chrisvoncsefalvay/vaers-outcomes huggingface dataset:
angioedema; arm swelled up; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) on 28-Dec-2020.  This case involves female patient of an unknown age who experienced arm swelled up (peripheral swelling) and angioedema, while she received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On 30-Sep-2013, the patient received suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [lot number: UH894AB and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date, (latency unknown) patient had a reaction as the arm swelled up (peripheral swelling). Patient was on a lot of vitamin D and then got the vaccines; that she had angioedema but had not had it in a few years.    The event angioedema was assessed as medically significant as per important medical event (IME) list. It was not reported if the patient received a corrective treatment. The outcome of the both events was unknown. There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a patient of unknown age who experienced swelling of her arm and had angioedema after vaccination with FLUZONE. The time to onset is unknown. Moreover, there is no information on patient's allergic history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Initial unsolicited report received from a pharmacist on 16-Feb-2017. This case involves an 81 year old female patient who was vaccinated with a dose of FLUZONE HD Batch number: UI731AA, (expiry date, dose, dose in series and route of administration were not reported) in left arm on 12-Feb-2017. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were reported as none. Any other vaccinations within four weeks of vaccinations was none. On 14-Feb-2017, two days following vaccination (on tuesday morning) patient experienced bruising left arm below the deltoid and pain into the elbow for which patient was unable to use the arm (injection site movement impairment) and was with terrible pain. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were none. Corrective treatment were not reported. The outcome of events were reported as not recovered. List of documents held by sender: none.
This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32. 4 Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Upper left arm swollen to double in size, flaming red, burning, itching, pain above arm in shoulder and through neck on the left side, stiffness in neck.
This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8737), at the age of 38, via an unspecified route of administration, left arm, on Apr 8, 2021, at 14:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have any allergies to food, medications or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EL9261), at the age of 38, via an unspecified route of administration, left arm, on Mar 11, 2021, at 16:45, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 9, 2021, at 10:00 (20 hours after the second vaccination), patient had extreme lethargy, fatigue from small movements (like sitting up), sensitivity to light, sharp and splitting headaches. Adverse events still occurred at 60 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of extreme lethargy, fatigue from small movements (like sitting up), sensitivity to light, sharp and splitting headaches: not resolved (at the time of this report). No follow-up attempts needed. No further information expected.
approx 4hr p/vax exp irritated eyes, feeling of having something caught in throat, swollen tongue then approx 7hr felt achy & had temp of 99.5;
On 4/9/20 patient developed bilateral numbness and tingling to arms, hands, feet and legs.  Went to ED on 4/16/20 Labs and CT head were normal.  Had decreased strength and sensitivity in extremities and Babinski's were upward going.  Discharged to home without medication and to F/U  with PCP in 4-6 days.  Saw PCP on 4/20/21. He had S&G hyeresthesia, + Rhomberg, failed tandem walk, and dysdiadochokinesia.  Neuropatic pain in shoulders, arms, legs, hands, and feet with weakness in hands and arms and sensory loss in left leg.  Was unable to get immediate MRI so patient was admitted directly to hospital.  MRI showed concern for transverse myelitis felt to be secondary to Covid 19 vaccine.  He will not get second dose.  Improved to near baseline with treatment of high dose steroids.  He also had an STEMI and was taken to the Cath lab where they found 50% blockage in a coronary artery.  They felt STEMI was caused by spasm.  Pt was discharged home on 4/26/21 and is having physical therapy to help regain his mobility.
Initial case was received on 28 October 2010 from a healthcare professional. A female patient (age not reported) received on 23 October 2010 a right deltoid intramuscular injection of FLUZONE (lot number U3726AA). On 24 October 2010, "48 hours" after vaccination the patient experienced right knee swelling. She had no difficulty walking and no other symptoms were reported. The patient had no vaccinations within four weeks and no illness at the time of the vaccination. Pre-existing medical conditions included arthritis. She had no concomitant medications. At the time of this report she had not recovered. Follow-up information was received 14 February 2011 from a health care professional. The patient was identified as a 65 year old female who developed right knee swelling on 24 October 2010 which changed the event latency from 48 hours to one day post vaccination. The event did not require treatment and the patient recovered (date of recovery not reported). Documents held by sender: None.
Received FLUZONE vaccination on 10/9/2014. Developed hives to left arm approximately 12 hours post vaccine. Resolved spontaneously by 10/13/2014.
fatigue; injection site pain; arm soreness / arm pain; muscle aches; nausea; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering. On an unknown date, the outcome of the fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering were recovered/resolved.   It was unknown if the reporter considered the fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix approximately 3 months ago from the date of reporting, specific date unknown. The day after vaccination, the patient reported that experienced arm pain, arm soreness, fatigue, headache, muscle aches, and nausea. Till the time of reporting, symptoms are resolved. The reporter did not consent to follow up.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose and route not reported) (incorrect product storage). No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter did not want to be contacted.
Acute blood loss anemia. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
9/14/07 Moderate soreness at injection site, then developed headache, photophobia, nasal congestion. AM of 9/15/07 developed fever 103 degrees and chills off and on until evening of 9/16/07. Felt lethargic 9/17 - 9/18 and missed work 1/2 day 9/17 and all day 9/18. Symptoms subsided and returned to normal activities and work on 9/19/07. No medical treatment. Rested at home.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1008 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Two hours post vaccination, arm was sore. By the following morning, arm was itchy, red, hot to the touch, and swollen to the size of a coke can.
Patient developed (5) vesicles on (L) arm and (L) back that appear to be varicella. No systemic reaction.
C/o feet swelling about double sizes after receiving vaccines.  Mother states patient had not pain in feet.  States feet starting swelling about 45 minutes after receiving vaccines.  Swelling went away after 1 1/2 hours.  Denies any other problems.
the vaccine did hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had shingles and they were the worst.  The reporter also stated that, the vaccine did hurt some but he/she would take the 2 shots any day over having shingles again. The follow-up would not possible as no contact details were available. For the tolerance of 2nd dose, refer case- US2021AMR259656, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259656:same reporter
Flu shot: time of shot hurt bad. Arm where needle shot began to hurt. Can't sleep on this arm - wake up 2 to 3 times. Hurts daytime. Feel like toothache at vaccination point still hurts 3/11/13.
Patient has redness, swelling, and pain at site of injection...patient also feels weakness of the legs.
Patient developed a rash/redness the day after receiving  Fluzone HD.  Patient didn't notice until it became slightly itchy. 3 days after vaccine, rash is softball sized.  Patient will take benadryl, but its not bothering her.
Fever to 39 degrees Centigrade, muscle aches; patient self indicated and administered acetaminophen.
This spontaneous report as received from a Doctor of Pharmacy refers to a 55 year old male patient. No medical history or drug reactions/allergies were reported. On 27-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J001697; exp. date: 06-MAY-2014), 0.65 ml, subcutaneous in the left arm for shingles prevention. On 29-AUG-2013, the patient experienced a red blotch over the injection site. The patient did not seek medical attention. At the time of the report, the outcome of red blotch over the injection site was unknown. Additional information has been requested.
pt recvd vax w/Hep B & converted to HIV pos; No further details were provided;
Patient received pneumococcal vaccine on 11/17/2008 and 2 days later complained that his right upper arm was hot to the touch red, and swollen. PAC recommended icing the arm and taking Tylenol for the pain.
Patient presented to eye doctor with blurred vision in right eye. Patient admitted to hospital with acute retinal necrosis with herpes zoster in right eye. Patient was hospitalized short-term while receiving acyclovir IV therapy. Patient was discharged to home with home health services to continue acyclovir therapy. Situation was not resolved upon hospital discharge.  5/18/07 Received medical records from hospital which reveal patient experienced pain & decreased vision of right eye & saw opthal who noted retinal abnormalities.  Vision worsened to blindness of right eye & acute retinal necrosis.  Admitted 4/6-4/9/07. ID consult done.  Treated w/IV antiviral.  PICC line placed for continued IV antiviral as outpatient for total of 14 days then to begin oral antivirals. FINAL DX: acute retinal necrosis, right side, likely secondary to herpes zoster s/p vaccine. Patient's condition (necrotizing retinitis) was noted to be improving per physician.
accidental needle stick while on job in ER one to five day p/incident & vax exp tinnitus, vertigo, varied degrees of hearing loss & exhaustion-same cont;
Pt. developed redness and swelling 2x2 cm on right deltoid (injection site for KINRIX). Noted 3 days after vaccine and redness and swelling 0.5cm on left arm (injection site for PROQUAD) 2 days after vaccine given. No treatment.
12:40pm: Mother called stated child received vaccines at 9:00AM and she has cried unconsolably for more than 5 hours.  Informed mother to take child to clinic.
Flu-like without the fever. Extremely chilled (and could not get warm) approximately 15 hours after vaccination. Took 1500mg TYLENOL and symptoms lessened. Chills were completely gone within eight hours of that. Was 'under the weather' for another 12 hours after that and then felt fine with the exception of a sore arm (like a tetanus shot) for four days. The flu-like symptoms came on very fast, were very extreme, and disappeared as fast.
throbbing pain in her upper body; This case was reported by a consumer via call center representative and described the occurrence of throbbing pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced throbbing pain. On an unknown date, the outcome of the throbbing pain was not recovered/not resolved.   It was unknown if the reporter considered the throbbing pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine (didn't remember which arm) and few days later she experienced throbbing pain in her upper body that was still continues (on and off) today (day of reporting). The patient stated that she had been to the ER x 2 since then. ER (emergency room) visit required. No further information reported. The reporter did not consent to follow-up.
It swelled all around the vaccine site. The size of a soft ball. I could hardly move my arm at all. The doctor drew a circle around where it appeared to be infected to make sure it did not go outside that area. They were not able to do anything about it. They asked me to take Benadryl, iced it, and continue to watch it. They did a COVID test and it was negative. After that I continued to keep a headache and I was really sick. I felt like I had COVID for about 4 days. The injection site is much better. Since then I have been keeping a really bad headache, nasal drip, and cough.
herniated disc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "herniated disc".  Additional information: Reporter was scheduled to get spinal injection for her herniated disc in a week or two. She wants to know how much time was needed for her to schedule an appointment to get the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 2nd dose of Pfizer vaccine at 14 day interval instead of 21 day interval. Patient mother notified of error. Pediatrician notified and consulted. Mother advised no need to repeat dose. No adverse reaction occurred.
Information has been received from a physician concerning his son, a 5 1/2 year old male who was vaccinated on an unspecified date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Subsequently the pt experienced pain in his legs and a rash. Unspecified medical attention was sought. The pt recovered from the pain in his legs and the rash. The physician also reported that another son experienced a speech impediment which was characterized by stammering and stuttering after vaccination with (+) mumps virus vaccine live (+)rubella virus vaccine live (second generation) (lot # not reported) (WAES #0302USA02465). further information is available.
It was discovered after administration that the vaccine was expired. Vaccine was pulled from the freezer on 6/23 and only valid in the fridge for 30 days. Patient does not report any adverse event.
This case was reported by a consumer and described the occurrence of injection site soreness in a 38-year-old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. The reporter is the husband of the subject. A physician or other health care professional has not verified this report. Concurrent medications included Methylphenidate hydrochloride (Concerta) for an unspecified indication. On 05 April 2006 at 1:30 p.m., the subject received two doses of Dtpa rather than the intended administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. The subject was injected in "the arm." The specified sites of injections were not reported. Dtpa is not recommended for immunizing individuals 7 years of age or older. On 05 April 2006 at 1:30 p.m., immediately after vaccination with two doses of Dtpa, the subject experienced injection site soreness. At the time of initial reporting, 05 April 2006, the injection site soreness was ongoing.
Patient presents with 6 raised, round lesions adjacent to smallpox vaccination site. Lesions have no pustules. Patient complains of severe itching.
Swollen, red, dry/flaky, itchy ears Itchy neck rash near hairline?tiny red bumps Began day after vaccination (Tuesday 10/18)  and has not improved (as of 10/23) Treated with aloe gel, moisturizer, and oral anti-histamine  (loratadine)
Pain at injection site started around 2/2/16. Stiffness, pain is worse now. Pain going down arm and into shoulder/chest. Unable to lift arm above shoulder.
- Feeling weak, wiped-out - feverish - mucus build-up in airways.
2 days after shot, itchy rash is starting to appear all over body.; Itchy hives all over body; Lip swelling; Itchy hives all over body; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732, expiration date not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 (age at vaccination 41-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation at workplace clinic. Medical history included Allergies to medications, food: penicillin and shrimp. Patient took concomitant medications within 2 weeks of vaccination included trazodone (TRAZODONE), loratadine (LORATADINE), vitamin d (VITAMIN D NOS) and naproxen sodium (ALEVE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number EN6199 and expiration date not reported) via unspecified route of administration on left on 05Mar2021 09:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with covid-19. On 04Apr2021 at 06:00 (2 days after shot), the patient experienced itchy rash is starting to appear all over body, Itchy hives all over body and lip swelling. Patient received treatment oral steroids, Benadryl and zyrtec. The events were assessed as non-serious by reporter with no seriousness criteria (Results in death/ life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient underwent lab tests and procedures which included nasal swab negative on 16Apr2021. It was unknown if the patient received treatment for events. Outcome of the events was unknown for rash and not recovered for all other events.  Follow-up attempts are completed. No further information is expected