chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 1 Patient received a dose of Moderna COVID19 vaccine with lot #019D22A as an additional booster/HCP would like to know if the following vaccine lot #019D22A corresponds to a monovalent Moderna COVID19 vaccine or a bivalent Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (1 Patient received a dose of Moderna COVID19 vaccine with lot #019D22A as an additional booster/HCP would like to know if the following vaccine lot #019D22A corresponds to a monovalent Moderna COVID19 vaccine or a bivalent Moderna COVID19 vaccine) 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)) (batch no. 019D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jan-2023, 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 10-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (1 Patient received a dose of Moderna COVID19 vaccine with lot #019D22A as an additional booster/HCP would like to know if the following vaccine lot #019D22A corresponds to a monovalent Moderna COVID19 vaccine or a bivalent Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (1 Patient received a dose of Moderna COVID19 vaccine with lot #019D22A as an additional booster/HCP would like to know if the following vaccine lot #019D22A corresponds to a monovalent Moderna COVID19 vaccine or a bivalent Moderna COVID19 vaccine) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (1 Patient received a dose of Moderna COVID19 vaccine with lot #019D22A as an additional booster/HCP would like to know if the following vaccine lot #019D22A corresponds to a monovalent Moderna COVID19 vaccine or a bivalent Moderna COVID19 vaccine).    No concomitant medications were reported. Caller stated she did not have further information to disclose at the moment of the call Commercial agent stated that the HCP mentioned that the patient received in the past different brands of COVID19 vaccines, The vaccine lot 019D22A corresponds to a monovalent Moderna COVID19 vaccine or a bivalent Moderna COVID19 vaccine. No treatment medications were reported.
Information has been received from a registered nurse concerning a 70 year old male patient who on 03-JAN-2011 was given a dose of PREVNAR instead of the PNEUMOVAX 23 in error. No adverse experience reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
night sweat; loss of cognitive function; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweat), COGNITIVE DISORDER (loss of cognitive function), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweat), COGNITIVE DISORDER (loss of cognitive function), CHILLS (chills) and NAUSEA (nausea). At the time of the report, NIGHT SWEATS (night sweat), COGNITIVE DISORDER (loss of cognitive function), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Tenderness to left shoulder where injected; face felt warm; loss of appetite; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 at 17:30 (Batch/Lot Number: Ew0182) as 2nd dose, single dose for covid-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included, on an unspecified date, patient received the first dose of bnt162b2 via an unspecified route of administration, as single dose for covid-19 immunization (Dose number 1, lot_number=Ew0182, for COVID-19 immunization, Vaccine location: Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive medication within 2 weeks of vaccination. On 09Jun2021 at 19:30, the patient experienced tenderness to left shoulder where injected, face felt warm, loss of appetite, chills, headache, and flu like symptoms. The patient did not take any treatment for the events. The outcome of the events loss of appetite and flu like symptoms on 10Jun2021 whereas other events were resolved on an unknown date.   No follow-up attempts are possible. No further information is expected.
patient might have received saline instead of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient might have received saline instead of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    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 INTERCHANGE OF VACCINE PRODUCTS (patient might have received saline instead of vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient might have received saline instead of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information not provided. Treatment information not provided
arm soreness; dull headache; nausea; today not feeling 100%; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On 14th June 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, headache dull, nausea and feeling unwell. On an unknown date, the outcome of the pain in arm, headache dull, nausea and feeling unwell were unknown.   It was unknown if the reporter considered the pain in arm, headache dull, nausea and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. on the day of reporting the patient not feeling 100 percent. He noted arm soreness, dull headache and nausea somewhat.  The reporter did not consent to follow up
Initial and follow-up information has been received from a certified medical assistant concerning a 70 year old, white, female patient, occupation, unknown, whose reported weight was 146 pounds with osteoporosis, hypercholesterolaemia and hypertension who on 27-SEP-2006 was vaccinated, intramuscularly into the left deltoid muscle with her first dose of Pneumovax 23 (Lot # 651373/0320F). It was reported, that the patient had flu-like symptoms at the time of vaccination. Concomitant therapy included ACTONEL, LIPITOR and enalapril maleate (manufacturer unknown). It was reported that within 24 hours of vaccination, approximately 27-SEP-2006 the patient developed severe cellulitis. It was reported that the patient had flu-like symptoms and fatigue. The patient's arm was red, huge and hot to the touch. The patient came to the office on 28-SEP-2006 and sought medical treatment. The patient was given a prescription for antibiotics. The physician requested a lot check. At the time of the report, the patient had recovered. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
No additional AE; vaccine stored out of recommended storage range was administered to patient; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 11-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot #T027937, expiration date reported as 08-AUG-2022 but upon internal validation established as 18-AUG-2022, for prophylaxis (strength, dose and route of administration were not provided). The administered vaccine was stored out of recommended storage range (product storage error). No additional adverse event (AE) reported.
Swollen lymph nodes in neck, head, collar bone, shoulder and chest; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 18Apr2021 at 10:00(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Apr2021 at 17:00, the patient experienced swollen lymph nodes in neck, head, collar bone, shoulder and chest. Swollen lymph nodes in collar bone and shoulder persisted 11 days later. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swollen lymph nodes in neck, head, collar bone, shoulder and chest were not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
See below notes for dos 8/17/21: Patient presents today stating that on 8/13 she began with numbness and tingling in both hands and feet. No paralysis. She had facial numbness and could feel it in the back of her throat. She was able to swallow and chew okay. No facial droop or blurry vision. She did have a headache, but not a migraine. The next day all her symptoms were still present so she went to ER. Labs were normal than. She states that she now having more muscle weakness, mostly in her legs, but some in her arms. She still has numbness in her feet and in her hands, but the tingling is gone. The facial numbness/tingling is improved. She still has some R sided facial numbness, but she has had this before. No headache now. She recently had the J&J COVID vaccine on 8/10 at Pharmacy. She denies any hx of reaction to vaccines in the past. She states that on 8/13 she had some SOB with vacuuming on 8/13, but she hasn't noticed any SOB since 8/13, but she has been resting. She does note some feelings of being off balance, but denies falls.        She had chills, fever, and body aches after the COVID for 48 hours.
Information has been received from a nurse concerning an 11 year old female who was vaccinated with a second dose of hep b vaccine. One week post vaccination, the pt developed mild Bell's palsy. The pt sought unspecified medical attention. Additional info has been requested.
Patient was scheduled to receive 1st dose of moderna, was mistakenly given moderna Bivalent. Pharmacist recommended patient receives 1st dose within one weeks time.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
Arm locked  up extreme pain. muscle spasm and cannot lift my arm above my shoulder (which is an improvement from the initial condition).  Pain was so bad upon movement I thought I was going to pass out.  It is improving, day to day, but still incapacitates me from my daily routine.
a patient had been administered with an expired dose of TENIVAC with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 60 years old female patient who had been administered with an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Oct-2023, the patient received 0.5 ml total (1X) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA) (Expiry date: 24-Sep-2023) (Strength: standard) (Frequency: once) via intramuscular route in the left deltoid for immunization.  On 18-Oct-2023, the patient had been administered with an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event (expired product administered) (latency: same day).   It was reported, Medical assistant called to ask about precautions that they need look out for as well as if the vaccine needs to be repeated after a patient had been administered with an expired dose of TENIVAC. This situation is reported as a medication error due to administration of expired medication. No adverse reactions has been reported by the patient.  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 and Regulatory Authority 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.
Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
Immediately after Menactra vaccine administered patient felt dizzy but did not lose consciousness, no seizure or seizure like activity. Reportedly initial systolic blood pressure was in 70 s , Patient was advised to lay down . Repeat blood pressure was normal . Orthostats were normal. Patient was referred to the ed for further management.
vaccination was administered, patient stood up and was a little unsteady on feet.  Patient sat back down and was flush from the neck up to face.  Blood pressure was normal.  Flushing resolved with 15 to 30 seconds.  Patient remained sitting and started having lower back spasms.  Spasms lasted for 2 to 3 minutes.  Patient remained in waiting area for approx 30 minutes.  Was fine when leaving.  Called patient 3 hours later and was reported to be doing fine with no other symptoms or issues.
Pt recvd 1st & 2nd dose of vax 4AUG92 & 26SEP92 & following 2nd dose exp pain in the entire deltoid area of the inject arm; a few days later the pain inc & it hurt on raising arm above the shoulder or when pushed things w/hand; seen by MD;
Since the vaccines I lost 2/3 of my hair; Within a week my hair texture changed dramatically. It went from soft, not oily or dry and curly to dry and straw like.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 (Lot number: EW0181) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Complex Regional Pain" (unspecified if ongoing); "Tarsal Tunnel" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benadryl, reaction(s): "Allergy: Benadryl", notes: known allergies: Benadryl and Voltarin; Voltarin, reaction(s): "Allergy:Voltarin", notes: known allergies: Benadryl and Voltarin. The following information was reported: ALOPECIA (non-serious) with onset 16Jul2021, outcome "not recovered", described as "Since the vaccines I lost 2/3 of my hair"; HAIR TEXTURE ABNORMAL (non-serious) with onset 16Jul2021, outcome "not recovered", described as "Within a week my hair texture changed dramatically. It went from soft, not oily or dry and curly to dry and straw like.". The events "since the vaccines i lost 2/3 of my hair" and "within a week my hair texture changed dramatically. it went from soft, not oily or dry and curly to dry and straw like." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia, hair texture abnormal.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received subsequent dose 2 on 30Jul2021( LOT number :EW0198) left arm for covid-19 immunization   No follow-up attempts are possible. No further information is expected.
rash began 10days p/vax on neck + upper chest; over next 2-3days began spreading to torso, arms, lower extremities; rash target erythema multiforme
Within 3 hours patient had severe debilitating arm pain which lasted for about 48 hours. She claims she could not use her arm at all.
Patient developed an itchy bump like rash on neck about 15 minutes after receiving the covid-19 vaccine. Patient monitored for  another 15 minutes with no worsening of symptoms. Advised patient to follow up with their MD immediately if symptoms worsened or did not improve.  Followed up with patient the same evening and patient stated that rash had resolved after taking a dose of claritin.
MINUTES AFTER RECEIVING VACCINE, PATIENT FELL AND WOKE UP CONFUSED. POSSIBLE SLIGHT SYNCOPE. PATIENT SEEMED FINE AFTER SITTING DOWN AGAIN. PATIENT TOLD TO WAIT 30 MINUTES LONGER AND TO CONTACT SOMEONE ELSE TO DRIVE HIM HOME. OFFERED TO CALL 911, BUT PATIENT DECLINED AND SAID HE FELT FINE.
Red, swollen, warm to touch, induration (L) thigh 6 1/2 cm x 5 1/2 cm. (R) thigh 3 1/2 cm x 3 1/2 cm.
Mom noticed red knot on child's right arm when giving bath. Arm increased in redness and tenderness and area on arm red, flaking skin. No fever.
Early morning the day after receiving the Moderna booster vaccine I awoke with severe vertigo,followed by diarrhea ,nausea and stomach spasm/vomiting.  ALL of these conditions continued for nearly THREE Days. I could not keep anything in my stomach,including any medications. This resulted in my blood glucose levels going high ( nearly 300. Usual daily average is 130 ).  I was week and exhausted,unable to get any rest. When able to sleep,I would be awakened by vertigo. These sane symptons occurred  with each of the two booster shots,but not with the original two Moderna shots.
Pericarditis; This is a spontaneous report from a non-contactable physician (patient). A female patient of unknown age received the second dose of bnt162b2 on 25Jan2021 (lot number: unknown) via unknown route of administration in Arm Right at single dose for COVID-19 immunization. Medical history and concomitant medications were reported none. Historical vaccine included the first dose of bnt162b2 on 04Jan2021 around 2Pm -3PM (lot number: unknown) for Covid-19 Immunization. Prior Vaccinations (within 4 weeks) there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE following prior vaccinations were reported as None. Family Medical History Relevant to AE was reported as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported None. Patient Had a problem and doctor told her to report this, did not know if it was related to the vaccine or not, wanted to know if there had been any other reports like this. Patient got pericarditis in mid Jun2021 that lasted until or around Aug2021. She did not know, maybe lasted until the second week in Aug2021. Clarified pericarditis started middle of Jul2021 on 16Jul2021. Patient did not have Pericarditis at the moment. Patient wanted to know whether it was ok to get the booster. Patient had No new medications, nothing changed in her life. Investigations included: Developed a positive Antinuclear Antibody, the autoimmune marker, around that time period after the pericarditis. First test was positive on 15Jun2021, repeat test was negative on 15Jun2021. The adverse event required a visit to Physician Office and Had tests done. The causality assessment between the event Pericarditis and the suspect drug was reported as unknown. The outcome of the event was recovered on 10Aug2021.  No follow-up attempts are possible; information about lot batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event Pericarditis due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.