chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, general body pain, pain in arm, injection site erythema and chills. On 23rd May 2018, the patient experienced feeling unwell and unable to eat. On 24th May 2018, the patient experienced vivid dreams and sweating. On 25th May 2018, the patient experienced fever blister. The patient was treated with TYLENOL. On 24th May 2018, the outcome of the fever, general body pain and chills were recovered/resolved. On an unknown and the outcome of the extensive swelling of vaccinated limb, feeling unwell and unable to eat were unknown and the outcome of the vivid dreams, pain in arm, fever blister, injection site erythema and sweating were unchanged. The reporter considered the extensive swelling of vaccinated limb, fever, general body pain, vivid dreams, pain in arm, fever blister, injection site erythema, chills and sweating to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell and unable to eat to be related to SHINGRIX. Additional details were provided as follows: On 22nd May 2018, at 10:30, the patient received SHINGRIX in the left deltoid. On the same day, 12 hours and 30 minutes after receiving SHINGRIX, the patient experienced 102 degree fever, chills and body aches around 11 pm on the day of vaccination. The patient took two TYLENOL to help with her fever and drank a lot of water. The patient stated that her arm was swollen, sore and red since the day of vaccination. The redness and swelling was about the size of 6 inches by 3 inches which starts from the injection site and radiates down below the site. One day after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101. 5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101.5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient woke up very wet with perspiration and had vivid dreams that night. The patient felt a little energetic since her fever was gone that day. Three days after receiving SHINGRIX, the patient again woke up with perspiration and vivid dreams along with a fever blister on lower left lip of the face. The patient had denied permission to contact their physician. All questions were asked, no further details were provided.
No other AE; RECOMBIVAX HB was administered after the expiration date; This spontaneous report as received from an administrator refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-JUN-202,1 the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # r028529, expiration date: 09-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine did not experience a temperature excursion prior to administration. No adverse event was reported.
Narrative: The patient received two doses of Pfizer COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 1 Jan 22. The patient presented to the ED on 8 Jan 22 with chest pain. The patient previously complained of myalgias, chills, runny nose. Then, he developed a cough with chest congestion, and pressure. The patient was admitted on 8 Jan 22 with diagnosis of COVID 19. The patient was monitored and treated with dexamethasone and fluids. The patient was discharged on 9 Jan 22 in stable condition. Reported per EUA.
Patient testing positive for COVID-19 8/2/21 Admitted to the hospital on 8/7/21   Sepsis secondary to COVID-19 - Community-acquired pneumonia secondary to COVID-19 - Acute metabolic encephalopathy secondary to COVID-19 - Acute hypoxic respiratory failure, secondary to COVID-19, requiring 4L NC, baseline 2-3L NC since recent COVID-19 infection
Nerve pain from head to toe, including pins/needles sensation in arms, sharp stabbing pain in fingers/hands, feet/toes, muscle pain in thighs
Generalized itching post COVID-19 vaccination. No medication administered. Extended monitoring time. Received vaccine at 12:11pm, reported symptoms subsided and was released at 1:03pm.
itchy rash; itchy rash that looked like hives and was bumpy; itchy rash that looked like hives and was bumpy; she is not comfortable; She cannot sleep/has not gotten enough sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 12May2021 16:45 (Lot Number: EW0183) as 1st dose, single for covid-19 immunisation (going to be traveling soon and needed it for work). The patient medical history was not reported. Concomitant medications included ongoing vitamin c [ascorbic acid] (VITAMIN C), ongoing vitamins nos (MULTIVITAMINS) and zinc with therapy date not reported, all for unknown indication. The patient has no previous immunization with the Pfizer vaccine considered as suspect or received additional Vaccines Administered on Same Date of the Pfizer vaccine. The patient did not receive other vaccines 4 weeks prior to vaccination. The patient mentioned that she had the vaccine yesterday, 12May2021 at 4:45pm in a hospital. She stayed for the 15 minutes after, and didn't feel anything but when she got home, she had an itchy rash (also reported as 02:30 am), like hives and she took some allergy pills. She further reported that when she got home, she felt something. It looked like hives and were bumpy, when she scratched it, it was like hives. It was in the middle of her body in the back, front and in her neck, that was 2:30 this morning. This afternoon, it was in her armpits, groin and all over. It happened again at 2:30am (13May2021), she had the itch again and took another pill. It has been on and off and is now all over her body and she is not comfortable. After lunch, again she took a pill and it hasn't stopped itching and is continuous. She mentioned that she has never had the flu shot. She was not planning to have this one, but her work said she had to get this. She did not have any allergic reactions to any vaccines in the past. She mentioned that she does not know what to do since the allergy pill does not work and she thinks she needs an injection. She added that her family (daughter is a nurse) is telling her this is not allergies it is the vaccine. The patient mentioned that the treatment used included allergy pills, an antihistamine, diphenhydramine, the generic form of Benadryl. She took the pills 3 times, every 3 hours. The adverse events did not require emergency room or physician office visit. The patient further mentioned that she just needs something stronger. She can't get any medicine for this and she would like to ask if she can get a steroid for this. She is not comfortable and has not gotten enough sleep. The patient is also going to ask for a prescription for Atarax, hydroxyzine. She added that she cannot sleep and the more she scratches it the worse it gets. Daughter told her she had to call because it is not just allergies. She took a shower to help the itchiness and it helped for a little bit. The outcome of the events was not recovered.
Body swelling, particularly legs, exhaustion, nausea, blurred vision, sore feet, muscle aches.
Varicella vaccine breakthrough. Diagnosed with varicella 2-17-07. Approximately 30 lesions afebrile.
Pain in arm shooting and burning not able to use the left arm at all since the time of vaccine severe pain numbness burning shooting pain down from vaccine site to fingertips
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 20-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUN-2020)  for prophylaxis and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included no drug reactions or allergies. On 15-NOV-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, administration site not provided., lot J011211, expiration date 21-JUL-2014. Concomitant medication included blood pressure and cholesterol medication. In November 2013 the patient experienced local reaction on back side of the arm, the patient's arm appeared to have a "welt the size of 2 golf balls next to each other; the arm was red, warm and blistering like water blisters". "The patient did not have fever, there was no pain, just a little itching, almost an allergic reaction of shingles". The patient had not sought treatment yet. The outcome and relatedness of the events were not provided. Additional information has been requested.
Expired Drug Used; bronchitis; malaise/sick; breathing problems; soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number M17058, expiry date 30th April 2019) for prophylaxis.   The patient's past medical history included scoliosis surgery.   On 20th May 2019, the patient received Menveo (intramuscular). In May 2019, 1 day after receiving Menveo, the patient experienced bronchitis, malaise, difficulty breathing and pain in arm. On 20th May 2019, the patient experienced expired vaccine used. On an unknown date, the outcome of the bronchitis, malaise and difficulty breathing were not recovered/not resolved and the outcome of the pain in arm and expired vaccine used were unknown.   It was unknown if the reporter considered the bronchitis, malaise, difficulty breathing and pain in arm to be related to Menveo.  Additional details were provided as follows: This case was reported by the patient's mother. The patient received Menveo which was expired already. The caller stated that the patient has been sick for 24 hours after receiving the vaccine.  The patient has experienced malaise and breathing problems and was diagnosed with bronchitis. The reporter consented to follow up. Emergency room visit required.
Patient is a 67 y.o. female with a past medical history of essential hypertension, moderate asthma, NICM with LVEF of 30%, chronic combined congestive heart failure, ongoing tobacco abuse, Obesity and Anemia who presents today with dyspnea.  Symptoms started on 07/29.  Initially symptoms were similar to a common cold with sore throat, nasal congestion, cough with yellow sputum.  The patient denies fevers chills body aches nausea or vomiting.  She does endorse a poor appetite along with altered taste and smell.  She was not suspicious for COVID as she has been vaccinated.  She received her last vaccination in February, 2021.  She initially called her PCP who ordered her a prednisone taper.  She states this did not improve her breathing.  The patient was seen at the heart failure clinic on 08/03.  Per the note, the clinician was concerned for her wheezing.  The clinician recommended that she go to the ER, but she did not go.  She comes in today because her breathing has not improved and she was having significant dyspnea with difficulty with activity due to this.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included TWINRIX. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the 1st dose was an unknown dose. On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever and pharmaceutical product complaint were unknown. The reporter considered the fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The lot number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. On the same day, the patient received the 1st dose of TWINRIX on an unknown arm. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Pain in both legs, neck and both arms (left arm scale 5/6 and right arm 4) with leg pain being  worse (scale if 8) Hard to walk in morning.  Treating with Advil 220mg x 2 and Acetaminophen 250mg x2 a day since 9/30/21
developed cough, Shortness of breath, chills, fatigue, headache, muscle aches, nausea, sore throat on 11/08/2021. ADmitted to hospital 11/10/2021 and still admitted.
Chills, headache, slight fever, sore arm, achy feeling. Chills, headache and fever began about 12 hours after injection and lasted about 2 hours.  Sore arm and achy feeling lasted until following morning.
Patient was brought to the ED with tachycardia and tachypneic and short of breath.  No fever, chills, or cough.  Patient was admitted to the hospital with Covid and pneumonia and treated with 3 doses of remdesivir.
3 days after 1st moderna vaccine. Got rash on forehead eye.  Went to dermotologist and was diagnosed with shingles on right side of face
After received flu vaccination, patient developed reddened eyes, wheeze, rash to extremities about with a few minutes of injection. Pt was given EPI-PEN jr., XOPENEX via HHN, tarist syrup & prednisone. Pt observed for 25 hours & D/C stable.
1wk p/vax had fever 102-105, rash on body for 2 days;no sz but had rigors & shakes;also cough c/o serious rxn to MMR;pt better few days later;
Fever of 102, total body aching, muscle, joint, and bone pain.  Chills, red blotchness on arm. DC DX: DOS 11/7/06-Resolving allergic reaction to flu shot. Immediately after receiving flu shot experienced server pain in injection sit. Later that day had server chills and shaking, myalfgia. Treated with tylenol and fluids. Follow-up: 3pm 11/6/06 received flu vaccine - developed immediate pain at site 7/10 intensely \ persisted - Later in evening entire body aching 10/10 with shaking "shaking so hard - heart hurt", heart aching took BENADRYL no helping 4 AM took TYLENOL 11/7/06. 11/7/06 9AM seen in student medical clinic T 101 degrees P 128 120/70 flushed. Blotchy rash body ache. Decreased to back and lower legs 8-9/10.
Rash at injection site and Induration; Rash at injection site and Induration; headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EH9899), on Left arm via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot no: EL3246) on Left arm on 06Jan2021 for covid-19 immunisation and experienced 12hours after injection felt like cold, malaise, bigger rash than first dose, 1 inch induration, felt better after 48 hours with Tylenol. It was reported on 16Dec2020 due to first dose patient experienced rash at injection site and Induration, headache that lasted until day 2 after taking Tylenol. There was no COVID prior vaccination and no COVID tested post vaccination. Patient was not pregnant while vaccination. There was no known allergies. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Hospital Medicine Admission History & Physical   Patient Date: 7/7/2022 Room: 31/31     Chief Complaint:  Idiopathic acute pancreatitis      History Of Present Illness: PT is a 62 y.o. male with a history below admitted for Idiopathic acute pancreatitis. Pt came in with complaints of abdominal pain, generalized, back pain. Started a week prior, attempted meds for constipation and did not improve. Pain 8/10. Constant. Nothing made better / worse. Sharp. Discussed with er and will admit. Labs concerning for pancreatitis.      Past Medical History:  Patient  has a past medical history of Back problem, Cigarette smoker, Colon polyp, Coronary artery disease, Deviated septum (1/2012), Diabetes mellitus, Disease of cardiovascular system, Diverticulitis, Heart attack (2005, 2010), Hyperlipidemia, Multiple sclerosis, Nasal turbinate hypertrophy (1/2012), and Sleep apnea.   Past Surgical History:  Patient's  has a past surgical history that includes Hx Other Surgical History; Hx Back Surgery; Hx Cardiac Catheterization; Hx Polypectomy; Hx Coronary Artery Bypass Graft (N/A, 11/13/2018); Hx Arterial Line Insertion (Right, 11/13/2018); Hx Swan-Ganz Insertion (Right, 11/13/2018); Hx Transesophageal Echocardiogram (N/A, 11/13/2018); Left heart cath (N/A, 10/31/2018); Drug-eluting stent placement (N/A, 10/31/2018); ACT (N/A, 10/31/2018); Hx Colonoscopy (N/A, 12/5/2015); Hx Septoplasty (N/A, 1/4/2012); Hx Turbinate, Submucosal Resection (Bilateral, 1/4/2012); Left heart cath (N/A, 10/27/2010); Drug-eluting stent placement (N/A, 10/27/2010); and Drug-eluting stent placement (N/A, 10/27/2010).   Family History:   Patient's family history includes Arthritis-Osteo in his mother; Cancer in his maternal grandfather and paternal grandfather; Colon Polyps in his mother; Diabetes in his mother and sister; Heart Disease in his father; Stroke in his mother.      Social History:  He  reports no history of alcohol use.  He  reports no history of drug use.  He  reports that he quit smoking about 15 years ago. His smoking use included cigarettes. He has a 30.00 pack-year smoking history. He has never used smokeless tobacco.  Social History   Social History Narrative ? Not on file  Patient left 0n 7/11/2022 Plan was to discharge patient today if VQ scan is negative. He had to wait for test all day, scheduled last due to positive covid test on admission (false positive). VQ scan done but px left without waiting for result. Repeat CXR also showed new patchy bilateral lower lung ill defined airspace disease - not discussed w/ px and addressed because px left as soon as he got back on the floor. Px left.
102 degree F fever, coughing badly, shivering nausea, feeling freezing cold.
pt recv vax 4JAN99 & suffered crib death 5JAN99;
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) (lot # L030592, expiration date 12-FEB-2017) (lot # L016395, expiration date 12-FEB-2017) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sick from shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick from shots".  Additional information: Patient reported that getting sick from previous shots and I protect myself vigilantly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
0830 severe chills, severe body and joint aches, fever 102.3, fatigue - took 650mg Tylenol and 800mg ibuprofen with resolution of symptoms
5 month old male (s/p 2 doses of Rotateq), s/p surgery for intussuseption on 2/14/07.  He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days, and questionable blood in the diaper 4 days ago.  He is currently still in the hospital.  2/26/07 Received medical records from ER which reveal patient had vomiting x 2 days prior to admit, temp 100.2.  Abdomen was mildly distended w/quiet bowel sounds.  Tx w/IVF, NGT, IV antibiotics & transferred. FINAL DX: Vomiting, bowel obstruction; dehydration. 3/13/07 Reviewed medical records for 2/13-2/19 admission.  No D/C summary available.  Patient transferred for SBO after 3 day hx of emesis, temp max 102, no diarrhea.  Had mild URI s/s.  Exam at ER revealed distended abdomen & KUB showed 3-4 distended loops in midabdomen w/possible SBO.  Patient treated in ER w/IVF, antibiotics, NGT & then transferred.  Exam revealed hypoactive BS but no tenderness or masses.  Ped surgery consulted. Abd ultrasound & air contrast enema recommended. Final DX: None given. Will request D/C summary in a couple of weeks. 4/3/07 Received D/C summary which reveals admitted for vomiting & possible SBO.  Surgery on 2/14 revealed IS w/small nodule as lead point which frozen section revealed to be ectopic pancreas.  Necrotic bowel was removed & end to end anastomosis was done.  Received IV antibiotics throughout admission. FINAL DX: Ileoileal intussusception, resolved; vomiting, resolved; s/p bowel resection.
Pt taken to ER on 21APR91 w/t103, irritable; dx mild vaccine rxn; tx Pediaprophen alternated w/APAP; Mom reports t104 w/inconsolable crying of 24hrs duration;