chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned one of the doctors in his assisted living facility had the dose of SHINGRIX and he did not feel well after. The reporter did not know the name of the patient. The reporter did not give consent to follow up. The reporter was asked repeatedly for more specifics regarding not feeling well and he kept repeating that he just did not feel well. This case was 3 of the 3 cases, reported by the same reporter.
Started with the hand of the injected arm going numb and feeling cool and tingly. This ascended up past the shoulder (at 4pm), up the neck(5:30 pm), and further to the level of nose (6pm). PCP instructed me to go the ER. ER had never seen this reaction before, but was unconcerned about it. Sent home with nothing. Overnight the symptoms started to recede. The next morning, approximately 21 hours post onset, only parts of the arm were still having the tingling numbness. Symptoms were fully resolved at 3pm on 9/29/12, approx. 25 hours post administration of influenza vaccine.
This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist reported that she administered the second dose of the vaccine two weeks earlier) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist reported that she administered the second dose of the vaccine two weeks earlier). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist reported that she administered the second dose of the vaccine two weeks earlier) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
This spontaneous report as received from an office manager refers to a 4 year old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 16-MAY-2017 the patient was vaccinated with first dose of improperly stored M-M-R II (lot # M029230, expiry date: 08-JUN-2018) for prophylaxis (incorrect product stored). The product had undergone a temperature excursion at a temperature of 47 to 77 F for 11 days. The sterile diluent did not undergo a temperature excursion. The lot number and expiration date of the sterile diluent is unknown by reporter. No previous temperature excursion were reported. No adverse effects reported. A call was made due to data logger. No additional information provided. No product quality complaint involved.
First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences  a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.
Pt had shot on 8/17. Stated she woke up on 8/18 with hives and rash all over body. Patient came into pharmacy 8/19 at 10:47am saying she had gone to urgent care and was told she can never have another flu shot and was prescribed a steriod pack
06/30/03 received injections; 07/04/03 small area of rash right ankle which resolved 07/06/03; 07/16/03 small area of raised red rash right buttock, mom relates no complaints from infant.
My wife have go low platelets; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (My wife have go low platelets) in a female patient of an unknown age 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 THROMBOCYTOPENIA (My wife have go low platelets) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (My wife have go low platelets) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Reported that My wife have go low platelets and I like to ask some questions? Thrombosis with Thrombocytopenia Syndrome (TTS) is a new health condition. It was discovered after the start of COVID-19 immunisation programmes worldwide. TTS is different from the other blood clotting disorders described above. In TTS, blood clots.; Sender's Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious (medically significant) unexpected events(s) of Thrombocytopenia. The event(s) occurred on unknown date, the patient received the dose of mRNA-1273, Moderna COVID-19 Vaccine on unknown date. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
After vaccination just sore arm, two days later tremors started in arms, head and hands, This lasted a couple of days and today she seems better.
Heart palpations, headache, muscle/bone aches, muscle spasms, chills, fever, fatique- Tylenol taken around the clock- started prior to start of symptoms. Symptoms improved after 36 hours after injection, but still continue. Pregnant 26 5/7 weeks
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 11-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 454G3, expiry date 30th June 2019) for prophylaxis. On 6th November 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 7th November 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced shoulder pain, neck pain, bone pain and back pain. The patient was treated with Lidocaine. On an unknown date, the outcome of the shoulder pain, neck pain, bone pain and back pain were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, neck pain, bone pain and back pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT 2018-2019 season on left arm and the next day she experienced shoulder, neck collarbone and back pain. The patient had no fever, swelling or redness. The patient's mother gave her a Lidocaine patch, but the pain had not resolved. On 9th November 2018, the patient had a doctor's appointment. There was consent to follow up.
This spontaneous report as received from a physician refers to a 61 year old male patient. Approximately on 05-SEP-2013 (reported as in the last 4 weeks), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial. Approximately on 12-SEP-2013 (reported as 1 week after receiving vaccine), the patient developed mild case of shingles one week after receiving ZOSTAVAX. The vaccine was not administered by the physician. The physician stated that the patient received ZOSTAVAX at a pharmacy. Over the summer, the patient's wife and son had Shingles. They had not received ZOSTAVAX. Patient sought medical attention (saw the physician). Lab diagnostics Studies Performed was none. The outcome of the event mild case of shingles was unknown. Additional information is not expected.
Pseudotumor Cerebri/Intercranial Hypertension October 19 - Received this year's Covid Vaccine (Spikevax by Moderna). I was having no symptoms of any illness at this time. October 23 - I went to the eye doctor with blurred vision and blind spots. He said my optic nerve was elevated into my eye and we needed to expedite an appointment to neurology. He advised that if I started to feel worse, I should go to the ER. Also ordered a CT. October 26 AM - CT with and without contrast (results were normal) October 26PM - I started to get weak, dizzy, and nauseous, headache, blurry vision, blind spots that came and went. Went to ER where they did a Lumbar Puncture. Opening pressure was 43. November 1 - Went back to ER with same symptoms as before (headache, blurred vision, blind spots, dizzy, weak, nauseous). They did an MRI with and without contrast as well as an MR Venogram. All tests came back normal. They performed another Lumbar Puncture. Opening pressure was 45.
Information has been received from a pharmacist concerning an 82 year old male who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient experienced shingles at an unspecified time after receiving ZOSTAVAX (Oka/Merck). The patient sought medical attention and was seen by the physician. Additional information is not expected. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Initial and follow-up information has been received from a pharmacist concerning an 82 year old male with high cholesterol and history of varicella as a child, who on 08-JUN-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # reported as 020900-invalid) 0.5 mL into his right arm. Concomitant medication included LIPITOR, aspirin and omega-3 marine triglycerides. On 01-AUG-2008, the patient experienced shingles after receiving ZOSTAVAX (Oka/Merck). The patient developed a rash and multiple lesions on his right axilla and chest. Distribution of herpes zoster lesions were found in T3 right dermatome. There was no pain in the lesions. Immediately post vaccination the patient was found to be hypothyroid with low testerone. He was good on prior testing. Patient was found to have hypothyroidism and low testosterone post zoster. There was no recent exposure to chickenpox or shingles. At time of reporting, the patient was recovered. The patient sought medical attention and was seen by the physician. Additional information is not expected.
The patient was tested on 9/13/21 and was asymptomatic. He tested positive.
9-27-09, 6-3-10, 3-4-11 ] shingles outbreak; ab & pain treatment given.
Hands tingling and numb, Lightheaded. EMS called, transported to ER. Released.
Mother called reported child has red whelped area where injection was given on left arm. Child denies pain but itches a little at the site. Mom denies fever, nausea or any other symptoms. Mother gave ibuprofen and BENADRYL this am. Recommended taking to MD but client said if worsen will take MD or ER. She said gave BENADRYL  and MOTRIN and will watch area.
This child got a light case of spots on 08/07/01 and on 08/10/01 developed a high fever of 102 or above for 4 days. She gave the chicken pox to her dad also his spots started on the 8th.
This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (Merck) (lot#: J014328, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005559, 1404USA005560, 1404USA005562 and 1404USA005563) from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to an unspecified pediatric patient of unknown age and gender. There was no information about patient's concomitant medication, pertinent medical history, drug reactions or allergies provided. On 02-OCT-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection (lot# H015537, expiration date 09-JUL-2015, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
pt to ER noc of 16JUL98 w/T102 w/sx;tx in ER;
1 week after administration of MMR and Pediarix in the left thigh a tender red lump developed.  Over the course of several days the size increased and had pustular drainage.  2 weeks after immunization fever to 103 developed with abscess and cellulitis in the area.  Nurse follow up on 11/12/04 states: "rash, cough."
Pain, tingling in rt leg, collapsed rt lung, problem diaphragm, drop rt foot, Nerve tingling in rt chest extending up to rt shoulder to back of head and rt cheek. This lasted about 20 sec but happened about 20 to 30 times a day, weight loss @ 24 lbs. loss of appetite and lethargic, was diagnosed with Guillain-Barre, then ALS and MS various flu symptoms and wanting to sleep all the time. Numbness in rt shoulder. Lost 2.5 inches in height dropped one shoe size in rt foot.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 20-JUN-2017 the patient was vaccinated with PROQUAD for prophylaxis. Other suspect therapies included VARIVAX. On 20-JUN-2017, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered no adverse event to be not related to PROQUAD and VARIVAX. The reporter considered inappropriate schedule of drug administration to be not related to VARIVAX and PROQUAD.
Hypertension. This may have been a chronic condition -- but it was first diagnosed on a visit to an urgent care facility for a Covid test, and 2-3 weeks after receiving 2nd Moderna Covid vaccination. Blood pressure at that time was about 180 over about 150. Yikes! I subsequently sought treatment from my internist, and I am not taking Lisinopril. Hypertension continues, and I continue under treatment.  I have a physical exam every year -- my last physical exam prior to vaccination was about February, 2020; at that time, my BP would have been normal, around 120/80. My doctor prescribed Lisinopril (10, then 20 mg) a couple of weeks later.
fainted; Patient was dizzy; migraine; Patient had a panic attack before heading to the emergency room; fatigue; uncontrollable vomiting; temperature was 103; injection site pain; joint pain; Headache; neck pain; back pain; general body pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21AE and 031L20AE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), FATIGUE (fatigue), VOMITING (uncontrollable vomiting) and PYREXIA (temperature was 103, high temperature). On 17-Apr-2021, SYNCOPE (fainted) had resolved. At the time of the report, DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), FATIGUE (fatigue), VOMITING (uncontrollable vomiting), PYREXIA (temperature was 103, high temperature), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 103 (High) 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Imitrex, Tylenol, Steroids, Benadryl, Zofran, and Morphine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient's daughter called phamacy today 4/13/21 to report that her father suffered a fall at his home on 4/4/21, the following day after patient received Janssen covid vaccine at pharmacy. Patient's daughter stated on phone that she took her father to hospital after she learned that he fell on 4/7/21 to be examined. Patient's daughter stated that he was diagnosed at hospital with having a stroke and discharged to return home on 4/8/21.
Patient was in for well check and immunizations in the morning of 07/17 about 9am. Mother reports patient seemed fine until the evening on the 17th (same day as vaccinations) when she started complaining of stomachache.  Mom said patient looked pale and said that she felt like she was going to throw up.  She gagged a few times, but did not throw up. Mother also reported patient has eaten and kept fluids down that day.  She had tried without success to stool.  Mother denies fever, or rash.  Mom gave her Tylenol.  Mother states she called because patient's stomach was hard.  Provider recommended Benadryl 5 ml and to watch patient.  Mother was instructed that if patient is having difficulty breathing, color gets worse, or the abdominal pain gets worse, mom will call 9-1-1 or take patient to local hospital.  Today (07/20/2020) mother has sent a picture and there is a raised, red, round patch that appears to be comparable to a quarter in size. We have recommended applying ice packs and hydrocortisone to the site and to continue to monitor.
One minute after receiving vaccine pt. claim to feel sick in stomach, started to breath heavily then became dosing off and not responsive. Gave 0.3mg epipen.
fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares
Anxiety, Depression, Teeth chattering, nerve tingling / "buzzing" sensation, stomach / abdominal clenching, feels almost like my muscles are acting "110%" of what's expected the I move sometimes. The teeth chattering seems to have somewhat died down recently, so roughly 10 months after. It is not gone but much better. The anxiety and depression have improved but I still do not feel "normal" as prior vaccination. The nerve tingling feeling is pervasive. Mostly in my extremities. Sometimes feels like my foot has "fallen asleep"  or hands / arms same thing. Seems to be more in my feet when I walk, run etc. It seems to improve when I lay down. But often times the tingling symptoms are worst in the morning when I wake up. The stomach clenching feeling has not stopped once since February and gets better and worse. I also had many times where I felt I could not breath "enough" air, even just laying down relaxing or sitting still. But can run just fine with no breathing issues. My pulse rapidly climbed upon receipt of the vaccine, both times, and took a long time to come down. Might have been a mix of the Excedrin and nervousness.
patient passed out in chair, fell forward, hit head against the wall. patient had 2 seziures. 911 was called
unknown cause of diarrhea 2 days after; This is a spontaneous report from a contactable other HCP reported for self. This 47-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 29Dec2020 16:30 PM on Left arm at single dose (Lot # Ej1685) for covid-19 immunisation. Medical history was not provided. Concomitant medications included escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included Known allergies: may be Dilaudid. She had unknown cause of diarrhea 2 days after on 31Dec2020. Last only one day. No other symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 01Jan2021.
Onset of rash - a few flat erythematous lesions ranging in size 3-4mm, 5 days after vaccinations.
Very severe allergic reaction; Very itchy rash in the back at night; Hot blushes; Chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Very severe allergic reaction), RASH PRURITIC (Very itchy rash in the back at night), HOT FLUSH (Hot blushes) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPERSENSITIVITY (Very severe allergic reaction), RASH PRURITIC (Very itchy rash in the back at night), HOT FLUSH (Hot blushes) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Very severe allergic reaction), RASH PRURITIC (Very itchy rash in the back at night), HOT FLUSH (Hot blushes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications included: Medication for high blood pressure.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of severe allergic reaction with pruritic rash, chills and hot flushes, a causal relationship cannot be excluded.
Patient reports limited mobility in arm, not being able to lift arms above shoulders. Patient reports pain so intense that "it makes her scream."