chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a company employee, referring to her friend's 1 year old daughter. Information of current condition, concomitant therapy and historical condition was unknown. On an unknown date in 2018, the patient vaccinated with M-M-R II (lot number, expiration date, dose, frequency and route unknown) for prophylaxis (reported as received "series of shots recently"). On an unspecified date in 2018, the patient was admitted to an unspecified hospital, and was diagnosed with idiopathic thrombocytopenia (ITP). Unspecified treatment was given for the event. The outcome of the event was not provided. The causality assessment was not provided by the reporter. Upon internal review, idiopathic thrombocytopenia was determined to be medically significant.
Bump, raised muscle on left deltoid, pain, swelling and inflammation, limited arm mobility. Dull pain more in the AM and at bedtime.
Same day: mild arm soreness Next day: severe arm soreness, headache, weak, felt like passing out, chills, extreme fatigue 2 day later: medium arm soreness, medium fatigue, dizziness, hives all over chest and face, swollen tongue and gums, fever
Patient also reports loss of appetite. Nausea, Vomiting and tongue swelling.
Menstrual cycle late by 6 days (I am regular normally)  and unusually heavy (frequent, large clots). I am continuing to bleed a large amount well beyond normal (day 5).
Joint pain; headache; nausea; vomiting; chills; body aches; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches). At the time of the report, ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-071072, MOD-2021-071206 (E2B Linked Report).; Sender's Comments:  MOD-2021-071072:First dose of vaccine case MOD-2021-071206:Daughter Second dose case
shingles on his face; A spontaneous report was received from a healthcare professional concerning a 33-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles on his face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced the event(s) shingles on his face.  Treatment details included Valtrex and Gabapentin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shingles on his face was unknown..
Information has been received from a physician concerning a 23 year old female with no allergy or medical history who on 02-JUL-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM. Concomitant therapy included YASMIN. 2 days after the vaccination (on 04-JUL-2008) the patient developed pancreatitis. The patient was admitted to an unknown hospital on 04-JUL-2008 and was diagnosed with pancreatitis. The physician is unable to provide details of the hospitalization except that the patient was discharged fully recovered on 09-JUL-2008. The patient underwent abdominal ultrasound during hospitalization. The physician considered the pancreatitis to be immediately life threatening and disabling. Additional information has been requested.  1/20/09 Reviewed hospital medical records of 7/5-7/9/2008 FINAL DX: acute pancreatitis; recent Gardasil shot; use of BCP for contraception. Records reveal patient experienced abdominal cramping pain, diarrhea, vomiting, fever after light ETOH consumption day prior to admit.  GI consult done.  Tx w/IVF & kept NPO.  Improved & d/c to home w/PCP f/u.
mini stroke; having vision issues; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient received the first dose on 02Mar2021 12:15 on the left arm. The patient medical history was not reported. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for birth control. The patient previously took erythromycin and experienced allergies. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 24Mar2021 8:15, patient started having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes, this lasted for about 45 min. Her doctor had the patient go to the ER where they did a CT scan thinking of possible mini stroke, no signs of that scan came back clear. AE resulted in emergency room/department or urgent care. No treatment received for the adverse events. Patient recovered from the events on 24Mar2021 09:00.  No follow-up attempts are needed. No further information is expected.
It started a serve pain in my arm at the injection site.  Then, I had a sore arm about week.  I noticed that my arm was getting stiffer and stiffer.  I feel like I had arthritis and stiffness in my arm since May.  I been doing rehab and therapy on my arm that I do every week.
10-22-07 1115 Employee comes in to office. shows nurse red, hot, swollen area on arm. States it has "come-down" from yesterday. Measure 32 cm x 55 cm (R) deltoid. Will recheck. 10-23-07/1500 same, no chge. 10-25-07/1315 Empl states all redness and pain gone.
Fever up to 101 2 days after injection of Pneumovax and inactivated Fluvirin L deltoid. Within 5 days a blistering rash started at the injection site and around her left breast..a cellulitis type reaction. She had pain under her breast and in her left axilla and at the injection site that lasted more than 2 weeks...all sx eventually resolved.
soreness; Couldnot stop shaking the night; rotatory vertigo; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness), TREMOR (Couldnot stop shaking the night), VERTIGO (rotatory vertigo) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESTRADIOL (ESTRADIOL TRANSDERMAL) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness), TREMOR (Couldnot stop shaking the night), VERTIGO (rotatory vertigo) and CHILLS (chills). On 11-Mar-2021, VERTIGO (rotatory vertigo) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (soreness), TREMOR (Couldnot stop shaking the night) and CHILLS (chills) outcome was unknown.            Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: follow-up received no new information On 22-Jul-2021: Follow-up received and contains non-significant information
At initial injection Feeling chills in both legs, then warm all over. Lasted less than 15 minutes. Feeling chills in legs or other parts of the body as though outside in the cold of winter.  No other side effects that I recognize. Still feel chills 20 days after vaccination.
At pharmacy, Customer received the shingles vaccine per her prescription. No contraindications existed. She was given VIS statement, had no questions, I counseled her to stay 20 minutes, she said she would leave with her husband. Vaccine given at 11:20 at about 11:30 husband said she was sitting on bench at entrance and was very pale and dizzy. I called a code white (customer accident page) and rushed to her. She said she did not feel well, got hot feeling and was dizzy. She refused emergency treatment. She quickly sat up and I asked to check her BP, it came up 56/41 which was very concerning, I asked her to call 911 she again refused. She said she was ok and laid back down. 5 minutes later I checked her BP and it was up to 102/72, color looked much better, she then decided she felt well enough to leave. I again offered to call for emergency help she refused. I told her I would follow up with her this evening. I spoke to Dr office and they are aware of the reaction and have documented it.
Sunday after receiving the vaccination she felt very tired, Monday was running a low grade fever, extremely tired and ached all over, Tuesday morning had localized rash all over on your arm, where the injection was, and was swollen, hot to the touch.  Went to urgent care on Tuesday, they prescribed doxycycline 100 mg 1 capsule twice daily for 7 days, Started to resolve in the next few days.
1 hour after receiving influenza vaccine noted nasal drainage, cough, body aches, fever.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 9:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.18.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43 and 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Soon after receiving vaccine had upper respiratory congestion. She began feeling dizzy. Friday the 13th she went to bed with dizziness and when she woke at 2 AM she stood up and the dizziness made her lose her balance and she fell. Several days later she found she had fractured her right 2nd toe from the fall caused by the dizziness.
24 Hours after injection on left upper arm, mom noticed area of redness and child scratching. Are is 4 X 81/2 cm with a small amount induration. Mildly tender on palpation.
Patient presented to pharmacy on 5/10/21 and reported not feeling well since first dose of covid-19 vaccine received on 5/3/21. Side effects began 5/4/21 and included nausea, vomiting, fatigue, fever, and dizziness. Recommended patient to continue otc analgesics, hydration, and contact PCP for further follow up.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 03-APR-2014 the patient was vaccinated with ZOSTAVAX (route, dose no., dosage and lot number unknown). On an unknown date in April 2014 the patient experienced ZOSTAVAX (rash/blisters in distal left forearm in c8 dermatomal distribution proximal to the wrist joint). The treatment plan included acyclovir 800 mg, oral tablets, i tab five times daily, during working hours. The outcome of the event was unknown. Additional information has been requested.
severe pain at injection site, some redness, warmth at site, pain to shoulder and right side of chest, anxiety,
Itching all over on second day. Lasted roughly an hour at the most. Subsided.
Patient was given Monovalent Moderna 6 months- 5 years on 4/21/2023. The vaccine was no longer recommended for use as of 4/18/2023. Dr. notified and recommend to notified patient to come back in one month for Bivalent dose. Patient notified on 4/21/2023 and verbalized understanding.
Pt states she received both her HD flu and pneumococcal 23 vaccine in same site. Next day swelling, redness, and pain below injection site.  Symptoms worsened the next day affecting about a 7x11 cm area, but had slight improvement by 3rd day after taking Motrin 400 mg x 1 (7x10 cm) and less tenderness, redness.
Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizziness, joint pain
only c/o is of local rxn-rt deltoid size 100mm x 75mm erythematous-warm to touch;
Patient received his first Pfizer vaccine, and was being monitored in our hospital clinic.  Nurse saw him bend over; he reported feeling awful, and then passed out for approximately 10 seconds.  Vitals:  B/P 126/71, HR 52, respirations 18, Pulse ox 99% on RA.  Rapid response called, but not necessary to go to ER.  Patient maintained in clinic for another 30 minutes.  Alert & Oriented x 3.  Given water & power bar and patient felt better.  Second set of vitals: B/P 145/80, HR 61, respirations 20, Pulse ox 97%.
pneumonia; experiencing cough; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and COUGH (experiencing cough). At the time of the report, PNEUMONIA (pneumonia) and COUGH (experiencing cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.  Company comment: There is not enough information to assess the causal association between the reported event and the administration mRNA-1273   Although based on the established profile of the vaccine product, the event is unlikely related to the product use. Critical details such as the onset of the event in investigations are lacking.  Additional information is being requested.   Reporter did not allow further contact; Sender's Comments: There is not enough information to assess the causal association between the reported event and the administration mRNA-1273   Although based on the established profile of the vaccine product, the event is unlikely related to the product use. Critical details such as the onset of the event in investigations are lacking.  Additional information is being requested
Three weeks after receiving her MMRV the child developed several watery painful blisters around the injection site. The family took her to her primary care provider and the doctor said that the child had the shingles. I reviewed the side effect information with the family and pointed out that a side effect of the varicella live virus vaccination is to have some chicken pox type blisters of limited quanitity within 3 weeks of vaccination and that she was not contagious and the blisters should crust and fade within a few days, just to keep them covered until crusted over. The mother wanted to file this report with VAERS.
Customer called to report temperature excursion for PROQUAD. Caller stated the product was administered to 1 patient after the excursion. Administered 7/31/2023. Caller stated patient had no symptoms. No additional AE/no PQC.          ?    Names of; Customer called to report temperature excursion for PROQUAD. Caller stated the product was administered to 1 patient after the excursion. Administered 7/31/2023. Caller stated patient had no symptoms. No additional AE/no PQC.          ?    Names of; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, (lot number X009883 has been confirmed to be valid for PROQUAD).  (strength, and indication were not provided).    On 31-JUL-2023, the On 31-JUL-2023, the patient experienced Customer called to report temperature excursion for PROQUAD. Caller stated the product was administered to 1 patient after the excursion. Administered 7/31/2023. Caller stated patient had no symptoms. No additional AE/no PQC.    The action taken with PROQUAD regarding the events was reported as Not Applicable
doesn't want to receive the second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.   Treatment medication not provided
Shoulder pain by late that evening. By next day, pain spread to entire arm & indurated numbness & limited range of motion. After a week pain included heat & bruising. Pt has been seen by physicians who diagnosed it was bursitis per pt.
This spontaneous report as received from a nurse via sales representative refers to a male patient of unknown age. There was no pertinent medical history. On an unknown date, the patient was vaccinated with the third dose of GARDASIL intramuscular (dose, lot #, expiration date were not reported). Concomitant medication included quadrivalent flu vaccine (dose, frequency and manufacturer were unspecified). In September 2014, the patient started to faint, but did not loose consciousness and his body began to jerk. On an unknown date, blood pressure test was performed (results were not provided). The patient sought medical attention, on an unknown date, he visited the office. The outcome of reported as recovered (recovery date was estimated as 2014). Causality assessment was not provided. Additional information is not expected as there is no consent to contact the reporter.
a five years old female patient received a 0.5 ml dose of Flublok Quadrivalent, No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA277241 (same reporter).  This case involves a five years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QSAA1903, expiry date: 19-May-2020 via intramuscular route in the left deltoid on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  Flu clinic visit on 03-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Information has been received from a consumer reporting on herself an 88 year old female with no allergies or drug reactions reported who on 12-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) on the left arm (route and lot number not reported). Concomitant therapy included vitamins (unspecified) and lovastatin (manufacturer unknown). On 13-APR-2011, the consumer reported that experienced swelling on her left arm at the injection site. The patient sought medical attention by referred to Health care professional. The patient was treated with antihistamine. On 14-APR-2011, laboratories were performed (no results were provided). At the time of the report the outcome of the patient was unknown. Additional information has been requested.