chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got a rash on different parts of body on back and private areas; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er 8734) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. Patient had allergies to medications, food, or other products which was not specific. Concomitant medications included metformin (MANUFACTURER UNKNOWN) 850 mg, lisinopril (MANUFACTURER UNKNOWN) 20 mg and simvastatin (MANUFACTURER UNKNOWN) 20 mg, all for unknown indications from  unknown dates. Prior to the vaccination, the patient was 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 02Apr2021 at 05:30, the patient got a rash on different parts of his body on his back and private areas. The event rash resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and included treatment with BENADRYL which helped. The clinical outcome of the event rash was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Blood sugar was high and that was the first thing that happened. It eventually went back to normal. Some time in the summer during the first week of July, I had a flare up of asthma with lots of wheezing and coughing. I had to go back on rescue meds. And at some point in the summer, I also had a great increase in my blood pressure. I?m not sure when that started because I had only been doing virtual visits, but at a doctor visit my BP was really high and had to go to my PCP. We?re still working on that now and I?m currently on several medications and my BP is still not where it needs to be.
A consumer report has been received. The report concerns a 4 year old, Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced fever which started on 05-Nov-2013. The patient recovered from the event of fever on 06-Nov-2013. The report was considered to be non-serious.
no additional adverse effect; Incorrect product storage??; This spontaneous report was received from a medical assist concerning a patient of unknown age. No information about the patient's current condition, medical history or concomitant therapy was reported.      On 02-DEC-2021, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion (product storage error) and was administered (dose and route were not reported; lot # U021995, 13-JAN-2023) as prophylaxis. This vaccine was stored above 9 degree Celsius (8.6 degree Celsius) for 15 minutes. No previous excursion was reported. No additional adverse event was reported.
Pt c/o flu like symptoms on Friday 8/24/07, date of administration. She then noted fever and left arm red swollen, redness. PMD saw pt advised her to use Tylenol. Area outside red 4x4", inner red area (darker red) 1 1/ 2x 1 1/2 in.
Received pfizer COVID19 vaccine on  12/18/20 and 01/08/21. Presented to ER on 12/31/21 and admitted for cellulitis. Was admitted for hand cellulitis, NOT COVID19. Treated for COVID19 at another facility. He  has a second home in another state and was there over the holidays and developed a  respiratory infection, which prompted an ER visit to a local hospital in the  area.  He was noted to be desaturating into the mid 80% range,  although he was told he had no acute pneumonia on x-ray.  He had 1 chest x-ray  done.  He was admitted to the hospital, was given 5 days of remdesivir and  Decadron per protocol and sent home just 2 days ago.  He has had a persistent  cough and he decided to come back to the city last evening and brought a  red-eye flight home to the city and on the flight, he was just absolutely  miserable with an uncontrollable generally nonproductive cough.  He got back  to another city about 11 or 12 last night and went home, but because of the  persistent cough, eventually showed up in the emergency room this morning,  more concerned about the cough than his leg. Dishcarged on 1/5/22
Hep B (Engerix) vaccine administered to right deltoid. Employee returned to work, and reported warmth, erythema, and itchiness to entire right arm and right neck. 50mg Benadryl given orally, and employee observed in office for 30 minutes. Employee remained with stated symptoms 30 minutes into observation, erythema subsided slightly. Employee reported new onset of headache. No other symptoms reported. Employee was able to return to work. Followed up with employee 2 hours later (1430) all symptoms subsided with the exception of the headache.
My injection siteis swollen, red and very itchy. But if it is touched it burns.
I received my second Pfizer booster for COVID-19 on 4/21/2022. On 7/8/2022, I began feeling bloated, nauseous, and tired. These symptoms continued for about a week and they worsened during this period. On 7/9/2022, I developed a headache and joint pains. The bloating was pretty significant; I looked about 5 months pregnant, and I'm normally pretty slim. I also experienced a loss of appetite, which I didn't regain until about 7/16/2022. On 7/10/2022, I had loose stools, though I wouldn't classify them as diarrhea. On 7/11/2022, though, I experienced diarrhea multiple times. The diarrhea continued off and on until about 7/15/2022. The headaches, bloating, joint pain, and fatigue continued. On 7/11/2022, I took a home test for COVID-19, and I got a positive result. I called my doctor's office that day and had a telemedicine visit with a nurse practitioner, who prescribed me molnupiravir. I started the molnupiravir that evening, and I also took OTC Tylenol to help with the headache and joint pain. The Tylenol provided some relief for the headache and joint pain, but it didn't eliminate them completely. As I was taking the molnupiravir for the prescribed 5 days, my symptoms gradually improved. The bloating became less pronounced and painful. The headache gradually diminished over a couple of days until it was finally gone. The joint pain went away within the day I started taking the antiviral. The diarrhea also resolved within a couple of days after I started taking the molnupiravir. I just gradually got better and was eventually able to return to my normal activities. I took another home test for COVID-19 on 7/16/2022, and the result was negative. During my illness, I lost 4 lbs. I had to gradually rebuild my strength after my recovery, and at the time of this writing, I feel that I have completely recovered.
Headache, Arthralgia, Fever, injection site reaction  Narrative:  Employee reports symptoms began in the middle of the night after receiving vaccine. Reported symptoms include fever (103 F), chills, joint pain, fatigue, headache, difficulty swallowing (did not go to ER or seek medical attention), and injection site pain/discomfort and swelling. Reports used Bufferin (aspirin) every 4 hours for pain/fever.
UNSPECIFIED ADVERSE EVENT; EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency time was 1 total administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-AUG-2021, the patient had used expired vaccine (reporter stated that the patient administered vaccine at approximately 22:00, it was administered approximately 23 hours after the beyond use date 16-AUG-2021). On an unspecified date, the patient experienced unspecified adverse event, and was hospitalized (reported as for an unrelated issue, not related to the vaccine) for an unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified adverse event and expired vaccine used was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and unspecified adverse event was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837798-covid-19 vaccine ad26.cov2.s-unspecified adverse event . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Left deltoid 6x6.5 cm of erythema.  Hot to the touch.  Hives at border.  No pus, minimal tender.
4cm raise red area on rt deltoid p/MMR #2 injection; no resp distress noted; R32, P108;
began feeling tired and slightly light headed a few hours after the vaccine.  Developed a headache by evening same day(Day 1).  Arm very sore.  Day 2- still tired with light head and headache, arm very sore.  Day 3- tired, light headed, headache, arm very sore.  Day 4- tired, light headed, headache, sore arm.  Day 5- pounding, splitting, incapacitating headache that required 800mg Motrin to start and 400mg every 5-6 hours, fatigue, light headed,  sore arm, felt horrible..  Day 6- Woke up back to normal.
This spontaneous report as received from a registered nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
"Covid arm" - sudden onset of rash around the site of injection. The area is red, hard, hot, and inflamed. Itchiness upon onset but that subsided. Mild soreness come on later.
A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed heart fluttering/cardiac flutter.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On an unknown date, The patient received her unknown of two planned doses of mRNA-1273 (Batch number: unknown)  for prophylaxis of COVID-19 infection.   On an unknown date, The patient husband mentioned that his wife had heart fluttering and she had no trouble before. Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event heart fluttering was unknown.; Reporter's Comments: Based on the 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
Nipple pain and discharge (right side) eleven days after 2nd Moderna shot.  (March 8)
Received a phone call from client reporting that she had an allergic reactions to her Hepatitis B vaccination that was given on Wednesday, June14, 2017. She reported that she has a rash all over and is itching, her right hand is swollen and she is aching all over. States that this has happened before when she received the Hepatitis B vaccine. Stated she did take BENADRYL which has helped and has also contacted her primary physician. This was the 3rd dose of Hepatitis B but this nurse advised her to not ever get any more doses of the vaccine. Client was going to follow up with her PCP.
AFTER RECEIVING THE VACCINES THE PATIENT FAINTED AND BECAME RIGID. AFTER A FEW SECOND HE RESPONDED. WAS TAKEN TO THE ER.
Describe adverse events(s) (symptoms, signs, time course) and treatment, if any. She received seasonal flu shot in right arm 4 weeks prior to H1N1 shot. She received H1N1 shot on 11/4/09 at 10 AM in left arm. At 4:30 PM she felt her head itching, the scalp, and itching behind left ear. On 11/5/09 AM she had several welts on left side of her hairline, they were like red blotches and warm to the touch about the size on a dime an elongated. By midmorning her left ear was itching. On 11/6/09 AM she had welts all around her hairline and on her cheeks to near her nose. On 11/7/09 2 AM she was itching and had hives all over her body, they were concentrated on her lower back, up the spine, under her breasts, her face. She saw her doctor on 11/7/09 at 11:30 AM at 11:30 AM and was put on Medrol pack. On 11/8/09 most of the hives were gone and by 11/10/09 they were all gone. ON 11/13/09 she had hives on her ankles and inside her upper lip. On 11/14/09 she had welts on the scar that runs up her back, also on her legs, arms and face. She was restarted on Medrol on Saturday. She is still taking it.
Initial unsolicited report received from a Consumer on 01 September 2016. This case involves a 23-year-old male patient who was vaccinated with a booster dose of Meningococcal Vaccine (batch number, expiry date, site and route of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, reported as past June for 15 days the patient had experienced encephalitis meningitis, patient also experience optic nerve damage to the left eye. It was reported that night mare meningitis comes in many forms not just bacterial. Laboratory investigations and corrective treatment were not reported. The patient was recovered from event (duration 15 days). Upon internal review the case was considered as serious because of important medical event Encephalitis and optic nerve damage. List of documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented social media case, where manufacturer of the MENINGOCOCCAL VACCINE was not provided. Encephalitis meningitis was reported after administration of MENINGOCOCCAL VACCINE. Time to onset of event is unknown. Details regarding relevant medical history, CSF, MRI or other diagnostic reports, any history of infection after vaccination are needed to further assess the case. Based on available information role of the vaccine can not be assess.
First 2-3 days there was soreness around the injection site. Ten days after (2/25/2021) I developed a red rash, warm to the touch, around the injection site, about 3 inches in diameter. It was also slightly itchy around and in the area. After four days, the rash went away.
have pain in her elbow under the injection site; had pain at the injection site for 3-4 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain and pain in elbow. The patient was treated with diclofenac (Voltaren Gel). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in elbow was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in elbow to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. Patient received dose of shingrix a month ago.  After getting the shot she stated that she had pain at the injection site for 3 to 4 days. She stated that the injection site pain resolved but she had developed and continued to have pain in her elbow under the injection site.  She had started rubbing voltaren gel on her elbow.  The reporter did not consent to follow up.
Erythema lesions of right anterior thigh area 14 cm (width) X 11 cm (height). Treatment-benadryl
Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed left facial swelling, left facial droop, left ear sensitivity, left eye blurriness. She had a HA for 5 days. She took NSAIDs as needed. States symptoms are persisting.
Rash on chin and parts of body. Recommended patient take antihistamines to help with the itching which is her only complaint.
Large red itchy circle. At first it was bumpy, I thought it was a bug bite but then it became flat. It?s been 5 days but still itches. Not as bad, though.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium
Shortness of breath started after 5/3/2021.   Angioedema started around 5/9.
pt recv vax 7APR95 & 8APR95 or 9APR95 pt exp pain around site & swelling;lymph node in the lt axilla swelled;14APR95 t103 & soreness & enlargement of the node cont;MD gave cephalexin for tx;15 or 16APR95 pt exp joint pain, sore throat;
Patient with history of CHF, CKD, and type II diabetes. He was seen in the ED on 12/4/22 for issues with his blood sugar; patient states it has been running high. Additionally, he had been experiencing weakness, lethargy, and a constant cough. A COVID PCR test was done and resulted positive. Ultimately patient was admitted 12/4/22 - 12/8/22. During admission, patient required 2L O2 NC and was 87% on RA, but at discharge he was no longer hypoxic. Additionally, patient was admitted for hypotension, hyponatremia, hypokalemia, and hypocalcemia likely secondary to diuretics. He has received the COVID primary series and two boosters.
On sunday april 4th at @ 1am woke up to burning itching large red blotches on thighs arms and left side of rib area and also right palm of hand. Took benadryl tablet and applied benadry cream on the spots affected. After about an hr was able to get to sleep. When I got up next morning the redness was gone but still felt itchy and weird. Today its still feels weird and I have redness and itchiness on elbow of right arm.
The next day after the vaccine the child showered then noted and felt body rash. The patient took Benadryl. She continues to have mild fever, headache, backache, abdominal pain; she called her own physician.
Starting 07/09/2022, I started having a scratchy sore throat and feeling kind of tired. It progressively worsened over the day. I tested myself for COVID-19 late in the afternoon that day and I was positive. I called my doctor's office and they prescribed me Paxlovid and I was started on that. I was extremely exhausted and slept most of the day for about 4 days. After that, for the rest of the month, I was weak and would intermittently test positive for COVID-19. I was having shortness of breath. Before COVID-19, I would walk about 4 miles per day. After COVID-19, I would barely be able to walk a quarter mile. I would break out in sweat and be short of breath. I started having heart palpitations and chest pain. By September, it got so bad, that I went to the ER and they sent me home. The next day the pain and heart palpitations got so bad that I went to another hospital where I was hospitalized. I was hospitalized for Tachycardia and they referred me to a cardiologist. I wasn't able to get in to see them until this past February. When I did see them in February, they put me on a medicine called Flecainide. I was on that for a month and was still having breakthrough symptoms. I went back to see them in March and they increased the dosage. The symptoms have improved a lot now.
Pt states shortly after receiving PPSV-23, she began having chills and sweating.  She presented to the ED the next evening and was diagnosed with a Non-ST Elevation Myocardial Infarction.  The hospital has listed her as having an "allergic reaction" to the vaccine.
Patient found down, unresponsive, pupils unequal, amnestic with delayed responses. Head CT:  Acute hematoma in left thalamus with IVH.  CTA Head/Neck:  Subarachnoid Hemorrhage with hydrocephalous, 1.5 cm saccular aneurysm posterior aspect of basilar tip, 4.5 mm aneurysm left opthalamic artery, 2.5mm infundibulum vs aneurysm at right posterior communicating artery.  Emergently intubated and Right Coronal EVD placed in Neuro Critical Care.  Procedure in Neuro Interventional Radiology:  found 4 total aneurysms.  Returned to NIR on second day for embolization.
This spontaneous report as received from a other health professional. The primary reporter is a nurse who states the same expired GARDASIL lot # (666595/0096Z) expiration date 14Oct2012, was administered to 3 clients. This was the second dose in the GARDASIL series for all three clients, and they were vaccinated on 30Nov2012. Client one, vaccinated in right deltoid. No other co-suspects were reported. No treatment information was reported. All drop down boxes apply to all three clients. No concomitant medications were reported. No other information was provided.
After rt deltoid COVID Vaccination, rt axillary lymphadenopathy developed that was biopsy proved to be follicular lymphoma.
Information has been received from a registered nurse concerning a female (age not reported) who during her childhood was vaccinated with "childhood" doses of MMR. The nurse reported that on 20-FEB-1990 and 12-MAY-2006, the patient received subcutaneously 0.5 mL doses of MMR because of low titers. Concomitant therapy included alprazolam, ZYRTEC, LUNESTA and ACIPHEX. The patient still has low titers. No other symptoms or information reported. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow up information received from the registered nurse indicated that the patient did not surovonvert in that she was immune to mumps after childhood immunizations and 2 adult doses of MMR II. No further information is expected.
Information has been received from a physician concerning a 4 year old pt who on 02/22/00 was vaccinated with varicella virus vaccine live. On 03/10/2003, the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one of 40 reported. Thirty nine other cases (WAES 0407USA01446 and 0409USA01855, 0409USA01856, and 0409USA01858 through 0409USA01893) experienced varicella after vaccination with varicella virus vaccine live. No additonal information is expected.
The next day I had cold symptoms (fever and body aches). This lasted for two days. On the third day the body aches got worst along with a really bad headache.  This continued and on the fifth day after the shot I got bad chest pains especially when breathing in and the other body and head aches. I went to the Dr. that morning.  They diagnosed me as having pericarditis and prescribed me naproxen.
Pt reported headache one day following immunization. Reported localized redness swelling, pain and itching at vaccination site. Symptoms are improving. Advise to use hydrocortisone cream, cool compresses & loratadine until resolved.