chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed rash on hands/arms and itching 15 mins after receiving injection. Pt was given IM Benadryl and symptoms improved within 30 mins. Pt was able to return home, pt was transported home by family member.
Left arm was sore for several days, then began getting pain and stiffness in left elbow.; Left arm was sore for several days, then began getting pain and stiffness in left elbow.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 62-years-old) at 11:45 as a single dose for COVID-19 immunisation. Medical history included low thyroid, sleep apnea, arthritis in knees and ankle, osteoporosis. Birdshot retinopathy was once suspected but if the patient had it was in remission. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), and vit d (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 10Mar2021 at 13:00, after vaccination, the patient experienced left arm was sore for several days, then began getting pain and stiffness in left elbow (pain in elbow). This has remained. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The clinical outcomes of pain in arm and pain in elbow were not resolved at this time of report.  No follow-up attempts are possible; information about lot number cannot be obtained
pt recvd vax;it was later noted that the vax used had expired in dec90;
AT around  07:00 on Thursday, Feb. 25th I lifted my head from bed and whole room was spinning violently.   Told my wife that something was seriously wrong.  Tried to slowly move to side of bed but never made it before falling back into bed.   Waited to see if would improve and when it didn't my son and wife put me into car and I was taken to an Emergency Center.   I was hooked up for monitoring (pulse OX, cardiac monitoring, and an EKG was taken,   Blood Work was done, and the Doctor said he was worried about a stroke/and or tumor because I looked so bad coming into their facility with help from their Nurses and sent me to get a head CT.   When trying to get up from CT I  fell backwards onto CT table.   Whole room was not just spinning but was moving from floor to ceiling and then back to floor to ceiling.   When I got back to room Doctor performed tests on moving my head and following his finger with eyes.  He had to stop because I was spinning so much.  He told me that I had Nystagmus.
slight fever; soreness in the muscle.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and MYALGIA (soreness in the muscle.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Paraplegic (He has broken back from 44 years ago and it's paraplegic.).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PYREXIA (slight fever) and MYALGIA (soreness in the muscle.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (slight fever) and MYALGIA (soreness in the muscle.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. Treatment was reported as Tylenol.
seriously stiff muscles that compromised her breathing; back muscles were hurting so bad along with her shoulder blades that she could not sleep; back muscles were hurting so bad along with her shoulder blades that she could not sleep; back muscles were hurting so bad along with her shoulder blades that she could not sleep; seriously stiff muscles that compromised her breathing; lost her appetite; headaches that lasted for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DYSPNOEA (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite), INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep) and BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite) and HEADACHE (headaches that lasted for 3 days). On 19-Apr-2021, the patient experienced INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep). On an unknown date, the patient experienced DYSPNOEA (seriously stiff muscles that compromised her breathing), BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) and ARTHRALGIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep). On 19-Apr-2021, HEADACHE (headaches that lasted for 3 days) outcome was unknown. On 22-Apr-2021, MUSCULOSKELETAL STIFFNESS (seriously stiff muscles that compromised her breathing), DECREASED APPETITE (lost her appetite) and INSOMNIA (back muscles were hurting so bad along with her shoulder blades that she could not sleep) had resolved. At the time of the report, DYSPNOEA (seriously stiff muscles that compromised her breathing) and BACK PAIN (back muscles were hurting so bad along with her shoulder blades that she could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  Treatment information include Aspirin
Swelling and pain at site of injection. Swelling was 3inx3in on left upper arm
Pt. had "baseball" size swelling 2d after shot given SQ in (R) arm. Pt. has taken BENADRYL & applied cool packs to site. Site: red, raised & hard.
1:45 'p shot felt very weak & dizzy felt hot and face was very red. Pt. ad taken inhaler 'p shot as she felt wheezy. (Went away with inhaler. Eyes were very blurry 1:55 p 120 B/P 162/92 R-24 2:04 p 76 B/P 138/90 R-18 2:13 - took H2 ORSOGAR - feeling better 11/23/09 @ 2:13 vitals - p. 88 R 16 B/P 138/93
Info has been received from a health professional concerning a pt who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed arthralgia and myalgia. It was noted that a nurse from office told the pt the dose received must have been from a "bad batch". A lot check was requested by the physician. No lot info on the pneumococcal vaccine 23 polyvalent (MSD) had been provided. It was noted that the pt reported to the clinic in this report as follow-up and did not receive the vaccine there. It was also noted that the reporter could not recall the first or last name of the pt and could not provide any more info. Unspecified medical attention was sought. No further info has been requested.
Headache; Arm was swollen and bruised; Redness around the injection site; Injection site bled; Arm was swollen and bruised; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PERIPHERAL SWELLING (Arm was swollen and bruised), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE HAEMORRHAGE (Injection site bled) and CONTUSION (Arm was swollen and bruised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (Headache), PERIPHERAL SWELLING (Arm was swollen and bruised), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE HAEMORRHAGE (Injection site bled) and CONTUSION (Arm was swollen and bruised). The patient was treated with MELOXICAM on 17-Jan-2021 at a dose of 15 mg. At the time of the report, HEADACHE (Headache), PERIPHERAL SWELLING (Arm was swollen and bruised), VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE HAEMORRHAGE (Injection site bled) and CONTUSION (Arm was swollen and bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Extreme soreness at injection site, hard to lift arm above shoulder. Chills, low grade fever, nausea
Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of injection side; severe fatigue, tiredness; chills; This is a spontaneous report from a contactable (patient). A 44-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 01:30 PM as a single dose for COVID-19 immunisation, lot number: EL 1283. Medical history included quinolone antibiotics allergy. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, 08:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EL1685. Concomitant medications in two weeks prior to the vaccination included ibuprofen, Tramadol, Meloxicam. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Jan2021 at 06:00 pm patient experienced body aches, joints aches, head aches, injection site pain, neck pain, swelling of arm, pit of injection side, severe fatigue, chills and tiredness. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
The patient received her booster 3 days earlier outside the 4-day window.  No adverse effects were noted.
Irregular heartbeat. 55 - 115 bpm for 14 hrs. Watch ecg showed  a fib.
vertigo upon standing; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 16Aug2021 (at the age of 64-years-old) as dose number unknown, single for COVID-19 immunization. The Patient medical history included asthma from an unknown date. The patient concomitant medications was not reported. The Patient was not pregnant at the time of vaccination. The Patient had no known allergies. The Patient did not received any other vaccine in four weeks. Patient was not diagnosed with COVID-19 prior vaccination and Patient was not tested COVID-19 post vaccination. On 21Aug2021, the patient experienced dizziness, vertigo upon standing. The Patient did not received treatment for the events. The outcome for the events dizziness, vertigo upon standing was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
UNRESPONSIVE, CARDIAC ARREST Narrative: Death following Covid Vaccine dose # 1 According to nursing note 3/4/21: "pt was found unresponsive in bathroom this AM, no foul play suspected" No evidence of ADR immediately following vaccine or up until date of death. No recent hospitalizations before, at time of or following vaccination up to time of death. No illnesses recently around vaccination or time of death. No pre-disposing factors to death. Unlikely that vaccine contributed to patient's death, but was likely a result of advanced age (74 y/o) in combination with comorbidities.
weakened immune system; brain fog; felt an intense burning "like a match was in arm" / sore arm; Diagnosed with shingles; lethargy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles), IMMUNE SYSTEM DISORDER (weakened immune system), LETHARGY (lethargy after 2nd dose), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (felt an intense burning "like a match was in arm" / sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LETHARGY (lethargy after 2nd dose). On 15-Mar-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (weakened immune system), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (felt an intense burning "like a match was in arm" / sore arm). On 15-Mar-2021, LETHARGY (lethargy after 2nd dose) had resolved. At the time of the report, HERPES ZOSTER (Diagnosed with shingles) had resolved and IMMUNE SYSTEM DISORDER (weakened immune system), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (felt an intense burning "like a match was in arm" / sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-090238 (Patient Link).
I had sharp joint pains that prohibited me from lifting the arm that the shot was NOT received in. I also experienced those pains in my legs. The pain was sharp and shooting; it  felt like nerve pain. It was unlike the aches that typically come with a fever. That lasted a few days and then left when the injection site pain did. I have been feeling some slight pains like that here and there since.  Just thought it should be known since that isn?t described anywhere.
Vaccine administered after published expiration date.  We received the vaccine from the distributor  02/16/2023, the vaccine had expired 02/12/2023.  With multiple Moderna expiration extensions, the vaccine was labelled with the incorrect expiration date at our facility.  While double checking vaccine expirations, the discrepancy was discovered.  We contacted the distributor and they corroborated that the vaccine was sent after the expiration date had passed.  We contacted Moderna who then performed a vaccine analysis of that lot number.  We contacted the recipient of the Moderna vaccine notified them that the vaccine was administered after the expiration date.  Patient verbalized understanding and does not desire to repeat dose.  The patient was advised to talk with their PCP.
Urticaria onset 11/13/2021. Sought treatment with a burst of PO prednisone on 11/18. Today, 11/23/2021, generalized morbilliform rash was noted, with urticaria still lingering.
Lip swelling followed by racing heart beat, some difficulty swallowing and shortness of breath. Lip quickly returned to normal and the other symptoms came in waves for about 2 hours. Went to urgent care and was given steroids.
This spontaneous report as received from a other refers to unspecified number of patients of unknown age. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, oral for prophylaxis. No adverse event. Sender's Comments: US-009507513-1708USA013476: Original Case: 1708USA013476; US-009507513-1708USA013505: Original Case: 1708USA013476; US-009507513-1708USA013503: Original Case: 1708USA013476.
I feel so exhausted; Muscles were sore; I slept 18 hours straight; This is a spontaneous report from a contactable consumer (patient, self-reported).   A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and expiration dates were not reported), via an unspecified route of administration on 24Apr2021, as single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and expiration dates were not reported), via an unspecified route of administration on 29Mar2021, as single dose for COVID-19 immunization. Patient reported that on 24Apr2021, she experienced odd side effect that her muscles were sore but otherwise she felt okay. She also reported when she laid down at 3pm yesterday afternoon and slept all the way through the night. Patient slept 18 hours straight. Patient was feeling so exhausted. she felt like she could not keep her eyes open. This was not a normal routine in her sleep that is why she wants to know if this is a common side effect of the vaccine. Patient husband had to wake her up this morning. Patient had 3 small children who tried to wake her up yesterday but she did not wake up. The outcome of the event was unknown.   Follow-up (27Apr2021): This is a follow-up spontaneous report from Pfizer Sponsored Program. A contactable female consumer reported for herself that: no new information was updated.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
red-hot patch on her arm; Hot patch; Flu symptoms that last one or two days; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced localized erythema, feeling hot and flu symptoms. On an unknown date, the outcome of the localized erythema, feeling hot and flu symptoms were recovered/resolved.   It was unknown if the reporter considered the localized erythema, feeling hot and flu symptoms to be related to Shingrix.  Additional details were reported as follows: The case was reported by spouse of patient. The reporter stated that after receiving the 1st dose of Shingrix patient had experienced a red-hot patch on her arm and flu symptoms that lasted one or two days.  Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix because of the Covid pandemic. The patient did not had the virus but did not get an appointment for the second Shingrix dose. The reporter inquired could the patient still get her 2nd dose. All information was not available. For the tolerance of 2nd dose refer US2021AMR094049 this case. This was 1 of 3 cases reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094049:Same reporter. US-GLAXOSMITHKLINE-US2021AMR094040:Same reporter. Husband's case. 2nd dose. US-GLAXOSMITHKLINE-US2021093364:Same reporter. Husband's case. 1st dose.
Within 15 minutes of injection patient developed urticaria, swelling, redness, pain, diaphoresis, headache, and nausea. Patient was given Benadryl 50mg and Motrin 800mg within 30 mins of the injection. The patient received a steroid pack with rapid improvement.
Achy; Cold; Tired; sore arm; Her arm was a little bit swollen; Red rash around injection site; it itches like crazy around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (Her arm was a little bit swollen), RASH ERYTHEMATOUS (Red rash around injection site), PAIN (Achy) and NASOPHARYNGITIS (Cold) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced RASH ERYTHEMATOUS (Red rash around injection site) and INJECTION SITE PRURITUS (it itches like crazy around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (Her arm was a little bit swollen), PAIN (Achy), NASOPHARYNGITIS (Cold) and FATIGUE (Tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (Her arm was a little bit swollen), RASH ERYTHEMATOUS (Red rash around injection site), PAIN (Achy), NASOPHARYNGITIS (Cold), FATIGUE (Tired) and INJECTION SITE PRURITUS (it itches like crazy around the injection site) outcome was unknown.            It was reported that patient received Moderna booster dose (lot 026D21A or 028D21A) on 02-Nov-2021. Patient reported taking ibuprofen prophylactically before taking the Moderna booster.  No concomitant medication was reported.   This case was linked to MOD-2021-377123, MOD-2021-377133 (Patient Link).
A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) 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 (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.) 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 (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.).    Dosage text for suspect product was reported as additional booster. Concomitant drugs were not reported. Treatment medications were not provided.