chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to an unspecified number of patients' of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patients received unspecified doses of improperly stored ROTATEQ (lot # L039141, expiry date 16-AUG-2017), concentration, dose, route of administration were not provided, orally. It was reported that the temperature excursion was for cumulative 95 hours 24 minutes at -1.1C, according to the data logger. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
left foot swells in the evening; red dots on thigh, top of feet, knees; red dots are on both legs; red dots spreading; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left foot swells in the evening), RASH MACULAR (red dots on thigh, top of feet, knees), RASH ERYTHEMATOUS (red dots are on both legs) and RASH MACULAR (red dots spreading) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID] and GLIPIZIDE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left foot swells in the evening), RASH MACULAR (red dots on thigh, top of feet, knees), RASH ERYTHEMATOUS (red dots are on both legs) and RASH MACULAR (red dots spreading). At the time of the report, PERIPHERAL SWELLING (left foot swells in the evening), RASH ERYTHEMATOUS (red dots are on both legs) and RASH MACULAR (red dots spreading) outcome was unknown and RASH MACULAR (red dots on thigh, top of feet, knees) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history, lab data,  and treatment medications are provided.
pressing hard and the syringe broke; fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in; needle still in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYRINGE ISSUE (pressing hard and the syringe broke), UNDERDOSE (fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in) and INJURY ASSOCIATED WITH DEVICE (needle still in arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced SYRINGE ISSUE (pressing hard and the syringe broke), UNDERDOSE (fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in) and INJURY ASSOCIATED WITH DEVICE (needle still in arm). On 04-Jun-2021, SYRINGE ISSUE (pressing hard and the syringe broke), UNDERDOSE (fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in) and INJURY ASSOCIATED WITH DEVICE (needle still in arm) had resolved.            Concomitant medications were not reported.   On 04 Jun 2021, the patient received the second dose of the Moderna COVID-19 vaccine. Per the reporter, the health care professional (HCP) that administered the vaccine was pressing hard which caused the needle to break off into the patient's left arm. This cause the fluid from the vaccine to the spray the patient in the face. The needle was removed by the HCP. Per the reported, the HCP stated, they did not believe the patient to get the full dose of the vaccine due.  Treatment information was not provided.  This report refers to a case of Product administration error for mRNA-1273 with no associated AEs.  The causality assessment of the events remains as not applicable.; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273 with no associated AEs.  The causality assessment of the events remains as not applicable.
coughing; swelling; Swelling of lips; Eye swelling; rash on the side of her breast, buttocks and side of her body; itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2018).   On 22nd March 2019, the patient received the 2nd dose of Shingrix. On 23rd March 2019, 1 days after receiving Shingrix, the patient experienced rash and pruritus. On 23rd April 2019, the patient experienced facial swelling, lip swelling and eye swelling. On 18th July 2019, the patient experienced cough. On an unknown date, the outcome of the rash, pruritus and cough were not recovered/not resolved and the outcome of the facial swelling, lip swelling and eye swelling were unknown.   It was unknown if the reporter considered the rash, pruritus, facial swelling, lip swelling, eye swelling and cough to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After receiving 1st dose of Shingrix, the patient had no problems. The patient reported that, after vaccination with 2nd dose, experienced rash on the side of her breast, buttocks, and side of her body. The patient reported that 32 days after vaccination, the patient experiened swelling on her face, lips, and eye. 118 days after vaccination, the patient had cough. On an unknown date, the patient planned to continue follow up with her physician. The patient consented to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Nausea, leg stiffness with difficulty walking for 2 days, beginning on day of vaccine administration or early next morning. Symptoms are now resolving. Patient did not seek medical attention for these complaints.
11/07/2023- had a strong metallic taste in mouth 11/08/2023- broke out with an itchy rash across neck and upper chest area
Public Health was notified by pharmacy regarding an individual who had been "double vaccinated".  Received Moderna Vaccine (Lot #: 031L20A) on  2/18 .  Pfizer vaccine on 3/11 ,  Second dose Moderna (Lot # 020B21A)  on 3/24 , and then the second  Pfizer on  4/1 .
About 3cm diameters erythematous circular lesion at injections site with local itching negative signs of INFX/Abscess
24 hrs p/vax had diffuse itching; 48 hrs had hives 72 hrs later diffuse hives; 80 hrs later swollen, numb legs-went to ER & was given Epi & DPH & Pred; 36 hrs later lips became swollen & numb again & pt recvd Epi, Cortisone & Pred;
Diagnosed with varicella 03/28/05. Had fever of 103 degrees and cold symptoms started 03/24/05. Rash started 03/25/05. At time of visit had 12 papular lesions with vesicles on trunk, arms, legs and face. Rash was not itchy. Had impetigo involving lesion. Rash crusted after 6 days. Fever lasted 3 days. Patient had vaccine for varicella on 02/24/03.
later that day patient noticed some swelling under her left arm pit. Next day she could tell that the lymph node in the left arm pit was swollen.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccine have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 08-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). Additional information has been requested.
On 2-3-21 at 8:30a, he had a 1 minute seizure.  He also had a fever of 101.3F.  The temp responded to Tylenol.  He did have another seizure at 12:05p for 1 minute. He continued to require medication for fever thru 12:15am on 2-4-21.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
The pt experienced low grade headaches everyday after the 4th vax, After the 5th, the pt experienced flu like symptoms for a couple of days with increased severity in headache pain. Eventually they returned to the everyday low grade headache that the pt deals with daily.
Rash and swelling at site. Small, red spot became 3.5 inches in diameter. Itching at site.
Left upper arm medial aspect with a 14 x 14 cm in longest dimension erythematous, edematous with central area darker with firm tender area. Patient states area is very painful to touch. Increased warmth to touch. No drainage noted. Acute illness with fever 101.
T78.3XXA ANGIOEDEMA, INIT 4/13/2023 HTN (HYPERTENSION)
Patient has a bruise about 1.5 inches in diameter around injection site.  There is no swelling or itching at the injection site.
This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. The patient's medical history included hypoglycaemia. The patient's drug reactions or allergies were not reported. On 11-MAY-2016, the patient was vaccinated with her first dose of GARDASIL 9 (lot # L036245 and expiration date 09-FEB-2018, dose and route of administration were not reported). Concomitant therapy was not reported. On 11-MAY-2016, the patient fell and hit her head, then had one seizure and developed a skin rash across her chest, along with swelling of both feet. Both of her feet turned purple in color. the patient sought medical attention and on 11-MAY-2016, she was hospitalized. It was stated that they tested all of her systems. On the same day, the patient was released from the hospital. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review the event of seizure was considered as medically significant. Additional information has been requested.
pt had mild onset of measles, limited splotches, high fever 104, lack of energy, severe nausea & diarrhea; this progressed into a neurological condition named GBS; pt was placed in ICU; temporary paralysis;
The exposure to Covid would have been on 07/28/2021 or 07/29/2021. On 07/30/2021 when I woke up I had a very minor itchy throat. I kind of attributed that to allergies because I typically have those allergy type symptoms. On Saturday when I woke up I noticed I had more itchy throat and stuffiness and congestion in my nasal passages. I did not check my temperature but I think I had a mild fever. On Sunday I woke up with more stuffiness, nasal pressure, minor sinus headache. The same thing on Monday. It progressed a little bit more to where I was running a low grade fever. I went to the doctor and got tested for Covid, strep, and flu on 08/03/2021 and it came back positive for Covid. He prescribed me some antibiotics or antivirals I do not remember which one it was. On 08/04/2021 and 08/05/2021 I continued to get more symptoms. From there, I started to have no taste or smell, getting body aches, more severe headaches, nausea, fever. I went to the doctor on 08/06/2021 and received a referral because I was pushing to get the antibodies but they were not offering them to me. On 08/06/2021 it progressed more. My oxygen was around 92 during that weekend. On 08/09/2021 I had a telehealth with the doctor I was referred to. He prescribed 2 other antivirals and I was given a steroid breathing treatment. They started me on zinc, vitamin D, and vitamin C. I had the antibodies treatment on 08/10/2021. At that time my oxygen was at 91. On Friday 08/13/2021 I started feeling that I was getting better. During that whole time I had a fever between 100.5 to about a 100.9. When I received the antibodies, there were a couple of times that my oxygen will be at 85 or 88. It took about 3 complete days before I started feeling better. The exposure to Covid was at my workplace, 6 of us ended up getting Covid during that same event. It was a coworker. 2 days before I received the antibodies treatment I felt so horrible I just wanted to die because I felt so horrible. Right now I just have monthly follow ups for chest x-rays because I have Covid pneumonia pockets in my lungs.
His stroke started on 07Jun; This is a spontaneous report from a Pfizer sponsored program. consumer (patient) reported for himself that a 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 07May2021 (Age at Vaccination was 61 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), at single dose for COVID-19 im-munisation on 16Apr2021 and did not feel any symptoms with her first dose (Age at Vaccination was 61 years). Patient experienced stroke (medically significant) started on 07Jun2021 and is 99% sure due to the COVID vaccine. He mentions that he was an athlete and a pilot. He states that he was in excellent condition and have no family history of stroke. He also said that doctors did not know about anything. Caller wants to know if it can recur again in the future. Outcome of the event was unknown.
Red-swollen arm of vaccination site (pain in entire arm). Client got hives over entire body 2/3 days after injection. Medications provided.
Soreness in injection site (left deltoid). Was unable to lift elbow above shoulder height from 6AM March 24 to 6AM March 25.  Developed fatigue, light fever, and chills by 11AM on March 24. Slept 12+ hours each night of March 23 as well as March 24.
rash under right armpit; pain under right armpit; itching under right armpit; Shingles; pain in right arm and nipple; radiating to right breast and nipple; flu-like symptoms; feverish; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd December 2018, 2 days after receiving Shingrix, the patient experienced shingles, pain in arm, radiating pain, influenza-like symptoms and fever. In January 2019, the patient experienced rash, axillary pain and pruritus. The patient was treated with gabapentin and benadryl (nos) (Benadryl). On an unknown date, the outcome of the shingles was unknown and the outcome of the pain in arm, radiating pain, rash, axillary pain and pruritus were recovering/resolving and the outcome of the influenza-like symptoms and fever were resolved with sequelae.   It was unknown if the reporter considered the shingles, pain in arm, radiating pain, influenza-like symptoms, fever, rash, axillary pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that within 48 hours of receiving dose 2 of Shingrix, patient was feeling feverish, with flu-like symptoms and pain in the right (non-vaccinated) arm - in the armpit, radiating to right breast and nipple. 8 weeks later, the patient developed a rash in the same area which was accompanied by sunburn-like superficial pain and itching. Mammogram of right breast conducted prior to rash appearance. Results negative. The reporter consented to follow up. Emergency room visit was required.      Lab Comments: On an unknown date mammogram of right breast conducted
patient  received 2nd dose of moderna vaccine and called to reported full body hives. she said after vaccine she did have mild fever, chills, fatigue and then developed hives.  she said hives are all over her body and she took benadryl without relief.  patient was contacted and instructed to reach out to occupational health for further treatment and if unable to reach them seek care at urgent care, with her pcp, or at the emergency room. current status is unknown at time of writing.
Rash from the neck to top of feet, little itching, no pain fever of 104 degrees the evening of 10/20/10.
Sore arm, she could barely move it. She took Tylenol. She then developed swelling and rash below the site by 8/10/05.
swollen lymph nodes on right side, opposite of vaccination site; Stated she had Sars-COV-2 in October; Stated she had Sars-COV-2 in October; This is a spontaneous report received from a contactable consumer (patient self-reported). A 60-year-old female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date in Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included Sars-COV-2 in October which anticipated an adverse event. Concomitant medications were not reported. The patient reported that she received first dose a week ago, and had swollen lymph nodes on right side, opposite of vaccination site. She had a difficulty reaching HCP. Contact pharmacy where received, indicated to call MI and asked for treatment recommendation of hot or ice. She felt better with "hot", husband stated cold. She asked that if should receive second dose. It was also reported that the decision to receive the second dose for any other reason cannot be made by Pfizer. The patient referred to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knew her health situation and was access to information that can better help inform this decision. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
extra dose of IPOL was administered to a patient with no adverse event; Initial information was received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 13 years old male patient who experienced extra dose of IPV (VERO) [IPOL] was administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) hepatitis b vaccine, hepatitis a vaccine and varicella zoster vaccine live (oka/merck) (varivax [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for prophylactic vaccination (Immunisation).  On 14-Oct-2010, the patient received a dose 1 of suspect IPV (VERO) ) (lot, dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 17-OCT-2023, the patient received 0.5 ml of suspect IPV (VERO) suspension for injection, (lot:V1B891M and expiry 01-Jun-24) (strength: not reported) via intramuscular route in the left deltoid  prophylactic vaccination (Immunization).  On 17-OCT-2023, the patient developed a non-serious extra dose of ipol was administered to a patient with no adverse event (extra dose administered) (latency 3 day).  Action taken: not applicable. outcome was unknown.  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.
This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Raised itchy rash on hands) and RASH (Raised itchy rash on feet) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and LISINOPRIL for an unknown indication. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced RASH (Raised itchy rash on hands) and RASH (Raised itchy rash on feet). On 05-Jan-2021, RASH (Raised itchy rash on hands) and RASH (Raised itchy rash on feet) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had three negative Covid-19 tests after rash. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: IRD date, patient  height, weight, concomitant drugs and event outcomes were updated; Sender'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.
Approx. 12 hr. after vaccine was given I developed muscle aches/pain/weakness (& some minor tingling in fingers & toes occurring approx 7 days after vaccine). Joints (fingers, wrists, knees, feet) ache along with generalized muscle aches & weakness. Headache almost continuous as well. NSAID's help but does not eliminate symptoms. Symptoms continuing & getting worse.
During the patient's 15 minute waiting period, patient developed chills, hot sweats, vomiting, and dizziness. patient had stated that they had not eaten all day.
Hospitalized with shortness of breath and generalized weakness, hypoxia 88%. COVID positive. GI bleed.  4/6 admit with positive COVID test on 3/28