chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of administration to asthmatic was received from a pharmacist, concerning a ten year-old female patient, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Narrative: Symptoms: Headache  Treatment:  ACETAMINOPHEN 500 MG ONCE
I had a rotator cuff repair done in February and I had my first vaccine I was a little tired but that was it.  When I had my second vaccine about seven weeks after my surgery I had a really adverse reaction in my surgical shoulder where the rotator cuff repair was done. My right shoulder swelled up and I lost the ability to really even use my right arm it took about five days for me to regain function in that arm.
broke out in severe hives; booster; peeling; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2), administration date 11Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: REMICADE. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Sep2021, outcome "unknown", described as "booster"; SKIN EXFOLIATION (non-serious) with onset Sep2021, outcome "not recovered", described as "peeling"; PRURITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "itching"; URTICARIA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "broke out in severe hives". The events "peeling", "itching" and "broke out in severe hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, pruritus, urticaria. Additional information: Subject was patient assistance. Patient (wife) received the booster (3rd dose) and three days later she broke out in severe hives. She got the booster on 11Sep2021 and was still peeling, itching, and breaking out with hives. Patient was on Remicade and waited 13 weeks after the booster to get her Remicade when she normally gets it every eight weeks. Patient was very miserable and had seen three doctors to no avail. Patient needed to talk with someone that could direct her to what she needed to do to get well. Patient was told to take benedrill.  The lot number for bnt162b2 was not provided and will be requested during follow up.
positive covid-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional. A 29-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733, Expiry date was not reported),  via an unspecified route of administration, administered in left arm on 12Apr2021 11:30 (at 29-years-old)  as dose 1, single for covid-19 immunisation in the hospital. Medical history included irritable bowel syndrome (IBS) and onion allergy. The patient's concomitant medications were not reported.  The patient previously took Junel for birth control. The patient did not receive any vaccine within 4 weeks prior to covid-19 vaccine administration. Prior to vaccination, the patient has not been tested for covid-19. On 13Apr2021, the patient experienced headache, loss of taste, cold like symptoms, stuffy nose, runny nose and sore throat. It was reported that the patient tested positive for COVID 19 via rapid test on 17Apr2021 at 6.30pm after exhibiting loss of taste and "cold like" symptoms earlier in the week after receiving the first dose on Monday 12Apr2021. These symptoms included chills, stuffy nose, runny nose, sore throat and headache. Laboratory test on 17Apr2021 included SARS-CoV-2 test (rapid test) and result was positive. There was no treatment received for the reported event. Outcome of the event was reported as not recovered.  Follow-up attempts are possible. Further information is expected.
All of his joints ached, they hurts so bad.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (All of his joints ached, they hurts so bad.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced ARTHRALGIA (All of his joints ached, they hurts so bad.). At the time of the report, ARTHRALGIA (All of his joints ached, they hurts so bad.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided.  Treatment information was not provided.
6 pm 2/10 I started experiencing severe chest pain. I went to the ER for the pain (no cardiac history). They did all the cardiac tests which were negative and administered morphine for the pain (not effective) and then fentanyl which was effective. I was admitted overnight and discharged at 2pm the following day (2/11). The attending cardiologist could find no explanation other than the vaccine. Although I felt fairly good in the morning (the pain had subsided after the fentanyl administration the previous night) I was tired and went to bed when I got home.  Almost immediately severe chills started with violent shaking for several hours, followed by vomiting large amounts three or four times. About 7pm when I attempted to get out of bed to use the bathroom, I fell on the floor as I could not support myself. I was unable to get myself up due to extreme muscle weakness. My wife had to call my stepson to come over to help get me back into bed. A couple of hours later I tried to get out of bed very carefully and at that point I was able to stand with no problem. There then were no further symptoms other than headache. The following day (2/12) I felt much better but spent the day in bed. 2/13 I was up much of the day but still felt somewhat weak and tired. 2/14 (today) I am still much better but somewhat tired with slight malaise.
Information has been received from a registered nurse concerning a 67 year old female patient with arthritis, chronic obstructive pulmonary disease (COPD), osteoporosis, hypertension, hypercholesterolaemia and no known allergies who on 02-AUG-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# 665307/1171Y). Concomitant therapy included LIPITOR, allopurinol, MOBIC, hydrochlorothiazide and potassium chloride. On 02-AUG-2010, within 24 hours of receiving ZOSTAVAX (Merck), the patient developed an injection site reaction described as "red, raised, the size of a fifty-cent piece". Nurse further reported that the patient called the health department today ("20-AUG-2010") to report that she had developed a single pustule on an unspecified wrist at an unspecified time subsequent to the vaccination. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was not reported. Follow up information has been received from the registered nurse concerning the 67 year old female with arthritis, chronic obstructive pulmonary disease, osteoporosis, hypertension and hypercholesterolaemia and a history of kidney stone, fibromyalgia and chickenpox who on 02-AUG-2010, at 12:30, was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (also reported as VARIVAX (Merck)) (lot# 665307/1171Y) into the right deltoid. Concomitant therapy used at time of illness included tobramycin drops 3% for conjunctivitis. On 12-AUG-2010 the patient developed local reaction of right deltoid of injection, which was the size of egg, red, raised, itchy and warm that lasted for 5 days. She also developed 2 pustules on right wrist, 2-3mm in size with duration of 12 days. The patient had titer drawn prior to administration of vaccine and the titer results were positive. The patient had no recent exposure to chickenpox or shingles. The patient reported her pain to be 7-8 on a scale of 1 to 10. No photos had been taken. No specimen was collected and no direct antibody was done. At the time of this report, the patient had recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the registered nurse who confirmed that the patient was vaccinated ZOSTAVAX (Merck). Additional information is not expected.
Admit for COVID pna. Fully vaccinated. Treated with steroids, updrafts, vit-c, vit-d, zinc, singulair, rocephin and doxy, remdesivir. Improved and discharged with HH.
Severe rash underarms with redness and puss draining from rash. Also experienced chest pains and chest pressure especially at night.
Client came in for school shots at 12:13. Parent had given consent to bring child in for vaccination. She received Tdap and meningitis vaccine. Client sat for a few minutes after getting vaccines. Later left with guardian to go up front to pay for vaccine. Client was standing by guardian then all of a sudden fell to the floor and hit back of head hard. Client was given ammonia inhaler and then taken to exam room vital signs monitored 12:45 96/62, P 70, Temp 98.4, O2 sat. 99, 12:50 102/65, P 78, 12:55 110/66, P 78. Applied cold compress to back of neck, monitored for any neurological changes. Instructed guardian to notify parent of incident and take to hospital for further follow up. No neurological changes noted client stable left at 1:10.
Patient was given immunization and reported "not feeling well" and becoming pale in color after administration.  Patient was instructed to lie down for 30 minutes, eat, drink and ambulate prior to leaving the clinic.
A male patient under the age of 18 was administered Moderna's COVID-19 vaccination; A spontaneous report  was received from a nurse concerning a male patient under the age of 18 who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, a male patient under the age of 18 was administered Moderna's COVID-19 vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 7 Jan 2021, the nurse reported the Moderna COVID vaccine was given to a patient under the age of 18. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, a male patient under the age of 18 was administered Moderna's COVID-19 vaccination, was considered resolved on 4 Jan 2021.; Reporter's Comments: This case concerns a male subject under the age of 18 who experienced a non-serious unexpected event of Inappropriate age at vaccine administration.  There were no reported AEs associated with this case of Inappropriate age at vaccine administration.
unconfortable red rash on face with slight pores on edges; itchy; This case was reported by a other health professional via sales rep and described the occurrence of red rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th June 2019).   On 7th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, 7 days after receiving Shingrix, the patient experienced red rash and itchy rash. The patient was treated with triamcinolone. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: Th patient received dose of Shingrix and 1 week after had red rash on face was not blistering or painful but it was uncomfortable with slight pores on edge. 3 weeks after vaccination, the rash was itchy and has not resolved. The reporter consented to follow up.
A report was received from a health care professional on 10/24/2003, concerning a 32 year old female vaccinee who was pregnant when she received Fluvirin on 10/22/2003. On 10/22/2003, the vaccinee received Fluvirin and subsequently reported she was approximately 5 weeks pregnant when vaccinated. No adverse event was reported at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Client  recieved Twinrix by mistake No reported side effects  Unable to reach parent via phone
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date. Per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. There is no further follow up needed with the patient.
On March 22, 2021, I began to develop a few spots on my upper thighs. When I awoke the next morning, many appeared on my upper arms and several new spots on my upper thighs. As the day went on, they began to move down my arms and legs. I went to the urgent care. They gave me a steroid shot. The next day, the rash continued to spread to my hands and feet and the spots were growing in diameter. The rash has yet to appear on my face, neck, trunk, or back.
Extreme fatigue lasting a week. Vax site feels as if it has "been harpooned".
Allergic Reaction, tongue swelled; Allergic reaction; A spontaneous report was received by a consumer concerning a 20-30-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction, tongue swelled (swollen tongue).  The patient's medical history was not provided by the reporter. Concomitant product use was unknown.  On an unknown date, prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.  The reporter stated that on 23 Jan 2021 at 5:30 PM he was informed that his friends fiance had an allergic reaction shortly after receiving a dose of Moderna's vaccine (mRNA-1273). The patient's tongue swelled, and an EpiPen was administered.  The patient was then taken to the emergency room (ER) for monitoring.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, allergic reaction, tongue swelled, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
@ 1.5 hours - bottoms of feet felt like they're going to sleep @ 5.5 hours - 99 degree fever with chills and aches @ 7.0 hours - 100 degree fever with more chills and worsening aches @12 hours - 101 degree fever with shaking, chills and aches - took 650 mg acetaminophen  Chills, aches everywhere, sore muscles, sweats and chills all night - took 650 mg act. very 4 hours  Day 2 Am -Chills, aches everywhere, sore muscles, didn't want to move and start of headache. Noon - Bottoms of feet still feeling like they were going to sleep. Worsening headache Pm - 102 degree fever,  dizzy with movement, bad headache despite act. every 4-6 hours, some nausea Second Night - Hot and cold spells all night
I have had psoriasis since i was little. I have been on otezla for 5 years now and it is the only thing that made my symptoms subside. After getting the vaccine while still taking my medication for my condition it came back on the scalp and has not subsided at all. It is an autoimmune disorder.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Caller was an Office Manager. There have been no power outages that would have impacted the Moderna vaccine. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022. Thus, they considered need to treat this issue as a temperature excursion. No adverse event was reported.
pt recvd vax 1st & 2nd dose of vax 14APR93 & 14MAY93 respectively; 26JUN93 pt had LMP & became pregnant; during the pregnancy took pre-natal vitamins; during 6month exp lower abdo pains; 4APR94 delivered a full term 6lb 10oz male apgars 9/9
Patient denoted that she had not yet had the COVID vaccine. Vaccination itself went without issue. Upon attempting to bill for the administration, a third party rejection indicated she got the J&J vaccine already. I confirmed this using the immunization registry that she received this on 3/13/21. Patient has been notified she is not to receive another dose.
A non-serious spontaneous report of administration of expired dose of FLUMIST was received from a health professional concerning a child older than five years of age. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 19-Jan-2010. On 15-Nov-2010, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
I received my 4th Bivalent booster on 09/29/2022. On 11/10/2022 my Flu symptoms started in the morning around 08:00AM. I felt weak and I fell down on the floor while waking up. I had low blood pressure. After 1 hour I called the EMS  and they took me to the emergency room. They prescribed me with TAMIFLU for 5 days and lots of liquids since I was dehydrated. On the 3rd day of the medication I was feeling better than before.
This spontaneous report was received from a nurse concerning 2 unspecified patients (demographics unknown). On 05-OCT-2015, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot# L012034; expiration date: 07-APR-2017)(dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday; Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday. Itchy and it hurts and is swollen; Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday. Itchy and it hurts and is swollen; Large red quarter size bump at injection site which has grown to size of fifty cent piece since yesterday. Itchy and it hurts and is swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308a) via an unspecified route of administration in the left deltoid on 11Oct2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and PCN (penicillin) allergy. Concomitant medications included hydrochlorothiazide/ telmisartan (TELMISARTAN HCTZ) 40-12.5 mg (milligram) for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy.  On 11Oct2021 at 16:00, the patient experienced large red quarter size bump at injection site which had grown to size of fifty cent piece since the previous day of report. It was itchy and it hurt and was swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large red quarter size bump at injection site which had grown to size of fifty cent piece since the previous day of report, itchy and it hurt and was swollen was not resolved at the time of the report.   No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via other manufacturer and described the occurrence of hives in a 64-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. After vaccination with FLUARIX QUADRIVALENT the patient experienced large severe hives on the side that the shot was administered. Later it spread to other side. Hives lasted on an off for 3 weeks.
Bruising; Warmth; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising), VACCINATION SITE WARMTH (Warmth) and VACCINATION SITE SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruising), VACCINATION SITE WARMTH (Warmth) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE BRUISING (Bruising), VACCINATION SITE WARMTH (Warmth) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided by the reporter.   Patient reported that she had delayed site reaction one week after injection. No treatment information was provided.