chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started while she was very sore; Now has a headache; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number and expiry date were not reported) via an unspecified route of administration on 21Jul2021 as a single dose for covid-19 immunization. The patient's medical history, investigation assessment and concomitant medications were not reported. The report was related to a study or programme. The patient experienced headache, felt tired and she was very sore on an unknown date in Jul2021. She wondered how long the events will last. She asked if the same thing will happen with the second one, she was kind of hesitant to get it. She stated that maybe she will wait and see her doctor. The outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
headache; soreness; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   The reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but captured as an adult as per vaccine indication. The patient was vaccinated with Shingrix and experienced headache and soreness. The patient was asked if to take Tylenol or Advil for headache and soreness.
Severe viral rash on chest, arms and legs. Very itchy.  I have photos.
On way out of visit, was walking in waiting room with dad and grabbed the wall and started to crumple. Dad caught her and led her to the chairs and sat her down, she looked "white as a sheet". She was in and out of consciousness but responding to her name for 30-45 seconds per dad.
I woke up the next morning and I was just on fire. My entire body was red and I was burning up with a fever up to 103.0, chills and body aches all over. My husband put cool rags on me and we called the hospital. We did not go since the ER told us that was common symptoms over the phone. My fever did go down the next day but I felt lightheaded and felt like I had the flu. This lasted almost 2 weeks. Within a couple of days of the vaccine, I could not lift my left arm that was vaccinated. I also had pain all the way up to the left side of my neck at the same time as the arm. After 3 weeks, my feet became swollen and my vision became blurred. I then started going to the doctor and he prescribed fluid medicine then sent me to a cardiologist for a check up. I also started having trouble catching my breath at 3 weeks after vaccination so then I was sent to a lung specialist. No other medications. This lasted 4-5 months. I don't feel sick anymore but I still don't feel myself yet.
R thigh, Pentacel administered 10/30/13. Significant swelling (22 cm) warmth and erythremia at site. Very fussy all day. Seen back in office at 4:15 PM due to symptoms.
Developed soreness and pain at the injection site about 30 minutes after injection. After a couple hours, the pain became unbearable, and she had an ED physician look at her arm. She had limited use of her arm on Monday 1/11 and Tuesday 1/12. Wednesday 1/13 her arm started to feel better and she could lift it. She went to her PCP and he said the injection site looked higher than it should have been. Today 1/14 she still has sharp pain with movement and limited range of motion.
Patient had a seizure immediately after administration of vaccine 911 was called however the patient recovered after a few moments.
Erythema/ Edema/ Paresthesia/ Dysesthesia of entire right arm. At exam erythema 31cm x 5-8cm
Pt. given VARIVAX 11-15-08. Per pt., on 11-17-08, 8A pt. developed pruritic rash with red, blotchy spots over shoulder-neck area. Pt. was seen by Dr. 11-18-08. Slight blotchy erythema on cheeks other wise most hives have resolved (PRN BENADRYL/hydrocortisone cream)
A report was received from a consumer on 10/15/2003 concerning a 50 year old male vaccinee who experienced neurological symptoms with shaking at the back of the head and alteration of mental status approximately 5 hours after vaccination on an unspecified date. On an unspecified date the vaccinee experienced neurological symptoms with shaking at the back of the head and alteration of mental status described as a dream-like or fog-like state.  The vaccinee recovered on an unspecified date without sequalae or treatment.  The vaccinee developed similar neurological symptoms (though not as marked) in the past after receiving antibiotics and unspecified pain medications. Follow up pending.
Pt recvd vax & exp severe swelling @ inject site followed by nausea & vomiting;
for relative who is hospitalized and will be released on 08Apr due to an infected wound (POST 1st Pfizer shot); The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 07Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient's relative) via a Pfizer-sponsored program and the other contactable consumer (the patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was looking for information for relative who was hospitalized and would be released on 08Apr2021 due to an infected wound (Post 1st Pfizer shot) and should be getting 2nd Pfizer shot tomorrow, Currently on antibiotics wondering if he can receive the 2nd shot while on antibiotics. The outcome of the event was unknown.  Information on lot/batch number had been requested.
got very sick; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced got very sick after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  Information on the batch number was requested.  On an unknown date the patient developed a non-serious got very sick (illness) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got very sick).  At time of reporting, the outcome was Unknown for the event got very sick.
No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Burning during vaccination.  Almost immediate swelling and hot.   Used ice pack only. Still red circle and sore 12/20/2014.
That evening I woke up with fever 100.4, chills and body aches; the unusual thing was that my lungs hurt like burning and felt like a weight on my chest. Three weeks later I noticed it was not going away and seen my doctor and had a Covid test and got a negative but chest X-ray said I was diagnosed with acute pneumonia and I'm on medication. All week I've been in bed weak.
Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions). At the time of the report, IMMUNISATION REACTION (Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions) outcome was unknown.            Patient's height was reported as 5"2"  Concomitant medications were not provided.  Treatment medications were not provided.   This case was linked to MOD-2022-666268, MOD-2022-666297, MOD-2022-666289 (Patient Link).
Patient received her vaccine as normal at about 1:30pm while at work. She started feeling symptoms of stomachaches, lightheadedness, and chest pains. Her workplace called the EMS for further evaluation. They did an ECG which was normal and her vitals were normal as well. She said she has had chest pains off and on at baseline for the past several months but were more pronounced now (4-6 on a 10 point pain scale per patient). The stomach pains and lightheadedness were new to her. EMS did not take her and they advised she go home and rest and monitor herself for any worsening symptoms.
Extreme pain in knee, unable to bend knee, fear of clot but health professional confirmed it was an adverse reaction and not a blood clot. Pain persisted for more than 2 weeks where I was unable to bend my knee and I am a very fit, thin, healthy individual who exercises daily with cardio and strength exercises.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, itchy upper limbs, pain in arm, erythema of extremities and rash. On an unknown date, the outcome of the allergic reaction, itchy upper limbs, pain in arm and erythema of extremities were not recovered/not resolved and the outcome of the rash was unknown. The reporter considered the allergic reaction, itchy upper limbs, pain in arm and erythema of extremities to be related to SHINGRIX. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient did not received any concomitant vaccine. The patient received SHINGRIX vaccine on her right deltoid. The pharmacist reported that the patient came in on the reporting date and had a circular red rash a couple inches below the injection site that was red, itching and tender that appeared the same day as the injection in the right bicep per the pharmacist. The appearance had not changed since last week as per the pharmacist.
On 8/3/00 AM, mother stated child's right arm, area below deltoid muscle is red and slightly swollen. He was given Tylenol and Benadryl. Child was afebrile, good appetite. At 14:00, mother called HD, stating redness and swelling was worse. Brought child in to MD. Deltoid at below shoulder with reddened area 50mm X 80mm. Referred to private physician.
Post vax, the pt developed a 5 cm induration around site of Typhoid vax. Symptoms resolved in 24 hours on Zyrtec and Tagamet.
Manuel factor report number 2021094198 Manufacturing report number 2021093966 Stomach hurt nauseated throwing up dehydrated low platelet count admitted to the hospital.
Hyperactive; Could not sit still; Was really hungry; Start sweating; Arms hurting; Body aches / severe body aches; Headache; Low grade temperature; Chills / bad chills; So weak / really weak; Low appetite; Really cold with terrible chills then really hot and sweating; Been really sick for 2 and half days; Really hot/felt like sun burned; Felt like sun burned; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite) and FEELING COLD (Really cold with terrible chills then really hot and sweating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HCTZ) and AMLODIPINE for an unknown indication.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills). On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still) and HUNGER (Was really hungry). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram, every 6 hrs. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HUNGER (Was really hungry), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-348139 (Patient Link).
received third dose in 4 months, instead of six; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by patient himself. The patient received third dose of Twinrix in 4 months, instead of 6 months, earlier than recommended interval, which led to shortening of vaccination schedule. No demographics provided. The reporter did not consent to follow-up.
pt took first dose of oral typhoid at 1230p today and 2 hrs later pt started to experience bone pain, difficulty taking deep breath, pain rt flank, diarrhea, swelling in both cheeks.
The injection site has been sore since the vaccine was administered.  Today it is red, swollen, and hot to the touch.  I used a digital thermometer, and my temp is under 98 (normal for me to be low), but the injection site is 101.2.
Patient has been complaining of arm pain that extends beyond the injection site. She has also complained of a rash appearing on the upper shoulder of arm that received the injection, 3 days after she received the immunization. She was advised to watch to make sure that pain and rash do not spread and trouble breathing does not occur. Patient was told to contact doctor and inform if reaction worsens.
Patient vaccinated x3 (Pfizer: 2/5/21, 2/26/21, 10/26/21)  Patient hospitalized and tested COVID positive on 9/6/22
Hospitalization: 12/4/2022 - 12/8/2022 (4 days) Presentation to the ED: generalized malaise, fever. ADMITTED FOR SEPSIS.  COVID + date: 12/5/2022. Treatment: bronchodilators, systemic steroids, remdesivir.  Discharge to: SNF  Pfizer Lot # EN6199 3/11/2021 Pfizer Lot # EP6955 4/1/2021 Pfizer Lot # 33026BD 11/18/2021
This spontaneous report was received from a physician regarding a patient of unknown age and gender. No medical history, drug reactions or allergies were reported. On an unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On an unknown date, one day post vaccination the patient experienced swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain and tenderness. The patient sought medical attention(office visit). The patient had started treatment with unspecified antibiotics and mild analgesics. No laboratory diagnostic studies were performed. The outcome of swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain and tenderness was reported as recovering. This is one of several reports received from the same reporter regarding patient #1. Additional information has been requested.
Dizziness, swollen lymph nodes, nausea, headache, muscle soreness, swelling at injection site
34 YO FEMAL W/PMHx OF SOCIAL ANXIETY C/O COMPLETE NUMBNESS IN HER FOREARM WHICH ASCENDED UP TO THE LEVEL OF HER ELBOW. SHE STATES THAT IT FEELS AS IF "SHE LEFT A TIGHT  HAIR SCRUNCHY ON HER WRIST AND IT CUT OFF HER CIRCULATION OR A PRESSURE FEELING SIMILAR TO THE USE OF A BP CUFF".  PT MENTIONED THAT THIS HAS NEVER OCCURRED BEFORE AND SHE HAS NEVER HAD A REACTION TO A VACCINE BEFORE. PT ALSO C/O NAUSEA WITHOUT ACTIVE VOMITTING. PT DENIES HEADACHE, BLURRED VISION, DIFFICULTY SWALLOWING, CHEST PAIN, OR SOB.  VS @ 3:54 BP  108/54 HR 88 SpO2 95% ON PHYSICAL EXAMINATION, PT LEFT ARM AND FINGERS ARE MOBILE WITH MODERATE WEAKNESS. THE LEFT FOREARM IS NONERYTHEMATOUS AND NONEDEMATOUS WITHOUT ANY LESIONS. THERE ARE NO RESTRICTIVE BANDS OR JEWELRY PRESENT. PT BREATHING IS NORMAL . PT WAS GIVEN WATER AND INFORMED THAT THE "PRESSURE" SENSATION SHOULD RESOLVE ON ITS OWN AND TO F/U WITH HER PCP IF SYMPTOMS WORSEN. AFTER CLOSE OBSERVATION, HER SYSMPTOMS BEGAIN TO RESOLVE AND SHE WAS COMFORTABLE WITH LEAVING THE VACCINATION SITE. PT VERBALIZED UNDERSTANDING OF THE INSTRUCTIONS GIVEN.
Caller looking for information on second dose administration following a positive SARS-Cov-2; Caller looking for information on second dose administration following a positive SARS-Cov-2; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller looking for information on second dose administration following a positive SARS-COv-2 on an unspecified date. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
late for the second dose / has not yet been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 38-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 2nd March 2020, batch number 2573g, expiry date 28th May 2022).   On an unknown date, the patient received the 2nd dose of Engerix B and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Engerix B at primary reporter's facility. The pharmacist reported that the patient was late for the second dose of Engerix-b and had not yet been given till the time of reporting, which led to incomplete course of vaccination.  No adverse event was reported. The reporter consented to follow up.
I was exposed to COVID-19 via infected family member approximately June 7th and was mildly symptomatic by the 9th. I tested positive for COVID-19 on June 15th with worsening symptoms, however, mild respiratory issues. I began having issues with double vision on June 17th and contacted the emergency nurse hotline on June 18th as I had lost the ability to walk/stand, experienced waves of paralysis, numbness in hands and feet, rapid heart rate, and vision and hearing impairment. I was directed to the ER by the on-call Dr to test for possible encephalitis and have an EKG. I was discharged after a few hours. These symptoms align with Guillain-Barre Syndrome, however, I did not receive a spinal tap to confirm.
FLUZONE HD: chills, flu-like symptoms on late Friday 10-16-15 -> no treatment needed. PREVNAR 13: redness (size palm of hand), no pain, swollen start on Sat. 10-17-15 last 3-4 d.
Arm became achy after vaccine, a large red spot formed at the injection site; Subsided after 3 days; Started getting daily severe headaches on 12/15/2022; Given an MRI, didn't find a Spinal Fluid Leak; Prescribed TOPAMAX, but it doesn't seem to be helping.