chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area was small to work in with paperwork, supplies, and vaccines on table. One area of vaccines for COVID booster shots, one area of vaccines for Afluria, and one area of vaccines for Fluzone High Dose.  Grabbed supplies and vaccines (Afluria and Fluzone High Dose) and then administered to patient, under impression that one vaccine was Fluzone High Dose and one vaccine was COVID booster. When writing time for booster, nurse noticed that there were still all COVID boosters present and nurse realized she grabbed the wrong vaccine and she had given the patient one regular flu vaccine (Afluria , L arm) and one high dose flu shot (Fluzone High Dose, R arm), and booster was not given. Patient was monitored for 45 minutes. Took temperature of patient and it was 97.9 degrees F, caregiver took O2 saturation 94%, and heart rate was 92 beats per minute. Patient was responsive and talking, alert (voiced a need for diaper change to caregiver). Tried to call primary care provider's office, but provider was not in. Contacted Care Home manager to report incident and followed further instruction. Provided caregiver with the flu vaccine information sheet to monitor for side effects and further monitored patient as noted above. Caregiver was informed of incident.
I had a scratchy throat when I went to get my covid booster on 12/2/21 but I had no other symptoms. The following day, 12/3/21 I had rapid progression of sore throat and hoarseness. Late 12/3/21, I developed significant noisy breathing and difficulty breathing/chest tightness. I went to the emergency room and was given steroids, which helped my symptoms. It is unclear if this is related to the vaccine and having some underlying existing infection, but I have never had an event like this while sick.
Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    Concomitant Medication use information was not provided by reporter.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 25th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
102 fever; sicker than a dog; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via Social Media.  This case involved an adult patient of an unknown age and gender who experienced 102 fever (pyrexia) and sicker than a dog (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient got a flu shot years ago and had 102 fever (pyrexia) and was sicker than a dog (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events were reported as unknown.  There will be no information available on the batch number for this case.
slight cough, lips tingling right after shot, then back pain and discomfort, headache  4 hours later, then next morning - extreme fatigue, nausea, then through the day - brain shut down, slept all day, extreme pains throughout body like being stabbed and twisting the knife, convulsion like movements from pain, couldn't eat or drink. Didn't feel better until next morning. That was the worse experience I've ever been through. This was my second vaccine. I reacted to the first vaccine also, but not with such pain.
LITTLE RED MARK AT INJECTION SITE; DIARRHEA; BODY ACHES; STOMACH ACHE; NAUSEA; TIREDNESS; HEADACHE; LIGHT HEADED; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  Non-company suspect drugs included: paracetamol (caplet, oral, batch number: 2GE1525C expiry: 31-JAN-2015) 500 mg, 2 times every 1 day, from 13-APR-2021 for headache; and ibuprofen (caplet, oral, batch number: 9DE2742A expiry: 31-JAN-2021) 200 mg, 2 times every 1 day, from 13-APR-2021 for body ache, and headache. No concomitant medications were reported.  On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced burning during injection. On 13-APR-2021 07:00, the subject experienced headache. On 13-APR-2021 07:00, the subject experienced tiredness. On 13-APR-2021 13:00, the subject experienced stomach ache. On 13-APR-2021 13:00, the subject experienced nausea. On 13-APR-2021 17:00, the subject experienced diarrhea. On 13-APR-2021 17:00, the subject experienced body aches. On 14-APR-2021, the subject experienced little red mark at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and burning during injection on APR-2021, and had not recovered from light headed, headache, nausea, stomach ache, little red mark at injection site, body aches, and tiredness. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-MAY-2015, the patient was treated for a severe vesicular outbreak, which was diagnosed as  shingles. The patient was prescribed acyclovir and gabapentin for management of his painful symptom and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested. This is an amended report, primary reporter was added.
Chemosis, Angioedema, Acute urticarial symptoms, generalized itching, Periorbital Edema. Information received 11/06/00 indicated that the pt recovered.
pt c/o fever 101 & diffuse body aches starting w/in 24 hrs of vax; no upper resp tract sx, NO GI sx;
1st Dose Administered was Moderna and the 2nd Dose Administered was Pfizer
Chills; Fever; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated no improvement after taking paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information received reporter contact details updated.
Received Pfizer booster vaccination at approx. 1200.  At 8pm began to have red, raised rash to both anterior thighs with itching.  Rash and itching lasted approx. 5 days, spreading to slightly larger area on ant. things.  Slowly resolving since then.  Used over-the-counter creams on rash.  Denies shortness of breath, difficulty breathing, facial swelling, generalized rash or any other symptoms.    Janssen vaccination give on 6/13/21
A 43 year old female pharmacist reported that she received an injection of tetanus toxoid adsorbed, purogenated on 05/23/2001. On 05/24/2001, she developed a fever. On 05/25/2001, she developed a red wheal at the injection site.
Information has been received from a physician concerning a female friend in her 20's who on unspecified dates was vaccinated with the first and the second doses of GARDASIL (lot numbers not provided). Within the last year (in 2009) the patient experienced one lymph node under the arm in which the vaccine was given. The node was removed as an outpatient. A biopsy was performed and the result was benign. The patient fully recovered on an unspecified date. There was no serious criteria. This is one of several reports received from the same source. No further information is available.
Pt reports arthralgia. The most recent info was received from the infectious disease specialist on 04/16/2001. This physician considered the arthralgia to be moderate in intensity and possibly related to LYMErix administration. The arthralgia persisted as of 03/13/2001. As of 03/28/2001, the pt's serologies have continued to remain negative. The adverse event of arthralgia does not meet serious criteria, but is being submitte as an expedited report by special FDA request per the June 28, 2000 letter.
Pt received FLUZONE HD on right deltoid area. PNEUMOVAX 23 shot on left deltoid area. Left deltoid (hand) area, swelling, warm to touch, itching and started spreading by the office. Note: Pt received flu shot only every year in past without adverse effect.
Vaginal bleeding/uterine shedding about 10 days post 1st and 2nd vaccination. The vaginal bleeding was inconsistent with my cycle. I confirmed by my OBGYN this was a side effect from the COVID-19 vaccine. I was trying to get pregnant at this time and lost 2 months of potential conception due to an irregular period and ovulation.
Headache, low-grade fever, rash, weakness, fatigue, stuffed up sinus, sinus pressure, sore throat, drainage, earache
Red rash at injection site occurred on 11/6 (48 hours after shot).  Treated with Zyrtec and it went away.  Appeared AGAIN on 11/13 in the same spot with bumpy skin.  Treated with Zyrtec.  Bumps went away but it's still hot and red.
puritic rash onset approx. 7am on 11/11/07, seen at Bloomington Hospital ED at 1:20pm 11/11/07, Decadron injection, Medrol Dose pack and Vistaril po.  Dx:  erythema multifomre and allergic dermatitis
Received Pfizer vaccine second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine second dose) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine second dose). On 03-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter  No Treatment was provided by the reporter.
Significant pain at injection site, mild swelling, interfered with sleep, pain in shoulder joints.   Started acetaminophen morning after injection at 10.30.  Took every four hours and at bedtime. Slept well last night and pain diminished in morning. Continuing acetaminophen second day and pain is diminished.  I feel much better.
Site of shot swelled and was painful for first 24 hours, then went away,  shot was on Friday morning, on the following Sunday blood sugar, as keasured by Dexcom G6 monitor rose up in the morning, by 11:00 am went off the monitor scale which stopped at 400. I had taken my normal Lantus 55 units at 10:00am, normally would take 14 units Novalog at then same time, I took 36 units, then waited to 3pm to see if numbers went down, they leveled at 200-225, then took 10 units Novalog, waited until 6 pm, leveled to 180, took additional 10 units,  ate a light meal, at 7:30 pm, BG at 140,  held off more insulin, Until 10:30, BG at 125 which is my norm usually. By Monday morning all BG back to my normal, with no further complications. Started  Ozempic med, 2.5 mg at 11:00 first time, no complications or discomfort. No further suer high BGs after that. 2nd Medena shor scheduled for February 12, 2021
had neuropathy (tingling) in left shoulder and left thigh; had pox scattered on the body /pox as "bumps."; (tingling) in left shoulder and left thigh; This case was reported by a nurse via call center representative and described the occurrence of neuropathy in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), raised rash and tingling. On an unknown date, the outcome of the neuropathy was not recovered/not resolved and the outcome of the raised rash was unknown and the outcome of the tingling was recovering/resolving.   It was unknown if the reporter considered the neuropathy, raised rash and tingling to be related to Shingrix.  Additional details were reported as follows: The case reported by the patient herself. The patient received 2nd dose of Shingrix vaccine and couple of days later she had neuropathy (tingling) in left shoulder and left thing. She also had pox (bumps) scattered on the body. The patient stated that tingling was getting better on the left thigh and but the left shoulder and pox was in the same condition. The patient noticed the adverse event the couple of days after receiving the 2nd dose of Shingrix. The reporter gave the consent to follow up with the Health care professional, however, she did not have fax number or an email address to health care professional. The provided her personal email address. The reporter did not have the following information, lot number, expiration date and dose of Shingrix. The reporter consented to follow up.
Before vaccine I did take Benadryl and took my advice 500 inhaler concerned about previous anaphylaxis. I was fine in observation and about 1hour after my heart started racing and I became flushed with hives on my chest and mild difficulty breathing. My mother is a nurse and I had her stay with me and took 50mg more Benadryl and my albuterol inhalers and breathing issues subsided  and  I went to sleep for about 4 hours. When I woke up my heart rate was fine, flush was gone but I still had mild hives. For the next 4 weeks I have had hives on and off and itching. I have had this happen before during almond harvest but never this time of year. I am currently breast feeding and hives have resolved everywhere except for my chest.
Local reaction erythema, progressed and radiated from injection site, warm to touch. Pt. followed at urgent care. Keflex 500g, D20 x 10 days - Cellulitis
Muscle spasms in legs & feet; hives & rash around neck; migraine with heavy sweating.
Sore arm; headache; fatigue; chills; foggy headed; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Feb2021 at 10:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to amoxicillin family. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jan2021 at 09:30 as a single dose for COVID-19 immunisation.  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 02Feb2021 at 10:00, the patient experienced sore arm, headache, fatigue, chills and foggy headed. 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 for the events pain in arm, headache, fatigue, chills and foggy feeling in head were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Approximately 4 months post vax the pt developed herpes zoster/shingles. Follow up states that on an unspecified date the patient recovered. No further information is expected.
I got the second shot and I was feeling good. I was actually in a walking contest and I walked 18 miles the day I got the shot and 18 miles the day after. The third day I walked several miles but after that I kept sleeping. I lost my smell and taste. On Wednesday, Thursday and Friday I slept pretty much all day, like 20 hours a day. I got like a tickle on my throat type of thing. When I would go to sleep I would get a bad cough. Then I went to sleeping from 20 hours a day to not being able to sleep at all. On Sunday I called my son who is a doctor and he said he would like to take my vitals so I did. He got concerned and he told me to go to the hospital right away. They did a Covid test and I do not remember what other tests because I was pretty far gone. Looking at my paperwork it says they did Sputum culture, Blood culture, Urine culture, Basic metabolic, CBC, Hepatitis C, C reactive protein. I was admitted with pneumonia.  I think I had Covid or a reaction to a reaction, but they told me it was just pneumonia. I recovered from the pneumonia but I still have acute  diarrhea since February but I blame the antibiotics.
WENT THROUGH HELL FOR A WHILE AFTER VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 went through hell for a while after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of went through hell for a while after vaccine was not reported. This report was non-serious.
Pt recv vax & pt's mom reported that the pt devel a red bumpy rash on the arms 1wk following vax;no further details were provided;
This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. The pharmacist reported that on 16-JAN-2014, the patient received a dose of ZOSTAVAX (lot # J007857, expiration date: 28-SEP-2014) (0.6 ml, once, subcutaneously left deltoid). The patient received a dose of ZOSTAVAX that had been reconstituted with Sanofi Pasteur saline diluent. She (the pharmacist) stated that she was "busy", and she grabbed a diluent for a yellow fever vaccine; she stated, "The labels of Merck diluent and the Sanofi diluent were so similar, I didn't notice until I was documenting the vaccination after it was administered." The diluent that was used was NDC# 49281-912-01, lot # UH380AB, expiration date 15-MAR, and the volume was "between 0.5 and 0.6 mL" of 0.9% saline solution. The patient had not any adverse effect. Additional information has been requested.