chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient got sick; Initial information regarding an unsolicited valid non-serious case was received from a consumer via social media  and transmitted to Sanofi on 07-Dec-2020.  This case involved patient with unknown demographics who got sick (Illness), while patient received vaccine INFLUENZA VACCINE. Relevant medical history and concomitant medications were unknown.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date (latency unknown), after taking INFLUENZA VACCINE, the patient got sick (illness).  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown.  There would be no information available on batch number for this case.
Sharp pain in knees and elbow, nausea ... took pain pill and pain was gone in am.  Have been feeling bad (like I was hit by a Mack truck all day. (Flu like aches) nausea on and off but cant throw up.  Feeling weak.
sore arm; didnt sleep very well due to the soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received Shingrix. On 17th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and sleeplessness. On an unknown date, the outcome of the pain in arm and sleeplessness were recovering/resolving.   It was unknown if the reporter considered the pain in arm and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at 4 pm, on the day before reporting. After vaccination in last night, the patient experienced sore arm and did nnot sleep well due to the soreness in the left arm. On the day of reporting, the patient felt better. The reporter did not consent to follow up.
6h after vaccines, high pitch screaming, vomiting, arching of back, explosive diarrhea, refused tummy time, stopped drinking formula, after 15h, excessive sleeping and hard to wake.   when to several dr visits within the next few days for excessive crying and fussiness, and refusing to eat with diarrhea,
Patient received vaccine 11/17/09. Swelling around injection site (about 3 in diameter) developed w/pain, fever, and headache per patient. She still felt this way next morning, so she called to report and see if she could take TYLENOL. She did not actually take temp, so that is unknown. She was instructed to take the TYLENOL and contact her physician. She was also instructed of side effects associated with vaccines.
Numbness and soreness in left arm (vaccine was administered in this arm).  Situation has continued for one week. Patient is taking narcotics (Lortab) and Advil to help with the pain.
Nausea, chills, body aches, fever (to 104f), sudden onset. Fever reduced in a few hours to 101. Fever broke 2/2 at 2AM.
My hair has thinned out (loss of volume) and I have excessive hair loss. This was not an issue priori to receiving the vaccines.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 16Sep2021 (Lot number: EW0164) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Food allergy" (unspecified if ongoing), notes: Known allergies: sunflower seeds. Concomitant medication included: VENTOLIN. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: Known allergies: amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL0164, Anatomical Location: Right arm), administration date: 26Aug2021, for COVID-19 immunisation.  The following information was reported: ALOPECIA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "My hair has thinned out (loss of volume) and I have excessive hair loss. This was not an issue prior to receiving the vaccines". Therapeutic measures were not taken as a result of alopecia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Had a positive result after getting the Covid-19 vaccine; Had a positive result after getting the Covid-19 vaccine; Her father has rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. He also had a rash on his arm that cleared up after getting the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's father) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history included patient had rheumatoid arthritis including pain all over, rash on his arm. Concomitant medications were not reported. The patient had a positive result after getting the vaccine. Patient had rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. He also had a rash on his arm that cleared up after getting the vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Next morning (~ 16-20 hours) woke up with red area - large very painful. Saw Dr and put on antibiotics & steroid shot.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
pain and swelling under arm that received injection, chills, joint ache, metallic taste in mouth
A physician reported that occurrence of a subject testing positive for "Hep B" after being vaccinated with Hep B vaccine recombinant (Engerix-B). The medical history noted that the subject was a dialysis PT. Concurrent medical conditions and concurrent medications were not specified. On an unknown date, the subject received an injection of Hep B vaccine recombinant (Engerix-B). The physician reported that the "subject tested positive for Hep B after receiving the vaccination." The outcome of this event was not specified.
pt recvd vax & devel redness & swelling; soreness in RA;
This spontaneous report was received from a physician regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 10-SEP-2015, the patient was vaccinated with improperly stored ROTATEQ lot # K006456, expiration date 08-MAR-2016 and lot # L000568, expiration date 10-JUL-2016. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
influenza A; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp ( non-health care professional ) .  This case involves an unknown age and unknown gender patient who reported  influenza A after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE ( with unknown strength, form, route, frequency, batch number and expiry date) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event  influenza A (influenza) (unknown latency)   No lab data included.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza A).  Outcome : Unknown.
This spontaneous report as received from a consumer (also receptionist at the physician's office) via company representative refers to her/her daughter unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. Previous drug reactions/ allergies were not reported. On an unknown date, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly (strength, dosing details, anatomical location, lot# and expiration date were unknown). Other suspect therapy included vaccination with hepatitis A vaccine (manufacturer unknown) (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date, the patient was diagnosed with multiple sclerosis. The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review, multiple sclerosis was considered to be medically significant. Additional information has been requested.
Swelling, which is hard like an egg, at the injection site; Redness at the injection site; Very lethargic; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry date unknown), via an unspecified route of administration at the age of 78 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing urinary tract infection, hyperparathyroidism from 21Jan2021 and ongoing, ongoing osteopenia, ongoing meningioma, seizure from an unknown date and unknown if ongoing. The patient received the first dose on 02Jan2021. On 23Jan2021, the patient experienced swelling, which was hard like an egg, at the injection site and redness at the injection site. The patient was also very lethargic on an unspecified date. No treatment was received for the events. The outcome of the event lethargic was unknown while other events were not recovered.   Information on the Lot/Batch number has been requested.
Itchy rash, widespread >9 papules/macules. Dx: varicella. Tx: Acyclovir.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient called to inform, but unable to speak with patient.
Pt reports "Saturday Temp about 102 with arm pain & splotchy red area to (L) upper arm/deltoid area." Denied having evaluation on any further treatment/OTC. States lasted about 2 days then resolved. No symptoms at present time in clinic for unrelated concern.
like someone sucked all the energy out of her; have general feeling of not feeling well; muscle pain; I am so tired I can hardly go; She is 5 feet 5 inches now, she is shrinking; aching; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FN5318 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at the of 83-year-old), as single dose for COVID-19 immunization. Medical history included atrial fibrillation from Apr2016 to an unknown date. Concomitant medications included apixaban (ELIQUIS) 5 mg , twice daily, taken for atrial fibrillation from Apr2016 and ongoing and blood thinner. The patient reported that she had her first dose of vaccine on Saturday 30Jan2021 and on 01Feb2021, the patient got up during the night and noticed she was so tired she can hardly go, she also experienced muscle pain, felt unwell like someone sucked all the energy out of her. so tired can hardly go, I have muscle pain, have general feeling of not feeling well, On an un-known date, she also experienced aching. It was also reported that the patient was 5 feet 5 inches and was shrinking. The reporter wanted to know if this could be related to the vaccine and how long does it last. The patient reported she was hurt so bad she was treated her symptoms with Advil. Declines to provide HCP information. NDC and expiration date unknown, not listed on card. The reporter stated that the Lot number starts with either E or F and clarified it as F. She also had difficult time with the last number to the lot number, stated that it could possibly be K, but reported it as 8. The outcome of the events so tired she can hardly go, muscle pain, felt unwell like someone sucked all the energy out of her was reported as recovering, while events aching and shrinking were unknown.   Follow-up attempts are completed. No further information is expected.
high fever of one hundred nine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever of one hundred nine) 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 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (high fever of one hundred nine). At the time of the report, PYREXIA (high fever of one hundred nine) outcome was unknown. Not Provided           The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not Applicable.  No concomitant medications were reported  Treatment medication for this event was not reported
Pt recvd 3 doses of Engerix-B & did not convert; pt recvd booster dose of Engerix-B on 28FEB92; titer was not checked;
redness and swelling at injection site. severe fatigue, head aches and body aches, 9 days after injection
Ankylosing spondylitis flare up; Reaction with Vaccine causing sore arm; Jaw ache; leg weakness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362679-00 (Company).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant) with onset 2021, outcome "not recovered", described as "Ankylosing spondylitis flare up"; PAIN IN JAW (non-serious) with onset 2021, outcome "not recovered", described as "Jaw ache"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Reaction with Vaccine causing sore arm"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "leg weakness". The action taken for adalimumab was dosage not changed. Clinical information :On unknown dates, the patient experienced ankylosing spondylitis flare up, jaw ache and leg weakness. In Jan2021, the patient experienced reaction with vaccine causing sore arm. In Sep2021, the patient experienced reaction with vaccine causing sore arm. In 2021, the reaction with vaccine causing sore arm resolved. Pfizer BioNtech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the event(s) of reaction with vaccine causing sore arm with BNT162b2 was probable. The reporter's causality for the event(s) of ankylosing spondylitis flare up, jaw ache and leg weakness with Humira(adalimumab) was a not reported.  The reporter's causality for the event(s) of reaction with vaccine causing sore arm with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ankylosing spondylitis flare up, jaw ache and leg weakness with Humira(adalimumab) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Ankylosing Spondylitis, Vaccination site pain, Pain in JAW AND Muscular Weakness  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient (11/3/1946) received her second dose of moderna vaccine on 9/9/2021 and started experiencing rash around the injection site, fever, and trouble breathing the next day 9/10. She stated that she does have COPD and uses oxygen for respiratory issues but needed to up her oxygen that day. As of today 9/11, she is no longer experiencing any issues with her breathing nor fever, and the rash has subsided with hydrocortisone. Patient is aware to head to the emergency room if she has difficulty breathing.
Client stated that she started to develop a fever later in the evening and then woke up in the night with joint pain that involves each joint in each finger up to her wrists in both hands.  She did not take any medicine that night for her joint pain or fever.  The fever resolved over night but the joint pain has persisted.  She consulted her PCP early February about the joint pain who stated that the pain could be a side effect from either vaccine and that it should resolve on it's own.  The PCP did not conduct an examination that the client could remember.  The client has since tried to apply lidocaine 4% with gloves covering her hands at night, Tylenol, and oxycodone with no relief.  The client has another appointment with her PCP tomorrow and will ask for an examination at that time.
Slight redness and swelling on left deltoid measure 60mm x 40mm, mother said patient c/o itching and pain last night 11/6/07. No c/o pain today at time of TB skin test reading 11/07/07.
3 inch by 4.5 inch area of erythema and swelling over (L) bicep. Area of erythema is tender to palpation.
headache, nausea/vomiting, low grade fevers, malaise, myalgias
Injection site red, swollen and painful. Fever, chills, headache and extreme muscle pain
Pt had in arm after administration of PREVNAR 1/6/17. By 1/10/17 pain spread to elbow. Pt called and talked to pharmacy 1/10/17.
48 hrs after vaccine, pt presented with bruising at site which was surrounded by about a 3" diameter area of erythema, which was hot to touch. Also with low grade fever -> CLARITIN and KEFLEX prescribed.
Fast heart beat; Blood pressure readings of 150/103, 140/100 and 180/113; Felt her heart moving around; Pain in her arm; A little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113), FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113), FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued). On 13-Feb-2021, HEART RATE INCREASED (Fast heart beat) and BLOOD PRESSURE INCREASED (Blood pressure readings of 150/103, 140/100 and 180/113) had resolved. On 16-Feb-2021, FEELING ABNORMAL (Felt her heart moving around), VACCINATION SITE PAIN (Pain in her arm) and FATIGUE (A little fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Hypertension: 180/113 (High) 45 minutes until her blood pressure went down to 135/80..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
unknown side effects; This spontaneous report was received from a physician and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were unknown.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml intramuscularly (strength not reported; lot #, expiration date, unknown by reporter), for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus.   After the administration, on an unknown date, the patient experienced unknown side effects (adverse event). Medical attention was sought. It was unknown whether treatment was given for the adverse event. At the time of this report, the outcome of the adverse event was unknown.  The causal relationship between the adverse event and the suspect vaccine was unknown.