chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid spontaneous report was received from a pharmacist, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (thimerosal free) lot # R004185 with expiration date on 06-NOV-2020 (strength, anatomical location or route of administration were not provided) for prophylaxis. The storage temperature of the vaccines was reported as 9 to 25 degrees Celsius (°C) (maximum 8.5 °C) for a time frame of 1 hour; digital data logger involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This case is considered non-valid due to the lack of patients' identifiers.
Pt received Moderna vaccine for first dose and was inadvertently administered Pfizer vaccine for 2nd dose.
Started with nasal congestion x 2 days then developed a cough on 9/10/10.  Was reported to start having shortness of breath with exercise on 9/13/10.  Was seen in the office for the first time on 9/14 and found to have moderate wheezing on examination which improved with inhaled beta-agonist.  No prior history of wheezing before this event.
18APR97 ER rt upper arm red & swollen, 11x11cm erythema, induration non tender;dx local rxn to varicella vax;19APR97 swelling worse today;dx local rxn immunization;
Patient received an Antibody Test at pharmacy. We went to pharmacy to get the Covid Booster. The results showed he had NO antibodies. The pharmacist said he is the second person she has seen with zero antibodies after receiving the J&J vaccine.  So he has started all over being vaccinated, receiving the Moderna. Makes you wonder how many more people this has happened to.  The public should be made aware of the efficacy of the J&J vaccine.  Also, how many  people got Covid after having received the J&J vaccine??  Apparently it isn't just the Unvaccinated getting Covid.  I feel sure there are many people walking around thinking they're fully vaccinated, when in truth, they have NO antibodies and aren't aware!  This issue needs to be faced immediately!
48 hours post vaccine developed quarter sized red and itching area at vaccine site - over last 2 weeks has developed increased size now 13 x 8  cm - blotchy, increased temp and tender - right arm swollen to wrist -  myalgia - both shoulders No SOA, facial swelling, wheezing
Lump approx 4? by 6? under injection site, cellulitis radiating from injection site. Cellulitis site red and hot to touch
left arm 1.5 in diameter erythematous, warm, edematous, lesion. No fever, chills
mild flu-like reaction; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received Shingles vaccine and had a mild flu-like reaction. The patient had shingles before and was hoping to not have it again. For tolerance of second dose, refer case US2021AMR208490.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208490:same patient and reporter
10/16 vaccine subq RA. 10/17 painful, mild edema and erythema. 10/18 pain with itching, hot, edema, erythema (12cm x 11.5cm), Ibuprofen 800mg, Benadryl 25mg q 4d. 10/19 S/A continue Benadryl and Ibuprofen. 10/20 S/A measures 17cm x 20cm, consult with PCP, continue Benadryl, Ibuprofen, etc. If edema increases post markers, begin Prednisone.
At Christmas I started coughing and I could not stop and short of breath, wearing feeling that I was going to die. I went to the hospital. They send me home after X-ray, they said I had Pneumonia. That night at home, I felt sick again and I went to a different hospital, they told me I was severe anemia, I might need blood transfusion. They will start a treatment called Venofer Infusion. For 5 weeks treatment.
12/27/21: 45-year-old with past medical history of bipolar disorder who comes to the ED because of shortness of breath.  She has had fevers, chills, chest pain.  She has had diarrhea she says, nausea, vomiting, abdominal pain.  No bloody stools.  She has been experiencing symptoms of cough, nasal congestion, shortness of breath, myalgias, polyuria for the past 5 days.  She has been vaccinated with Johnson and Johnson.  She had chest x-ray that shows linear stranding, right base, suggesting atelectasis.
I felt something go down the left side of my body once injected. A few hours later hives (small bumps red, itchy) 4 to 5 hours after vaccine  administered hives on legs, back of knees, arms, shoulders, back, one on forehead, neck back.
pt recvd vax;lab tests showed WBC count dec;reporter felt that further dec in wbc due to pt being vaccinated w/ varicella vax;f/u info stated that pt had reactive airways & perennial allergic rhinitis;MD felt pt sxs was poss related to vax
The next day after receiving the vaccine I felt like I got hit really hard in the arm. Then I started to experience abdominal pain and headaches. I would get chills and feel hot in the head area, but when I checked my temperature, I would not have a fever. I started getting some chest pains starting from the left side going in towards the center. I would get a tingling sensation from head to toe, it did not make me feel right. I did not feel like myself. It felt like something was wrong. Along the left side of my back, I would get some muscle pain on the side that the vaccine was injected. Along with abdominal pain I would get a really weird feeling in my stomach. I ended up going to the ER on 11/7/2021, at hospital because the abdominal pain got so bad to where it was starting to be difficult to breath. Through the IV they gave me fluids and medicine to help with inflammation. The doctors did test but everything came back normal. They just said they do not know what it is. I have an appointment with my PCP today. This has been going on since then but it is slowly going away. There are days that I would not do anything because I did not feel good.
running a temperature; headache; arm was swollen; arm was swollen; arm was swollen and very sore; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 73 years old, administered in arm left on 22Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient stated she hasn't taken anything before or after the vaccine and was not on any medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration at the age of 73 years old, on 18Jan2021 as single dose for covid-19 immunisation and had arm was swollen. The patient received the second dose on 22Feb2021 and she was not feeling well left on 22Feb2021. Her arm was swollen and very sore, she was running a temperature and each time that she took it is going up, she also had a headache. The patient said that her arm was swollen after the first dose too. She did not know what to do with herself. She said that she wanted directions on what she should do, is there anything that she can take to bring her temperature down. The patient said that her arm started getting sore last evening, on 22Feb2021. She massaged it and iced it. She had swelling this morning on 23Feb2021. This happened the last time, but she did not run a fever last time. The patient said that her temperature was 98.5, then 98.7, then 100.2. She woke up on 23Feb2021 with the temperature and the headache. She stated that the writing after the 6 in the lot number was not clear and was scribbled on the card. The patient provided the second dose Lot as EN6 and the rest was unclear. The outcome of the event not feeling well was not recovered, of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extremely heavy menstrual flow, much heavier than what is normal for me.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Apr2021, the patient experienced extremely heavy menstrual flow, much heavier than what was normal for the patient. The event did not result in 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely heavy menstrual flow was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
arm hurt; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced arm hurt after getting it. Outcome of the event was unknown.   Information about Lot/batch has been requested.
Prolonged headache (x months, still present). Fatigue - diagnosed with Chronic Fatigue Syndrome. Symptoms started 2 days after immunizations.
Swollen Lymphnodes above right clavical and under right armpit.  Sore joints in right arm.
Lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the 2nd shot; Lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the 2nd shot; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient (consumer) received DOSE 2 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Apr2021 at 13:15 (age 39-year-old at the of vaccination) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient had no relevant medical history and concomitant medications. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the dose 1 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 13:15 (age 39-year-old at the of vaccination) as a DOSE 1, SINGLE for COVID-19 immunisation. 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 an unknown date in May2021, the patient experienced lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of events lingering pain sometimes severe in the area where the vaccine was administered almost 4 weeks after the second shot were not recovered at the time of this report. Follow-up received on 20Aug2021, included Reporter comment: Consumer did not give consent for information for follow-up questionnaire.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
patient complained of numbness in right arm and limited mobility for the past 3 days since vaccination. He had radiating burning pain up his neck and down his arm.  patient has been taking aspirin for his pain. it has been getting better but has not completely gone away yet. patient pointed to just below his shoulder when asked where he received his vaccination.  Possibly vaccination given too high on his arm? patient got flu vaccine in left arm on 9/9/20 and said no symptoms from that.  Has not seen doctor about it. I did advise patient if pain persists to call MD.
No other AE and no PQC; His first dose ofGARDASIL 9 was back in February 2020. 10-SEP-2020, the patient received his second dose of GARD A SIL 9; This spontaneous report was received from the patient's mother referring to her son a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   The patient's mother stated that her son received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) back in February 2020 for prophylaxis.  On 10-SEP-2020 (reported as "today"), the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and was informed he should have received the second dose 2 months after the first dose (April 2020). No other adverse event was reported.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - 7/28/2021?   Is this your first or second dose- First Date of symptom onset - ? 8/2/2021 Symptoms - ? Headache, congestion, and fatigue Last day of work and shift - ? Unknown Home remedies- Tylenol Extra strength 500 mg  X 2 Any improvement- Employee just took it so not as of yet. Recommendation- Advised employee to take Tylenol Extra Strength 500 mg per package instructions and if symptoms not resolving or get worse to call us back. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Within less than 24 hours after receiving the vaccine I developed hives on my face. I have had breakouts of hives on my face every day since then. I have woken up with them in the morning and then they will come and go throughout the day up to 3 times. Also experienced rashes on my face. No pain, wheezing, or other adverse effects.
A non-serious spontaneous report of sore throat, headache and weakness has been received from a registered nurse concerning a seven-year-old female subsequent to receiving FLUMIST. The patient did not have any other medical history and was not taking any concomitant medication. In November 2009, the patient received one dose of FLUMIST, intranasally. Within 24 hours of vaccine administration, the patient experienced fever, headaches, chills, body aches, and vomiting. Treatment with TAMIFLU was initiated. The events of fever, headaches, chills, body aches and vomiting resolved.
50 yo F with no past history of becoming lightheaded or dizzy with a blood draw or injection was  given COVID-19 J&J vaccine (lot # 207a21a) and became lightheaded within 3 minutes. Pt was reclined, ice pack applied to the back of her neck. Pt was allowed to recline for 5 minutes. She then reported feeling better and was allowed to sit. Pt's BP was 115/81 HR 82. Pt rested for an additional 5 minutes and stated she felt back to normal. Pt was able to stand and ambulate without feeling dizzy or lightheaded. Pt was escorted to car with husband at her side. Pt remained alert and oriented during the encounter.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
This is a 48yo female with PMH of DM 1 on insulin pump, hypertension, peripheral neuropathy who presents to the ED with about 7d of subjective fever, chills, body aches, shortness of breath and an overall feeling of unwell. She says she also was not eating well and has been staying in bed. She says her son was also sick so they both went for COVID and flu test on Thurs but has not yet been made aware of the results. Since Thurs she has also noticed increased shortness of breath which has gradually worsened as well as some chest discomfort. This is what prompted her to call EMS and come to the ED.    She has a history of DM 1 and is on an insulin pump but, because she has not been eating, she had not been checking her BG. She says the last time she checked was a couple of days ago. At that time it was in the 180s. She has not taken her bolus insulin also because of this.    In the ED, VSS. Labs notable for glucose of >600, K 5.2, CO2 16, BHB of 7.2. UA showed ketones and >1000 glucose. VBG with pH of 7.22. Troponin nex. CXR unremarkable. Unable to find results of COVID test from OSH so she has been re-swabbed. She was given a fluid bolus and started on isulin drip. She will be admitted to medicine for management of DKA.  1/17/2022 PROGRESS NOTE ASSESSMENT: 48 y.o. female with history of DM Type1 on insulin pump, HTN, and GERD admitted 01/09/22 for DKA in the setting of COVID infection. Has been on and off insulin ggt due to being a very brittle diabetic and varying oral intake . Did not tolerate going back onto her PTA insulin pump. Transition  lantus/aspart dosing.   PLAN: DKA x 2, resolved DM Type 1  on PTA insulin pump Iatrogenic hypoglycemia, resolved COVID infection. Criteria for DKA-- PH of 7.22, ketosuria, bhb elevated at 7.20, AG of 19, CO2 of 16 on amission. Was able to be weaned insulin ggt in the ED. Attempted to switch back to PTA insulin pump for 2 days (1.45 units/hr), but had recurrent lows. Hospital policy does not allow adjustment of this pump, so switched to SQ lantus/aspart dosing however went back into DKA. Placed back on insulin ggt and had required ~ 1 unit/hr consistently) but then suddenly a morning low (58) with rapid rebound 428 within 4 hours of holding insulin ggt    continue carb consistent diet with 1 unit per carb  d/c insulin ggt 1/16 , start lantus 17 units daily  MDSSI  reduce BMP to q12H continue Mg and K replacement protocol  consider reaching out to outpatient endocrinologist     COVID-19 infection Vaccinated,overdue for booster. This was delayed due to recent episode of shingles which is resolving. symptom including fatigue, subjective fever, decreased appetitie, shortness of breath   No hypoxia and CXR clear. No decadron  continue full barrier precautions F/u PCP for booster   Sinusitis  Not improved on conservative therapies with sudafed.  continue augmentin BID x 7 days  continue sudafed BID   Hyponatremia 2/2 hyperglycemia    Corrected sodium WNL.    Hypertension   PTA lisinopril and HCTZ   Gastroparesis PTA Reglan   Anxiety/ Depression  PTA Zoloft and Xanax   GERD  PTA Protonix    HLD  PTA pravastatin
I had a slight fever and achiness with headache and cough. I tested positive for COVID-19 on March 25, 2023. I called and received PAXLOVID for 5 days. On day six I tested negative. As of today, I feel fine but still have a little bit of a cough.
Patient began noticing weakness, numbness, tingling in extremeties, fatigue.  Fell to ground while traveling.  Came home to follow-up with physician, weakness, numbness, tingling, loss of strength, lack of coordination, decreased sensation.  Diagnosed eventually with Guillan Barre syndrome and treated around 4/14/14.  Pt. has made 85% recovery.  Still states he is wobbly, tingling sensation in extremeties, decreased sensation to face, back pain.
Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021 and administered on 11-Nov-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021 and administered on 11-Nov-2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021 and administered on 11-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021 and administered on 11-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Date the vial was placed in refrigerator was on 29-Oct-2021. Temperature excursion was not reported. The patient did not experience any adverse event. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Treatment information was not provided.