chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose on 5 Aug 2021, second dose on 10 Sept 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 5 Aug 2021, second dose on 10 Sept 2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Every two weeks) since an unknown date.   On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 5 Aug 2021, second dose on 10 Sept 2021). On 10-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 5 Aug 2021, second dose on 10 Sept 2021) had resolved.            No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-318336 (Patient Link).
This spontaneous report was received from a physician assistant and refers to a 25 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 07-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1200 hours (50 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA009167:
Pt received 0.5ml Pfizer vaccine when the correct dose is 0.3ml. No adverse symptoms reported by patient or family at this time
Hives itch discolored injection site-red than dark, improved with time and Benadryl by 8/2 rash greatly improved, itch almost gone, injection site still discolored.
Pregnant female vaccinated with H1N1 LAIV.  11/25/09 Immunization record received.   12/23/09 MR received for DOS 11/25/09. Pt presented to ER with N/V. Pt pregnant in first trimester.
Got flu shot 9/26 at 10:37 AM-Developed serious case of hives later in the day- still with me today, 9/30.
Neck stiffness still 7 days after. Muscle pain (severe), fever 72 hours after vaccine. Neck pain still has not gone away
expired dose of Pentacel was accidentally administered (with no reported adverse event); Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 6 months old male patient who was accidentally administered expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination.  On 16-Oct-2023, the patient received 0.5 ml (Dose 3) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ791AB) (Expiry date: 10-Oct-2023) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization.  On 16-Oct-2023, the patient was accidentally administered expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] (with no reported adverse event) (expired product administered) (latency: same day).  It was reported, Caller reporting an expired dose of Pentacel was accidentally administered. Caller with question on whether dose needs repeating. Caller also reporting the shipment was received in MAY 2023 and doses are already expired, caller asking to speak with someone regarding the short expiration dates. This is considered a medication error due to administering an expired dose  Action taken: not applicable.  Outcome: Unknown   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 the 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.
14 yo Female received a second dose of Pfizer 5-11 yo instead of appropriate does of 12 and older.
cold; Fever with temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and PYREXIA (Fever with temperature of 105) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal) and Cholesterol.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced NASOPHARYNGITIS (cold) and PYREXIA (Fever with temperature of 105). At the time of the report, NASOPHARYNGITIS (cold) and PYREXIA (Fever with temperature of 105) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine administered Wed afternoon. By Thursday AM pt had severe pain and stiffness in shoulder. Pain progress to entire arm to max. Pain on Sat and it lessened by Sun. Monday night she got itching to upper arm when injection occurred. With itching was a bright red area like bulls eye around inj. site. 7 days after injection there is a red raised area 5" x7" covering injection area downward to elbow. Pain gone.
Pt was given influenza vaccine and pneumococcal vaccine 3/13/2006 prior to discharge from hospital. He came to the ED 3/15/06 @ 5:39 with a swollen face he was given Benadryl and Prednisone.
Child slept periodically after receiving vaccines on 1/9/13 and throughout the day of 1/10/13 child began vomiting at 10 PM on 1/10/13 after each attempt to feed. Parent gave child 2 oz of Sprite on 1/11/13 at 5 AM and child was able to tolerate without emesis. Child's temp on 1/10/13 PM was 100 degrees F. Same on 1/11/13 at 0930. Child has had 3 wet diapers on 1/11/13 from 5 AM - 10 AM. Child's cheeks are reddened- warm 1/10-1/11/13.
Pt experienced numbness in left face and hand 30 min after H1N1 flu vaccine in 2010. Has not received the influenza vaccine since that event. Reviewed case with 2 neurologists who had differing opinions on whether this was a TIA or not based on documented physical exam from that time, and if it was r/t the vaccine. A 3rd neurologist saw pt and stated that she should not receive the influenza vaccine again. Pt was given the influenza vaccine (AFLURIA, single dose syringe) and was observed for 1 hour. No neurologic events occurred then or within next 24 hours.
Spontaneous bleeding from the mucosa of the underside of superior left eyelid at approximately 130 am.  I awoke from sleep at that time with mattering in my left eye making it difficult to open.  Upon examination in the mirror it was obvious the mattering was due to blood.   The blood was obviously coming from my left eye.  There was no bleeding from my nose.  I had apparently been bleeding for sometime as pooled and clotted blood was also present on my face, arm, pillow, and sheets.   Uncertain exactly how much blood total but I would estimate 20 ml of blood.  The bleeding stopped spontaneously a few minutes after I awoke.  There as an additional scant bleeding the following morning.  I was later evaluated by an ophthalmologist who did identify a small punctuate superficial capillary on the mucosal side of my left eyelid which was thought to be the source of bleeding.  I have not had further events since.
Pt recvd Engerix-B & became very sick following the 2nd vax dose, exhibiting stiff joints & h/a;
10/27/06:  Employee in Employee Health Services to report generalized rash and pruritis and attributes symptoms to receipt of the flu vaccine given 3 days ago. On 10/24/06 employee received the inactivated flu vaccine administered in the Right Deltoid. Employee denied any contra-indications to receiving vaccine. No signs of rash/redness at injection site. Employee noticed rash and itching on noc of 10/26/06 after returning from her Beautician.  Denies respiratory symptoms.  Denies use of new products i.e shampoos, soaps, perfumes.  Employee was referred for further evaluation.
Within 5 minutes developed wheezing and itching. Gave patient nebulizer tx and 2 IV BENADRYL. Symptoms resolved.
p/vax exp a severe episode of asthma;pt hosp for 2 to 3 days;
pt had bilateral conjunctivitis, rash & marked lethargy; t104 R; duration of illness 4 days;
Knots under arm pits that makes it hard to move arm; Knots under arm pits that makes it hard to move arm; Migraine; Body aches; Fever; Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Knots under arm pits that makes it hard to move arm), MIGRAINE (Migraine), MYALGIA (Body aches), PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MIGRAINE (Migraine), MYALGIA (Body aches), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and CHILLS (Chills). On 27-Mar-2021, the patient experienced MOVEMENT DISORDER (Knots under arm pits that makes it hard to move arm) and LYMPHADENOPATHY (Knots under arm pits that makes it hard to move arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 28-Mar-2021, MIGRAINE (Migraine), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved, VACCINATION SITE PAIN (Sore arm) outcome was unknown. At the time of the report, MOVEMENT DISORDER (Knots under arm pits that makes it hard to move arm) and LYMPHADENOPATHY (Knots under arm pits that makes it hard to move arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Information has been received from a licensed practical nurse at a physician's office concerning a 2 month old patient (gender not reported) who, on an unspecified date, was vaccinated with Rotateq. Subsequently the patient experienced diarrhea. Therapy with Rotateq was discontinued. The patient outcome was not reported. Follow up information received from a licensed practical nurse indicated that on 13-MAR-2007 at a pproximately 7:00 PM, the patietn experienced diarrhea and vomiting for one week. the mother refused the second dose of ROTATEQ, feeling it was the cause of the patient's symptoms. Subsquently, the patient recovered. There were no relevant diagnostic tests or laboratory data. No  additional information is expected.
Wrong vaccine given. Patient was expecting varicella and was given zoster (shingles). No adverse or localized reaction.
pt recvd vax & 4hrs later w/diffuse erythematous wheal formation over neck & trunk-face erythematous-extremities clear x/for eczema;resuscitation measured initiated;
I had pain beyond comprehension in my stomach area. I eventually called and had an ambulance take me to the hospital. I had P.E.T scan. C.A.T, X-RAYS , it was discovered that I had a DVT in my stomach. I was put on blood thinners and they feel I may be having a relapse of pancreatic cancer. I have appointments scheduled later this week to see where we go from.
Pt had syncopal episode about 5 minutes after receiving vaccine.  Pt was sweating and dry heaving for a couple of minutes before briefly losing consciousness.  Pt recovered and was fine within about 10 minutes.  Pt stated the same thing happens when he gives blood.
first dose of the Pfizer-Biontech COVID-19 vaccine on Monday (08Feb2021) and tested positive for COVID yesterday (11Feb2021); This is a spontaneous report from a contactable consumer. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date were UNKNOWN), via an unspecified route of administration on 08Feb2021 as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Patient stated that she was vaccinated with the first dose of the Pfizer-Biontech COVID-19 vaccine on Monday 08Feb2021 and tested positive for COVID yesterday (11Feb2021). She is scheduled for her second dose on 01Mar2021. The outcome of the event was unknown. No PQC present.
Muscle weakness; she experienced redness/ covid arm; itching/ covid arm; vaccination site swelling/ covid arm; covid arm/muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), VACCINATION SITE ERYTHEMA (she experienced redness/ covid arm), VACCINATION SITE PRURITUS (itching/ covid arm), VACCINATION SITE SWELLING (vaccination site swelling/ covid arm) and MYALGIA (covid arm/muscle soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), VACCINATION SITE ERYTHEMA (she experienced redness/ covid arm), VACCINATION SITE PRURITUS (itching/ covid arm), VACCINATION SITE SWELLING (vaccination site swelling/ covid arm) and MYALGIA (covid arm/muscle soreness). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), VACCINATION SITE ERYTHEMA (she experienced redness/ covid arm), VACCINATION SITE PRURITUS (itching/ covid arm), VACCINATION SITE SWELLING (vaccination site swelling/ covid arm) and MYALGIA (covid arm/muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-255394.
Pain at the injection site / still comes and goes; Shivering; Lingering arm pain; throbbing pain and sometimes a pain sharp; Redness at the injections tie; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 2XG53, expiry date 12th February 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in September 2020, refer case US2021AMR030448).   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, several hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, shivering, pain in arm and throbbing pain. The patient was treated with cbd. Rechallenge with Shingrix was positive. In November 2020, the outcome of the injection site pain, injection site erythema and shivering were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. On an unknown date, the outcome of the throbbing pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, pain in arm and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received 2nd dose in right arm. The patient had lingering arm pain following the second dose and experienced pain at the injection site a few hours following the injection. The pain resolved a little but it still comes and goes. It was a throbbing pain and sometimes a pain sharp. It was not present all the time. It presented 4-6 times a week.  The patient also had redness at the injections site that resolved after about a week.  The patient experienced shivering either the night of the vaccination or the next night. He could not remember. It lasted a few hours.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR030448:Same reporter
got a cortisone shot a few weeks ago and now his back is killing him again; nauseous; weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BACK PAIN (got a cortisone shot a few weeks ago and now his back is killing him again) and NAUSEA (nauseous) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (weak) and NAUSEA (nauseous). On an unknown date, the patient experienced BACK PAIN (got a cortisone shot a few weeks ago and now his back is killing him again). At the time of the report, ASTHENIA (weak), BACK PAIN (got a cortisone shot a few weeks ago and now his back is killing him again) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-029597 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029597:Husband case
Within 24 hours patient reported having a rash that she described as a little bigger than a 50 cent piece. At this time she reported no other symptoms. We reached out to the patient again on 7/17/19 and she reported the rash as spreading. She states that it feels hot, is red and is starting to itch.
Shaking  chills for several hours the first night.  Slight fever for ~24 hours.  Nausea, fatigue, ache in lower back (kidney area), and injection site (right upper arm) for ~36 hours. Hydrated prior to vaccination.  Took over the counter Aspirin and nausea medicine until symptoms abated.
Red boils on right arm, rash on inside of left and right legs rash on face, neck and stomach.  Lasted for 14 days.
A couple days after the third shot, I had swelling in my left arm pit and a rash on my chest. The swelling went away after a week and the rash has gradually decreased. I went to the doctor on 10/18/2021 and was diagnosed with Guttate psoriasis a couple weeks after the swelling went away.
partial dose being administered to a patient instead of a full dose; A spontaneous report was received from a pharmacist concerning a unknown patient of an unknown age and gender, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "partial dose being administered to a patient instead of a full dose".  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection.  The pharmacist reported that about a partial dose was administered to the patient instead of a full dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event,"partial dose being administered to a patient instead of a full dose" was considered as resolved on an unknown date.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # Unknown.  There were no reported AEs associated with this case of Incorrect dose administered.
did get COVID; did get COVID; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did get COVID".  Clinical course: Reporter stated, know people who are not immunized and are in the hospital right now, also know people who are fully immunized and did get COVID except their symptoms are quite mild. Okay, so getting the vaccine will not prevent you from getting Omicron but it will prevent you from getting terribly ill. And yes, I know people who had gotten terrible ill who are not vaccinated. Reporter stating causality as related to events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, COVID-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
We had a vaccine reaction today at pharmacy 1870. Patient signed up vaccine online.   I saw on her form that she had a reaction to vaccine. , and discussed the vaccine reaction with her.  She said she had hives to influenza vaccine five years ago, but had influenza vaccines every year since including 2020 without incident.        I gave her the vaccine (Janssen) and almost immediately she said she felt tingling in her arm.  I had her sit in site of my gatekeeper for the vaccines.  In less than 5 minutes, she was swelling and red in the arm and it crossed over to her chest neck and the other arm.  She asked for a benadryl tablet and we complied, but the swelling continued to get worse. We immediately called 911 and the paramedics arrived in about 5 minutes. They gave her iv benadryl and transported her to hospital for observation.  Employee followed up with patient this afternoon.  She had been released from hospital and is doing well.  She was very pleased that we called to ask about her well-being.
right arm a little swollen, arm pain, right arm hurt to move, felt like pinched nerve, could hardly lift anything.... achy body and also some feverishness. symptoms began later that evening, peaked Saturday, and patient said doing much better today (sunday, less than 48 hours later)