chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration, lot #, expiration date, dose, dosage number and anatomical location were unknown). Subsequently, on 13-MAY-2015, the patient was vaccinated with a dose of PREVNAR (route of administration, lot #, expiration date, dose, dosage number and anatomical location were unknown) and on 17-MAY-2016, the patient was vaccinated with a second dose of PNEUMOVAX 23 (which had a lot # reported as K021881 and expiration date 30-JUL-2016; however dose, dosage number and route of administration were not reported). No adverse effect reported. No product quality complain (PQC) was involved. Additional information has been requested.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degree Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1308 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness/pain present since post-injection. Redness, rash, 1-2 vesicles noted on 10/30/2006. Seen by doctor today, 11/03/2006, and prescribed Kenalog 0.1% cream, Lodine 400mg bid, and Ultram prn.
01/25/22 presents to ED for "abnormal labs" "fatigue, leg swelling, and weakness" "recently was diagnosed is COVID positive". PMHx of "hypertension, Atrial fibrillation, GI bleed, colon ca,CKD"
Headache, Sedation, Myalgia, Fever, NauseaVomiting,  Chills, arm pain  Narrative: Received 1st dose at 1030 03/12/21 and noted onset of arm pain at 1530. Was very painful to move her arm next day. She also noted extreme fatigue, mild headache all day 3/13/21. Also reported fever/chills and nausea/vomiting on 3/13/21 and 3/14/21. Symptoms mostly resolved by 3/15/21, though missed 1 day of. Prior COVID infection 12/28/20.
Patient tested positive with Covid-19 on 3/25/22.  Patient had history of head and neck cancer.  Brought to hospital per ENT for inpatient hospice services.  Patient admitted with epistaxis, hemoptysis, right distal common carotid artery pseudoaneurysm.  Patient continued to have more bleeding and was seen by palliative care, hospice and admitted to inpatient hospice service.  Patient expired on 5/6/22.
This spontaneous report as received from a physician refers to a 61 year old female patient with no drug reactions/allergies or pertinent medical history. On 11-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported). There was no concomitant medication. On 16-MAY-2013, the patient experienced a mild case of shingles on one side of the face after receiving the ZOSTAVAX. The patient went to physician's office for medical attention. No treatment was given. No lab diagnostics studies were performed. The outcome of case of shingles on one side of the face was reported as recovering/resolving. Additional information is not expected.
Dizziness, shortness of breath, chest discomfort, numbness and tingling in both arms
pt did not achieve acceptable titer level p/3rd vax w/Hep B vax;
soreness on her arm; This is a spontaneous report from a sponsored program. A non-contactable consumer(patient) reported this female patient of unspecified age received doses 1 and 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on unspecified dates as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced soreness on her arm after receiving doses 1 and 2 of BNT162B2. The patient did not feel any other side effects. She wanted to know if this meant the vaccine did not take effect. The outcome of soreness on her arm was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
I95.9 HYPOTENSION 3/26/2022 ALCOHOLIC CIRRHOSIS I95.9 HYPOTENSION 3/26/2022 ALCOHOLIC CIRRHOSIS I95.9 HYPOTENSION 3/26/2022 ANEMIA I95.9 HYPOTENSION 3/26/2022 BILAT PLEURAL EFFUSION
I am perimenopausal, so my periods are neither regular nor (lately) heavy (I use tracking software for my periods-- in 2021, other than some occasional light spotting, I had periods on Aug. 1, July 6, May 3, Mar 29, and Feb. 12).    My adverse event that I believe is vaccine-linked is my current period, in which I am experiencing an exceptionally heavy flow, compared to what is usual for me.  I started experiencing normal vaccination side effects (slightly elevated temperature of 99.1F, injection site soreness, general muscle aches, swollen lymph nodes under armpit and in neck on side of injection) by early evening the day of my vaccination (1/5/22).  Just after midnight on 1/6, my period started accompanied by moderate cramping.  Within a couple of hours I was also experiencing back cramping, which is not usual for me.  I had to change my pad in the middle of the night, again in the morning.  Today it's been three times so far-- I've been experiencing a MUCH heavier flow than usual.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 21-APR-2015, was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Patient was supposed to receive moderna vaccine for covid-19, received alfluria vaccine instead. No adverse reaction at this time.
Pt in the evening on day of Immunization felt chills, aches, and run down and pain in his arm - so he went to walk in/ER and got LEVAQUIN, then next day couldn't move, so he got doxy from another MD at hospital, then week later got AUGMENTIN and Prednisone - pt. had a swollen red hot sore arm around pneumonia shot - very painful - MD thought at 1st cellulitis, then Lyme disease, then pneumonia.
joint pain; tingling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and PARAESTHESIA (tingling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pain) and PARAESTHESIA (tingling). At the time of the report, ARTHRALGIA (joint pain) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
Pt experienced joint pain (in all joints) and aches (joints) for the past month. Pt also experienced stomach pains and loose bowel.
I began experiencing symptoms Thursday evening, December 8, 2022. During the night, I was coughing and felt like I was trying to cough up material to clear my lungs. On Friday, December 9, 2022, I was concerned that something was going on in my respiratory system. I took a COVID-19 rapid test. The result was negative. Friday evening, I was beginning to have pain all over my body. Everything that could possibly hurt did. Saturday, December 10, 2022, I thought I needed to take another COVID-19 test before going out in public. The result was positive. I called the medical line to speak to a nurse that answered my questions and gave me advice. She told me I needed to isolate and wear a mask in the house so I wouldn't infect my wife. She said to isolate at home until December 13, 2022. She said there was no medication they could prescribe due to the medication I'm already taking. She said to get rest and drink plenty of liquids. My symptoms lessened during the night of December 11, 2022. On Monday, I felt much better. Today, I still feel better, but I still tested positive for COVID-19 and am self-isolating.
Guaiac positive stool with symptoms of discomfort requiring emergency room visit to rule out intussusception.
Noticed pain at injection site with redness and swelling developing at both inject. sites within 15 hours after injection - unable to raise arms above waist level about 12 to 15 hours after injection; Also had dizziness, chills
Pt. recieved vaccine greater than 12 hours after being drawn up. No adverse event. Md contacted pt. pt. declines revaccination
Patient received his first Anthrax vaccination on 29 Jan 2003. He did not experience any immediate reactions. That evening he had some mild shortness of breath, particularly with lying down therefore making sleep difficult. He thought he must be getting a chest cold. These symptoms resolved within 5 days. He received his second anthrax vaccination on 20 February 2003. No other shots were given in between the 1st and 2nd dose of the anthrax vaccine. He experienced local swelling and redness at the injection site (left upper arm over triceps). He awoke the morning of 21 February with tightness and dryness in his throat causing him to have difficulty breathing. That morning he began wheezing on expiration and the labored breathing continued. He did not have any symptoms of fever, rhinorrea, cough, myalgias. The difficulty sleeping did lend to him being tired throughout the day. He sought treatment. THe PA he saw found patient to have clear lungs and a local vaccination reaction. He gave patient Naproxen for the local reaction swelling, Albuterol inhaler and Prednisone 20mg BID for the breathing. After several days on the medication the breathing had improved slightly yet he was still having some throat tightness and some slight wheezing. He returned to primary care and he was told to continue the prednisone. By 10 Mar 2003 his symptoms of throat tightness and labored breathing had resolved (total of 18 days of symptoms). The VHC referred patient to an allergist for immediate evaluation due to a pending 14 March deployment and issued a temporary medical exemption from the anthrax vaccine. VHC recommended rhinoscopy be performed to rule out vocal cord dysfunction and spirometry to rule out any obstruction to breathing. Dr. evaluated patient on 11 March and diagnosed him with a delayed hypersensitivity to the anthrax vaccine. The VHC is awaiting the dictated notes from Dr. to determine if a permanent exemption is needed for this patient. The patient is currently temporarily medically exempt for a six month period. VHC will review records and issue revised exemptions as needed. VHC discussed with the patient the potential of receiving an additional dose only in the case of exposure to the bacillus anthracis bacteria.
Arm swollen red, hot to touch, leg weakness, fatigue, unable to stand, fever 102.2, headache on the night she received vaccine. Arm remained and swollen for several days. Headaches were daily for 6 weeks, during which she experienced double vision and other visual disturbances, sleep issues, mood issues and brain fog.  She was seen by ophthalmologist, nothing wrong with eyes. Visual disturbances increased, began to lose control over limbs. Could not walk, would "lose" limbs. Seen by neurology after no improvement. Diagnosed with Alice in Wonderland Syndrome as an adverse reaction to the vaccines she received.
Tdap given on 11/24/2008- next day pt. experienced severe left deltoid pain, fever to 102F, weakness, chills.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dosage, dose number and route were not provided) lot #L029113 and expiration date 27-MAR-2017, that was improperly storage. No concomitant medications were reported. No adverse effect was reported. No product quality complain was involved. Additional information has been requested.
Patient's first dosage of covid vaccine was on 04/17/2021. Patient was given second dosage on 05/07/2021. This is only 20 days separation from 1st dose, Manufacturer recommendation is 21 days from 21st dose
Mild headache the day after vaccination, soreness at injection site, 2 days post vaccine blood from vein in right eye (no pain noted)
Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.
I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm.  My first dose 3 weeks prior was in my right arm.  I did not experience any side effects from the shot for 4 days.  I woke up on Tuesday, February 23rd and had pain in my right arm - the arm I had the 1st shot in, not the 2nd!  I continued to have pain in my right arm for several days and then 6 days after my 2nd dose I started having extreme pain in my legs - from my knees up the back of my thighs for two days.  Then 8 days after my 2nd dose my other arm became very sore, the arm I had the 2nd dose in.  So both arms are sore and the lymph nodes under the arms are tender.  Today I am 11 days out since my 2nd dose and I woke up and could barely lift my left arm. I have pain in both arms and lymph nodes.  I went to my family doctor and he does not have any answers for me.  I need to know if this is something I should be concerned about and if there is anything I can do to help these side effects go away.  How long can this last???
At midnight the day of the shot woke up with teeth chattering chills, then fever, diarreha, fatigue, weakness, diffuculty breathing, arm is terribly sore, hard & a little warm. Spent the entire day in bed on 4/10 on 4/11 moved to the couch & finally ate & drank. Felt like a mild case of Covid Pneumonia which I had in December 2020.
Outdated med.  Dating 08Mar07 interpreted as March 7, 2008.
I felt extreme fatigue and general malaise at 14:30. I took a Vicodin for my chronic back pain and lost consciousness at 15:00. I Went to bed and woke up at 16:25. 30 min later I slept again for about 90 min. Then I woke up and walked outside for some fresh air and got this extreme ice pick pain in the left side of my head for a few seconds. Then a few seconds later again. Now it just nags a bit behind my left eye and it feels a bit off in the left side of my brain. Bright lights hurt a bit. My back pain and Sciatica is also a lot higher than normal.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. 64 y/o male with HTN, HLD, DMII, ETOH abuse, Tobacco use, chronic pancreatitis/b exocrine insufficiency on PERT, multiple pseudocysts and splenic vein thrombosis on anticoagulation. On March 06th patient was also admitted to ER for upper abdominal pain after eating. Also had an history of Pancreatitis.
The needle malfunctioned while being administered to the patient. Patient received a dose of 0.3 instead of 0.5
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling in arms shaky hands feeling lightheaded and dizzy. We laid patient flat and elevated feet.
vaccination failure; Herpes zoster; Information has been received from the RA (agency#AU-TGA-0000731022) on 19-JAN-2023.  This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine (conflicting information, also reported as varicella virus vaccine live [manufacturer unknown]). 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 Information: GSK Receipt Date: 16-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media The patient had the shingles vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Walking out of the clinic after 15 minutes of observation, noted sharp stabbing pain in left calf/thigh.  Returned to the vaccine clinic and observed breaking out in hives.  EMS as called.  Given epinephrine and benadryl.  Transferred to the ED.  Upon exam, hives were improved.  Remained in the ED for a few hours for observation.  Vital signs were stable.  Ultrasound was done to rule out DVT.  DVT was negative.  Discharged home.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 06Feb2021 15:00 (Lot number: EM9810) at the age of 82 years as dose 2, single and intramuscular, administered in arm, administration date 01Jan2021 14:00 (Lot number: EL3249, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Jan2021, outcome "recovered" (Feb2021), described as "sore arm".  Additional information: Patient reported she got her the first and the second and she had almost no reaction just a little bit sore arm(dates were unspecified). Consumer stated, "Is this the right number to report side effects from the Pfizer drug?". In the past January and February she got her first and the second and almost had no reaction just a little bit sore arm, but this booster shot was totally different. Consumer was informed about the role of Pfizer Drug Safety Department. Consumer stated, "My height is 5'6 I think." and "Oh I don't know I am not over weight, lets see I haven't weight myself from a long time I am not over weight, I don't know." Expiration date: "31May2021 oh boy it was expired so they shouldn't be given to me right." (further confirmed the expiration date was for the first shot and for the booster it was not provided on the card) Consumer stated, "And lot# you asked me about LOT# EL3249. Ok hang on this may be the previous one it may be previous I don't know, the date on 15 that was the first one I got. But I don't have an expiration date for what I got yesterday." The reporter was a researcher. Consumer stated, "I was very surprised I didn't get the barely any reaction in Jan and Feb and this was quite a reaction I got, I was surprise". There was no prior vaccinations, Concomitant drugs, patient's medical history (including any illness at time of Vaccination) or relevant tests done for the patient. Onset date the event after dose 1 was 15Jan2021 and after dose 2 06Feb2021. Patient stated am feeling ok again. Specific relevant test for thromboembolic events with thrombocytopenia: None  Follow-up attempts are completed. No further information is expected.
The next day I was very fatigue and had body chills and mild fever. On monday I had chest tightness . I was still able to breathe and noticed that this was not normal. I pressumed my day as usual. On Thursday I went to my local urgent care. They performed an EKG, Blood test to rule out infection and blood clots and a chest x ray. All of my test came back NORMAL. My Dr. stated that it was " CHEST WALL MUSCLE PAIN" The CHEST TIGHTNESS WENT AWAY ON SUNDAY. 1 week later from the day of the injection.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On20-OCT-2012 00:18, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.