chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose vaccine was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose vaccine was expired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose vaccine was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Second dose vaccine was expired) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-132195 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132195:Boyfriend's case
Extreme pain in vaccine area for 72 hours post shot/ dull ache; Could not perform daily activities; This is a spontaneous report from a contactable other healthcare professional. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899;expiry date: unknown) via an unspecified route of administration (arm left), on 29Dec2020 at 15:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medication included an unspecified birth control. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 29Dec2020, at 18:00, the patient experienced extreme pain in vaccine area for 72 hours post shot. The patient could not perform daily activities. Post 72 hours extreme pain subsided and became a dull ache for 2 days. The patient received pain medication as treatment for extreme pain. Outcome of the events "extreme pain in vaccine area for 72 hours post shot/ dull ache" was recovering, while for the other event was unknown.
Breakthrough case admission after 2 vaccines Moderna 05/07/2021 Lot# 002C21A;  Moderna 6/4/21 Lot# 033C21A
Pt received Dtap and IPV in left arm for 4 yr boosters. MMR in right arm. When he woke up this morning he was crying, will not let anyone touch left arm. It is red, swollen and tight. Required Ceftriaxone IM and Tx in office for cellulitis and PO antibiotics.
so much pain; burning; very severe generalized rash all over from her head to her toe; itching; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00514936) and transmitted to Sanofi on 11-Mar-2021.  This case involves female patient of unknown age who experienced so much pain (pain), burning (burning sensation), very severe generalized rash all over from her head to her toe (rash) and itching (pruritus), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, Physician stated that she was calling about side effects of ADACEL. Physician stated that a patient experienced non-serious so much pain (pain), burning (burning sensation), a very severe generalized rash all over from her head to her toe (rash) and itching (pruritus) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   Physician also stated that the patient was currently in the hospital and was asking for further details regarding the reports of rash in the ADACEL prescribing information. Also was asking about the severity of the rashes reported and if any rashes led to patients being admitted to the hospital.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient did not recover from all the reported events.  There will be no information available on batch number for this case.
Redness on injection site starting on 8/1/15. Not getting worse at all. Still redness on 8/3/15 A.M.
sneezing and tasting the after vaccine.; sneezing and tasting the after vaccine.; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced symptoms like sneezing and tasting the after vaccine. She would like to get the guidance on whether she should receive the second dose after experiencing these symptoms. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.
pt recv vax;was found to be pregnant;at 8 wk of pregnancy pt  devel bleeding fr which she recovered;p/ delivery baby was jaundiced & tx w/ phototherapy for 4 days;
Patient was due for Pneumovax23 and received and second dose of Prevnar13 after 1 year instead. No adverse event occurred.
Immunization was given too soon. Age of patient at time of event: 4 years.
1/19/17: Woke to knot between armpit and injection site. Numbness and tingling down her left all the way to toes. PCP diagnosed as delayed systemic reaction. Medicated with steroid shot and BENADRYL.
Patient got Tdap shot at center where mass vaccinations were given. Immediately after, noted a rash originating at site of injection which spread to chest, trunk and upper arm. He went to ER, was given Rx for Medrol pack and told to take Benadryl. He came to our clinic for rash on 8/17/07, noted rash to be red, confluent and urticarial in nature. Gave samples of Claritin in clinic. Follow up phone call on 8/21/07 revealed patient had recovered and was attending school.
Blood rushing from head to arm of injection. Also, tingling in arm of injection. Also, feeling light headed just after injection.
Fell ill with COVID-19: onset of fatigue, chills, nausea, nasal congestion, cough, headache, lack of appetitie on Day 0; nausea intensified and required Rx for Zofran Days 3-7; return to work on Day 10; continued symptoms (currently Day 12) include fatigue, cough, nasal congestion, headache, nausea (reduced and no longer requiring Zofran), lack of appetite
Flue like symptoms; Profuse bleeding from nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Profuse bleeding from nose) and INFLUENZA LIKE ILLNESS (Flue like symptoms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINOXIDIL for an unknown indication.    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 EPISTAXIS (Profuse bleeding from nose) and INFLUENZA LIKE ILLNESS (Flue like symptoms). At the time of the report, EPISTAXIS (Profuse bleeding from nose) had resolved and INFLUENZA LIKE ILLNESS (Flue like symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
red raised rash; sore arm for three days; hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red raised rash), PAIN IN EXTREMITY (sore arm for three days) and URTICARIA (hives) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 18-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 RASH ERYTHEMATOUS (red raised rash), PAIN IN EXTREMITY (sore arm for three days) and URTICARIA (hives). At the time of the report, RASH ERYTHEMATOUS (red raised rash), PAIN IN EXTREMITY (sore arm for three days) and URTICARIA (hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received Smallpox vaccination 1/27/04.  Three to four days later noticed acne-like lesion on abdomen.  Within 6-7 hours noticed same type lesions on trunk anteriorly and posteriorly, and thighs (R>L).  Developed ulcer on tongue 13 days after receipt of Smallpox vaccine.  None of these had resolved when patient deployed.
Pt. waited 15 minutes after injection .Injection tolerated well.  Pt. returned to us about 45minutes later.  She was experiencing hives all over body.  EMS notified.  Benadryl 50 mg given by mouth.  Facial swelling and swelling of lips noted.  life saving crew arrived. Oxygen started at 2liters/minute.  Pt. transported to E.R.   Numerous phonecalls to pt. after this event were made without reaching her.
Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 3/2/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
had a kidney failure; severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down; letargic; could not stand up/could not use her legs; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (had a kidney failure) and NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis. Concurrent medical conditions included Kidney failure. Concomitant products included PREGABALIN (LYRICA), GABAPENTIN and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (had a kidney failure) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down) (seriousness criterion medically significant), LETHARGY (letargic), DYSSTASIA (could not stand up/could not use her legs) and GAIT DISTURBANCE (could not walk). At the time of the report, RENAL FAILURE (had a kidney failure), NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down), LETHARGY (letargic), DYSSTASIA (could not stand up/could not use her legs) and GAIT DISTURBANCE (could not walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was in prison when she took the second dose and they sent her home early as she had a kidney dialysis on 19-4-2021. The patient was in ICU after 9 days of second dose. Concomitant medications- Pracoceic Treatment- Physical therapy twice a week, medication for neuropathy.  Very limited information regarding this event has been provided at this time. However, discharge summary/hospital notes are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, discharge summary/hospital notes are required for further assessment.
Patient states feeling itchiness and throat started to feel tight about 15 minutes after getting TDAP vaccine.
Two hours after injection, my arm swelled to 3 times its normal size. Saw Dr on sat and was told I has cellulitus from receiving  The shot either from injection site not being cleaned properly or a dirty needle. Was put on a 7 day treatment of omnicef and vicodin for pain .
Swelling and redness to left arm 5x4 cm and induration, warm and tender to touch. 4/14/14 ff-up vaccine site much better greater size redness. 4/16/14 completely healed.
Woke up the next day 01/16/2021 with vertigo and severe nausea. Took Zofran and slept till vertigo had cleared around noon. Then chills for 2-3 hours and then fever to max of  100.9 lasting 6 hours.  Had myalgia, nausea for all day. Intermittent headache. Had  abdominal pain in AM with the nausea but no vomiting. Took both ibuprofen and Tylenol during afternoon and evening after fever started. Fever stopped around 8 or 9 pm. Left arm swelling, redness and pain started  01/17 and progressed for 2-3 day then started to fade. 8 by 8 cm swelling on 01/18 and 10 by 10 on 01/19.  Have 2 by 2 cm painful nodule in Left arm on 01/27/2021.
Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. Severe pain and swelling of the left shoulder, tachycardia or change in heart rate, mild swelling of the hands, mild headache, weakness and tiredness for 48 hours after the first 5 hours of getting the vaccine.
8/22/06: Prior to immunizations, client seemed less socially responsive than other children of same age. Mother stated no recent illness and no allergies.  Upon giving immunizations, child became aggitated and nurse needed assistance from another staff member for restraint.  IPV and DTaP administered.  Within seconds, child's eyes rolled upward and both arms stiffened.  Lasted approximately 3-5 seconds.  Child also became very lethargic which lasted 3-5 minutes.  Responded normally when given a toy - able to walk out of clinic.  Mother instructed to see pediatrician.  MMR withheld at this visit.
About 3 hours after the vaccine I had an elevated heart rate, that came down after couple of minutes of fresh air. The next day, at about 10 pm,  my heart beat was going up and down during rest. The next morning I went to the hospital and was diagnosed with heart palpitations.
Patient had received a Pfizer bivalent covid vaccine 9/10/2022. Patient then erroneously received a second Pfizer bivalent booster on 1/10/2023. No adverse reactions were reported by the patient, but this second bivalent booster does not follow CDC guidelines.
Started hives on day 3 that turned into painful blister on vaccine arm.  Has continued to spread to other parts of my body. Still having new hives and blisters on Day 12.  Itchy, red.
Right after vaccine, felt like she was freezing. Got home from work, took Tylenol felt achy, went to bed, woke up about 11:00 pm shivering really bad, breathing heavily, temp was 102.3, took more Tylenol. Up all night off and on with body aches, headaches, chills and fever. Felt the same way as when she had COVID.
Pt recvd 3 doses of Engerix-B in 1991 & 3months p/3rd dose was found to be anti-HBS non reactive; recvd a booster dose & 3 months later (still 1991) remained anti-HBS non-reactive; may be given 2 addtl booster doses;
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016) (strength, dose and route were not provided). On 08-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# L000610, expiry date 31-JAN-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Macula rash and Arthralgia 11/26/99. Warm sweaty palms 11/21/99. Pain in hands and feet, Raynaud's like 11/29/99. Moves to knuckles 12/10/99.
After administering final vaccine (GARDASIL) the pt. passed out, ammonia inhalant was used to help regain consciousness. The pt. continued to sit for awhile until feeling better.
Information has been received from an investigator regarding a 6 month old female who received her third dose of Prevnar as part of a safety post marketing trial on 11/14/2001. On 12/22/2001 at 7 months of age, the pt was diagnosed with cellulitis. Serotype 19A was isolated. The investigator considered this event possibly related to vaccine administration. The medical monitor's assessment is unknown.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \"was going to die\"). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided
Presented to the hospital for worsening SOB and fatigue, intermittent fever. Diagnosed with acute COPD  exacerbation due to covid pneumonia. Treated with steroids and bronchidilators. Also received Remdesivir.
Hives, began the following day & were generalized; Only med APAP (had taken APAP the previous week w/out problem);
Patient reports extreme local reaction beginning 2 hours post-vaccination.  Reaction stemming from subcutaneous vaccine site of the left extremity continuing up through deltoid region.  Reports welts, raised skin area that is gradually resolving.  Area noted today to be approximately softball size at posterior arm, very heated and tender to touch.  Also, patient reports fever up to 101 starting yesterday.
felt a little tender where the shot was; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported for two patients (herself and her husband). This is the second of two reports.   A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not had any reaction at all, maybe felt a little tender where the shot was, also reported as felt nothing except maybe a little soreness on the arm in Jan2021. The outcome of event is unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057886 same reporter, suspect product, and event, different patient
Have had Covid 2x; Have had Covid 2x; stroke; TIA; Hypoglycemic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I don't drink, smoke. Or do any drugs" (unspecified if ongoing); "I don't drink, smoke. Or do any drugs" (unspecified if ongoing); "I don't drink, smoke. Or do any drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Have had Covid 2x"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; HYPOGLYCAEMIA (non-serious), outcome "unknown", described as "Hypoglycemic". The patient underwent the following laboratory tests and procedures: So many tests: unknown results, notes: to find out why stroke and TIA with no luck. Clinical course: Since having this vaccine patient had several other issues. Stated that the only thing that has been consistent was this COVID Vaccine. Mentioned that patient was very healthy before. Asked if there were many complaints of stroke.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills) and INJECTION SITE PAIN (injection site pain) in a 31-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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced CHILLS (chills) and INJECTION SITE PAIN (injection site pain). At the time of the report, CHILLS (chills) and INJECTION SITE PAIN (injection site pain) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication  was reported.No treatment information was provided. This case was linked to MOD-2021-388148 (Patient Link).
Pt had a vasovagal episode post vaccination. Patient appeared to feel dizzy, recognized his symptoms and notified nurse. Patient was accompanied by his wife.   Patient was instructed to lay down and elevate legs. Pt was given  Water, crackers,. Then took vitals. Outcome: Patient recovered without difficulties Pt educated about ER precautions, Patient acknowledged understanding. Patient fully recovered @ 11:18.  Pt left observation after 15 minutes.  Vital Signs: @ 10:55 Blood Pressure: 100/76  Pulse: 83 O2: 97% Vital Signs: @ 11:05 Blood Pressure: 114/80 Pulse: 79 O2: 99% Vital Signs: @ 11:10 Blood Pressure: 119/79 Pulse: 79 O2: 97%
patient had rash and discoloration at 3 days after vaccination at site which progressed to cover almost side of upper arm. arm also became painful and lymph node enlargement (as described by patient) was noticed a few days after. consult with physician was done on 13th day when rash and node enlargement did not go away.