chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Room spinning; Dizzy; Nauseous; Tired; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room spinning), PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizzy), NAUSEA (Nauseous) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired). On 04-Mar-2021, the patient experienced VERTIGO (Room spinning), DIZZINESS (Dizzy) and NAUSEA (Nauseous). The patient was treated with CLONAZEPAM (KLONOPIN) at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired) had resolved. At the time of the report, VERTIGO (Room spinning), DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a pharmacist via sales rep and described the occurrence of migraine in a female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for 1st dose refer case US2018GSK050304). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced migraine and stomach discomfort. On an unknown date, the outcome of the migraine and stomach discomfort were recovered/resolved. It was unknown if the reporter considered the migraine and stomach discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist who herself received the SHINGRIX vaccine. The age at the vaccination was not reported. The patient experienced sickness to her stomach and consistent migraines. This case was linked to the case US2018GSK047403, reported by the same reporter for different patient.
Woke from being sound asleep being unable to breathe (inhale) and unable to speak more than one whispered word.
Developed fever, aches and nausea around 7 hours after receiving injection. Also had chills and lethargy. Symptoms lasted 36 hours. Highest temperature taken 101 degrees.
Experienced strong flu-like symptoms (fever, body aches) for several days beginning a few hours after injection.  Experiencing chest pains and shortness of breath especially upon exertion.  Experiencing insomnia.  Experiencing increased sinus congestion and headaches.
Large bruise left thigh 10x8cm indurated, erythema, non-tender, non-purulent.
NUMBNESS IN LEFT SIDE OF THE FACE FOLLOWING VACCINATION AND A WARM SENSATION AT INJECTION SITE, NUMBNESS CAME ON WITHIN 15 MINUTES OF ADMINISTRATION AND LASTED APPROXIMATELY AN HOUR AFTER, ALSO EXPERIENCED SORE ARM FOR SEVERAL DAYS FOLLOWING VACCINE
Moderna COVID-19 EUA     Large 3 inch hard knot. Red. Very hot to the touch, Sore and itches. NO treatment as of yet  Noticed 2/26/2021
became paralyzed from Guillian Barre Syndrome; became paralyzed from Guillian Barre Syndrome; Initial information received on 20-Dec-2021 regarding an unsolicited valid Social Media serious case received via a consumer/non-healthcare professional.  This case involves an adult male patient who became paralyzed from guillian barre syndrome after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine with unknown (formulation, strength, dosage, dosage frequency, route, lot number and administration site) produced by unknown manufacturer.  On an unknown date (unknown latency) the patient developed serious became paralyzed from guillian barre syndrome (paralysis), (guillain-barre syndrome)  following the administration of Influenza vaccine. Both the events were assessed as medically significant.  Action taken with Influenza vaccine was not applicable for both the events.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: This case involves an adult male patient who became paralyzed from guillian barre syndrome after receiving vaccine Influenza vaccine produced by unknown manufacturer. However, information on patient's health condition at the time of vaccination, relevant medical history, previous vaccination tolerance and other relevant laboratory data was not provided. Rationale or medical condition of the patient  was also not provided. Based upon the reported information, the role of an individual suspect vaccine cannot be assessed.
hands and feet to itch; hands and feet peel; hands and feet crack open; This case was reported by a consumer via interactive digital media and described the occurrence of localized itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 20 years before the date of reporting and it was horrible).   In December 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 6 and 7 months after receiving Shingles vaccine, the patient experienced localized itching, skin peeling and skin cracked. On an unknown date, the outcome of the localized itching, skin peeling and skin cracked were not recovered/not resolved.   It was unknown if the reporter considered the localized itching, skin peeling and skin cracked to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient was recently told that patient need the Shingles vaccine. The patient received the first dose of Shingles vaccine and had bad reaction that caused hands and feet to itch, peal and crack open. The patient had been suffering ever since. The patient was on several medications now just to contain the problem and it was not fully under control. The patient reported that not everyone did well with the vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available.
A few minutes after receiving the Moderna vaccine, pt reported feeling "warm and heavy," seeing spots. Felt faint right away.  Pt pale and clammy. Does have a hx of anxiety and reports taking propranolol 40 mg prior to vaccination. She had this reaction prior to a Hepatitis A vaccine
Vaccine administered 8/29/13 in the morning. Overnight patient had 2 seizures described as "full blown" - bruising less to face, head, feeling much better 8/30/13.
worst and longest migraine headache; worst and longest migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 08:15 (Lot number: EP6955) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I suspect I may have had covid-19", start date: 16Feb2020, stop date: 25Feb2020, notes: I suspect I may have had covid-19 16Feb2020-25Feb2020; "allergy" (unspecified if ongoing); "sinus" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; ADDERALL. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin. The following information was reported: MIGRAINE (non-serious), HEADACHE (non-serious) all with onset 06Apr2021 16:00, outcome "recovering" and all described as "worst and longest migraine headache". The event "worst and longest migraine headache" and "worst and longest migraine headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine, headache.  Additional information: approximately 12 days post-1st injection, I had the worst and longest migraine headache I have ever had. The first one was 5 days long and then I had at least 2-3 a week (sometimes totaling 3-4 days of headaches) thereafter for approximately 7 weeks. OTC medicines, including migraine meds, only provided at most 1-1.5 hrs of partial relief. Approximately 6 weeks after onset the frequency had decreased to approximately 2-3 days a week and I began an aggressive course of magnesium, coQ10 and B2, which helped. The patient receive other medications within 2 weeks of vaccination includes Fluoxetine, Bupropion, Adderall. The 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. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Fever; Headache; Feels like my tongue is swollen; Body aches in different places; Started feeling poorly, my condition got worse; This is a spontaneous report received from a contactable consumer (patient). 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration on 01Jul2021 at 10:00 (at the age of 74-year-old) as single dose for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient stated I called because I had the Pfizer vaccine at 10: 00 on 01Jul2021 2 days ago and I started feeling poorly yesterday afternoon and today my condition got worse, I just wanted to know if that is normal, I have fever, a headache, my body aches in different places, and it feels like my tongue is swollen on Jul2021. Therapeutic measures were taken as a result of the events with Tylenol 500mg. The outcome of the events was reported as unknown.   Follow up attempts are possible. Further information is expected.
12/21/20 - First shot at local Medical Center, aches in the injection site, minor headache 12/24/20 - woke up at 2:45 am with night sweats, headache and head pressure; had upset stomach/diarrhea. 1/9/21 - second shot at another hospital, fatigue all afternoon 1/10/21 - low grade fever and chills 1/11/21 - joint pain all over 1/12/21 - lower GI symptoms, and achy headache that felt like pressure in the head, insomnia 1/13/21 - all symptoms except for head pressure and insomnia subsided
Heart attack; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4497950-00.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Intramuscular), for covid-19 immunisation; Bnt162b2 (DOSE 2, Intramuscular), for covid-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Dec2021, outcome "recovering", described as "Heart attack". The action taken for adalimumab was unknown.  Solicited report by a consumer of a 63 year old male with an event of Heart Attack with Humira (Adalimumab). There was no reported medical history. In Dec2021, the patient experienced heart attack. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect.  The reporter's causality for the event(s) of heart attack was not provided for Adalimumab, the opinion is that the event of heart attack is not assessable for Adalimumab. The reporter's causality for the event(s) of heart attack was possible for Pfizer BioNTech COVID19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be totally excluded for the reported event of Myocardial infarction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had 3 shot of Shingrix vaccine; This case was reported by a consumer via interactive digital media (GSK Chatbot) and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient had 3 shot of Shingrix vaccine, which led to extra dose administered.
Birth control, no PMS for 3 years, headaches, depressed, moody, sweaty hand and feet (extremely).
apprx 2 minutes after shot, upper and lower lips, tongue started to tingle and get numb. some swelling of lips tongue, roof of mouth and throat started to itch, flush feeling.  Observed for apprx 10 minutes, symptoms did not go away, offered care in emergency room. Admitted 11:28 am about 18 minutes after shot. Observed until 12:05pm,  took two Benadryl, 3 corticosteroids, and pepsid. Became drowsy, slept about 1 hour. Symptoms went away was released a round 3:00pm. Advised not to get second dose
This spontaneous report was received from a physician refers to an hundred (unspecified) patients of unknown age and gender. NO pertinent medical history was reported. On an unknown date, the patients were vaccinated with GARDASIL (lot # K007264 and expiration date 02-MAR-2017) (dose and route were not reported) which were exposed to temperatures outside the recommended range. No adverse effects reported. No  Product Quality Complaint (PQC) was involved. This is one of two reports received from the same source. Additional information is not expected as the reporter was not receptive to follow up or contact.
Pt was given immunizations at 730 (HPV #01 and Flu). Had no c/o adv. sxs; able to walk; conversed with nurse and mother. About 3-5 minutes after shots, patient lost consciousness and fell, face-first, onto (cement) floor in clinic hallway. Had seizure lasting 15-20 seconds. EMS called. Pt transported to hosp. by ambulance.
T 104 F, swelling of entire leg, no prior problems, 2nd DTP.
Pt was given injection and immediately had a vagal reaction. Followed by nausea with vomiting 15 minutes post injection.
Injection 5/16/12; pt reports arm redness, swell & pain started Friday 5/18 with fever 5/19 of 102.3. 5/20 fever 100 degrees. 5/21 No fever arm still red, swelling cleared.
EE called with positive results collected 8/28/2021.  EE vaccinated 1/2021.  Symptoms remain cough which has progressively gotten worse, runny nose and congestion wednesday 8/25, loss of taste and smell on 8/28/2021.  Last day of quarantine will be 9/3/2021 so EE will call on 9/4/2021 if symptoms have resolved/improved.
Nurse returned from flu clinic and student looked very pale. He had received flu shot. Nurse completed vital signs, feet elevated. O2 sat of 98 percent. Pulse 76. Resp rate 18. BP 106/72. He rested and his color returned and he reported feeling better. Rested for awhile. Notified mom. Eventually student returned to class.
+ swelling, + tenderness, + warmth + redness, decreased range of motion of affected arm. Pt's left arm had to be put on a sling because of significant swelling and was treated with Cephalexin and ibuprofen, Benadryl and icepack. Symptoms resolved after 2 wks.
With hours pain, raised rash at injection site, itch 101.7 fever lasted 24 hrs
bruises on his armpit area; bruises on his armpit area and experienced some pain; experienced some pain; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (parent) reported for his son who is 16-year-old (who will turn 17 years old next month) male patient received second dose of BNT162B2 (COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient took the first dose of BNT162B2 on 01Apr2021 for covid-19 immunisation. Caller said that his son has bruises on his armpit area and experienced some pain. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash on back, abdomen, arms, face after vaccine (24 hours) no high fever. Mother plans PMD visit due to current ear infection also.
Left upper arm pain, swelling, redness. Pain radiating to distal arm, head, fingers. Ice and ibuprofen helped relieve discomfort. Swelling and redness resolved at office visit 4/19 9AM. Still left upper arm soreness but improving.
The patient received the third/booster dose of BNT162b2; Intermittent extreme fatigue after all COVID-19vaccines for at least one week; Achiness after all COVID-19 vaccines for at least one week; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 (at the age of 45-years-old), received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 07Apr2021 (at the age of 45-years-old) and also received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the right arm on 25Oct2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on 26Sep2021 for immunisation. On an unknown date in 2021, the patient felt  intermittent extreme fatigue and achiness after all COVID-19 vaccines for at least one week. For dose two, those symptoms continued for 2 full weeks. On 26Oct2021, after third dose the patient continued to have these symptoms now (at the time of this report). Therapeutic measures were not taken as a result of the events felt intermittent extreme fatigue and achiness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt intermittent extreme fatigue and achiness was not resolved at the time of this report.
The adverse symptoms started on 8/27/21 -I felt nausea and vomited and was really fatigued, drowsy, and all body soreness for the rest of the day. In the afternoon I had chills and a  fever that fluctuated between 98-100 (I checked my oxygen and that went down to 92 a few times). On my left arm, I got a red itchy rash around where the injection was done (about 2 inches below the shoulder).
Patient had a rash surrounding the injection site of the yellow fever immunization. A rash began to form up around his waist line and then the patient's chest began to feel tight, not so long after the patient developed a wheeze and a cough. Patient went to Hospital to receive further treatment.
General discomfort; Sore throat; Soreness; Joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General discomfort), OROPHARYNGEAL PAIN (Sore throat), PAIN (Soreness), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (General discomfort), OROPHARYNGEAL PAIN (Sore throat), PAIN (Soreness), ARTHRALGIA (Joint pain) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (General discomfort), OROPHARYNGEAL PAIN (Sore throat), PAIN (Soreness), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication information was provided.
Patient came to the pharmacy and her left arm/deltoid region appears to have an Injection Site Reaction after vaccine administration. Vaccine was administrated 3 days ago. Sx/sx: redness, tenderness, warmth and pain area. Patient exptect to visit the clinic.
Extremely tender right arm around injection site.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the right  arm on 06Apr2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, allergy to sulfa (sulfonamide) drugs and multiple food allergies. Concomitant medications included montelukast sodium (SINGULAIR), ethinylestradiol; levonorgestrel (CAMRESE LO) and paracetamol; hydrocodone bitartrate (LORTAB) all taken for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021 at 15:30, thirty minutes after the vaccination, the patient experienced extremely tender right arm around injection site. The patient reported that she felt like she was punched in the upper arm. The event did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extremely tender right arm around injection site was unknown.  No follow-up attempts are needed. No further information is expected.
Case number PHEH2013US020559 is an initial spontaneous report received from a pharmacist on 30 SEP 2013. This report refers to a 14-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 28 SEP 2013. No adverse event was reported following this medication error.
Patient faxed letter on 10/16/09-complaining of left shoulder joint pain the evening of the day of the injection. Pain caused inability to elevate arm; complained of a red rash covering left shoulder and halfway down the arm. By day three 10-20-09 rash resolving. Minimal discomfort persists at shoulder joint.