chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative refers to a 10 year old female patient. No medical history was reported. On an unknown date approximately in 2004 at the age of 1 year, the patient was vaccinated with (merck) VARIVAX (lot #, expiry not reported)dose 1, subcutaneously. On an unknown date approximately in 2007 at the age of 4 years, the patient was vaccinated with (merck) VARIVAX (lot #, expiry not reported) dose 2, subcutaneously. No concomitant medications were reported. On 29-APR-2013(two days ago), the patient experienced zoster like rash on the trunk. The rash was red, vesicular, with no exudates, and no report of pain at rash site. No treatment was received. Patient sought medical attention (unspecified). The company representative expressed his concern that it might be an Merck strain zoster virus. Therapy with (merck) VARIVAX was discontinued 4 years ago (approximately April 2009). The outcome of zoster like rash was reported as not recovered. Additional information is not expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number P57AA, expiry date 5th July 2021) for prophylaxis. The patient's past medical history included sinus infection (she had a sinus infection a few weeks previous) and multiple allergies (her allergies were acting up again). On 6th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash. On an unknown date, the outcome of the injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist noted that the patient experienced with redness, tenderness, and raised skin around injection site. The health care professional describes the tenderness as sore. Raised skin was described as appearing to be a hive but not itching. The patient reported that she got SHINGRIX this week about 2 pm. And by 9 pm that evening she was running a fever and not feeling well. She wasn't sure if that was due to the SHINGRIX or that she had had a sinus infection a few weeks previous and her allergies were acting up again. She currently has a 2-inch diameter red knot on her arm and what looks like a rash that was not itchy, but was very sore to the touch.
rxn occurred 3 days p/vax;s/sx 3 red stripes radiating down from inj site rt deltoid to the lt hand fingers & chest area;c/o pain & swelling @ inj site;T103 for 2 days w/ n/v & some trouble breathing;rash all over;
chills; headache; 101 fever; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 28Jan2021 at 13:30 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. The patient has no relevant medical history. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril. On 29Jan2021 at 05:30, the patient experienced chills, headache, and 101 fever. Therapeutic measures were taken as a result of event 101 fever included Ibuprofen. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events chills and headache was unknown while the outcome of the event 101 fever was recovered on 30Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx 15-30 mins p/leaving office mom stated that pt devel constant screaming & crying for 6-7 hrs; no appetite & cried if arms were touched; no swelling;
The pt experienced a rash to the face and neck, purpuric lesions, gave Benadryl 1 hour after vaccine when this appeared. (Most probably 2nd to forceful crying however not sure.)
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: redness 2 in diameter below injection site appeared 3 days after injection-Mild
I had caught covid back in November 2020. After receiving my 1st and 2nd dose I had a fever, chills, and felt like I had covid. Those symptoms lasted for about 36 hours. Then I started spotting. By the time May 2021 came around I had a full period again after being in menopause for about 6 years. I went to a gynecologist. They did multiple tests, but couldn't figure out why I was bleeding. When I got my booster in October 2021 I stopped bleeding, but then I started bleeding again back in February 2022. Now I am in the process of getting a hysterectomy in  July 2022.
Fever, Rash, ErythemaMultiform, UrticariaPruritus, low grade fever, LUA sore,pain, hot, and itchy Narrative:
Information has been received from a pharmacist concerning his child who was vaccinated with MMR (lot number not provided). Subsequently, the child developed autism. The child did seek unspecified medical attention. At the time of this report, the child's autism persisted. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.  Follow up on 12/16/2003: "Additional information has been received from the pharmacist who reported that the child in this case had received MMR vaccination along with other vaccines that contain mercury in them and has since been diagnosed with Autism.  At the time of this report the pt's autism persisted.  The reporter felt that autism was related to therapy with MMR and the mercury in the vaccines.  Upon internal review autism was considered to be an other important medical event (OMIC). No further information is expected."
Pt relocated from another state, no prior h/o any problems. I gave MCV, Tdap, MMR on left arm. I gave HPV on rt arm. I was administering Hep A, when pt felt dizzy and fainted on the exam table. Pt recovered within 10 secs. Vitals at the time were WNL. Pt had not eaten breakfast. I gave pt oral juice and fluids, water. Explained to mother and pt.
74 year old patient who just received the Fluzone Quadrivalent instead of fluzone high dose, no AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 74 years old female patient who received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiration date for both the vaccines were not reported) via unknown route in unknown administration site for prophylactic vaccination on 23-Sep-2020 (PT: wrong product administered).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).it was also reported that several other patients that could have received the Fluzone High-Dose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
On 01/24/2021 @ approximately 6pm my left arm began to hurt quite a bit. I stood up and about 5 seconds later was overcome with chills/shivering and had to lie down under blankets. Temperature excursions for next 2 days were between 99 and 101. Total body aches, loss of appetite and loss of energy for next 60 hours. I felt ok on 01/27/2021 but beginning 01/28/2021 I had a debilitating headache and concurrent loss of energy that persisted for next 72 hours until 01/31/2021 when I finally felt better.
3/9/07 AM left arm became tender and sore. Later that afternoon began to feel achey.Left work early around 3:30pm. Continued to feel very achey all over and felt "flu-like". 3/10/07 Called in sick at work. Seen by Administrator: Left arm very sore, slightly swollen, warm to touch, no redness. No fever. 3/11/07 stayed in bed and rested. Took Ibuprofen. Symptoms subsided by 3/12/07. Returned to work 3/13/07. Mild tenderness in arm only.
pt recvd vax & reported flu like sxs of fever, malaise, congestion beginning 2 days p/vax & lasting for 3 days;
Immediately after administration patient states that her arm felt the pain from the shot. Pharmacist gave her an ice pack to put on arm. Patient then states that she felt like she is going to faint and throw up. Pharmacist asked if patient wants her to call 911. Patient said no. Took patient's blood pressure at 12:10pm was 93/62 and 12:38 pm was 113/73. Patient does not know normal blood pressure value. Patient states she feels good at 12:39 pm and asked to leave.
Began vomiting approx 6-8 hr post injection - vomiting cont with dizziness, lightheadedness & soreness @ site of immunization Sl. swelling, no redness @ R deltoid site rash on R cheek.
I was pressured to get vaccinated under identity listed under patient information after I reported that that?s NOT my identity. The shelter was aware the entire time that I do not hold any status under that ID therefore it?s  attempting murder to insist I get vaccinated under someone else?s identification. On 4/24/21 and 4/29/21 immigration Officer confirmed my urgent notification to the shelter regarding my id that I do not hold ANY STATUS in this country at least I?m NOT respectively registered under id "private" DOB: Unknown and that?s considered at least immigration fraud. The shelter also had NO justification to hold as a client (Hostage) under ID that?s  not  even registered in Internal system. I?m NOT safe living here, being force to take drugs under a fake identification. I haven?t felt well or the same since taken the vaccine and since I?m unable to get assistance from police I reported my medical conditions to another authority on 9/28/22 and I still haven?t her back from any agency is against the law.
Received flu vaccine on 10/16/14. I have had persistent pain in my left arm at injection site. Pain, stiffness with immobility got worse on 11/1/14 and continued to 11/3/14. Pain became unbearable extremely sensitive to touch at injection site.
This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered a unspecified number of improperly stored doses of LIQUID PEDVAXHIB (lot # L038502, expiration date 16-AUG-2018; lot # L042257, expiration date 17-AUG-2018; lot # reported as L051122, expiration date 12-OCT-2018) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32F for 2 hours and 8 minutes. NO previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt began screaming shortly p/vax; pt taken to ER; cont irritability for approx 5 hrs then passed out for a few minutes; woke up was well & w/o sequelae; seen by MD next day who Dx DTP rxn; 2 days later raised red rash w/10 bumps @ LD;
0859 Pt received the first dose of Pfizer Lot # ew0168 at approximate 0830. Pt states having "heavy feeling in chest, dizziness, and it's hard to concentrate my vision on things", but denies throat swelling, tongue swelling, itching, and no hives noted.    Per pt she has had an allergic reaction in the past to the flu vaccine, TDAP, and TB test.    Vital Signs at 0859 BP: 138/91 (108) HR: 80  SPO2: 100% RA RR: 20 Pain:0/10 Temp: 96.3 F   0908 Pt states heaviness in chest lessened after drinking water and states it is no longer difficult to focus her vision.     0910 Spoke with Dr about patients symptoms and he recommended patient be given Cetrizine 10 mg and monitor patient until she returns to baseline. Dr also advised that pt see her PCP and discuss reaction to first dose so that it can be determined if she is safe to receive the second dose of pfizer.    0917 Pt states she no longer has chest heaviness and lip numbness is lessening.    Vital Signs at 0925 BP: 120/67  HR: 77 SPO2: 99% RA Pain: 0/10   0929 Administered Cetrizine 10 mg. Advised patient not to drive or return to work after receiving medication.    0940 Pt states no chest pain or heaviness, no lip numbness. Pt stable and not in distress. Pt passed walking test. Reminded patient not to drive or return to work after receiving medication. Advised patient to see her PCP to determine if it is safe for her to receive the second dose of the Pfizer vaccine.
The Hib vaccine needs to be reconstituted. However, after finding the hib powder vaccine in the box, we realized the saline was only given and the vaccine was never reconstituted.
Day 1-3 pain,swelling, redness and warmth Day 4-7 redness, itching Day 8- 9 increase redness, swelling and area more enlarged and hard.
arm swoll up all around inj site; turned bright red w/a white ring around it;swelling lasted 3 days;site itched but burned when itched;On day 4 site changed from a red color to a rust color;itching cont for more days;had a bad h/a;
Treatment for COVID-19; Treatment for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 at 09:30 as dose 1, single (Lot number: EN6201), in left arm, on 14Apr2021 at 09:30 as dose 2, single (Lot number: EW0162), in left arm and on 29Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL oral, start date: 21May2022, stop date: 23May2022; MUCINEX oral, start date: 21May2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment for COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are needed. No further information is expected.
Patient stated that he experienced leg paralysis 12 hours after vaccine administration. He did not consult a physician.
severe headache-unable to think/concentrate/read due to extreme pain aches and pains from head to feet, unable to hardly walk dizziness unable to sleep fri 10/25 and sat 10/26
I experienced flu like symptoms, fatigue, brain fog, hair loss. I went to the ER and the doctors performed a series of kidney tests, and performed an EKG. I was admitted for overnight observation for 1 day.
Resident was previously positive for Covid-19 on 6/29/20.  She received both doses of the Pfizer vaccine.  She tested positive again on 2/8/21.
Photosensitivity on skin covering zygomatic arch. Itchy, red pimples turned into small blisters. Would get irritated if re-exposed to sunlight. Slow to resolve. Still lingering as sensitive area at time of second shot on Aug 22, 2019.
Tenivac vaccine was given to patient by mistake which was expired approximately past 15 days/No AE; a patient received Tenivac vaccine at left thumb/No AE; Initial information received on 12-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 24 years old male patient who was mistakenly vaccinated with 0.5 mL DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC](pre-filled syringe) which was expired approximately past 15 days batch number U6021AA and expiry date 27-Jul-2020 via unknown route at left thumb on 11-Aug-2020 for prophylactic vaccination (expired product administered).  The patient's medical treatment(s), vaccination(s) and family history were not provided.  The patient's medical history included ongoing skin laceration (cut to his thumb due to superficial laceration from a box cutter) at the time of the event.  No concomitant medication was given.   It was an actual medication error case due to expired vaccine used and vaccine administered at inappropriate site.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Entire arm and shoulder are inflamed, raised, hot to touch, swollen, indented border, and continues to spread throughout remainder of left arm and shoulder.
Headache (After Second Dose); Hives all over the body (After Second Dose); Dizziness (After Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (After Second Dose)), URTICARIA (Hives all over the body (After Second Dose)) and DIZZINESS (Dizziness (After Second Dose)) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 UNK. In 2021, the patient experienced HEADACHE (Headache (After Second Dose)), URTICARIA (Hives all over the body (After Second Dose)) and DIZZINESS (Dizziness (After Second Dose)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and RUPATADINE FUMARATE (RUPALL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache (After Second Dose)), URTICARIA (Hives all over the body (After Second Dose)) and DIZZINESS (Dizziness (After Second Dose)) outcome was unknown.            No concomitant medication were reported.
I feel HORRIBLE!!! Dry heaves, nausea, fatigue, stomach ache and cramps (it feels Like someone is making balloon animals out of my intestines), chills, malaise. I just dry heaved, cried and now I?m pissed I got this 3rd dose!
Patient received Pfizer COVID-19 vaccine 1/2/2021.    Exposed to infected coworker.   Although asymptomatic patient positive by PCR for COVID-19.
same day rash on forearm/  1am woke up with bad headache, chills, stiff neck, aches, pain at injection site, fever 101
Pneumonia booster the caller had swelling in the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient medical history and concomitant medications were not reported. It was reported that Pneumonia booster the caller had swelling in the arm on an unspecified date. Outcome of the event was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.
Complaint of cough, chills, elevated temperature, sore/scratchy throat, headache, runny nose/congestion, myalgia, malaise, diarrhea, nausea and vomiting.
Bone pain. Hospitalized with group B strep four days later (3/25/21) - fever, shakes, chills, nausea
Patient received vaccine on 03/24/2021.  Reported to pharmacy that after 8 days a red welt appeared at injection site that doubled in size overnight and is hot to the touch, swollen and itches.  Pt took Benadryl and applied hydrocortisone to site to treat symptoms
Sore throat, arm pain, slight swelling at injection site, chest pain(left side) persistent 1mnth,  tongue numbness (1mnth- persistent), no sense of smell, or taste (1mnth- persistent), throwing up,  diarrhea (2wks- continuing), fever,  cough(1 month-persistent), body aches, chills, extreme fatigue, shortness of breath, trouble breathing, chest pain, tightness left side(2wks-persistent).
After three days, couldn't sleep the whole night. The next day,  went to work, came home felt jittery. Close to midnight bp 200/90. Took Clonidine 0.1 and went to ER,  bp 180/90.  waited for almost two hours bp came down to 141/80. Today, bp is back to normal. Took sleeping medication Zzzquil to go to sleep.
Chest hurting from shoulder to shoulder, arms going numb, hard time breathing. Start 1 day after second Pfizer shot, lasted for 3 days until taken to ER. Taken to ER, thought he was having a heart attack but heart was fine, just inflammation around the heart. Diagnosis was acute myopericarditis and demand is chemical myocardial.
Pt received PNEUMOVAX to Rt upper arm on 4/29/08.  The next day, woke up with swelling & tender of injection site.  Symptoms progressed & migrated down to his Rt hand & fingers, on 5/1/2008 and admitted to another hospital that day.  Had the following diagnostics - Blood & Urine C&S-no growth.  Diagnosis was post-PNEUMOVAX cellulitis.  Pt received IV ANCEF followed by 7 days of oral antibiotics with resolution of cellulitis.  Symptoms: 1. cellulitis and swelling of arm.  Treatment Drugs Used: 1 - CEFAZOLIN Dose: Units: Freq: Route:
No adverse reaction. Pt was given expired vaccine. Exp date 9/22/2021.
During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling tightness in her chest and feeling harder to breath. Pt reports that this has occurred in the past with other allergic reactions. VS assessed 136/74, HR 105, SPO2 97. Pt transferred to ER for continued monitoring. Patient given dexamethasone, diphenhydramine, famotidine, ipratropium, and ondansetron
Adult Hep. A vaccine was inadvertently given to a 20 month old. Child should have received Pediatric Hep A. This was child's 1st Hep A vaccine. Parent was notified that child was given a double dose of Hep. A. Advised of any outward signs/symptoms to look. No adverse reaction a this time - will F/U with mom before I Leave at 5pm.
On the same I had a little fatigue and sore arm for 1st dose. 2nd dose similar. COVID- 13Aug2021- fever and very mild cough and achy and for 40hrs I had flu like symptoms.