chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 Year old son received 1st dose; He was little fatigued; He had headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 Year old son received 1st dose), FATIGUE (He was little fatigued) and HEADACHE (He had headaches) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 Year old son received 1st dose), FATIGUE (He was little fatigued) and HEADACHE (He had headaches). On 09-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 Year old son received 1st dose) had resolved. At the time of the report, FATIGUE (He was little fatigued) and HEADACHE (He had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case refers to a 16-year-old male patient who experienced headache and fatigue following the administration of Covid-19 vaccine. 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.   This report also refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 014M20A.   This case was linked to MOD21-066509, MOD21-066510 (E2B Linked Report).; Sender's Comments: This case refers to a 16-year-old male patient who experienced headache and fatigue following the administration of Covid-19 vaccine. 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.   This report also refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 014M20A. MOD21-066509: MOD21-066510:
Day 9 after vaccination, arm became red and very itchy, was warm to the touch.  Looked similar to cellulitis.  Also small bump from injection spread to a large knot. Knot disappeared within one day. Itching, redness, and heat went away in three days.   2nd dose/shot was 01/30/2021. Within 24 hrs of shot: Some redness,  heat and swelling  near injection site (upper r. arm). Mild itching.  It is now 4 days after 2nd shot. Bump/Swelling has reduced, itching and redness are gone. Some mild heat still at injection site. Do not yet know if there will be another delayed reaction.   I did not see a doctor. I do not need a call. I just wanted you to have the report.
Mother states approximately 10 min after vaccines given, while she was driving home with pt he stopped talking to her. She observed his eyes rolled back, mouth open. He involuntarily kicked his legs up once and hands jerked at the same time. This happened within 5 seconds as patient "woke up" he stated he felt nauseated and felt as if he had been asleep for a long time. 8/30/04: spoke with RN regarding medical follow up. The mother reported the incident the day after it occurred. There was no medical follow because the family is now away and didn't know where to do.
Patient reported some hardness around the site. Slight swelling. Some itchiness around the area. Denies any redness. Patient's primary care provider was notified .
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified date in December 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose, frequency and route were not provided. Then on 21-AUG-2016, he was vaccinated with the second dose of RECOMBIVAX HB (lot # M01864, expiration date: 31-MAY-2018), (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. Lot number M01864 has been verified to a be a valid lot number for RECOMBIVAX HB. Additional information has been requested.
Vomiting 3 hours after vaccine (about 1pm). Seizure 5 hours after vaccine (about 3pm), stiff on left side of body, smacking mouth & deep breathing. This would start & stop about 4 times. Hallucinating for a while beginning about 5 or 6pm, hot all evening, has had a headache every since the seizure, still has body aches & does not feel well.
Redness, swelling, itching, soreness at injection site expanding down to elbow.
Death NOS; Shingle within the same week, permanent until he died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and shingles. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the shingles was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's relative.  The age at vaccination was not reported. The patient received Shingles vaccine when it first came out. Less than a week after receiving Shingles vaccine, the patient got a full-blown shingles breakout within the same week. The patient had permanent shingles until the day he died. This case had been linked with case US2021AMR201151, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201151:Same reporter.; Reported Cause(s) of Death: Unknown cause of death
limited mobility; pain from top of shoulder all the way down arm; This spontaneous case was reported by an other health professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (limited mobility) and VACCINATION SITE PAIN (pain from top of shoulder all the way down arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 39K20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine shot. Concurrent medical conditions included Penicillin allergy (Augmentin) and Allergy to nuts (Pine Nuts). Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 16-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain from top of shoulder all the way down arm). On 16-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limited mobility). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and Immobilization for Vaccination site pain. On 12-Feb-2021 at 12:00 PM, VACCINATION SITE PAIN (pain from top of shoulder all the way down arm) had resolved. On 19-Feb-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (limited mobility) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with acetaminophen, ice, and an arm sling. Patient has experienced similar event (arm limited mobility) with pneumonia vaccine shot.  patient took  tylenol which helped with the pain but did not make it mobile. she used ice on and off and after 3 days It got use of it back..   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received on 2-apr-2021 contains suspect drug dose one, concomitant and treatment details.
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 03-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Urticaria - facial swelling and skin welts. Started hours after 2nd HPV vaccination. Treated with steroids and antihistamines.
No adverse event; doses were administered beyond 30-day use by date; received booster doses from the monovalent pediatric primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date), WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date), WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series).    Concomitant medications details were not reported by the reporter.  Reportedly, three adults were received booster doses from the monovalent pediatric primary series.  Treatment details were not reported by the reporter.
After my 2nd shot which was Pfizer, I began having foot issues on my heal with itching and burning at night. I saw a physician about it, and they gave me a cream for it. They refused my referral for podiatry. I was scared to get the booster because I was scared of my circulation getting worse. I got the 3rd vaccine and I got COVID arm for 5 days. This month, I got out of bed one day 12/13-12/14 my feet felt weird. They felt like they were numb, and it was every day and every night. And I started feeling tingling and they were very cold to the touch. So, I wrote to my Physician Assistants on 12/18 and asked if I could get a podiatry referral because my toes are affected. Now all my toes are affected. When I bend my knees, it becomes a discomfort for my toes, calves, and knees. And there's a bit of burning and then it goes away. And this is all new because I've never had this before. I would like to go to a doctor right away so I can get this figured out right away. Today, I've also been experiencing aches where the numbness would be on my foot. There is no skin discoloration. No bruises. After my 2nd vaccination as well. I did have weird sensations behind my knees and had a ultrasound scan done on June 24, no clotting. Doctors said they had no idea why my calves were feeling that way and said it could have been arthritis related. Symptoms subsided until recently. Calve symptoms have only come back this week. Feet started first. Hard to sleep because numbness, tingling feeling in my toes is annoying. Unsure if related to vaccine.
This spontaneous report as received from a nurse refers to a 10 week old patient of an unknown gender. On 09-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date 17-MAR-2016 or lot # K006805 and expiry date: 24-MAR-2016. No adverse events were reported. No product quality complaint PQC was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Red, swollen, hard,  painful, extremely itching full upper arm --' still red surrounding upper arm and itching 5 days later despite using prescription steroid cream...still waiting
Immunizing pharmacist spoke with patient prior to vaccine. Patient said after her first dose, she did experience chest palpitations for a few seconds, 12 hours after her first dose on 7/29/21. The patient said the palpitations did not occur again - it was just that one time. Pharmacist told her there have been reports of myocarditis/pericarditis after the vaccines, but nothing that Pharmacist could see relating to palpitations. Pharmacist did tell her it's her body, so it's up to her if she wants to receive the vaccine - there are always risks. She confirmed that she did want the second dose. After administering the second dose, Pharmacist told her to wait in the pharmacy for 15 minutes after the dose like last time. Pharmacist believes she only waited 5 minutes, then proceeded up to health and beauty to shop. About 10 minutes post vaccine, she came right back stating she felt like she was going to faint and was having heart palpitations. We sat her down and took her blood pressure and heartrate. 5:14pm it was 153/97 and HR 129, at 5:17pm it was 126/93 HR 95, at 5:21pm it was 121/91 HR 85. We told her to stay sitting for a while because she said she still felt dizzy, like she could faint. at 5:30pm she grabbed our attention again and said her palpitations were back. I asked if she wanted us to call an ambulance and she said yes. I  called an ambulance and relayed all of the information to the paramedics. Patient did receive about 3-4 ounces of water at 5:15ish. Paramedics arrived at 5:38 pm and the patient's vitals were taken, prior to being escorted out by them to where they were awaiting the arrival of the ambulance. She was able to walk out of the store with the paramedics on her own. I tried calling the patient at 8:44pm on 8/25/21 to check on her and see how she is doing, but there was no answer and I had to leave a voicemail.
For the first few days, soreness, redness, heat, itching. After about 5-6 days the redness was completely gone and barely any itching. On day 11 it started itching again , the redness returned but worse this time. Extreme heat coming from it and the red area seems to be getting bigger. It is also swollen. There?s no hole that can be seen from the needle going in, just a huge red circle.
Pt recv vax on 2/21/98; on 2/22/98 pt exp vax site pain, swollen/ painful lymph nodes in left axilla, malaise &flu-like sx, red rash on arms; 3/11/98 pt exp patchy hives/itching on trunk, itchy/watery eyes; tx=Benadryl, Cortaid cream
Right-sided swelling of neck, sore throat, audible respirations, BP 202/120.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 77.23.  On 11-Jan-2021, Excursion time was 09 AM and 02 PM, temperature was 34 and 35 respectively, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Soreness in injection site Body aches Back pain, and pain shooting down both of my legs.
ONCE ADMINISTERED, THE IMUNIZER NOTIZED THAT IT WAS GIVEN BEFORE THE 21 DAYS SPACING.  FIRST DOSE WAS ON 01/24/2022. NO ADVERSE REACTION REPORTED, PATTIENT ASISTED SCHOOL  ON 02/07/2022.
Bad headache 5-530 AM. Extreme tiredness starting at 12 PM. Ongoing chills from 1 PM-9 PM. No fever. Left arm site pink (slap appearing) with hardened orange-sized area. First time having side effects in history of vaccinations from any series.
Left bicep with pulsing/achy/burning/itching pain at a level of 3-4 on pain scale 1-10. Started around 5 pm on the day after injection with gradually increasing intensity -- radiating to below elbow and to shoulder. Difficult to preform activities of daily living at this time. Did see Dr. at Employee Health today. Started a methylprednisolone 4mg taper and will follow-up on 1/11/2019.
The pt seemed to be developing normally during his 1st 2 months. On 7/16/86, during a routine newborn check-up, the pt was given his 1st IZ of DPT and Oral Polio vaccine. Three days later, while at his grandmother's home, he began crying, stiffened up and then went limp. His grandmother was concerned and told his mother that when she returned home she should contact the doctor to report the episode. The doctor was not concerned at the time. It was within a few days from that episode that the mother and the grandmother began noticing that he would not hold his head up unassisted any longer and episodes of what the grandmother called excessive crying and seizures. The grandmother called the child's doctor to report these changes and he asked her when she noticed them. She said on or about 7/16/86, when he came to visit. The grandmother also remembers writing a letter to the MD to inquire about the episodes the child was having and the relationship to the IZ he had received. She never got a satisfactory answer from anyone regarding the strange behavior of the child. On the next visit to the doctor, 8/6/86, 3 weeks post vax, the doctor noticed that the child was not fixing on movement or objects and the eyes had searching movements. Subsequently, the child was dx'd as hydrocephalic and with cerebral palsy. After speaking with the staff at the doctor's office where the pt received the IZ's, I was told that they no longer have any records pertaining to the manufacturer or lot number of the IZ given. They also informed me that the pt was not given the same IZ after that initial injection on 7/16/86, due to a possible reaction.  Diagnosed with congenital hydrocephalus, chorioretinitis resulting in blindness, seizure activity, mental retardation, cerebral palsy-spastic
Pt received DTaP and Comvax on 5/31/07. On 6/2/07 mom called to report 2 days of fever but eating, drinking and playful. On 6/3/07 seen by Dr. in office; fever 106 and at home mom was giving Tylenol and Motrin but fever not responding. Pt referred to ER and admitted for 2 days for fever and work-up. CXR negative. WBC normal. Was put on Rocephin IV but then discharged. Spinal tap negative.   10/19/2007 Reviewed hospital medical records which reveal patient experienced fever x 3 days s/p vax followed by irritability & vomiting on day of admit.  Seen by pcp w/temp 106.7.  Admitted 6/4-6/5/2007.  No source for fever found.  Tx w/1 dose antibiotics.  Improved & d/c to home w/pcp f/u. FINAL DX: fever w/o source s/p vaccination.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 6 June 2013 at 11:45 the subject received a dose of KINRIX (.5 ml, unknown route, left thigh) as the 5th dose in the series, and experienced vaccine administered at inappropriate site. KINRIX was administered in the thigh rather than the deltoid as indicated. On 6 June 2013, 12 hours after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness and injection site rash ("rash down leg"). The adverse events were reported as local injection site reactions. The subject was treated with antibiotics, and medical attention was required at a doctor's office. At the time of reporting the events were resolved within approximately 8 to 9 days.
Left arm was sore after injection on 11/2/10. But was also immobile due to pacemaker insertion. Used a sling until 11/20/10. Had first cardio rehab on 11/19/10.  The morning of 11/20/10, developed severe pain in left arm, shoulder, back shoulder blade, under the left arm. Entire area tender to touch, swollen, not red. Pain was so intense independent of movement and movement was worse. No pain at site of pacemaker or chest. Cardiologist checked the area and sent me to primary doctor. Primary doctor did xray. No conclusive Dx other than bursitis. The pain continued intensely until 12/20/10. prior to decrease in pain I took ibuprofen which did not help. Primary doctor then gave me pain relief injections which improved mobility and pain. I took these for 2 weeks.I still have some pain in the left arm at site of injection and the back shoulder blade.