chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. It was reported that patient had gone under some type of surgery for unspecified cancer prior to ZOSTAVAX administration and patient experienced swelling of her wrist post-surgery, prior to ZOSTAVAX administration. Date of surgery was unspecified. On an unknown date in June 2016 the patient was vaccinated with ZOSTAVAX lot # M001747/expiration date-07-APR-2017 with no issue. No concomitant medication was reported. It was reported that pharmacist saw patient in July 2016 and patient was doing fine with no problem. However, in August 2016, pharmacist received a call from patient's physician (name unspecified) and physician told pharmacist that patient had been experiencing swelling of arm and leg, on one side of body (did not specify left or right side but same side as ZOSTAVAX, and physician thought that swelling was due to ZOSTAVAX getting into patient's vein from administration. Patient visit physician to seek medical attention. It was unknown if any treatment was given for event. The outcome of event was unknown. Causality was unknown. Additional information has been requested.
Patient experienced severe pain in her arm a few days after receiving the flu vaccine (she think 4 days to 1 week after receiving the vaccine). It moved to shoulder and back of her neck. She could not lift up her arm or move her neck. Symptoms did not improve and patient did look for medical help. She contacted the pharmacy 5 months later and stated that she still experienced pain which keep her up at least every other night.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (vaccination a few years ago). In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 1 day after receiving SHINGRIX, the patient experienced fever, chills, upset stomach and weakness generalized. On an unknown date, the outcome of the fever, chills, upset stomach and weakness generalized were unknown. It was unknown if the reporter considered the fever, chills, upset stomach and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received ZOSTAVAX shingles vaccination a few years ago and last year had a very mild case of shingles (a single mark, no itching). The physician said the vaccine had apparently protected me from a more serious case and recommended to get the SHINGRIX vaccine. After several attempts when pharmacy had run out. In September on Friday, the patient received 1st dose of SHINGRIX. The next evening, the patient had fever, chills, upset stomach and general weakness and spent 14 hours in bed. The reporter had already received one dose of older vaccine and one dose of SHINGRIX so she was asking if still she need to receive the 2nd dose of SHINGRIX.
That night I had chills and fevers which lasted all night. The next day I was tired and got a rash on my leg. By Thursday, I had little red dots all over the bottom half of my legs. That cleared up a couple days later. Since then, I have had spots on my leg that itch all the time. About 2-3 weeks ago I began experiencing pain in my pinky finger. Also, my index finger began getting stiff with pain. I went to see a doctor, where they did some blood work and Xrays. Both were normal. I am scheduled to get an ENG done next.
pt c/o pain @ inj site which radiates down underside of arm & into armpit;on a scale of 1-10 pain is a 7;mom reports there is a 1" cong horizontal bruise across inj site;pt c/o frontal h/a also
Approximately 30 minutes after receiving the COVID-19 vaccine, my daughter started experiencing trouble getting a good breath. She was taking lots of deep breaths and holding her chest area. She said it felt tight like she couldn't breathe right. About 10 minutes later, she had a headache. She seemed very uncomfortable. I took her back to the hospital where she received the COVID-19 vaccine and they immediately walked us to the ER. Her blood pressure and oxygen levels checked immediately before taken back to a room. A doctor came in and suggested trying some Benadryl and just watching/monitoring her. About 30 minutes after receiving Benadryl, her headache subsided. Within an hour, her breathing was much easier. She was monitored for a total of 4 hours. During that time, her blood pressure was checked periodically and oxygen levels monitored.
Initial case received on 11 January 2010 from a phamacist. A male patient (age unknown) received an injection of H1N1 (lot number UP062AA) on 30 December 2009. On an unknown date, the patient experienced intermittent shooting pain in the arm of injection. The pharmacist reported that as of the patient's phone call on 08 January 2010 the pain persisted. The patient had a medical history of hypertension. Documents held by sender: none.
I had severe muscle pain in lower legs that continued for 7 days, and they are still sore, but not so severe  Also after 3 days, I started to have muscle ache in arms and shoulders, pain in wrists. Still have weakness in wrists
I am not feeling good; arms very sore; neck area sore; Muscle ache; Bad headache everyday since I have gotten the shot; Nausea; Vomiting; Fatigue; middle back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 20Jan2023 as dose number unknown, single (Lot number: FR2583) at the age of 64 years for covid-19 immunisation; vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), (Batch/Lot number: unknown). The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LOSARTAN taken for hypertension.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arms very sore"; NECK PAIN (non-serious), outcome "unknown", described as "neck area sore"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache everyday since I have gotten the shot"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "middle back pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, pain in extremity, neck pain, myalgia, headache, nausea, vomiting, fatigue, back pain.  Additional information: Consumer stated that it going to be a long speech because she was not feeling good. she just heard a whole long speech about the COVID and everything. She asked should she continue or don't get any more shots. She just had my first dose on Friday (Clarified as 20Jan2023). Consumer stated that her arms very sore, neck area sore, muscle ache, bad headache every day since she has gotten the shot and nausea, vomiting, feeling fatigue and my middle back pain. Consumer stated her weight is About 240. She took vitamins, the day before she had a Vitamin B12 Shot and she take a lot of vitamins.
Received Pfizer dose 2 (Tues 3pm), 10 hours later (Weds 1am), nausea hit along with aches, chills, headache and fever. Didn?t get much sleep, took my temp at 10am and it was 101.  Clothes were wet from sweating. Had to take the day off work. Symptoms (all of them) persisted the whole day, took temp again around 11:30pm (Weds), 101.2. Tylenol helped with sleeping (took the headache down enough to sleep) but the following day still had symptoms the whole day (Thurs), about  25 % less I?d say, couldn?t work Thursday either.  Friday finally felt well enough to eat, shower, do household chores, etc. 2 full days of really rough symptoms. Fever, headache, nausea the worst.
Woke up next morning (12/12/19) w/swollen face & eyelids. Rash. Otherwise felt fine; no SOB Just to head area. Spoke w/Mom again 12/13/19. Swelling & rash resolving Patient woke up w/a bad headache 4AM 12/13/19. Better w/OTC med
pt recvd vax 3DEC92 devel t102 w/vomiting; father states poss sz-took pt to ER uncertain if vax & sx related;
Since the second vaccine I have had numbness and tingling in my thumb and 1st 2 fingers of my right hand.  I have also had a continued dull aching pain in my hips and lower back that is not relieved by ibuprofen or acetaminophen.
Patient asked for a flu shot; flu shot was admin in left deltoid. Patient tolerated vaccine well. - 1 checked pt. file and noticed pt received a INFLUENZA vaccine 10/5/2011. FLULAVAL: AFLLA664BA manufacturer: GlaxoSmithKline.
Burning sensation in the arm the injection was given in.  Went into the hand,  then felt like his lungs were getting tight. The burning started about 15 minutes after the injection the chest tightness was about 40 minutes after the injection.  Patient was given diphendydriamine 25mg, because he didn't want 50mg, PO. Started to feel better, didn't want to be transported to the ER via ambulabnce. So left, office after about 30 minutes.  On way back to the office he works out of he stopped at the ER for evaluation and was told he had a mild reaction to the vaccine.
Patient presented to pharmacy 2/19/19 to get a prescription for an antibiotic filled and stated it was to treat an infection from the vaccine. Patient reported that he had redness, swelling, and pain in his arm and couldn't raise his arm above his shoulder.
I have had 3 bouts of unconsciousness since receiving the vaccine yesterday.  They just happen with about a 3 second warning, something feels off in my head then I collapsed and was out for a short time.  The front of my head has been painful since, it feels like swellings.  I am not prone to migraines or headaches.
Tingly; Sore; Had those shots, still got shingles/Suspected vaccination failure; Got shingles last month; 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. In November 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced tingling and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the tingling and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, tingling and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles shots. The patient stated that he/she still experienced shingles in last month. The patient still had tingly and sore. The patient received medications for the treatment. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
he received a full third shoot as an error; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (he received a full third shoot as an error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (he received a full third shoot as an error). At the time of the report, ACCIDENTAL OVERDOSE (he received a full third shoot as an error) had resolved.            Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Swollen, red arm x 7 days, nausea/vomiting x24 hours, fever over 100.0F x 24 hours, fatigue/malaise x3 days.
Breakthrough Covid; Breakthrough Covid; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant) with onset 06Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 06Jan2022, outcome "recovered" (2022) and all described as "Breakthrough Covid". The event "breakthrough covid" and "breakthrough covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. Therapeutic measures were taken as a result of covid-19 included Herbal supplements treatment. No other vaccine in four weeks. No COVID prior to vaccination. Patient tested COVID positive post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200085835 mother/fetus
24 hours after receiving TDAP injection pt D/V tenderness, swelling and warmth at injection site. DX with cellulitis - treated with BACTRIM BID X 10 days, KEFLEX 250 mg X 10 day, ROCEPHIN IV X 2 doses.
I am breastfeeding; I am breastfeeding; I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period; I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 06Aug2021 18:00 (at age of as 37-years-old) DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. Patient had not known allergies. Other medical history was reported as None. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on 08Aug2021 14:45 the patient was breastfeeding and she had been for 8 months and have not had menstrual cycle this whole time. Patient received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got period. Patient did not receive any treatment for AEs. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101015626 maternal case/Child case
Full body rash/hives with a lot of raised red welts.  Very uncomfortable and very itchy.  Worse where clothing contacts skin but appears everywhere: ears, hair, bottom of feet, palms of hands, face, back, legs, arms etc.  Any scratch to skin results in raised red welts to the skin for several hours afterwards.  Over the counter Zyrtec once a day helps with symptoms but does not cause hives/welts/itching to go away completely.  11 days after first sign of symptoms and they still persist.  If a dose of Zyrtec is delayed or missed, symptoms come back.
Patient called to report that after receiving her vaccine on Friday: during the middle of the night she starting feeling chills and had a temp of 101. She took some ibuprofen and her fever broke around 9030 or 1000 on Saturday because she became very diaphoretic. She reports that she slept approx 19 hours on Sat and she had chills and sweats off on during this time period. She just felt weak and tired. On Sunday she felt better, just tired. Today, Monday 2/1 she did not come to work due to being tired and feels dehydrated due to the fever and being weak and sweating spells she had.   She also states that her Right arm pit is swollen
patient started to have chills, burning in hands and forearms, as well as a feeling like she could pass out after returning home from vaccination. She had some chills and stated her blood pressure was 80/40 when she checked it. she did not call the pharmacy/vaccinator nor her physician. she took a nap and woke up with a pretty bad headache. She had taken some tylenol prior to the nap.  She called us the following day to report that she had issues.
my ear started hurting; almost fell down from being so dizzy; I had the JnJ in Apr2021/ most recent dose details:brand=pfzer booster; booster; I had the JnJ in Apr2021/ most recent dose details:brand=pfzer booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 15:00 (Batch/Lot number: unknown) at the age of 60 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Im never sick. Ive had the flu once in my life at the age of 10" (unspecified if ongoing), notes: Other medical history: Im never sick. Ive had the flu once in my life at the age of 10; "I rarely get colds" (unspecified if ongoing), notes: Other medical history: I rarely get colds. There were no concomitant medications. Vaccination history included: Janssen vaccine (Dose:1, I had the JnJ with no issues), administration date: Apr2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "No issues". The following information was reported: OFF LABEL USE (non-serious) with onset 14Nov2021, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Nov2021 15:00, outcome "unknown" and all described as "I had the JnJ in Apr2021/ most recent dose details: brand=Pfizer booster"; IMMUNISATION (non-serious) with onset 14Nov2021 15:00, outcome "unknown", described as "booster"; EAR PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "my ear started hurting"; DIZZINESS (non-serious) with onset 17Nov2021 02:00, outcome "not recovered", described as "almost fell down from being so dizzy". Therapeutic measures were not taken as a result of ear pain, dizziness.  Additional information: Prior to the vaccination, the patient was not 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. and no Known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
injection site pain, pain started within 20 minutes of the injection; swelling at the injection site; Pain in her left elbow which radiates down the top of her hand towards the wrist; Pain in her left elbow which radiates down the top of her hand towards the wrist; Wrong Injection Technique; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, less than an hour after receiving Shingrix, the patient experienced injection site pain, injection site swelling, pain, arthralgia and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, pain and arthralgia were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, pain and arthralgia to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received the Shingrix vaccine at a pharmacy (details not specified) and reported that the pain started within 20 minutes of the injection which was ongoing. The pharmacist injected the vaccine below the deltoid region in her left arm, which led to vaccine administered at inappropriate site. The patient reported that there was a swelling at the injection site, but it had resolved.  The patient also experienced pain in her left elbow which radiated down the top of her hand towards the wrist which was ongoing. The patient questioned the efficacy of the vaccine injected below the deltoid region.  The patient did not consent to follow up.
A non-serious spontaneous report of administration of expired H1N1 was received from a pharmacist concerning three children of unknown age and gender. Neither relevant medical history nor concomitant medications have been reported for these patients. The product expired in 15-Jan-2010. On 28-Jan-2010, three patients received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Post third vax, pt experienced his right knee feeling stiff and tight. No treatment was given. The follow up received on 8/4/00 states that the pt has a medical history that includes two cases of Lyme disaese. The first episode occurred a few years ago, maked by erythema chronicum migrane. The last episode occurred in early 1999 manifested by a bull's eye rash, followed by Bell's palsy. The bell's palsy was treated with antibiotics and resolved in 3 weeks. In July 2000 he developed a red swollen itchysite that was thought to be a bug bite. In May 1999 and later in May 1999, the pt received his first two injections with Lymerix for prophylaxis. Approximately 2 months after the first injection, in June 1999 he received the third dose of Lymeris. Approximately 9 monthsafter the third dose of Lymerix, the pt experienced his right knee feeling stiff and tight. No treatment was given. In approximately mid July 2000, the pt received a booster injection of Lymerix (4th) dose and within two weeks he experienced a bull's eye rash from his naval across his back. He saw a physician at an "urgent care center" and was treated with Doxycycline 100mg 2x day fofr 30 days. A Western blot for Lyme antibody was performed and was negative. The info received on 7/7/00 reported the stiffness resolved after a few weeks. The pt has had "no further problems." The most recent info received on 8/4/00 reported the rash resolved. The events of tightness and stiffness in right knee do not meet serious criteria but are being submitted expeditiously for informational purposes.
arm swollen around area-reddened area-hot to touch; pt has had this rxn to Td prev forgot about it until got this rxn;