chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have friend had shots and he got them/Suspected vaccination failure; I have friend had shots and he got them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had shots and he got shingles, he said 10 percent could get them even had the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103703:same reporter
Patient had febrile seizure and rigors. Went to ER and had a follow up appt in office.
Swelling, erythema and itching noted to left arm. Patient treated with 10 days of Cefprozil 500mg.
pain in neck; pain travels from shoulder to Spine; stiffness and pain in neck; head cold; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness and pain in neck), NASOPHARYNGITIS (head cold), NECK PAIN (pain in neck) and ARTHRALGIA (pain travels from shoulder to Spine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness and pain in neck) and NASOPHARYNGITIS (head cold). On an unknown date, the patient experienced NECK PAIN (pain in neck) and ARTHRALGIA (pain travels from shoulder to Spine). On 06-May-2021, NASOPHARYNGITIS (head cold) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness and pain in neck), NECK PAIN (pain in neck) and ARTHRALGIA (pain travels from shoulder to Spine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified allergy medication.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up received on 30-jun-2021. patient date of birth was added
I woke up in the middle of the night running a high fever, I felt achy and exhausted. I had a really bad headache, my head felt like it weighed a lot, I had issues walking because I was very dizzy. The fever subsided by evening time. Injection site was warm to the touch.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 06-NOV-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Sore right arm, fever 100.3, general body aches.  As of May 27, 7:45, only thing left is sore arm but better.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates since 10-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot # K016311 with expiration date of 26-MAY-2016, dose and strength unknown) orally. No adverse effect reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient with significant bruising following Immunization. Patient with blue/ purple colored ecchymosis extending down her right arm to the elbow and wrapping around her upper arm, except the axilla.
Left calf cramp and swelling.  Found to have left peroneal DVT per workup in ED on 4/14/2021
mild diarrhea; fatigue; This is a spontaneous report from a non-contactable consumer.  A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Jan2021 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced mild diarrhea and fatigue on Jan2021. The outcome of mild diarrhea and fatigue was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
REDNESS WITH MILD INDURATION AROUND THE INJECTION SITE ON THE LEFT DELTOID AREA , WARM TO THE  TOUCH, NO FEVER. RX: CEFDINIR 250MG/5 ML; 5 ML PO Q12H FOR 10 DAYS.
Patient reported "blurry vision" during his observation period following COVID vaccine #1 Moderna. BP found to be elevated at 178/120. No prior history of high blood pressure was reported. His blood pressure came down to 130/100. Patient advised to be checked at a nearby urgent care center. No further information available.
This case was reported by a physician and described the occurrence of allergic skin reaction in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic skin reaction. On an unknown date, the outcome of the allergic skin reaction was unknown. It was unknown if the reporter considered the allergic skin reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician was the patient. The patient received the SHINGRIX vaccine and developed a topical allergic reaction. The patient had photos of allergic reaction and was ready to provide them. This case has been linked with US2018GSK093092, reported by the same reporter.
Information has been received from a registered nurse (RN) concerning an approximately 16 week old female who was vaccinated with the first dose of ROTATEQ (date unspecified). It was reported that the patient received the first dose of ROTATEQ (date unspecified) at 16-17 weeks of age. The RN reported that the patient may receive the second dose now on 13-Jun-2008. The patient sought medical attention in the office. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 10-DEC-2014 the patient was vaccinated with a dose of PEDVAXHIB (lot # K004541, expiry date 04-DEC-2016 (also reported as 13-OCT-2016), dose, route and frequency were not provided) post not supported temperature excursion. Patient didn't report any adverse effect. This is one of several reports received from the same source. Additional information has been requested.
Vaccine series:   Dose 1 completed 2/15/21    Dose 2 completed 3/15/21
She states "has had nausea every day since injection" but no vomiting and eating as normal. Has occasional dizziness which last for seconds. CC: hair loss. This African/American lady states comb and brush removed large amounts of hair causing her to braid hair and buy a wig 1 week from having injection of Engerix-B. Referred to a Dermatologist for consult.
G3P1 who is admitted with c/o N/V, sweating, back pain. Estimated delivery date 3/3/22. Treatment includes EKG and monitoring. Tested positive for COVID after admission to hospital.
This spontaneous report as received from a medical assistant and refers to an adult patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-SEP-2018, the patient was vaccinated with a pediatric dose of VAQTA intramuscularly, (exact dose, frequency, lot # and expiration date were not reported). No known adverse effects were reported. No causality assessment was provided.
Redness & Swelling in shot area the size of my hand. (Hand size from wrist to fingertips.) Hot to the touch. Itching, headache. Patient is recovering, but still has redness in the shot area.
vision is blurry. When look at the computer screen it looks blurry and am leaning forward to try to see the screen more clearly.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 16:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine besilate (NORVASC), ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, thiamine, nicotinic acid, pantothenic acid, riboflavin, betacarotene, iron, magnesium, manganese, molybdenum, potassium, chromium, copper, vanadium, zinc, calcium, iodine, phosphorus, selenium, vitamin d nos, vitamin k nos, vitamin b12 nos, chloride, xantofyl, nickel, silicon, vitamin e nos (CENTRUM SILVER WOMEN) and colecalciferol (VITAMIN D3); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 08:30, the patient experienced vision was blurry. When she looked at the computer screen, it looked blurry, and she was leaning forward to saw the screen more clearly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurry vision was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sinus drainage, body aches, sore throat, hoarseness and right sided headache, right arm pain, and right leg and foot pain down to toes; Ibuprofen 800 mg as needed; Amoxicillin Pot-Clavulanate 75/125 mg
Patient is 17 years old and received moderna booster.  Moderna not indicated for under 18 years old
Headache, NauseaVomiting, chills, fatigue, injection site pain Narrative:
stiffening x 10seconds followed by episodes of drowsiness;no fever, 5-6 episodes;
Wrist stiffness; Swollen wrist; Hand stiffness; Finger stiffness; Swollen fingers; Finger pain; Finger pain; Swollen fingers; Swollen hand; Hand pain; Wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Wrist stiffness), JOINT SWELLING (Swollen wrist), MUSCULOSKELETAL STIFFNESS (Hand stiffness), MUSCULOSKELETAL STIFFNESS (Finger stiffness) and the first episode of PERIPHERAL SWELLING (Swollen fingers) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included ATORVASTATIN and THYROID (ARMOUR THYROID) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced JOINT STIFFNESS (Wrist stiffness), JOINT SWELLING (Swollen wrist), MUSCULOSKELETAL STIFFNESS (Hand stiffness), MUSCULOSKELETAL STIFFNESS (Finger stiffness), the first episode of PERIPHERAL SWELLING (Swollen fingers), the first episode of PAIN IN EXTREMITY (Finger pain), the second episode of PAIN IN EXTREMITY (Finger pain), the second episode of PERIPHERAL SWELLING (Swollen fingers), PERIPHERAL SWELLING (Swollen hand), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Wrist pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (Wrist stiffness), JOINT SWELLING (Swollen wrist), MUSCULOSKELETAL STIFFNESS (Hand stiffness), MUSCULOSKELETAL STIFFNESS (Finger stiffness), the last episode of PAIN IN EXTREMITY (Finger pain), the last episode of PERIPHERAL SWELLING (Swollen fingers), PERIPHERAL SWELLING (Swollen hand), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2 hours after vaccine patient reported headache, sweating, and generally not feeling well, employer sent employee to ER via ambulance. Released shortly after.
Information has been received from a health professional concerning an approx 26 yr old female pt who 2-3 years ago in approx 2002 or 2003 was vaccinated with varicella virus vaccine live. The pt believes that she received two doses at the same time using two different injection sites. A recent titer did not show seroconversion. Unspecified medical attention was sought. It was reported that the pt had no symptoms at the present time. There was no product quality complaint involved. Additional information has been requested.
Fatigue, Generalized Musculoskeletal pain, Difficulty talking, Respiratory difficulty while talking, Shortness of breath.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 at 12:00 as dose 1, single at the age of 53 years, in right arm for covid-19 immunisation. The patient relevant medical history included: "Asthma" (unspecified if ongoing). The patient concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient received COVID-19 treatment with paxlovid drug (lot number: GC8236). It was also reported that the patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.   No follow-up attempts are possible. No further information is expected.
very sore muscles in right arm day after injection - 2 days later - sore arm and red rash
patient says she feels sleepy, denies other symptoms. patient rested on cot x 15 min, BP= 100/70, p=100,  patient alert and oriented but report she had TBI 2years ago.
No additional AEs; patient received improperly stored vaccine; This spontaneous report was received from healthcare worker and refers to a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-AUG-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #w004504, expiration date: 16-JUN-2023 or lot #w002562, expiration date: 12-OCT-2023) administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 11.3 degrees Celsius for 34 minutes. There was no previous temperature excursion.  There was no adverse event reported (no adverse event).  This is one of two reports received from the same reporter (link report #2209USA001298).; Sender's Comments:  US-009507513-2209USA001298:
overall body weakness for 3 days and 1 day of severe right leg muscle cramping.
03may90 pt vax hepta B. pt devel eczematous rash on face, 24 hrs following vax.  treatment w/ aristocort
Pt received DTap LUE deltoid on 9/10. Pt seen 9/12 with 10.7 cm x 9.5 cm erythremia area at injection site. MTR informed to monitor for inc. in size or fever. Pt and mother informed to use/take Benadryl 25 mg once every 6 hours PRN. RTC if not better/improved.
Sore arm for about 3 days that progressed to very painful arm that patient was unable to lift arm over her head. Went to urgent care - they prescribed antibiotic and prednisone. Prednisone relieved pain. After finished w/ pred -> pt. developed migraine. Went to family MD-prescribed EXCEDRIN Migraine, arm still sore as of 11/7/16.
Sudden gastroparesis, had nausea, vomiting, got full quicker. Was diagnosed by Dr in July after two months of suffering with the symptoms. Still unable to eat red meat and dairy without vomiting in the morning.
Vaccine given on 2/26/2021;  3/1/2021 noted enlarged lymph node under left armpit; 3/15/2021 sharp needlelike pain shooting in my left breast lasting 48 hours.  Checked my left breast and noted breast quite enlarged. 3/25/ 2021 pain resume in left breast for 48 hours.   3/29/2021 had a previous appointment for checkup on right breast as a follow-up for breast cancer 7 years ago.  had Dr check my left breast and he said I still have an enlarged node under my left armpit and my left breast definitely has lymphedema.  Prior to this my bilateral breasts were more or less symmetrical.
High blood pressure 140/72; fever; A spontaneous report was received from a (Reporter like consumer) concerning a  68 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.        The patient's medical history was not provided. No relevant concomitant medications were reported.        On 12-JAN-2021 prior to the onset of the events, like increase in the blood pressure and fever the patient received their first planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the Anatomical location of left arm for prophylaxis of COVID-19 infection.      On 12-JAN-2021, The patient experienced the events list (verbatims) with non serious   Patient took metoprolol, and lisinopril. Symptoms have subsided.     Action taken with mRNA-1273 in response to the events was not reported.     Patient took metoprolol, and lisinopril. Symptoms have subsided.  The patient was recovered after took the medication for events and it was as non serious case  The reporter assessed the event(s), [EVENT VERBATIM TERM(S)], as not related to study drug.
Pt received FLUMIST on 10-9-08, but still tested positive for influenza A on 1-31-09.
Myalgia, Fever, Fatigue Narrative: Reports taking Tylenol and Ibuprofen on a alternating schedule.
Patient  came in  for  6 month shots and received pentacel and variax  together  = to  double doses  of  tdap ipv and him; This non-serious spontaneous case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2292667-1. The original narrative from the sender is as below:  Patient  came in  for  6 month shots and received Pentacel and variax  together = to  double doses of tdap ipv and him.  Current illness reported as not applicable.
Patient is a 76 y.o. male admitted to the service on 10/20/2021 with acute hypoxemic respiratory failure secondary to COVID 19 pneumonia, generalized weakness. PMHX significant for CKD III, CAD S/P PCI, essential HTN, DM II, prostate CA S/P radiation, chronic urinary incontinence, morbid obesity. Pt received modera vaccine x 2, last dose in Feb 2021. Onset of symptoms 10/14.   He was treated with remdesivir (x4 days) and decadron during stay.  He was able to wean to 1 L FIO2 at rest, 2 L with activity by day of DC.  Home FIO2 was arranged.  Home care service were arranged.    The patient is stable for DC home on 10/23/2021.
injection site is still sore; injection site is still hot to the touch; injection site is still red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 24th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The Shingrix was administered in right arm.  The patient also had flu vaccine administered in left arm that on the same day. The patient's injection site (right arm) was sore, hot to the touch and red at the time of reporting.  The reporter asked how long would this last.  He or she was told to expect soreness for 2-3 days. Patient's right arm was really red and sore at the time of reporting. Patient did not have lot number of Shingrix that was administered to her.
The patient was inadvertently given the afluria vaccine, which is meant for individuals 3 years and older, despite only being 2 years old. I have tried to contact the patient's parents to determine if there are any adverse events from this but I have not been able to get through to them and they have not called back.
Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not available/provided to reporter at the time of report completion), via an unspecified route of administration from 22Dec2020 to 22Dec2020 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks was unknown. Covid prior vaccination and Covid tested post vaccination was unknown. The patient experienced very sore arm (pain in extremity) (non-serious) on 23Dec2020. This report is for the first vaccination only. I will put a second report in for adverse events reported for the second vaccination as well. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Right after I administered the vaccine into the right deltoid, a bump appeared with a bruised appearance.  I consulted pt and applied ice to bump.  I also advised her to wait 10 minutes at the store.  She did this.  No further adverse effect at this time.  She will call us if she seeks additional information.