chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took the shot at 11:45. By 3ish my shoulders and neck began to become stiff with slight pain which progressed throughout the evening until I developed a severe headache. By 6pm I had difficulty turning my head due to neck stiffness with a resting HR:98 SpO2:99%. I then developed a cough, SOB, dizziness, and balance deficit. Around 9pm my lips went numb with tingling when touched. I then developed small blisters around my lips. I was awake till around 4am with a severe headache. By 9am all these symptoms subsided except for the tachycardia and lips tingling with paresthesia which resolved by the next morning. 48hrs later I was back to normal.
Solicited report from a consumer of a 40 year old male with events of non-serious thumb arthritis and COVID-19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced thumb arthritis. In 2022, the patient experienced COVID-19. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of thumb arthritis was not provided. The reporter's causality for the event(s) of Covid-19 with Humira (Adalimumab) was a reasonable possibility. Suspect Drug(s) Information: Suspect Drug(s): Humira (Solution for injection in pre-filled pen) (Adalimumab) Route of administration: Subcutaneous Indications for use: Psoriatic Arthritis Therapy Dates: Unknown - Discontinued Causality: Finger arthritis (Arthritis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Covid-19 (Covid-19) Action(s) taken with drug: Drug discontinued Outcome after reintroduction of dose: Not applicable Causality as per reporter (Drug/Vaccine): Probable Dechallenge: Yes Rechallenge: No challenge Seq. No: 2 Suspect Drug(s): Pfizer BIONTECH Covid-19 vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown Daily dose:  1) 1st dose 2) 2nd dose 3) 3rd dose Route of administration: 1) Intra-Muscular 2) Intra-Muscular 3) Intra-Muscular  Indications for use: Covid-19 Vaccination Therapy dates (from/to):  1) 24Jun2021 - 24Jun2021 2) 14Jul2021 - 14Jul2021 3) 14Jan2022 - 14Jan2022 Causality: Finger arthritis (arthritis) Action(s) taken with drug: not applicable Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A. Covid-19 (Covid-19) Action(s) taken with drug: Not applicable Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A Did event abate after stopping drug: NA. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported. Other relevant history: Not reported. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. Based on the limited information provided, causal relationship cannot be clearly established and cannot be excluded for BNT162B2 in onset of the reported arthritis. Start date of Arthritis was not provided. Case will be reassessed upon receipt of additional information.
Pt received 1st dose on 03FEB2021 and 2nd dose on 14FEB2021; A spontaneous report was received from a caregiver regarding a 94-year-old female patient who received Moderna's mRNA-1273 vaccine first dose on 03 February 2021 and second dose on 14 February 2021/Inappropriate schedule of vaccine administered.  The patient's medical history was not provided. Concomitant medications were not provided.   On 03 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection.  On 14 February 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. This dose was administered earlier than guidelines recommend.   Treatment information was not provided.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, receiving first dose on 03 February 2021, and the second dose on 14 February 2021, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
1st dose of Hep B recvd 15OCT90; In OCT90 pt exp disorientation & memory loss which lasted about a wk; NOV90 devel arthralgia; Later recovered;
Sore arm but the worst was the horrible headache the next day since waking up. It felt like a really bad hangover. Also felt a lot of fatigue and kept feeling faint. I couldn't even stand for very long. Felt better after eating breakfast. This is for the second dose. The first dose was similar but not as bad (no faint feeling, but still big headache)
Client received Varicella vaccination in Left Arm, subcutaneous on 7/16/07 around 1100. - Mid day on 7/17/07, client's mother says he came home from camp with headache, sore throat and extreme nausea and went to bed.  - Early AM on 7/18/07, mother checked child's left upper arm because of complaints of being "really painful" with movement.  Mother noted "baseball sized" red area on posterior left upper arm that was "hot to touch".  Child reports not feeling ill on 7/18 but his Left arm just "hurt alot".  Around 8:45 a.m. on 7/18, Mother & child returned to health department for assessment of injection site.  Immunizations nurses X 2 evaulated site and noted a reddened, inflammed area approximately 6 1/2 cm X 7 1/2 cm, round in shape and warm to touch.  Mother & child both verbalized child was not longer "feeling bad" except for his arm.  Child was alert, animated, smiling and visiting with staff.  Mother was told just to monitor site and to notify health department if symptoms changed, child began feeling ill again or injection site worsened.  Mother agreed and left without concern.
I received the dose 9 days ago.  Arm was sore, but no fever no fatigue.  Perhaps headaches.  Today, arm is itchy, still aches, is warm (not hot), swollen, red and hard.
Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for herself).   A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration single dose arm left (at the age of 30) on 02Feb2021 for covid-19 immunisation. No other vaccine was received in four weeks.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness on 02Feb2021, minor fatigue on 02Feb2021. No treatment received. The events outcome was recovered.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Additional Details: Within 5 minutes of receiving COVID vaccine, patient just collapsed to the floor. For about 30 seconds patient was unresponsive to name. Upon awakening, patient was very confused and reported severe headache and dizziness. 911 was called and patient was escorted
10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on floor and raised his legs, then stated he needed to use the restroom. Pt got up and attempted to ambulate towards restroom, but began to fall forward. Pt placed in chair, increased diaphoresis and gasping respirations with "seizure like" activity and moaning.   10:12am - On site EMS assessed and attended pt. HR 45, O2 100%RA, unable to assess BP as pt removed cuff. 10:15am - 911 called, pt informed staff of his history of syncopal episodes and bradycardia 10:25am - EMS arrived 10:32am - Pt transported via Ambulance.
Pain in his chest / Pain on the chest; Pain on the chest that goes to the back; This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced chest pain and back pain. On an unknown date, the outcome of the chest pain and back pain were unknown.   It was unknown if the reporter considered the chest pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain on the chest that went to the back. The reporter consented to follow up.  The vaccine administration facility was the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021033076:Same reporter
Receives DTaP booster about 24 hours after large localized reaction approx 7cm in diameter was demarcated edges, erythematous non tender to touch.
Herpes Zoster in a previously vaccinated person. Symptom onset began 6/27/2017, consisted of a painful unilateral 1 dermatome rash lasting less than 4 weeks.
experienced a neurological event after receiving the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (advocate). A 4-decade-old (reported as in his 30's) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, caller was called on behalf of a family whose family member experienced a neurological event after receiving the Pfizer COVID vaccine and currently in the hospital and doctors have not been to determine what the diagnosis was, and they don't have a treatment plan for him. Caller stated that, the doctors were just sending the patient for physical therapy without having a diagnosis for the patient. Caller wanted to know if Pfizer could provide treatment recommendations for the patient. The response included Pfizer cannot provide treatment recommendations for patients. The outcome of the event was unknown.  Information on batch/lot number has been requested.
Cessation of the menstrual cycle; stopped menstruating.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16May2021 (Lot number: EW0179) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dont know, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0175), administration date: 25Apr2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Cessation of the menstrual cycle"; AMENORRHOEA (non-serious) with onset 27Jul2021, outcome "not recovered", described as "stopped menstruating.". Therapeutic measures were not taken as a result of menstrual disorder, amenorrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Cessation of the menstrual cycle. Teen child with regular menstrual periods has stopped menstruating. Not other possible cause was found. No previous history of irregularities before getting the vaccine. Reporting in case there could be a connection. Doctor visit will occur before October ends if periods do not return. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Janssen COVID-19 Vaccine EUA  Chills and body soreness from 1am 03/28/2021 and on
Swollen arm with redness and black and blue at the center; Injection site hot to touch; Swollen arm with redness and black and blue at the center; Swollen arm with redness and black and blue at the center; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLORATION (Swollen arm with redness and black and blue at the center), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Swollen arm with redness and black and blue at the center) and VACCINATION SITE SWELLING (Swollen arm with redness and black and blue at the center) 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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLORATION (Swollen arm with redness and black and blue at the center), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Swollen arm with redness and black and blue at the center) and VACCINATION SITE SWELLING (Swollen arm with redness and black and blue at the center). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLORATION (Swollen arm with redness and black and blue at the center), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Swollen arm with redness and black and blue at the center) and VACCINATION SITE SWELLING (Swollen arm with redness and black and blue at the center) outcome was unknown.            No concomitant medication information was provided.  Patient suggested to take oral steroid.
On the afternoon of 10/19, the left side of my face began to feel like it wasn't functioning properly despite appearing to look normal.  By evening I was dropping food out of my mouth.  I went to the ER late that evening and was diagnosed with Bell's palsy.  The next morning I awoke to find the right side of my face was paralyzed and the left had pretty much returned to normal.  I haven't fully recovered 14 weeks later.
Patient received Pfizer COVID vaccine on 2/25/21 (lot #EL9266), 3/19/21 (lot # ER2613), and 10/21/21 (unknown lot #, received at a health Care Center, lot # not in state database).  Patient tested positive for COVID on 1/31/22. On 2/2/22, patient admitted to our inpatient facility with septic shock, urosepsis, acute on chronic respiratory failure secondary to COVID-19, COPD exacerbation, and acute on chronic diastolic heart failure, and COVID19 pneumonia. As of today (2/4/22), patient is still admitted in the med/surg unit.
I was diagnosed with vasculitis (blood vessel disease). It was treated with Prednisone.
Vaccinated for MMR approximately 3 weeks post vaccine developed redness and swelling at injection sight . No fever, auxiliary nodes etc. advised to follow up if persist.
February 4: Immediately following injection (approx 4:35), I began to feel itching all over my body. I felt slightly light-headed. About 3 minutes later my throat began to itch. As I traveled home, I became more itchy and my voice became hoarse.  I took 50 mg Benadryl when I returned home and the reaction subsided. February 5: I developed a red, swollen, painful lump at the site of injection.  February 6: The injection site became redder and more swollen, and was extremely itchy, and had a burning sensation. The injection site was warm to the touch.  February 8: Swelling and pain at injection site reduced significantly. February 10: Developed swollen and tender lymph nodes and sensitive skin in and around the armpit of the right arm. This subsided after two days. February 12: Around 2:00 pm, the injection site on my right arm began itching. A large red welt appeared. The welt was slightly raised, red, and warm to the touch.  February 14: Still experiencing itching and redness at the injection site.
mouth gets really dry; tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine.; tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine.; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2020 (Lot number: EL1284) as dose 1, single, administration date 20Jan2021 (Lot number: EL1284) as dose 2, single and administration date 05Oct2021 (Lot number: 301358A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome "unknown", described as "Booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine."; DRY MOUTH (non-serious), outcome "not recovered", described as "mouth gets really dry". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive. Therapeutic measures were taken as a result of dry mouth.Caller said that she was on the phone and holding but then it was disconnected. She had explained that she had took the Pfizer vaccine twice and had the booster and she ended up with COVID. Product clarified to be the Pfizer COVID vaccine. Her symptoms started a week from today on last Tuesday, 28Dec2021. The only symptoms that she had was cough, headache and nausea from COVID. At first her symptoms were worse, and she stayed in bed and drank a lot of fluids. She had tried to keep moving around and she took some Emergen-C stuff and that helped her out a whole lot. Inquired for outcome of her COVID symptoms and she stated that the only thing she had now was the cough and her mouth got really dry every now and then and she was nauseated still. She tested positive on 28Dec2021 with an at home COVID test. She also had another test when she got back to work that said she was still positive.  No follow-up attempts are possible. No further information is expected.
Initial and follow up information has been received as part of a Pregnancy registry for GARDASIL.  A nurse practitioner and a certified medical assistant reported that a 25 year old female patient with no allergies and two previous pregnancies with full term deliveries and a bilateral tubal ligation (2006), on 11-OCT-2007 was vaccinated with GARDASIL.  There was no concomitant medication.  Subsequently the patient had a positive home pregnancy test.  On 18-OCT-2007 the patient was seen in the office and underwent an ultrasound of the pelvis to confirm pregnancy.  The patient's LMP was 01-SEP-2007 (EDD 29-MAY-2007).  Follow-up information was received from a nurse who reported that the patient was scheduled at 39 weeks EGA for a repeat Cesarean section and delivered a healthy and normal male, weighing 7 lbs 3 oz.  According to the nurse, the patient recovered postoperatively without problems.  Additional information is not expected.
The lymph nodes in my arm pit are still sore; And slightly swollen/ lymph nodes in my arm pit; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPH NODE PAIN (The lymph nodes in my arm pit are still sore) and LYMPHADENOPATHY (And slightly swollen/ lymph nodes in my arm pit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (The lymph nodes in my arm pit are still sore) and LYMPHADENOPATHY (And slightly swollen/ lymph nodes in my arm pit). At the time of the report, LYMPH NODE PAIN (The lymph nodes in my arm pit are still sore) and LYMPHADENOPATHY (And slightly swollen/ lymph nodes in my arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.
Vial was stored in the refrigerator post expiry; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the vial was stored in the refrigerator on 04-APR-2022. The vial did not undergo any temperature excursion.  No treatment information was reported.   This case was linked to MOD-2022-551714 (Patient Link).
Patient had corona virus 3 days after receiving the first dose of the vaccine; A spontaneous report was received from a pharmacist concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event patient had corona virus 3 days after receiving the first dose of the vaccine./Covid-19.  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.  On an unknown date, the patient experienced the event(s) Patient had corona virus 3 days after receiving the first dose of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient had corona virus 3 days after receiving the first dose of the vaccine was unknown.
Pt. saw allergist re: hives and was instructed at that time she had serum sickness that seemed to be caused from sec dose of GARDASIL inj.