chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing Ears; Swollen glands; Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration  in the left arm on 25Mar2021 at 18:30 (at the age of 58-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were reported as none. On 16Apr2021, the patient experienced ringing ears, swollen glands and severe headache. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing ears, swollen glands and severe headache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-MAY-2017 the patient was vaccinated with ROTATEQ lot # L048854, oral for prophylaxis. Concomitant therapies included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (rash on the side of her body, one line of rash on the side of the body where she received the injection) and RASH PRURITIC (it´s very itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 026L20A and 026L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 06-Jan-2022. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced VACCINATION SITE RASH (rash on the side of her body, one line of rash on the side of the body where she received the injection) and RASH PRURITIC (it´s very itchy). At the time of the report, VACCINATION SITE RASH (rash on the side of her body, one line of rash on the side of the body where she received the injection) outcome was unknown and RASH PRURITIC (it´s very itchy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vitamins reported as concomitant. It was reported that the patient did not take any other vaccines within 1 month prior to receiving the Moderna COVID-19 vaccine. Patient had no medical history related to the adverse event and both acute and chronic illnesses at the time of vaccination. Patient height: 5' 6". Patient received three doses of vaccine on non dominant arm. No treatment information was provided. This case was linked to MOD-2022-500858 (Patient Link).
Within a few hours after her two-month vaccinations, the baby developed a rash, restricted to the lower torso, mainly her legs, which cleared after five days.  No reaction at the immunization site, no swelling.  The parents did not report this.  With her second vaccination, this repeated itself but more prominently, showing petechial and confluent, intense erythema, same distribution, and timing, but no symptoms of systemic illness.
headache; diarrhea; rash under her breast, between the breast; the color of her nipples changed, they were kind of pinkish, definitely different color; rash around navel; Felt like warm under the skin where rash was; pain stomach increase, the double over in pain; malaise stomach, the pain increase; chills; very painful; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise stomach, the pain increase), PAIN (very painful), CHILLS (chills), HEADACHE (headache) and ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), AMLODIPINE, METOPROLOL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-1902, the patient experienced PAIN (very painful). On 16-Feb-2021, the patient experienced MALAISE (malaise stomach, the pain increase) and CHILLS (chills). On 18-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain). On an unknown date, the patient experienced HEADACHE (headache), DIARRHOEA (diarrhea), RASH (rash under her breast, between the breast), SKIN DISCOLOURATION (the color of her nipples changed, they were kind of pinkish, definitely different color), RASH (rash around navel) and SKIN WARM (Felt like warm under the skin where rash was). At the time of the report, MALAISE (malaise stomach, the pain increase), PAIN (very painful), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain), DIARRHOEA (diarrhea), RASH (rash under her breast, between the breast), SKIN DISCOLOURATION (the color of her nipples changed, they were kind of pinkish, definitely different color), RASH (rash around navel) and SKIN WARM (Felt like warm under the skin where rash was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortaid cream, cortisone cream
Patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-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 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.  Date of refrigeration was 07 May 2021.
Large palpule developed instantly. Red and raised 0.5 cm. Approx 6cm in length and 3cm in width. Feels sore.
I am currently 30 weeks pregnant (EDD 12/12/17) and received Tdap in my OBGYN's office 1.5 days ago. Of note, my previous Tdap was July 2014. Reaction started with small nodule/induration and then progressed in size to now 1.5 by 1.5 inches. Area is red, raised, warm, and indurated. I have a slight fever. Injection was lower than normal, so is possible that it was administered subcutaneously rather than intramuscularly as intended.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-JUL-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose:  the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his (Conflicting information. Patient is reported as a female) body. The patient did not have a shingles outbreak until 16-MAR-2015 and a reoccurrence of Shingles on 05-OCT-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information) condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the events to be related to  ZOSTAVAX. The events of Shingles outbreak and Recurrence of shingles were considered to be disabling. Additional information has been requested.
Pt received DTaP (L) thigh on 11/5/11 - about 18h later developed redness around injection site and pruritus. No fever. Area of redness on 11/7/11 was about 6cm x 7cm.
Sore injection site left arm. for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm. for 2 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site left arm. for 2 days). On 05-May-2021, VACCINATION SITE PAIN (Sore injection site left arm. for 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-354402 (Patient Link).
Monday 20 SEP 2021 at 1500(L) GMT, against my will, I had my first dose of the fPizer vaccine. 28x hours later (21 SEP 2021) I began to vomit and feel very unwell. I was about to go in for a 12.5 hour night shift for work, when at 2000(L)GMT, my body collapsed, and I started to go into a state of paralysis.  My fists clinched shut, my jaw seized shut, my speech was slurring, face dropping, and my body was all seized up and I was shaking uncontrollably. My wife raced me to the hospital, where I had to be lifted out of the car and onto a stretcher. The doctors performed tests for hours, they thought I may have had, or had been close to having had a stroke. I am a healthy 38 year old by the way;  They hooked me up to an IV and continually kept adding different drugs to it and after hours, my muscles started to relax and body slowly started to stop shaking. I was released the next morning (22 SEP 2021), as the hospital E.R. waiting room area was full, and after doing chest X-rays to check for blood clotting, they said that there was nothing further that they could do. The doctor said "oh, I doubt it was the vaccine that did this, no, we checked and you are low on potassium, so just eat a banana or, two every day"...This was NOT from my lack of eating bananas, and I am now certain that the hospitals just don't want any bad reporting or, slandering of the vaccines. In fact, earlier in the week I had made a huge banana bread pudding for my mother in law to try, so I am not buying the doctor's lack of potassium excuse. My body was nearly going into shock, as they even had the EKG sticky pads on my chest. The nurse at my bed side said that he had not seen a reaction this bad to the vaccine.  Today is  Friday (24 SEP 2021), I still feel very unwell (nauseous, headache and unable to focus, with very low energy) but, knew that I had to gain the strength to write this email for your situational awareness and for the records.
pt recvd vax & reports that 3 days later @ 1230PM had 2 szs; parent called MD & was told to go to hosp; due to late hr they did not go & gave APAP instead;
felt mentally "foggy"; very dizzy/light headed; disoriented; unable to operate his car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 3 (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: Moderna covid-19 vaccine (Dose 2; Moderna,), for Covid-19 immunization; Jnj covid vaccine (dose 1;JnJ,), for Covid-19 immunization. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset May2022, outcome "recovered" (May2022), described as "felt mentally "foggy""; DISORIENTATION (non-serious) with onset May2022, outcome "recovered" (May2022), described as "disoriented"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset May2022, outcome "unknown", described as "unable to operate his car"; DIZZINESS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "very dizzy/light headed". Therapeutic measures were not taken as a result of mental impairment, dizziness, disorientation.  Clinical course: Reporter stated that patient had second COVID booster (this one from Pfizer) last week. He recounted that, shortly after receiving the vaccine he very dizzy and light headed and was unable to operate his car. He recalled that he continued to feel this way for the rest of the day and that he felt mentally "foggy". In the next day he felt normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Ringing in the right ear Fever 100.1 Tired Groggy Dry mouth  Thirsty
He received his first dose on 22Dec2020, then on 29Dec2020, he tested positive COVID.; He received his first dose on 22Dec2020, then on 29Dec2020, he tested positive COVID.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable healthcare professional (patient) reported for himself that a 30-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 22Dec2020, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The healthcare professional is physician assistant. He received his first dose on 22Dec2020, then on 29Dec2020, his COVID 19 test revealed positive. He is supposed to get a second dose on 14Jan2021. He wondered if he is going to be able to take second dose or not. He doesn't have a prescribing doctor. He got it (vaccine) at work/at the hospital he works at. Outcome of the events was not recovered.; 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 is needed for meaningful medical assessment.
Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval, and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related, but with timeline of events I was advised to report this per medical director of facility, as well as Pharmacy who administered the vaccine.
I feel that the injection was not in the deltoid muscle as intended.  The injection was in the shoulder joint. I have had pain achiness, sharp pains and numbness and tingling.  It has been approx. 6 weeks now and I cont. to have pain and decreased mobility requiring assistance taking off my shirt and coat.
Patient received COVID-19 Pfizer vaccine 09 Sep 2021, 1 of 2 series, and developed symptoms 15 days after this first dose. Presented with pleuritic CP day 15 Trop I 0.050 (ref 0.012) ESR 1 CRP <0.5 Eos 0.2 Treated with torrodol, ibuprofen, colchicine and discharged
On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Attempted to reach patient to report error but patient has not responded to our phone calls.
The injection site was tight, sore hot and inflamed. The symptoms did not go away and spread from that day down my arm into my hand and over into my scapula and up into my neck and into my head. I lost the use of my arm and range of motion. As of today it has spread to my head and my leg. Continuous pain in arm and affected areas.
I had the shingles vaccine a year later I got the shingles in my left ear/ suspected vaccination failure; shingles in my left ear; The whole left side of my face dropped/ smile is crooked; My left eye droops; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), facial droop (serious criteria GSK medically significant) and ptosis. On an unknown date, the outcome of the vaccination failure, herpes zoster otitis externa, facial droop and ptosis were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, facial droop and ptosis to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient had the shingles vaccine and a year later got the shingles in left ear. The patient also had dropped face on the whole left side with left eye droop and crooked smile. The patient thought of having a stroke. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
During drive home (approximately 40 min post vaccine) had tachycardia event, heart rate went to 153bpm.  After approximately 15 minutes, it started going down.  Since then, I have had numerous subsequent episodes and have been diagnosed with paroxysmal tachycardia, dysautonomia/POTS, and tinnitus.
Soreness, lump, redness, heat, and low grade fever to 100F.
The day after the immunization the patient experienced redness and itching of  injection site. 4 days post injection she experienced moderate pain under her right shoulder blade (opposite side from injection) on her backside and a itchy, blistery rash under both breasts. She saw her pcp and they prescribed acyclovir cream to apply and patient thinks she has developed shingles. 14 days post injection she thinks that the cream is maybe providing a little relief and her pain comes and goes under her shoulder.
weak, appetite worsened, less balance, uncoordinated, poor muscle control;sx began;atonic sx dx later;
Pt vax w/DTP/OPV had a very brief grand mal tonic/clonic seizure. Had no T @ the time of seizure. Seemed to be doing fine, was feeding & the seizure occured. No other problems in the 3 wk interval since.
Pt. mother states on 9/15/16 9:30AM pt. right side of face, head, fists seized hard and shook. No fever, short episode. 9/16/16 mother states pt had the same episode and flailing backward, no eye contact; tongue going back and forth in and out of mouth. Went to ER had a CAT scan. Later 9/16/16 at night lips curling over teeth and tongue at top of mouth. Tongue muscle was noted to wave. Multiple events, longer up to 30 mins. Stomach muscle has a wave.
Tasting alcohol and medication at the time of injection. Headache, pressure in head, nose bleed, cotton mouth.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lift nodes on their collar bone, on their left side, got swollen) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037c21a) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced LYMPHADENOPATHY (Lift nodes on their collar bone, on their left side, got swollen). At the time of the report, LYMPHADENOPATHY (Lift nodes on their collar bone, on their left side, got swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information was reported by reporter. This case was linked to MOD-2021-300750.
COVID vaccine given at 10:58 AM.  Patient had syncope (fainted) at 11:00AM.  Patient did not fall but was brought down to lay on floor and became conscious in 30-60 seconds.  911 was called with EMT's responding.  Patient felt fine, no further faintness, dizziness, was able to ambulate on her own.  Desired no further treatment.  Patient left Pharmacy at 11:30 AM with no further adverse events.
Patients menstrual cycle started the day she received the moderna vaccine, the next day,02/13/2021, she stated it was heavier than she had ever had. Patient reported changing birth control 1-2 months previously. On 02/16/2021 Patient's father reported she was standing in the kitchen and her pupils were huge. Patient told parents she couldn't see or hear. Patient became unconscious for approximately 3 seconds. took patient to ER. ER was unable to find a cause. Loss of vision and hearing lasted approximately 3-5 minutes.
Mom called PCP office 6/30/21 about 4:00 and reported Cainan had a headache and mild chest pain. She brought him into the ED that evening. Mom called 7/1/2021 in the morning and informed us that he had been admitted to BAH for heart swelling.  myocarditis
30 minutes after vaccine, metal taste in mouth then tongue slightly swollen and greenish/yellow coloring to tongue.
Patient was administered an adult bivalent dose instead of dose for their age.  Patient guardian was contacted and patient has not had any side effects at this time.
E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified