausea) and SKIN INFECTION (skin infection) outcome was unknown.        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.   The patient's medical history was not provided. Treatment details included Diclofenac, Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: fallow up information received on 05-apr-2021 updated the outcome of the event skin infection from( unknown to unknown)