chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gout attack/gout flare up, it lasted a week then went away but came back worse after that; Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose; arm pain/Soreness for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout attack/gout flare up, it lasted a week then went away but came back worse after that) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout attack.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain/Soreness for 2 days). On 23-May-2021, the patient experienced GOUT (gout attack/gout flare up, it lasted a week then went away but came back worse after that) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose). The patient was hospitalized from 23-May-2021 to 26-May-2021 due to GOUT. The patient was treated with CELERY SEED EXTRACT at an unspecified dose and frequency; BETULA LENTA (CHERRY FRUIT) at an unspecified dose and frequency and APPLE CIDER VINEGAR for Gout attack, at an unspecified dose and frequency. On 16-May-2021, PAIN IN EXTREMITY (arm pain/Soreness for 2 days) had resolved. At the time of the report, GOUT (gout attack/gout flare up, it lasted a week then went away but came back worse after that) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose) outcome was unknown.            No concomitant medication was reported. Patient got back gout, a condition he only experienced once before in his life. The patient claims that he also experienced a sore arm.  Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # 026621A and with no associated AEs.   This case was linked to MOD-2021-201425, MOD-2021-246801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional events and updated treatment medications.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # 026621A and with no associated AEs.
No treatment. Seen at clinic on 2/19/16. Redness and warmth noted from right deltoid to shoulder area. Last seen on 2/24 and redness resolved.
Gave Patient MMRV Proquad, which is not indicated for under 4 years old.
She got the vaccine and started feeling sick, got a rash on the arm at the site of the vaccine the size of an egg, started getting bigger with itching and head in the area.  She had a temperature that went to 100.8.  Then the rash started getting bigger, longer.  She took Ibuprofen for the symptoms.    They lasted for 2 days or more, and then went away.  The arm was red and took a while to go away.
pt recvd vax; pt devel local reaction manifested by swelling, redness & tenderness of her left deltoid;
My sinus infection symptoms started on 12/12/2022 in the morning at around 08:00AM. I had a runny nose, and nasal drip. The next day on 12/13/2022 I had the same symptoms but I had pain around my eyes. On 12/14/2022 I had a sore throat. On 12/17/2022 I woke up without a voice and I also had cough. I felt really bad that morning. I called my doctor and scheduled an appointment. On 12/19/2022 at 10:00AM I went to my doctor's office she said I had an upper respiratory infection so, she prescribed me with amoxicillin for 7 days.
On Thursday Oct. 1st, I answered the clinic phone for a "question about vaccinations" per front desk. The phone call was from mother. She reported that she brought her 16 year old daughter to hospital for "immunizations." Mother reported that daughter was given Hepatitis A, HPV, and Meningitis vaccine at about 5pm on Tuesday 09/29/09. Mother commented " they talked to me into getting the meningitis one." She said that daughter got "dizzy" right away and had commented that she felt the meningitis shot "in elbow." Mom reported that daughter said her knees hurt on the way home and was rubbing her knees and legs in the car. Mother took daughter to the ER at around 9pm. She said that daughter was "delirious", she "couldn't walk or talk" and her "eyes were rolling back in her head." Mom denies fever, respiratory distress or seizure activity in her daughter at that time. Pt was admitted to hospital on 09/29/09 and kept for 24 hours while "tests" were run. Mother stated that doctor was called in "consult" and that her daughter's MRI showed "fluid in the brain". Her symtomology resolved spontaneously according to her mother, "going backwards" with the last symptoms resolving first and finally the pain in legs, knees, and her arm resolving. Mother said that doctor told her this could only happen if the meningitis vaccine had been give "direct IV". At this time mother is mainly concerned because daughter's arm bled and she didn't know if that meant the shot went into her vein or not. I reassured mother that bleeding from the injection site after an immunization is not uncommon and does not mean that the vaccine accessed the vein. She seemed to be calmer after that, talking a little slower and with less emphasis. I told her I would check with my superior and call her back. Discussed the reaction with PNP. She suggested I file VAERS report and encourage mother to do the same. Called mother at home and asked if she still had the VIS sheets given at time of daughter's vaccinations. She did, I asked her to look at the back of the sheet under number 6 (What if there is a severe reaction?) and 7 (How can I learn more?). I told her I would be filing a VAERS for the three vaccinations daughter received on 9/29/09. Mother said she "knows" it was the meningitis vaccine. I encourage her to file a VAERS as she sees fit. At this time I asked her how pt was doing today and she replied, "Oh, she's back at school. That girl is tough as nails and never gets sick, that's why we were so scared the other night". I told mother I would be calling to follow up on pt. 10/2/09 (Fri pm). Called mother to see how her daughter is doing. Mother reports daughter is "fine" and tonight is homecoming and she has to run and "get stuff". Gave mother the number of the clinic as well as my name and number and told her to call us if any other untoward reactions occur for daughter. 12/8/2009 ED records for 9/30/2009, patient with c/o's dizziness, loss of balance and slurred speech.
Redness & swelling noted at 20 hrs after vaccine. Fever started 48 hrs after vaccine administration with worsening of local redness.
A non-serious spontaneous report of expired FLUMIST was administered was received from a health professional concerning a 41-year-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received expired FLUMIST on 04-Oct-2011. FLUMIST expired on 01-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
diagnosed with pneumonia; This is a Spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient (consumer) of an unspecified age received BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medication included cefalexin (CEPHALEXIN AMEL). Transferring agent stated, she got diagnosed with Pneumonia two days ago and she was also scheduled to have the second dose today. So, she wants to know if she can still have the second dose even though she got diagnosed with Pneumonia." When clarified the concern, consumer stated, "Yes, she wanted to know if she can still get her second dose today as now, she was on antibiotic, Cephalexin." It was reported that, she was due to receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine today. However, she said that 2 days ago, she was diagnosed with pneumonia on an unspecified date, but tested negative for Covid-19. She also mentioned that she was currently taking antibiotics. Consumer wants to know if it was still advisable for her to receive the 2nd dose despite this. Outcome of event was unknown.
fever p/12hr;local erythema, tenderness, warm to touch p/18hr;
Slight disorientation, dizziness. BP 133/79 (pulse 59).
Information has been received from a nurse practitioner concerning a female who was vaccinated with the first dose of GARDASIL vaccine (yeast) IM in her arm. The patient experienced a rash after receiving the vaccination, but did not notify the nurse. The rash went away without treatment after 1 week and it was not known where on the patient's body occurred. Additional information has been requested.
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up information received includes non-significant information updated.
Subsequent to receiving vax, the pt developed a body rash. The reporter indicated that the rash resolved spontaneously. This is 1 of 3 pts who had an adverse experience following receipt of Prevnar.
pt recv vax 29JAN96 & 1APR96 IgG titer was 0.08;no further details were provided;
transferred from an outside hospital  # COVID, 1st diagnosed 10/14 Likely represents continued shedding of virus.  Will touch base in the morning to discuss removing isolation.
about an hour after injection, i noticed a bitter taste in the back of my throat and upper back toward tonsils and is still there for now.  i am fine.. i just wanted you to. know it has that side effect. i plan to get the second part of the vaccine.
Severe asthma attack...had to do 4 lung treatments and steroids and Benadryl and symptoms took a full 48 hrs. to subside
Pain and swelling (R) thigh. Refusal to bear weight x 24h then lingering for at least 2 more days.
HCP was called to a patient with "tongue swelling".  HCP asked MD for an Epi Pen and the paramedics are O2. O2 was applied at 2L per NC. . HCP approached vehicle where a 68yo white male was sitting in his vehicle on the driver side. Quick assessment revealed erythema of the face and angioedema. Pt was able to speak clearly, was CTA and had RRR. 911 was called. BP 160/90.  EpiPen dose 1 was injected into right vastus lateralis and pt reported improvement at 1057.  HCP asked for injectable diphenhydramine. HCP continued to monitor pt with RRR and CTA but erythema and angioedema began again along with swollen tongue so EpiPen dose 2 was injected into right vastus lateralis. 50mg IM diphenhydramine was injected into the right deltoid while fire rescue began to arrive on scene. Pt did not report difficulty breathing. Pt did report previous anaphylaxis to fire ant bites/stings and did report being allergic to bee stings. Fire rescue transported patient without difficulty. HCP called pt later that night at 2030 who reported doing better but still having tongue swelling.
Both calves are very sore. No edema. Not warm to touch. I woke up 6 days after the booster with these symptoms. I have not done anything new as far as walking, or exercising. I have used Aspercreme and Extra strength Tylenol. This is day number 2 of symptoms. Not bad enough to be concerned to see my Dr.
08/21/06 phone call from parent. States onset began 8/16/06, worsens 3 days ago. C/o pulling sensation in arm left and into chest/ Parent state bruise to injection site but no redness or swelling. Feels a "man in the arm". Has been taking Tylenol with some relief. PHN advised see PMD today. Parent called back this am and reports pt has appointment today with infants and children. Also she called previous PMD (out of state) and last TD was in 2005. We have no record of this.
One week after vaccine at 9 am I felt a rash on my arm it burn it was hot and then I had abdominal pain spasm on my stomach on Feb 24 I stayed home from work. My intestines were hurting I was inflamed Brain fog and vertigo I had to quit work because it hasn't stopped and went to the doctor and said my IBS flared up. I went to the ER and the doctor  there advised to wait on taking 2nd dose for right now. In the ER they did a CT scan but they didn't see anything big.
Physician ordered Hep B, medical assistant administered Adult Td in error. Administered to 9 mos. old vaccine intended for ages 7 yrs and above.
1st dose received on 12 Apr 2018, 2nd not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 12th April 2018.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose received on 12 Apr 2018, 2nd not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 The reporter reported that a patient received first dose of Shingrix but then never received the second dose.  The reporter stated that the consumer intended to receive the second dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility is the same as primary reporter for 1st dose. The reporter consented to follow up.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On 21-APR-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with a dose of GARDASIL intramuscular (dose, anatomical location or lot # were unspecified). Later, on 06-OCT-2015, the patient was vaccinated with another dose of GARDASIL intramuscular (dose, anatomical location or lot # were unspecified); additionally the reporter informed that the patient was going to receive another dose on 15-DEC-2015 (inappropriate schedule of drug administration). No concomitant medications were reported. No adverse effects were informed. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID: (Unknown). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) and all described as "product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered". Additional information: The reporter clarified that patient was a Pharmacist, provided only as unknown type of Healthcare professional by inbound transfer agent. The reporter clarified that they had administered a couple of Pfizer Covid-19 Vaccine, gray cap formulation, to patients that were past the beyond use date. The reporter did not confirm the number of patients, however, it was more than one patient. She wanted to know if the vaccines were still viable or not. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Follow-up (09Aug2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Additional information: Query: Dear colleagues, Morning: Regarding case Report Number #, AER number 202201045242 & 202201046437, in initial source, the reporter stated "two shots" were given, and in follow-up source, narrative stated only one patient received "a couple of" shots. Could you please confirm if only one patient received the shots? Thanks so much. Please see below screenshots and source document for your information. Additional Context: Warm transfer from (Name withheld) with a caller on the line who is an unknown type of Healthcare professional. She has Pfizer Covid-19 Vaccine, gray cap administered a couple of vaccines to a patient that is beyond use date. She wanted to know if vaccines are still viable or not. Caller clarified that she is a Pharmacist, provided only as unknown type of Healthcare professional by inbound transfer agent. Caller clarified that they have administered a couple of Pfizer Covid-19 Vaccine, gray cap formulation, to patients that were past the beyond use date. She wanted to know if the vaccines are still viable or not. Response: Good Morning, After reviewing call recording, transfer agent provided that they administered a couple of Covid 19 vaccines to a patient. This was documented as provided. Caller confirmed that they have administered a couple of Covid 19 vaccines to patients. Caller declined to complete a report for the patients. Caller did not confirm the number of patients, however, it was more than one patient. Kind Regards, (Name withheld); Sender's Comments: Linked Report(s): US-PFIZER INC-202201045242 same reporter/drug/event, different patient.
Pt recvd 3 doses of Engerix-B vax on 15APR91 & 15MAY91 & 15OCT91 & 13NOV91 titers were checked & a value of 0.8 was obtained; pt was a non-responder;
-Following the vaccination, client became ILL + had a Emesis. at no time was the clients breathing compromised. I assisted with a Emesis bucket + cool compresses to the client forehead. The Emesis was full of food + other liquids.  -TX: I Made sure Client was safe at all time + did take vitals, following (Vitals: 2:30 114/68, 64, 20, 97.8/ 2:45 110/64, 68, 18, 97.6 LOC: A&O x 3.
Patient developed swelling and pain in arm with redness. Headache. first noted evening of injection. Seen in office 2/15/2002. Arm Swollen red, warm, swelling extently to upper forearm. T 98.76. treatment: Tylenol, Apply ice to area, Medrol dospack18 Feb 02-swelling resolved.
He said he and his whole family got these vaccines and they were sick all the time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "He said he and his whole family got these vaccines and they were sick all the time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200130513 same reporter/drug/event, different patients;US-PFIZER INC-202201394111 same reporter/drug, different AE/patients.;
This case is linked with the case# 2012-08034 (0). Initial information received from a health care professional on 29 August 2012. A patient (unknown age and gender) whose medical history and concomitant medication were not reported received an intradermal dose of FLUZONE ID vaccine (Batch lot number, anatomical position and dose: not reported) on 27 August 2012. It was reported that the patient who was 1 of the 12 employees had a funny feeling at the time of the injection and later in the afternoon. Also the patient had welts, it was mosquito bite size to 1/2 dollar size and some were red. Laboratory details and corrective treatment were not reported. Outcome of the event was not reported. Documents held by sender: none.