chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 15Dec03 concerning approximately 10 children of unk sex and less than 4 years of age who inadvertently received Fluvirin between the 22Oct03 and 10Dec03. Between 22Oct03 and 10Dec03 approx 10 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP200301313.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PULMONARY EMBOLISM 10/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
No additional AE reported; The involved vaccine had a labeled expiry of 03/31/2021 and was administered on 04/08/2021.; This spontaneous report was received from a medical assistant and refers to a 18-month-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2021, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) lot # S009753, expiration date: 31-MAR-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Dry coughing, wheezing, fatigue. Fever of 101.8 (by 8pm) headache
Cold and clammy; Fever of 104 F; Injection site pain; Headache; Muscle pain; Chills; Joint Pain; Fatigue; Nausea; Hallucinations; Tachycardia; Felt Unwell; A spontaneous report was received from a healthcare professional, concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hallucinations, injection site pain, headache, muscle pain (arthralgia), chills, joint pain, fever of 104 F (pyrexia) with fatigue, nausea, felt unwell (malaise), tachycardia and felt cold and clammy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration on unknown date.  On 05 Feb 2021 at 10:00 am prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, approximately at 18:00 patient developed injection site pain, headache, muscle pain, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy. On 08 Feb 2021, patient was cold and clammy and heart rate was 110-120 bpm. Patient treated symptoms at home. No treatment information was provided.  Consent for safety follow up was given.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, experienced injection site pain, headache, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy were unknown. On 08 Feb 2021, The event, muscle pain considered resolved.; Reporter's Comments: This case concerns a 41 year old, female patient, who experienced a serious unexpected event of Hallucination after receiving second dose of mRNA-1273.  Very limited information regarding this event has been provided at this time. Further information has been requested.
Warmth at injection site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No Medical History Provided).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Nausea, headache, moderate arm pain, mild chest tightness, chest fluttering, increased heart rate, short of breath (mild), fatigue, itchy watery eyes, hiccups, indigestion.
Client presented to clinic for seventh grade vaccinations on 6/13/2022. At 11:40AM, client received vaccines listed above. Twenty seconds after completing vaccine administration, client stopped talking mid-sentence and leaned against cushion of exam table. Eyes staring ahead unfocused, client not responsive to verbal stimuli. After four seconds, client spontaneously sat up, becomes awake and alert x 4, and commented "I must have fell asleep for a moment" then continued with conversation. Lip color pale (client skin color very fair as baseline). Mother stated client has never passed out to vaccines before. Mother stated client admitted not have breakfast before coming. Client also stated attended camp all week the week before and "still sleep deprived." Mother stated family history of father passing out routinely for vaccines and blood draws. Gave water and Goldfish crackers, able to tolerate. After five minutes, client stated felt good to go. Escorted out to private vehicle by mother.
Ilness that started as a cold; Bronchitis; Coughing; lots of mucos; This case was reported by a consumer and described the occurrence of cold in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, less than 3 weeks after receiving Boostrix, the patient experienced cold, bronchitis, cough and mucus discharge. On an unknown date, the outcome of the cold and bronchitis were unknown and the outcome of the cough and mucus discharge were not recovered/not resolved.   It was unknown if the reporter considered the cold, bronchitis, cough and mucus discharge to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. Illness that started as a cold or bronchitis. After 2 weeks still coughing and lots of mucus. No further details were provided.
very high temperatures/101.6; shakes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high temperatures/101.6) and TREMOR (shakes) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 042220A and 031220A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (very high temperatures/101.6) and TREMOR (shakes). At the time of the report, PYREXIA (very high temperatures/101.6) and TREMOR (shakes) outcome was unknown.            Concomitant product usage were not provided. Treatment details were not provided.
PT REPORTED TO ED WITH C/O SOB/DYSPNEA, CHEST PAIN, PROBLEMS WITH INSPIRATION AND FATIQUE-TACHYCARDIA HR 119- BILATERAL LEG PAIN SINCE 4/26/21
suspected vaccination failure; shingles; sick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle shot and still had a horrible case of shingles. The patient was really sick and anyone who had them gets his/her sympathy. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
A couple of weeks after the vaccine, I started noticing difficulty whistling to call my dog inside and holding fluids/food in my mouth. While at work, co-workers noticed I had paralysis in the left side of my face. I was rushed to the emergency room under suspicions that I was having a stroke. The doctor diagnosed me with ?Bells Palsy?. The left side of my face is noticeably paralyzed.
The baby received her 1st Hep-B on 2/5/02 at 1 month of age at 19:15. Approx. 3 hours later, the baby awoke from sleep screaming and gasping, flush (no cyanosis). She was taken to ER. No fever, normal CBC, no local shot reaction. She was monitored overnight and did fine. Discharged to home in the AM without evident problem.
Patient is not herself for weeks at a time after being vaccinated. Her personality completely changes. She is fussy and refuses to eat the foods she likes for weeks. She doesn't act like her normal self: no babbling, smiling, laughing for weeks at a time. Also had a fever for four days that would not go down with Tylenol or Motrin. Diarrhea for longer than one week also.
3 hours after injection extreme pain in the muscle of my left shoulder.  Can not raise my arm without extreme pain.  (on a scale of 1-10, this is about an 8).    Just a little sore when touched.  Sleep last night was very difficult.  Still painful to raise my arm this morning, still at least a 7.
Pt had 2 moderna shots, gave her a pfizer booster shot.  Pt is fine.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 13-month-old patient of unknown gender. On 09-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Patient febrile with swollen, erythematous left shoulder after receiving vaccination, diagnosed with cellulitis requiring a 10 day course of antibiotics.
shingles in my toes; will not get the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine.On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine,the patient experienced shingles and incomplete course of vaccination.On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported for first dose and not applicable for second dose. The patient got the first shot and shingles in her/his toes will not get the second shot heck no,which led to incomplete course of vaccination. The followup would not possible as no contact information was available.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history reported.    On 12-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 PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Products known to have been used by the patient, within two weeks prior to the event, was not reported.  Treatment for the event  was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-054253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054253:crosslink
body aches in entre body; joint pain in entire body; chills; extreme headache; dizziness; Arm pain; did not feel like herself; mild fever; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (Arm pain), MALAISE (did not feel like herself), PYREXIA (mild fever) and NAUSEA (nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (Arm pain), MALAISE (did not feel like herself), PYREXIA (mild fever), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (extreme headache). On an unknown date, the patient experienced MYALGIA (body aches in entre body) and ARTHRALGIA (joint pain in entire body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FEXOFENADINE at a dose of 1 mg. On 11-Feb-2021, DIZZINESS (dizziness), MALAISE (did not feel like herself), PYREXIA (mild fever), NAUSEA (nauseous) and CHILLS (chills) had resolved, HEADACHE (extreme headache) outcome was unknown. On 14-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MYALGIA (body aches in entre body) and ARTHRALGIA (joint pain in entire body) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-207513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Initial additional
Received yellow fever vaccine and approximately 5 days post vaccine patient complained of redness, swelling and slight warmth at sight of injection.  Ice pack and OTC Pain reliever with effect.
congestion; Coughing; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events coughing, congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the patient experienced the coughing, congestion. The event congestion was considered to be medically significant.  Treatment details included Amoxicillin, cough medicine, Z-pack.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, coughing, congestion was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose; Fatigue; Sneezing; Tingle; Kind of dizzy spell when had the vaccine; Had an stomach flu or something like that and tested negative; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine), GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PARAESTHESIA (Tingle) and DIZZINESS (Kind of dizzy spell when had the vaccine). In April 2021, the patient experienced GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative). On 18-Aug-2021, the patient experienced SNEEZING (Sneezing) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose). At the time of the report, SNEEZING (Sneezing), PARAESTHESIA (Tingle), DIZZINESS (Kind of dizzy spell when had the vaccine) and FATIGUE (Fatigue) outcome was unknown and GASTROENTERITIS VIRAL (Had an stomach flu or something like that and tested negative) and PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID 19 Vaccine and later had COVID symptoms and missed the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: negative (Negative) Negative. On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  The patient reported that she was sure that had COVID since she had all the symptoms.
The doctor reported that the patient experienced an infection and was prescribed an antibiotic. The area appeared to be rather in a circular pattern.
Client reported "burning" sensation when receiving influenza vaccination on 10/17/2019.  Client reports she woke up early the next morning with extreme pain in her left shoulder.  Client reported this pain to administrator and was referred to follow-up with doctor.
A female patient (DT) experienced a massive headache, pain down the legs and felt tired after receiving RabAvert therapy. The patient received the first dose of post-exposure RabAvert, 1 ml into the deltoid on 05/20/2004. The patient had a history of a bat bite. At the time of the report the headache was persisting. No furhter information at the time of report
Pt had Sanofi Pasteur IM flu vaccine 9/18/2011. Next day developed diffuse polyarthritis with pain, swelling, MPPs, PIPs, Wnots, knees, feet.
This medically confirmed spontaneous report (initial receipt: 03-Oct-2012) concerns a 34-year-old female patient, who had a pertinent medical history of ankle ulcers and unspecified diffuse connective tissue disease and was allergic to penicillin and sulfa drugs. Concomitant medications included methylprednisolone acetate, hydroxychloroquine phosphate, oxycocet, hydrocodone; paracetamol combination, calcium carbonate, folic acid, nifedipine and prednisone. On 28-Sep-2012 the patient received AFLURIA (batch number: P58507) injection at a dose of 0.5 mL intramuscularly in left arm. On 30-Sep-2012, after receiving AFLURIA, the patient developed blisters on both legs, below the knees. The patient sought medical attention by calling to office. No treatment was given for the event. No lab diagnostics study was performed. The event outcome was not reported.
Patient was accidently administered a vaccine that expired on 05/23/21. No known side effects. PCP notified
5-14-21 1735:  had arm pain from injection, light headedness slightly dizzy  5-14-21 0200 woke up with headache took ibuprofen 800mg  5-14-21 0630 am woke up feeling fatigued and like my body weighed 500 pounds I'm 510 and weigh 160 pounds but started to feel better after moving around so I decided to work out from about 930 til 1030 am     5-15-21 approx 1120 in the am was showering after working out  :  Lip tingling and numbness followed by lip swelling, slight facial swelling and feeling of throat swelling like need to cough to get something out of throat , heart racing but was a little anxious (no new foods or products and have never been allergic to anything before) took a benadryl 25 mg tablet approx 1135 but felt like throat feeling swollen getting worse so I went to ER.   Approx 5 pm  5-15-21 slight fever, muscle aches headache began to worsen  lingered through until currently filing report benadryl 25 mh taken 8pm per MD orders to take around the clock for couple of days
tingling on the left arm @ redness at injection site; B/P- 129/77, P- 79, pulse oximeter- 98%. Client seen & cleared by EMS
Fatigue, weakness, body aches, shortness of breath, eyes blood shot and face flushed. Pt received shot at 10AM and came to center at 16:45. Pt Received EPI 1:1000 and IM, Benadryl 25 mg IM. Felt better then rebounded over the next hour. Received Benadryl 50mg IM x EPI 1:1000 SC solumerol 125.
Headache, Fever, CoughWheeze, Syncope, chills, pain in shoulder and body shortness of breath Narrative: