chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Pharmacist concerning a 72 year old male with high cholesterol and without drug reactions or allergies who on an unspecified date "more than 5 years age" was vaccinated with the first dose of PNEUMOVAX 23. On 15-OCT-2009 was vaccinated with his second 0.5 ml dose of PNEUMOVAX 23 intramuscularly (Lot # 664871/1142Y). On the same day, the patient also received the flu vaccine. Concomitant therapy included FLOMAX, simvastatin (manufacturer unspecified) and ibuprofen. It was reported that when the pharmacist withdrew the needle from the patient's arm and "blood came out from the site". The pharmacist stated she applied pressure and cleansed the area with alcohol. It was also mentioned that a hard knot was formed at the site. Not specified laboratory and diagnostic test were performed. The patient sought unspecified medical attention. At the time of reporting the patient PNEUMOVAX 23 not recovered.
Sudden onset of upper and lower extremity weakness about 2 weeks after vaccine administration. Patient hospitalized for 9 days, diagnosed with Axonal Variant of Guillain-Barre. Treated with IVIG. Symptoms are improving at this time.
This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 71-year-old male patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 12th August 2018, 6 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The physician reported that one of her patients came in with an itchy rash all over his body.  The physician was not sure if this was related to the vaccine. However, there was nothing new in diet or medication.
10 April 2003, pain at site, fever, headache, malaise, and swelling. By the end of first day swelling spread down the left arm. 11 April 2003 noticed rash down left arm and swollen, and hardened lymph node under left arm. At 1300 on that day ,pt was given Keflex 500mg BID. By 2000, pt reports rash spread to both arms, back, chest, and legs. Pt reported to ER that evening. No additional meds were given.
Information has been received from a health professional concerning a 9 year old male who sometime in 2000 was vaccinated with his first dose of MMR II. The second dose of MMR II was administered to the patient when he was 4 years old. On 09-Jun-2008 the patient inadvertently received a third dose of MMR II (lot number unspecified) instead of VARIVAX (MSD) because of human error. On 09-JUN-2008 the VARIVAX (MSD) (lot number unspecified) was administered as scheduled. No adverse symptoms were noted. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information indicated no new information. Additional information is not expected.
Body is feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Body is feeling hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Body is feeling hot). At the time of the report, FEELING HOT (Body is feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
I received the Moderna Bivalent booster on 9/12/2022. On 11/28/2022, I developed a sore throat, nasal congestion, chest congestion, and cough, but they weren't severe. I was also more fatigued than usual, but it wasn't severe at that point. I took a 12-hour nasal decongestant with pseudoephedrine and menthol cough drops. I started taking another OTC medicine that contained dextromethorphan and guaifenesin, but I don't know if I started taking it on 11/28/2022 or 11/29/2022. On 11/29/2022, my symptoms worsened. The sore throat and coughing became moderate to severe. The fatigue worsened. The nasal and chest congestion also worsened, and I developed a headache and body aches. I took ibuprofen in conjunction with the aforementioned medicines. They didn't get rid of the symptoms, but they lessened their intensity. On 11/30/2022, all of the symptoms worsened, and the severity reached its peak. I had a low-grade fever of 99.4(?); my body temperature is usually about 98 degrees. I took a home antigen test, which yielded a positive result. On 11/30/2022, I had a telehealth appointment with a doctor, who prescribed PAXLOVID, which I began taking on 12/1/2022. On 12/1/2022, my throat was still sore, but it didn't hurt as much. My other symptoms, though, just reached a plateau. During the duration of my illness, I continued to take the aforementioned OTC medicines in conjunction with the PAXLOVID. On 12/2/2022, I no longer had a fever, and though I still felt bad, my symptoms had improved overall. On 12/3/2022, the overall improvement of my symptoms continued. This trend continued for the next several days. On 12/6/2022, I felt well enough to work; I work remotely, so I did not have to go far. At around this time, the majority of the symptoms had decreased in their intensity and they were similar to those of a moderate cold. The sore throat persisted, and since the other symptoms had become milder, most of my attention was drawn to my sore throat. At this point, I stopped taking the nasal decongestant, but I continued to take the cough suppressant and non-menthol cough drops. The rest of the symptoms tapered off gradually, but a mild cough and an intermittent mild sore throat have continued to the time of this writing. On 12/7/2022, I tested negative on a home antigen test at around 5 AM. On 12/10/2022, I had another negative test result at around 2 AM. The persistent cough I continue to deal with does not cause any discomfort, but it's more like I have to frequently clear my throat.
Tested positive for COVID; Tired; Just body aches; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID), FATIGUE (Tired) and MYALGIA (Just body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Tired) and MYALGIA (Just body aches). On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID), FATIGUE (Tired) and MYALGIA (Just body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test positive: postiive.     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.   This case concerns a patient of unknown age and gender who experienced non serious events of unexpected SARS-CoV-2 test positive and expected fatigue and myalgia.  Event onset 3 days after the first dose of mRNA-1273, followed by SARS-CoV-2 test positive on Day 8. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced nonserious events of unexpected SARS-CoV-2 test positive and expected fatigue and myalgia.  Event onset 3 days after the first dose of mRNA-1273, followed by SARS-CoV-2 test positive on Day 8. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Shortly after 2nd dose of Pzifer COVID vaccine, I started experiencing urticaria all over my skin. Large spaces of hives would flare up in no predictable areas, would be present for 10 minutes or so, then usually go away. This still happens to present day several times a day. Associated itching and redness. Still no specific area, but is usually on the arms, legs, and back.
GI upset consisting of Diarrhea. It started on 3/19/21 in the morning. I have been taking Imodium  and drinking gatoraide but this has not subsided yet. If it continues I plan to seek medical treatment.
PT COMPLAINED OF LINGERING PAIN ON THE LEFT ARM AFTER RECEIVING THE FLU SHOT. THE PAIN HAS BEEN ONGOING FOR OVER A WEEK
Approximately 10 days after receiving my Moderna booster shot, I developed  Dermatographia.
Swelling, itching, redness and rash; treated with Benadryl and cortisone cream.
Onset 4am, 12/13/2005 - Generalized erythema, jerking head back and forth, shaking arms/legs, increased heart rate, fever 104.3-102.6  Possible febrile seizure.  Prescribed Tylenol, Motrin, Oral fluids.
Bilateral shoulder pain 10-14-22 R > L (R) hand pain and swelling - 12-30-22 HH/Physical Therapy Neck shoulder & hand xrays - 12-30-22 given prednisone & cyclobenzaprine. 1-6-23 MRI C-spine, prednisone, cyclobenzaprine 1-26-23 Ortho consult 1-26-23 DVT proximal to distal brachial vein - Eliquis
burning back pain; burning back pain; sickness; experienced "sickness" headache; injection site pain; heart burn; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced sickness, headache, injection site pain, heartburn, burning sensation and back pain. On an unknown date, the outcome of the sickness, headache, injection site pain and heartburn were recovered/resolved and the outcome of the burning sensation and back pain were not recovered/not resolved.   It was unknown if the reporter considered the sickness, headache, injection site pain, heartburn, burning sensation and back pain to be related to Shingrix.  Additional details were reported as follows: On 4th December 2019, the patient received 1st dose. The patient received 2nd dose of Shingrix and experienced sickness, headache, injection site pain, heart burn and burning pain across back.  The healthcare professional (HCP) reported that all the symptoms went away after 1 day except the burning pain across back. No additional information provided. The reporter consented to follow up.
c/o right deltoid with mild erythema, hematoma, and warm to touch. Hematoma measured 2"x2" Advised mom to apply cold compress and will re-evaluate in 2 days.
This spontaneous report was received from a healthcare professional referring to a 12 months female patient. Information about the patient's medical history and concurrent conditions was not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Patient called pharmacy to report adverse reaction thursday 5/27/21 after vaccination monday 5/24/2021. Patient reported feeling tingling, like a pin prick and numbness similar to your arm falling asleep in her right arm, the opposite arm that was vaccinated.  She noticed the onset about 2 hours after receiving the vaccine.  She reported it was reoccuring, but on and off, the next few days.  She feels is is a constant feeling today, 5/27/21. The feeling starts about at the elbow and is felt down through the hand. After vaccine, other side effects reported were headache and mild chest pain the first day only.  I referred patient to her primary care provider after no other explanation could be determined over phone consultation.
Dizzy with loss of consciousness /fainting x2. Minor closed head injury secondary to fainting.
I lifted my left arm that same evening of the injection and under my armpit I felt swelling. The next day I called my PCP and they examined my left arm, under armpit but told my lymphnodes had no swelling. Within a few days, the swelling went down.
Had vaccine #1 on March18, 2021.  Had no effects of any kind.  A little sore  at injection spot but no problem. Had vaccine #2 on April 8, 2021.  Still no side effects.   Then 14 days later on 04/21/2021 I had total loss of taste and it has not returned.
Red, hard, hot mark around injection site, severe headach/migraine, severe body aches, dizziness, severe  fibromyalgia flare, 101.5 degree fever, trouble sleeping
After dose 1: sore arm for a day and a half; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (After dose 1: sore arm for a day and a half) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After dose 1: sore arm for a day and a half). At the time of the report, VACCINATION SITE PAIN (After dose 1: sore arm for a day and a half) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug was reported. No concomitant drug was reported.   This case was linked to MOD-2021-420839, MOD-2021-420890 (Patient Link).
Pt got ZOSTAVAX on 9/12. Called on 9/14 to let us know that injection site was red, swollen w/itchiness about size of half dollar. F/U on 9/18 and it has improved.
Patient was at summer camp for the week and developed severe leg pain, headache, stomach pain, diarrhea and shortness of breath. I had to go and pick him up from camp. He then added dizziness and exhaustion to his symptoms. Wednesday he seemed to be a little better but Thursday he could barely move. He was dizzy and fell down. He could not function. He was disoriented and in terrible pain. He was rushed to urgent care where they called an ambulance to take him to the emergency room where he had the above symptoms plus a fever of 102.7, rapid heart rate (122) and low blood pressure. He underwent three attempts at a lumbar puncture before it was successful. Nothing was unusual looking. This is how my son spent his 18th birthday...in the emergency room.
Information has been received from two Licensed Vocational Nurses (L.V.N.) referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 27-JAN-2016 the patients were vaccinated with improperly stored M-M-R II (lot # L020189, expiration date: 03-JUN-2017; lot # L024265, expiration date 01-JUL-2017; lot # L028274, expiration date 28-JUL-2017; lot # L027591, expiration date 23-JUL-2017; route and dose were not reported). The vaccines were exposed to 47.8 for 1 hours and 5 minutes with previous temperature excursion of 27.5 for 1 hour 20 minutes. No adverse event had been reported. This is one of the several reports from the same reporter. Additional information has been requested.
Severe pain in my legs, my back, my arm where they injected me/Pain in arm; Severe pain in my legs, my back, my arm where they injected me; Can't move right now; I am slow moving because I am in pain; severe pain in right side and in right arm at injection site; Muscle pain; cannot lift right arm; Dizziness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 17:15 (Lot number: EN6198) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Mar2021, outcome "not recovered" and all described as "Severe pain in my legs, my back, my arm where they injected me"; HYPOKINESIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "Can't move right now; I am slow moving because I am in pain"; DIZZINESS (non-serious) with onset 03Mar2021 17:45, outcome "recovered" (04Mar2021 17:45), described as "Dizziness"; HEADACHE (non-serious) with onset 03Mar2021 17:45, outcome "recovering", described as "Headache"; INJECTION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "severe pain in right side and in right arm at injection site"; MYALGIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Muscle pain"; LIMB DISCOMFORT (non-serious) with onset 04Mar2021, outcome "not recovered", described as "cannot lift right arm". Therapeutic measures were taken as a result of pain in extremity, back pain, pain in extremity, headache, injection site pain, myalgia.  Additional information: Consumer took some Tylenol for pain in extremity, back pain, pain in extremity, headache, injection site pain, myalgia, Tylenol 500 mg 2 tabs every 6 hours. Consumer reported his right leg seems okay and no fever. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The AE(s) did not require visit emergency Room and physician office. No prior vaccinations within 4 weeks and no AE following prior vaccine reported. No follow-up attempts are possible. No further information is expected.
I got shot, spoke with pharmacist who injected for about 3 min, they didn?t behave me sit and wait 15min like my husband  did (different location) this morning. I started to leave store and immediately had metallic taste & my head felt different. I knew something was off! The taste is still there, my head is achy but everything else is fine.
pt recv vax 27OCT97 & 28OCT97 pt exp cellulitis appearance 14x17cm described as edema in the rt arm extending to rt hand, induration, arm pain & redness & warmth @ the inj site;devel fever;seen in ER;
The patient passed out a few min after having the FLUARIX shot. The Patient?s dad said that this is the 2nd time that the patient has passed out in the last few months. The 1st time the patient passed out the patient was just at home. We called the paramedics and they took the patient to the ER. I talked to the patient and the patient?s dad later that same day and the doctor told them that he could not find anything wrong with the patient.
PAIN AT INJECTION SITE AT TIME OF VACCINATION WHICH HAS PERSISTED TO REPORT DATE (7 WEEKS). REPORTS DECREASE IN ROM OF AFFECTED ARM/SHOULDER. THESE SX ARE STILL BEING EVALUATED.
This spontaneous report was received from the registered nurse regarding a 12 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
no adverse event; PROQUAD was inadvertently administered 1 day after its expiration date; This spontaneous report as received from an office manager and refers to a 5 year old male patient. On 12-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T034826 exp date 11-APR-2022) (dose 1 subcutaneously in the right thigh at a private clinic. Concomitant therapies included sterile diluent. It was reported that the vaccine was removed from storage and no adverse response was noted in the patient.; Sender's Comments:  US-009507513-2203USA003273:
Continued joint soreness, low grade fever, fatigue, clammy, plaque psoriasis continuing to flare up after a year of none!
This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on 09-OCT-2012 was vaccinated on left arm with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that initially post vaccinated the patient experienced some soreness after the injection, which resolved. Now weeks later, the patient had left arm pain throughout her whole arm, not at injection site. No swelling, no rash and no warmth. The pharmacist stated that the patient was doing some gardening recently and did not know if that could be attributed to the pain. The patient sought medical attention, she talked with the pharmacist. The patient did not receive any treatment for the event. At the time of the report, the patient had not recovered from the adverse event. The relatedness for the adverse events was unknown for ZOSTAVAX. Additional information is not expected.
After flu shot, patient got a cold shortly without any treatment. School didn't start at that time. Patient didn't go out. We, parents, weren't not sick. A week ago (9/16/2017), patient got this tingling feeling, but he didn't tell us. The symptom got worse due patient's PE class, and he finally complained to us. First we thought maybe he played computer too much, but the more we asked, the more we felt something wrong. We went online to search and found something called Guillain-Barre Syndrome with tingling leg which may lead to death. I can't stand those words. Patient is such a bright boy. We try to do good for the society. Why does it happen to him? Maybe it's not. But please help! help! help! Patient is a heathy boy. Why is this?!