chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reported back to clinic with report of "some pain at (L) arm site" immediately after second injection + "around" 2am this morning (2-3-09) - Pt c/o onset of sharply -type pain/(L) arm with radiation to hand, also nausea/vomiting, weakness + mouth dryness approx 5am given TYLENOL + codeine tabs per father. Pt. present in clinic, Pt alert and oriented, with guarding noted per (L) arm - noted no swelling, redness or induration  of (L) arm-ADVIL with warm compresses-See PCP, if symptoms worsen.
On Feb 22, 2023, patient asked if "normal: for her arm to still hurt after getting a fly shot on 2-2-23. Advised patient to see her physician because pain usually subsides after 2 days.
This spontaneous report was received from a pharmacist refers to a currently 65 years old female patient with a medical history of having treated for pain and depression and none drug reactions/allergies who on 06-JAN-2012 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX23 (Lot # H013581, Exp date: 03-MAR-2014). No other co-suspects were reported. Concomitant medications included FLUZONE, zolpidem tartrate and trazodone hydrochloride. The pharmacist reported that a patient developed 5-6 inches of redness and swelling at the injection site after receiving the second 0.5 ml dose IM of PNEUMOVAX23 on 18-OCT-2012. Patient's outcome was reported as recovering. Action taken with PNEUMOVAX23 was not applicable. The relatedness between PNEUMOVAX23 and the events was unknown. Additional information has been requested.
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 17-SEP-2021, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T026961, expiration date: 02-APR-2023 (exact dose, injection site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707457, expiration date: 23-FEB-2022, orally (exact dose was not provided) both for prophylaxis.  On 10-SEP-2021, the administered doses experienced a temperature excursion of 48.7 degrees Fahrenheit for 10 minutes. No previous temperature excursion had occurred.
4 pfizer vaccinations with no underlying health issues should have not home tested positive for covid for any strain; 4 pfizer vaccinations with no underlying health issues should have not home tested positive for covid for any strain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "4 pfizer vaccinations with no underlying health issues should have not home tested positive for covid for any strain". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: should have not home tested positive for COVID for any strain. Clinical course: The patient with 4 Pfizer vaccinations with no underlying health issues should have not home tested positive for COVID for any strain. Thus, the patient quarantined away from family and life for the next 5 days. The patient further stated "Pfizer make more potent cocktails. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a lot of pain in their hips; he pain has moved down to both their knees; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (a lot of pain in their hips) and ARTHRALGIA (he pain has moved down to both their knees) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, APIXABAN (ELIQUIS) and METHIMAZOLE for an unknown indication.    On 05-Feb-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 ARTHRALGIA (a lot of pain in their hips) and ARTHRALGIA (he pain has moved down to both their knees). At the time of the report, ARTHRALGIA (a lot of pain in their hips) and ARTHRALGIA (he pain has moved down to both their knees) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, X-ray: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient recd vaccine and 2 days later developed rash, swelling, pain on vaccinated arm
On Oct 12, 2020, I took Flucel Vax Quad 2020-2021 0.5 Vial (made by Seqirus, Inc) shot for the flu. The next morning I had a sudden and severe back pain. I had to go to the hospital ER where I as admitted and treated.
15mm knot in lt deltoid noted on 29UAG96 none tender to palpation, pt given DPT/HIB lt deltoid on 2AUG96;pt had 2 MD visits given ATB;10SEP96 15mm mass in lt deltoid unchanged from 29AUG96;
No adverse event; monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series; Monovalent booster dose administered instead of 2nd primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series), INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) 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 15-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series) and INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series), INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (monovalent booster dose of 0.25 mL potentially administered instead of 2nd dose of primary series) and INCORRECT DOSE ADMINISTERED (Monovalent booster dose administered instead of 2nd primary dose).    Concomitant medication was not provided.  The dose administered was monovalent booster as second dose  instead of primary series second dose.  Treatment information was not provided.
pt recv vax rt arm 10JUN96 & presented to MD office on 30SEP998 w/herpes zoster rt antecubital;
Reported arm red and warm at injection site, reported 10/21/16, On 10/22 said it felt better.
Area where the shot is puffy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Area where the shot is puffy) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Area where the shot is puffy). At the time of the report, VACCINATION SITE SWELLING (Area where the shot is puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Under my arm like armpit, it's very tender and bruise; Had a bruising which happened the first time as well; Under my arm like armpit, it's very tender and bruise; Had a bruising which happened the first time as well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration on 30Apr2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 09Apr2021 as dose 1, single for covid-19 immunization. The patient experienced under my arm like armpit, it's very tender and bruise; had a bruising which happened the first time as well on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient has an muscle pain and weakness for about 4 weeks following the flu vaccine. Patient has seen a doctor for the pain and received pain medication that has partially resolved the issue
4 days after my 2nd dose I had hives from my scalp to the soles of my feet. I'm now on steroids, but they continue to reappear every morning when I wake for a few hours; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 (at the age of 38-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma. Known allergies were reported as no. Concomitant medication(s) included Fluoxetine HCl 40 mg taken for an unspecified indication, start and stop date were not reported. Patient did not have any other vaccine in four weeks. Other medications in two weeks included Fluoxetine HCL 40mg. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 17Mar2021 16:45 (at the age of 38-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient reported that 4 days after her 2nd dose, on 13Apr2021 04:00, she had hives from her scalp to the soles of her feet. She was now on steroids, but they continue to reappear every morning when she wakes for a few hours. She had no known allergies and the fact that they disappear and reappear point to the cause not being an allergy, but more likely something related to her vaccine. Adverse event resulted in emergency room/department or urgent care. Patient received treatment as Oral Steroids for 5 days. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Beau lines; This spontaneous case was reported by a consumer and describes the occurrence of NAIL RIDGING (Beau lines) in a  patient of an unknown age and gender 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 NAIL RIDGING (Beau lines). At the time of the report, NAIL RIDGING (Beau lines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.
COVID-19 hospitalization; respiratory failure requiring mechanical ventilation. Also in septic shock from a bacterial co-infection (thus mechanical ventilation likely multifactorial).
Hives and stiff/painful neck occurred 3 days after injection. Hives continue 3 weeks later.
Fever, shortness of breath, difficulty breathing, cough, runny nose, sore throat
Information has been received from a nurse practitioner concerning a 26 year old female who on an unknown date was vaccinated with the first dose of GARDASIL vaccine (yeast) and on 08-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 mL, IM. On 08-JUL-2008, the patient fainted after receiving the second dose of GARDASIL vaccine (yeast). On 08-JUL-2008, the patient recovered. Additional information has been requested.
Pt recv vax on 10/15/98; on 10/19/98 pt exp aseptic meningitis-fever, fussy, poor eating; herpes I & II
After vaccination, woke up in the middle of the night with chills, headache/nausea, and a fever of 102.0F (oral temp).  Took two Aleve tablets in the morning on 1/18, and two Ibuprofen tablets in the evening on 1/18 to reduce symptoms.  Symptoms were gone in the morning on 1/19.
The patient received the Tdap vaccine and experienced nausea/vomiting, axillary lymphadenopathy, blotches, beginning 8 hours after vaccine administered. The lymphadenopathy and blotches lasted 6 days.
Narrative:  Patient was admitted to local hospital 24 hours after his 2nd COVID vaccination. His symptoms were altered mental status, intractable headache and febrile. Patient was later discharged on 1/25. Symptoms:  Confusion, Headache & febrile Treatment:
Upper right arm swelling, redness, severe pain and itch. 2 nights post vaccination, throat swelling relieved by Benadryl. Tylenol not helping with pain at all.
Moderna COVID-19 Vaccine ; Feb 7 AM: arm sore and stiff, no fever.   By afternoon, feeling "punk" and some body aches Feb 8 AM: feeling a bit better but not great, no fever Feb 9 AM: red itchy rash at site of injection approx 2" x 3", arm feels stiff, systemic symptoms gone.   Rash treated with HC 1% cream and ice Feb 10 AM: rash feels about the same, rash is a bit more red.  Still treating with topical HC and ice. Feb 11 AM: Still itchy, rash still red but has more of a "bruised" look and is overall a bit more disseminated (approx 3" x 4").  A white nodule has formed at the injection site. Still treating with topical HC and ice Feb 12 AM: still itchy but feels better, still has a bruised appearance.  Treating with ice Feb 13 AM: less itchy, still red and bruised looking but much less than the previous days.  White nodule is still present.  Treating with ice. Feb 14 AM: much improved.  Just a small bruised looking area (approx 1" x 2") and the white nodule is still present.  No treatment needed at this time
Dizziness; face tingling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 19Apr2021 at 14:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 19Apr2021 at 15:00, the patient experienced dizziness and face tingling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and face tingling was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bell's palsy; A spontaneous report was received from a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Three to four days after receiving the vaccine, the left side of the patient's face was frozen. The patient was rushed to the emergency room because he thought it was a stroke. The physician confirmed that was not a stroke, and diagnosed Bells' palsy. The patient reported that he spent 6 hours in the hospital and the doctor prescribed him prednisone and valacyclovir. The patient reported feeling better now.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, Bell's palsy, was considered recovering.; Reporter'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.
Mom noted hives around mouth while eating pancakes approx. 30 minutes after vaccine administration. Was not sure if pancakes had dairy (pt is allergic to dairy) These hives fades.  4 hours after vaccine mom noted hives and itching to abdomen, and the groin area was reddened.  She also noted some congestion.  Rash and redness faded after bath.
3RD DOSE MODERNA COVID VACCINE GIVEN 02/10/2022, LOT # 068H21A; pt to hospital with worsening SOB; septic and hypoxic; O2 supplementation; given ABX, bronchodilators, and IV steroids; worsening respiratory status requiring intubation; continued to desaturate; fevers began; infectious work up was negative; positive for COVID; renal failure worsened; worsening shock requiring vasopressors; became bradycardic and PEA arrest; ACLS with ROSC but pupils were dilated after code; CXR showed a large volume pneumomediastinum and subcutaneous tissue bilaterally; blood transfusion ordered; family decided to transition pt to comfort care and she passed away in the hospital
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200641912 Different patients, Same reporter, drug, event.
There was a local reaction at the vaccination site. A scabby area of about 4x8 mm appeared right at the injection site needle mark. There was no pain, no oozing. I contacted my doctor and he said not to worry about it. It seems to be healing like any ordinary scabby area. It looked like I had scraped it. But with something this size I would have remembered doing this. I have a photo but you don't have any way to upload it.
Immunizing Technician had a needlestick following giving the injection. Went to Urgent Care to begin a preventative treatment.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a medical clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2015, the patient was treated at the same medical clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Low-grade fever, chills, painful joint and muscle aches all over, bruising and redness at site of injection,  soreness of injection arm, extreme fatigue
Continuous crying x 4 hrs; fussy, restless @ night painful/limping on leg x 24hrs; poor appetite;
Information has been received from a pharmacist concerning a 56 year old female with no pertinent medical history and no drug reactions/allergies who on 11-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (672604/1656AA, exp. 21-JAN-2013), S.Q., (dose not reported). The pharmacist reported that "on 12-JUN-2012 the patient developed a rash. The rash started at the site of injection and extended a few inches down the arm. There was no itch or pain. The rash had a shingles-like appearance." The patient sought medical attention by calling the pharmacy. No treatment was given. No lab diagnostics was performed. At the time of reporting, the patient had not recovered. The follow up information has been received from a registry nurse refers to the same patient with allergic to Penicillin and sulfa. She stated that the patient was not seen at her facility for either vaccine or reaction. The patient was vaccinated at pharmacy. Additional information has been requested.
Redness - swelling of upper arm shoulder to elbow. Right arm diagnosed as cellulitis.
Case previously recorded as MA2009-4403.  Initial case report received from a nurse, via agency on 16 NOV 2009.  A 3 year-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009, an off-label indication.  No adverse event was reported.  Vaccination in children younger than 4 year-old is an off-label use and unexpected for FLUVIRIN (2009/2010).  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.