chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient was administered an expired dose of PROQUAD; No additional adverse event; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 04-FEB-2020, the patient was administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD), one dosage form as prophylaxis (expired product administered) (lot number R020678 has been verified to be a valid lot number, expiration date reported and validated as 15-JAN-2020) (concentration, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (indication, concentration, dose, frequency, lot number and expiry date were not reported).   No additional adverse events were reported.
Extremely cold within 2-3 hours of dose; Sore arm; Woke up hot in the middle of the night; Woke up hot in the middle of the night; This is a spontaneous report received from a contactable Consumer.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 12:00 (Lot number: EP7534) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01, lot number: EN6198, administration time: 12:00 PM, vaccine location:Left arm), administration date: 28Feb2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 21Mar2021 14:30, outcome "recovered" (Mar2021), described as "Extremely cold within 2-3 hours of dose"; FEELING HOT (non-serious), INSOMNIA (non-serious) all with onset 21Mar2021, outcome "recovered" (Mar2021) and all described as "Woke up hot in the middle of the night"; PAIN IN EXTREMITY (non-serious) with onset 21Mar2021 14:30, outcome "recovered" (Mar2021), described as "Sore arm". Therapeutic measures were not taken as a result of nasopharyngitis, feeling hot, insomnia, pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
2 hours after the vaccine felt like she was hit by a bus. Had facial droopiness. Has Migraines with the same facial droopiness.  Left eye blurred vision. Stroke like symptoms. Fatigue, weakness.
This is a spontaneous report from a contactable Pharmacist communicated to a Pfizer sales representative. An 84-year-old female patient of an unspecified ethnicity received PREVNAR 13 at single dose on an unspecified date for immunisation, recommended by the doctor because she had never received the vaccine. The patient medical history and concomitant medications were not reported. The patient experienced redness at the injection site on an unspecified date for 3 to 4 days post vaccination with outcome of unknown.
1 1/2 hours p/recvd vax pt cried for aobut 6 hrs only stopped for a few minutes when tired, then started up again; cry high pitched;
itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something; Spots on her arm that look like dried out little pimples; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something), RASH (rash) and ACNE (Spots on her arm that look like dried out little pimples) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something), RASH (rash) and ACNE (Spots on her arm that look like dried out little pimples). The patient was treated with ACETYLSALICYLIC ACID (ASPRIN) for Arthritis, at a dose of UNK, qd and MULTIVITAMIN [VITAMINS NOS] at a dose of UNK, qd. At the time of the report, PRURITUS (itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something), RASH (rash) and ACNE (Spots on her arm that look like dried out little pimples) outcome was unknown.            treatment information includes Ceravia Cream, Wrapping up the areas at night Stopped using soap, perfumes, and laundry soap. No concomitant medications were reported.    This case was linked to MOD-2021-162442 (Patient Link).
patient is on day 49 past first dose and wants to get second dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is on day 49 past first dose and wants to get second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is on day 49 past first dose and wants to get second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is on day 49 past first dose and wants to get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.
Body aches; headache; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were unknown.   It was unknown if the reporter considered the general body pain and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just got the 1st shot the day before reporting and it had knocked them on his/her butt. He/She had body aches, headache etc. However, it was better than getting shingles. Additional supportive information: Follow-up would not possible, as no contact, details were available. The verbatim - Knocked me on my butt was not captured as an event because it was just a Idiom used by the reporter while reporting.
Immediate overwhelming metal taste in mouth Immediate prickles on head and face and went down to arms. 20 min after injection moderate dizziness and severe itching. Most severe on face, neck, head, arms, and hands but also on back and torso.  Took 10 mg liquid Benadryl orally. Symptoms still bad after 15 minutes so another 10mg liquid Benadryl orally. Very nauseated so took ODT Zofran. Symptoms did not get worse after 10 mins so went home. At home: 5 hours after injection severe cold shivering profuse sweating, nausea, and stomach pain. 8 hours post injection violent vomiting and continued cold shivering profuse sweating. Now 11 hours post injection continued cold sweating, vomiting, and now persistent diarrhea with abdominal pain.
Seizures; 2nd dose missed (more than 42 days)/s rescheduling the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose missed (more than 42 days)/s rescheduling the 2nd dose). At the time of the report, SEIZURE (Seizures) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose missed (more than 42 days)/s rescheduling the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not  provided. Before the 2nd dose patient suffered seizures and 2nd dose was delayed. Patient is rescheduling the 2nd dose and  wondering if she will need to start all over again.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient came to pharmacy to say that for about 3 hours around  5 days after his 2nd dose of Moderna Covid-19 vaccine he experienced some temporary confusion/stroke like symptoms.   His physician is currently trying to rule out other causes, such as an actual stroke/blood clot. At the present time, the patient feels like his normal self.
Admitted 6/13 with headache, weakness and progressive mental status changes. CSF with 120 WBC, culture negative, MRI consistent with acute disseminated encephalomyelitis. Treated with IVIG and steroids. Became comatose, required intubation. Now recovering.
wheal approx 3cm @ site of inj w/in 2min of vax;no s/s resp involvement on systemic rxn;monitored x 1hr prior to departure; t97;
2 days after administered DTaP ; right thigh and IPV/MMR  in left thigh, pt had developed swelling erythema and pruritus right thigh noted by parents around noon. Walked into clinic given 25 mg po Benadryl and leg elevated. WBC 8.9, pt afebrile. Reaction for cellulitis, given Rocephin (50 mg/kg/dose). Took Augmentin BID. Took 1.5 days to minimize./ Benadryl x 4 days. 11/29/04
after dose was administered by began to shake and then lost consciousness, patient was laid on floor were he immediately regained consciousness, when he felt up to it he was sat in his chair, given energy drink and water and instructed to place his head between his knees if he felt light headed, he was then monitored for the next 30 mins without further incident
My hair came completely out around my temple area on both side sides. I went to my  dermatologist on 4/19 and steroid injections have been started once a month for the next 6 months to see if that treatment works. If not a biopsy will be performed to try to figure out the next plan of action.
Caller found out she tested positive for COVID-19; Caller found out she tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Apr2021 the patient experienced she tested positive for covid-19. she asked if she can still get the second dose of the vaccine. She took first dose on 22Mar2021 and scheduled to take the 2nd dose 12Apr2021 but she was tested covid 19 positive. She was asking if she can take the 2nd dose today. The patient underwent lab tests and procedures which included COVID-19 test positive on 12Apr2021. The clinical outcome of the event was unknown.  Follow up (12Apr2021): This follow up report contains no new medically significant safety information.  Information on the lot/batch number has been requested.
Very lethargic; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar event for two patients. This is the second of the two reports (husband).  A male patient (Age: 71; unit was not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 18Jan2021 at a single dose for COVID-19 immunization at the clinic. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was very lethargic. The patient had COVID test in Jan2021 (results were not provided). The patient had no symptoms. The outcome of the event, 'very lethargic', was unknown. The patient was due to get the second dose of vaccination on "the 8th", but the schedule has not been filled up yet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115530 same reporter/product/event, different patient
Extreme back pain radiating from lower back outwards up and down spine. Unable to bend or sit for long periods, Pain is 7 while sitting, 12 when bending.
On 12/11/2022, I woke up not feeling well I was coughing; nose was stuffed up and general tiredness. I thought I had a cold. I tested with the home test it was positive. I tested with the pharmacy COVID-19 test and it was positive. My right knee became sore and it would give out on me. I did not get any treatment until I got back home. I saw the doctor on 01/26/2023.  I told her I had COVID-19 and my right leg was still bothering me. Then I went to the orthopedic care on 04/10/2023 and was they did an X-ray. They were offering a Cortisone shot and physical therapy and I turned both of those down.  I tested negative for COVID on 12/25/2022, but my right leg is still bothering me.
fever 106 R 2 or 3 days p/vax; taken to ER & then to MD following day;
Four days post vax, the pt experienced bright green mucous stools. Two days after that the pt had blood in his green stool. The pt saw a physician on 12/18 and after several stool samples a diagnosis of allergic colitis was made. The pt has been placed on special formula, he could not tolerate breast milk. pER DOC 214441,Annual follow-up, patient continues to have allergies, green stools. Speech delays.
mycardatis; Chest pains; high blood pressure; skipping heartbeat; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration, administered in left arm on 07Sep2021 at 02:30 (Batch/Lot Number: FC3183) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced mycardatis on 08Oct2021, chest pains on 08Oct2021, high blood pressure on 08Oct2021, skipping heartbeat on 08Oct2021. The patient was hospitalized for the events for 6 days. Treatment received for the events included blood pressure and heart medicines (as reported). The events were reported as serious due to hospitalization and life-threatening. The patient underwent lab tests and procedures which included blood pressure: high on 08Oct2021. Therapeutic measures were taken as a result of mycardatis, chest pains, high blood pressure, skipping heartbeat. The outcome of the events was recovered with sequel on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sudden onset of rash on my back Sunday evening, spreading to most of body by Monday. Applied hydrocortisone 2.5%, took benadryl (2) every 6 hours, prednisone 10mg on Monday, prednisone 20mg on Tuesday.  At this time rash is still active, meeting with dermatologist on 1/13/21
lost my sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost my sense of smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (lost my sense of smell). At the time of the report, ANOSMIA (lost my sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Moderna COVID-19 Vaccine EUA Fever, chills, body aches, shortness of breath, increased anxiety with palpitations and dizziness, soreness at site of injection.   Symptoms started at approximately 11 p.m. the night of the injection (Wednesday) and lasted throughout the next day (Thursday).  I took some Zyrtec on Thursday at approximately 8 p.m., slept great,  and felt back to normal on Friday.
My hands swole so much that I couldn't close them. Got x-ray and it was determined that I have  Psoriatic and Osteo Arthritis swelling. I had arthitus mildly in my past in only one hand, but it spread painfully to both hands. Dr. advised me to take an OTC anti-inflammatory, so I took Aleve which helped me with pain. Took for about 3 weeks then my swelling started going down.
I had flu-like symptoms, a fever, chills, headache, muscle pain, and sinus congestion. I didn't take any treatment. I just rested and focused on hydration.
VACCINE RECEIVED 2 DOSES (ACCIDENTAL OVERDOSE, ACCIDENTAL OVERDOSE) (OVERDOSE ACCID) - Not reported  A report was received from a health care professional on 27 October 2003 concerning a vaccine of unknown demography who received 2 doses of Fluvirin vaccine 2 weeks apart on unknown dates.  On unknown dates, the vaccine received 2 doses of Fluvirin 2 weeks apart.  The outcome was not reported.  There was insufficient information to determine the reporter's causality assessments.  Update 1, 01 December 2003: Further information received from a health care professional on 01 December 2003 indicated theat the vaccine was male and received Fluvirin intramiscularly.  Follow up pending.
Information has been received from a pharmacist concerning her son who was vaccinated with a dose of Varivax at one year of age. On 03/14/02, he developed a lesion and had a possible breakout of chickenpox. Unspecified medical attention was sought. It was reported that the patient's unvaccinated sister who has had two bone marrow transplants and who has had an allergic reaction to IV Immune gloin has been exposed, but it has not broken out in chickenpox. On 03/25/2002, the pharmacist reported that we are now 13 days from possible pox onset and the one lesion was the only lesion he developed. The patient's sister is fine with no apparent illness. It was reported that he was exposed to chickenpox at school. Additional information has been requested.
Patient under 2 years of age given FluMist. The patient did not show any symptoms
Adverse event with kidneys; This spontaneous case was received on 05-Oct-2021 with additional information received on 07-Oct-2021 (being process together) from other non-health professional via customer service centre and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, indication, route of administration and anatomical location: not reported).   On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced unspecified adverse event with kidneys.  The outcome of the event was not reported.  The reporter assessed the event of 'kidney disorder' as related to Flucelvax Quadrivalent. As reported, it was adverse reaction to kidneys with influenza vaccine.  Company comment: A patient of an unreported age and gender was vaccinated with Flucelvax Quadrivalent. An unknown amount of time following vaccination, the patient experienced unspecified adverse event with kidneys. There is lack of information regarding the vaccination date and event onset date. Information regarding medical history and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear temporal relationship.; Reporter's Comments: As reported, it was adverse reaction to kidneys with influenza vaccine.; Sender's Comments: A patient of an unreported age and gender was vaccinated with Flucelvax Quadrivalent. An unknown amount of time following vaccination, the patient experienced unspecified adverse event with kidneys. There is lack of information regarding the vaccination date and event onset date. Information regarding medical history and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear temporal relationship.
Child very anxious regarding injections but was cooperative, received IM vaccinations. Within 6 min child began coughing with wheezing. RN and EMS in attendance. Child's inhaler not available. EMS transported to ER.
This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 21st October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hives, itchy scalp, rectal pain and burning rectal. The patient was treated with cetirizine hydrochloride (Zyrtec) and prednisone. On an unknown date, the outcome of the hives, itchy scalp, rectal pain and burning rectal were not recovered/not resolved. It was unknown if the reporter considered the hives, itchy scalp, rectal pain and burning rectal to be related to SHINGRIX. Additional details were provided as follows: The patient after getting the dose of SHINGRIX she started getting hives, her whole scalp and her stomach started itching. She had burning pain inside her rectum.  The patient had consented to follow up and provided contact details of her treating physicians. For tolerance to 2nd dose see case US2019004268, reported for the same patient.
Information has been received from a Licensed Practitioner Nurse concerning a female patient (age not reported) who on 11-MAR-2014, was vaccinated inadvertently with a dose of PROQUAD (Batch J014238, exp. 07-MAY-2015) (dose, route and site of administration were not reported) instead of a dose of MMR. After been administered the PROQUAD was exposed to an unsupported temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient with hoarsness, stridor, shortness of breath. 50 mg/mL of benadryl administered intramuscularly. 0.3 mg of epinephrine administered intramuscularly.
Woke up 9 days after my first vaccine and left arm was throbbing. I went to run it thinking I had slept funny and there was a knot and my arm was very hot starting about 1 inch below the injection site. There was also a new bump that looked like a mosquito bite at the injection site. It has been a little over 24 hours and my left arm is still very sore, red, and hot.
PER SON - DECEDENT WOULD BECOME ILL AFTER VACCINE SHOTS(X3) - NO TREATMENT PROVIDED