chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Pleuritic and positional pain over precordium, clinically consistent with pericarditis, starting about 24 hours after injection. Treatment includes aspirin and ibuprofen.
HE PASSED OUT ABOUT 7 MINUTES AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. VITALS LISTED BELOW. HE SAYS HE HAS A HISTORY OF PASSING OUT.  HE RECOVED AND DID NOT WANT TO GO TO ER, SO HE WAS RELEASED TO HOME.
Initial report received from a health care professional on 14 September 2012. 20+ patients (date of birth and gender not reported) with no reported medical history and concomitant medications had received FLUZONE intradermally on an unspecified date (batch number UT4474AA). According to the reporter, the patients had a couple of "weird reactions" that may not be associated with the vaccine. Laboratory investigations and corrective treatment was not reported. The outcome was not reported. Documents held by sender: None.
No additional AE reported.; Customer reports a patient received VARlVAX intramuscularly 03AUG2021.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 03-AUG-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) which was reconstituted with sterile diluent as prophylaxis, 1 dose, by intramuscular route (concentrations, number of administered dose, vaccination scheme frequency were not reported; lot number T032321 and expiration date 22-SEP-2022) (incorrect route of product administration). No adverse events were reported.  Lot No. T032321 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 22-SEP-2022.
Attempted to give TDAP, but due to faulty syringe, injection was unsuccessful. Manufacturer, Sanofi Pasteur was contacted and they stated if patient did not receive full injection, he is due for another injection at any time. No waiting period. Mother aware, and will bring him back with her to appointment 7/26/10 due to already leaving the office.
Pt states her arm developed a rock like bump at injection site. Pt Developed a rash after receiving  vaccine within 1 day.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; Product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications details were reported.  Beyond use date of the vaccine was 21-May-2021.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.  This case contains information for one of the patient who received Monovalent vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received includes no new information (NNI); Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:case
two days after getting the shot I got heart palpitations and my tongue started throbbing, and since then I have had an irregular heartbeat and have experienced ED
Extreme soreness, redness, swelling moving over a large portion of my upper arm. Using ice packs and taking BENADRYL.
This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th September 2018, the patient experienced feeling unwell, injection site erythema, injection site warmth, injection site rash, injection site pain and hypersensation skin. On an unknown date, the outcome of the feeling unwell, injection site erythema, injection site warmth, injection site rash and injection site pain were not recovered/not resolved and the outcome of the hypersensation skin and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the feeling unwell, injection site erythema, injection site warmth, injection site rash, injection site pain and hypersensation skin to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. One of his nurses reported that pharmacist gave SHINGRIX to the patient by subcutaneous route instead of intramuscular route, which led to incorrect route of drug administration. Then at morning of the reporting day, the patient called and went to the office because she was not feeling well, she had a giant rash near the injection site. The injection site was also very painful, red, hot to the touch. It was a sensitive spot.
Woke up feeling extremely tired, achey, had chills, sore arm. As the day went on I was nauseous and have a swollen lymph node in injection arm.  And I have had a headache whenever I move for 2 days.
Bruising in the arm that received the injection, extending from wrist to upper chest, restricted to the side of the chest of the arm that received the injection.  This was associated.
Wheal over site, erythematous, pruritic. Subjective tongue swelling.
Pt given 0.5 ml of Moderna booster injection. No s/s of adverse reaction during observation and exit
Called mom and to see if he was having any reactions and she states that he was doing just fine and napping when I called. I told her to just keep an eye on him and call back if his symptoms change.
8-16-16-Dose #1 TWINRIX and Typhoid VI. 8-171-6 red swollen tingling watery eyes.
This spontaneous report has been received a vaccine coordinator, concerning an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 29-MAY-2017, the reporter stated that the patient received an improperly stored doses of ZOSTAVAX lot # M032638 and expiration date 04-OCT-2017 (dose and route of administration were not provided) for prophylaxis which was reconstituted with an improperly stored of sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse event was reported. The vaccine was stored at a temperature of 9° Centigrade to 25° Centigrade (11° Centigrade), time frame of 1 hour; no previous temperature excursion was reported. Digital Data logger report was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA002297.
This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored RECOMBIVAX (Lot number M029233, expiration date 09-AUG-2018). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects was reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same reporter. Additional information has been requested.
pt recv vax 15JUL98 & exp mouth & tongue dryness, white plaque-like oral surface & lip swelling;seen by ENT specialist;dx poss Sjorgren's disease;
Two vaccinees experienced total muscle weakness following Engerix-B vaccinations ("mostly in legs, occurring the day after").
asked about the safety of receiving the vaccine in the context of breastfeeding and then went on to receive the vaccine; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a female patient of unknown age. Her concurrent conditions included breast feeding. The patient's historical conditions included delivery. Her concomitant therpies were not provided.   On an unknown date, she asked about the safety of receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) in the context of breastfeeding and ensuring it would not affect her baby and then went to receive the vaccine (maternal exposure during breast feeding).    This is one of two reports derived from the same literature article ( linked MARRS # 2105USA000246).   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2105USA000246:
Patient was in the office for his 12 month shots. MMR, VZV and Hep A were given. We were not made aware that shots were given at the health department until after shots were given
minor injection site pain (started during the day of vaccination), chills, fever, faster than normal heartbeat (started that night, about 16 hours later, and lasted until morning)
This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), MALAISE (has felt so sick) and PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A, 001B21A and 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)), MYALGIA (body aches) and CHILLS (chills). 24-Nov-2021, the patient experienced MALAISE (has felt so sick). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), MALAISE (has felt so sick), PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, Body temperature: 100.5 (High) Fever (highest's 100.5 F). On 29-Nov-2021, Body temperature: 99.6 (High) Low grade fever (99.6 F).         Concomitant medication was not provided Patient says she also used a decongestant for her adverse events.   This case was linked to MOD-2021-400255 (Patient Link).   Reporter did not allow further contact
I had terrible urticaria all over his body.?I took antihistamine 3 times for 4 days.
A report was received from a health care professional on 2/24/04 concerning a 46 year old female vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Three days after the vaccine I started to have tightness in my chest when exercising.  On June 9, I had a mild heart attack.  One June 10th, heart catheterization revealed that I had blockage in two arteries
Patient started to experience swelling, itching and redness at the injection site 1 day after receiving the pfizer covid 19 vaccine.  The site is warm to touch and is the size of is that of 2 quarters per patient's dad.
Began with pain at the opposite side of the body in the extermities but today I have an inflamation, like if I am retaining liquid, under the left side (vaccination side) of the left arm
Rec'd flu shot 11-5-15. 24-49 hours late developed localized pain. Over the course of days to week pain worsened and by mid December pain involved whole shoulder, arm pit, clavicle, upper chest, side and back. Pain radiated down left arm into hand, thumb, index and middle finger. Point tenderness was severe. interrupted sleep. Used ibuprofen. applied warmth and continued to use arm.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
-Pt received COVID19 Moderna Vaccine today around 10:30 on 01/08/2021.  -Pt has type 1 diabetes. -Just before and after vaccine was given, her sugars climbed to 299 (she has a monitor that checks constantly). Her normal sugars range from 120-150. -She reports that reaction is normal for her in stressful situations. Patient has history of mid anxiety. No hx of allegies. -She gave herself 1.5 units of insulin.  -She denied blurry vision, headache, dizziness, polydipsia polyuria, polyphagia, headache, chest pain, shortness of breath, difficulty breathing, rash, itchiness, nausea, vomiting, abdominal pain, fatigue.  -I evaluated patient.  -Vitals normal. -After a couple of hours, her sugars were back to normal.  -Pt was observed for multiple hours, as she was also simultaneously working in the vaccine clinic.  -Pt discharged after 4-5 hours.
Blister; Mouth ulcer; This is a spontaneous report from a contactable consumer (parent), from a Pfizer Sponsored Program Pfizer Rx Pathway. An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included type one diabetes. Concomitant medications were not reported. It was reported that, reporter son, age 18 who has type one diabetes probably had a blister, mouth ulcer, severe reaction to his first dose of Your Pfizer covid 19 vaccine. He was seen by his pediatrician, and his DM physician . an immunologist and infectious disease doctor were consulted via photos. All appropriate test were done- herpes, cytomegalovirus, mono. a CBC were all negative . The time frame suggests an adverse reaction. All experts advice was mixed on whether patient should receive his second. The patient underwent lab tests and procedures which included Cytomegalovirus (cytomegalovirus test): negative on an unspecified date, Mono. a CBC (full blood count): negative on an unspecified date, Herpes Test (herpes virus test): negative on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Started as mild rash on left hip on Sunday (2 days after injection) Spread for several days until it was intolerable on Monday 10/4/21. It had become very large on my left hip/flank area, spread to both arms, my chest, and lower back. Spoke to infection control nurse at work on Monday 10/4. She recommended I be seen. Went to ER physician. He said it was a systemic reaction to vaccine. My throat felt odd that night and worsened the next morning.  Started Prednisone and antihistamine Tuesday 10/5 AM.
Severe cramping massive bleeding; severe cramping massive bleeding on 24May2021; I found out I was pregnant a few days after receiving my first vaccine a few days later, Severe cramping massive bleeding; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administered in Arm Left on 30Apr2021 12:15 (Lot Number: Ew1067) at 38-year-old as 1st dose single for covid-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient found out she was pregnant a few days after receiving her first vaccine a few days later, severe cramping massive bleeding on 24May2021. The patient ended up bleeding for a total of 19 days. The outcome was unknown. The patient became pregnant while taking bnt162b2.  The patient was due to deliver on 07Jan2022.  The lab tests included blood test: negative  on 28May2021. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.
MMR given 1/21/09.  Came in with swollen R side of face on 2/9/09
16  year old previously got 1st dose of Moderna, so had to give 2nd Moderna per guidance, no problems identified
Everyone she talks to that had reactions from the booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Everyone she talks to that had reactions from the booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Everyone she talks to that had reactions from the booster). At the time of the report, VACCINATION COMPLICATION (Everyone she talks to that had reactions from the booster) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-388496, MOD-2021-394964.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: No new information added
24 hours after vaccination developed dizziness and muscle pain which progressed rapidly to confusion,  slurred speech, and labored breathing. Acute onset (minutes) developed full body ?pins and needles? and numbness especially prominent in hands, feet, and sides of neck. Bilateral. Acute symptoms lasted approximately 30 minutes. After 30 minutes, acute symptoms improved but followed immediately by chills, extreme lethargy, and flushing of face. I was disoriented (?dazed?) for approximately  3 hours after episode. I was in a remote area and was not able to present to medical care by the time symptoms subsided.
PAtient presented  After  vaccine: Nausea , weak FatiGue  HBP  143/91