chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; Administration of a ROTATEQ dose to a patient / Temperature -7.9 for 53 minutes and -10.5C for 52 minutes; This spontaneous report was received from a licensed practical nurse concerning to a 8-week old patient of unknown gender.  No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies, concurrent conditions or concomitant therapies was provided.         On 29-JAN-2021, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number reported as 1688504 and expiration date as 19-NOV-2021, had a temperature excursion of -7.9 degrees Celsius (°C) for a time frame of 53 minutes and another temperature excursion of -10.5 degrees Celsius (°C) for a time frame of 52 minutes. It was also reported there was not a previous temperature excursion and digital data logger was not involved. No additional adverse events were reported.  On the same day, the patient was vaccinated with the mentioned improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) per oral route for prophylaxis, (formulation, strength, dose, vaccination scheme and anatomical site of vaccination were not provided).
3 cm area of redness developed at site developed next morning. (Likely at site of varicella).
Since having the vaccination in my left arm on Oct 30, 2017, I have had chronic muscle ache mid-deltoid, moderate weakness, and reduced range of motion of my upper arm unlike anything I have ever experienced before. Never before has the flu shot caused this prolonged pain in my arm. I cannot raise my arm and it is very difficult to remove my clothing over my head. The pain at night keeps me awake and it is very hard to find a comfortable way to sleep. I've been using ibuprofen and naproxen sodium and that does help, but if I do not take those throughout the day the pain is debilitating. I have had a follow-up with my doctor and he prescribed Tramadol and MOBIC. I have taken those for one month with little relief.
61 y/o male received 1st vaccine dose on 4/12/2021 which was Janssen (Lot #1808980,  Exp-08/04/21). *Provider portion of PEF was not completed or signed.  61 y/o male received 2nd COVID-19 vaccination on 5/25/2021 which was Pfizer (Lot #ER8729, Exp-07/31/21) at pharmacy.
SIRS and NSTEMI: Patient presented to the ER with altered mental status, lethargy rigors, chills, and fever. He developed symptoms near the end of his regular hemodialysis treatment. Prior to dialysis, per patient and son, he was feeling well. Patient noted that he received his COVID booster shot the day before, but did not note any adverse reaction prior to that morning.   Patient became hypotensive and tachycardic in the ER. He was found to have significant tropinemia and lactic acidemia. He was admitted to the hospital.  He was treated with antibiotics, antipyretics, IV fluids, and heparin. During his course he had a cardiac stent placed. No infection source was identified to explain the patient's SIRS Antibiotics were subsequently stopped. Patient recovered and was discharged 3 days later at baseline mental status.
APROX 20 MINUTES AFTEER INJECTION BEGAN TO FEEL SHAKEY & FLUSHED - EXTREMITIES FELT WARM & WEAK
My whole shoulder is soar $ swollen and hurts to move. I also noticed on the second day that I was sooo exhausted.. to the point of sever fatigue and exhaustion!
Severe diarrhea & hemoccult positive stools after receiving Rotateq vaccination as reported from PCPs office.  Treated with Pedialyte & withholding formula temporarily.
Pt recvd a series of 3 doses of Engerix-B & exp no adverse exp, however, did not convert; plan to revax;
PSORIASIS FLARE ON TRUNK AND BACK Narrative:  PATIENT EXPERIENCED A MILD RASH AFTER THE FIRST DOSE OF MODERNA THAT HE TREATED WITH BENEDRYL AND HYDROCORTISONE CREAM WITH GOOD EFFECT. AFTER THE 2ND DOSE OF MODERNA PATIENT EXPERIENCED A SEVERE RASH AND DEVELOPED PSORIATIC PLAQUES ALL OVER HIS BACK, ON TRUNK AND ARMS THAT WAS INITIALLY TREATED AT HOME WITH THE SAME MEDICATIONS BUT WORSENED SO ON 04/08/2021 HE WAS EVALUATED AT THE AGENCY CLINIC BY PA WHO THEN PRESCRIBED A PREDNISONE TAPER AND CLOBETASOL PROPIONATE 0.05% CREAM.
Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020.    Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl).    The next day patient again had hives, trouble swallowing, and difficulty breathing.  She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2).    Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days.   Patient again had trouble breathing 2/1/2020 and returned to the ED.  Patient 10 weeks pregnant.
Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's brother in law. The reporter got the shingles twice. Once he/she was eleven and last year from the date of reporting in eye. The reporter did not receive vaccines. The patient's age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Healthcare provider states improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE reported.; This spontaneous report has been received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, the patient was vaccinated with one improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, lot # W006595 confirmed to be valid with expiration date 10-OCT-2024 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis.  On an unspecified date, before administration, the vaccine underwent a temperature excursion of 57.49 degrees Fahrenheit for 1 hour and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Between then and now I tested positive; Between then and now I tested positive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I have taken the vaccine (1st dose) on 28Dec2020 at the hospital. Between then and now I tested positive on the 04Jan2021, the hospital sent me home for 2 weeks. The 2nd part of the vaccine is coming up, it isn't until the 18Jan2021." The outcome of the events was unknown.   Information about lot/batch number has been requested.
"Pfizer-Bio-Tech COVID-19 Vaccine EUA"  Individual received the Pfizer Covid-19 vaccine. She began to feel burning at site and body itching at 2:35 pm. Patient denied SOB of breath, dizzy, and was swallowing well. Her vitals were 150/96, 20, 72, 90/% at 2:40 am. Her fingers were cold unable to get a good pulse oxygen reading. Applied 2 L NC and gave Benadryl 50 mg IM in right Deltoid at 2:40 pm. B/P 152/94,18, 95 P, 95 % 2 L. 11:46 am. Individual called her doctor office. Dr. was given report of patient condition and advise patient to come to his office now or go to ER.  Patients opt to go to physician's office. Individual stated she felt better, and her Sat's were 98% RA with no acute distress. 3:05 pm vitals 180/92, 20, 99, 98% RA. 3:15 pm Individual was escort to car with no noted distress.
This case meets criteria for vaccine breakthrough review. SxS include SOB, cough, sore throat, headache, loss of taste and smell, body aches, was dx originally 11/10/21.
Rash; skin blotchiness; This is a spontaneous report from a contactable consumer. This 69-years-old consumer (patient) of an unspecified gender reported that the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:00 as dose 1, single for covid-19 immunization. Medical history included multiple allergies. The patient's concomitant medications were not reported. No Covid prior vaccination and Covid tested post vaccination. No other vaccine in four weeks product. The patient experienced rash and skin blotchiness on 06Mar2021 at 10:00. No treatment received. Ae resulted in none of the above. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Acute myocarditis with chest pain and elevated troponin with EKG ST segment changes, muscle aches
passed out; Initial information was received on 08-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient).  This case involves a patient (demographics unknown) who passed out (loss of consciousness), when received INFLUENZA VACCINE.  Medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history of egg allergy. Due to this, the patient could not get flu shot.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient passed out (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient did not receive vaccine since the event nor got the flu.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient who had loss of consciousness after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Concurrent condition included egg allergy. Additional information regarding medical history and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
I developed Chilblain like lesions on all my fingers at the nail growth plate in early January.     They have slowly gotten worse.   I never had this before and doctors can't find a reason.
Pain, redness, swollen, hot to touch and hard left arm 8 days post injection. Size of a baseball
Pt. seen on 2/10/11 and 2/28/11 and received vaccines both times.
It started with feeling like a sinus infection settling in to my frontal sinuses at 8th hour. Then a feeling of lethargy settled in at 10th hour. Body aches and exhaustion at 12th hour. All of those symptoms continued on till approx 38th hour. When suddenly no body aches, exhaustion or sinus pressure was present.
4 days p/dose in pre-exposure pt devel generalized rash, hives, swelling of knees, hands, feet & lips; sciatica of lt leg & pain in shoulder;
A non-serious spontaneous report of breakthrough influenza has been received from a non-healthcare professional concerning seven children, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. The patients received FLUMIST for the 2010/2011 season. The Department of Health reported seven cases of breakthrough influenza following vaccination with FLUMIST. Six of the infections were type H3N2 and one was type B. All the patient's received treatment but no patients were hospitalized. The outcome of the event was not reported.
Non-serious case received from a healthcare professional on 28 September 2010 under the local reference number 10-0607. A 02-year-old male patient, with a medical history of development delay, speech therapy and allergy to ZITHROMAX, had received his first dose of PENTACEL (batch number C3747AA, route of administration not reported) in the right arm and his third dose of Hepatitis B vaccine (other manufacturer, batch number 1991Y, route of administration not reported) in the left arm on 22 September 2010. The patient had received his two previous doses of Hepatitis B (other manufacturer) on an unspecified date. The patient had no reported illness at the time of vaccination and no reported history of adverse reaction post-vaccination. On 23 September 2010, the patient developed right upper arm area red and swollen. He also had one large blister and several smaller blisters within redness area of upper arm but lower than injection site. He experienced fever to 102 degrees F. The patient's outcome was unknown. Documents held by sender: none.
We both had a sore arm around 3:30 in the afternoon; excruciating pain going through my body/pain was off the scale; I felt like I was dying. I felt my life force was leaving me and all my necessary internal organs were shutting down; I felt so weak I couldn't even talk for 6 days; This is a spontaneous report from a contactable consumer (patient) .This case refers to events occurred after second dose of BNT162B2.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) on 08Mar2021 at single dose for covid-19 immunisation. The patient medical history included surgeries . Concomitant medications were not reported. Previously on 15Feb2021 patient received the first dose of the vaccine and after receiving the vaccine, she was extremely fatigue ,had a little pain in her arm and she couldn't get from one room to another; it only lasted a day.Patient took the second dose on 08Mar2021  and had a sore arm around 3:30 in the afternoon. However, 11 -12 hours later (in Mar2021) she was awaked by excruciating pain going through her body. It felt like all the surgeries, concussion and multiple injuries she had in the past manifestoing all at once.Her pain was off the scale. None of the opioids would have helped, she took morphine which didn't help. She felt like she was dying, she felt her life force was leaving her and all her necessary internal organs were shutting down. These symptoms lasted 6 days. She stated she wouldn't have survived if her husband wasn't with her. She felt so weak she couldn't even talk for 6 days in 2021. Patient was okay at reporting time. She didn't do well with chemical that why she took natural treatments. Patient was diagnosed with Hashimoto disease, dysautonomia and hyper mobility on an unknown date. The outcome of the events Hashimoto disease, dysautonomia and hyper mobility was unknown; outcome of the other events was recovered on an unknown date in 2021.Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021405494 same patient/drug, different dose/AE
Tinnitus in left ear developed approximately two weeks after my second dose. The onset at the time was instantaneous. I was sitting at my desk and it was as if my ear just shut down. I cannot hear out of the left ear now. My best guess is my hearing is down to 5% or 10% of normal in that ear.
Some swelling of the injection site a few days after the initial injection, redness, itching and hot area. Size of the swelling was approximately 5 cm in diameter. Area also became hard and hot. Left untreated for a few days but when itching was uncomfortable applied some topical Benadryl to the area and swelling and itching went away within a few hours. No other side effects for the first dose. Still awaiting for appointment for second dose
rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.
Hospitalization for AFIB/RVR/COVID 19 POSITIVE 12/6/21-12/12/21. RECEIVED 1 DOSE BARICITINIB, 5 DOSES REMDESIVIR
several 12-18hr p/vax local inflammatory response then progressed to general muscle tightness, myalgia intermittent arthralgia;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included vitamin d. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 7th June 2018, the patient experienced energy decreased, chills, malaise, injection site lump, injection site induration and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved and the outcome of the energy decreased and malaise were recovering/resolving and the outcome of the chills and fever were recovered/resolved and the outcome of the injection site induration was unknown. The reporter considered the injection site pain, energy decreased, chills, malaise, injection site lump, injection site induration and fever to be related to SHINGRIX. Additional information was received as follows: The patient stated that she felt pain during the injection and later that evening her arm was sore. The patient stated that in the 24 hours following the injection the pain in her left arm increased and her left arm became tender to the touch and she noticed a hard knot at the injection site. The patient stated that the day following the vaccination, she also experienced chills, fever, low energy, and general malaise. The patient stated that she took 400 mg of Ibuprofen a few times and morning of reporting day when she woke up, she felt a little better, but still feeling wiped out and with low energy. The patient had denied permission to contact their physician. The patient stated that everything went very well, with her report to GlaxoSmithKline of Adverse Event and a customer service agent was very polite and respectful and very efficient. Overall, very, very positive.
Large hard area above elbow, hot, red rash, approx. 3X5, not near shot administration spot, entire arm sore and achy, body aches and tiredness.
Chest pain and rib pain lasting about 3 hours. Tylenol was taken.
Patient has hx of cardiac issues "kissing lesions" - when stressed/excited - takes 1/2 toprol and s/s resolve.  She did this for her heart palpitations r/t vaccine dose #2 and this s/s resolved. 1/30/21 530pm- fever of 100F, was 102, took 2 tylenol - 99F after that. 1/31/21 10am - fever, itching all over 9scalp, toes, every where). Patient declined COVID testing at this time. Patient advised to call back with s/s update, patient verbalized understanding.
This is a spontaneous report from a contactable consumer, reportinfg for herself. This 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date to an unspecified date in Jul2017 at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received an unspecified pneumococcal vaccine 7 years before. The patient experienced a "red-band" around the arm 2 inches wide and red band around arm with outcome of not recovered, half way around arm it was hot, the site warm,  on an unspecified date with outcome of recovering.
pt recvd vax & 3 mins later pt fell to floor hit head on book reac; exp body stiffness, unresponsive w/a n airway open-color pale, lips pale, body idaphoretic BP 112/60; p/sz activity ceased pt responded-very fatiguued; bump on forehead;
10 minutes after his vaccine, he reported being unable to see. His mom noticed that he had "no pupils"(?pinpoint pupils). He passed out 1-2 minutes later.  LOCx 2 minutes. He was lowered him to the ground by his mom and a nurse. Afterwards, he was quiet and appeared confused (ie. "he was looking around"). Laid on the couch until the next morning. Did not feel normal until the next morning.
Moderna Vaccine received after patient received a different COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine received after patient received a different COVID-19 vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: AstraZeneca on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with AstraZeneca.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine received after patient received a different COVID-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine received after patient received a different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient had no adverse reactions to the vaccine. The Moderna Covid-19 vaccines were administered greater than 35 days apart.  Treatment information was not provided.   This case was linked to MOD-2022-507075 (Patient Link).
Immediate localized reaction following injection of right upper deltoid. Erythema, edema, warmth, muscle ache: swelling (per pt) size of lesion: now 2.5cmx2.5cm 6 days later. Use heat to arm.
45-year-old female received her first dose of the Covid-19 vaccine mRNA Moderna on August 06, 2021. On August 06, 2021, the patient complained of pain and soreness to the left arm at the site of injection. Patient did not request any treatment to treat the pain On August 10, 2021, I spoke with the prescriber who states that patient is doing okay, and pain related to COVID-19 vaccine has resolved.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 08-OCT-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012. No other co-suspects and no concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This case has been cross referenced with case 1210USA004308 and 1211USA000607, which concerned 2 patients who received the same expired vaccine (no adverse event was reported in these 2 cases either). Additional information is not expected.
On 4/12/21 I was out on a walk and my fingers turned white and cold between both knuckles, on each finger, on both hands, excluding my thumbs. This lasted about an hour to an hour and a half. Today, 4/13/21, while out on my walk my fingers did the same thing but then went numb, this started at about 6:30 AM and is the same right now at 11:00 AM