chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shots at separate times and came down with shingles within 2 days.  The follow-up would not possible as no contact details were available. This case was linked with US2022AMR006100, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR006100:same reporter
within a few hours of being vaccinated experienced dizziness, nausea and "eye vibration". Lasted into the next day and resolved.
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171062   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: The reporter reported that the patient experienced gray dots on the left thigh after received Pediarix vaccine. The gray mark noted on 25th October 2022 visit prior to receiving additional vaccine doses. The reporter did consent to follow up. Additional supportive information: This case had been linked with US2022AMR171062 by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171062:Same reporter
Swollen, redness, itchiness, hard to touch was felt that evening of the vaccine and its getting bigger in diameter. Its the 8th day and it is throbbing and seems like the redness  is getting bigger in diameter. It is hard and hot to touch.
A bruise started coming up on his injection site arm; He could no longer lift his arm above shoulder length, or above his head; Excruciating pain if he tried to lift it or lift something above his head; A bruise started coming up on his injection site arm, & giving him a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (A bruise started coming up on his injection site arm), LIMB DISCOMFORT (He could no longer lift his arm above shoulder length, or above his head), PAIN (Excruciating pain if he tried to lift it or lift something above his head) and VACCINATION SITE PAIN (A bruise started coming up on his injection site arm, & giving him a lot of pain) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hard of hearing.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE BRUISING (A bruise started coming up on his injection site arm) and LIMB DISCOMFORT (He could no longer lift his arm above shoulder length, or above his head). 05-Nov-2021, the patient experienced PAIN (Excruciating pain if he tried to lift it or lift something above his head) and VACCINATION SITE PAIN (A bruise started coming up on his injection site arm, & giving him a lot of pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Nov-2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL, TRAMADOL HYDROCHLORIDE (ULTRACET) on 22-Nov-2021 for Pain, at a dose of 37.5-325mg mg take every 6 hrs twice daily for 7 days. At the time of the report, VACCINATION SITE BRUISING (A bruise started coming up on his injection site arm), LIMB DISCOMFORT (He could no longer lift his arm above shoulder length, or above his head), PAIN (Excruciating pain if he tried to lift it or lift something above his head) and VACCINATION SITE PAIN (A bruise started coming up on his injection site arm, & giving him a lot of pain) outcome was unknown.            No Concomitant medication was reported.  The patient had no pain if he let his arm just hang down. Patient called the pharmacist on 18 Nov 2021 and he told to take Tylenol and call the doctor if it didn't get better. On 22 Nov 2021 the patient went to emergency clinic (Urgent Care). The doctor gave him a mild pain pill Ultracet 37.5-325mg mg take every 6 hrs twice daily for 7 days. He only took 1 today at around 9:30am. They thought he might have a blood clot and went to Urgent Care and Doctor said he doesn't  have blood clot.  The patient had no reaction from the first 2 doses of vaccine.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 08-APR-2015 the patient was vaccinated with GARDASIL (unknown dose and lot number) via intramuscular route which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of GARDASIL underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Pain/stiffness with redness and swelling within one hour of receiving injection. Increase heart rate while in Er 10/13/02. Tx with antibiotic and Ibuprofen off work x 4 days per client.
Patient was inadvertently administered Pfizer COVID vaccine dose #1 prior to age 16 - no known reported adverse effects. Patient presented for WCC with PCP this week and PCP reached out to question if we were administering vaccine under age 16. Per CDC guidance patient will be rescheduled to receive 2nd dose after 16th birthday.  Patients PCP informed. Support team director informed and will follow-up with support team to assure age screening is in place for future appointments. The doctor ran a report and confirmed no other patients under 16 have received vaccine and no other patients under 16 are scheduled at future vaccination clinics.
Mild case of shingles 3 days ago (beginning 7/28) and still progressing on lumbar region of the back and at the waist.  Itching and pain.
Mother states that patient got vaccine on 07/28/2021, and that same night patient was having severe body pain. And next day, patient had  pains in right leg.
Erythema, swelling tenderness from injection site to surrounding area approximately 5 inches in diameter.
1.DOSE #1:  EXPERIENCED TINNITUS IN BOTH EARS FOR FOUR EVENINGS IN SUCCESSION FROM TUESDAY, MARCH 2 THROUGH FRIDAY MARCH 5. THE TINNITUS   SUBSIDED GRADUALLY OVER THE NEXT 2 WEEKS (APPROXIMATELY).  I AM NOT CURRENTLY, AS OF THIS DATE (MARCH 25) , EXPERIENCING THIS.  ASIDE FROM A MINOR SORENESS TO MY ARM LASTING LESS THAN 30 MINUTES, I COULD NOT 'FEEL' THIS INJECTION AND  HAD NO OTHER ISSUES FOLLOWING THE VACCINE DOSE #1 UNTIL THE FOLLOWING: 2. DOSE #2: AT ABOUT 9:30 AM ON MONDAY, MARCH 22.  THE INJECTION (LEFT ARM, AGAIN) WAS, IN COMPARISON TO THE FIRST 'JAB', CLEARLY UNCOMFORTABLE BUT THIS DID NOT CONCERN ME.  HOWEVER, ON MY DRIVE HOME (ABOUT 20 MINUTES) MY ARM GRADUALLY BECAME VERY SORE, AND CONTINUED TO BE PAINFUL AND GET WORSE OVER THE FOLLOWING HOURS.  I COULD NOT USE OR LIFT MY LEFT ARM WITH SIGNIFICANT PAIN NOT ALEVIATED BY IBUPROFEN (3 TO  4 AT A TIME).  THIS CONTINUED THROUGH WEDNESDAY, MARCH 24 AT WHICH TIME I TOOK ONE (1) TYLENOL AND ONE (1) IBUPROFEN, AND THAT HELPED WITH THE ACHE.  AS OF THURSDAY, MARCH 25 (WHEN I AM RECORDING THIS) IT  IS LESS PAINFUL, AND I AM ABLE TO LIFT THE LEFT ARM WITH LESS DISCOMFORT.   MY SHOULDER SOCKET ALSO SEEMS TO BE LESS PAINFUL.  I AM SENDING THIS INFORMATION BECAUSE I READ THAT TINNITUS HAS BEEN EXPERIENCE BY A SMALL GROUP OF VACCINE RECIPIENTS, AND BECAUSE I AM CONCERNED THAT PERSONS THE EXPERIENCE WAS MORE THE WAY THE VACCINE WAS INJECTED (MAYBE NOT IN THE CORRECT LOCATION).  I HAVE NOT FELT THE NEED TO SEE A PHYSICIAN OR OTHER HEALTH PROVIDER.  I HAVE CHANGED MY insurance AND AM REVIEWING NEW PROVIDERS.
No additional adverse effects were reported; patient received an expired dose of VAQTA; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-JUN-2020, patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) Injection, 0.5 milliliter, lot # S002507, expiration date 04-APR-2020, for prophylaxis (patient route of administration was not provided).   According to the reporter, the vaccine was properly stored, and no additional adverse effects were reported.
No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 18-Oct-2022, the patient experienced UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed). At the time of the report, PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Reportedly, a thawed shipment of vials of the Moderna COVID-19 vaccine were received. Once received, they placed the shipment in the refrigerator except for 1 vial, that was stored on the freezer. The vial was again thawed and then administered to 4 patients in the facility. The doses applied were 2 second boosters and 2 first boosters on the 16Apr2022. No treatment details were reported. This case was linked to MOD-2022-545269, MOD-2022-545270, MOD-2022-545272 (Patient Link).
6/18/08 vomiting & diarrhea x2 days.  6/20/08 macular rash on chest, abdomen, back, bilateral-not itchy, not painful not numb/tingling.  Had been exposed to family member with vomiting & diarrhea.
Patient reports that about 1 week after receiving the injection she started noticing redness around injection site as well as a hard spot or knot at the injection site. She reported no pain, swelling, or warmth during any of this time. Ten days after injection, she is experiencing an area of redness that is 3-4 inches around injection site. Pt denies any swelling, warmth, or pain at this red area.
Moderna COVID-19 Vaccine EUA  Vomiting,diarrhea,arm edema, temperature severe body aches,headaches . Started approx 24 hrs after vaccination. Today is the first day out of bed . I have had COVID . This was worse.
09/08/2022 COVID arm spread across my chest. I was restless and started to run fever. The next morning, I noticed the red spots across my chest. I used a topical cream called clobetasol propionate to treat the symptoms. It took 2-3 days to recover. I took TYLENOL and ibuprofen for the fever. My fever was around 102.0.
7 minutes after left arm swelling shoulder to elbow, told pharmacist- they didn't care,  14 minutes in got migraine with aura and felt like a steel spike entering head. Left store pharmacist said take 2 Tylenol.   Arm swelling lasted only 30 minutes, migraine for 4 hours.  By 10 pm that night chills off and on.  Next day in evening slight fever 100. 3 lasted off and on through the night, responded to Tylenol. This morning woke to swelling under left armpit.  took Tylenol and shower just now going down after  7 1/2 hours.    NOTE: first shot resulted in arm swelling where the vaccine site watched me for 30 minutes it went down after an hour. Second shot only resulted in a migraine lasting 4 hours.
Pain and redness of the face. HA, joint pains, body aches, fatigue
Patient's caregiver reports that she was very dizzy about 20 minutes after receiving the vaccine. Within the first hour of receiving the vaccine she was vomiting.
Mom reported he started favoring right leg when walking, wasn't bearing much weight on that leg, mild swelling at injection site.  Took him to ER after poss seizure.
A few weeks after vaccine I had numbness and pain on my back and went to urgent care and was diagnosed with shingles. I was prescribed valacyclovir. I took this medication for 7 days and the symptoms went away at 1.5 weeks to 2 weeks after the medication.
This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-JUL-2015 and on 24-SEP-2015, the patient was vaccinated with two separate doses of improperly stored oral, ROTATEQ (doses were not provided) lot # K015816, expiration date: 29-MAR-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (administration routes, lot number and expiration dates were not provided). No concomitant medications were reported, neither was any adverse effect. This is one of two reports from teh same reporter. Additional information has been requested.
Pain- Immediate.  Lower shoulder ROM until 1 hour, increased swelling by evening, warmth, redness by evening. Extensive warmth with hardness, redness and bruise around injection site (from above the dot to 3 inches from elbow 1/2 way around arm. 4 days recovery.
Gums in her mouth started to hurt. Real bad cold sensitivity on her from teeth also pain to the gums upper and lower jaw.  Went to dentist and nothing was found that could have been causing the pain or sensitivity.
Information has been received from a registered nurse concerning a 5 year old male patient with no allergies and no pertinent medical history, who immigrated from another country, who on 07/18/05 was vaccinated intramuscularly with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot # 649241/0032R). It was noted that the patient was not ill at the time of vaccination. On 08/18/05, the patient had a titer drawn which showed that the patient was immune to measles and rubella but failed to seroconvert and hand no immunity for mumps. It was noted that the same child was vaccinated with varicella virus vaccine live on 08/01/05, and had varicella antibody response failure (WAES#0511USA03158). The reporter indicated that the patient did not have adverse events following prior vaccination. There was no product quality complaint reported. The patient sought unspecified medical attention. No additional information is expected.
Client reported tingling of the tongue. Denies any other symptoms. HR 64, B/P 140/82, RR 12. Client waited for another 30 minutes with no new symptoms. Instructed him to call 911 or go to ER if new or worsening symptoms develop.
Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus symptoms, headaches- continue to have sinus symptoms- "congestion, headaches, nasal drainage daily with bleeding" Not sure if related to the Pfizer vaccine- just have had continuation of sinus symptoms post 2nd vaccine. Nasal bleeding miner however, frequently throughout day when blowing nose- have been using OTC saline gel or spray-
Patient reported that at 09:25 AM she had problems in class with equilibrium, "lightheadedness and dizziness", inability to easily hold her head up, or focus visually on a screen in a classroom, "wobbly vision, glazing over", tingling on the anterior surface of both legs.   She stated that all effects lasted 40 minutes in length, except for visual effects that lasted 15 minutes.  She also reported having orange juice, pancake and strawberries at 9AM this same morning.  She denied any respiratory issues, pain, numbness or strength/weakness problems.  Vital signs: T 97.4, P 78, R 14, O2sat 98%, BP sitting 118/70, BP standing 120/74.  Pupils were equal and reactive to light, and she was oriented to person, place, and time.
Fever limiting activity to staying in bed; headache, body aches, congestion, nausea, diarrhea
Patient became very dizzy, facial flushing, warmth almost immediately after receiving vaccination; patient was monitored closely - deep breaths and began feeling better, felt okay after 20 minutes
Patient C/O itching and bumps on abdomen that she at first thought were mosquito bites approximately 48 hours after receiving Tdap, MCG and Gardasil #1 vaccines. By the following morning the rash had spread to include her legs, arms, chest and neck. No report of SOB, HA, Fever or GI symptoms. She was seen at hospital ER where she was treated with Benadryl, and sent home on a Prednisone taper (20 mg 1 tab PO X 5 days). Symptom: Hives Start: 08/11/2007 End: 08/13/2007 Comment: First appeared on abdomen. Symptom: Rash, pruritic Start: 08/11/2007 End: 08/14/2007
dose started squirting out where the needle attaches to the syringe; don't know how much the patient received and don't know how much came out of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (dose started squirting out where the needle attaches to the syringe) and INCORRECT DOSE ADMINISTERED (don't know how much the patient received and don't know how much came out of the syringe) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 017C21A) 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 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (dose started squirting out where the needle attaches to the syringe) and INCORRECT DOSE ADMINISTERED (don't know how much the patient received and don't know how much came out of the syringe). On 01-Jun-2021, PRODUCT ADMINISTRATION ERROR (dose started squirting out where the needle attaches to the syringe) and INCORRECT DOSE ADMINISTERED (don't know how much the patient received and don't know how much came out of the syringe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Presented with cough, headache, SOB, hypoxiax 7 days; Admit 9/21 to tele with Covid PNA; tx with zithromax, rocephin, steroids, remdesivir, actemra, zinc, singulair, Vit C, maxipime, Vit D3; initially on room air, progressed to HF O2; 10/1 to ICU with HF O2; 10/2 intubated; Spo2 80's; 10/2-10/3 family transitioned to hospice/comfort care; Patient expired.
Mother states child's upper left arm was starting to swell and was red. States child could move arm but complained of pain.
I think there was some sort of reaction between my vaccine and my antidepressant. For the next 10 days after my vaccine I has spikes of both anxiety and depressive episodes , also a mild headache. All is better now but thought you all ought to know.
Hives on trunk, cellulitis at injection site Treated with prednisone, claritin, hydrocortisone cream and antibiotic for cellulitis
About 20 - 25 minutes patient developed scratchy throat in the parking lot after initial 15 minute observation period. Was brought back to Observation for assessment. Denies other sx (no SOB, palpitations, sensations of lip or throat swelling, itchiness, etc.) Patient observed for additional 20 minutes . Symptoms improved and no development of additional or denied symptoms. Patient requested to leave after repeat observation. Discharged with strict ED precautions. All questions answered.
Mild nausea, Right deltoid red, swollen, arm aches and hurts more when moved, rash developed on upper arm.
The syringe failed during administration and the vaccine did not go into her arm.  I prepared another dose and administered it.
Next day from TDAP, had fever 100.4 and diarrhea.  One week later had severe joint pain with swelling and fever again. Went to Dr., was put on antiinflammatory meds and did blood work.