chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heat at the injection site/ hot at injection site; pain at injection site; redness at injection site; chills; first dose well over a year ago, second dose in March 2022; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago before reporting date).   In March 2022, the patient received the 2nd dose of Shingrix (intramuscular). In March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In 2022, the patient experienced injection site warmth, injection site pain, injection site redness and chills. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site redness and chills were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site redness and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-JUL-2022 Reporter's Comments: The reporter was the patient.  She received her first Shingrix dose well over a year ago and second dose was in March 2022 which led to lengthening of vaccination schedule.  In 2022, less than 4 months after receiving Shingrix, the patient experienced injection site warmth (heat at the injection site), injection site pain, injection site redness and chills. These effects lasted two or three days. She had nothing else to report.  The reporter consented to follow up.
patient felt hot and clammy. nauseated.  watched patient and he improved.  no longer nauseated and feeling better
Vaccine administered into bursa per patient resulted in Dr visit and bursitis. Pt had visible bruise (10/12/16) still on arm vaccine administered too high.
Vaccine is placed in refrigerator on 04-Nov-2021, expired product date on 13-Oct-2021, administration date on 08-Dec-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 04-Nov-2021, expired product date on 13-Oct-2021, administration date on 08-Dec-2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 04-Nov-2021, expired product date on 13-Oct-2021, administration date on 08-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 04-Nov-2021, expired product date on 13-Oct-2021, administration date on 08-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 04-Nov-2021. Patient did not experience temperature excursion and any adverse event. No treatment medication information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Redness; Slight swelling; Itching; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), swelling (Verbatim: Slight swelling) and pruritus (Verbatim: Itching). The outcome of the erythema, swelling and pruritus were resolved (duration 1 month).   It was unknown if the reporter considered the erythema, swelling and pruritus to be related to Shingrix.     It was unknown if the company considered the erythema, swelling and pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 20-JUN-2023 The patient complaints of redness, slight swelling, and itching for approximately 1 month after vaccine administration. The reporter agreed to follow up from GSK.
COLD; FEEL LIKE FAINTING; DYING; SETLHABI ON LEFT BOOBIE; HIGH FEVER AND TEMPERATURE; POUNDING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cold, dying, setlhabi on left boobie, high fever and temperature, pounding headache, and feel like fainting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and temperature, dying, pounding headache, setlhabi on left boobie, cold and feel like fainting was not reported. This report was non-serious.
January 27, 2021--No immediate reactions other than very slight tenderness and a dime-size bruise from vaccine.  February 3-present--vaccination site is swollen, hot, and itching
NUMBNESS OF  TONGUE; SWOLLEN LEFT SIDE OF FACE; NUMBNESS OF LEFT SIDE OF FACE; SWOLLEN TONGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had taken an antihistamine one hour prior to injection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced numbness of tongue. On 06-APR-2021, the subject experienced swollen left side of face. On 06-APR-2021, the subject experienced numbness of left side of face. On 06-APR-2021, the subject experienced swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness of tongue, swollen left side of face, numbness of left side of face and swollen tongue was not reported. This report was non-serious.
Narrative: Dizziness, Sore Arm/Fatigue/Left Argic
Child and 2 other siblings received Pfizer covid19 vaccination on 11/29.  Immunizer administered doses to 2 siblings, but accidentally left used recapped syringe on counter instead of disposing into sharps container.  The used syringe from sibling was administered to patient.  Patient was administered with proper syringe with vaccine in syringe.  No adverse reactions are reported as of 2;30pm on 11/30.
This spontaneous report as received from a nurse prescriber via a company representative refers to a 77-year-old female patient. In approximately June 2017, reported as "at an unspecified time last week", the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N001007, expiration date: 19-SEP-2018, for revention of pneumonia. The day after the PNEUMOVAX 23 was administered, the patient visited the nurse prescriber and was experiencing swelling on the bicep of the arm in which the injection was administered. The swelling was closer to the elbow and hot to the touch. The swelling was not at the injection site. The following day after visiting the nurse prescriber about the swelling, the patient was seen in an unspecified emergency room, but was not admitted into the hospital. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 were not reported.
Temp of 102.7, Treated with Motrin in ER and given script for Motrin and Tylenol
I felt fine after the shot until about 7 pm when I started experience an intense, pressurized sensation in my head, jaw, chest, and arms. This was accompanied by dizziness, nausea, fatigue, ringing in my ears, and feeling flushed. Over night I felt some numbness in my hands and arms. The next day the feeling of  pressure and tightness was gone but the dizziness and nausea has remained. I have more energy but  am feeling concerned about the persistent vertigo.  I have a history of allergic reactions. I was also scheduled to begin my menstrual cycle this weekend and it has been delayed.
Severe spasms of lower back muscles stomach muscles shooting pain down the legs to the feet, chest pain. Very elevated blood pressure. Was brought to the hospital by ambulance EKG done Blood pressure  Cat scan  Blood work Chest X-ray   Follow up needed with primary care Dr Follow up with cardiologists needed Follow up with spine and pain doctor More blood work needed
Seven days after patient received Moderna vaccine in her left arm, she noted a red and indurated circular rash around the injection site. Mildly tender. I saw her one week after onset. Symptoms are resolving, no with minimal erythema. She did not try any treatments. Recommend she use ice and Tylenol for discomfort as needed.
developed congestion on 11/27/22- test positive for COVID on binax rapid antigen test
itching; big red circle; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching) and ERYTHEMA (big red circle) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itching) and ERYTHEMA (big red circle). At the time of the report, PRURITUS (itching) and ERYTHEMA (big red circle) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
From the morning after, until that evening, I had fever up to 102, chills, headaches, extreme fatigue.  Also cough that continued periodically in decreasing severity, and still persists to a minor degree.
Patient began itching right after the shot was administered.  I gave her a benadryl 25mg tablet and she felt okay to leave.  I checked back in with the patient after the clinic and she said that she felt fine.
Woke up with nausea. As day went on increasing fatigue in arms and legs.
The minor came into the store with her guardian to get a flu shot. The pre screening questions were done with my help, i asked if patient had any seizures in the past, guardian said she had one previously, but only one. Patient was seated while wating for the vaccinatio. I administered it, using proper technique. Directly after, i asked how the patient was feeling, she said she wanted to sit for a while. I went back into the pharmacy to gather her paperwork for checkout, and patient began to convulse. Guardian shouted at patient to get patient's attention, but she was unresponsive during the seizure. I immediately ran to her aid. Patient slipped through the chair and caught her neck where the chair handle was. I was able to free her from the chair without hurting her and place her on the ground to her side. I also cleared the area and stayed by her side until she woke up, approiximately 10 seconds at this point. I would describe the seizure as a 20-30 second tonic-clonic episode in full. 911 was called by a bystander. Patient woke after, disoriented and confused. She didnt realize fully what happened. She stayed on the floor seated until EMS arrived and stated she felt fine when they showed up. She was still taken away on a stretcher.
complained of substantial arm pain for an extended period of time / arm was sore for about 2 weeks following vaccination; This spontaneous report was received from a pharmacist and refers to a 71-year-old not pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscularly, lot # T017385, expiration date was reported as 01-SEP-2001, and upon internal validation established as 01-SEP-2021, in the right deltoid for prophylaxis. On 20-NOV-2020, the patient experienced substantial arm pain for an extended period of time. Her arm was sore for about 2 weeks following vaccination. The pharmacist stated that they give a lot of the vaccine and have never had people complain about the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) being so painful after administration. The outcome of the event was reported as unknown. The causality assessment between the event and the suspect therapy was not provided.     This is one of two reports received from the same reporter.
Patient came back to the pharmacy on 4.13.21 approximately at 2:40pm describing on going chest pain and grasped his right side of his chest.  Pain first started on Saturday  04/10/21 and has not subsided.  Advised patient to seek medical attention/ closest ER to rule out any major SE of Janssen vaccine.
A pt received an injection of pneumococcal vax and subsequently died. No further information was available at the date of this report. Follow-up reports a dx of pneumonia and sepsis. Cause of death was reported as "septic shock associated with pneumococcal bacteremia".
It was reported that a 45 year old female received Fluzone 98-99 sometime from 11/9/98 through 10/12/98. Reportedly sometime after the vaccination the pt experienced a headache for 24 hours. Reportedly the pt recovered form this experience.
pt devel high grade fever immed p/vax;temp in office to 102.5;
Hives Itch Flushing Right throat/dry throat  Treated with Benadryl Pepcid epipen
I tested positive for COVID-19 with a home test. First I got fever and a lot of coughing. Then I started to get headache. After I talk to Dr. I began taking ibuprofen. In the night I got chills and fever broke. I was very tired. The third day I had brain fog and could not think straight. Lots of coughing still. Ten days later I tested negative.
Baseball size red area with swelling at the injection site, Sharp, stabbing deep intermittent pain in L side back under L shoulder blade
Adult Caucasian Male (red blotchy, hot, shinny, itchy, skin.
I had some expected side effects: muscle aches and headache, but I started having nausea/vomiting approx 24 hours after receiving my 3rd dose of Moderna. That is a side effect I haven't experienced before.
Description: SM received 3 doses AVA May-June 2004: also several other vaccines (HepB, Influenza, MMR, Smallpox, & Meningocccal) from Mar-Nov 2004; beginning Oct-Nov 2004, he had unexplained weight loss 42 pounds; SM was subsequently diagnosed with hyperthyroidism March 2005 Symptom: Weight loss, unexpected Start: 10/01/2004 End: 03/01/2005 Comment: unexplained weight loss 42 pounds over 3 month period
Headache, bruising, shortness of breath, nausea, dizzy, extreme fatigue, muscle aches, joint pain going on 11 days
Noticed scalp tenderness in shower 6/13 AM EDT. On 6/17 PM noticed what felt like the beginning of a pustule (zit) on rear of left scalp, and one on back of neck, also left side. 6/18 noticed more sore spots, at ~11:30 PM asked wife to look and see if I was having an acne attack. She said it looked "like a rash." Within the hour I made a tentative lay diagnosis of shingles. Called facility in the morning, and my diagnosis was confirmed by MD at about 11:15 AM. Acyclovir and Norco prescribed. Lesions at back of neck have proliferated markedly since last night/this morning.
pt said she passed out as she was getting home, within 5 to 10 minutes of receiving the vaccine.  She hit her head and ended up going to the emergency room.
Pt states that the day of and 2 days following her 3rd HBV vaccine, she experienced muscle spasms and pain at site of admin- L delt. She also had episodes of heart palpitations and a feeling of "spaciness" which self-resolved by the 3rd day post-vaccine.
The night of 04/28/2021 was really sore, I developed a rash the next morning, my lymph nodes were swollen and I had a headache. It lasted for a week but I did not see the doctor.
I had a rash that started to itch underneath my right breast.  About 2.5 inches width by 1 inch height.  This rash got worse and the bumps were raised/blistered.  I went back to the same clinic I received the vaccine to see a doctor on site.  She was able to see me that day within the hour.  She did confirm that I had a mild shingles outbreak and prescribed me antiviral to take for a week.  Since taking the medication the outbreak has not worsened and is very, very slowly getting a little better.  I am experiencing numbness at the site now as well which has started just yesterday (08/19/2021).  I understand that the vaccine does not CAUSE shingles, but that factors can contribute to an outbreak of shingles such as stress or immune conditions (my system was potentially weakened by the vaccine which allowed this outbreak??)   I have never had a shingles outbreak before in my life, so I would say this is indeed an adverse event related to the vaccination I received.
Family states that 4 days after receiving the COVID vaccine, patient had episode of bloody stool. No fever, No nausea, vomitting or diarrhea. No URI, no sick contacts. Of notes, sibling in the same family recevied COVID vaccine at same time too with similar c/o.
Received HIB/Prevnar 5/8/07, fever 5/9/07 103 - sneezing and decreased appetite vomiting with Tylenol or food yesterday - decrease appetite except breast milk; left otitis media results in Antibiotics
Woke up the next day feeling hungover. By lunch time, I had a pounding headache and chills. Got into bed, and could not get up myself to get medicine. Had a 101.9 fever.
She was totally fine and then she got dizzy and couldn?t see and then almost passed out. She had to lay down until she could even stand up and she is still extremely dizzy.
6 days after second dose (on March 18), I woke up with one of the worst migraines I've ever had (8 out of 10 on pain scale). It was unbearable and I had to go into the doctor for a toradol shot and prednisone treatment - that only brought the pain level down to about a 6 out of 10. Then I had a lingering migraine for 2 months (until May 13) - where most days I had some form of a migraine (ranging from 2 to 6 on the pain scale).  Prior to the covid vaccine, I was averaging about 2 migraines per month that were manageable with medication. After the covid vaccine, I got about 15 migraines per month and some of which were not manageable. It has taken multiple rounds of trying different medications and treatments with my neurologist to get back to my baseline level of migraine, and I am still not currently there (currently as of August getting about 5 migraines per month).
Received a spontaneous report via email on 31JAN2017 from a consumer. A male reported that he went from a healthy vibrant person to a sick patient that spend most of his time seeing doctors who can't tell what is wrong exactly. He states he has been diagnosed with an autoimmune following his anthrax vaccines and deployment in 2013. He also noted that he has always been active playing basketball and training for Jiu-Jitsu tournaments but that year his health quickly declined and he has not recovered. Additional information has been requested.
Large redness on arm 3 inches below injection site.  Hands feel a little tingly
Incident Details: Per Dr. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient, was seen in office on 9/6/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) in error as patients are now only supposed to receive the bivalent booster per Dr. email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked at clinic. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters until clinic receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also ?monovalent? and ?bivalent? are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS. Recommendation: I would recommend holding a meeting to notify Leads/Supervisors/Managers of any changes regarding COVID vaccine administration, rather than sending out an email that may not be read by all staff. If an email is needed to be sent, I recommend making it clear that a process is being changed.
Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039B21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal).   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). On 07-Apr-2021, VACCINATION SITE PAIN (Injection arm soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included acid reflux medication. No treatment information was provided.   This case was linked to MOD-2021-133391 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.