chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 16-year-old female patient received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation and co-administered with Hepatitis A and Flu. The patient medical history was not reported. The patient experienced fainted on an unspecified date. The outcome of event was unknown. Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that fainted is related to TRUMENBA administration cannot be excluded.
stomach distress; pain in her stomach; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of gastric disorder (received 1st dose on 18th January 2019, refer case US2019AMR117304).   On 18th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced gastric disorder, stomach pain and upset stomach. The patient was treated with omeprazole. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the gastric disorder, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the gastric disorder, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The customer initially called on behalf of his wife. The patient received Shingrix and she experienced stomach distress. pain in her stomach, upset stomach.  The symptoms have been worse after the 2nd dose of Shingrix.  She was still experiencing these symptoms because they come and go and they come back when she eats something. She has visited her physician and her physician has prescribed omeprazole but that did not help.  She had been taking omeprazole for a month already. She was having an ultrasound on her abdomen after the date of reporting. The patient said that she only weighs 115 pounds. She said that she was a tiny person and maybe the shingrix was too strong for her.  The reporter consented to follow up. The caller put the patient directly on the phone.  The patient said that we could contact her physician.
I had a breakthrough case of Covid and did a teleconference call where the doctor prescribed PAXLOVID.
PERIPHERAL NEUROPATHY 8/4/2022,  10/26/2022,  12/18/2022,  11/29/2022  -- RECURRENCE OF SAME SYMPTOMS
Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Vertigo; This is a spontaneous report from a contactable pharmacist.  A 50-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscular at arm right on 17Dec2020 13:30 at single dose for COVID-19 immunization at a Workplace clinic. The patient's medical history was reported as none. No known drug allergies. Concomitant medication (received within 2 weeks of vaccination) included ergocalciferol (VIT D). The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that while getting first dose, patient experienced instant "funky lightheadedness, vertigo. Normal tinnitus got louder and oscillating up and down. Next day after first dose (18Dec2020), patient had sinus headache and vertigo, took meclizine and went back to bed. Felt fine when she woke up. The outcome of the events sinus headache and vertigo was recovered on an unspecified date, for the rest of events was unknown. The reporter consider the evens as non-serious.
5JAN91 developed lt periorbital cellulitis-Resolved w/Ceclor; 2nd HIB given 13FEB91 at Pub Hlth 27FEB91 reoccurance of lt periorbital cellulitis; Resolved w/Ceclor;
I have had gas and bloating for 5 weeks right after my 1st injection of Pfizer COVID vaccine on April 8, 2021.  It has been extremely uncomfortable.   I have never experienced this kind of gas/bloating/constipation for this prolonged period time prior to my vaccines.
diagnosed with Bell's Palsy; Extreme pain in my right elbow; loss of strength; Numbing and tingling in my left arm; Numbing and tingling in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 (Lot number: FH8030) at the age of 45 years as dose 1, single and administered in arm right, administration date 01Dec2021 (Lot number: FY8762) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BELL'S PALSY (medically significant) with onset 31Dec2021, outcome "recovered with sequelae", described as "diagnosed with Bell's Palsy"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "recovered with sequelae", described as "Extreme pain in my right elbow"; ASTHENIA (non-serious) with onset 11Nov2021, outcome "recovered with sequelae", described as "loss of strength"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 11Nov2021, outcome "recovered with sequelae" and all described as "Numbing and tingling in my left arm". The events "diagnosed with bell's palsy", "extreme pain in my right elbow", "loss of strength", "numbing and tingling in my left arm" and "numbing and tingling in my left arm" were evaluated at the physician office visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. covid prior vaccination was no. covid tested post vaccination was no. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Arm soreness, chills, headache on Day 1 and 2.  Low grade fever on Day 5.   5-10 cm erythematous area, blanchable on pressure at injection site (left arm) on Day 12 and soreness.
This is a serious literature case, initially received on 29-Apr-2019, concerning an adult female patient of an unspecified age (reported as in her late twenties). The objective of the article was that a variety of environmental risk factors can trigger the onset of rheumatic disorders. Vaccines stand next to antibiotics as a nineteenth-century medical breakthrough impacting the human evolution and survival. Evidently, an age-old process of conferring immunity without active infection, practiced in civilizations, introduced and advocated in modern medicine at the time of renaissance by prominent physicians. Vaccines tend to stimulate both the humoral and cellular immunity depending on the type of antigenic stimulation. As with any other medical-intervention, even vaccines sometimes result in adverse events. Vaccine-related side effects were increasing exponentially with higher availability, awareness, and reporting. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date after vaccination (reported as close proximity to immunization), the patient developed systemic lupus erythematosus initially manifesting with lupus neuritis presenting as classical fortification spectra permeated by the diversity of different colours. It was reported that the disease remained chronic, required continuous standard treatment. The outcome of the events was not reported. It was reported that the vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart and this might direct towards slightly altered pathologic mechanisms directed at vaccine-related phenomena (related). This case (201903242) is third of the 3 cases linked due to same reporter (author). The reporter concluded that although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, they might be able to find the at-risk groups and lower the incidence.; Reporter's Comments: An adult female patient of unknown age developed systemic lupus erythematosus initially manifesting with lupus neuritis presenting as classical fortification spectra permeated by the diversity of different colours, after administration of INN Flu Vaccine (reported as close proximity to immunization). Considering the plausible temporal relationship between vaccination and reported event and lack of any underlying conditions or alternative more plausible causes, the company conservatively assessed the event as possibly related to suspect vaccine. The company assessed the case as serious (medically significant).
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremities)-Medium, Systemic: Allergic: Rash (specify: facial area, extremities)-Medium, Additional Details: rash and itching on arm from injection and leg below knee to tip of toes.
No additional AE information.; the patient was administered a properly stored but expired dose of PROQUAD; This spontaneous report was received from a medical assistant referrins to a patient of unknown age and unknown gender. Information about medical history and concurrent condition was not provided. The patient's concomitant therapy included sterile diluent.   On 20-MAR-2020, the patient was vaccinated with a properly stored but expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026717, expiration date 17-MAR-2020, therapy type recombinant Human albumin (rHA); dose detail and route was not reported) for prophylaxis (expired vaccine used). No additional adverse event (AE) information. The outcome of the event was unknown. The causality of the event was not provided.
Per patient report: pain started minutes after vaccine administration. It became pink the next day and the next day after this it was erythematous and slightly swollen and warm.  This lasted several days and gradually improved. However, she was left with pain with pressure on the deltoid and pain leading up to the anterior shoulder and to the right neck; the pain sometimes goes into her right forearm and hand. No fevers.    Right shoulder still has small swollen area around deltoid; pain with abduction and pressure.   No hand/forearm edema
Big hard bump where shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 15:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Apr2021 at 15:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 15:00, the patient experienced big hard bump where shot was administered, 4 days in and had not gone at all. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event big hard bump where shot was administered was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Could not lift her arm for a few days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not lift her arm for a few days after the vaccine) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Could not lift her arm for a few days after the vaccine). At the time of the report, HYPOKINESIA (Could not lift her arm for a few days after the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient received vaccine on a Thursday and patient recovered from reported event on a Saturday.  Treatment information was not provided.
Headache, Fever, BODY ACHES, COUGH, SORE THROAT, CHILLS Narrative:
pt recv vax 24APR96 & exp fever 100-101, h/a, diarrhea, bloating;exp sweating, lost 5lbs, flu, 5-6 stools a day for a week;urine clear-strong smelling, sl cough, back pain-mid & low;
Swollen face; Swollen around eyes; Swollen around lips; Rash on arm of injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swollen face), EYE SWELLING (Swollen around eyes), LIP SWELLING (Swollen around lips) and VACCINATION SITE RASH (Rash on arm of injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swollen face), EYE SWELLING (Swollen around eyes), LIP SWELLING (Swollen around lips) and VACCINATION SITE RASH (Rash on arm of injection site). At the time of the report, SWELLING FACE (Swollen face), EYE SWELLING (Swollen around eyes), LIP SWELLING (Swollen around lips) and VACCINATION SITE RASH (Rash on arm of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
8 days after receiving my first vaccine, I developed an itchy rash, redness, arm was warm to the touch and tender as if I had just gotten the vaccine. Per articles I read, it seems to be "covid" or "vaccine" arm.  It has now been 3 days since the symptoms have started and haven't cleared up.
Initial information received on 21-Sep-2018 regarding an unsolicited non-valid non-serious case received from a non-health care professional (pharmacy other). This case is linked with 2018SA271680 and 2018SA271669. This case involves a female patient (unknown age) who was exposed to vaccine FLUZONE HIGH DOSE in context of FLUZONE HD inadvertently given to several pregnant patients, increase rate of injection site reaction. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported FLUZONE HD inadvertently given to 3 pregnant patients, increase rate of injection site reaction and FLUZONE HD inadvertently given to several pregnant patients occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. 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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route while she was pregnant. Other relevant tests included no lab test. Final diagnosis was FLUZONE HD inadvertently given to pregnant patient. It was not reported if the patient received a corrective treatment. Additionally, at time of reporting, the outcome of the pregnancy is unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none. Follow-up information regarding an unsolicited valid case received from a health care professional (pharmacy other) on 25-Sep-2018. Event and reporter updated. List of documents held by sender: none.
Patient received Janssen COVID-19 vaccine on 8April and tested positive for COVID-19 via nasal swap 24May.
Pt given shot 01/20/04.  Came to clinic 1/21/04, with left arm red, swollen-referred to MD.  Telephone call from MD, reported localized reaction on left upper arm.  No other complaints.  MD thought reaction to DTAP, reported to pediatrics.
The vaccine was administered on Thursday, February 22nd. Left arm was sore on Friday. On Saturday morning, the 24th, the arm could not be raised higher than the waist and was extremely painful. After several days the movement was easier, but movement was still painful. I wake in the night to extreme pain which will not improve without getting out of bed and moving around. The pain is located in the left shoulder and into the back and neck muscles adjacent to the shoulder.
Shoulder so sore I could not sleep very well. 3- 200 mg Ibuprofen slightly dulled the pain with cold compresses, but only minimally.  I cannot pick up my arm without excruciating pain. Pain is in my upper back on that side as well. No redness or swelling.
Pt recvd vax & exp local react @ both sites; react included papules (goose bumps) 1 inch "square"; no systemic react; pt recovered p/2 days;
Information has been received from 64 years old female medical assistant referring to herself. Concurrent conditions included diabetes and having trouble hearing. In 2017 (reported as last year), the patient had taken a bad fall and was in rehab. She had never received that vaccine previously. On an unknown date in August 2017 while in rehab, the patient started vaccinated with PNEUMOVAX 23 (dose, frequency, route and strength were not reported) for prophylaxis. She was told at that time that she was supposed to receive PREVNAR 13 a year from there and 5 years later another pneumonia vaccine 23. She was reporting that on an unknown date in February 2019 (reported as last week) she went into her family doctor to get flu shot and the pneumonia shot. They gave her another PNEUMOVAX 23 and she should have received a PREVNAR 13.
Swelling and redness around injection site, about 6in in diameter.  Itchiness days 2 and 3.  Evening day after receiving the shot fever, muscle aches all over, sensitivity to light. I took 2 Advil at night and in the morning.  I missed 1/2 day of work.
Information has been received on 7/16/01 from an internet site through a consumer, concerning a 9 month old male who received his 3rd dose of DTP on 8/22/84. He immediately began vomiting. The next day, he stopped eating. He reportedly, stayed alert but was no longer active. That night, he cried out every 15 to 30 minutes. He was seen in the pediatrician's office where the pediatrician immediately noted "obvious circulation collapse". His eyes rolled back in his head an he stopped breathing. He was taken to an ER. Resuscitative efforts failed and he was pronounced dead.
This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a certified medical assistant and a 24 year old female veterinarian with no past medical history who on 28MAR2003 at 13:30 was vaccinated subcutaneously on the right with a second dose of varicella virus vaccine live. There was no concomitant medication. Approximately two weeks post vaccination in April 2003, the patient developed a low grade fever and a raised rash at the infection site that was approximately 3 centimeters in diameter. The patient described the rash as a localized injection site reaction with 2 to 3 lesions that never became wheeping. On 10APR2003 the patient experience3d malaise and the rash was still present. On 15APR2003 the patient was feeling better, but the injection site was itching and the rash had gone down to 0.5 cm in diameter. Hives were also reported. Unspecified medical attention was sought. Treatment included topical and oral over the counter dephenhydramine hydrochloride (benadryl) and ibuprofen (Motrin). As of 23MAY2003, the patient felt fine and had recovered from the malaise and itching. The rash had resolved in a few days. The patient also recovered from the hives. The doctor did not want to give the patient a booster because of this adverse experience and it was noted that the therapy was discontinued. A product quality complaint was not involved. Additional information has been requested.
Unsure as to when other than he got a rash. It was reported 2 1/2 months after it happened.
16 hours after my second dose of the Moderna vaccination, I started having intermittent sense of smell episodes.  The smell is very strong and very unpleasant, almost revolting.  They are combination smells that I can't readily describe.  I have been inside my home while this is happening and not cooking or being exposed to anything new or different.  I have not ever in my life had this experience and believe that somehow it is related to the vaccination I just received yesterday.  My first does was fine with no side effects other than a sore arm.  Again, my arm is sore and a little swollen at injection site but that is fine and expected!  The smell thing is extremely strange.  I'm just going to wait it out but I thought for research sake, Moderna would want to know about this side effect.
The patient did not experience any issues. There was no adverse event. What happened is that the Moderna SPIKEVax vaccine that was administered 1 day past the vaccines BUD  (by use date).  We just wanted to know if the patient needed to be revaccinated or if there was a concern with the patient receiving the MODERNA SPIKEVax vaccine one day after the BUD.
It started on June 3rd. I woke up with a rash on my neck that felt like a sunburn. About a week before that I had pains like pins and needles. I also had a fever of about 101 degrees. I also had extreme fatigue.  I went to the urgent care later that day on the 3rd of June. They did a rapid COVID test, and it came back negative. They diagnosed me with shingles and prescribed gabapentin for nerve pain and an antiviral. I was sick for about a week and had flu like symptoms. I also had the shingles in my mouth. I went back to urgent care, and they said I was all clear. On June 15th the pain came back, and I went back to urgent care and the shingles had come back. They put me on another round of medication. All together it about 5 weeks to finally get over the shingles.