chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt relates that the area that the shot was given got red, irritated and scabbed starting the day after(10/1/2019). He says he used Neosporin on it. He came in late afternoon yesterday(11/20/2019) to report it and there was a small red mark on his arm. I related due to his concerns that he could see his provider and that I would report it.
Patient received SHINGRIX vaccine NDC 58160-0823-11 in her left arm on 11/27/18. Patient reports waking up today with flu like symptoms and redness/swelling in her upper left arm near injection site reaction. She was recommended to use OTC therapy to help relieve symptoms but if symptoms persist to contact her PCP.
Frequent dull headaches that rapidly comes and goes Tinnitus (did not have before Covid 19 Pfizer vaccine) Face, Arms, Legs: tingling, pins & needles, crawling, itchy, burning Legs, Arms: heavy weak sensations Sensitive to light and sounds, aromas Internal sensations electric buzz vibrations Intense hot flushes Hands and feet ice cold that comes and goes Chest & back pressure that comes and goes Continue to experience the adverse events. Strong intensity level that has now lessened some except the tinnitus is worse. Headaches have gone away. Reported to my Primary Care Physician . No treatment
Swelling of lymph nodes on the left side of my body that were very tender and lasted about 2 weeks, extreme fatigue began day 2 and has continued, SOB began day 2 and has continued with Spo2 dropping from my normal of 98-100% to now staying 93-95%, I have developed a "smokers cough", and generally "feel sick" all th time.
Acute respiratory illness; bronchial swelling; Acute bronchittis with bronchospasm; Voice was completely hoarse; chest pain; painful; Body ache; bronchospasm; Nasal congestion; Sore throat; Productive cough; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Acute respiratory illness) and BRONCHIAL OEDEMA (bronchial swelling) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis, Pneumonia and Asthma.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat) and PRODUCTIVE COUGH (Productive cough). On 02-Jun-2021, the patient experienced BRONCHOSPASM (bronchospasm). On 09-Jul-2021, the patient experienced DYSPHONIA (Voice was completely hoarse), CHEST PAIN (chest pain), PAIN (painful) and MYALGIA (Body ache). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Acute respiratory illness) (seriousness criterion medically significant), BRONCHIAL OEDEMA (bronchial swelling) (seriousness criterion medically significant) and BRONCHITIS (Acute bronchittis with bronchospasm). The patient was treated with ALBUTEROL [SALBUTAMOL] for Bronchospasm, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (DEXTROMETHORPHAN HBR AND GUAIFENESIN) for Cough suppression, at an unspecified dose and frequency and NAPROXEN for Bronchial oedema, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT INFECTION (Acute respiratory illness) had not resolved, BRONCHIAL OEDEMA (bronchial swelling), NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Productive cough), BRONCHITIS (Acute bronchittis with bronchospasm), DYSPHONIA (Voice was completely hoarse), BRONCHOSPASM (bronchospasm) and MYALGIA (Body ache) outcome was unknown and CHEST PAIN (chest pain) and PAIN (painful) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: negative (Negative) negative. On 02-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medications were not reported.  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.   This case was linked to MOD-2021-111160 (Patient Link).; Sender's Comments: 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.
11:42am Patient complaint of feeling  "tingling and warm" throughout body. RN present and took patient to treatment area. Vital signs BP 142/91, HR 68, RR 18, O2 sat 98% on room air. Patient reports NKA, no past medical history, and takes vitamins at home.  Patient observed and noted to be diaphoretic. Post vital signs patient states feeling better. Vital signs recheck BP 138/84, HR 66, RR 18, O2 sat 97% on room air. Education on sign/symptoms to monitor and adverse reactions provided by RN. Patient escorted to car accompanied by patients wife and RN at 12:10pm.
Swelling of lymph node in left breast and under left arm, same side as vaccination site. The swollen lymph node was frightening and thought it might be a sign of breast cancer. The lymph node swelling decreased within two weeks, and was totally back to normal after 4 weeks.
After giving both vaccines, pt became dizzy, skin pale & clammy. BP 80/60, P 64. Placed in lying position with legs & feet elevated. BP 84/60 (5 minutes later). Pt given cold water to drink. Said she had not had food this a.m. BP 100/64, P75. Pulse OX 98. Pt feeling better within 10" of incident, given PB crackers to eat. Did not want to go home when offered.
Redness, rash, fever and pain on site of injection, given BENADRYL and TYLENOL for pain.
Patient says his arm was itchy today so he looked at it and the injection site had a red rind around the area and he said it was a hard knot under the skin.
Shortly (1 week) after nasal vaccine developed painful large throbbing (L) ear (+) Hyperacusis - sx's Lepsis.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. On 9/17, I received my first Anthrax shot. The only side effects at the time was a lump on my arm where the shot was administered that lasted for over two weeks. The second shot was given on 10/04 with the same side effect. The third and final shot I received was on 10/18 with the same results as well. 11/29, I was awaken by a sharp pain in my chest that I had never felt before. My entire left arm was numb and I was scared to move it. I was debating on whether to go the emergency room, but decided to look up chest pain on the internet. In the mean time, I wrote a note to whom ever incase I did not wake up in the morning (b/c I had never felt anything like it; I was worried what might happen). When I woke up in the morning the pain was completely gone. 12/4, I was driving home from a party when a sharp pain in my chest that resembled the 11/29 pain but not as intense. Went to bed that night; woke up I was fine. 1/1/05, I was visiting family and driving home from dinner the same chest pain came back. It lasted the entire night but went away by the time I woke the next morning. 12/20, I was at my grandmother's house when my neck started itching really badly. I asked her what the back of my neck looked like because it felt like little bumps all over. She said it just looks like a rash. Not thinking anything about it, I went to bed. For the next week, my entire neck itched really bad and felt like little bumps in certain areas. On 1/8, I was in training when my neck festered to the point where it started oozing. I went to the emergency room worried /bc I had not ever seen anything like it. I have not started using any new products so I didn't think it was an allergic reaction to anything, besides it was only on my neck. I told the ER doctor my symptoms and he said it sort of looked like eczema, but then again it looked like an allergic reaction. He gave me a 4 day dose of Prednisone 20mg. I just took my last dose a few hours ago and still have red bumps and itching. Before taking the Anthrax shot, I have never had any type of chest pain, for that matter, any type of ache or pain which I have been feeling before my Anthrax shot. And for the rash, I have never seen or felt that type of rash before. It has been 20 days now and I still have this persistent rash. I have an appointment to see the doctor on Monday now that I'm back home. I have always been a very healthy person, so I find it strange that after taken the Anthrax shot, I am having all these strange symptoms I've never had before. Although I have no conclusive evidence these symptoms are from the Anthrax shot, I would like to bring it to government's attention.
The nurse administering the Pfizer injection misunderstood reconstitution instructions and re-diluted her vial with normal saline prior to administering the dose to this patient. Therefore, patient received diluted version of vaccine.
(L) arm swollen with a half a dollar red surface. To put warm compresses and take MOTRIN.
My entire body was shaking in the beginning. i was very cold and couldn't warm up. Then i had no balance and was bouncing off walls.  the next morning i was still off balance and shakey but not as severe as during the night.  8;00 A.M. i took a shower. About 5 minutes in the shower I felt my Knees giving out. I lowered myself to the tub. I could not get out of tub. My body felt paralyzed. i couldn"t sit up, roll over, or get out. after 45 minutes i pull myself out and went to bed for the day(Dec. 1st) i was better on the next day. i have talked to 2 other woman who have had similar stories. They were both hospitalized and are ok now
This spontaneous report was received from a pharmacist and refers to a 49 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. Following the vaccination, the patient experienced shooting pain at the injection site. The pain extended down the patient's entire arm. It was increasingly getting worse on 18-NOV-2016. The patient's arm pain was preventing her from sleeping at night. The patient sought the medical attention and called to the pharmacy. There was no treatment given. The outcome of injection site pain and sleep disorder was reported as not recovered.       The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Narrative:  Pt COVID positive despite 3 doses of COVID vaccine. 7/4/52022 - Patient presents to the emergency department complaint of shortness of breath since onset of a cough this past Thursday. Patient indicates he also has had nasal congestion and a little bit of sore throat and a slight headache. He indicates gradually increasing shortness of breath without any chest pain since this past Thursday. He has COPD. Pt admitted to medical floor 7/4/2022 - 7/9/2022. Pt had 5d treatment with Remdesivir. Medical treatment: COVID-19 with Acute Hypoxic Respiratory Failure - Completed dexamethasone 6mg daily; Day #6 - Completed Remdesivir; Day #5 - Home O2 evaluation with no Home Oxygen needed - Tesselon perles PRN
VARIVAX administered on 11-30-10. On 12-7-10 a rash consisting of 4 red raised spots covering the size of a quarter appeared. Tender to touch, not itchy, no vesicles. No treatment. Foster mother will monitor. 12-20-10 Foster mother reports no other symptoms.
Initial report received from a nurse on 18 Dec 2009: This patient received FLUVIRIN on 16 Dec 2009. The patient experienced itching and swelling on both arms and trunk and later had face and throat itching on 16 Dec 2009. The patient was treated in emergency room but not admitted. The outcome of the event was reported as recovered.
The patient is a 87 year old female with PMH including non-hodgkins lymphoma, RA, HTN, and HLD. Today, she felt flushed which is similiar to the same feeling she gets when her blood pressure is high.Her caretaker took her blood pressure multiple times and when the SBP was consistently around 200 even after taking her usual cardizem dose, she came to the ED. In the ED, she was given vasotec IV without any improvement in her BP. She was started on a cardene gtt. Incidentally, her rapid SARS test came back positive. She has no c/o SOB, cough, sore throat, headaches, or body aches. She has had her Covid vaccines and a booster 2 weeks ago.
The pt developed greater than 50 vesicles (varicella). No treatment was received.
Woke AM with temp 100.9, shaky, muscle aches, 3/4 red circle L arm Tdap inj site, nausea, leg aches - but were better about 9 at time call retn. Mom says was fine the next day. Ice-cool compress inj site, supportive care, rest Tylenol, Motrin, Temp and comfort observation.
Discharge Physician: MD Primary Care Physician: MD  Date of Admission: 3/30/2023 Discharge Date: 03/31/2023 Room Number:   PRESENTING PROBLEM: Chronic ulcer of left foot with fat layer exposed (HCC) Sepsis due to pneumonia (HCC)  Pneumonia of left lower lobe due to infectious organism  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC)  COVID-19    HOSPITAL COURSE: 58-year-old man with past medical history of myelofibrosis status post stem cell transplant and splenectomy, severe sepsis from Streptococcus resulting in cardiomyopathy, CKD, loss of multiple digits from septic emboli who presented with fever and fatigue.  Patient had debridement of a left foot ulcer that probes to the bone on 03/28/2023 with Dr.  He also had skin grafting from his left anterior thigh to his right foot performed on the same day and now has a wound VAC in place.  Patient was found to be COVID positive and meeting severe sepsis criteria on presentation to the ER.  Chest x-ray concerning for developing secondary bacterial pneumonia procalcitonin was elevated.  Infectious Disease was consulted to help manage antibiotics in an asplenic patient, and noted results from prior wound culture growing multiple bacteria.  Current tissue culture growing Staph aureus.  Infectious Disease adjusted antibiotics and recommended wound care consultation to consider wound VAC placement on the left foot.  Transfer was requested to local Hospital for in-person wound care consultation as well as consultation for Dr.'s team.
This spontaneous report was received from a nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-NOV-2011, the patient was vaccinated with first dose of ZOSTAVAX. On 26-OCT-2015, the patient was vaccinated with second dose of ZOSTAVAX (extra dose administered). No adverse effects were reported. Additional information has been requested.
Right side face swell hives down right arm and chest and neck Rapid pulse  180/89 bp shaking trembling  Redness nauseous pain in rt arm
MADERNA:  two days after vaccine I was numb from the waist down and right arm.  I went to Hospital at 0930 ER..   As of 18Mar2021 I'm still numb from the wait down and my right arm.  Two weeks later after going numb I have an infection on my second toe on my right foot.  Looks like the Covid toe.
Side effects of / her arm hurting; Side effects of how it didn't feel great; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that the patient received 1st dose of Shingrix and experienced pain in arm and feeling bad. The nurse enquired if it would be harmful for the patient to redo vaccine series. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163645:Same reporter
Diarrhea; This is a spontaneous report from a contactable consumer (patient's child). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 11Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the vaccine on Thursday (11Feb2021) evening. Today (13Feb2021), the patient has the runs (diarrhea). The event was considered non-serious. The patient's child was asking if that was normal and if it would last for three days. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Onset of Itching on arms and ears within 3 hours of injection. Took one dose of OTC Benedryl.  Fully resolved itching symptoms
This spontaneous report as received from a pharmacist via Pfizer field representative refers to a female patient of unknown age. The patient's medical history and concurrent condition were not reported. On an unknown date approximately in August 2015 (also reported as "about tow months ago")/September 2015, the patient was vaccinated with a dose of PNEUMOVAX 23/PNEUMOVAX or PREVENAR 13 (concentration, dose, route of administration and lot number were not reported). The reporting pharmacist was not sure which vaccine was administered: PNEUMOVAX 23/PNEUMOVAX or PREVENAR 13. No concomitant medication was reported. On an unknown date in September 2015 (reported as "two months ago"), after receiving the vaccine, the patient experienced pneumococcal pneumonia. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23/PNEUMOVAX was not reported. Additional information has been requested.
anxiety; depression; insomnia; anxiety, depression and insomnia have all intensified; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: She has a history of depression and anxiety; "Anxiety" (unspecified if ongoing), notes: She has a history of depression and anxiety. The patient's concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "anxiety"; DEPRESSION (non-serious), outcome "unknown", described as "depression"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "anxiety, depression and insomnia have all intensified".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom stated arm became red, swollen, fever in arm, itching to arms, hard, it caused pt to have asthma attack & pain to arm; did not bring pt for nurse to see & no eval;
Arm was Swollen and Red (Injection Site); Shortness of breath; injection site really red; Fatigue; Rash (Injection Site ); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE RASH (Rash (Injection Site )), VACCINATION SITE SWELLING (Arm was Swollen and Red (Injection Site)), DYSPNOEA (Shortness of breath) and VACCINATION SITE ERYTHEMA (injection site really red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash (Injection Site )). On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was Swollen and Red (Injection Site)), DYSPNOEA (Shortness of breath) and VACCINATION SITE ERYTHEMA (injection site really red). At the time of the report, FATIGUE (Fatigue), VACCINATION SITE RASH (Rash (Injection Site )), VACCINATION SITE SWELLING (Arm was Swollen and Red (Injection Site)), DYSPNOEA (Shortness of breath) and VACCINATION SITE ERYTHEMA (injection site really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
bilateral pulmonary embolism; right DVT; sinus tachycardia; Afib with RVR.; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 68-year-old male patient received BNT162B2 (Pfizer COVID vaccine), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as single dose for Covid-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease (GERD), and deep vein thrombosis (DVT) original diagnosis from Jan2018. The patient previously received the first dose of BNT162B2 on 19Mar2021 for Covid-19 immunisation. The physician reported the patient had bilateral pulmonary embolism and a right DVT on 11Apr2021. The patient went to the ER on 11Apr2021. She confirms the pulmonary embolisms and the DVT were diagnosed 11Apr2021 when the patient went to the ER. She has more of the patient's story, caller does not think this would be linked to the vaccine but that is for someone else to decide she is reporting. The day of the event the patient's heart was racing, he passed out and went to the ER, he had sinus tachycardia and Afib with RVR (date/s unspecified). His heart rate was up to 140s and 150s. The patient has history of hypertension, GERD, and previous DVT, the original DVT that patient had was diagnosed in Jan2018 and he was placed on Xarelto at that time and he was on Xarelto until Jun2019. He has not been on anything for this since that time, until this episode. Caller says reporter did not provide any specific treatment information that the patient has received for the event she is reporting. Reporter provided the patient went to the emergency room, he did not say if the patient was admitted or had hospitalization. The outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Drug causality would seem unlikely for  BNT162B2. The reported events may be regarded as natural progression of patient's pre-existing conditions. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.