chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Morning patient was seen in our office by Dr.  Dr. ordered a Hep B ped/adol and a Hep A ped/adol vaccine, before drawing the vaccine up I questioned why the patient was going to receive pediatric vaccines since she was 18 years and 3 months old. I had asked Associate and we pulled the package inserts for both the HepB ped/adol and the Hep A ped/adol vaccines. In the package insert for the Hep B it stated that it is to be given to patient up to the age of 19 years and the Hep A ped/adol was to given up the age of 18 years. So Associate and I came to the conclusion that the patient should be receiving the Hep A adult vaccine since the package insert states up to 18 years of age. I had informed Dr. of the change and that I had T-up the order for her to sign on the Hep A adult vaccine. She said that was fine and went into her office to sign the order while I went into the patients room and administered the vaccines. After I came out of the room Dr. asked for my help because EPIC would not allow her to sign the order. I took a look at her screen and asked her to give me a second to figure out why she could not sign the order. Associate and I then double checked to make sure we read the package insert correctly and gave the health Department a call. Per Health Department Hep A ped/adol vaccine is to be given to patients up to 18 years and 11 months of age. Since the patient was 18 years and 3 months of age she should have received a pediatric dose. The Health Department did inform us that there is no harm to the patient and that when she comes back for her second Hep A dose that as long as she is in the 18 years and 11 months age range she is to receive a Hep A peds/adol vaccine. We then questioned the Hep B ped/adol vaccine and we where told by the health Department that it is to be given to patient up 19 years and 11 months of age. I will file the Red Form and I am filling out a VAERS form for the Health Department. I will also call the patient to inform her on what happened and to assure her that there is no harm to her for receiving the Hep A adult vaccine.
2 days after Varivax and Gardasil vaccine, had redness and swelling to Varivax site.
Pt was given 1 vial (gray top)of a 2 vial vaccine.  The vial of diluent with strains C,W,Y  was administered without constituting with the orange topped vial of A strain of meningococcal vaccine.  This was discovered on Wed. 11/8/23 when an orange topped vial was spotted in the manufacturers box with out the gray vial.  Printed list of all patients that received Menveo vaccines 11/6/23-11/7/23.  After speaking with staff, found the staff memeber who remembers only using 1 vial of Menveo to administer to pt.
After returning from traveling, I noticed while running, I would be short of breathe.  However while running when in traveling, I could run 2 miles without stopping however now before the 1 mile mark, I would begin to get winded and become short of breathe.
High fever 105.8, all over joint pain, hives, swelling of eyes and lips, migraine headahe, muscle stiffness (cramping). Treatment Motrin, Tylenol, Benadryl, Prednisone.
No adverse event happened the patient was given a high dose influenza vaccine instead of a regular influenza vaccine.
pt recvd vax; whelps on extremities & trunk; itchy;mom denies fever;not fussy or irritable;also denies new foods,clothes etc..; whelps come & go;
This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, frequency and route were not reported) lot # M013156 with expiration date of 15-OCT-2017, for prophylaxis. The temperature of the PNEUMOVAX23 was 47 °F for a time frame of 15 minutes. Also, a prior temperature excursion occurred and the temperature was 50 °F for a time frame of 12 hours. No adverse effects were reported. The excursions were called due to data logger. Additional information has been requested. Follow-up call was placed to the pharmacy technician and answered by the pharmacist. The pharmacist stated that two patients were vaccinated (with PNEUMOVAX23) and provided patient initials, date of birth and vaccination date. Please see MARRS case # 1704USA005193. No further information was available. This is one of two cases. Additional information is not available or expected. Sender's Comments:  US-009507513-1704USA005193.
reported his arm was sore; he had flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: reported his arm was sore) and influenza-like symptoms (Verbatim: he had flu like symptoms).  The outcome of the pain in arm and influenza-like symptoms were not reported.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the pain in arm and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt date: 12-OCT-2023 A reporter reported that his/her father in law got the first dose of shingrix Monday 09 October 2023 and reported his arm was sore and he had flu like symptoms. The reporter did not agree to follow up from GSK.
Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's age, medical history and concurrent conditions were not provided. On or about 23-AUG-2012, at a pharmacy the patient was vaccinated with ZOSTAVAX, (route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 24-MAY-2016, the patient was treated by a physician at a medical center for a vesicular outbreak that was diagnosed as shingles. The patient has been prescribed VALTREX to attempt to manage and relieve her painful symptoms.  As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
w/in 1 1/2hr p/vax pt devel redness of skin & diffuse hives over entire body;
patient was given vaccine and syringe popped off. patient received more then 50% of vaccine. patient was not given another vaccine.
17JAN92 mom called stating because form asked that if pt has to go to MD p/shots call in; 15JAN92 coughing, runny nose, congested, went to MD taking Amoxicillin & PV tussin, t100.2 R feeling better today;
Low grade fever started around between 6:30-7pm the day of the vaccination. I took an Ibuprofen around 7pm and went to bed. By 1am my fever had broken. The next day, 4/13/2021, I had a mild headache from 8am-1pm. I took another Ibuprofen and was headache free by 3pm. On 4/14/2021, I had a slight headache, I did not take medication for it, and by late afternoon, it had dissipated. I also have muscle soreness in the arm that I received the vaccination that started the morning after, 4/13/2021, it is still present today, 4/17/2021.
It was reported that a pt (6 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. reportedly sometime after the vaccination the pt develope a local reaction. No specifics were provided. Further information is requested.
This spontaneous report as received from a medical assistant, refers to a currently 18 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9, (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Patient received 1st dose and a VAERS report was created. I notified the child's parents and they wanted their child to receive the second dose. This is the second dose given with approval from the health department and the patient's parents. Patient did not have any adverse reactions to either vaccine.
Covid monitoring documentation. PT admitted 10/24/21 documented to have positive covid. PT received Pfizer 1/11/21 Lot EL0140 for dose 1. Dose 2 was Pfizer given on 2/1/21 Lot EL3302.
fever, shaking chills, body aches, weakness and bad headache. Fever 1/26, was 101-104F. Today 1/27-100.6-101.7F. Was Covid positive  on 1/6/21.
Urticaria BENADRYL 3.5ml PO Q6 x 2 days.
Information has been received from a physician concerning a 67 year old female who on 11-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658207/0883U). In October 2007, the patient developed encephalitis. On 16-OCT-2007 the patient was admitted to the hospital. The patient was treated with steroids and acyclovir. The patient's encephalitis persisted. There was no product quality complaint. The physician considered encephalitis to be immediately life-threatening and an other important medical event. Additional information has been requested.  10/30/07 Follow up initiated at request of CDC.  11/16/07 Reviewed hospital & pcp medical records which also included vax info.  VAERS database updated w/same.  Records reveal patient experienced trouble talking, body aches, weakness, balance difficulty, SOB, malaise & fever x 2-3 days.  Admitted 10/16-10/30/2007 & then to swing bed from 10/30-11/1/07.  LP done.  Had seen her pcp 10/11 w/complaints of LLQ abdominal pain, diarrhea, nausea & back/left leg pain.  Started on oral antibiotics at that time for diverticulitis & received zoster & pneumo vax that day.  On 10/15 left arm very red & swollen w/red streaking by phone & instructed to apply ice.Apparently had word retrieval difficulty beginning 2 days s/p vax. Neuro consult.  Tx w/IV antibiotics & antiviral.  Tx w/steroids & antiseizure meds & transferred to ICU.  PICC & feeding tube inserted.   FINAL DX: Encephalopathy; UTI.
the left shoulder is almost nonfunctional, unable to sleep due to pain all movement is restricted.  sitting, walking, getting out of bed is difficult is this normal? My primary will not see me for another 2 months.
cough; Nausea; Headache; Fatigue; Sore throat; A spontaneous report,  was received from a health care professional concerning a 33Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 21/01/2020,  prior to the onset of the events, the patient received their first dose of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.    On 21/01/2020, The patient experienced the events list nausea, headache with non-serious.  on 22/01/2020, the patient experienced the events like sore throat, cough, fatigue, body ache but not too much with are non serious.    no treatment provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not provided.
Pt complained of one week of foreign body sensation in her left eye (starting 3/26, presented to md on 4/2).  Her boyfriend was vaccinated 3 weeks prior to 4/2.  Her optho exam was completely normal.  She is a CONTACT.  Only boyfriend was vaccinated.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Pain when touching skin and when scratching an itch on the skin-Severe, Systemic: Nausea-Mild, Additional Details: Patient has rash that started on wrist and has spread over her entire body that is itchy and painful. She has experienced some facial swelling, throat soreness, and nausea. No difficulty breathing nor throat tightness.
Very high fever-(mom did not have thermometer), decreased po intake, decreased urination x 2 d, requiring hospitalization secondary to dehydration.
Unusual, unconsolable cry beginning 8 hrs; P/persisting 48 hrs; MD told mom it was an allergic rxn to DTP & should receive DT (PED), t102; 3AUG rash & fever;
About 6 hours after receiving vaccine, I got very tired. Soon after, I had a bad headache and uncomfortable temperature issues (feeling hot and cold). My heart rate seems a little elevated and I am experiencing sensitivity and body aches. I have taken naproxen and acetaminophen. It is now 4 hours since symptom onset and I have not gotten much relief, if any. I would describe my symptoms as moderate.
Severe chills; temperature of 101.5, body aches, fatigue, lasting 24 hours.
The wrong medication never reached the patient.  The patient received Hepatitis vaccine as prescribed.  Outside packaging looks the same.  Both items are ordered in large quantities.  Both items stored in same location in the refrigerator due to space constraints.  Flu vaccine only available from August-March.  Syringes look-alike so even after opening they are not easily distinguished.  All the hepatitis was removed from the packaging and placed into a bin.  All the flu vaccine was bagged into zip lock bags and labeled FLU VACCINE.
Initial report received from a nurse on 01 Dec 2009. This patient (a child younger than 4 years) was vaccinated with FLUVIRIN (batch no: 1008132P) 0.5 ml once, on an unknown date. No adverse event was reported.
PATIENT WANTED OMICRON BOOSTER BUT WAS GIVEN UNDILUTED PFIZER PEDIATRIC ON 11/17/22. MULTIPLE ATTEMPTS MADE TO REACH PATIENT BUT NO RESPONSE. NO KNOWN EVENTS.
Hives on upper & lower extremities x 4 days. Tx oral prednisone & CLARITIN.
severe fatigue with wide spread pain, sore throat , arm pain at injection site, chills,sweating
p/vax pt began burning then approx 30min p/vax began having SOB & tightening of throat;also exp some dizziness & disorientation;called immunizations & was referred to ER for tx;
Information has been received from a physician concerning a female who on an unspecified date was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck). Subsequently the patient experienced a rash around the injection site. Unspecified medical attention was sought. There were no lab tests performed. There was no product quality complaint involved. No further information is available.
Couldn't use thumb; Numbness; A lot of pain; Cannot raise arm above the eye or shoulder level; Outside of the injection site has become hard; I can feel a knot; Needle was inserted way down into the triceps and nowhere close to the deltoid muscle; A spontaneous report was received from a nurse who was a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced needle was inserted way down into the triceps and nowhere close to the deltoid muscle/incorrect route of product administration, couldn't use thumb/ limb injury, a lot of pain/pain, numbness/hypoesthesia, injection site has become hard/ injection site induration and unable to raise arm above eye or shoulder level/ injected limb mobility decreased.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17-FEB-2021., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in her left arm for prophylaxis of COVID-19 infection.  On 19-Feb-2021, She reported that there was an administration error wherein the needle was inserted about two inches above the elbow into the triceps and was nowhere near the deltoid muscle. She stated that the the patient experienced pain in thumb and could not use it, numbness, outside of the injection site become hard, knot and could not raise her arm above shoulder level.    No laboratory details were provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, needle was inserted way down into the triceps, was considered resolved.  The outcomes of the events, couldn't use thumb, a lot of pain, numbness, injection site has become hard and unable to raise arm above eye or shoulder level, were considered unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 030M20A) with  associated AEs reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Polio" (unspecified if ongoing), notes: Polio at age 1; "Psoriatic arthritis" (unspecified if ongoing); "HBP" (unspecified if ongoing); "osteomyelitis in left arm" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: 01Dec2021, stop date: 01Dec2021; OTEZLA, start date: 01Mar2022, stop date: 01Mar2022; SULFASALAZINE, start date: 01Mar2022, stop date: 01Mar2022; HYDRALAZINE, start date: 01Oct2021, stop date: 01Oct2021; METOPROLOL; AVAPRO; PROLIA, start date: 01Jul2019, stop date: 01Jul2019; PRAVASTATIN; AMLODIPINE; CLARID [LORATADINE]; FISH OIL; FENOFIBRATE. Past drug history included: Daptomycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 09Jul2022 to 14Jul2022, lot number: GC8123 for treatment of COVID-19. Completed taking Paxlovid on (Wednesday) 16Jul2022 morning. Tested negative Saturday. Woke up Monday (today) with symptoms (sneezing, chills, headache, congestion) again. Tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe and terrible joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe and terrible joint pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 08-Nov-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced ARTHRALGIA (Severe and terrible joint pain). At the time of the report, ARTHRALGIA (Severe and terrible joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received and contains No new information
PT RECVD INJECTION OF EITHER 5-15 OR 5-17, 1990. PT EXP DIARRHEA, FEVER, HEADACHE, AND FLU LIKE SYMPTOMS.
Costochondritis, slipped disc's at L4, L5, L6 & S1, R/leg radiculopathy, sciatica, R/angle cardiophrenic pericardial cyst. Cyst on heart, nodule on lung that were not there in Apr. 98.  Also slipped disks in back with sciatica & right leg radiculopathy + lock jaw in mouth.
Breakthrough case admission after 3 vaccines Pfizer 4/8/21 Lot# ER8729;  Pfizer 4/29/21 Lot# Ew0176;  Pfizer 11/27/21 Lot # 330308D   THIS IS THE LOT # IN THE STATE'S DATABASE
S/S x 3 days.  Patient noticed upper right arm pain, muscle tightness, pink slightly raised lump on back of upper arm, same location that the Varicella was given on 9/18/08.  Area is also warm to the touch and hurts to touch area.  Denies noticing any concerns after immunizations were given in arm on 9/18/08.  Medication and allergy lists have been reviewed/updated with the patient today.
Patient got 2nd Pfizer vaccine too early, 2 weeks after the 1st shot (date 1st 5/19/21).
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 09-APR-2015 the patient was vaccinated with an expired dose of MMR II which was administered subcutaneously (dose and lot # was not reported). No adverse effects reported. Additional information has been requested.
Patient received the lower dose (6month -4 years) and needs to get the 5-11 year old vaccine. A 2nd shot of the lower dose was given in order to equal a full dose for his age group. Reviewed with physician and, ok'd to give.   Parents were notified of the error and wanted patient to get the full dose. 2nd shot given. Parents verbalized understanding and agree with plan of care.
Within 5 mins of receiving Pfizer kid vaccine (dose 2), patient suddenly turned pale and fainted on the floor. Pt was asked to lay down right after. Pharmacist on duty monitored pt's blood pressure and heart rate every 5 mins and they were within normal range, 110/70 hr 70, 111/69 hr 74, 95/66 hr 70. After 20 mins of laying down, pt raised up to drink some gatorade and then she started fainting again. Paramedic arrived to the scene 10 mins later and provided a check up for patient. Her HR, BP, and EKG were within normal range. Patient felt better after drinking some gatorade and laying down for another 10 mins. Once her skin tone returned to normal and she was fully recovered,  her family decided take her  home for her to rest per paramedic advice
Information has been received concerning a 21 year old female who on 04-JUN-2004 was vaccinated with her first dose of Gardasil (lot 657617/0384U) and her second dose of Gardasil (lot 658222/0927U) on 23-AUG-2007 without any ill effects.  Concomitant therapy included ADVAIR and albuterol.  On 28-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot 659437/1266U) and experienced a full body rash.  She was sent to her primary health care provider.  Additional information has been requested.