chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large red hives with intense itching on arms, back, torso, legs; This is a spontaneous report received from a contactable consumer (patient). A 84-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198), via an unspecified route of administration on 26Feb2021 at 15:15 (at the age of 84-years-old) as first dose, single in the left arm for covid-19 immunisation. The patient medical history included diabetes, atrial fibrillation and high blood pressure. The patient's concomitant medications included lisinopril, metformin, metoprolol, apixaban (ELIQUIS), "multi vit". 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 vaccination. On 26Feb2021 at 20:00, the patient experienced large red hives with intense itching on arms, back, torso, legs. The patient did not receive any treatment for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
The next morning he had a fever for 24hrs, I gave him Advil, didn't work, he complained about arm and muscle pain for at least 36 hours. On 01/02/2022 he had chest pain as well. This continued until 01/05/2022. As of today he still has pain in his chest pain. On 01/05/2022 around 2:30 AM he got up in the middle of the night vomiting and diarrhea. He still has abdominal pain but the diarrhea has stopped.
Pain / at the injection site; Redness / at the injection site; Swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's mother in law. The age at vaccination was not reported. The reporter asked about common side effects and when mentioned the most common side effects were pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach then mother in law stated that the patient had all those side effects after his Shingrix vaccine. The reporter did not want to provide her address or any additional information. The reporter was referred to HCP (health care professional). The reporter did not consent to follow up. The case was linked with US2021156444 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156444:Same reporter. Daughter case.
I got sick two months later and I don't connect it with the vaccine.  I had no reaction to the vaccine.
Around 630pm I began to have a really bad had a bad headache, feverish and body aching.  Tenderness in the injection site area which eventually turned into full body aches and was tired.  No vomiting or nausea.  No redness at the site or injection site issues
1.  Bell's Palsy on symptoms starting 10/9/2021 2.  Arm and shoulder muscle pain since 10/6/2021 day of the vaccination
rph found that the vaccine was expired by one day , so we contacted pfizer and they said it is okay and doesn't need revaccination
J96.00 ACUTE RESPIRATORY FAILURE 10/12/2021 ANEMIA J96.00 ACUTE RESPIRATORY FAILURE 10/12/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Pt received Td vaccine to LD on 6/18/07 pt woke up next am with pain, swelling, fever chills to site. Denies any prior reaction to Td. Warm compresses applied. Benadryl HC, Allegra +Pruritus + superficial site reaction = infection.
eye dryness and itchiness. denies blurred vision or vision loss called md who recommended Claritin daily.  Claritin has provided mild relief.
Acute demyelinating encephalitis; patient presented with fatigue, dizziness, dysarthria, diplopia, and gait imbalance that progressively worsened during his hospital admission, requiring ICU admission. He was successfully treated with plasma exchange and displayed improvement in MRI findings.
pt recvd vax & 15-30mins later began wheezing w/SOB vs P100, BP 100/60, R32; chest-wheezing bilat; no hx of asthma or URI; pt taken to clinic to be examined;
Had headache that was similar to migraine; Feeling foggy; Diarrhea; Episode of nausea; Extreme fatigue; Muscle ache; Rash inside armpit; Anaphylactic reaction; Tingling in arm; Itching; Rapid heartbeat; Started feeling hot; Petechia eye; Tiny broken vessel on both ankles; A spontaneous report  was received from a consumer who was also a female patient over the age of 55 but under 60 years of age who received Moderna's Covid-19 vaccine (mRNA-1273) and who experienced anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  tiny broken vessel on both ankles, headache similar to migraine, nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea. The patient's medical history was significant for anaphylactic reaction to cephalosporin antibiotics. No other medical history was provided by the patient. Concomitant product use was not provided by the patient. On 24 Jan 2021, prior to the onset of symptoms, at the County Health Department, the patient received the first of two planned doses of mRNA-1273 intramuscularly into her upper left arm. Because of her past medical history, the patient was observed for 30 minutes at the facility for any adverse reaction. When the observation period ended the patient went to her car and sometime later began having a delayed reaction. She reported experiencing the following symptoms: "tingling in arm", "itching", "rapid heartbeat", "started feeling hot", "rash inside of armpit", "petechia eye", and "tiny broken vessel on both ankles". The patient went to an Urgent Care Clinic, where she was treated with an injection of diphenhydramine and an oral prednisone.  She was given a prescription for diphenhydramine, and prednisone. The patient was informed that she had an anaphylactic reaction to the vaccine. On 25 Jan 2021, the patient stated she had a "headache similar to a migraine", "episode of nausea", "extreme fatigue", "feeling foggy", "muscle ache", and "diarrhea". She was being followed up by an allergist. Action taken with mRBA-1273 in response to the events was not provided. The outcome of the events, anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye,  and tiny broken vessel on both ankles, and  headache similar to a migraine, episode of nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea, was considered unknown.; Reporter's Comments: This case concerns a 55-60 year old female who had a serious unexpected anaphylactic reaction, with NS unexpected paranesthesia, pruritus, HR increased, feeling hot, rash, petechia, telangiectasia, migraine, feeling abnormal, diarrhea, and NS expected nausea, fatigue, myalgia. Event onset 1 day after first dose mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Red , hard, hot bump in arm (in  shot site) Irritation at time of shot had disappeared and after a week, showed symptoms again.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). On 22nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. The patient was treated with medication unknown (Ice Pack (NOS)). On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. The reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: At 15:28, the patient received SHIGNRIX in left deltoid. The following morning the patient woke up with redness, swelling, and an red patch at the injection site. The healthcare professional instructed the patient to apply ice and call her if events had not improved. The healthcare professional had not heard back from the patient since.
Over 2 days of chills and fevers. Over 4 days of feeling lethargic. Headaches for 2-3 days after.  Reported chest pain in daily check in. It was not an option so I wrote it in.  2 weeks after the shot I still have mild pain when breathing in and feel like I am winded more easily to the point that even before the vaccine was in the news I made an appointment with my doctor. He did EKG and D Dimer tests. Both came back normal but I still don?t feel myself.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 7th February 2023, the patient received Havrix. On 7th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Feb-2023 Reporter's comment: Nurse reported a patient was administered expired Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: As patient received expired Havrix vaccine which led to expired vaccine used.
Nauseous; Fever; Chills; Headache; Sick; Arm hurt; Arm became tender; Arm became swollen; Arm became achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PAIN IN EXTREMITY (Arm hurt), TENDERNESS (Arm became tender), SWELLING (Arm became swollen) and PAIN (Arm became achy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 11-Jan-2021, Gout attack (Gout attack in his ankle 2 Months ago.) and Sinus infection (sinus infection 2 months ago.).    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced ILLNESS (Sick), PAIN IN EXTREMITY (Arm hurt), TENDERNESS (Arm became tender), SWELLING (Arm became swollen) and PAIN (Arm became achy). On 27-Jul-2021, the patient experienced NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 28-Jul-2021, NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, ILLNESS (Sick), TENDERNESS (Arm became tender), SWELLING (Arm became swollen) and PAIN (Arm became achy) outcome was unknown and PAIN IN EXTREMITY (Arm hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  On 28-Jul-2021 the patient's arm still continues to hurt. He was still alternating medications. He already feels better.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Non-significant information regarding contact and communication.
5-10 min p/inject, felt warm, c/o nausea, had 10-20cc emesis, unconscious, tremors, dicorticate rigidity, loss of bladder control x 2; disoriented; felt tired & sleepy; Taken to Hosp-ER told poss sz; mom to f/u w/neurologist;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# L035505 with expiration date 16-DEC-2016). Concomitant medications were not reported. On an unknown date the patient experienced injection site swelling and redness that was warm to the touch. Outcome of the events was unknown. The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Feb. 15, 10:45 pm - Noticed muscle ache in upper thoracic spine area. Took tylenol Feb. 16, 6:00 am - Woke up to same muscle ache, now in general thoracic spine area.                                   Alternated btwn tylenol/ibuprofen  q, 4-6 hrs. Feb. 16, 7:00pm - Same discomfort in back, but now progressing to my left side. Feb. 17, 2 pm - Discomfort now progressing from spine to left side to left, front chest. Muscle ache                            and slight pressure at left chest. Tylenol/ibuprofen  q, 4-6 hrs. Feb. 18, 3 am - Woke up w/ more muscle ache & pressure in left chest area FEB. 18: 8:30 am - Went to Urgent Care-Sent to Hospital. Admitted for observation, more tests. FEB 19: Seen by Internist, who ruled out any cardiac problems. Wondered if the line of pain/discomfort could be precursor to Shingles, with activation of Herpes Zoster as a result of 2nd Covid-19 vaccine. Back area examined and no presence of rash noticed. Ordered MRI of thoracic spine. FEB. 19, afternoon: Discharged to home - MRI nonsignificant FEB. 20: 8:30am - Presence of red rash, in a continuous band from thoracic spine around left side to left chest, circling 2inches up on sternum. FEB 20: 10am - Confirmation of Herpes Zoster/Shingles at Urgent Care.  Put on Valacyclovir (x3/day for 10 days); HYDROcodone-acetaminophen (5-325 mg/tablet q. 6hr PRN); Ibuprofen (600mg q.6hr PRN) MAR. 1 - Office visit - continue w/ meds MAR. 9 - Messaged Dr. that neuralgia pain worsening albeit rash subsiding. Lidocaine suggested, continued w/ PRN meds. Mar 17 - Neuralgia pain intensifying from spine, left to sternum, no relief from above meds.  Put on: Gabapentin 100 mg x2/day. March 25 - Severe Neuralgia pain-Dr. increased dose to 200 mg x3/day. April 5 - Neuralgia pain subsiding, gabapentin lowered to 100 mg x2/day.  Today, April 21 - Gabapentin continues to be taken at 100 mg x2/day.
This case was reported by a physician to a sales representative and described an adult male patient who did not respond to immunization with hepatitis B vaccine and expired to chronic hepatitis B. On unspecified dates, the patient received an unspecified number of doses of hepatitis B vaccine. Subsequently, on an unspecified date, a hepatitis B surface antibody titer was negative. The physician stated that the patient later died of chronic hepatitis B.
Pt. stated "her "Throat felt as if it was closing." "Starting to feel like I cant breathe." Emergency team evaluated VS. Final VS are BP: 177/88 O2 Sat:99%  HR:96 .
Vaginal bleeding - menstruation for 12 days (Be advised I have been postmenopausal without menstruation for several years)  Menstruation stopped on 4/21/21 - after ultrasound
Swelling of fingers and forearms, no pain, no fever, no itching or irritation. No irritation or swelling of injection site.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 48 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was brought to the office for a Covid booster vaccine by his mother.  Patient had previously received Pfizer vaccine on  1/18/2022 and 12/9/2021.  Discussed with Dr requested that I speak to mom and tell her that the patient (her son) could go elsewhere to receive the Pfizer vaccine (no longer offered at the office) or that he could receive a full dose of the Moderna.  Mom requested the full dose of the Moderna for the 6month-5 year population.  Vaccine given.  No adverse reaction noted at this point in time.  Learned later that the Moderna was not suggested as a booster for the childrens Pfizer primary vaccines.
Information has been received from a registered nurse concerning an 18 year old female smoker (1/2 pack per day) with genital warts who on 02, Mar 2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654510/0962F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). On 02, Mar 2007, the patient experienced chest pain several hours post vaccination. The character and location of the chest pain was unknown. On 04, Mar 2007, the patient recovered from chest pain without medical attention on treatment. No further problem reported. Additional information has been requested.
Rash on chest, stomach, back and legs; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 16Mar2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (ZITHROMAX) on an unknown date and experienced drug allergy. 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 vaccination. On 09Apr2021 at 07:00, the patient experienced rash on chest, stomach, back and legs. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash on chest, stomach, back and legs was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
None at the time.  7 Months after 2nd vaccine shot, hospitalized in ICU for complete heart block.  No previous heart or any other medical issues.  Ended up with a permanent pacemaker.
MILD REACTION; This spontaneous report received from a patient via a company representative 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. No concomitant medications were reported. The batch number was not reported, per procedure no follow up will be requested for this case. On an unspecified date, the subject experienced mild reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild reaction was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions included prostate cancer which was treated with an unspecified treatment every 6 months for an unspecified duration. Known allergies and concomitant medications was not provided. On 02-NOV-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU with lot # M041085 and expiration date on 30-JAN-2018 (anatomical route of vaccination was not provided) for prophylaxis reconstituted on sterile diluent (MERCK STERILE DILUENT) lot # M034444 with expiration date on 27-MAR-2019 (product use issue). No adverse effects were reported.
Following the vaccination (3 hours later). Symptoms - swelling and redness of the eyes - severe migraine - fever (low grade).
pt called morning after shingrix admin w/ c/o nausea, near syncope, lightheadedness, widespread body aches, headache, and fatigue. Pt evaluated in ED with BP of 97/64 (low for pt) she was given NS bolus, oral ondansetron, and diphenhydramine. She was discharged as stable and is to follow up with PCP with failure to improve or return to ED with worsening.
Special needs client received an Janssen covid19 vaccination to left deltoid, within 10 min of receiving vaccine , client developed a rash at the site if inj. and he neck. She was itching. She also experienced some bells palsy or drooping of her face on the right side. She was coherent and responsive the whole time Adult dose of Benadryl was give immediately and within 15 minutes the rash was going away. resolving. client was feeling better and released to home with her mother
Tingling in finger tips/ Trigger finger in middle finger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0161) as dose 1, single and administered in arm left, administration date 2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SINGULAIR. The following information was reported: PARAESTHESIA (non-serious) with onset 29Apr2021, outcome "recovered with sequelae", described as "Tingling in finger tips/ Trigger finger in middle finger". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included vitamins, synthroid, singular. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Adverse event: tingling in finger tips after first vaccine. Trigger finger in middle finger after second vaccine.   No follow-up attempts are possible. No further information is expected.