chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient was given FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE, No AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of above 65 years of age who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ441AA, Expiry date 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   It was reported that patient had no concomitant medications and may have pre-existing medical conditions.  It was an actual medication error case due to wrong vaccine administered.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Fever 103- 104 degrees x 3days. Generalized joint pain, dizziness, fatigue, weakness. Pain swelling, redness Lt arm (injection site) from shoulder to elbow lasting 6 days
Vaccine administration error.  The patient is 11 years old.  The Pfizer COVID 19 vaccine is not indicated for pediatric patients under the age of 12.   Mother called and informed to please do not bring the child in for their 2nd dose until the Pfizer COVID 19 vaccine is authorized for pediatric patients under the age of 12.  The patients mother did not report any adverse side effects.
Patient received Hib, PCV, and Hep A vaccines yesterday. She woke up this morning at 0600 and was normal. 0640, she took a one hour nap. When she woke up, her right arm had no movement for 30 minutes and she was trying to use it. She had a large amount of drool under her face when she woke up. She was wobbling her head for a few minutes when she woke up. She has been on TYLENOL and MOTRIN and mother noticed that she seems "drugged" from the medication. She has been acting fine after her episode of not moving her arm.
Comminuted right peritrochanteric fracture of the right hip. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
fever; headache; body aches; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 6th of six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache, body aches on an unspecified date. The outcome of events was unknown.    information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
Mom reports took child to ER and PMD due to elevated fever, leg pain and back pain, white blood count was 38,000 and sed rate was normal, PMD reports maybe a viral response to Tdap.
Lot  # expiration date had been extended. Vaccine had remained in the freezer until date of administration but was given 4 days past expiration date.  Moderna was consulted and they deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported by the patient.
All info interpreted and understood. VIS given 2/11/04. Crying prior to vaccines given. Asked to sit x 20 min afterwards. Mother and 10 yo sis (rec'd vaccines also-no incident) sat approx 4 ft behind me talking with family. Pt answered-"good," "no" problems when asked. Approx 3:40 pm, heard a noise. Saw mom and sis standing to my L with pt falling to the floor next to them with eyes staring. Sis and mom over face. Sis removed, mom leaned back. Pt was suppine, eyes rolled upward while arms flexed/ hands went to chin (appeared like a seizure). Lasted approx 10 secs-unresponsive to verbal stimuli. Eyes returned forward, responded to verbal stimli, reached for mom. AAO x 3, PERRLA; 4-5 mm, clear speech/ appropriate, MAEW A+342/p approx AHR: 108 bpm, RR 20 bpm BP 118/82. A+340/p AHR + 96bpm, BP decreased 100/58 L. Pt stated she fainted and hti her head on floor. 3:50 p to hospital via ambulance with mother. Admitted to eating breakfast only about 8:30 am; nothing to eat or drink in schol. Pointed to occiput-sm, nickel sized redness/ no swelling. Wrapped ice applied x 10 min. Rested teaching done/ understood by mother, importance of eating lunch and sitting full 20 min.
She stopped breathing and lost consciousness for approximately 15 seconds. As soon as she resume breathing on the floor, her body ceased convulsing. I gave her 2 quick breaths. Firemen arrived at around 12:10pm.
Syncope, vertigo, nausea, fever- started approx 24 hrs post vaccine. Syncope, vertigo, and nausea lasted approx 6 hours. Low grade fever was gone by morning. Headache off and on for 3 days, last time Saturday morning. Severe arm pain- swollen, red, hot to the touch, knot in arm and bruising. Sharp pains from area, hurts to raise arm, currently ongoing. Have been treating with ice and ib profen, little relief.
I developed a red area the size of my palm. The area was raised, red, surrounded by a rash and sore to the touch. It hurt to move my arm. The soreness, hot to the touch and raised area lasted for 4 days. I still have a red area and a rash. It also itches. I developed a severe headache and low grade fever in the next morning that was on going for about 3.5 days.
General malaise beginning evening of vaccination. Patient was unable to leave bed for 3 days. No rash. Fever, fatigue, chills, nausea, headache, and a cough. Patient experienced adverse reaction after receiving first vaccination as well. Aching from head to toe.
Feels like pinched nerve; Muscle spasms in arm; Lost sense of taste; This is a spontaneous report from a contactable consumer.  A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications included B12 and probiotic (unspecified) for an unknown indication, started from unknown date, had taken within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 04:00, the patient woke up with muscle spasms in arm, feels like pinched nerve and lost sense of taste. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle spasms in arm, feels like pinched nerve and lost sense of taste were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shingles; Severe fatigue; Weakness; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 15Apr2021 at 10:00 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation in pharmacy. The patient was retired registered nurse, no other medical history and concomitant medications were reported. Family medical history was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) or any other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date, the patient experienced shingles. On 15Apr2021, the patient experienced severe fatigue and weakness. The event shingles required a visit to physician office. The clinical course of the events was reported as the patient was a retired registered nurse, stated got the Pfizer Covid vaccine on 15Apr2021 and one week later she developed shingles, states she just wanted to report this, knew it had been a topic of concern. Patient stated she spoke with her doctor on 23Apr2021, symptoms had started prior to that, about 7 days after the first dose of the vaccine, exact date unknown. The doctor put her on Valtrex first, could not tolerate this medication, did not have product information at this time, no further details provided. She then started Acyclovir, 800mg five times a day by mouth, finished this medication yesterday 03May2021. Patient stated she was terrified to get next dose, scheduled for Thursday (as reported). Stated her doctors assured her that it was okay. No relevant tests were reported. The seriousness and causality assessment were not provided. The outcome of the event shingles was not resolved and recovering from the other events.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of VAQTA (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
All of the following symptoms lasted for a minimum of 4 days:extreme fatigue, headache, muscle pain, chills, joint pain, fever as high as 101.8, nausea, feeling very unwell, difficulty breathing off and on. I have also been experiencing dizziness and being very unsteady on my feet which is now into its 5th day.
Soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm of the injection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the arm of the injection). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm of the injection) had resolved. Not Provided          Action taken with mRNA-1273 moderna vaccine with event was not applicable. Concurrent medical conditions included Diabetes and Heart disorder. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-041113, MOD-2021-041113 (Patient Link).
Pt received DTaP #5, IPV #4 (2 IPV, 1 OPV previously) after one hour developed redness and pruritis to ears, scattered development of hives on face, neck, anticubital and right foot and 1-2 on trunk. No respiratory difficulty. Benadryl 2 tsp-resolution after 20 minutes.
I couldn't move around because I was in pain; stomach is still bothering me; still has slight chills; still has fatigue; Myalgia; my joints were hurting; Vaccination site pain; very thirsty; My stomach was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (I couldn't move around because I was in pain), ABDOMINAL DISCOMFORT (stomach is still bothering me), THIRST (very thirsty), ABDOMINAL PAIN UPPER (My stomach was hurting) and CHILLS (still has slight chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced THIRST (very thirsty), ABDOMINAL PAIN UPPER (My stomach was hurting), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia) and ARTHRALGIA (my joints were hurting). On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is still bothering me), CHILLS (still has slight chills) and FATIGUE (still has fatigue). On an unknown date, the patient experienced PAIN (I couldn't move around because I was in pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of UNK UNK, q4h; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, PAIN (I couldn't move around because I was in pain), ABDOMINAL DISCOMFORT (stomach is still bothering me), THIRST (very thirsty), ABDOMINAL PAIN UPPER (My stomach was hurting), CHILLS (still has slight chills), VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (still has fatigue), MYALGIA (Myalgia) and ARTHRALGIA (my joints were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant include Vitamins.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The pharmacist report that on approximately 14-SEP-2016 (reported as "six days ago"), the patient was vaccinated with ZOSTAVAX (strength, dosage, frequency and lot# were not provided) and the patient also was prescribed Prednisone (manufacturer unknown) 10 mg, for a pre-existing unspecified medical condition (product use issue). There were not adverse effects reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot# L025205 with expiration date: 07-JUL-2017 (dose and route of administration were not reported) or lot# M002062 with expiration date: 12-JAN-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 08Dec2021 as dose 3, (booster), single (Lot number: FJ8726) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "chronic gut issues" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: Jun2021; TRAZODONE, start date: Sep2021; PROGESTERONE, start date: Jan2018; LIOTHYRONINE, start date: Jan2020; PSEUDOEPHEDRINE, start date: 01May2022; OLIVE LEAF EXTRACT, start date: 29Apr2022, stop date: 16May2022; N ACETYL CYSTEINE, start date: 25Apr2022; VITAMIN D3 K2, start date: Jan2001; LIPOSOMAL VITAMIN C, start date: Jan2020; B COMPLEX SUPREME, start date: Mar2022; CULTURELLE, start date: Jan2020; MUCOSA, start date: Dec2021; CETRIZINE, start date: Jun2020; ADVIL [IBUPROFEN], start date: Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received COVID 19 treatment antiviral started on 03May2022, and treatment stopped on 07May2022. Patient had received vaccine and other medication in 2 weeks. The patient had other medication in 2 weeks Zoloft, trazadone, progesterone, liothyronine, advil (ibuprofen), pseudoephedrine (sudafed), olive leaf extract d-lenolate, nac, vitamin D3 K2, reacted multimin, liposomal vitamin c, SBI protect, B suprem culturelle probiotics (culturelle), mega mucosa and cetrizine hydrochloride. Adverse event Relapse of COVID symptoms beginning 2 days after completing Paxlovid treatment. Tested positive for COVID again 3 days after completing Paxlovid treatment', start date on 09May2022 08:00, event outcome was recovering and no received AE treatment. Patient had known allergies with gluten and casein intolerance. Relevant med history reported as anxiety, depression, hypothyroid and chronic gut issues.  No follow-up attempts are possible. No further information is expected.
Significant Tinnitus like I've never experienced. Extremely loud and very concerning. Sounds like a deafening number of cicadas. The sound can be masked by external sounds at times but when it would otherwise be quiet the ringing becomes overwhelming.
positive isolated total core antibody (anti-HBc);   This literature marketed report has been received from the authors of the published article, titled as stated above and refers to a 62 year old male patient with type II diabetes mellitus and insomnia. On an unspecified date, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot # not reported).     On 27-APR-2015, the patient was found to have positive isolated total core antibody (anti-HBc) from his physical checkup. On 21-MAY-2015, the patient received a hepatitis b vaccine (recombinant) (manufacturer unknown) booster (dose, route and lot # not reported) and repeated blood work on 25-JUN-2015 found still isolated anti-HBc. Further blood work in August 2015, including hepatitis B e antigen and hepatitis B e antibody and viral load, verified the patient did not have an active infection. He finished the three dose vaccine series on an unspecified date.  Incidental hepatitis B panel drawn on 23-DEC-2015 found detectable DNA (< 20) with negative hepatitis B surface antigen and positive hepatitis B surface antibody. The outcome of positive anti-HBc was considered to be recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same article (MARRS 2002USA009087).; Sender's Comments:  US-009507513-2002USA009087:
Redness, hives. Treated with BENADRYL, hydrocortisone.
Rash and itching all over body 1. Allegra 180 mg , once a day 2. MethylPREDNISolone Tablets 4 mg,  5 day course Rash and itching is still there
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: itchy on her arms and back - at first she said her throat felt itchy too - took benadryl but felt better
Headache, stuffed head, extreme fatigue (slept for 36 hours w/periodic wakening for urination), muscle pain and weakness, dry mouth with metallic taste, grand malaise.
Left arm from top of shoulder to elbow had intense pain and limited range of movement in the shoulder.
Woke with red, hot, swollen palms & bottoms of feet.  Tongue was swollen and had difficulty talking and swallowing
While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm; While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm; While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: UNDERDOSE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), outcome "unknown" and all described as "While they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm".  Additional information: Pharmacist asking if they will be needing to do another shot of COVID-19 vaccine orange cap to a 5 year-old (patient). Because while they are giving a shot to the patient he moved so much so a little bit of the shot came out of his arm. Pharmacist clarified further that after the injection using Pfizer bivalent orange cap, a little bit of the vaccine mixed with blood came out of the injection site.  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.
No adverse event. Patient's birthday was wrong in chart so she was given Hep A peds instead of adult dosing.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE,
Developed redness, warmth, and multiple hive-like areas within area of where flu vaccine was administered
PAC and cardiac arrhythmias. Persisted for approximately one month post vaccination. PACs occurred 12 times per minute post vaccine
Patient wanted to be vaccinated with the bivalent Pfizer COVID vaccine.  We accidentally ordered the monovalent Pfizer COVID vaccine, and because the vials are nearly identical, gave the patient the monovalent dose instead.
Pt developed a fever of 105 (taken rectally) two hours after the shot. Has cont. to be febrile for 11 day.
FEVER, COUGH, CHEST CONGESTION, NASAL CONGESTION, BODY ACHES
Soreness at site, inflammation, hardening, and pain in left lymph node in lower neck.
Mom reports that patients Rt. arm swelled locally to about the size of a half-dollar and broke out in a hive-looking rash at the injection site, with redness and hard area encircling arm. Mom reports that within 24 hours the swelling increased all the way around the arm and was warm to touch. Mom gave BENADRYL and TYLENOL x 2 days, swelling decreased and rash almost gone now.
"Patient" fainted right after I gave GARDASIL injection. She was only out for a few seconds.
Came in for her 2nd dose of COVID-19 vaccine.  She received Pfizer for dose #1 on 1/26/2021.  The vaccinator administer Moderna for dose #2 in error
Patient received 0.5ml of the (NDC 80777-0279-05) Moderna vaccine for 6 months- 5 years instead of the Moderna Bivalent 0.5ml dose. Since this was the monovalent vaccine at the appropriate dose (still 50mcg) we are waiting 2 months and if the patient still wants, giving the Moderna Bivalent vaccine.
Dx:  cold sore, cellulitis of face Same type of red, itchy rash that extends from shoulder to elbow after vaccinations