chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (incorrect product storage) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specific temperature excursion details were unavailable at the time. This case is linked to case number 1610USA009568 and 1610USA011175 via same reporter link. Additional information has been requested.
6-16-received Tdap. 6-20-pain and redness at injection site. 6-24-because of increasing erythema placed on cephalexin. 6-29-resolved.
Patient had a vasovagal episode.  He loss consciousness for a few seconds.  He laid supine with feet elevated for 10 min, then his symptoms improved.  Denies any SOB or rash.  He stayed for 30 min post vaccine.
Swollen leg/pain- taken to urgent care- became unresponsive - CPR initiated- expired
Information has been received from a physician concerning a 4 year old female patient who on 27-Aug-2009 was vaccinated with a 0.5 ml dose of MMR II. Secondary suspect vaccination on 27-Aug-2009 included VARIVAX (MSD) (lot # 664693/0724Y). Concomitant vaccination on 27-Aug-2009 included KINRIX. On the same day the patient experienced shortness of breath, wheezing, tightness of the chest and hives at the injection site where the MMR II was administered. The patient recovered on the same day. Unspecified medical attention was sought. Follow up information has been received from a physician concerning a 4 year old female patient who on 27-Aug-2009 at 9:40 was vaccinated with the second 0.5 ml dose of MMR II subcutaneously into posterior of left arm. Secondary suspect vaccinations on 27-Aug-2009 included VARIVAX (second dose, lot # 664693/0724Y) subcutaneously into posterior of left arm and KINRIX (first dose, lot # AC 20B103DA) intramuscularly into the left deltoid. On the same day at 09:50 the patient began coughing, vomiting and experiencing shortness of breath, wheezing, urticarial wheal noted at site of injection. The patient was given albuterol 4 inhalations and epinephrine 1:1000 (1 mg/ml) 0.2 ml SQ. Symptom abated significantly. After 15 minutes the patient was given 0.15 ml of epinephrine and 4 inhalations of albuterol. Prescriptions were written for prendnisolone, EPIPEN JR and albuterol. Subsequently the patient recovered. Upon internal review, the adverse events treated with epinephrine were determined to be other important events. Additional information is not expected.
I have COVID symptoms that are much worse than when I had the real thing back in November.  My temperature is way above 103 degrees F and cannot be reduced via tylenol or ibuprofen.
Patient got vaccines Tdap and MCV4#1 on right arm at his 11 year well child check on 05/16/2016. Called office 05/18/2016 morning to report that arm had been swollen and red. No fever or other symptoms, just arm pain and redness/soreness. Patient was seen at clinic on 05/18/2016 by Doctor and diagnosed with cellulitis. He was placed on antibiotics Cephalexin for 10 days.
~5-10 min after receiving first dose of Pfizer COVID-19 vaccine, patient started feeling dizzy/lightheaded/nauseous/iron metallic taste in mouth but did not pass out; RRT called at 1440 and transported via wheelchair to ER triage for assessment.  Patient d/c'ed home alert & oriented x 4 in NAD and ambulating with steady gait.
Decreased Milk Production; Decreased Milk Production; Decreased Milk Production; fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Sep2021 (Batch/Lot number: unknown) at the age of 33 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination,  the patient was diagnosed with COVID-19. Concomitant medication(s) included: TYLENOL; IRON; PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]. Past drug history included: Penicillin, reaction(s): "Known allergies Penicillin", notes: Penicillin, Sulfa; Sulfa, reaction(s): "Known allergies Sulfa", notes: Penicillin, Sulfa. The following information was reported: SUPPRESSED LACTATION (non-serious), OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 22Sep2021, outcome "unknown" and all described as "Decreased Milk Production"; FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 22Sep2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of suppressed lactation, off label use, product use issue, fatigue, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Prolonged Hospitalization. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101268645 mother/baby
I received my second vaccine on a Friday at 11:00 a.m. After just a few hours, I presented with extreme arm soreness.  About 10 hours later I began experiencing  aching knees and legs and began to have a headache.  I went to bed and at 3:00 a.m., approximately 15 hours later, I woke up with a migraine like headache to where I felt extremely nauseous and had chills.  An oral thermometer reading was 100 degrees.  This continued over the next several hours until late into the evening Saturday night.  I alternated Acetaminophen and Ibuprofen until symptoms subsided.  By Sunday I felt a lot better.  If I had received this vaccing on a Wednesday I would have most likely needed to call in sick to work for the next day, possibly two days.
Swollen reshot itchy sore hard hot lump on arm accompanied by 100 degree temperature
On July 5th I woke up feeling not good and having diarrhea with stomach cramps with aches and pains. I tested negative this day. Two days later I still had those symptoms but now had sore throat and dry cough. Tested positive July 7th. I had a PCR test on same day and it was positive. That same day I called my doctor to see about PAXLOVID. We decided that I wouldn't take it because of drug interactions with current medications. (Amoxicillin and prednisone for continued sinus infections). I isolated at home. After another couple of days I was feeling better but still had cough and sore throat. This continued until the 6th day after the first symptom. As of July 14 I was symptom free.
No patients reported any additional adverse experiences; receiving the improperly stored vaccine; This spontaneous report as received from a medical assistant via a company representative refers to a 19-year-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.    On 30-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T014309, expiration date: 24-APR-2022; route of administration was not provided) 0.5 ml. No adverse event was reported.  This is one of the six reports from the same reporter.; Sender's Comments:  US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013620: US-009507513-2011USA013200: US-009507513-2011USA013293:
Pott's; chilblain on fingers; small fiber neuropathy on hands; brain fogs; Patient developed anti-phospholipid antibody with no clotting; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE TUBERCULOSIS (medically significant), outcome "unknown", described as "Pott's"; CHILLBLAINS (non-serious), outcome "unknown", described as "chilblain on fingers"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy on hands"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fogs"; ANTIPHOSPHOLIPID ANTIBODIES (non-serious), outcome "unknown", described as "Patient developed anti-phospholipid antibody with no clotting".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
gained weight; Shaking; Fear of COVID; wakes up at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained weight"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; FEAR (non-serious), outcome "unknown", described as "Fear of COVID"; MIDDLE INSOMNIA (non-serious), outcome "unknown", described as "wakes up at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Withheld called in asking for more information about boosters for COVID-19 and would like to know the strength of the vaccines as he was concerned if he had taken enough shots of it to be immune to the virus. He said that he gained weight and wakes up at night shaking due to the fear of COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Constant daily headaches since I got the vaccine worse at night and early morning waking up with terrible headache.   And itchy blotch on my chest 24 hrs after the vaccine shot. Nausea on and off  and pressure in my sinuses pain also down side of my face and nose ,pain while I was sleeping.  My headaches have been Constant all  since I got this vaccine , pain and pressure in my face.
tingly sensation and numbness along her jaw and ear; Nausea; Headache; Sore arm; Whole right side of face went numb including her nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), HYPOAESTHESIA (Whole right side of face went numb including her nose) and PARAESTHESIA (tingly sensation and numbness along her jaw and ear) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm) and HYPOAESTHESIA (Whole right side of face went numb including her nose). On an unknown date, the patient experienced PARAESTHESIA (tingly sensation and numbness along her jaw and ear). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm) and HYPOAESTHESIA (Whole right side of face went numb including her nose) had not resolved and PARAESTHESIA (tingly sensation and numbness along her jaw and ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within 15 minutes, she experienced nausea, headache, and a sore arm. About 45 minutes after receiving the vaccine, she noticed her whole right side of the face went numb including her nose. She described it as what it feels like after a "dental surgery numbing injection." Within 15 minutes of discovery, the numbness started to subside. Currently, the numbness has gotten better, but she still has a tingly sensation and numbness along her jaw and ear.  Concomitant product use was not provided by the reporter.  Treatment information not provided.
Fever. Rash appeared the next day as well. Fever lasted 3 days. Rash is still present.
Maculopapular rash all over body 7-6-05. V/ST: 100.3 7-7-06: rash worsening.
the pt mom and her said she usually gets dizzy or even faints when getting a vaccine. she was very nervous before getting the vaccine and basically went thru these reactions as a result of this. Myself, mom, and pt, and paramedics all agreed to this point of reference. After getting the vaccine the pt felt dizzy and said she could not see. So I did what i could to keep the pt and mom calm and called a code white and had the paramedics  come out to the store.
Unconsolably crying, sleep terrors, difficulty waking up out of terror/crying spells. Apnea/breath holding requiring more than light stimulation to wake up. Movement monitor alarmed due to hold of breath longer than 20 sec which required me having to pick him up and pat back in order to get him to catch his breath. Fever, sweating and unusually sleeping all day for few days following vaccine.
Terrible chills,  Terrible headache and a fever. started 12 hours after the shot and continued for 48 hours.  was noticibly better after 24 hours but lasted for about 48 hours.
Described by grandmom 2 days ago was irritable noc a/last had temp (but not taken) slept later than usual-woke up feeling hot to touch t103.5 R @ 10AM; t101 R throat pink; MD stat probably rxn to measles;
Irritation behind left ear noticed 12/4/21, incorrectly attributed to mask strap. Detected swollen occipital lymph node on left side of head approximately two weeks later (12/18) along with swelling of the preauricular and posterior auricular lymph nodes surrounding the left ear. Sought medical care 12/20 from primary care physician. Diagnosed with lymphadenitis. Prescribed augmentin. Blood tested for shingles, negative result. Swollen lymph nodes eventually resolved, scarring resulted.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-DEC-2016, the patient was treated by a physician/MD at a healthcare facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Rash around injection site.  Does not itch yet.  About 2" in diameter.
The following symptoms occurred, starting 3 and one half hours after receiving flu shot: General malaise, Shaking chills, Fever to 101.8 degrees F. After taking CLARITIN, 2 ALEVE, and 2 ADVIL, fever subsided to low grade. General malaise continued for 24 hours.
Woke up with aching in both shoulders, inside of both arms, back of legs, buttocks & bottoms of feet. ER doctor diagnosed with Polymyalgia Rheumatica.
Patient experienced symptoms following day (6/6/18) at injection site: swelling, redness, hot to the touch.
After the vaccine I was fatigued, had diarrhea, a 102 fever and headache which lasted exactly 24hrs I took tylenol and zofran and the symptoms resolved .  At the time of the vaccination i was 23 weeks gestation, EDD-04/12/2021.
All the injections were given in gluteal muscle; Initial information received on 06-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Media Information (GMI reference number 00800617).  This case involves a 46-year-old female patient (40 kg) who was by mistakenly administered all the injections were given in gluteal muscle, after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (product administered at inappropriate site).  The patient's past medical history included bite was on her left forearm.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 25-Sep-2021, the patient received a second dose of suspect RABIES (HDC) VACCINE (batch number and expiry date: not reported) via unknown route in gluteal muscle for Post exposure immunization.  On 29-Sep-2021, the patient received a third dose of suspect RABIES (HDC) VACCINE (batch number and expiry date: not reported) via unknown route in gluteal muscle for Post exposure immunization.  It was an actual medication error case due to product administered at inappropriate site (latency: same day).  It was reported "The third injection is due today. She weighs 90 pounds"  At the time of reporting, no adverse event was reported.   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.  There will be no information on the batch number for this case.
Patient reports nausea, sinus drainage with scratchy throat, and some general malaise since having her second Covid vaccine 5 days ago. No fever. Had taken Benadryl for the first 2 days. No fever. States her arm was also sore with some swollen glands in the same side axillary area. Has Phenergan and Tylenol at home that she has not taken at this point.  BP (!) 158/86  | Pulse (!) 110  | Temp 97.1 °F (36.2 °C) (Temporal)  | Resp 18
This case was reported by a physician via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that one of his patients had a SHINGRIX vaccine at a pharmacy. It was not at the physician's office. The patient experienced 102 degrees (fever) and shaking chills for several hours when she had the vaccine. It was just temporary. The patient was fine.
Information has been received from a healthcare worker concerning a 10 year old male patient with no pertinent medical history, drug reactions or allergies who on 20-MAY-2010 at 9:00 A.M. was vaccinated SQ with a dose of VARIVAX (Merck) (dose and lot number not reported). There was not concomitant medication reported. At 3:00 P.M. on the same day, while the patient was on a field trip, he developed swelling around the eyes and redness. He reported back to the office where he received EPIPEN and then he was sent to the emergency room. Subsequently, on the same day (unspecified hour), the patient recovered from swelling around the eyes and redness. It was later discovered that the patient received an expired product (13-MAR-2010). No laboratories tests were performed. Swelling around the eyes and redness around the eyes were considered to be an other important medical events. Additional information has been requested.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with PROQUAD (Merck) (batch#/lot# L010143, expiration date, route and dose were unknown) which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, fever, nausea/vommiting, fatigue, headache muscle pain. Symptoms lasting roughly 14 hours. Treated with Nyquil and Ibuprofen
Swollen lymph node in left arm pit pain 3/10; Swollen lymph node in left arm pit pain 3/10; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El9264), via an unspecified route of administration on left arm on 05Feb2021 15:00 (at age of 37 years old) at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received his first dose of BNT162B2 (lot number=El3302) on left arm on 15Jan2021 01:00 PM for COVID-19 immunization. The patient experienced swollen lymph node in left arm pit pain 3/10 on 06Feb2021. The outcome of events was not recovered.
generalized  Weakness and SOB right after receiving the COVID VACCINE TODAY.  She admits to eating and drinking earlier today.  She states that her mouth is very dry despite drinking water.  She denies any dizziness, chest pain or palpitations.  No rash.
Child developed hives after vaccine administration. Epinephrine and Benadryl administered, transported to ER, given prednisone in ER. No further symptoms.
Swelling, redness & discomfort (R) deltoid were pneumococcal polysaccharide vaccine was administered & influenza.
pt recvd pneumococcal vax 19NOV91 & that evening pt exp marked edema, erythema, pain & swelling in rt arm; t100 also exp severe pain & substantial edema to wrist; pt hospitalized for pain control;