chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumococcal conjugate and hib vaccine received on 12/29/10. Day of vaccine patient was irritable and had low temp common reaction but right leg very tender. You couldn't even brush by the site without him being in a lot of pain. Pain persisted but slowly improved over next couple days. Then 1/3/11, he woke from his afternoon nap around 4:30pm with neck pain and only able to look to the right. He was held all afternoon if he was put down would cry in obvious pain. He was given Tylenol. Unsure if he had a temperature. He had a good appetite for dinner. When I returned from work at 8pm I assessed him. He was still in a lot of pain. Unable to look straight ahead. I took him to ED for evaluation. He was afebrile, ears and throat looked normal. We were discharged home. He is slowly improving but but still unable to look easily to the left after 2 days. We will follow up with his new pediatrician Monday 1/10/11.
I had my tooth removed, what would be called a big teeth on the right, they had to cut it off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL9269, Expiration Date: 31May2021) 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: TOOTH EXTRACTION (non-serious), outcome "unknown", described as "I had my tooth removed, what would be called a big teeth on the right, they had to cut it off". Therapeutic measures were taken as a result of tooth extraction.  Additional Information: The patient was now taking an antibiotic for the event and was asking if that would affect for her going to get the second shot.  No follow-up attempts are possible. No further information is expected.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company productB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2022, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) had not resolved.            No concomitant medication was reported.  The co--suspect Humira formulation was reported as solution for injection in pre-filled pen. On 19-Nov-2021, the patient received the Booster dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in COVID-19 Vaccine   No treatment information was reported.  The reporter causality for event sinus infection with co-suspect Humira was a reasonable possibility  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
COVID arm- 1.  small , round , quarter-sized rash at injection site   2. 2?wide x 4? long oval shaped rash on left bicep itchy, red, warm to touch
Approximately 10 minutes after receiving the H1N1 Vaccine live, Flu Vaccine inactivated and a PPD test patient fainted and then vomited. Blood pressure was taken and patient was watched for 15 minutes until able to go home. Parents to watch over patient today increase fluids and call the clinic if any other problems exist. Clinic number given to patients parents.
Information has been received from the mother of a 23 year old female who in 1992, at 11 years of age, was vaccinated with a second dose of  measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient received the first dose of vaccine in 1982, at the age of 15 months. On 29 JAN 2004 the patient developed bilateral swollen parotid glands and fever, up to 100 deg F. The mother reported that the patient's physician felt that the patient had mumps and commented, "those antibodies were elevated a little". the patient was treated with ibuprofen for 5-6 days. No known exposure was reported. It was also reported that blood samples were taken 1 and 2 days after the appearance of clinical symptoms, which revealed the presence of Mumps-specific IgG, but Mumps specific IgM was negative. As of 05FEB2004, the patient's mumps persisted.  Additional information has been requested.
Breakthrough case admission after 2 vaccines ; Moderna 7/27/21 Lot# 052C21A;  Moderna 8/24/21 Lot# 091D21A
This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  No other vaccinations were administered on the date of Flulaval administration.  The subject had received Flulaval in previous years with no subsequent adverse events.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint.  The subject returned to the clinic for further evaluation.  The healthcare professional considered the events were disabling.  The clinic used a 1 inch, 30 gauge needle to administer the vaccinations.  The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it.  The healthcare professional reported that the injection site pain lasted greater than two weeks and the outcome of the events was unspecified. Follow-up received on 22 January 2008 via the healthcare professional and it was reported that she was not aware of any other reactions at this time.
Mother states child c/o headache, neck pain, fever & diarrhea-3 days after receiving immunization. On 5/08/11-child also developed hives head to toe and was taken to Urgent Care facility to be treated.
Day 1: exhaustion Day 2: sore body, fevers (high of 102.4), exhaustion, chills, hot red ?rash? on arm (under injection shot)  Day 3: mild fevers (high of 99.7), sore body Day 4: hives (treated with Benadryl)
sever fatigue; swollen lymph nodes in left arm pit and behind right ear; Myalgia; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 11:30 (Lot number: FH8027) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 32 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 32 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 11:30, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 08Dec2021 06:30, outcome "recovered" (Dec2021), described as "sever fatigue"; LYMPHADENOPATHY (non-serious) with onset 08Dec2021 06:30, outcome "recovered" (Dec2021), described as "swollen lymph nodes in left arm pit and behind right ear"; MYALGIA (non-serious) with onset 08Dec2021 06:30, outcome "recovered" (Dec2021), described as "Myalgia". Therapeutic measures were not taken as a result of fatigue, lymphadenopathy, myalgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior and post to vaccination.  Follow-up attempts are completed. No further information is expected.
hearing loss; melanoma on arm; basal cell on face; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number Unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "melanoma on arm"; BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "basal cell on face"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed upper lip swelling day after vaccine.  Went to bed and when woke up in the morning both lips were significantly swollen.  No SOB/respirations regular unlabored-VSS.  Treated with Benedryl 50 mg IM, Pepcid 40 mg po,  celestone 2 cc IM
Vaccine recipient received 1st vaccine dose on 12/16/2020. The vaccine recipient returned for the 2nd dose of Pfizer-BioNTech vaccine on n 1/5/2021. They  reported at the clinic that 5 days after receiving the vaccine on 12/16/2020 developed bilateral tinnitus that was hissing in nature. The hissing abated after a week. Vaccine recipient reported that they will follow up with an ENT provider. The vaccine recipient was not sure if it could be related to the vaccine. Patient has a history of tinnitus but noted it was nothing like prior. Vaccine recipient is a physician. Pfizer-BioNTech COVID- 19 Vaccine EUA.
This spontaneous report was received from a certified medical assistant and refers to a 15 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 02-MAY-2016 at 16:12, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017) dose 1, intramuscularly in the right arm. On unspecified date, the vaccine that was administered to the patient had been improperly stored by being exposed to temperature: 34F for a total time of 65 hours. There were no previous temperature excursions. No adverse event, signs or symptoms were reported. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all available information was obtained.
difficulty breathing/had a very difficult time breathing; fast heart rate/rapid heart rate; contraction in the chest near the heart or the abdomen; some muscle tightness/tightness in the chest that was muscle tightness; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. This is the first case out of two cases. A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 19Jun2021 in the evening (age at vaccination was 47 years) as 1st dose, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The reporter stated that she was calling because her husband and she went to the (Facility Address), yesterday at 1 O' Clock and got a shot for COVID and she had 2 side effects but she was okay, her husband had some side effects that were not really listed here under severe or more common side effects. On 19Jun2021 at 21:30 pm, last night the patient had tightness in the chest that was muscle tightness difficulty breathing and a rapid heart rate. They give them a paper work after getting the shot which listed some common side effects but not all possible side effects. It just listed few of the severe ones and then some common less severe side effect but it did not mention anything about some muscle tightness, contraction in the chest near the heart or the abdomen and difficulty breathing and a fast heart rate which was what her husband had been experiencing since last night had a very difficult time breathing but he was not allergic, he was not swelling, he didn't have a rash. The reporter confirmed that it was Pfizer COVID 19 Vaccine. No treatment was received for the adverse events. The reporter stated that it has not been resolved and it was still persisting the last time he had checked his heart rate because he was a runner and right now its 101 that was the resting heart which was high for him he normally had very low heart rate like 67 it was 136 about 20 minutes ago, it was raising without exercising. The reporter was informed about the Pfizer Medical Information. The reporter was also advised to visit nearby healthcare profession in the case of emergency. This case LRN W2021388441 was cross linked with LRN W2021388442. The outcome of the event fast heart rate/rapid heart rate was not resolved. The outcome of the other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
pt devel swelling, erythema, warmth, & pruritus of the upper arm (inject site) p/receiving vax; pt was given vax following a puncture wound injury to hand; pt was seen by MD 14FEB92 & 12MAR92 for poss sterile abscess;
tested positive for Covid after the vaccine; tested positive for Covid after the vaccine; This is a spontaneous report from a contactable consumer reported for her husband. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine and then he tested positive for Covid after the vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Pt developed fever and redness at injection site the day following the vaccination.  Went to ER and was admitted.  Cultures were negative.  Pt had an MRI of affected arm; PICC line placed for administration of abx. 12/29/06 Received medical records from hospital which reveal patient admitted to hospital 10/28/06-11/1/06 with fever, chills & left arm cellulits & hereditary xerocytosis s/p splenectomy remotely at age 3 years.  Patient received both flu & pneumovax in left arm.  ID consult notes that site of flu vax was unremarkable but site of pneumovax was red, tender, angry, inflammed & very painful.  Temp max 102.7 Treated with IV antibiotics, pain meds & continued on oral antibiotics at d/c.  Consult by ID & ortho. FINAL DX: Severe left arm cellulitis; anemia; asplenia secondary to remote splenectomy for hereditary xerocytosis; PCN allergy; & severe leukemoid reaction.
Incorrect dose was given.  We gave 0.25 mL instead of 0.5 mL.
Bells Palsy, Left side of face paralysed, tearing in left eye. Drop / fluctuations in blood pressure. Fluid in lungs. Pain under ears. Higher sound in left ear. Drumming sound when yawning. Red swollen dry left eye. Dual blurred vision.
4/26/2021 I got almost immediately in about 2 hours and later in the evening I had a twitch in my eye, on the same side as the injection.   Minor soreness in the arm at the vaccination site. On the the next day 4/27/2021 I had a messy slimly BM that only happened onetime, but it was slimy which was unusual.  Around May the 1st or 2nd, I developed a in itchy rash behind my ear, neck , wrist, torso, 2 middle fingers on right hand, left eye lid and to a lesser degree on my right eyelid, but it styed a long time and it is still on my left eyelid. 5/3/2021 I had considerable redness and swelling around my left eye, left side cheek, nose, the face very itchy, that continued for about 10 days. By 5/13/201 most of the itchy ness went away, with still bumps and puffy ness around the left eye.  I used Benadryl for the itching.  I saw the dermatologist on May 6th thought it could be related to the Covid vaccine, Ophthalmologist also on the same day and she did not think it was related.  On 5/13/2021 I consulted with my PCP, I showed him pictures and he though that it was from the  vaccine and discouraged me from getting the  second vaccine. unless I was visiting someplace that has a high rate of incidences or high risk areas. He described it as a severe reaction from the vaccine.
Patient up to date on COVID vaccinations who admitted with COVID symptoms and COVID detected PCR.  Provider D/C note: " 68-year-old female with past medical history of chronic kidney disease status post kidney transplant with solitary kidney, cadaver, on immunosuppressive therapy (tacrolimus, prednisone), hydronephrosis status post stenting, DVT, hyperlipidemia,type 2 diabetes, hypertension, who presented to the emergency department with complaints of generalized weakness with onset 3-4 days prior to admission at which time she had a  positive COVID contact.  In the emergency department patient's vitals are stable, Accu-Chek with significant 48 blood glucose (given D10W in ED), labs significant for 8.3 hemoglobin, creatinine and BUN elevated, CO2 11, anion gap 17.  CT of head was done, unremarkable.  Patient reports she was supposed to have her stent removed 2 days prior but was too weak to see the urologist.  Patient was admitted to the general medicine team for further evaluation.  For her acute kidney injury on CKD status post renal transplant, patient had a renal ultrasound done which was significant for hydronephrosis/ hydroureter with stent present. urology was consulted stat.  UA was pending however previous UA was significant for Citrobacter freundii and meropenem was started.  Antibiotics were subsequently discontinued following benign UA results.  Urology deferred stent exchange and negated emergency intervention due to positive COVID status.  Urology continued to follow for the duration of the admission with instructions to follow-up following completion of severe respiratory isolation.  Nephrology was also consulted, patient's tacrolimus levels were maintained, patient was started on bicarbonate drip for her anion gap acidosis subsequently being transition to oral bicarbonate.  Patient was maintained off of all nephrotoxic medications and started on gentle hydration. Patient's AKI improved.  For her COVID + patient was started on remdesivir, did not require supplemental oxygen or any further treatment, tolerated well, symptomatic improvement.  Following improvement of her AKI and per recommendations of nephrology and urology patient was ready for discharge. For her covid 19+  Patient's hospital stay was not complicated"
sinis infection; excess mucous; can hardly sleep because of the mucous; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinis infection), RHINORRHOEA (excess mucous) and INSOMNIA (can hardly sleep because of the mucous) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinis infection), RHINORRHOEA (excess mucous) and INSOMNIA (can hardly sleep because of the mucous). At the time of the report, SINUSITIS (sinis infection), RHINORRHOEA (excess mucous) and INSOMNIA (can hardly sleep because of the mucous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up document was received and no new information was reported.
Information has been received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (strength, dose, frequency and route were unknown; lot number M005714 and expiration date 03-OCT-2017). No adverse effects reported. This is one of the two reports that received from the same source. Additional information has been requested.
anorexia; severe abdominal pain; severe weakness; Fall; fever; vomiting; appendicitis; Mild facial swellling; This spontaneous case was reported by a non-health professional and describes the occurrence of APPENDICITIS (appendicitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011JQ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Food allergy (Allergies to foods). Concomitant products included FEXOFENADINE for an unknown indication.    On 26-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SWELLING FACE (Mild facial swellling). On 29-Jan-2021, the patient experienced APPENDICITIS (appendicitis) (seriousness criterion medically significant), DECREASED APPETITE (anorexia), ABDOMINAL PAIN (severe abdominal pain), ASTHENIA (severe weakness), FALL (Fall), PYREXIA (fever) and VOMITING (vomiting). The patient was treated with LORATADINE ongoing since an unknown date for Adverse event, at a dose of 1 UNK. At the time of the report, APPENDICITIS (appendicitis), SWELLING FACE (Mild facial swellling), DECREASED APPETITE (anorexia), ABDOMINAL PAIN (severe abdominal pain), ASTHENIA (severe weakness), FALL (Fall), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        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.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the events of Decreased appetite, Pyrexia, Vomiting Abdominal pain were due to the event of Appendicitis and not to the product. Further, the Company believes the event of Appendicitis is unlikely related to the product.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Significant follow-up with serious and non-serious events added and email added; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the events of Decreased appetite, Pyrexia, Vomiting Abdominal pain were due to the event of Appendicitis and not to the product. Further, the Company believes the event of Appendicitis is unlikely related to the product.
As of right now there is no adverse event that we are aware of. We are reporting this due to her receiving her Prevnar20 vaccine without an indication and without a prescription.