chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1045:  Pt reported feeling itching, slight redness noted to bilateral arms.  No hives noted.  Pt agreeable to be further assessed in procedure room. 1048:  Pt brought to procedure room.  BP 129/49 HR 63 SpO2 97%.  Pt reported feeling anxious and reported hx of anxiety.  Pt rubbing on her face and arms and reports itching behind knee and ears.  No hives observed, breath sounds clear to auscultation, no angioedema noted, pt denies SOB.  Will monitor. 1053:  VS updated.  BP 116/53 HR 62 SpO2 97% RA, no changes in itching.  1056:  Pt also c/o flushing, states she feels hot.  Pt offered wet wash cloth.   1057:  Pt continued to c/o pruritis and flushing, skin around face is red.  I have called Dr. and informed her of pt's complaints.  While on the phone pt also complained of nausea and abdominal pain, Dr. was informed. Orders in process, provider will be ordering benadryl 50 mg IM.  Pt to be monitored for one hour post benadryl, and Dr. to be given an update of pt's symptoms after 30 minutes. Pt does have a ride, states her mother is outside in the parking lot.   1103:  Orders received.  Benadryl 50 mg IM given to left ventralguteal.  Pt tolerated well.  Pt called her mother and informed her, she will be leaving and coming back after an hour.   1120:  Pt reported feeling sleepy, pruritis and nausea are improving, pt continues to have flushing, abdominal pain, headache.    1132:  Pt reported all symptoms are improving.   1137:  Called Dr. to inform her of pt's status.  Per Dr., ok to discharge patient in 30 minutes if she is feeling better and symptoms have resolved, she will be putting in an order for benadryl pt may take at home, pt to be instructed if she develops any rash, SOB, throat or tongue swelling or difficulty breathing pt to call 911 or go to nearest emergency room.  Read back completed.  1145:  Pt observed repositioning in bed.  Pt reports h/a 1/10 on scale, denies itching, abdominal pain or nausea, flushing or any other complaints.   1213:  Pt was sleeping in bed, easily aroused, pt reported feeling well, just sleepy.  Denies any other symptoms.  Given ER precautions. Pt has called for mother to come and pick her up.  Awaiting for her to arrive.   1215:  VS updated.  BP 131/56 HR 72 SpO2 98% RA.  1220:  Report given to RN.
Patient came in looking to receive a meningitis shot.  The technician administering the vaccine failed to communicate and confirm with the patient which vaccine they were receiving and they ended up getting a COVID shot when they were supposed to receive the meningitis shot.  After the injection, the patient stated they had completed the Pfizer 2-dose series back in June at another pharmacy, so this was the third COVID dose they had received.  We contacted Pfizer for guidance and there was no information/recommendations currently out for patients who inadvertently received a third dose.  They advised the patient to monitor for any adverse reaction and to follow up with their healthcare provider as needed.
Swelling on the left bicep area: red, raised, painful, warm, fever and chills. Patient returned for the PPD reading and informed us of the swelling and pain to her left upper arm. Ice pack wrapped around her arm. Keflex Rx (1 TID #30) given to patient.
COVID vaccine breakthrough case. Moderna 2/18/21 023M20A, 3/18/21 002B21A, 12/3/21 012H21B and Pfizer bivalent 10/5/22 GJ6665
Left upper arm (site of MENACTRA) showed redness, warmth, tenderness, swelling - 2-2-12. Right upper arm (site of Tdap) - minimal chgs.
administration of the second dose of Shingrix after a patient had treatment with antibodies for Covid-19 diagnose.; This case was reported by a pharmacist and described the occurrence of covid-19 in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (unknown). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called regarding the administration of the second dose of Shingrix after a patient had treatment with antibodies for Covid-19 diagnose. The reporter did not consent to follow up.
Information has been received from a physician and gynecologist's office manager, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with no known drug allergies, who on 22-APR-2009 was vaccinated intramuscularly with the first dose of GARDASIL (lot # not available). On 28-JUL-2009, the patient received the second dose of GARDASIL (lot # not available). In August and September 2009, the patient experienced urinary tract infections. On 23-NOV-2009, when the patient went to receive her third dose, she found out she was pregnant. A urine beta-human chorionic gonadotropin test was performed. The third dose was not given. The patient was referred to a gynecologist. The gynecologist's office manager reported that on 16-DEC-2009, the patient had a therapeutic abortion. The reason for the elective procedure was not specified in the chart. This was the patient's first pregnancy. Last menstrual Period was on 05-OCT-2009. There were no serious criteria (patient "in and out"). The outcome was unknown, as the patient did not return for follow up visit. Additional information has been requested.
Site pain, fatigue, chills, aches of muscles and joins.  Resolved in 48 hours
Case number PHEH2013US024852, is an initial spontaneous report received from a nurse on 26 NOV 2013. This report refers to a patient of unknown gender of unknown age Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308301) intramuscularly on an unknown date, which was exposed to temperatures down to 1C on 25 NOV 2013. No adverse reaction was reported following this administration error.
Patient reported itchiness and a small rash after the vaccine. They went to the doctor's office for an unrelated matter and the PA that saw the patient said she had cellulitis, they didn't prescriber her anything and told her to put ice and take Benadryl.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. No demographic information was provided. LIQUID PEDVAXHIB (lot number not provided) was improperly stored. The improper storage started on 29-DEC-2012. The improperly stored LIQUID PEDVAXHIB may have been administered to an unspecified number of patient on unspecified dates. No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008945, 1307USA008946, 1307USA008947 and 1307USA008949). Additional information has been requested.
heart palpitations and racing heart started soon after vaccine - a few days later, irregular heart beats/palpitations consistently throughout the day and would frequently happen during sleep.  This continued quite heavily for 3 weeks-  I was extremely tired and out of breath.  After 3 weeks, the irregular heart beats would come and go during different times of the day.  This lasted over 2 months, when I consulted my general practitioner (DO).
Arm swelled, hot red swollen spot 6"x6". Fever 101.9, extreme body aches through early 11/5/11. 100 fever, reducing body aches 11/5. 11/7 spot reduced to 4x4, still swollen, rash looking.
Patient complained of numbness in lower extremities and lower abdomen. Was admitted to hospital on 9-15-2018 with diagnosis of Guillan Barre Syndrome. Discharged from hospital on 9-25-2018 and transferred to Rehab.
Patient received 5 immunization shots and later found weak and complaining of not feeling well. Noted by MA pale and cold. Code blue called. Pt awake & alert but noted to be lethargic told to lie down. Presently a little color and VS as recorded. C/L = clear. Heart regular rhythm. Neuro = no ? except lethargy.
allergic reaction to a Tdap vaccine (probably an Boostrix) after giving birth; She had troubles to breath; patient´s throat closed out; This non-serious case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   The patient's past medical history included delivery.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced allergic reaction (Verbatim: allergic reaction to a Tdap vaccine (probably an Boostrix) after giving birth), difficulty breathing (Verbatim: She had troubles to breath) and throat constriction (Verbatim: patient´s throat closed out). The outcome of the allergic reaction, difficulty breathing and throat constriction were unknown.   It was unknown if the reporter considered the allergic reaction, difficulty breathing and throat constriction to be related to Boostrix.     It was unknown if the company considered the allergic reaction, difficulty breathing and throat constriction to be related to Boostrix.   Additional Information: GSK receipt date: 19-MAY-2023 The nurse from a pediatric office reported that a patient delivered her baby and after that she received on the hospital, a Tdap vaccine (probably a Boostrix) and suffered an allergic reaction.  She had troubles to breath and her throat closed out.  Nurse and patient were concern about the newborn child and wanted to know more safety data about Pediarix first dose on infants whose mothers had allergic reactions to Boostrix. No other information was available at the moment of the reporting because health care professional (HCP) worked from a pediatric office. The reporter consented to follow up.
patient was accidentally administered YF-VAX as a IM injection instead of a Sub-Q injection with no reported adverse event; Initial information was received on 05-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 18 years old male patient who was accidentally administered yellow fever vaccine - [Yf-Vax] as a im injection instead of a sub-q injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-May-2023, the patient received a dose of 0.5 ml of suspect yellow fever vaccine - (Solution for injection) (Frequency : Once) (lot UJ818AA, Expiry date: 31-Jan-2024) (strength unknown) via intramuscular route in the left upper arm for Immunization.  On 01-May-2023 the patient developed a non-serious event of patient was accidentally administered yf-vax as a im injection instead of a sub-q injection with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of yellow fever vaccine - .  Action taken with yellow fever vaccine (Yf-Vax) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was accidentally administered yf-vax as a im injection instead of a sub-q injection with no reported adverse event.  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.
Worsening heartburn. I already had heartburn prior to the my booster dose of the Covid vaccine but I noticed the heartburn got a lot worse a few days after ? which could have been linked to another factor, but when I called the doctor to figure out what I could do since I could feel the stomach acid going up my throat, she asked if I?d recently had a viral infection. I said no, but I did get a booster Covid shot. She didn?t say whether she thought they were linked though.
Myalgia Narrative: Per nursing report: "called today 9/30/2021, to report adverse events after receiving her first dose of Moderna vaccine received on 9/29/21. Employee complains of body aches."
tested positive for COVID-19 despite being vaccinated; tested positive for COVID-19 despite being vaccinated; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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 "recovering" and all described as "tested positive for COVID-19 despite being vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for COVID-19 despite being vaccinated. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
neck arthritis is really bothering her; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (neck arthritis is really bothering her) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Hypertension and Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, METOPROLOL for Hypertension.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRITIS (neck arthritis is really bothering her). At the time of the report, ARTHRITIS (neck arthritis is really bothering her) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Starting the day after the vaccine (02/04/2022) I started experiencing  pain at the injection site, muscle aches, swelling, itching at the injection site. Also, I had a fever of 101. So, I called the doctor last Thursday and they told me to take 2 extra strength Tylenol. They told me to wait 2 hours to see if it came down and it came down to 98. I made an appointment for yesterday (02/10/2022) and he looked at my arm and explained that most people's swelling of their arm after the vaccine goes down. However, mine did not and it also involved the right side lymph nodes on my neck, which he contributed to the vaccine. He told me to take aleve or advil, and ice it but it hasn't improved much. He told me it could be the ingredients in the vaccine that I am allergic to but I am unsure.
Arm soreness, large area of redness around site of injection painful and warm to the touch, swollen left armpit, fatigue for 2 days, headache, body aches
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received FLUARIX quadrivalent. On 10th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 10th October 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details provided were as follows: This case was reported by the patient herself. The patient experienced soreness at the left arm (injection site). The patient has denied permission to contact their physician. The caller stated that, she did not wish to receive mailing of safety report.
Left arm redness and swelling around site.  Site warm and hard to touch.  Redness all the way to the shoulder and down to elbow.
started with chills, slight fever, went away after about 3 days, and then a hoarse cough like he needs to clear his throat, currently been 7 days and teen continues to cough about 15 times per day. Is this normal? doesnt seem to bother him much? Is this something to worry about?
Day 2 after the injection I suffered a massive migraine and I started to experience terrible pain under my left arm pit. The pain is still there 5 days later. The doctor advised to report my experience..
Delayed 2.5 inch circular red rash around the injection site; rash was red; red area was a little warm to the touch; red area was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Delayed 2.5 inch circular red rash around the injection site), VACCINATION SITE ERYTHEMA (rash was red), VACCINATION SITE WARMTH (red area was a little warm to the touch) and VACCINATION SITE PRURITUS (red area was itchy) in a 38-year-old female patient who received mRNA-1273 (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE RASH (Delayed 2.5 inch circular red rash around the injection site), VACCINATION SITE ERYTHEMA (rash was red), VACCINATION SITE WARMTH (red area was a little warm to the touch) and VACCINATION SITE PRURITUS (red area was itchy). At the time of the report, VACCINATION SITE RASH (Delayed 2.5 inch circular red rash around the injection site), VACCINATION SITE ERYTHEMA (rash was red), VACCINATION SITE WARMTH (red area was a little warm to the touch) and VACCINATION SITE PRURITUS (red area was itchy) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Med Info Agent: Moderna transfer case.  Caller said she received a vaccine 8 days ago, 22apr21, and she had a red spot on her arm.  Caller said she had a 2.5 inch circle around the injection site.  Callers first dose was on 22apr21, LOT#044B21A.  Caller said she had the Covid virus in late december, early january.  Caller said her rash was red, a little warm to the touch and a little itchy.  Caller was  concerned because the rash was delayed by a few days after the injection.
Patient received bivalent Pfizer dose for second dose in primary series, instead of receiving monovalent Pfizer dose
@ 430AM on 21JUL92 pt awoke to eat & MOC states body stiffened extremities became jerky, eyes rolled back in head; lasted approx 5 sec then stared into space for several mins; seen by MD;
Within approx 5 min of receiving FLUMIST, patient felt heart racing and was "hot". Face flushed. 2 hrs. later had "really sore lungs" and had pain under sternum. Was healthy the day she received the mist. By 11 pm had deep cough, fever and sore chest and achy. Had to miss work. T. in am - 100.3 by report. Emesis from FLUMIST x 1.
Left axillary and clavicle lymphadenopathy, large, painful, and erythematous
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with PNEUMOVAX 23, intramuscular which underwent a supported temperature excursion. The concomitant medications were not reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Systemic: Confusion-Medium, Additional Details: Husband reports patient asked for groceries from grocery store when they had not been in a grocery store. She began opening drawers and searching for grocery bags. Husband almost called police because she was so severely agitated.
Admission Date: 8/19/2022 Discharge Date: Aug 22, 2022  PRESENTING PROBLEM: Delirium [R41.0] UTI (urinary tract infection) [N39.0] Acute cystitis without hematuria [N30.00] COVID-19 [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 88 y.o. female with past medical history of dementia, bed bound at baseline, hypertension, presented to the emergency department from assisted living with chief complaint of fever and fatigue, rectal temperature was 38.6° with mild tachycardia of 101 which has improved with Tylenol, workup was significant for positive COVID-19 PCR, and urinalysis was positive for white cells of 22.7 and red cells 25.5 with moderate leukocytes and negative nitrite.  Blood cultures and urine cultures were sent. Urine cx grew resident flora. Patient was given 1 dose of IV Rocephin after which abx were d'ced.    Chest x-ray showed atelectasis without focal infiltrate.  CT head showed mild atrophy and moderate white matter changes with findings of old infarct in the left basal ganglia without acute abnormalities or hemorrhage.       She briefly required 1-2 L oxygen but quickly weaned off. She discharged home without incident.
VERY SICK; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20221257837 and 20221257738.
Patient develop a rash all over the body on 8/4/22. Mother administered Children's Benadryl. Rash lasted for 3 days and resolved.
LOCAL RED, WARM AND INFLAMMED REACTION ON LEFT ARM, SHOULDER AREA.  ITCHY RASH ALSO ON SHOULDER AREA.
2 inch red, itchy spot on arm showed 8 days after vaccination.  Fading on day 10 after vaccination
Headache/ shooting pains in head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/ shooting pains in head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache/ shooting pains in head). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/ shooting pains in head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Fever of 99 degrees, severe chills and shaking, extreme fatigue, headache, some muscle aches especially at base of neck; lasted until 6a next day and still feel mild cold but not severe chills as did.  Took 2 Tylenol at 5:10p and 8:40p on Nov 29 and at 3:10a Nov 30, which has not totally worn off so unsure if symptoms will recur or still exist.  It is less than 24 hours since injection.
Very large red warm and swollen spot on right thigh. Measured 3.5 x 2.5 inches. Advised to give Benadryl and apply cool compress. MMR and DTAP given in right leg.