chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates in 2016 (reported as "since 29-AUG-2016"), the patients received improperly stored doses of  (lot # M002063, expiration date: 12-JAN-2018; lot # M004328, expiration date: 26-JAN-2018; lot # M009768, expiration date: 23-FEB-2018; lot # M014309, expiration date: 21-MAR-2018; exact doses and route of administration were not reported). It was reported that the administered doses of VARIVAX were improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Follow up information was received on 19-DEC-2016. All telephone attempts to obtain follow-up information had been unsuccessful. Sender's Comments: US-009507513-1610USA011133.
Patients dad came in with his 10 month old for immunizations and had no record of immunizations in immunization site. Dad had no previous immunizations from any where else.  Dad had said the child needed  Polio and Tdap., I should have rechecked when the father said that and realized the Tdap was not right it was Dtap  . It  should have been investigated more and rechecked it was late in the day and we were short staffed. I will make sure this doesn't happen again .
I had the booster shot 10 04 2021.   Shortly after, I'm not sure exact time or date, I started noticing symtoms of tinnitus.    I now have a constant noise in my ears.    It sounds like I'm in a field of trees with locusts.   The sound is constant.   I have never had this problem before.   The symptoms have increased over the past couple of weeks.    I didn't have any idea the vaccine and tinnitus could be related until I started searching tinnitus and stumbled on the possible connection.   All of my vaccines were Pfizer, UTMB 2 21 21, 3 14 21 and 10 04 21.    Regarding below, I don't have any idea if this is permanent or otherwise.   I hope not.   It is a significant problem.
Felt like the flu; Dry cough; Loss of voice; Bed ridden; couldn't lift her arm/couldn't move her arm; arm was killing her; arm was sore; Muscles aches; Joint ache; Head throbs; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden) and MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (a year ago).   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden), MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm), LIMB DISCOMFORT (arm was killing her), PAIN IN EXTREMITY (arm was sore), MYALGIA (Muscles aches), ARTHRALGIA (Joint ache) and HEADACHE (Head throbs). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden), MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm), LIMB DISCOMFORT (arm was killing her), PAIN IN EXTREMITY (arm was sore), MYALGIA (Muscles aches), ARTHRALGIA (Joint ache) and HEADACHE (Head throbs) outcome was unknown.            Concomitant medications were not provided. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow Up information was received on 24-Aug-2021 and contains new events.
Patient reported that 2 hours after receiving injection, his eye started getting very red and painful along with throat irritation.  He reports that he took Ibuprofen and Zyrtec and symptoms resolved shortly after.  He denies any rash, redness at injection site, wheezing, shortness of breath or chest pain.  Notified Medical the next day.  He was then given Claritin and Zantac to take daily for one week
lost voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), METFORMIN, INSULIN GLARGINE (LANTUS), LIRAGLUTIDE (VICTOZA) and PIOGLITAZONE for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced APHONIA (lost voice). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency. At the time of the report, APHONIA (lost voice) had not resolved. Not Provided          Action taken with respect to mRNA-1273 was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Additional information provided that patient needed to took a deep breath for the voice to come out and states that the symptoms were ongoing. Patient denied experiencing sore throat or cough. No relief had received from the treatment    This case was linked to MOD-2021-098227 (Patient Link).
Client reports, "I got the shingles from my shingles shot".  Client reports getting Zoster shot on 2/11/08 and having blisters appear (2) by her (L) eye then (1) in her (L) eye.  Client reports pain being so severe that she can't wear her glasses.
An hour after the shot he noted neck pain which was intermittent, the next morning he noted his throat feeling like it was closing up. Has had trouble swallowing since then now for 6 days with feeling of swelling under his tongue, no SHOB, but he feels weak.  Diagnosis is mild angioedema treated with loratadine and prednisone taper begun the date of this report.
Started to feel badly (headache, slight fever, typical side effects) around 10-11pm Thursday... Was very thirsty so got out of bed to go the bathroom and get more water around 3am.  On the way back, fainted.  Not sure how long was out, but came to and was able to get up and back to bed after lying on the floor for ~10 minutes.  The rest of Friday, just felt feverish, headachy and fatigued.
Fainted twice the day after vaccination.  Patient followed up with provider who advised to drink plenty of water and report to pharmacy.
Urticaria of right upper arm and left face. No wheezes or difficulty with breathing.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided  Treatment medications were not provided  Once they received the shipment, the vaccines were placed at freezer temperature, at around -20 degree Celsius After that, a vial was removed from the freezer to administer vaccine. Doses that were viable up to 14-Apr-2021, the 30 days since it was thawed were administered to the patient beyond that day.
Her arm is red and warm. The rash started right around the area of injection but has spread over most of her arm.
Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022; Received vaccine which expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacy received the vaccine on 23-Feb-2022. The reporter stated that, they thought vaccines will expire in Jun-2022 however vaccines were expired on 01-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Fatigue, muscle aches and resting heart rate 70. It is usually 40-45. Fever (right ear 101.0 and left ear 101.4). Took Motrin.
Flu like symptoms such body aches, then fever then chills started about 14-17 hours after the shot
Per provider, pt. had dizziness x 12 hours, and had emesis x 2 weeks.
pt recv vax & 48hr later devel rapid heartbeat p/running around @ a church social w/other children;sx resolved w/cessation of activity & has not reoccurred
9hr after injection I started to feel cold and shivering, went to bed and on 07 Dec 3.00 AM I woke up with body ache, headache and my neck muscles and back muscle feeling stiff,  and pulsating pain at the injection site; at 6. 00 AM I work up feeling tired, with headache, body ache, feeling very stiff, no Appetit,  fever 99.7 F, enlarged and painful axillary lymph nodes.  I felt like this all day until 8.00 pm when I tool Tylenol PM and went to bed.    On 08 Dec body pain is much less then 24h before- slight body ache specially in my upper back, enlarged and painful axillary lymph nodes more than the day before, temp of 97.3F.
Fluarix QIV was administered subcutaneously to more than one patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number PM35E, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2023-2024 season (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Fluarix QIV was administered subcutaneously to more than one patient). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 26-OCT-2023 The nurse reported to inform that Fluarix Quadrivalent was administered subcutaneously to more than one patient. The reporter didn't provide an exact number of patients, as that information was not available at the moment. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
I awakened on the morning of June 8th with swelling in both legs. The swelling increased over the next 4 or 5 days. By Sunday evening, both legs were discolored. I called my PCP on Monday morning. She was out of the office. Her nurse told me to go to Urgent Care to rule out DVT. The Urgent Care P.A. sent me to get a venous lower extremity bilateral ultrasound. It was normal. I had a CBC and a Chem Panel which were both normal. On Friday, the 17th, I saw my PCP. I still had the lymphedema. She ordered extensive blood work. I had an exam. She told me that she wanted to rule out a cardiac problem, blood clots, and a renal problem.
Joint aches in legs, sore at shot site, bad headache, chills, loss of appetite.
large raised, swollen area's of forehead, back, hip, abdomen & marked swelling of both hands. Started on 1Feb91 & resolved by 10Feb91, Rx /w Benadryl
The patient developed papular urticaria approximately 24 hours post-vax. This was a waxing and waning generalized rash. No respiratory, upper airway, or edema complications. The patient had an erythematous localized reaction at the MMR site. Patient was seen in the clinic and treated with Benadryl.
Two vaccines were given in the deltoid of the left arm. Patient subsequently developed severe pain from the injection site to the left elbow; also c/o intermittent numbness of the fingers; red streak noted on the anterior upper arm; c/o also nausea, anorexia, body aches. Dx cellulitis. Cream provided. Plan KEFLEC 500 mgm, PO BID. Heat/sling/Ibruprofen PRN.
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever.  Severe right arm pain.  I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot # L014878, expiration date 17-JAN-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 128 hours with the highest recorded temperature of 49 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 20APR95 @ about 2Pm by about 21APR95 started having sx of severe abd pain/nausea & vomiting which lasted through the noc but ended by morning 22APR95;
This spontaneous report was received from a nurse practitioner via Poison and Drug Center (PDC) regarding a 13-year-old male patient. The patient's medical history included that his hand was smashed in a door on an unknown date and experienced a skin reaction on his hand. The patient's concomitant medications included KEFLEX for several days to treat the skin reaction on his hand. The patient's concurrent conditions was not reported. On 03-MAY-2018, the patient was vaccinated with VAQTA 50U/1mL, 1 mL dose, once, intramuscularly in the left arm (lot# M028743, expiration date: 23-NOV-2018) for Hepatitis A outbreak. The patient was mistakenly provided the adult 1mL dose instead of the pediatric 0.5mL dose (drug administered to patient of inappropriate age) (incorrect dose administered). The patient had no relevant laboratory data. At the time of the call, it was unknown if the patient had experienced any untoward effects. It was unknown if the patient continued on VAQTA. Lot number [M028743] is an invalid lot number for VAQTA.
Patient allergic to thimerosal. Instead of getting FLUVIRIN prefilled syringe which only contains < 1mcg of thimerosal patient received FLUVIRIN vial which contains 25mcg of thimerosal. Spoke with patient on 10/20/13 approximately 2pm she stated she is fine. On 10/19/13 she stated some soreness and redness at injection site but is fine today. Has had vial before previous year. Her reaction was soreness and redness.
Resident noted to have a fall the next morning while ambulating to the restroom.  Resident right upper arm noted to have significant swelling and pain.  Resident is not able to use her right extremity at this time.
Patient came with her husband to get MENACTRA shot on 11-09-2017. On the same day, patient experienced redness around the inject site. The size of redness has progressed throughout the entire week. Patient reports that she had fever and the redness becomes painful to touch since 11-15-2017. Instruct patient to go to nearby urgent care to take a look. The site is warm to touch and it's all over the entire front forearm. Husband and the other 2 family member who got the same vaccination with same batch number have no problem.
This spontaneous report has been received from a consumer who saw the information online posted by the patient's mother regarding to a 2-day old male patient. The patient's concurrent condition, medical history, drug allergies and concomitant therapies were not reported. On an unspecified date in 2012, the patient was vaccinated with RECOMBIVAX HB (lot number, expiration date, route of administration, dose and anatomical location of vaccine were not reported) for prophylaxis. On an unspecified date in 2012, after his parents took him to home, he was screaming on and off for 20 hours; therefore, the patient began to turn red (erythema) and purple in his face (skin discoloration). The patient was taken to the emergency room and afterwards he seemed to be recovered from the events. The causality assessment between all the events and RECOMBIVAX HB was unknown. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA000943; US-009507513-1902USA001350.
On the evening of 1/3/2022  11 days after Pt. received Moderna COVID-19  booster Pt. developed itchy scalp and rash / hives on back of neck and ears that was very itchy.  On 1/4/2022 in the AM,  12 days after Moderna booster pt. developed hives in groin area, inner thighs and trunk that was very itchy.  Pt took benadryl and slightly helped with the itching.  Pt. Saw PCP on 1/8/2022 and received a Rx for Hydroxyzine and recommended to take Hydroxyzine along with Allegra and Pepcid.  Pt. has been taking Hydroxyzine 3-4 times a day as well as Allegra a Pepcid  and hives have improved significantly.  Pt. never has any swelling in mouth, tongue or trouble breathing. Pt. has f/u visit with PCP tomorrow 1/11/2022.
Pain at base of skull/ Feeling of a hook pulling at the base of skull; Intense Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of OCCIPITAL NEURALGIA (Pain at base of skull/ Feeling of a hook pulling at the base of skull) and HEADACHE (Intense Headache) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCCIPITAL NEURALGIA (Pain at base of skull/ Feeling of a hook pulling at the base of skull) and HEADACHE (Intense Headache). At the time of the report, OCCIPITAL NEURALGIA (Pain at base of skull/ Feeling of a hook pulling at the base of skull) and HEADACHE (Intense Headache) outcome was unknown.            No concomitant medications provided No treatment medications provided
Within 10 minutes my whole arm had this horrible burning sensation go down my entire arm from the point of the shot to my wrist. Then shortly thereafter my arm started to hurt very badly. By the time I left the store it was painful for me to even lift my bags. The pain continued to get worse each day and was difficult to even sleep because the arm was so sore. Here it is 4 weeks later and I still have pain, not as bad as the first few weeks but still I have problems. I have limited mobility with the arm. There are certain tasks that I can't do because I can't move my arm properly. It has affected my work because I cannot lift. My arm will seem good for a time and then out of nowhere the pain returns and it is impossible to do simple things like open a jar, put sheets on the bed or take clothes out of the washer. I have been extremely affected in my day to day life, especially because this is my prominent arm.