chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early).    No concomitant medications was reported. No treatment drug details was reported.
hurting on her arm/ the hurting in her arm was the same arm she got her COVID vaccine, which was the left arm; tickle in her throat; cough; This is a spontaneous report from a Pfizer sponsored program,  Support. A contactable consumer (patient) reported that a 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 25Feb2021, at 14:30 or 15:00 (as reported) (Lot Number: EN6205; at the age of 76 years old) as dose 2, single for COVID-19 immunisation. The patient stated that she knew she had some kind of heart problem but it did not bother her and an eye condition and she was not a very sickly person; she also had two blood clots that were found in the latter part of Nov2020. The patient also took three of the COVID tests over the past 2-3 months and those were negative. Concomitant medication included apixaban (ELIQUIS) taken for blood clots from Nov2020 and ongoing. She did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, via an unspecified route of administration, administered in the left arm on 04Feb2021 (Lot Number: EL9264; at the age of 76 years old) for COVID-19 immunisation and she felt absolutely nothing. On 25Feb2021, the patient experienced hurting on her arm, tickle in her throat, and cough after the shot. She stated that all of this started on 25Feb2021, about two hours after she took the injection. Once she took the shot, she waited 15 minutes to make sure she did not have a reaction and the reported events did not start until about two hours after she took the shot. She reported that she was up all night with her arm hurting and it still was hurting; the hurting in her arm was the same arm she got her COVID vaccine, which was the left arm, and it began hurting the same day she received her shot. She reported that the pain was just a thumping type of hurt when she moved her arm. On 25Feb2021, she also got a tickle in her throat after she got the shot. The tickle in her throat started and she coughed all night and in the morning. It was just something that tickled in her throat and made her cough and she did not know what was going on. She reported that the tickle in her throat was just irritating. The events did not result to a physician office or an emergency room visit. She did not have any treatment because the events just happened, but she stated that she would see a doctor if it were to continue for a few more days or weeks. The patient stated that apixaban did not do anything in terms of side effects while she took the COVID vaccine. At the time of report, the patient has not recovered form the events.  No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of malaise (hasn't been feeling well) and arthralgia (recently hurt her shoulder moving/ache in her shoulder) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced malaise (hasn't been feeling well) and arthralgia (recently hurt her shoulder moving/ache in her shoulder). At the time of the report, malaise (hasn't been feeling well) and arthralgia (recently hurt her shoulder moving/ache in her shoulder) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not provided. Most recent follow-up information incorporated: On May 21, 2021: Updated event outcome (resolved); updated 2nd dose information.
County Public Health was doing a vaccine event.  Vaccinated pt with 1st dose Moderna.  Pt had waited 15 min after getting vaccine without incident, but remained near event.  After 25 minutes, pt approached staff saying that he was having sharp chest pains.  Pt was immediately sat down and VS taken: SaO2 98%, HR 64, BP 145/75.  Pt stated that after he received his COVID vaccine, he then received a hepatitis A vaccine on the other side of clinic; he then had sharp chest pain that lasted 2-3 minutes but the chest pain was gone by time VS were done being taken.  Staff contacted jail guards, who then contacted jail nursing staff, and County Public Health on-call physician was then contacted.  Staff continued to monitor pt until jail nurses arrived, then taking pt into their custody for further evaluation and treatment.
Had flu shot and approximately 45 minutes later mouth, tongue and throat feels numb able to swallow ok.
Client's mother brought baby in for an assessment of baby's arm on 5/23/11 @4:45 PM.  His L deltoid had a 2 cm in diameter redden and swollen area which was normal temperature.   Mom sstates baby was seen by Dr. @ medical center about red area on 5/20/11.  Rx for Cephalexin.  Mom states child had fever of 100 during illness.  Afebrile today.  Child does not react to pain when touched.  MD diagnosed with "cellulitis".
Redness and swelling noted that has worsened, afebrile. Cool compresses, Ibuprofen, Benadryl.
slept for over 24 hours, fever, severe body aches, severe fatigue, blood sugar elevated to 577, worsened headaches, nausea and vomiting
I received the injection around 10 am and within an hour felt feverish- sweating, dizzy, blurred vision, fatigue. When I got home about 5 pm I was running a fever over 103, had started vomiting, my vision was spinning and I couldn't see or think clearly. By 8 pm I had vomited everything on my stomach and couldn't keep down water, I experienced severe fatigue and muscle weakness - couldn't stand or walk without assistance and slept when possible. Family reported that I wasn't fully aware of surroundings or others by about 10 pm. The next afternoon I started keeping down water and eventually other fluids, my fever went down to 102. Two days after the initial injection my fever broke and by the fourth day I was fully recovered. I took Tylenol and maintained a constant fluid intake when awake.
RED BUMPY RASH ON LEFT THIGH FROM HIP TO KNEE. SLIGHT REDNESS AND SEEMS ITCHY. SITE OF VACCINE IS CLEAR AND LIGHT COLOR, NO PAIN OR SWELLING IS NOTED.
I started to experience body aches, hip pain, and chills that was on the Sunday and Monday after. On the 18th I was up all night, I was uncomfortable. On the 19th I started to have shortness of breath, I drove to an urgent care near me. My oxygen was measured at 99 percent but when I walked it got down to 90 percent. We called 911 from the medical center and I was taken by ambulance to another medical center. They gave me some IV fluid and IV vancomycin. They ran a viral test, urine test, and chest x-ray. They all came back negative. I was discharged around 3PM on the 19th. On the same day around 4:45PM my temperature spiked to 100.6 degrees. We called 911 to take me back to the hospital. They said all they could do is give me TYLENOL and MOTRIN. I had a temperature on and off from the 18th to the 25th. I also vomited a couple of times during this time. I also had chills. On the 19th I had temperature of 100.6 degrees. On the 22nd it spiked again to 104.7 degrees. My wife pushed fluids every 15 minutes and gave me TYLENOL and MOTRIN. My temperature fluctuated up and down between 99.6 and normal at that point. From 10/16/2022-10/25/2022 I lost about 15 pounds. Now I'm starting to eat more, I have insomnia, and I have trouble walking because I am so weak. I have not recovered. I think it will be a while before I am back to full health.
Pediatric vaccine was mixed on 11/24/2021 at 9 am and was not salvaged by closing pharmacist end of day. Pharmacy was closed on 11/25/2021. On 11/26/2021 at 2 pm, the pharmacist drew out 1 dose from the expired diluted vaccine kept in the fridge since 9 am 11/24/2021 and gave it to the patient. After incident happened, at around 2:45 pm, Pfizer was contacted and the case was reported with all of patient's demographic info and vaccine info (with patient's father's consent). Patient's parent was contacted same day. On 11/29/2021 at around 8:20 am, patient's parent was contacted, and we were informed that patient experienced sore arm and no fever or other side effects reported. Additional information for Item 18: Safety report was done with Pfizer on 11/29/2021. Regarding stability of vaccine, we're still waiting from Pfizer to get the info.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number-K021487, expiry date-03-NOV-2016, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccine for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and M-M-R II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/26/2021 and 3/3/2021. Presented to ED on 1/21/22 after referral from urologist for IV antibiotics due to urinary tract infection with MRSA and Enterobacter cloacae. Admitted with septic shock with multi-organ dysfunction, Nstemi II, and Covid-19 PNA. Patient treated with: antibiotics and steroids. After discussion with family, transitioned to DNR/COT. Code blue called shortly after patient was noted to be hypoxic on tele with oxygen saturations in the 80s. He had widening QRS briefly after and then PEA arrest. Patient expired 1/22/2022.
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
Pt had vaccine for (shingles) on 11/13/09. Pt started to feel pain and heaviness in her legs on Tue evening 11/17. Pain in fingers and knee joint continued for about 36-48 hours, then gradually went away.
The patient presents with 65-year-old here for evaluation of reaction.  Patient endorses that she had her first Covid vaccination at 830 this morning.  She was doing fine afterwards and went for a walk and then had breakfast and then did some yard work.  However a couple hours after receiving the vaccination she developed progressively worsening tightness of her throat, tongue and lips on fire, generalized severe itching all over her body.  At first she was going to just get driven in by her family but she noticed that it was becoming harder and harder to talk and she felt like her throat was closing so they called 911.  She has only had allergic reactions to codeine but has no other known allergies.  Patient did get epinephrine and the ambulance and that has significantly reduced her difficulty breathing.  Right now she is just feeling shaky from the epinephrine and itchiness all over and a tongue that feels hot.. The patient did return 7 days later with return of hives, trouble breathing and throat tightness,  resolved with diphenhydramine
This spontaneous report as received from a physician via field representative refers to a patient of unknown age. The patient's drug allergies and medical history was unspecified. On an unknown date the patient was vaccinated with second dose of PNEUMOVAX 23. Concomitant medications were unspecified. On an unknown date the patient's arm was red, swollen and itchy from the injection site down to the elbow. The patient sought medical attention and was treated with unspecified antibiotic, BENADTYL. Lab diagnostics studies performed were unspecified. The outcome of patient's arm was red, swollen and itchy was unknown. The causality of arm was red, swollen and itchy was not reported. Intervention to prevent serious criteria was unspecified. Cancer and overdose were reported as no. No product quality complaint (PWC) was reported for PNEUMOVAX 23. Additional information has been requested.
Pt received injection on 10-2-12. That evening arm became red from shoulder to elbow, fever 102 degrees, nausea.
Information has been received from a Certified Medical Assistant (C.M.A.), for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who on 17-JUN-2008 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 659962/1740U) in the left arm and on 22-SEP-2008 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 660620/0571X) in the right hip. Concomitant therapy included hormonal contraceptives (unspecified). The patient became pregnant before the GARDASIL series had been completed. No adverse symptoms. It was reported that the last menstrual period (LMP) was 26-AUG-2008. Medical attention was sought via phone call. No product quality complaint was involved. Follow-up information was received from the nurse practitioner. The nurse reported that the patient had not received any concomitant vaccines when she received the first two doses of GARDASIL. The patient had not received the third dose of GARDASIL. The patient had a miscarriage sometime between August 2008 and December 2008. The patient had recovered from the miscarriage. The patient's last menstrual period (LMP) was also reported as 14-DEC-2008. Additional information has been requested.
Migraine; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of MIGRAINE (Migraine) and the first episode of MIGRAINE (Migraine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (but had not had one in greater than 12 years).    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of MIGRAINE (Migraine). On 01-Sep-2021, the patient experienced the second episode of MIGRAINE (Migraine). At the time of the report, last episode of MIGRAINE (Migraine) had resolved.            Concomitant  and treatment medications were not provided. On 01SEP2021 she experienced another migraine that lasted 3 days
Patient presents to the emergency department complaining of 2 days of worsening shortness of breath and increasing lower leg edema. She was subsequently admitted for further management of recurrent pleural effusion. She was discharge home 3 days later in stable condition.
had a pretty mild reaction to second dose; the patient's arm swelled up each time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a pretty mild reaction to second dose) and PERIPHERAL SWELLING (the patient's arm swelled up each time) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 VACCINATION COMPLICATION (had a pretty mild reaction to second dose) and PERIPHERAL SWELLING (the patient's arm swelled up each time). At the time of the report, VACCINATION COMPLICATION (had a pretty mild reaction to second dose) outcome was unknown and PERIPHERAL SWELLING (the patient's arm swelled up each time) had not resolved.            The patient was on concomitant medication, but does not specify which ones.  No treatment information was provided.   This case was linked to MOD-2022-474781, MOD-2022-474811 (Patient Link).
No adverse reactions at this time. The problem was that I did not dilute the Pfizer pediatric bivalent vial prior to administering to two 12 and under.
Intussusception. On 10/12/23 had 8 episodes of runny, mucous, non-bloody diarrhea. On 10/13 had streaks of blood in the diarrhea. Parents reported fever to 101.3, fussiness, decreased oral intake. No emesis or sick contacts at home. Went to urgent care 10/13 and found to be afebrile, fussy, with bloody diarrhea in diaper. Was sent to ED. KUB in ED revealed intussusception vs stool burden. RLQ ultrasound revealed small bowel-small bowel intussusception, that spontaneously resolved by end of exam. Pediatric surgery determined no surgical intervention was required. Patient discharged home 10/13.
mild soreness; Peripheral neuropathy; heightened sensory feelings at night; Feet feel different; feels heat and warmth; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D 3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) (seriousness criterion medically significant), SENSORY DISTURBANCE (heightened sensory feelings at night), LIMB DISCOMFORT (Feet feel different) and FEELING HOT (feels heat and warmth). On an unknown date, the patient experienced PAIN (mild soreness). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy), SENSORY DISTURBANCE (heightened sensory feelings at night), LIMB DISCOMFORT (Feet feel different), FEELING HOT (feels heat and warmth) and PAIN (mild soreness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No treatment was prescribed for her events. The patient received both vaccine doses by a Pharmacy. The patient shared that she had heightened sensory feelings at nighttime within the sheets and that her feet started feeling different in February. At the end of March she saw an Internist who did blood work for her because of a procedure she was to have to remove basal cancer from her nose.  The patient thought her Vitamin B12 levels might have been low, however from lab work her B12 levels were actually high and she was advised to stop taking her B12 supplementation at that time. The patient had a future appointment scheduled for August but wanted answers sooner regarding her inquiry.  Company Comment : 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 case was linked to MOD-2021-194667 (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 events, a causal relationship cannot be excluded.
Severe burning pain from injection site to fingers at time of injection with continued pain in left arm and tingling in fingers, within 8 hours developed 2 day period of fever ( not more than 100.2) chills, joint pain in hips, knees & shoulders, severe headache with scalp pain and piercing ringing in ears ( not able to sleep), severe nausea and stomach cramps.  As of today 6/11/21 still have headaches with scalp pain and severe ringing in both ears preventing me from sleeping, pain in left arm with tingling in my fingers.
breastfeeding and received vaccine; A spontaneous report was received from a consumer concerning a female patient who was breastfeeding: Maternal exposure during breast feeding  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  In Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 the patient reported having had a baby on 01-Sep-2020 and was breastfeeding as the time first dose was received.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.   The reporter did not provide causality for the events.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
PT REPORTED HEADACHE, LIGHT HEADEDNESS AND FLUSHED FEELING AFTER INJECTION.