chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 hrs. after injection, developed (L) shoulder and neck pain which migrated to knees by next morning (20 hrs. after injection). Widespread myalgia and arthralgia increased daily which impaired mobility due to pain. No fever, no redness, no edema, no neurological s/s. 5-4-12 Improving, no further complaints.
Patient finished 15 minutes of observation time and was in his car about to leave when patient became very warm and nauseous. Patient walked back into clinic and began to throw up and develop a headache. Patient sat down and blood pressure was taken which was noted to be slightly high (160/72). Patient initially did not want to go to the hospital. However, another 10 minutes went by and patient began to throw up again. Patient agreed to call an ambulance and be checked out by the hospital. 911 was called. Patient did not have a reaction to his first dose of Pfizer COVID vaccine.
Patient explained that she developed SOB on 1/16 and on 1/17 was worsening and no relief from her nebs and had her mother take her to the ER. She was treated and released. The ER doctor and her doctor think it may have been an allergy to a component of the vaccine, such as  PEG in the vaccine and she is going to be retested for allergies. She has not had an asthma attack in 4 years.
On 12/23, baby was given rotavirus vaccine. On 12/25/11, patient presented with decreased appetite and feeding. At 6:30 pm on 12/25 baby has first loose stool. At 2:30am on 12/26 baby had diarrhea, each episode occuring every 1 to 2 hours. Baby had one occasion of vomiting on 12/26, one occasion on 12/27, one occasion on 12/28 and two occasions on 12/29. Diarrhea has continued since 12/25. Patient was brought to physician who administered vaccine for office visits on 12/26 and 12/27 was was told that this was "just a little diarrhea" and not to be concerned. Baby was brought to a different physician on 12/29 who preformed an exam including blood draw to determine diarrhea's origin. It was this physician's conclusion that the diarrhea was brought by the vaccine. I, as the patient's mother, was advised by this physician not to have the second or third doses of the rotavirus vaccine to be given.
Patient experienced chest pain for 2 days. Presented to our ER with ST segment elevation and a troponin of 4.49.  Patient with to cardiac cath lab and was diagnosed with possible pericarditis.
PATIENT PRESENTED TO THE PHARMACY 2 DAYS FOLLOWING MODERNA VACCINATION DUE TO CONCERN THAT THE INJECTION SITE WAS RED, SWOLLEN, AND HEAT WAS PRESENT. STATED THESE SYMPTOMS STARTED THE DAY FOLLOWING THE VACCINATION. THIS WAS HER FIRST MODERNA VACCINE. ADVISED PATIENT TO ICE THE AREA TO REDUCE INFLAMMATION AND HEAT AND TO TAKE ORAL BENADRYL. ADVISED PATIENT TO SEEK MEDICAL ATTENTION IF THE REACTION WORSENS AND DOES NOT RESOLVE ON ITS OWN.
5/24 female who presented to the hospital with Seizure activity in triage. She has a prior history of CVA with residual right-sided hemiparesis.
This spontaneous report as received from a physician via company representative refers to a 68 years old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for shingles vaccination. Concomitant medications were not reported. On an unknown date, a few weeks after getting ZOSTAVAX the patient developed bell's palsy. The outcome of bell's palsy was reported as recovered/resolved on an unspecified date. The relationship between ZOSTAVAX and the events was not reported. This case is linked to case 1308USA008729 via same reporter link. Additional information has been requested.
Approximately 30 hrs post-injection, pt. developed local Rxns including swelling, hot to the touch, hard, 2 inch diameter of redness, itching and pain described similar to a bee sting. She experienced on-and-off headaches. Her symptoms persisted and RPh was contacted after approximately 48 hrs. Pt. was counseled to apply ice, use an analgesic and to follow up w/her PCP (no fever). Pharmacy also notified PCP.
Patient experienced apprehension, flushing and numbness and tingling.  Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications.  O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine  observed by staff and released
On Saturday morning mom noted a hardened area the size of fist; No redness, no fever; refused to walk on rt leg;
Severe rash on neck, four days after vaccine. Major symptom was burning sensation on skin, secondary was itchy skin.  Another doctor in  my PCP's medical group saw me, and prescribed steroid ointment (2.5%).
At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS).  The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were provided by the reporter.     On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had not resolved.            The concomitant medication includes blood thinner as reported by the reporter. No treatment information was reported by the reporter.
approx 3 cm round erythematous rash around right posterior arm at site of the varicella vaccine reported by the patient . patient noticed it 4-5 hours after vaccine was administered. pt states it was itchy rash and over the next 24-34 hours the rash got larger. at todays visit rash was 6cm in diameter. pt had not taken any medications for the rash/allergic response.
administered vaccine left arm at 12:08pm about 5 minutes later, 12:13pm patient reported feeling mild dizziness, denied any other symptoms including breathing difficulties. patient was observed for 20 minutes from time the vaccine was administered. blood pressure was normal at 140/70, pulse was normal at 65 and pulse rate was regular. patient's color remained normal during observation. symptoms never worsened and patient wanted to go home. she then left the clinic accompanied by her son.
Started to get red at site, redness got larger, hard center, raised. Pt discharged on 5/15 with redness around 10 cm in diameter.
swollen arm and injection site is red and feels like a knife under the skin; swollen arm and injection site is red and feels like a knife under the skin; swollen arm and injection site is red and feels like a knife under the skin; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced swollen arm and injection site is red and feels like a knife under the skin after receiving 1st dose of Pfizer covid 19 vaccine yesterday. The outcome for the events was unknown.
03/21/2021  Diverticulitis, Liquid diet and antibiotics for two weeks 06/03/2021 Shingles ,right side of torso around to my back 08/09/2021 Diagnosed with Diabetes type 2. Metformin given 500MG once per day
Anemia, IBD, anxiety attacks, depression, back pain, hair loss, insomnia, racing heart, sore throat, sweats, fatigue, swollen nodes, yeast infection in breasts, headaches.
Gave pt varicella #2 9/26/9 (1st dose was 5/03) within 24 hrs flat rash noted on chest, face & neck.  Wo c/o rash to chest c/o itching on neck, face with approx 8-9 small bumps noted.  P.O. Benadryl & topical hydrocortisone does not relieve symptoms.  No adverse reactions noted to injection on site.
No other AEs or PQC reported; GARDASIL 9 was administered to 7 year old male.; This spontaneous report was received from a nurse and refers to a 7 years old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 05-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly, lot # T030746, expiration date 16-MAR-2023, for prophylaxis (anatomical location was not reported) (product administered to patient of inappropriate age).    No other adverse event reported.
Mother of client reported that 1 day after vaccine the client reported right buttock pain. The following day on 10/28/23 she noted to have a rash on left stomach.  This rash is still present and has progressively spread to chest, back, and groin area.  Denied anything around injection sites but did report soreness post vaccination. Denied fevers, N/VD, s.s. of anaphlaxisis. Did report the rash is occasionally itchy, is red splotched, with bumps but not blister like.
Patient received a influenza vaccine on 11/17/2020. Patient reports that he experienced a dull pain on the arm the day afterwards that has continually worsened. Patient reports that he is having trouble lifting arm for normal day to day activities and the pain is conistent and dull. Patient reports that he saw a chiropractor approximately 2 weeks after vaccine administration. Per patient, chiropractor conducted immaging and found no abnormalities. Patient has not taken anything for pain excpet for using hot compress on the injury area. Patient stated on 12/11/2020 that he has not yet seen his primary care provider regarding this pain.
Information has been received from a pharmacist concerning a 74 year old (previously reported as 68 year old) female patient who on approximately 01-JAN-1010, "three weeks ago", was vaccinated with a first SQ dose of PNEUMOVAX 23. After getting the vaccine, the patient developed cellulitis on a "pretty significant area of her arm". The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Information has been received from a registered pharmacist who indicated that the patient with no illness at the time of vaccination on 31-DEC-2009 at 15:00 was vaccinated with a dose of PNEUMOVAX 23 (lot# 663441/0504Y) in her right upper arm and a first SQ dose of ZOSTAVAX (Merck) (MSD) (lot# 664274/0959Y) in her left upper arm. On 01-JAN-2010 the patient developed cellulitis. The patient sought medical attention by a doctor visit. Additional information has been requested.
I woke up with violent rush at right thigh; This is a spontaneous report from a contactable consumer (patient). An 85-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 17Feb2021 07:30 at single dose for covid-19 immunisation. Medical history includes Emphysema, Penicillin Allery and Covid. Concomitant medications in two weeks were not reported. The patient reported, she woke up with violent rush at right thigh spread to several places in half hour. Red bumpy spots spread to left inner thigh and both arms on 19Feb2021 04:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.  Information about lot/batch number has been requested.
unspecified number of patients have potentially been given a smaller than recommended dose; prescribing information is confusing and contradictory; no additional information; This spontaneous report as received from a nurse, referring to multiple unspecified patients of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date,  the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 ml, strength, route and lot# were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (0.5 ml, strength, route and lot# were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, strength, route and lot# were not provided) for prophylaxis (an unspecified number of patients have potentially been given a smaller than recommended dose) (underdose). The prescribing information was confusing and contradictory (product label confusion). In section 2.2 of the prescribing information it states to withdraw the entire amount of the reconstituted vaccine, inject the total volume and discard the vial. She states that most of the time the reconstituted amount is greater than 0.5 ml. She has always administered 0.5 ml which the prescribing information also states as the appropriate dose (section 2.1). She was concerned because "for 10 years" that she has worked in pediatrics she had given and taught other nurses and MA's to give 0.5 ML dose of the vaccine. She is worried that the children have not been adequately vaccinated based on this information in the prescribing information (Section 2.2). No additional information.  This is a non-valid case due to no patients' identifiers.
numbness in the tongue and lower face; tingling in the tongue and lower face; numbness and tingling in lower face; tingling in lower face; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face). At the time of the report, HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included benadryl.  No concomitant medication was provided.
Covid19 breakthrough.  1st Vaccine received on 05/05/2021.  32 y/o presents to ER with c/o left lower quadrant abdominal pain that radiates to right lower quadrant, severe in intensity.  CT suggests acute appendicitis.  Pre op covid pcr ordered and resulted positive.  Pt started on IV abx.
Patient told personnel at clinic that he didn't have the vaccination previous and was given 15 sticks because he was born in another country. On day 8 of vaccine patient had severe headache, vomiting not relieve with antiemetic medication, Headache not relieved with medication, given IV fluids for 2 days, IV pain medication and IV antiemetic medication, continued to c/o headache and had vomiting, symptoms finally relieved after 7 liters of fliud, and given around the clock antiemetic and pain medication IV. Continued on po medication for headache and increasing diet slowly. Unable to go to duty for 5 days due to vomiting and pain.
This spontaneous report refers to a female patient of unknown age who reported regarding herself. On an unknown date the patient was vaccinated with GARDASIL dose 1 and unknown date, dose 2. Dosage details, lot number and expiry date for both doses were unknown. The patient reported that she did not receive the third shot of GARDASIL. The patient does not want to receive the third shot because she wanted to become pregnant and start a family. The patient did confirm that she was not pregnant at the time of report. No other adverse events were reported at this time. Additional information has been requested.
pt recv vax 14FEB96 &  exp severe, prolonged localized soreness, swelling, redness & itching in an area approx 4x6 inches described as almost nodule/encapsulated looking;sx persisted for wk & gradually dec in severity;
Information has been received from the authors in a literature article concerning an unknown gender 25 year old patient with MMR (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 56 year old female patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
shingles - like rash / symptoms of pain.; symptoms of pain.; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vesicular rash and pain were unknown.   It was unknown if the reporter considered the vesicular rash and pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient experienced shingles-like rash on hand within 2 days of Shingrix vaccination. Valacyclovir decreases symptoms of pain.  The patient asked if it was possible the vaccine caused the shingles-like rash?
sore arm; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.