chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inappropriate schedule of vaccine administered; Mild paresthesia on right thigh area like tingling sensation; tingling crawling sensation; Head ache; Pain and swelling site of injection; Localized pain; 1/2 inch diameter at site of injection; Hardness on area; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation), FORMICATION (tingling crawling sensation), VACCINATION SITE INDURATION (Hardness on area), HEADACHE (Head ache) and INJECTION SITE SWELLING (Pain and swelling site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension in 2003, Allergy to animal dander (Allergic to cat dander) and Shellfish allergy (Allergic to raw shrimp). Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension, MEDROXYPROGESTERONE, POTASSIUM CHLORIDE (K-TAB) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced VACCINATION SITE INDURATION (Hardness on area), INJECTION SITE SWELLING (Pain and swelling site of injection) and VACCINATION SITE PAIN (Localized pain; 1/2 inch diameter at site of injection). On 23-Dec-2020, the patient experienced PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation), FORMICATION (tingling crawling sensation) and HEADACHE (Head ache). On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 25-Dec-2020, VACCINATION SITE INDURATION (Hardness on area), INJECTION SITE SWELLING (Pain and swelling site of injection) and VACCINATION SITE PAIN (Localized pain; 1/2 inch diameter at site of injection) had resolved. On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation) and FORMICATION (tingling crawling sensation) had not resolved and HEADACHE (Head ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not seek treatment or advise from her physician.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Medical history updated, patient demographic details updated, concomitant medications updated, event outcome updated, new event inappropriate schedule of vaccine added based on 2nd dose information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PT sts within a few hours of second vaccine, he experienced sore arm, tiredness, body aches, and chills, no reactions outside of those anticipated from the vaccine literature. Next morning, Wednesday 13JAN21 woke up with new onset of sharp, right-sided chest pain.  Worsens on breathing and coughing.  PN is otherwise persistent, does not radiate, but changes when breathing.
1 of 3 pts vaxed from the same vial who devel a fever of 103-104 & was very irritable w/persistent crying w/in 24hrs following vax;pt recvd vax 28FEB95;required MD visit;treated w/APAP;
Low grade temp 100.7 limp/listless. EEG/CT scan lab normal.
Received a call from patient's mother stating patient had rash from neck down to arms area of injection swollen and no fevers.
Urinary tract infection. I woke up to extreme burning and pain around my bladder about a week after the booster. The pain did not go away like it usually does for UTIs, which I seem to be prone to. It continued for several days before I started feeling pain in my back and a slight fever. I went to the emergency room. They didn't think it had infected my kidneys yet and gave me antibiotics and antinausea medicine. However, I notice that drinking lots of water makes my back ache and a fever flare again. I am waiting to make sure to get through a few more days of antibiotics before returning to the hospital. There is no blood in my urine yet. I have beem drinking lots of water and cranberry juice, but still feel fairly miserable.
Information has been received from a physician, a consumer and a secretary concerning a 15 year old female patient with no history of allergies who on 08-MAY-2009 was vaccinated with the first dose of GARDASIL in her right arm.  Almost immediately the patient felt like that she had no circulation and no blood flow.  She experienced numbness, pain all down the arm and hand, and she had the inability to move and her hand became swollen.  The patient's mother reported that the patient could not use her hand.  There was no rash or itching and no systemic symptoms.  On 11-MAY-2009 the patient went back to see her physician.  The physician stated that it was GARDASIL that was causing the experience and she should not get any more doses of GARDASIL.  The physician did not offer any treatment nor did he do any treatment.  On 14-MAY-2009 the patient's hand was still swollen and had pain, but there was no more pain in her arm.  The patient's mother gave the patient ADVIL 200 mg which seemed to help.  The patient's mother reported that she was going to take the patient back to see the physician.  The outcome for other adverse events was unknown.  Follow up information was received from the physician which reported that on 08-MAY-2009, the patient with no pertinent medical history and no known drug allergy received four different vaccines.  The patient was given GARDASIL (lot # 661766/0652X) and RECOMBIVAX HB (manufacturer unknown, lot # AHBVB663AA) in the right arm, ADACEL (lot #C3032AA) and MENACTRA (lot # U2842AA) in the left arm.  On 11-MAY-2009, the patient came back to the office complaining of right arm pain and swelling.  There was no redness and only minor swelling.  No treatment was given, and cold compresses were suggested.  On 18-MAY-2009, the patient again returned to the office complaining of right arm pain.  The patient was seen by another physician who noted normal findings, but referred the patient to a neurologist.  The physician could not say if the condition was disabling, but did say that the patient was not hospitalized and the event was not life threatening.  At the time of reporting, the outcome was unknown.  Additional information has been requested.
I received my 2nd Moderna vaccine shot on Wednesday at noon and wanting to report that starting about 11AM on Thursday I started experiencing fever type of feeling. By 3PM I was knocked out with a fever of 99.4 and felt generally lousy with no appetite. Had difficulty sleeping throughout late PM, evnening and overnight . up every 2.5 hours.  Fever is normal this morning but lagging effect of fever and general weakness remains.
Patient received Covid-19 Moderna vaccine @ 0750, no adverse reaction noted after 15 min of receiving vaccine. Patient reported back to work & noticed Right upper chest/shoulder to mid chest on opposite side of where vaccine was given (L deltoid) flat, red rash w/ 7 small bumps ?hives w/ some itching. No difficulty swallowing, wheezing, SOB or tightness in chest   Page to Allergy team, verbal order for 10mg PO cetirizine, no further workup needed and patient can return back to work
pt recv vax & immed exp inj site pain;pain persisted as 10DEC97;this is 1 of 2 pt from this facility to exp inj site pain p/vax lot# 4978142;
Inadvertently administered additional Bivalent Booster after 2 months of Bivalent booster
Fever of 102, Diarrhea and Vomiting for 36 hours.
Redness, swelling. Concern of cellulitis. Pt to ER - given IV antibiotic - Rt thigh swelling/redness
This spontaneous prospective pregnancy report was received from a physician referring to a pregnant female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-MAR-2018, the patient was holding her child during administration of VARIVAX (dose, route of administration, lot #, expiration date) for prophylaxis and the child moved causing a drop of VARIVAX to splash in the woman's eye. It was reported that the exact amount of VARIVAX that was splashed in the eye was unknown. No adverse effects were reported. The patient's last menstrual period and estimated date of delivery were not reported. The pregnancy outcome was pending.
Pt states her arm was hurt/swollen the day after vaccination. She said the swelling continued to decrease up until Friday. Swelling gone on Saturday. Then reddness reappeared Monday am around 11a.
Pt c/o anxious and claustrophobic, & nausea. "I just want to get out of here, I want to go outside."
Patient reports an itchy rash at injection site that has increased in size over the last week since injection.  Will be reaching out to his MD this week
suffered a massive heart attack on May 8, 2021.  2 arteries 100% blocked with blood clots
Headache, Myalgia, Fever, HA, body aches, fatigue, fever Narrative:  Took OTC aleve and excedrin for above sx  Other Relevant History:
pt recvd vax & was found by mom less than 1 hr later w/o pulse/resp; healthy prior to event per mom; transported to hosp ER; coroner declared death as SIDS;
Information has been received from a registered nurse concerning an 8 year old male who on 21-OCT-1999 was vaccinated with a first dose of Varivax. On 19-JAN-2007 the patient reported to the physician's office with pink papules on trunk and face, vesicular lesions. It was reported that none of the lesions were crusted over and the symptoms began the night before (18-JAN-2007) with sore throat and fever. The patient was diagnosed with chickenpox and was treated with supportive care. The patient outcome was reported as recovered. Additional information is not expected.
pulse is 118; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse is 118) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (pulse is 118). At the time of the report, HEART RATE INCREASED (pulse is 118) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 118 (High) Pulse is 118.         Relevant concomitant medications were not reported by reporter. Treatment information was not reported by reporter.   Reporter did not allow further contact
experienced everything on the FAQ sheet side effect except for vomiting; her arm was hurting and it went up into her neck; Sore Throat; diarrhea; was hurting so bad; she also could barely get off the sofa; Headache; temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea) and PAIN (was hurting so bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea), PAIN (was hurting so bad), GAIT INABILITY (she also could barely get off the sofa), HEADACHE (Headache) and PYREXIA (temperature of 105). At the time of the report, VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea), PAIN (was hurting so bad), GAIT INABILITY (she also could barely get off the sofa), HEADACHE (Headache) and PYREXIA (temperature of 105) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
got red dots all over his arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (got red dots all over his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (got red dots all over his arm). At the time of the report, ERYTHEMA (got red dots all over his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Heart palpitations started about 3 hours after vaccination.  Lethargy, headache, nausea and severe abdominal pain started about 24 hours after vaccination.  Symptoms subsided approximately 60 hours after vaccination.
I'm over 8 weeks over due for my second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I'm over 8 weeks over due for my second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I'm over 8 weeks over due for my second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I'm over 8 weeks over due for my second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the evens not reported.   Reporter did not allow further contact
Tinitus; Other vaccine same date dose number 2/other vaccine same date dose number 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 13:00 (Lot number: EN201) at the age of 52 years as dose 1, single, administered in arm left, administration date 12Feb2021 (Lot number: EN619B) as dose 2, single and administered in arm left, administration date 12Feb2021 (Lot number: FA7484) as dose 3, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Darvacet. The following information was reported: TINNITUS (non-serious) with onset 13Feb2021, outcome "not recovered", described as "Tinitus"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Feb2021, outcome "unknown", described as "Other vaccine same date dose number 2/other vaccine same date dose number 3". Therapeutic measures were not taken as a result of tinnitus, inappropriate schedule of product administration.  No follow-up attempts are possible. No further information is expected.
No Adverse event; 17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date) 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 17-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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use 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 (17 patients received doses of the Bivalent Moderna COVID-19 vaccine as booster doses after the 30 day beyond use date).    This case included information for 15 patient  out of 17. Concomitant and treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2023-698998 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Live follow up received with non significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-698998:master case
Site of injection got very warm/hot and very sore. Swelling from elbow down to fingers (right arm).On the fingers there were a few little pockets of puss. Fingers were itchy and painful. (all of these were reported 2 days after immunizations administered). The Shingle vaccine was administered in Right Arm (top) and Flu vaccine Right Arm (bottom)
tongue swollen so bad; blisters on tongue and lips; blisters on tongue and lips; This is a spontaneous report from a contactable consumer reported for herself. A 54-year-old female patient received first dose of bnt162b2 via an unspecified route of administration on 20Mar2021 15:00 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID vaccine on 20Mar2021 around 3 pm. The next morning around 6 am her tongue swollen so bad she couldn't close her mouth and she had blisters on tongue and lips. She was still dealing with the blisters. Her doctor wanted her to go to the emergency room but she decided to stay home and took Benadryl for a day and a half, the swelling went down but the blisters remains. Patient would like to know if she should receive the second dose. The outcome of tongue swollen was recovered, blisters on tongue and lips was not recovered.  No follow-up attempts are needed. No further information is expected.
Possible incorrect administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) had resolved. Not Provided          Concomitant medications were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-071216 (E2B Linked Report). This case was linked to MOD-2021-071216 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071216:CROSS LINKED TO DOSE 2
FLUBLOK being administered to pediatric patient, with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402443(CLUSTER), 2022SA402619(CLUSTER), 2022SA402396(CLUSTER), 2022SA402662(CLUSTER), 2022SA402500(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402964(CLUSTER), 2022SA402707(CLUSTER) and 2022SA402514(CLUSTER).  This case involves a 10 years old male patient who was administered Influenza Quadrivalent Recombinant Vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation, strength: unknown) (lot UJ887AA, expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for prophylactic immunization at 10 years of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken: was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received a vaccine that was 10 days behond the use-by date (3/6/2023),  (Mislabeled 4/6/23)  Per physician, patient experienced no adverse effects.
left arm began having generalized weakness and difficulty holding pen.; Mild tremors of left hand and fingers.; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscular on 18Dec2020 at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient's medical history and concomitant medications were not reported. Around 6 hours post-administration on 18Dec2020, patient's left arm began having generalized weakness and difficulty holding pen. Mild tremors of left hand and fingers. Lasted approximately 2-3 hours and resolved spontaneously. No other symptoms. No treatment was given. The events were reported as non-serious. Outcome of the events was recovered in Dec2020.
2 days after, I noticed my chin and lower lip was red and itched a little and the skin was flaking off especially on my lower lip. Lotion didn't work and didn't work. I took the Benadryl helped with the skin flaking but didn't help with the redness and itching . Still taking Benadryl and hasn't completely went away but tolerable.