chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The doctor gave the patient only the diphtheria, tetanus, acellular pertussis (DTAP) Polio part of Pentacel without ACT-HIB by mistake, no AE; Initial information was received on 07-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four month and 5 days old female patient who was given only the diphtheria, tetanus, acellular pertussis (DTAP) polio part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without ACT-HIB by mistake (Product preparation issue)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 07-Aug-2020, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ258ABA, expiry date: 04-Apr-2021)(DTAP/polio: Lot: UJ344AA, expiry date: 04-Apr-2021) (frequency: once, single dose vials) via intramuscular route in the right thigh for prophylactic vaccination. The patient still had to get the Act-Hib part  This was a case of an actual medication error case due to inappropriate reconstitution technique.  No adverse event was reported at the time of reporting.  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 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
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Severe swelling and redness at injection site, injection site warm to touch, nausea/vomiting, fevers 101-103, severe headache, dizziness, weak
sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported that he/she received 1st dose of shingles vaccine and experienced just sore arm.
Information has been received from a physician a practice manager referring to a patient of unknown age and gender. On 18-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hours), the lowest recorded time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 72,29 and R. The total cumulative excursion time (hour), the lower recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 112, 30 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the forth excursion was 32, 32 and R. The total cumulative excursion time (hour), the lowest temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 208, 31 and R. This is one of several reports received from the same source. Additional information has been requested.
General aches, pain, tiredness. Moderate headache. No diarrhea or vomiting. Slept for 18 hours and feel fine now (2 days later.)
Patient under age 18 was vaccinated with Moderna 046a21a, which is a vaccine error, on 4/2/2021. He received his second vaccine  Moderna  008C21A on 4/30/2021, Troubleshooting: Neither original dose vaccinator/screener nor second dose vaccinator validated birthdate.  Unreported as error, found in data mining. He was eligible for the second vaccine per standing orders. A policy requiring vaccinators/scribes to check age was instituted shortly after his first vaccine to prevent this from occurring again.
had the vaccines but still got them several years ago/suspected vaccination failure; still got shingles several years ago; got shingles several years ago and still suffers from nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's comment: This case was reported via interactive digital media. The reporter's father had the vaccines but still got them several years prior to the reporting and still suffered from nerve pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Day 1-21: Frequent waking and head jerking; irritability-crying; less babbling-less responsive; stall in development; unable to relax; some rubbing feet against each other.
Stomach virus; Nausea; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 15:55 (Lot number: EN6206) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot, for shot, reaction(s): "Flu". The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Stomach virus"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient reported that the second vaccine was scheduled at 20 days. The patient was at risk for missing second vaccine due to illness. She confirmed that second dose was scheduled for 01Apr2021. Patient stated she was due for her second shot tomorrow, and she had no reaction to the first vaccine. Patient stated she had stomach virus. She did not know when it occur but it was probably 8 am. Patient stated she experienced nausea in the morning and headache probably about 8 am. patient reported about another suspect product she stated that when she took Tylenol, to treat her headache, it let's up and then comes back. She also reported issue with clarifying the Lot number of Tylenol. She reported Lot number as PGAO or zero, 61. She did not know if it is an O, letter, or 0, number. Manufacturer name not given. Extra strength reported was 325 count of 500mg caplets. Expiration date of Tylenol was Dec2022.   No follow-up attempts are possible. No further information is expected.
Sharp, painful muscle cramps in both left and right feet and ankles, relieved by self-administered massage.   Cramping began when first lying down in bed, relieved by massage, then recurred about 20 minutes after falling asleep, and again relieved by self-administered massage.    Not persistent.   Did not recur after being relieved by self-administered massage the second time.   I was physically exhausted due to only 3 hours sleep the night before, so this may have been the result of exhaustion and not the vaccine, but has never happened before and seemed severe enough to file a report about it.  My arm was not particularly sore where vaccine administered and no other SE.
Moderna COVID-19 vaccine EUA, slightly swollen tongue, painful mouth and tongue sores
9/10/2011 HE GOT WORST SO I BROUGHT HIM TO SEE THE DOCTOR. HE IS NOT EATING OR DRINKING.
After vaccination, I had swelling and pain in both lower legs and both feet for several months. I sought treatment in June, 2021. I was treated with two courses of steroids at that time. Since then I have also developed some form of psoriasis in my scalp which is being treated with steroid medication.
Patient was administrated with only the adjuvant of Shingrix; Patient was administrated with only the adjuvant of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number b257h, expiry date 26th June 2023) for prophylaxis.   On 2nd May 2022, the patient received Shingrix. On 2nd May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Medical assistance reported that a patient was administrated with only the adjuvant of Shingrix. No adverse event was reported . The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
pt had a positive COVID test on 10/1/21 and was treated with ABX for COVID Pneumonia at a Hospital; was flown to another hospital ED; pt had cleared COVID precautions 3 days earlier; c/o worsening abdominal pain over past 2 days; pneumoperitoneum; refused any surgical intervention; pt in A Fib and flutter; DNR/DNI; pt's condition worsened; was transitioned to comfort care and had a palliative admission; pt expired in the hospital
no adverse events at time of vaccination. Hi Dose Influenza IIV4 given to client under 65 yrs of age.
6 hours after receiving the PNEUMOVAX 23 vaccine patient reported a 5 inch in diameter itchy welt at the injection site. F/u 9/11, patient's whole arm, shoulder to elbow, is swollen and tight.
she developed onset of bodily rash in the past 24 hours extending from scalp to upper thighs including GU region.  Non pruritic in description.  Mother states that child was exposed to 10-month-old infant with high fever and subsequent pinpoint rash last week prior to the onset of rash this week in this particular child.  Diagnosis for the 10-month-old was viral and no treatment was given.  MMR dosing was given on 06/19/2020 at this child's routine 12 month exam.  Given live vaccine at the time and the development of today's rash, highly suspicious for vaccine related measles rash.
almost immediately after the shot was given, my arm started to get tingly. i felt my arm gradually go numb, starting at my shoulder and going all the way down to my fingers. then my throat started getting tight and it became hard to breathe. i got light headed, my heart started beating really fast, and the next thing I am aware of I am laying on the floor. I passed out and fell out of the chair and hit my head on the way down so I woke back up with a headache. I have no idea how long I was out. They just gave me orange juice and had someone drive me home. two hours later my vision was still blurry and I am dizzy.
Rash, periods of fussiness with back arching-started 5/30/07
No adverse effects were reported.; Patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 13-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (lot number was S003170, expiration date was 30-JUL-2020) (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (product storage error).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008722: US-009507513-1906USA008789: US-009507513-1906USA008790: US-009507513-1906USA008903:
Uncontrollable shaking and jerking of arms, legs and head. Lasted 1.5 hours. Took Tylenol and Advil. Went away after 1.5 hours.
sore arm; "didn't feel well"; nausea; "stomach upset"; tired; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 6th March 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling unwell, nausea, upset stomach, tiredness and low grade fever. On 9th March 2020, the outcome of the pain in arm, feeling unwell, nausea, upset stomach and tiredness were recovered/resolved. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, nausea, upset stomach, tiredness and low grade fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and on same day started with a sore arm, nausea, upset stomch, tiredness, low grade fever and patient did not felt well.  The patient stated that all these symptoms resolved after three days except for the low grade fever which continued till the time of reporting. The patient stated that she did discuss these symptoms with her health care provider. The reporter consented to follow up.
Significant swelling and soreness the night of the vaccine injection.  2 days later, very red, swollen, and pain with redness down to the elbow.  Low grade temp of 99.1 F.
Pt developed red, hard, sore area around injection site, size 4X4cm.
Patient has a red, hard, swollen and warm lump about 5 inches in diameter on her left arm at injection site. She is being treated with ice packs, Ibuprofen & rest.
Redness, warmth and induration around site of PENTACEL injection. Developed within 24 hours of vaccination. Also had fever. Treated with antipyretic and cool compress.
3 hours after I got it, my HR shot up to 178. I was SOB and tight chest and had a lump in my throat and coughing. I was super jittery!! EMS called to take me to the ER. The ER doc said ?I don?t *think* it was anaphylaxis, but an allergic reaction can cause all of your symptoms.? So he?s sending me to an allergist. Since I?ve been home, I keep having episodes of chest pain and SOB and tachycardia mainly upon standing and worse with any kind of exertion- walking, talking, etc. I also now have a referral for a cardiologist. I see both this week.
Skin sensitivity at the injection site area; Severe arm pain; Fatigue; 102.8 fever, lasted 3 days to 101.2; Massive and violent chills; Throwing up, projectile vomiting; nausea; Stomach cramping; Non stop diarrhea; Violent shaking; Radiating arm pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea) and VACCINATION SITE PAIN (Skin sensitivity at the injection site area) in a 48-year-old female patient 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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea). On an unknown date, the patient experienced TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue). The patient was treated with HYDROXYZINE at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 07-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea) had resolved. At the time of the report, TREMOR (Violent shaking) and LIMB DISCOMFORT (Radiating arm pain) had resolved and VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue) outcome was unknown.            Patient reports adhering to a diet of energy drinks, water, hot tea, ginger ale, and broth to treat nausea and vomiting after receiving her second moderna dose on 5Apr2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-069999 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email received from reporter with additional AEs (violent shaking, radiating arm pain) for this second dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069999:First dose case
Initial report received on 16 February 2012 from the investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the database. The subject had previously received 3 doses of PENTACEL; dose 1 received on 26 January 2011, dose 2 received on 16 March 2011 and dose 3 received on 23 May 2011 (lot numbers, route and site of administration not reported). The subject developed cold-like symptoms on 23 December 2011, approximately 7 months after the last dose and cough began on 25 December 2011. The subject developed paroxysmal cough on 02 January 2012 with posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 03 January 2012. Chest x-ray results were unknown. Corrective treatments consisted of azithromycin starting on 03 January 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 33 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I started coughing and having mucus in my throat got sore and scratchy, blowing my nose, a fever on and off, I was tired and got wore out easily, felt like I was in a fog, felt like I had a noisy head. I took a home COVID 19 test that was positive. I went in for a follow up visit on June 7, 2022 the PCR COVID 19 test came back positive. I was prescribed molnupiravir, benzonatate and nasal spray and I am feeling so much better than I did. I tested negative on June 18, 2022.
Sunday April 11 12:30pm ? injection left arm dose 1 12:32pm My fingers went numb  5:30pm my arm started to stiffen up  (took Tylenol 2x at 4 hour intervals) 8:00pm hives and reddening at/around injection site  (applied benadryl cream)               Chills and fever set in 10:30pm  terrible nausea and fatigue  Monday: Called out of work Body aches Terrible fatigue was in bed all day long felt drugged up Very thirsty and lethargic  Tuesday Hard to wake up  Body aches Struggled to drive to the office  ? Neck is hurting and It?s hard to keep my head up right
Vaccine expired on 10/21/21 and was given on 10/25/21. expired vaccine given
The patient was happy that she got her 1st dose.  She did not report any adverse reaction.
Called  at the vaccine table where she had been put on the floor by her father as she was about to "fall out of the chair" in the first minutes after her vaccine. She was pale and c/o nausea and dizziness and appeared dazed 1:20pm. HR-60 regular. R-8 conjugate. Moved all extremities on command. Raised legs in supine position and she began to improve immediately BP 97/53 with HR improved to 75. Sitting up created dizziness so supine again at 1:31. BP 97/60  HR-92. Transferred to Lobby couch at 1:37. Supine BP 97/53  HR 76   PO2 100. Symptoms resolved but didn't want to sit up again. Sat at 2:04 feeling fine//good color. BP 103/61. HR 108  RR 20. Discharged with Father and 3 sibs ambulating well. Vasovagal reaction to vaccine administration. F/U with Peds- if further problems.
Pre syncope immediately following injection. Whole body urticaria (hive/wheals) developing within 15 minutes of injection, enlarging and spreading for approximately 30 minutes before beginning to resolve.