chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practice nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L035880 (expiration date: 11-AUG-2018) or lot # M006710 (expiration date: 06-DEC-2018) (doses and routes of administration were not reported). There was no adverse effect reported. Administered doses of vaccines had been stored at the temperature of 0.5 Celsius degrees for 1 month and of 0.6 Celsius degrees for 2.5 months. Data logger was involved. There were no previous temperature excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Post vax, the patient had a local reaction. The patient was treated with Benadryl and ice packs for 5 days.
A nurse reported that a male infant, now 11 months old, received his 3rd dose of Hib-Titer, as well as, Prevnar, on 8/28/00. On 2/10/01, he developed Haemophilus influenza bacteremia. This event is considered "Medically Important". Upon further review, Prevnar is considered not suspect in this report.
Localized irritation to the left thigh, presenting redness, swelling and warm to touch, non tender. For a past 48hrs, recommended treatments with ice packs, Tylenol and/ or Motrin for pain.
Information has been received from a physician concerning an approximately 10 week old female infant with "severe protein food in tolerance" who "a week after she was 2 months old" on approximately 26-MAY-2008 was vaccinated orally with a first dose of ROTATEQ (Oka/Merck) (lot # 660378/1928U). There was no concomitant medication. Subsequently, on approximately 29-MAY-2008, "3 days after getting the vaccination" the patient experienced diarrhea, vomiting and rash. It was noted that the gastroenterologist said it was ok to give the vaccination to the child. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Have a one under arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Have a one under arm) 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 ADVERSE EVENT (Have a one under arm). At the time of the report, ADVERSE EVENT (Have a one under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment products were not provided.
Moderate pain at inj. site with erythema. Burning of lips and oral pharynx 20 hours later, coupled with eye pain and dryness. 36 hours, urticaria plus/minus pain in inj. site with moderate eye pain and urticaria.
Child was crying continually after getting the shot. Within a few minutes developed a hive on the left forearm. 5mg of Zyrtec was given shortly afterward but since he was so upset he vomited prior to first attempt to give it to him. After the Zyrtec was given he developed red patches on his upper extremities. There was no further vomiting and at no time in over a half hour of observation did he have any difficulty breathing, coughing or wheezing or any other symptoms. He did calm down however and went home with both parents who are RNs. His 4 year old brother had the same vaccine without any immediate reaction.
Patient received second dose of Pfizer on February 4th. She tested positive for Covid-19 on March 9th. Symptoms started March 4th, She was exposed by her children on March 2nd. She only has a cough and runny nose.
Pt was vaxed w/HIBTITTER @ 9mos of age & given 2nd dose @ 15mos of age; approx 6 mos later, exp high fever, vomiting & lethargy; hospitalized; dx H. Flu Meningitis; tx included IV Rocephin & Steroids x 10 days;
Extreme fatigue, cold like symptoms, sinuses, head cold for the past 2 days
pt recv vax JUL95 & devel a rash @ inj site;No further details were provided;
Answered phone and someone began talking about suspected adverse reaction to vaccine administered, stating she had texted a number that asked her about vaccine side affects that failed to respond to her.  I asked to verify ID and led to patients chart.  Client then said she wanted it reported that she had adverse affects.  She reported that she has "terrible throbbing pain in head and neck and legs, and rapid heart beat".  I told her to go to hospital or call 911 if she cannot make it to the hospital.  She demanded I take note of her symptoms which I was in her EHR.  I stated again that these symptoms sound worrying and she should go to the hospital right away.  continued on next page... She questioned if I was taking note of her symptoms, I assured the patient I was noting what she told me and emphasized due to her symptoms she should see a doctor right away.  She then stated she wanted us to report this so 'her attorney could reference it'.  I told her she needs to be examined by a doctor immediately, she stated 'she will see her own doctor virtually'.  Made clear point to go to emergency room.
pt recv vax 19MAR96 & arm turned cold & then returned to nl temp w/in 15min;pt also exp burning & stinging @ the inj site;no further details were provided;
This spontaneous report as received from a physician refers to an 84 year old male patient with unspecified cardiac issue. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# not reported) subcutaneously. While on ZOSTAVAX, the patient developed shingles. The patient sought unspecified medical attention. At the time of reporting, the outcome of shingles was unknown. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.73. Concomitant products were not provided.  On 03-Apr-2021, excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration at 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Fever, fatigue, swollen lymph nodes in armpit of left arm - began afternoon on the date of vaccination. Fever resolved by evening of 6/5. Swollen lymph nodes persisted until morning of 6/7
Swelling at deltoid, hot & red. Cold compress and hot compress later. Swelling & persistent pain again following day. Elbow painful to touch as reported by patient.
Delayed reaction; Upper right arm hurts, left arm hurts; mild Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Delayed reaction), PAIN IN EXTREMITY (Upper right arm hurts, left arm hurts), PYREXIA (Fever) and CHILLS (mild Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 03-Mar-2021, the patient experienced CHILLS (mild Chills). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Upper right arm hurts, left arm hurts). On an unknown date, the patient experienced UNEVALUABLE EVENT (Delayed reaction). The patient was treated with NAPROXEN SODIUM (ALEVE) for Chills and Fever, at an unspecified dose and frequency. On 03-Mar-2021, CHILLS (mild Chills) had resolved. On 09-Apr-2021, PAIN IN EXTREMITY (Upper right arm hurts, left arm hurts) had resolved. At the time of the report, UNEVALUABLE EVENT (Delayed reaction) outcome was unknown and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.    This case was linked to MOD-2021-039737.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Event (Right arm hurts and delayed reaction) added
RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE, APPROXIMATELY AROUND 0.3ML; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 37 year old male. 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced received less than 0.5ml of the janssen covid-19 vaccine as the initial dose, approximately around 0.3ml. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the janssen covid-19 vaccine as the initial dose, approximately around 0.3ml and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209679, 20211209706, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210733, 20211210824, 20211212082, 20211212088, 20211210588, 20211210112, 20211209775, 20211210610, 20211210409, 20211210555 and 20211210408.
Thirsty; Tired; little tingling on my left cheek (face); Runny nose; Felt like a stab in my calf; R arm tingling; Upset stomach; Increased HR; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling) and ABDOMINAL DISCOMFORT (Upset stomach) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling), ABDOMINAL DISCOMFORT (Upset stomach), HEART RATE INCREASED (Increased HR), THIRST (Thirsty) and FATIGUE (Tired). On 31-Jan-2021, PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling), ABDOMINAL DISCOMFORT (Upset stomach), HEART RATE INCREASED (Increased HR) and FATIGUE (Tired) had resolved. At the time of the report, THIRST (Thirsty) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Patient is a hospital worker who was due for a Tdap booster.  He had tolerated Tdap previously with no adverse event, and consented to receive the Tdap booster during a routine annual employee wellness visit.  The vaccine was given around 2:30 PM on 4/25/23 with no immediate reaction or concerns, and the patient returned home.  However, approximately 7 hours post-dose (at about 9:30 PM) patient developed severe chills and muscle weakness.  These symptoms quickly progressed and within 20 minutes the patient collapsed.  He could move his limbs but did not have the strength to stand and walk.  Patient remained laying for about 90 minutes, at which point he gathered sufficient strength to walk and get assistance.  His temperature at that time was measured at 102.8 F.  Patient was given aspirin 325 mg, acetaminophen 1000 mg and ketorolac 10 mg with no reduction in fever or symptoms.  He finally defervesced below 100.8 F at approximately 9 hours from symptom onset (around 6:30 AM on 4/26/23) after a dose of ibuprofen 800 mg was given.  Patient required scheduled doses of ibuprofen, acetaminophen and aspirin to maintain temperature below 100.8 F for approximately 36 hours from symptom onset.  During this time, muscle weakness and fatigue continued and patient's urine was dark.  Urine color returned to normal at approximately three days post-dose, at which point all symptoms appeared to be resolved.
4DEC91 MD seen @ ER erthromycin given 5DEC91 seen again in ER w/cough, not feeling well, congestion, numbness of hands; feet & SOB; transferred to hosp 5DEC91;
(R) deltoid localized vaccine reaction noticed by mother on 10/4/12 with redness, warm, minor tender to touch, no pain measured at 4 x 3 inches on 10/5/12 at 16:00.
A 2 year old patient received a Quadracel vaccine instead of a Pentacel vaccine with no reported adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who received a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of a pentacel vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine suspension for injection (lot U7526AA, expiry date - 07-Sep-2024) (dose, frequency and strength: unknown) via unknown route in unknown administration site for immunization.  On an unknown date 2 year old patient received a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine instead of a pentacel vaccine with no reported adverse event (interchange of vaccine products) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event
He had the usual flu-like symptoms for about 24-36 hours following injection but then had vertigo consistently for a week and has vertigo off and on for the weeks since the vaccine.  This is a new symptom for him and started almost immediately after the vaccine. It does seem to be remitting.
Event: Ischemic Stroke, Left Thalamus (30 May 2021, day 12 after second dose of Moderna Covid-19 Vaccine) Treatment:  Hospitalization (4 June 2021, day 5 after suffering Ischemic Stroke) Outcome:  Impairment requiring Medical Treatment and Rehabilitation (Physical Therapy, Occupational Therapy, Speech Therapy).
Patient was standing against the wall after getting his vaccine and watching his brother get his shots when he just slid down the was on to the floor and was unresponsive to mom and became stiff and ridged on the floor.  The nurse came and he was responsive again.
Headache, Myaglia, Nausea Vomiting, chills, flushed Narrative:
Mother reported that patient felt dizzy after receiving the Meningitis vaccine last year.  So prior to administration of vaccine patient was given apple juice to drink and laid down on exam table prior to administration of vaccine.  HPV-9 VIS given and discussed with Mother.  HPV-9 vaccine administered to patient in left deltoid while patient was laying down on exam table and cool compress applied to forehead.  Patient monitored.  Patient reported not feeling well after receiving the vaccine, feeling dizzy.  Patient was examined by Dr., vitals taken, given cool compress for forehead, and given another apple juice.  Patient was monitored further then reported having a headache, feeling nauseous and dizzy again.  Patient examined again by doctor, vitals taken.  Vitals stable. Patient monitored further.  Patient then complained about still feeling lightheaded and not wanting to walk.  Ambulance called for transport to the ER.   Patient in no respiratory distress.
Cardiac  Arrest Narrative: Patient received vaccine at 1209 on 3/13/2021, observed for 15min no reaction noted. Later that evening patient was not feeling well presented to ER where he was admitted. Had cardiac arrest during hospitalization on 3/16/2021 where patient passed away. Had a Hx of CHF, A-Fib, had  a cardiac stent placement in 2020..
Within 10 minutes it was a wave of itchiness starting all over my body. The itchiness lasted for 3 days. Doctor suggested I take Zyrtec the itchiness went away. After the second dose same reaction just less because I took Zyrtec before and after.
no additional adverse events provided; administration of expired MMR and sterile diluent; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 01-OCT-2021, the patient was vaccinated with expired doses of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 ml (reported as .5 ml) lot # R036582, expiration date 17-DEC-2020 (route of administration was not provided) and sterile diluent lot # S008565, expiration date 09-AUG-2021 (dose and route of administration were not provided). No adverse events were reported.
On 12-21-2020, elevated heart rate and persistent 12-22-2020  with chest discomfort. On 12-23-2020, I went to the emergency room because my chest pain got worse and peaked.  The ER blood pressure was also elevated 200/100.
Janssen COVID-19 Vaccine EUA Received J&J vaccine at 1:45pm on 4/10/2021. Started feeling slightly lightheaded around 8:00pm. Experienced chills and a fever (elevated to 103.5 degrees), elevated heart rate, headache, and muscle pain from 9:00pm - 4:00am Sunday, 4/11/2021 and could not sleep at all during that time. I took 1 extra-strength tylenol around 2:30am. Finally fell asleep around 4:30am on 4/11/2021 and when I woke up again at 7:30am on 4/11/2021, all side effects were gone. All side effects came on and then went away in about a 12 hour period.
This spontaneous report as received from a physician via a field employee refers to a male patient of unknown age. On 16-SEP-2014 the patient was vaccinated with the first dose of GARDASIL typical dose, (lot #, strength and route unknown). On 16-SEP-2014, the patient experienced being light headed, breathing  heavy and dizzy after taking GARDASIL. The medical staff told the patient to stay calm bu tit was unknown whether the patient "passed out" or not. The outcome of breathing heavy, dizzy and light headed was unknown. The patient was given unspecified treatment. Additional information has been requested.
Tenderness at injection site started a few hours after injection, on 16-FEB-2020. Body aches started in the evening of the day the vaccine was administered (16-FEB-2020). On 17-FEB-2020, experienced fever to 101.5 degrees F, chills, headache, tooth pain. I took 400mg of ibuprofen immediately after receiving the vaccination on 16-FEB-2020 and again on this same date at 10:30 PM. I took the same dose of ibuprofen again on 17-FEB-2020 at 10:30 AM Fever to 101.5 degrees F, chills, resolved on 17-FEB-2020. Body aches, headache, are resolving/improved as of 17-FEB-2020. Tooth pain not resolved Tenderness at injection site not resolved
Pt recv vax on 10/14/98; on same day pt exp pain of rt arm; dx=classic rotator cuff, tendinitis; tx=Motrin
Initial report received from a health care professional on 16 Dec 2009: This patient was inadvertently vaccinated with FLUVIRIN (batch: 102135P1) 0.5 ml, intramuscular, on 15 Dec 2009 (off label use). The outcome of the event was not reported.
had a sore arm; hives from her neck down to her thighs; terrible itching; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in end of October 2020 refer case US2021021105).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix and an unknown time after starting Atarax, the patient experienced pain in arm, hives and pruritus. The patient was treated with hydroxyzine hydrochloride (Atarax), prednisone and cimetidine (H2 Blocker). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, hives and pruritus were recovered/resolved.   It was unknown if the reporter considered the pain in arm, hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. Age at vaccination was not reported. The patient received 2nd dose of Shingrix at the end of December 2020.  The patient had a sore arm from 2nd injections that resolved quickly.  1 week after her 2nd dose, the patient developed hives from her neck down to her thighs that caused terrible itching.  The patient taken prednisone, Atarax and a H2 blocker to treat this.  Her symptoms resolved after one week of treatment.  No lot number or expiration date for either vaccine was known. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021021105:same reporter