chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a rash/welts one week after vaccination.  Red rash/welts along right collar bone.  Additional rash developed 4 days after the first one.  Did not improve with hydrocortisone cream.
Bad headache, Bad  spinal pain, chills lasting two days, sore arm for 2 weeks headaches on 6th day aftwer vaccination
Information has been received from a physician via Pfizer referring to a 65 years old patient of unknown gender. Medical history of the patient was not reported. In 2014 ("last year"), the patient was vaccinated with PNEUMOVAX 23 (lot#, route and dose not reported). It was reported the patient had swelling, redness and discomfort upon PNEUMOVAX 23 "last year" (in 2014). the outcome of the events was unknown. The reporter asked if it was recommended the patient should have a PREVNAR 13, or would that be a problem for adverse reaction. Additional information has been requested.
BODY ACHES, RESTLESS SLEEP AND PAIN DAY OF INJECTION. SLEPT ALL DAY AFTER WORK, BUT FELT BETTER NEXT DAY
Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with two doses of GARDASIL (lot number not reported). Subsequently the patient had an abnormal Papanicolaou smear (PAP), positive for human papillomavirus (HPV). The patient visited the physician in the office. The patient was scheduled for a colposcopy. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
My daughter became very dizzy,  pale, and hot (sweating through her clothing) almost passing out after receiving her first dose . Paramedics were called, vitals taken, and she was taken to an observation area. She started to feel a bit better after about 15 minutes.  She was observed by paramedics and a nurse for another 30 mins and we were able to leave and go home. At home she was exhausted the remainder of the night.
Rash on back of neck, legs and redness of ears little on face. Patient took BENADRYL and its reducing rash.
Injection site / l arm soreness - 2-3days Headache - 2 days, treated with Tylenol
Case previously recorded as MA2009-4037. Initial case report received from a nurse via MedCom on 10 NOV 2009. A patient 3-year-old male was vaccinated with S-OIV FLUVIRIN (batch no. 102044P1) i.m on 10 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-007935.
This 46 year old received Typhoid, Tetanus-diphtheria, influenza, immunoglobulin, and meningococcal vaccinations on 03 Jan 1991 along with a PPD skin test (negative) prior to deployment. She reported feeling "ill" upon arrival with fevers up to 102, body aches, cough and other flu-like symptoms lasting approximately 7-10 days.  She was diagnosed with bronchitis and treated by increasing fluids, resting, and using Tylenol/Motrin with resolution of these symptoms.  Her first Anthrax vaccination was administered 20 Jan 1991 with no adverse events remembered.  Her second AVA vaccination was administered on 11 Feb 1991, again with no remembered adverse events.   While demobilized she remembers having another "cold" with "allergy-like" symptoms treated with Flonase and Seldane. Review of medical records on 08 May 1991 document notations of a productive cough, fever of 102 and diagnosis of Bronchitis in Jan 1991 with sinus problems during demobilization diagnosed as post nasal drip treated with Amoxicillin, Seldane and Beconase nasal spray (March-May,1991). She reported experiencing exposure to multiple "sand storms near an area being blown-up." She also experienced a contaminated needle stick with negative HIV/Hepatitis screening while deployed.   She began to experience intermittent repetitive left then right foot joint pain 2-6/10 following her return home with worsening of symptoms between 1992-1995. She initially attributed the discomfort-achiness in her feet to her pregnancy in 1993-94; however by 1995 this discomfort caused her to seek medical care-orthopedic evaluation.  She reported her left foot hurt worse than the right, had morning stiffness that resolved some during the day but worsened after sitting in the evening. She was given cortisone injections with some relief reported.  She stated she had a "Positive Bone Scan" but cannot clarify further.   She moved to another state where she saw a podiatrist who recommended NSAIDs and shoe supports.  In 1999, increasing foot pain sent her again to a podiatrist and orthopedist where x-rays diagnosed "degenerative joint disease."  She stated her fingers began to "bend" in 2002-2003. She described her right third fingertip digit (DIP) was bowed. She again complained of morning stiffness and variable pain with swelling now in her hands and feet. X-rays and an MRI showed "degenerative joint disease."  She was referred to a rheumatologist in Dec 2005-Jan 2006 who diagnosed her with Rheumatoid Arthritis. She requested evaluation by the Vaccine Healthcare center for rheumatoid arthritis after AVA vaccinations. She also reported receiving a letter from the government 05 December 2000 stating if she was active and deployed between 1997-10 March 1991 she may have been exposed to a "low level chemical agent".  She is initiating follow up.
p/vax pt had some erythema & swelling as had a/w/ vax but 2 days p/vax parent changed pt diaper in AM & noticed it was red, swollen & hard, hot to touch & sensitive;
Patient registered online for his 2nd dose of Covid 19 vaccine. He registered through database for 2nd dose on 04/01/2021 in which he picked a 2nd dose Moderna clinic. He received his 1st dose of Pfizer on 03/11/2021. He received  Moderna on 04/01/2021. Patient was made aware. Also, Medical Physician was notified. Physician gave guidance in which was discussed with patient. Patient was having no signs or symptoms of adverse events.
sore arm at injection site; lightheadedness; This is a spontaneous report received . A contactable other healthcare professional (patient) reported a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 09Mar2021 (at the age of 72 years old) (Batch/Lot number: en6206) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history included hay fever and food allergy to egg. Concomitant medications were not reported. The patient previously received carbamazepine (TEGRETOL), fluvoxamine maleate (RELAFIN) and clonixin lysinate (SKELAXIN) for unspecified indications and experienced allergies. On 09Mar2021 19:30, the patient experienced sore arm at injection site with a few episodes of lightheadedness. The patient received no treatment for the events. The patient was able to recover from the events on 12Mar2021 (reported as lasted for 3 days).  No follow-up attempts are possible. No further information is expected.
fatigue; headache; body aches; chills; violently sick; like covid again; smells exhaust fumes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), PAROSMIA (smells exhaust fumes), FATIGUE (fatigue) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included GABAPENTIN and CLOZAPINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAROSMIA (smells exhaust fumes). On 03-Feb-2021, the patient experienced ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, PAROSMIA (smells exhaust fumes) outcome was unknown and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
decreased stamina; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (decreased stamina) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), ATORVASTATIN CALCIUM (LIPITOR), CALCIUM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (decreased stamina). At the time of the report, FATIGUE (decreased stamina) outcome was unknown.            No treatment details were provided.   This case was linked to MOD-2021-074941 (Patient Link).
Coughing, wheezing, difficulty breathing, congestion, stuffiness, fatigue, brain fog
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9604) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 3 (booster), single), second regimen (Batch/Lot number: unknown) at single (dose 2, single) and third regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "cardiac sarcoidosis" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "allergic to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had tested  negative two times in a row with 48 hours  between; Negative, notes: Had tested  negative two times in a row with 48 hours  between; positive, notes: Then 2 days after the last  negative test I got cold-like symptoms and  tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2023 to 27Sep2023.  No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Medium, Systemic: Weakness-Medium, Additional Details: Pt fainted within three seconds of receiving J&J vaccine. Slouched down in chair where bowls and urine was released. Guided pt to floor but in that process, pt fell forward hitting his forehead on the bottom of rolling chair. Pt was unresponsive for a total of 10 seconds. Once he came to, feet where elevated on chair and pt layed supine on floor for about 8 minutes. Pt obtained a quarter sized bump on his forehead from fall.  once pt left.
This case was reported by a physician via call center representative and described the occurrence of generalized urticarial in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced generalized urticarial. On an unknown date, the outcome of the generalized urticarial was unknown. It was unknown if the reporter considered the generalized urticarial to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that a patient broke out in generalized hives. The reporter declined to provide any further information because he did not administer the vaccine.
Pt called to report that about 1 hour after receiving the vaccine her shoulder became sore, described as a dull constant ache.  Pt also reported that moving her arm, such as reaching for something in front or above her, causes sharp pain.  Pt reports that there is NO redness or inflammation at the injection site.   Pt reported taking ibuprofen for the pain.
Information has been received from an 85 year old female with a penicillin allergy, allergies to dyes and fillers in unspecified medications, and a reaction to "generic premarin" (manufacturer unknown) which the patient reports "almost killed her". In June 2007, the patient was vaccinated with Zostavax. Concomitant therapy included LANOXIN. Four to five days post vaccination, the patient developed diarrhea. The patient had a stool test (results not reported). The patient reported "getting very tired and feeling washed out". The patient reported that the diarrhea persisted for three months and that she lost ten pounds in less than one month. The patient reported "after three months I am beginning to feel like my old self". At the time of reporting the patient was not yet recovered. Additional information is not expected.
Myalgia, Arthralgia, Fever, Diarrhea, left arm swollen, spine feels hot to touch, back pain Narrative: Staff member was advised to go to PCP or Urgent Care if symptoms persist
Patient received the Moderna COVID-19 Vaccine EUA at 18:58. She developed minimal swelling around her upper lip post-vaccine at 19:08 . No other symptoms. After 25 min observation, symptoms were still present. Patient was given diphenhydramine 25mg PO by clinic RN.  Symptoms resolved and patient left clinic.
nausia, body aches, headache, no energy, slept alot, tenderness at sight rested, took tylenol, 3 days to fully recover.
Pericarditis; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), administered on the left arm on 03Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 05Mar2021, the patient had pericarditis; assessed as serious (medically significant). The event had resulted into an emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient had received bisoprolol as treatment for pericarditis. The patient had a negative nasal swab COVID-19 test on 10Mar2021. The outcome of the events was recovering. The patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 post-vaccination. The event occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Noticed itching and what looked like bug bites on left side of trunk with sensitivity to touch about 5-6 days after vaccine.  It then progressed into more of a rash that spread in a line and wrapped around to my lower back. Within two days blisters appeared. 8 days post vaccine I called doctor due to blistering rash, itching and pain. Doctor confirmed shingles. I don?t know yet if this was caught in time to prevent long term nerve damage. This is happening to others after the covid vaccine.
I woke up at 2am that evening with severe chills, muscles aches and pains.  No fever.  It lasted for 7 to 8 hours and then it went away. No medications taken.
The symptoms started a couple of days later. Back stiffness, pain, limited range and movement. Stiffness in the joints. Left hip, left foot or big toe joint was swollen. Right knee cap has extremely swollen. Different symptoms over the course of 3 weeks. Including night sweats.
This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 64-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. On 5th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm were unknown. The reporter considered the erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced 2 spots that appeared below the injection site that were red, discolored, swollen and warm to touch. The patient had arm soreness. The patient was seen by her physician today and was prescribed antibiotics. Emergency room visit was required. The patient's physician recommended the patient not to receive the 2nd dose of SHINGRIX due to the reaction, as he believed it was related to the vaccine.
pt behavior underwent extreme change;screaming non-stop x/when eating or sleeping;screaming x 6 days & abruptly stopped; difficulty holding up head;has trach & on ventilator; G-tube;hypotonia; GBS  Follow up received 10/5/00 states the the pt is ventilation dependent, has a g-tube, severe hypotonia, trac, non-verbal, non ambulatory, cannot sit up, roll over, hold up his head, lift limbs against gravity, wrist and ankle contractions due to poor tone and jaw tightness.
Parent reported noticing seizure activity on 02/10/04 at 12:30am-12:32am.  Rescue squad called.  Arrived at local ER at 01:00am.  Infant evaluated and released at 2:45am. Recommended treatment: alternating doses of Tylenol and Children's Motrin to lower fever.
had trouble staying asleep at night; This is a spontaneous report from a contactable Other Health Professional (Patient). A 43-year-old female non-pregnant patient (Age at vaccination: 43) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. No Allergies to medications, food, or other products. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose COVID-19 Prior to vaccination. Patient was not tested for COVID-19 Since the vaccination. The patient experienced had trouble staying asleep at night on 18Dec2020. No other Seriousness criteria was reported. The outcome of event was not recovered.  Information on the lot/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated her arm was warm and had a bump at the injection site.her arm was then numb for monday and tuesday and was feeling better on wednesday.She said today it felt better but it was not 100%
they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event; they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 2 years old male patient and reporter reported temperature excursion for Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]/ they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine Inact (Vaqta) for Prophylactic vaccination.  On 17-Oct-2023, the patient received 0.5 ml total (1 X) dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: U8202CA; Expiry date: 30-Jun-2024) (Frequency: once) (Strength: standard) via intramuscular route in the left thigh (Left Vastus Laterallis) for Influenza immunization/prophylactic vaccination (Immunisation).  On an unknown date, the reporter reported temperature excursion for Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]/ they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event (product storage error) (unknown latency).  On 17-Oct-2023, the reporter reported temperature excursion for Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]/ they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, Practice Administrator calling regarding FLUZONE QIV NP. Caller stated that they received a shipment of the vaccine a day late and one of the vaccines was administered to a patient.. reporting that a shipment of FLUZONE QUADRIVALENT PFS arrived today,17Oct2023, a day late as it was shipped on 14Oct2023. The caller states that 1 dose was administered to a patient. This situation is reported as a medication error due to the administration of a potential compromised product.  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 the 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.  Additional information was received on 17-Oct-2023: Indication verbatim was updated. Collection organization was updated. However, no new significant information was received. Text amended accordingly.
Rash at injection site; A spontaneous report  was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at injection site(Injection site rash).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Patient experienced rash on her arm after receiving the COVID- 19 vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash at injection site was unknown..
Pulmoary Embolism - Chest Pain, Shortness of Breath Hospitalization of 3 days Treatment of blood thinners
About 3 days after I received the vaccine, I experienced a large area of redness surrounding the injection site which was slightly painful and warm to touch.