chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days after receiving my vaccination, my tinnitus symptoms, which had been fairly mild, changed to be much more noticeable and louder.   It seems like before it was just in one ear and now it is both ears.  It used to noticeable and bother me only at bedtime when things were very quiet and now I can hear the ringing all the time day and night.
38 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days apart) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days apart) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
ACHES; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, tossed and turned all night, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches and tossed and turned all night was not reported. This report was non-serious.
Gave Novartis H1N1 vaccine (4 yr and older) 0.5 ml IM. Should have given Sanofi Pasteur H1N1 vaccine (6 months and older) 0.5 ml IM. No signs or symptoms of distress noted.
Expired Dose Administered/ expired dose of Bexsero was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31-MAR-2023) for prophylaxis.   On 21-JUL-2023, the patient received Bexsero. On 21-JUL-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered/ expired dose of Bexsero was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Jul-2023 The nurse declined to provide patient details with permission and also became disconnected from the call before being able to provide any additional details (also wanted to remain anonymous).  The reporter consented to follow-up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Covid vaccine related issues; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Covid vaccine related issues) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Knee replacement (Left knee). Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 21-Oct-2021, the patient experienced IMMUNISATION REACTION (Covid vaccine related issues). At the time of the report, IMMUNISATION REACTION (Covid vaccine related issues) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Platelet count: Low. On 21-Nov-2021, White blood cell count: Low.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of low white count and low platelet count with Moderna was provided as probable. The reporter's causality for the event(s) of right knee was bone on bone, fatigue, low white count, right knee pain, covid vaccine related issues and low platelet count with RINVOQ was not provided.  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.   This case was linked to MOD-2021-626133 (Patient Link).
Headache, Myalgia, NauseaVomiting, lower back pain, brain fog Narrative:
Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day.  Per family report starting complaining about L ear pain on Friday 1/29,  On Sunday 1/31, started to experience dizziness and some L ear discomfort,  Had cellulitis last summer after "new earrings" in left ear and assumed this might have been it, had NP check ear on Monday at work, some fluid on R ear.  Monday evening pain increased, heaviness and muffled sound increased, pain increased, started to "burn" and "itch".  Tuesday AM contacted three MDs, concerns of shingles.  Diagnosis later that day, vesicles in L outer ear, started on antiviral and antibiotics.  Pain and dizziness at work Tuesday morning however its only Tuesday night.  Pain/burning still very intense.
fever, body aches, headache, fatigue, pain at injection site, strange smell like gasoline,
pt recvd vax; wheals on face about 1 1/2 hrs p/ vax;
Patient stated that she wanted to get the Pfizer booster vaccine that we are advertising at our pharmacy.  I asked the questions on our form and it has been over 2 months since her last shot.  I gave the vaccine and asked for her card and she said this was her first shot.  Patient received the bivalent Covid vaccine as her first primary dose instead of the monovalent.  No adverse effects have been reported.
I was laying in bed and felt a pins and needles pain in my legs it was worst in my left leg so I stood up to go to the bathroom and my legs wouldn?t move I ended up falling over and hit my head and sprained my foot
Chronic Spontaneous Urticaria appeared less than a month after my vaccination.  It began very severely, and has gradually gotten better.  The ankle swelling has decreased, and the rash has been controlled by taking Zirtec every 48 hours.
This spontaneous report was received from a Nurse Prescriber referring to a 22 years old female patient. The patient had no concomitant medication, medical history or drug reactions. On 21-AUG-2018, the patient was vaccinated with VARIVAX (lot # N027001 and expiration date 28-SEP-2019; dose and route were not provided) for prophylaxis (reported as vaccination), which was reconstituted with sterile diluent (dose, route, lot #, expiration date and indication were not reported). At that same visit, a urine pregnancy test was performed and the result was negative. On 11-OCT-2018, the patient returned to the office and was 10 and 1/2 weeks pregnant. The last menstrual period (LMP) was calculated as 29-JUL-2018 and estimated date of delivery (EDD) was calculated as 05-MAY-2019. Patient was planning to continue the pregnant. The pregnancy outcome was pending. The fetal outcome was unknown. There was no treatment given for the event and the patient sought medical attention.
Medication Beyond Use Date 10/30/21.  Medication Expire Date 12/21.  Medication administered on 11/1/21.  No adverse reactions noted.   Pt was confirmed pregnant on 10/28/21
Local reaction, Redness, warm to touch 3x2cm with small blisters and itching started 03/17/2005.
PARALYSIS; This spontaneous report received from a consumer via twitter concerned a patient of unspecified age, sex, race and ethic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced paralysis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211050086-covid-19 vaccine ad26.cov2.s-paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Headache; Body pains; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and MYALGIA (Body pains). At the time of the report, HEADACHE (Headache) and MYALGIA (Body pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.   This case was linked to MOD-2021-097296 (Patient Link).
Started having symptoms of headache, dizziness, blurred vision, and brain fog three weeks after first injection and these symptoms lasted 2.5 months.  It was awful.  Affected my quality of life and my work to a point I could hardly work or enjoy life.  I would never take this vaccine again.
migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration in the left arm on 14Feb2021 07:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: ADHD (attention deficit hyperactivity disorder), severe migraine, unknown vestibular event in June-Jul2020 attributed to vestibular migraines based on normal CT, MRI, and EEG. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), amitriptyline, caffeine/ paracetamol (EXCEDRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL4262), via an unspecified route of administration in the left arm on 26Jan2021 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Feb2021, the patient experienced mild muscle pain at injection site onset 1 hour after injection (at 08:30) lasted about 24 hours. At 01:20 on 15Feb2021, also reported as 17 hours 10 minutes post-injection, the patient woke up with mild chills, temperature (oral thermometer) was 97.6°F. Chills and cold sweats progressed rapidly, with severe chills and uncontrollable heavy shivering and sweating present within 10-15 minutes (on 15Feb2021). Temperature at 02:00 15Feb2021 was 103.0°F. Fever slowly waned without medication. By 04:30, fever at 101.2°F, chills mild, sweating persisted. At 07:00 15Feb2021, the patient started to develop early stages of migraine (preexisting condition), took EXCEDRIN 565 mg tablet x 2. At 08:00 15Feb2021, the temperature was 98.2°F. By 10:00 15Feb2021, the fever resolved, temperature 97.6 (individual baseline) and chills had resolved. Sweating has improved to be more mild, but persistent now at 16:30 15Feb2021. Treatment was received for migraine. No treatment was received for the other events. The clinical outcome of mild muscle pain at injection site was recovered on 15Feb2021 08:30, chills and fever both recovered on 15Feb2021 10:00. The clinical outcome of cold sweats and migraine was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient stated that her left arm starting feeling hot on Sat, Oct 23rd in the afternoon. When she woke up on Sun, Oct 24rd there was blistering of the skin and it was very red. She went to urgent care immediately and got treated for the reaction.
Multiple episodes of pausing with breathing with perioral cyanosis. 1 episode of vomiting.
Patient was administered first dose of Moderna vaccine on 5/6/21 and returned for second dose on 7/2/21.  This is beyond the recommended range of 28 to 42 days between doses.  No adverse event
Narrative: He developed a headache and fatigue about 3-4 hours post-vaccination, which persisted for 2-3 days afterwards. On the 2nd day, he started to take OTC acetaminophen, which assisted with headache, but the issues did not completely resolve until day 3 and did not feel back to baseline until day 6.
Pruritic rash to injection site. Saw for rash 10/24/2011. Measures 10 cm papular, macular rash surrounding injection site.
Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients was vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route not reported, lot # L033698 an Exp. date 28-FEB-2017). The vaccinates were exposed to 13.8F for 43 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
A constant 24-7 ringing in the ears resembling tinnitus. Tried ear wav removal drops.
little pain for a couple days after second dose; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History), pain (Family History) and generalized rash (Family History) (The patient's sister and brother in law both had Shingles so bad, they were in severe pain and had rash all over their body, after seeing a few pictures of it the patient and her husband decided to get the vaccine). Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient and her husband received both Shingrix shots recently. The patient was in a little pain for a couple days after get 2nd dose.  She commented that, well worth a little pain than suffering for months with nerve pain from shingles. No contact details were available.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
moderate (101-102deg. F) for 24 hrs.  For first three hours strong chills.  Considerable chills for 3-4 days.
reported " it felt like the car was moving"  " I was holding my breath" " I hate needles"  " I did it to myself".   Report she never does well with needles & today was no exception.  Forgot to take her lorazepam.  TX - emotional support.   Mask removal.  Fresh air.  Waited 15 mins in observation lot.
Information has been received from a physician concerning an adult female patient who about two weeks ago on approximately Sep 06 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). In Sept 2004, the patient developed injection site reactions that included swelling and redness. Subsequently, the symptoms resolved within a week. Unspecified medical attention was sought. there was no product quality complaint involved. The reporter also mentioned another patient (Waes0409USA01764) who had developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). Additional information has been requested.
Patient received first dose of Moderna Covid-19 vaccine on 4/20/21.  On 4/21/21, the patient's wife called the pharmacy because she was concerned about his pulse-ox reading.  The wife stated that his pulse-ox was 91 and they were checking because he felt similar to how he felt when he had Covid-19 last year.  The pharmacist reminded the patient that some flu like symptoms were not uncommon within the first day or two, but also asked for more details and specifically asked about his breathing.  The wife stated that his breathing was constricted.  The pharmacist advised the wife that if the patient's breathing was constricted that they should contact a doctor or seek medical attention.  The wife said she would see how things go but she was not specific on if they were going to seek further help.
Dizzy, pale, body ache, vomited x 1, diarrhea x 2.
Acute pain and lack of movement.  Cipro was administrated orally and Rocephin was injected but the patient did not got better.    At the moment of this report the patient is taking Septra orally and Benadryl at night since she reported that she can't sleep at night.
On 7/13/21 patient came into the pharmacy to received his second  dose, and patient was given the Pfizer vaccination when he should have received the moderna  vaccination.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 16-OCT-2013 the patient ws vaccinated with PNEUMOVAX23 intramuscularly (lot # J000388 exp. date: 06-AUG-2014), (dose, strength, site of administration not reported). The reporter stated that PNEUMOVAX23 was exposed to -2.8C for 66 hours with the vaccine possibly going above and below 0C more than two times during this excursion. No adverse effect reported. This is one of two reports from the same reporter (MARRS case # 1310USA010366). Additional information has been requested.
Greater than 42 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 42 days since the first dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005821A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 42 days since the first dose). On 28-May-2021, PRODUCT DOSE OMISSION ISSUE (Greater than 42 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had  not received the second dose and it had been greater than 42 days since their first dose.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and nausea. On 28th September 2018, the patient experienced tiredness, headache, irritability and influenza like illness. On 3rd October 2018, the outcome of the injection site pain, tiredness, headache, nausea, irritability and influenza like illness were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, headache, nausea, irritability and influenza like illness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. On 28th September 2018, 1 day after receiving SHINGRIX, the patient experienced tiredness, headache, irritability and influenza like illness. The patient planned to continue follow up with his physician on an unknown date. The reporter consented to follow up.
Information has been received from a registered nurse concerning a 25 year old female with a history of tinea versicolour, polycystic ovarian syndrome and amenorrhea who on 24-JAN-2007 was vaccinated IM into left deltoid with the first 0.5 ml dose of Gardasil (Lot # 655619/1427F). Concomitant therapy included clomiphene citrate (CLOMID), metformin HCl (GLUCOPHAGE) and multivitamins (unspecified). On approximately 24-JAN-2007, the patient experienced pain. It was reported that the pain was worse on the second day after vaccination. The went away after a couple of days. On an unspecified date in 2007 the patient was vaccinated IM into left deltoid with the second 0.5 ml dose of Gardasil (Lot # 657006/0188U). Subsequently, in 2007, the patient experienced pain. It was reported that the pain was worse on the second day after vaccination. Subsequently, the pain "went away" after a couple of days. On 09-JUL-2007, the patient was vaccinated IM into left deltoid with the second 0.5 ml dose of Gardasil (Lot # 657622/0388U). On approximately 09-JUL-2007. The patient experience pain. It was reported that the pain was worse on the second day after vaccination. Subsequently, the pain "went away" after a couple of days. At the time of the report, the patient's arm still hurt, was sore, and felt like she "slept on the arm wrong". The arm was not getting better or worse and there was no redness or swelling. The patient was advised to take ibuprofen and apply warmth or heat to the affected area. This is one of two reported received from the same source. Additional information has been requested.