chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Mild swelling at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PRAVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE SWELLING (Mild swelling at the injection site). At the time of the report, INJECTION SITE SWELLING (Mild swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported on 02 March 2021, that she received first vaccine dose on her right upper arm on 01 March 2021, and had mild swelling at the injection site. Patient takes Pravastatin for her cholesterol.
2nd Dose not taken; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd Dose not taken) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A   or 052C4A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd Dose not taken). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd Dose not taken) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller called and need to know about  ability to take 2nd dose.   Reporter reported that 1st Moderna dose was on 30July2021 to left non dominant arm via IM injection. Due to work and weather, I was not able to take 2nd dose at appropriate time which was 27Aug2021. Patient eligible to receive 2nd dose still? what was proper procedure. Pharmacy said since patient did not receive in 42 days, so patient to wait for booster. Caller confirmed no side effects with 1st dose and is on no other medications.  Concomitant and treatment medications were not provided.
administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219377:same reporter US-GLAXOSMITHKLINE-US2021219382:same reporter US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter
18 hours after administration, vasovagal syncope and low blood pressure for 11 hours after onset; patient fainted and could not sit up or stand -- blood pressure would drop; symptoms persisted for 11 hours
Felt dizzy  Racing heart with chest pressure  Some difficulty breathing  Clammy palms  Placed me in supine position  Observation maintained until vitals returned to normal
Pt stated he has a phobia to needles before vaccine given. After given RN asked if he was OK. He stated "Yes." RN instructed him to sit in one of the chairs for 15 minutes before leaving. He stated understanding. He got up from the chair he was in and started walking toward the other chairs. When he got about 6' away he suddenly collapsed, falling to the ground. RN yelled for help and ran to his side. Pharmacy staff called 911. He was pale and not alert immediately. He came too in 4-5 seconds. As he was coming too he kept saying he wanted to get up and go home. RN encouraged him to remain laying on the floor and assisted him with his feet up on a chair. He called his mother. Water and food were given to patient.  Emergency paramedics arrived. Patient was a personal friend of one of the paramedics and told him he did not want to go to the hospital or have them take his vitals, insisting he was fine. After his mother arrived he tried sitting up on the floor for awhile, eventually he tried sitting in a chair. He was only able to sit in the chair for a minute before becoming too lightheaded and wanted to lay back on the floor to not pass out. He and his mother remained until 3:20 before patient was eventually able to be assisted walking to mothers car and she was going to take him home. The patient remained here for 1.5 hrs before able to ambulate and leave.
I developed stroke like symptoms as I was driving away. I did not recognize until I tried to drive that I was having a problem. I  felt like there was a disconnect between brain and body and could not safly drive and then could not speak when I called 911
Expired vaccine was stored in refrigerator; No adverse event; gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Unspecified COVID-19 vaccine dose 2) and COVID-19 vaccine (Unspecified COVID-19 vaccine dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and COVID-19 vaccine.    On 23-Aug-2022 at 2:27 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Aug-2022 at 2:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration 23-Aug-2022, vial was removed from the freezer and placed into the refrigerator on 22-Aug-2022. The vial did not undergo any temperature excursion.    No treatment details were reported.
No adverse effects reported; patient received a dose of improperly VARIVAX; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical historyand concurrent condition were not provided.  On 24-SEP-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R023502, expiration date 16-AUG-2010; dose, strength and route were unknown) for prophylaxis, which was reconstituted with properly stored sterile diluent. The vaccine was exposed to temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (21.7 degrees Fahrenheit) for 360 minutes (incorrect product storage). There was no previous temperature excursion. The data logger was involved. No adverse effects were reported.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication information was provided. Some people have had a serious reaction with the second shot of the Moderna vaccine. The wife of a friend of his stated her arm hurt really bad after the second Moderna shot and equated it to being in a car accident.  It w as a 6-10 inch area from shoulder to elbow and it lasted for 3-4 days.  She was 75 or 76 years old. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided.
*Note: I have never had allergies before my covid vaccine.  I woke up the following day with red, itchy hives on my face which soon spread to my hands.  These hives lasted for about 5 days.   Since my covid vaccine, I have developed anaphylactic allergies to random things including my birth control which I have been on for two years.  I also have discovered an allergy to something in my facial cleanser (maybe coconuts).
HEADACHE, FEVER, CHEST PAIN.  SEPSIS W/U, IV FLUIDS, IBUPROFEN, COVID SWAB IN ER
On 2/2/2021, I got my first dose of Moderna at 5:30PM. At around 5:30AM on 2/3/2021, I woke up shaking, freezing, and aching all over. I was shaking so hard that my bed shook, too. I alternated between freezing and feeling like I was burning up and sweating; when I was hot, I couldn't cool off fast enough and I would pass out. After that, I would then begin freezing again. I was also extremely dizzy. My symptoms were so intense that they felt worse than flu symptoms. I had an extreme headache, which gradually became less intense as the day progressed; I took Tylenol, which helped some with the headache pain. The body aches, shaking, chills, hot flashes, and headache all lasted until about 6:30PM that evening. I was then so exhausted that I slept for the following 12 hours. The next day, the symptoms were all gone and everything was back to normal.
Immediate local reaction, quarter size red swollen area around injection site, heat around read area, patient denies symptoms of systemic reaction, monitored patient in HO for 30 minutes after injection.
I contract covid around two weeks after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I contract covid around two weeks after the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I contract covid around two weeks after the first dose). At the time of the report, COVID-19 (I contract covid around two weeks after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment mediations were provided. Patient would like to know if patient contract covid around two weeks after the first dose, how long do patient have to wait for the second dose.
dry eyes, then decrease close vision (reading) acuity. No color, desat, wavy lines, pain, diplopia, redness or scotomoa
PATIENT REPORTS RASH DEVELOPED BILATERAL UPPER ARMS ON THE EVENING OF VACCINATION, RASH SEEMS TO BE SPREADING TO LEGS AT THE TIME OF PATIENT REPORTING TO PHARMACY 3 DAYS LATER.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On 05-AUG-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (lot # unspecified, expiry date: 23-JUL-2016). No adverse effects were reported. Additional information has been requested.
Received the second dose outside of the recommended intervals; Did not receive the second dose >35; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose >35) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose outside of the recommended intervals) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose >35). On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose outside of the recommended intervals). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose >35) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose outside of the recommended intervals) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Added event  was received the second dose outside of the recommended intervals.
blood pressure is very low/82 over 35; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (blood pressure is very low/82 over 35) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced HYPOTENSION (blood pressure is very low/82 over 35). At the time of the report, HYPOTENSION (blood pressure is very low/82 over 35) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 82/35 (Low) Blood pressure is very low.         Concomitant product use was not provided.  Treatment product information was not provided.
Case number PHEH2014US003793 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 04 JAN 2014. No adverse events were reported following the maladministration.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Had a sore arm in the area of injection; Fatigue; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient in Canada only got the 1st dose of the Pfizer vaccine and had a sore arm in the area of injection. The patient had soreness at the injection site and fatigue. The outcome of the events was unknown. . No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On or about April 17 he began having shortness of breath with exertion. On or about May 1 he began having severe right flank pain. May 3 he went to the ER a Bilateral pulmonary embolism diagnosed.
Had injection at 5:30 pm 3/18/21.  7:00 pm 3/19/21 had chills and was extremely lethargic. Went to bed. Slept 14 hours. Body aches. 1;45 pm 2/20/21, feeling back to normal. Perhaps these  adverse reactions due to the fact I had Covid-19 November, 2020?
Chest pain, tongue swelling, low blood pressure, EpiPen given, ER ambulance, EpiPen again, admitted to hospital for anaphylaxis.
p/vax pt devel inj site rxn by large area of swelling; redness; warmth;
This case was considered medically important (OMIC). Information regarding FluMist was received from the father of a 9 year old male who experienced retinal bleeding. AT 9 years of age, the child received a dose on 12/11/03. Upon awakening on 12/12/03, the child noticed "black spots" in the vision of his left eye. He was seen by an eye doctor who reported "bleeding in the retina but no detachment." The father indicated that his son's vision is improving but the spots persisted as of 12/12/03. The child's physician reported that he spoke with the mother of the patient and confirmed this event is accurate.No additional info was available at the time of this report. Follow-up information received from the physician provided confirmation of the event.
Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) 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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    No concomitant product reported.  051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  AR5186C was previously reported. Pediatric dose was given to adults mistakenly and each patient received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  No treatment medication reported.  This case included information of patient 48 out of 104 patients.
First dose was fine. Sore arm for a few days. 6 hours after second dose, I experienced severe injection site pain, no swelling or redness, mild chills. I went to bed at 10pm with no major issues other than a sore arm. I woke up at 7am no issues and went about my day working from home. At 7pm chills set in, I went to bed. I woke at 10pm to take 400mg of ibuprofen. Around midnight, I woke with a temperature of 103F. Went back to bed and awoke at 3am In puddle of sweat. Zero symptoms and felt great. One day later still feeling good. Just thought it was strange that the reaction was so delayed and scary.
Redness and swelling on the same arm where the vaccine was administered, but on the opposite end or underside. Advised patient to take ibuprofen 200mg to take 1-2 tabs 3 times a day as needed.
Within a minute of shot as he walked out of waiting area he became dizzy, weak and complained of severe HA. Did not faint but was clammy and pale. Vital signs stable. Laid down, HA so bad he was crying-MOTRIN given. Monitored for 75 minutes: felt better. Soon 24 hours later still having HA, dizziness, blurred vision (eye test normal).
ON 11/16/2022 PATIENT CALLED PHARMACY REPORTING A VERY SORE, DULL ACHE IN HER LEFT ARM AFTER RECEIVING THE FLU VACCINE. SHE FOLLOWED UP WITH HER DOCTOR AND WAS GIVEN AN ANTI INFLAMMATORY AND ANTIBIOTIC. SHE CONTINUES TO HAVE PAIN. I RECOMMENDED CONTINUING HER ANTI INFLAMMATORY AND ROTATE HER ARM. TOLD HER TO FOLLOW UP WITH DOCTOR IF PAIN PERSISTS.
he had some facial drooping then resolving and his hand released an object he was holding, limbs going numb and he felt like he was having a stroke.    This occurred about an hour after his vaccine.  in the next few days he experienced severe headaches.  All adverse experiences have resolved as of 1/6
Temporarily loss of cognitive abilities, ( about  3-4 hours) , lasting headaches ( about 8 hours)
Lingering arm pain at injection site. Patient has been feeling dizzy, especially when getting up from bed in the night. She made appointment with PCP and was told dizziness could be due to BP medications. Arm pain is normal side effect of vaccine and should reduce with time. Dizziness has reduced, however patient still experiencing lingering arm pain.
Pt. started with red, itchy, pain on Saturday 2/11/17 at localized site of reaction. Today Monday the pain is radiating down the arm. Still red.
Large red patch with pain and swelling appeared below approx 2-3 inches below injection site.  Patient reports fatigue and possible fever