chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient with history of anaphylaxis with iodine contrast despite prednisone prophylaxis (at outside facility), CAD, afib, HTN, Wolff-Parkinson White syndrome, gout, history of malignant hyperthermia post-op, and prostate CA s/p prostatectomy; patient also with history of pruritus with peaches and urticaria with erythromycin. Patient reported swelling within 30 minute observation window after vaccine administration. After administration of diphenhydramine in vaccine clinic, patient went ED; symptoms were resolved upon arrival. Patient was monitored for 2.5 hours total and then pt released home with prednisone, diphenhydramine, famotidine (x5 days of therapy), and epi-pen. Patient called 2/20/21 with swollen lips and tongue since 7:30a on 2/20/21; pt took diphenhydramine at 8a. Pt was instructed to come to the emergency department; on exam pt had no evidence of angioedema. Given cetirizine (instead of diphenhydramine) at discharge. Contact with patient 2/25/2021 notes patient stated "today is the first day that I don't feel swelling in my lips." Patient will be referred to Allergy Clinic for evaluation.
first shot two years ago, beneficial to get second shot now; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient had first shot of Shingrix two years ago and needed to know if it was still beneficial to get second shot now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Received 2nd (booster) dose of SHINGRIX vaccine for adults over-50 (approximately 4 months after 1st dose). After the 1st dose (June 2018), there was definite muscular soreness throughout the arm of injection, peaking about 36 hours after the dose. General flu-like body soreness occurred within the same timeframe. After the 2nd does (Oct 2018), same symptoms as above, only worse. Chills (without fever) and massive shivering convulsions occurred commencing about 10-12 hours after injection, in addition to injection-arm soreness. Flu-like body-pain encompassed the entire body causing significant pain and discomfort (worse than first injection), plus significant nausea. There was significant and wide-spread general touch-sensitivity throughout the body (i.e. a spousal hand placed on the back caused significant pain and recoil reaction). A migraine-like headache pain also emerged, with notable (painful) touch-sensitivity to the head and facial areas.  2-3x Oxycodone tablets (5mg oxycodone / 325 mg acetaminophen) were required to resolve the pain after 750 mg of regular acetaminophen, failed to resolve the pain-symptoms. Approx 200 mg GRAVOL was taken within a 4 hour period for nausea. 100 mg Baclofen was required to resolve muscular tension and stiffness approx 10-12 hours after the chill symptoms began, or about 24 hours after the this 2nd injection. Symptoms largely resolved to a manageable medication-free level about 60 hours after the injection was delivered. Of note, I suffered significant erythema multiforme as a 10-/11-year-old leading to Steven Johnson's Syndrome and 10x days hospitalization. From ages 10-25, ZOVIRAX was prescribed to mitigate cold sore outbreaks, with occasional prescriptions of prednisone to control inflammation. Commencing at about age 25, a long-term high-daily dose to ZOVIRAX/Valacyclovir was prescribed to keep the herpes virus in check (successfully).
Mild flu symptoms evening of the vaccination. Widespread hives the next day, with full-blown flu. Hives exacerbated by heat.
Adverse events -  Infraspinatus tendinopathy  - Frozen shoulder Pain medications Physical therapy Exercise at home Steroid Injection in the left shoulder Outcomes - Still suffering from severe pain, cannot move the left arm
Shingles two weeks after Shingrix; Pain on right side of his face, neck, upper back and shoulder; feeling pain on one side (side unknown) of his face; Feeling pain on neck; Feeling pain on upper back pain/ pain between neck and shoulder; Erupted into a rash/Rash on right side of his face, neck, upper back and shoulder; This case was reported by a nurse via sales rep and described the occurrence of shoulder pain in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date 6th July 2023) for prophylaxis.   Concurrent medical conditions included autoimmune disorder (have had autoimmune disorder). Concomitant products included adalimumab (Humira).   On 7th February 2023, the patient received the 1st dose of Shingrix. On 9th February 2023, 2 days after receiving Shingrix, the patient experienced shoulder pain, rash, facial pain, neck pain and upper back pain. On 14th February 2023, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and topical steroid nos (Topical Steroid). On an unknown date, the outcome of the shoulder pain, rash and shingles were recovering/resolving and the outcome of the facial pain, neck pain and upper back pain were unknown.   It was unknown if the reporter considered the shoulder pain, rash, shingles, facial pain, neck pain and upper back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment:Nurse reported that the patient was administered a dose of Shingrix and the rheumatologist at the clinic presribed the Shingrix because the patient was on Humira. The patient was monitored for 15 minutes after he received the vaccination, and the patient was fine. The patient developed the pain and rash in the right side of his face, neck, shoulder and between his neck and shoulder. On 10th February 2023,  the patient called the clinic about these adverse reactions. The patient's primary care provider applied topical steroid that did not help his symptoms and he was then referred to dermatologist.  On 13th February 2023, the patient was seen by the dermatologist in the clinic and on 14th February 2023 was confirmed to had an outbreak of Shingles, and provided education, and the patient was prescribed Valtrex (Valacyclovir) for the shingles by the dermatologist. The shingles was now resolving since it was two weeks after Shingrix was given. The dermatologist did recommend that the patient receive his second dose of Shingrix at the 14th February 2023 appointment, and the patient was scheduled to receive his second dose in April 2023. The patient consent to follow up with the health care professional was obtained.
In july 2021 I got the shingles, the pain felt like a short on the right and along the back of neck and on my shoulder like I got a shot on my right arm. It start on my back on the right and rubs and breast . I went to the urgent care twice
Hospitalization for severe sepsis likely due to UTI with metabolic encephalopathy on dates 1/27/2023- 2/1/2023. Treated with  vitamin D 25 mcg PO daily.
Shot was incorrectly adminiistered- possibly into shoulder cartilage-immediately extremely painful- patient reported feeling a "crunch", then feeling partial withdrawal of the needle, then rapid injection which caused more pain. As of today Jan 26, patient reports pain in armpit ,downward to ribs, had pain at the back of the shoulder yesterday Jan 25. This was a booster-first two shots did not result in any pain except the usual sore arm a day or so later.This pain is in unusual locations and concerning because of the "crunch" .Patient is planning on a doctor visit/checkup to determine if there is any permanent damage to his shoulder. Also doctor made the excuse like insult on patient. Unreadable signature.
This spontaneous report as received from a medical assistant concerning an 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 21-AUG-2014, the patient was vaccinate with improperly stored GARDASIL, (Lot number J013324; expiration date: 12-FEB-2016) (dose, frequency, strength not provided). Co-suspect or concomitant therapies were not reported. This is one of several reports from the same source. Additional information has been requested.
Within 15min of vaccine administration Mother noted cough, followed by facial rash. Review of notes remarkable for rash described as macular rather than urticarial rash on the face, which subsequently spread to chest and back. Diphenhydramine and Prelone given without resolution of sxs. Epinephrine administered with prompt resolution of dermatitis and cough. Temperature increased to 100F from initial of 98.7. Child observed for several hours with NO recurrence of sxs. Sa02 notably normal (99-100 on RA), with normal oral/throat/respiratory/pulmonary examination. No angioedema reported. No GI sxs reported.
w/in hr of vax pt devel a fever & malaise which persisted for 1wk;
harsh reaction to Vax 2; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (harsh reaction to Vax 2) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (harsh reaction to Vax 2). At the time of the report, VACCINATION COMPLICATION (harsh reaction to Vax 2) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   Reporter did not allow further contact
Patient was given TDAP on 6/28/16, state she noticed swelling and pain at the injection site around 3:00 the next day. Patient also notices some itching at site. Patient states that discomfort relived by Ibuprofen. Patient returned to Immunization clinic on 6/30/16, where I noted that Right arm (deltoid) was swollen, and warm to touch, 7L x2-3W cm raised area noted. Advised patient to continue Ibuprofen for discomfort.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # N014980 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1709USA001647:
I was feeling ill that evening; I was feeling ill that evening, and am worried; Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was feeling ill that evening), ANXIETY (I was feeling ill that evening, and am worried) and ACCIDENTAL OVERDOSE (Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 038C21A and 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 11-Nov-2020. Concurrent medical conditions included Grass allergy.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced ILLNESS (I was feeling ill that evening), ANXIETY (I was feeling ill that evening, and am worried) and ACCIDENTAL OVERDOSE (Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.). On 28-Dec-2021, ACCIDENTAL OVERDOSE (Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.) had resolved. At the time of the report, ILLNESS (I was feeling ill that evening) and ANXIETY (I was feeling ill that evening, and am worried) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Nucleic acid test: positive (Positive) tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.  Patient  have had COVID and received 2 full doses of the Moderna vaccine, and now have received the incorrect vaccine. The patient height was 180 cm.
Polio vaccine-Pain, muscle weakness of right upper leg and limp. Previous vaccine-Kinrix on 8/28/2015 caused hot, red, 12 cm rash.
Raised Blood Pressure to Hypertension Stage 2. Constant Headache all day,  Worsened Ringing in Ears to uncomfortable levels. Redness in Face started with whole face, now just right side.
This spontaneous report as received from a pharmacist via a company representative refers to a co-worker of the pharmacist of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, route location unspecified). The reporter stated that on an unspecified date, a co-worker of the pharmacist developed shingles after receiving the (ZOSTAVAX) and "lost a few weeks of work" due to the shingles. She also reported that the pharmacist informed that this case was already reported to the Food and Drug Administration (FDA). At the time of report, the outcome of the event was not provided. Upon internal review, event was considered as disability. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report was received from a consumer, who was the patient's daughter, on 13 July 2012, which also involved a case of misuse (vaccine administered at inappropriate site). A 53-year-old female patient had received a dose one intramuscular injection at the gluteal site for post-exposure of IMOVAX Rabies, sanofi pasteur SA (lot number unknown) on 11 July 2012. Within minutes, the patient experienced tightening of throat. The patient was treated with BENADRYL in the emergency room (ER). No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Patient is 13 y.o and was in clinic to receive her booster shot. She should have received the adult dose of pfizer and instead she received the pediatric dose of Pfizer. Provider has tried to make patient aware through a phone call but patient has not returned the call. Will send letter out regarding the incident. According to CDC there is not contra-indication or need for revaccination.   Team reviewed the appropriate ages and vaccines that went with the people when resuming session. Management was notified. There was no adverse reaction from the vaccine. Just too small of a dose.
This spontaneous report has been received from a licensed practical nurse referring to a 67 year old male patient. The patient did not have medical history, drug reactions or allergies neither concomitant therapies. Information regarding the patient's concurrent conditions was not reported. On 01-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011867 and expiration date 08-NOV-2018 (strength, dose and route were not provided) for prophylaxis. It was reported that in September 2017, the patient's injection site was swollen, red to touch and very painful, therefore, on 03-SEP-2017, the patient went to an unspecified urgent care where was diagnosed with cellulitis and was given KEFLEX as treatment. At the reporting time the patient's outcome was not recovered and the causality assessment between PNEUMOVAX 23 and the event was not reported. Upon internal review the event of Cellulitis was determined to be medically significant.
2-3 cm subcutaneous nodule lasting approximately 2 weeks with accompanying patch of swelling and rednes lasting less than 1 week in left arm at injection site.
C/o Thursday AM waking up with raised/swollen, warm, hard site. Pain from top of shoulder down to fingertips. Hand has been and is still tingling at a constant rate. Has used two rounds of Tylenol and warm compresses. Asked client to come into office today to view the site. 9/1/06: called to receive medical advice regarding symptoms mgmt. "Considered local reaction, self limiting, treat pain with whatever helps, i.e. Motrin, and apply warm compresses."
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 21-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. No treatment medications were provided.
Nose bleed, feeling of pulse in lower back, ringing in ears,  headache- all occurred simultaneously.
Pt had vaccine on 6/23 came back 7/9 complaining that arm still hurts a bit.
Pt reports headache, fatigue and rash beginning 3 days after the injection. He notes the rash to his upper chest and back (maculo-papular), described as itchy and not radiating to other areas of the body. The rash has not gotten better or worse and remains today. He also notes "discoloration" (which was not seen on exam by this NP) to the right lower shin.
11/9  Booster administered- No fever, negative Covid test, Chest xray mild pulmonary venous congestion. Seen by Attending physician and stated OK to receive vaccine.  11/11  lethargy, chest congestion,  Telehealth visit, Had MOST form for  DNR and do not hospitalize, Family requested to go to ED 11/11 To ED 11/12 Returned from ED with DNR and Hospice ordered. Seen by NP. Orders for IV fluids and IV antibiotic 11/13 Resident expired
painful blistering rash, which was diagnosed as herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 years-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-DEC-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequently, on an unknown date, the patient was treated by a provider for the following injuries resulting form patient's zoster vaccine live (ZOSTAVAX) use: painful blistering rash, which was diagnosed as herpes zoster. The outcome of the event was unknown. The event herpes zoster was related to suspected vaccine.
One week after receiving first Moderna COVID vaccine, patient noted moderate fatigue and "extreme body aches". Had redness and swelling overlying deltoid in irregular pattern centered on where she had received the vaccine. She slept poorly for two days and was uable to work, but did not have fever. She sought care from teledoctor who rx'd bactrim, which she did not take. Redness is improved today, still has some body aches. No inciting explanation for why symptoms started 1 week after injection
the day she got the shot she had arm pain. The next day she had chills, fever and body aches. As of the 23rd she still has body aches.
Extreme irritability illogical anger and anxiety about these feelings. Injection site soreness and stiffness lasting as long as the irritability: 2 1/2 weeks.
had slight red rash day following injection that was located one inch below injection site.  That mostly resolved within 4 days.  On 1/4/2021, the same area turned bright red, raised and extremely itchy ..now 2 inches x 1 inch.  Grew larger over course of several days and is now oval shape bright red and warm to touch roughly 5 inches h x 3 inches wide taking benadryl, zyrtec, pepcid , and using topical clobetasol to area still ongoing.  have seen my asthma allergy doctor
Persistent itching, redness, and swelling.  Left armpit pain and swelling.  Body aches and fatigue.
Received a flu shot on 12/8/2005 through my employer.  Within 5 minutes after injection, I was itching profusely, but itching ceased within 15 minutes.  Then, 10 days later, all hell broke loose.  I went into anaphylactic shock on two occasions and have been experiencing a long list of frightening symptoms which are consistent with chemical exposure:  Hives; mysterious rashes (on face, hands, knees and feet)experienced indoors and when exposed to cold temperatures outdoors; difficulty breathing; airway constriction; itchy burning skin; drastic shifts beween the chills and sweating; numbness in extremeties; pins and needles pain in extremeties; nausea; diarrhea; tachycardia; neurocardiogenic syncope; chest pain and tightness;  lightheadiness; constant sensation of wanting to "pass out"; constant dehydration; rashes and difficulty breathing with products, chemicals and odors the I was NOT previously sensitive to.  I've been living a nightmare for 5 months and have suffered financially as a result of lost working hours and medical bills.  I've seen numerous doctors including my primary care physician, been to the emergency room twice and have had various blood labs drawn.  I've been diagnosed as having an ongoing allergic reaction, but have received little to no help or direction for treatment from the medical community.  My pcp informed me that she had no idea of how to test for chemical poisoning or toxicity?  I asked for a mercury level test to be done via blood and am still awaiting results.  I also had a skin/tissue analysis done to see what toxins my body was releasing:  I tested positive for mercury, aluminum, copper and arsenic.  In addition, I've done much research on the chemicals used to preserve the flu vaccine and it's horrifying!!!  If I knew then, back in December, what I know know, I would have never received the flu shot.  I'm appalled, to say the least, that the FDA, the CDC and our governments would allow such toxic chemicals to be used in a vaccine that the masses receive.  Currently, my health has improved "a bit", but I await a long road to recovery before my immune system is back on track.  I require various medications to suppress/control the allergic reactions and to prevent cardiac dysfunction (tachycardia and NCS).
Patient came into pharmacy and requested his second vaccine (in the series, he said he had Pfizer before, indicated so on his consent form as well. I checked the dates and administered a Pfizer shot. Only when I updated his vaccination record card I saw that he actually received Moderna before. Patient said he wanted Pfizer and thought first one was Pfizer.