chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient got Covid vaccine shot 5 and flu shot same day; patient got Covid vaccine shot 5 and flu shot same day; received terrible pain that is described 15Oct and still in same pain after 7 days; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Oct2022, outcome "not recovered", described as "received terrible pain that is described 15Oct and still in same pain after 7 days"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "patient got Covid vaccine shot 5 and flu shot same day".  Additional information: Patient got Covid vaccine shot #5 and flu shot same day/same arm and received terrible pain that was described 15Oct and still in same pain after 7 days. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever - 101.3 degrees for 24 hrs Itchiness  with red dots - on back, arms, legs - 2 days later still having itchiness but fever has subsided.
Left arm reddened and swollen and itchy. Tylenol given for relief. Arm worsened second day post immunization. Patient taken to ER. Keflex given for infection control.
Diabetes; Osteoarthritis knee; trouble sleeping at night/sleeplessness; injured right wrist; fallen twice; Back pain; Neck pain; shoulders pain; Difficulty in walking; Pain; This is a solicited report from a marketing program received from a non-contactable consumer (patient) based on information received by Pfizer, (manufacturer control number: 21K-163-3786549-00). A 55-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular first dose in Mar2021 second dose in Mar2021 both at the 55 years old at single dose for COVID-19 immunization; adalimumab(HUMIRA) Subcutaneous from 2019 and ongoing at 40 mg, cyclic(1 in 2 wk) for Moderate to severe Rheumatoid arthritis.  The medical history included Non-smoker, Abstains from alcohol, Diabetes, Right knee replaced, Hysterectomy, Left foot ganglion cyst surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. The concomitant medications were not reported. The patient previously took Farxiga and experienced allergy manifested by Dehydrated dizzy and weak to get out from bed; Amlodipine and experienced allergy manifested by Broke out in rash all over the body. The patient experienced Osteoarthritis knee, fallen twice, injured right wrist, back pain, neck pain, shoulders pain, difficulty in walking, diabetes, pain and trouble sleeping at night, sleeplessness, all in 2021. The patient underwent lab tests and procedures, which included X-RAY on 03JUN2021: Needs Knee surgery. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events was not recovered.  Causality for adalimumab: The reporter causality for the events of left knee was bone on bone/osteoarthritis, fallen twice/injured right wrist unknown onset, pain and sleeplessness was no reasonable possibility. The reporter's causality for the events of trouble sleeping at night, back pain, neck pain, shoulders pain, difficulty walking and diabetes was not provided.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: The reported events are most likely intercurrent conditions or related to underlying medical conditions and unrelated to BNT162B2.
vial had been punctured for greater than 12 hours when the doses were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial had been punctured for greater than 12 hours when the doses were administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial had been punctured for greater than 12 hours when the doses were administered). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vial had been punctured for greater than 12 hours when the doses were administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-385958, MOD-2021-388696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received contains updated Reporter information, Patient details, Dose details and Event information.
Pt's mother returned to the clinic on 04/04/2002 with another of her children. Mother stated, "my daughter got chicken pox on 03/29/2002" Pt was never brought back to clinic for a medical diagnosis.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2018 the patient was vaccinated with VARIVAX (lot # R018139 and expiration date 25-JUN-2020), (dose, units were not reported) via intramuscular instead of subcutaneous route (incorrect route of product administration. No adverse effects were reported. There was no product quality compliant reported.
Rebound COVID after taking lower renal dose of Paxlovid; Rebound COVID after taking lower renal dose of Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 11:00 as dose number unknown, single (Lot number: FJ4989) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stage 3 kidney disease" (unspecified if ongoing); "charcot marie tooth disease" (unspecified if ongoing); "lumbar stenosis" (unspecified if ongoing). Concomitant medication(s) included: DETROL LA; TAMSULOSIN; ALLOPURINOL; AMLODIPINE BESYLATE; RAMIPRIL; GABA [GABAPENTIN]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound COVID after taking lower renal dose of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: COVID 19 Treatment with Brand Paxlovid Lower renal dose, treatment started on 28Aug2022 till 01Sep2022, unknown lot number.
headache, rash on face/itching, Rt side lympnode below ear swelling.  Pt. does not has history of egg allergy
pt recvd vax & devel localized urticarial eruption @ the site of inject, persisted for 15-20 mins & was not assoc w/any systemic sx & then subsided; pt is not yet considered immune;
Initial swelling and erythema that became approxiamately 10cmx10cm. Later that evening I developed hives and itching all over body. Hive lasted 4 days, itching 7 days. Injection site reaction last 2 weeks.
Tired Fever Dizzy/Passed Out  Treatment-rest, plenty of fluids, Advil Outcomes-feeling better
This case was reported by a pharmacist and described the occurrence of inappropriate schedule of drug administration in a 2 day old male subject who was vaccinated with Hep B vaccine (Engerix B) for prophylaxis. No significant medical history or concurrent conditions were noted in this newborn. Concurrent medications included Vitamin K. On 10/3/2006, one day following delivery, the subject received 1st dose of Engerix B at 10 mcg. The following day, on 10/4/06, the subject inadvertently received a 2nd dose of Engerix B at 10 mcg. This was considered to be an inappropriate schedule of drug administration. The subject was reportedly hospitalized or the hospital stay was extended following birth and the maladmininstration of vaccine. The first and second doses of Engerix B should be separated by one month. No adverse events were indicated at the time of reporting.
Pt. received flu injection 10/09. Pt. developed Guillain Barre syndrome 4/10. Pt. feels it was caused by the vaccine. Hospitalized at community hospital, then transferred to another hospital for tertiary care. Pt. was then transferred to acute rehab. Pt. had to be intubated with 4-limb paralysis for prolonged time. He was eventually extubated. He uses motorized wheel chair now.
Fever, weakness, general body aches, injection site pain starting evening of injection and continuing still today. Fever running 103-104 F and is reduced to 99-100 with NSAID and Tylenol use.
Got the shingles vaccine and got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shingles vaccine and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles. The patient stated that the vaccine is not guaranteed. This case was considered as suspected vaccination failure as details regarding completion of primary 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.
AUTISM; This spontaneous report received from a parent via social media via a company representative concerned a male of unspecified age, race and ethnic origin. 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, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced autism. Reporter stated that, ""It was nurses who shot vaccines full of mercury into my normal son to cause his autism. The psychos who planned this attack on our babies lied to the nurses". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of autism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220538898-covid-19 vaccine ad26.cov2.s-Autism. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Approx. 2 days after shot shoulder and neck area turned red for 24 hrs. Pt. experienced muscle aches for next 24 hours. Symptoms disappeared.
Initial report received on 22-October-2014 from a nurse. A female patient whose age, medical history and concomitant medications were not reported, received a doses of FLUZONE Intradermal (lot number UT4725AA) (site and route of vaccination was not reported). On an unspecified date, after receiving the patient experienced hard, red raised area 60 m diameter, blistered 15 mm center at injection site. List of documents held by sender: none.
1435 Called to treatment room. Patient pale and unresponsive in his mom's arms. Placed on treatment table in supine position. Opened eyes and cried asking where he was. C/O ringing in ears and decreased vision. Both returned to normal within 2 minutes. BP 82/50 HR 60. No breathing difficulty. Diaphoretic. Had not eaten anything since breakfast. Given a lollipop for some sugar. 1445 BP 92/50 HR 68 Lips pink. Denies ringing in ears or visual disturbances. Denies dizziness. Laughing and joking with siblings. Assisted to sitting position on end of treatment table. 1450 Accompanied to waiting area with instructions to his mom to remain seated for 15 minutes. If symptoms return further invention including ED will be put into place. Monitored by staff while in waiting area. 1510 Denies further symptoms. Discharged to home with family.
Right arm is red, painful, and mildly itchy. Redness starts at site of injection(s) and spreads about 2 inches towards elbow. Client states arm is painful at rest and tender to the touch. Pain interfered with exercise.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 27th October 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On 28th October 2018, the patient experienced injection site erythema and injection site swelling. On 29th October 2018, the patient experienced injection site itching, general body pain and tiredness. In November 2018, the outcome of the injection site erythema and injection site itching were recovered/resolved. On an unknown date, the outcome of the injection site swelling, general body pain and tiredness were recovered/resolved and the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, general body pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported The patient reported that while administering 1st dose, vaccine ran down her arm when injected, when led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The patient did not know how much of the vaccine if any she received. The patient did not experience any injection site reactions from that dose. The following day after 2nd dose, the injection area was red and swollen. The area of redness measured 2.5 inches in diameter.  The following day after vaccination she also felt achy all over and tired and the injection site became itchy. The swelling lasted 3 to 4 days. The redness and itchiness lasted a total of 7 days.  The achy and tiredness lasted 2 days. The patient had consented to follow up and provided contact details of the physician.
Booster; back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "Booster"; BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "back pain".  Additional information: Caller named took the booster shot last Saturday. He was having a back pain and he was asking if once he took the medication Medrol will the Pfizer covid-19 vaccine be less effective and would like to know if he would encounter some adverse reaction. He needed to take Medrol for his back and he wanted to know if it would have issues with the effectiveness of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tightness in throat - 2h. (started  5h p. inj.) Nausea - 1.2 h. headache 22 h. Rx: BENADRYL & TYLENOL.
it was rpt 3 days p/vax pt devel fever 103F, vomiting & diarrhea; hosp overnight; stool specimen was positive for rotavirus antigens;pt recovered;
Got the vaccine on 10/12 and then on 10/14 my shoulder was red, itch, pain and swelling part of my arm. Went to ER at hospital. After couple lab test they told me I have reaction to the vaccine, which they call "cellulitis". They admit me to the hospital with pain medication and antibiotic. Stay at hospital for couple day (2 days). Go back to my medical doctor because still painful and red, the doctor told me that is reaction to the pneumonia shot, so give a time. Well in about a week or two I feel like it I lost mobility on my right arm more and more, so I went to see my medical doctor. She told me again to give a time (11-15-2017). On January 5 2018 I visit my medical doctor and I saw Dr. and she told me that I have adhesive capsulitis and she send the order to see a rehabilitation Dr. (frozen shoulder). I start the rehab 3x weekly. But still pain, and not gain much mobility. On January 25 I went to see my Dr. and he order a MRI on my right shoulder. I went to health system. The report was rotator cuff tear and they send me to rehab 3x weekly. But still pain and not improve to moving so they do the operation on my R shoulder in March and now I'm still do the rehab. Hope to back my normal life and move my shoulder, my arm to touch the sky. By the way in December 2017 I went to visit my family. While I was there on 12/18/17 I have another episode of cellulitis infection. Went to doctor and he prescribe 5 injection of penicillin (one x day).
Received FLUZONE HIGH DOSE vaccine on 9/9/14. She reported on 9/12/14 injection site had erythema and induration of approx 3" diameter. This had resolved when she called, except for bruising.
Starting 3/18, Patient broke out in hives on his face and neck.  Hives continued to appear in the evening for several days. He  took Benedryll and starting taking Claritin, and eventually was prescribed an oral steroid to stop allergic reaction. The day after 1st steroid dose, tingling in his fingers on both hands started. Day2, this toes started getting tingly too. Prednisone stopped after 2nd dose. Allergy meds continue and here we are
Pt complained of sore arm from PPV2s Shot. PHN observed 3cm from shot site a 4cm x 3cm red swollen area. Pt does not believe it to be related to bandaid. Pt complained arm was more sore the day before. Flu shot was also given without event. Pt said arm felt better today.
"COVID 19 Arm" Hot and itchy at the site of injection 7 days after injection.
Patient given second booster (0.25ml) on  4/29/22 at 09:12am that was drawn from a vial of Moderna that was opened the previous morning on 4/28/22 at approximately 08:50am. Patient was observed for full 15 minutes and departed - discovery of error occurred while patient under observation and left after observation period with no reported symptoms or side effects.
He was given the Covid 5-11yr old vaccine. I contacted RN and she said it should be fine just monitor for any side effects and notify mom. Mom was made aware.
Pt was given the incorrect vaccine, Pt was given quadracel which is for ages 4-6
Patient called County Health Dept to report sore, red, swollen, itchy area size of 50 cent on left arm where she received varicella immunization. On 12-20-05 at RCHP, onset today at 0900. Has applied hydro-cortisone cream. Denies rash, hives, itch on rest of body. 12-22-05 PC to pt red area now pink, no itch, less sore.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache".  Additional information: Patient called-in saying that she received the 1st dose of our COVID 19 vaccine on 29Mar and currently has a headache. She is asking if it's okay to take Tylenol. Her 2nd dose is scheduled on 19Apr (exactly 21 days apart).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
As soon as she did the injection I can feel the med going into my arm and it started tinging and I stayed for the 15 mins and then my hand and arm started feeling numb. During the 15 mins I was waiting I ask the guy do this suppose to happen and he said that after the 15 min way, it should go away.  An then the next day my hand was still hurting and the next I called my PCP and said, nothing that we can do. An then I waited and I called a doctor friend at Clinic and take Claritin because it was itching and so he said to try calamine lotion. It seemed to help but I would still have the numbing feeling. It felt like nerve damage. So I called Dr. and she gave a prescription for  Betamethasone Dipropionate  cream USP (Augmented). It has helped but it is still there on my arm. I can only use it for 2 weeks. It has only been a week. So, we will see what happens.