chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has experienced paresthesia's/Tingling; numbness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 32 years as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "she has experienced paresthesia's/Tingling"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; ASTHENIA (non-serious), outcome "unknown", described as "weakness".  Additional information: received the first dose of the Pfizer COVID vaccine on 19Mar2021. Patient reported that since then she has experienced paresthesia's, numbness, tingling, and weakness that has lasted the past five weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness and tingling from neck to hand in the arm shot was given (left side).  Left after 2 days.  Had some mild angina after first shot on 9/27 that left after a few days, but noticeable during running.
17 year old accompanied by parent who had  requested moderna booster due to a reported immunocompromised family member. A quality check was done and the vaccine recipients guardian was contacted by the site clinician.  The mother reported that she had requested Moderna .  No adverse reactions were noted.
Pt recvd vax & exp a local reaction; pt devel warmth, swelling & erythema @ inject site; ice packs applied to area every 10 mins for 2-3 hrs;
School Nurse obtained consent from the child's mother to give 2nd dose of vaccine to the child at school on 8/13/2021.  The mother came to  Hospital on 8/11/2021 to get her 2nd dose for herself & also got the child's 2nd dose that day.  The school nurses were not notified that the child received the 2nd dose on 8/11/2021 & the child did not tell them that she had already had her 2nd shot.  This resulted in a 3rd dose given to the child on 8/13/2021.  The mother of the child did speak to the school nurse  after the event and the child did not have any adverse reaction at that time.
Confused, fever > 103F, hallucinations. CSF normal protein, normal glucose, WBC < 5. CT normal. ID consult: encephalopathy. Possible encephalitis. Possible delirium with fever.
6 & 7MAR shaking chills, fever, h/a-Ibuprofen;8MAR joint & muscular aching, malaise-flu like sx;9MAR malaise;11MAR 2 3/8 x 2 1/2" area of induration & erythema @ inj site lt deltoid;1/2" x 2 1/2" erythematous area distal to  above area;
Received Pfizer vaccines on 1/24, 2/14, 9/30/21 Tested positive for COVID by PCR on 12/7/21 Admitted  on 12/16/21 d/t A-fib, A-flutter, bradycardia.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.   On 26-AUG-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844, 20210931982, 20210932593, 20210932036, 20210932567, 20210931951, 20210932240 and 20210932874.
9 1/2 x 6cm area of cellulitis on right deltoid region. Augmentin given.
Information regarding PREVNAR was received from a healthcare professional regarding an infant who received a dose on an unspecified date along with ACT-HIB and developed a red lump next to injection site. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included ACT-HIB. Concomitant medications were not reported. On an unspecified date, the patient received a dose of PREVNAR and another childhood vaccine and developed a red lump next to injection site (injection site swelling) (injection site erythema). It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
headache; fever; chills; nausea; muscle and joint pain; muscle and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "Arthralgia", "Chills", "Fatigue", "Headache", "Myalgia", "Nausea", "Vomiting". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "muscle and joint pain".  Additional information: 16hrs following administration of booster dose for COVID-19, the patient experienced headache, fever, chills, nausea, muscle and joint pain. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; administered an expired dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     It was reported that patient had no known conditions.     On 24-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose of Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired dose of Moderna COVID-19 Vaccine).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  Reporter did not know if patient experienced any AEs. No treatment information was provided by the reporter.
not sleeping well; tingling in their feet/pins and needles on their forearm; Inflammation in hands and fingers / Inflammation in feet and toes; Pain behind knee; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in hands and fingers / Inflammation in feet and toes), INSOMNIA (not sleeping well), PARAESTHESIA (tingling in their feet/pins and needles on their forearm) and ARTHRALGIA (Pain behind knee) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ARTHRALGIA (Pain behind knee). On 25-Aug-2021, the patient experienced INFLAMMATION (Inflammation in hands and fingers / Inflammation in feet and toes) and PARAESTHESIA (tingling in their feet/pins and needles on their forearm). On 27-Aug-2021, the patient experienced INSOMNIA (not sleeping well). On 26-Aug-2021, ARTHRALGIA (Pain behind knee) had resolved. At the time of the report, INFLAMMATION (Inflammation in hands and fingers / Inflammation in feet and toes), INSOMNIA (not sleeping well) and PARAESTHESIA (tingling in their feet/pins and needles on their forearm) 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.   No concomitant medication provided.  No treatment information provided.
14 hours after shot was given, pt experienced diarrhea within the 1st hour at 3-5 minute intervals. Pt was healthy before the shot was given. Pt was home from school for 2 days. She did not have fever or "feel achy". Just weak with diarrhea. Stayed home, ate "Brat" diet and recovered by evening 12/10/03.
No adverse event; Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the vaccine was administered to 12 patients after the use by date of 06-Apr-2023. The vaccine was administered to 3 patients on 22-Apr-2023, 5 patients on 21-Apr-2023, 2 patients on 20-Apr-2023, 1 patient on 16-Apr-2023 and 1 patient on 12-Apr-2023. The patients involved were all over the age of 65. No other adverse events were reported. This case is reported for patient 7 out of 12 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
arm went numb little bit; hot at the injection site; neck hurt bad; chest pain; right shoulder pain; red at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain) and ARTHRALGIA (right shoulder pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (about 5 months ago). Concurrent medical conditions included Hypercholesterolemia and Hernia.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain), ARTHRALGIA (right shoulder pain), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain), ARTHRALGIA (right shoulder pain), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's Past medication history included steroid injection a year ago. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Significant follow up received on 19-Jul-2021 and updated the outcome of the events. All events are recovered now. Second dose details were given.
Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She said she got dizzy, extremely hot and felt like she was "swaying" She said she also got what she described as "menstrual like cramps" that radiated all around her abdomen and back. She was under observation as advised per Pfizer protocol.  An associate of the Pt noticed she passed out for a second she then turned beet red from her head to her neck as we could see. The associate yelled for us to grab a BENADRYL. They hooked her up to a BP machine and she did present with a spike in BP.  After a few minutes, the redness and symptoms subsided. She was observed by the medical staff at the facility.
Started with sore throat on 1/3/2021  in afternoon by evening throat was swollen could not handle my secretions with pain 10/10.  Went to the ED in the morning and was admitted with epiglottitis.  No fever only low wbc count of 13.9 concerned it is a delayed reaction to vaccine
About 8 months after 2nd vaccination, I started noticing being tired, weak and having diarrhea. I called my PCP and they suggested that I go to an urgent care. I ended up going to the ER and they told me to go and get a Covid test. I went to a walk in clinic on 3rd day of symptoms and was tested for Covid. 3 days later I found out I was positive for Covid. I started taking zinc, Vitamin C and Vitamin D supplements as well as oral steroids. I started feeling better after 2 weeks of symptoms. I am reporting my breakthrough case of covid.
After 2-5 minutes of administered vaccines patient was getting red spots on face mostly right side, arm, legs. Noticed at 10:29 AM vaccines administered at 10:25 AM. RL PEDIARIX, LL HIBERIX, LL PCV13.
Approximately 30 minutes after vaccine, patient developed headache. Then he began with nausea and vomiting accompanied by fever and chills. Patient had diarrhea throughout the night.
Infant developed fever and vomiting 6/16/03 PM, diarrhea 6/20/03. Febrile seizures x2 6/22, x1 6/23. Her physical exam was benign on 6/23/03. Infant recovered without any specific treatments.
7:30 PM mother concerned because of redness and swollen leg. Patient shows no signs of symptoms or fever. Notified provider Friday afternoon (8/11/17).
A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a 28-month-old male patient subsequent to FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up received 30-Apr-2009 added product complaint investigation results.   Follow-up received 30-Apr-2009 added product complaint
NEGATIVE EFFECTS OF VACCINE BUT DID  NOT SPECIFY WHAT THOSE EFFECTS WERE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced negative effects of vaccine but did not specify what those effects were. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative effects of vaccine but did not specify what those effects were was not reported. This report was non-serious.
perimeter marked with black sharpie, rec Tylenol and cold compress for now, let us know if anything worsens
Injection done 7-1-08; Called 7-2-08 complained of left arm red from shoulder to elbow and painful; Seen in office; Nurse also noted swelling of upper arm 7 1/2"x5" 3 finger lower shoulder to elbow; Redness and swelling worse; Diagnosed with cellulitis; RX Levaquin 500mg
The day after vaccine (10/07/18), mother states child complained of malaise, low grade fever(temp not taken by mother) soreness and redness at site.. that night as child undressed, redness and edema had increased. Redness was in a striped pattern on lateral upper area of rt arm. By the next morning the redness was generalized and covered upper 3/4 of upper rt arm. Edema was reduced with Motrin and malaise has improved. Child attended school with no issues. Redness began to subside on Wednesday 10/10/18 and had returned to normal 10/11/18. Child did not have to seek medical attention and missed no school. Mother did say that there was improvement after Benadryl given, also.
Information has been received from a license practical nurse concerning a 65 year old patient (gender unknown) who on 10-NOV-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of Pneumovax 23 (Lot # 651406/0620F).  On 11-NOV-2006 the patient developed an injection site reaction of a swollen arm which was very hard to move.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  No product quality complaint was involved.  Follow-up information indicated that no reaction occurred.  Additional information is not expected.
Numbness in tongue, mouth, lips, cheeks,  face  lasting approx 2hrs and 30 minutes
This spontaneous report was received from a Physician and refers to unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since September 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M018625 with expiry date 11-AUG-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M018625 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 11 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 17 hours on different days since 29-SEP-2016 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes. There was no previous temperature excursion. The call was not because of data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005436: US-009507513-1704USA014447: US-009507513-1705USA005439: US-009507513-1705USA005438: US-009507513-1705USA005437: US-009507513-1705USA005462: US-009507513-1705USA005463:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 04/13, Pfizer, dose #2 08/15 CXR impression: No radiographic evidence of acute cardiopulmona abnormality. 2. Stable enlarged cardiac silhouette and postsurgical appearance of the chest. 08/25 pt admit to medicine cc: nauseas, vomiting and SOB dx: LOS: 08/25 Chest CTA impression: Negative for pulmonary embolus. 2. Patchy infiltrates consistent with known diagnosis of Covid 19 pneumonia." 08/25 pt cc:nausea, vomitting, sob exposure: unknown 08/25 SARS-COV-2 Variant Sequencing result: pending 08/26 S.PNEUMONIAE AG Eval: result negative 08/26 LEGIONELLAAgUR Eval result: negative 08/26 FIBRINOGEN result: 422 08/26 DDIMER result: 3.96 08/26 ESR result: 68 08/27 FIBRINOGEN result: 503 08/27 DDIMER result: 5.79 08/27 ESR result: 39 08/28 FIBRONOGEN result: 353 08/28 DDIMER result: 6.45 08/28 ESR result: 47 08/29 FIBRINOGEN result: 308 08/29 DDIMER result: 6.89 08/29 ESR 21 08/30 FIBRINOGEN result: 353 08/30 DDIMER result: 7.48 08/30 ESR result: 39 08/31 FIBRINOGEN result: 378 08/31 DDIMER result: 7.61 08/31 ESR result: 58 09/01 clinically resolved 09/04 pt admit to medicine cc: dx: covid pneumonia LOS: 11 09/20 COVID swab, result: not detected