chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L044707, lot # M032649, lot# M036153 or lot # L0447707 for prophylaxis. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007005: US-009507513-1707USA011013: US-009507513-1707USA011014: US-009507513-1707USA011015.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sore arm sore, spread to rest of my body, then woke up shaking uncontrollably and took a hot bath in the middle of the night, nausea (but nothing came of it), and now gastro issues and headache. Also fever of 101.
Woke up at 4:00 am with fever and body aches and extremely sore arm. Fever and body aches were over by 8:00 am, after Tylenol.  Noticed a rash around injection site the second day (didn?t look at it the first day)
New onset Hypertension within first few wks of receiving vaccine, readings were mostly normal prior to Covid vaccine , 3wk later noted diastolic readings >100 with home monitoring, now requiring anti-hypertensive
At age two years realized severe learning difficulties, to this day at age 8 has ADHD and has still been unable to learn to read or do math. Had hep B at birth, 2+4, had multiple vaccines on 08/09/2000. On 08/28/2000 had complex partial seizure turned "deadly stop breathing." Med-flighted to hospital. Told them about the vaccinations but is on anti-seizure medicine. Follow up information received 09/25/02,stated "She continues to have seizures and is on medication to prevent them. She also has learning problems." An annual follow up report received 7/31/03 adds: She still suffers learning delays; she still suffers seizures.
Pt. presented to the emergency department with shortness of breath, chest pain and cough. He was hypoxic in the 80's on room air and was placed on 02. Bloodwork showed pt had a positive d-dimer and a covid-19 pcr test showed positive for covid. pt had booster dose 9 days ago. pt is currently admitted in hospital
pt recvd vax JUL94 & 24 hrs following vax pt stopped walking; pt would cry & sit back down; pt seen by MD & pt still refused to walk or crawl & when asked to stand would cry in discomfort & sit down; also had fever & held head as if had h/a
Patient presents to the ED with fever, chills, fatigue, body aches, sore throat, cough, diarrhea and nausea. She was found to have hypomagnesemia and was admitted for magnesium repletion. She was discharged in stable condition 6 days later.
Arm was sore and joint was very sore - hard to reach - injection site was swollen and red - was gone in 5 days - still sore almost 2 months later - still hard to reach.
Patient received three vaccines, upon completion of the third vaccine, the patient blacked out with no warning and fell to the ground, it is unknown if she hit her head or not. I (immunizer) immediately called for help and rolled the patient over an began to access the situation. After the patient regained consciousness (approx 30 seconds) I asked her her name, date, location.  At that time she refused an ambulance. She remained laying down for 5 minutes then sat up seated for some time. She was provided with a cool cloth, water, and crackers. She was observed  for around 30 minutes and left with the person who accompanied her to the store.
This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating) and COUGH (Light cough) in a 60-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.   In July 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced FEELING ABNORMAL (not feeling quite right). On 03-Oct-2021, the patient experienced COUGH (Light cough) and OROPHARYNGEAL PAIN (Sore throat). On 06-Oct-2021, the patient experienced COVID-19 (diagnosed with covid-19, confirmed with PCR). On an unknown date, the patient experienced DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse). At the time of the report, FEELING ABNORMAL (not feeling quite right), DISCOMFORT (tightness), MALAISE (Malaise, Getting sicker), ABDOMINAL DISTENSION (Bloating), COUGH (Light cough), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (shortness of breath), NASAL CONGESTION (Congestion), COVID-19 (diagnosed with covid-19, confirmed with PCR), MYALGIA (Muscle aches), CHILLS (Chills) and HEADACHE (severe headache that is getting worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, Oxygen saturation: 98% (normal) 98%. On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID-19, confirmed by PCR nasopharyngeal swab.. On 07-Oct-2021, Oxygen saturation: 96% (normal) 96%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received include NNI. On 11-Oct-2021: Follow up received include NNI.; Sender's Comments: This case concerns a 60-year-old female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of COVID-19. Time to onset from vaccination was not reported, as vaccination dates are not available. The rechallenge was not applicable, as no additional dosing will be given. The benefit-risk relationship of Covid19 Moderna is not affected by this report.
Within 2 hours of vaccine administration pts entire upper L arm began to swell parents administered benedryl that night and through the following day without relief.  Went to urgent care on day 3, prescribed amoxicillin for possible cellulitis, parent also continuing benedryl.  Symptoms gradually improved and now resolved.
This initial spontaneous case received from a consumer (patient) on 09-Nov-2017, concerning an elderly male patient of an unknown age. On an unknown date, the patient received flu shot (dose, route, anatomical location, manufacturer, trade name and batch number not reported). On an unknown date, the patient also administered ENTRESTO for an unknown indication. On an unknown date, after receiving vaccine, the patient noticed that he had some sort of allergic reaction, but not sure if it was from shot or from something he came in contact with outside while doing yard work. He also stated that it looked like a bug bite but was concerned as there were a bunch of them.Hes was still taking ENTRESTO. The outcome of the event was not reported.
Let deltoid swollen, harden round = 6 cm + painful. Received warm pack apply to area.
Pt. states no medical care during this time.  11-30-07 Pt. states on 11-18-07 noted 2 very small red areas on upper Rt. arm.  Pt. states area was about 1/2" above inj. site and 2nd red area was approx. 2" below inj. site.  In 24 hrs pt. states red areas gone.  Pt. states that 3 days after inj. received pt. noticed red discoloration and soreness on Rt underarm extending down to elbow, lasting approx. 7 to 10 days.  Pt. has no redness or soreness on this day.
Nausea, tachycardia, dizziness, h/o anxiety. BPs 152/66 (pulse 121), 149/83 (pulse 105).
Vial was stored in fridge for more than 30 days; No adverse event; Patient was administered bivalent vaccine that had been in the fridge past 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was reported that patient had no known chronic or long standing health conditions.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (1st dose) in May 2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 18-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days) and PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days).    Concomitant medications were not reported.  The patient received second dose of Moderna COVID-19 vaccine in November 2021.  The dose details for suspect bivalent Moderna vaccine was reported as initial booster.  It was unknown if the first patient experienced any adverse events.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720479, US-MODERNATX, INC.-MOD-2023-720524 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2023: Significant follow up received; Patient demographics updated, vaccine administration date, dose details, route of administration and event onset date was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720479:same reporter US-MODERNATX, INC.-MOD-2023-720524:same reporter
Facial filler reaction/ facial fillers swell; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt a facial filler reaction as facial fillers swelling. The follow-up would not possible as no contact details were available.
Pfizer 9/15/21, 3/17/22. Positive on 6/26/22
It was reported that a 63 year old female received Fluzone SV 98-99 USP  on 09/29/98. Reportedly sometime after the vaccination, the pt experienced an aching, swollen, red arm. From additional information received on 11/16/98 it was reported that the pt recovered from this experience.
her arm swelled up and it hurt, on the arm she got the injection; her arm swelled up and it hurt, on the arm she got the injection; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient herself) reported that a 56-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (also reported as a pneumonia vaccine, the patient did not know the brand name), via an unspecified route of administration, administered in arm on an unspecified date in 2010 (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2010, the patient reported that her arm swelled up and it hurt, on the arm she got the injection. The patient stated she had to go back to the doctor to get a shot, reclarified, for the arm swelling and did not know the name of the medication. The patient also took diphenhydramine hydrochloride (BENADRYL). The patient stated both medications were effective. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  The lot number for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
1st dose in Nov2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date:11-Aug-2022 Reporter comment: The healthcare professional reported that a patient received the first dose of Shingrix. The healthcare professional was asking that was there a need to restart the series or just to complete the second dose. At the time of the report, no mention was made about the administration of the second dose of Shingrix in the webform. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination
Witness seizure activity by the patient's wife and observation clinical (RN) staff. Per the patient's wife this type of seizure happens on a regular basis. The patient was seated at the time of the seizure and did not fall from the chair. The patient was transported to the ER for evaluation and post seizure activity monitoring.
Arm became warm and sore within seconds.  After about 90 seconds, a wave of heat flashed through the entire upper-body (torso, arms and head) followed by a mild tingling sensation throughout the entire upper-body (torso, arms and head). From minutes 3-6, increasing stomach discomfort and queasiness. From minutes 5-7,  profuse sweating of the entire head (everything from the neck up). At approximately 7-8 minutes, there was a single dry heave or gag (the sensation of vomiting, but nothing came up).  Other than the sore arm, all symptoms disappeared almost immediately after the dry heave occurred. There have been no symptoms other than continued soreness at the injection location as of 24 hours later.
08/25/2021 8 hours later That evening I started getting sore arm and mild swelling at injection site. Then the next day on 26th I developed a fever of 100.8 and I had body aches, especially in my hip joints, muscles, the injection arm, shoulder, neck, and chest pain. My pulse oxygen was back and forth between 94 and 96. I had some mild swelling of my lips and tongue and a mild headache and chills. I had slightly elevated heart rate all day yesterday that was around 100-115 at rest. I had Dry mouth and mild dehydration. As of today my fever has went down, but I still have dry mouth and I still have mild swelling and significant  pain at injection site and some body and muscle aches and fatigue. Also Mild lip and mouth swelling. I also have mild blurry vision that is still ongoing.
Approximately 10 hours after receiving flu shot, pt felt warm (not certain of temp), had chills, and experienced rapid pulse of 129 (normal for pt is 65). Arm was sore and area of around site was red. Pt did not treat with OTC's. By morning arm still sore, but other symptoms resolved. There was no respiratory difficulty. Pt did not call MD. Resumed ADL's within 24 hours.
Right upper am with papular erythematous eruption with mild scale 1d after vaccine.
Patient received his first dose of pfizer COVID-19 vaccine on 7/28/2021. Patient decided he wanted moderna COVID-19 vaccine for his second dose instead of pfizer COVID-19 vaccine. Patient denied receiving any dose of COVID-19 vaccine prior to receiving moderna COVID-19 vaccine on 8/20/21. Pharmacist found out about the first dose of pfizer COVID-19 vaccine while documenting the vaccine administration.
I tested positive for COVID-19 on 3/29/23. I had a fever, body aches, congestion, loss of taste, and fatigue. I contacted my doctor and because I had my symptoms for so long, we decided not to take medication. I was sick for about a week. I am feeling much better now.
Memory fog. I can look at something but can't say the word. I forget what I'm saying in the middle of a sentence. When walking, my right knee buckles. I never had these symptoms prior to having the booster. I have never had these symptoms prior to the booster.
Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th October 2018).   On 18th October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: After vaccination with 1st dose of Shingrix, the patient experienced sore arm. The patinet had no other side effects. For the tollerence of 2nd dose, refere case US2019GSK061598.
after administering both shots in left arm, 5 minutes went by and patient felt "clammy" and then fainted in chair. patient looked spaced out for 10 seconds but then claimed she felt fine. heart rate was ok and no trouble breathing.
Vaccine triggered Crohn's-related inflammatory arthritis, required month-long Prednisone taper for treatment
Information has been received from a registered nurse concerning herself, a 63 year old female with a history of herpes zoster and a penicillin allergy who at 4pm on 27-SEP-2007 was vaccinated with a dose of ZOSTER vaccine. Concomitant therapy included vitamins (unspecified). On 29-AUG-2008 the patient developed 2 inch segmented lines of vesicles on the left side if her mid abdomen which were very tender touch. She applied lidocaine to the area and began taking VALTREX 500 mg daily, adjusting the dose to TID when the outbreak was worst, She continued to break out, mostly on the upper part of her legs for the next 2 1/2 weeks. She indicated that this was a mild case of shingles compared to what she experienced prior to ZOSTER vaccine. She indicated that she was concerned that she had this outbreak. She did not seek any medical attention. Additional information is not expected.
Vaccine was administered 18 minutes AFTER vial discard time (6 hours after dilution).  Vial open 11/24/21 @812am.  Do not use after time = 212pm.   Administered to patient at 230pm.
First day fever, nausea, exhaustion, aches  Second day vomiting multiple times extreme headache ,
Pt C/O allergic reaction redness and swelling believes it was accident given SC instead of IM
Dizziness, blurry vision. diaphoretic. Had reaction to pediatric dose of some vaccine.
lost of taste; Legs. An not support walking; aching; weakness; Severe chills; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the right arm on 24Mar2021 15:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 27Mar2021, the patient experienced severe chills, weakness, aching, lost of taste and "legs. An not support walking" (as reported). The patient did not receive any treatment for the events chills, weakness, ache, loss of taste and difficulty in walking. The clinical outcomes of the events chills, weakness, ache, loss of taste and difficulty in walking were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax 8SEP92 & 6 to 7 hrs following vax exp irritability & aggressiveness;
Behavior changed right after shots: tantrum by hitting & choking; running non stopping; climb up & down a lot; covering his ears by water flashing; no eyes contacts; biting others; waking up at night; head down, crying and lying down the floor at school. Fever at 99.7F. Palms of hands & soles of the feet were very hot; measles whole body from feet to head including mouth, tongue & hands, flip hands, body back & forth, repeatedly.