chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with generalized urticarial rash and eye swelling, no respiratory distress, no other systems involved besides skin, no mucous membrane involvement, taken to ER, treated with prednisone and benadryl, improved, sent home with benadryl, rash resolved in 48 hours
Right arm locked up during 1st and second dose. Shortly after feeling my arm get tense my chest locked up and I was unable to breathe and lost consciousness. Since receiving my second dose I have woken up everyday with a headache and my legs frequently go numb.
Harsh Fever Vomit Trouble Breathing Asthma RSV Bronchitis Pneumonia almost died.
Client felt pain upon injection; it seemed "more than usual injection pain," soreness continued for 2-3 weeks. It was hard to move her arm for 17 days afterwards. Took ibuprofen for pain. As of the 18th day her arm began to feel better. It is still sore as of day 20, but she can lift it above her head with less soreness. Still taking ibuprofen. No other sxs.
The site  of the injection was swollen and I had   insomnia  the night of 10/10/20 when  I took the vaccine, with chills , fatigue and a very sore left arm that I could not lift up to shoulder height. I took Advil for the  pain  but could not fall asleep. I took Advil again twice on Sunday 10/11/20   and  had chills and slept most of the day and my left arm continued to be very painful. Monday 10/12/20 was better but I took the day off from work, I was finally back to normal on Tuesday 10/13/20.
fever, body aches, stomach ache, redness and tenderness around shot site began a few hours after shot was given on 6/29/22
Dizziness, sweating 5 minutes after the shot and it went away after 15-20 minutes and patient felt better
Received shot in left arm on 10/08/2020.  A few days later it was sore.  By 10/19/2020 she could not move her arm at all and in extreme pain. She feels it was given to high in the arm.
This is report # 2 of 3 for this patient re: 3 Gardisil vaccines.  Mother states that after Gardisil #2, she had a fever, nausea, and vomiting, and then within 24 hours developed flu-like symptoms.  Mother feels that after Gardisil administration, patient seemed much more susceptible to flu-like illnesses and various infections, e.g. sinusitis.
Patient came to the clinic for a Hepatitis B vaccine and received a 3rd dose of MMR in error.  No adverse patient reaction at the time .
On October 5th patient came in to get her flu shot in the morning, a few hours later it started to swell at injection site. Her arm became very swollen, hot to the touch and very red. A red band around her arm spread on day 2 from site down to elbow. She had some tenderness, but no pain, and felt fine, no fever or sickness. By Monday, October 8th it had calmed down. She did not contact her doctor or seek medical attention. She came in to report the reaction to us at the pharmacy on October 14.
Immediate stuff muscles, no longer rolling over, immediate high fever along with RSV diagnosis. Not putting weight on arms. All delays
Extreme fatigue, 103.2F fever- not responsive to ibuprofen or acetaminophen, severe joint aches in hips and knees, nausea, migraine headache, radiating pain from injection site (elbow to shoulder of left arm), chills. These symptoms lasted for 10-12 hours beginning approximately 20 hours after receiving the shot
5 doses were withdrawn from a vial punctured more than 6 hours ago; A spontaneous report ( was received from a healthcare professional, concerning a unknown patient of unknown age and gender, unknow race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced 5 doses were withdrawn from a vial punctured more than 6 hours ago (expired product administered) and error was made and 5 doses were given that were not valid.  The patient's medical history was not reported. No Relevant concomitant medications were reported like  On an unknown date, prior to the onset of the events, the patient received their unknown planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   On unknown date, the health care professional mentioned and reported that an error was made, and 5 doses were given that were not valid since doses were withdrawn from a vial punctured more than six hours ago. The vial was refrigerated. Five patients received an invalid dose and there was an error made for those five patients. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events, 5 doses were withdrawn from a vial punctured more than 6 hours ago and error was made and 5 doses were given that were not valid, were reported as recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot/batch: unknown) with no associated AEs. The expired product was administered to five patients.
Venous Thromboembolism with left shoulder and arm pain.  He is currently hospitalized.
Patient received a saline diluted (1.8ml)  0.3ml dose Janssen vaccine.  Patient was to receive a COVID Pfizer vaccine. COVID vaccine was given again this time being Pfizer vaccine in the left arm. Client was observed for 15 minutes after second vaccine without any immediate reaction.
Vaccines were provided to patients after June 16, 2016 that were not expired but stored over refridgeration date. No adverse outcomes reported or experienced. All patients impacted were notified and had the option to receive another dose.
pt recv vax & cried inconsolably for 4hr & devel a fever of unspecified degree;pt had recovered @ the date of this report;
felt a little tired; This is a spontaneous report from a contactable consumer.   A female patient (reporter's sister) of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown), via unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had no side effects. Patient felt a little tired but other than that she was okay. Outcome of the event was unknown.  No further details were provided or able to be obtained from caller due to her requesting to be transferred to USMI for her question.
This case was reported by a consumer and described the occurrence of abdominal pain in a female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). Concurrent medical conditions included multiple allergies (allergic to shellfish; iodine; latex; all sulfa drugs; and SEPTRA), factor v deficiency and Grave's Disease. Concomitant products included FARXIGA, levothyroxine, Loratadine, metformin, methocarbamol, nabumetone, ATIVAN and BENADRYL (nos). On 1st August 2015 15:00, the patient received BOOSTRIX. On 4th August 2015, 3 days after receiving BOOSTRIX, the patient experienced abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain. The patient was treated with BENADRYL (nos) and ADVAIR. On an unknown date, the outcome of the abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain were not recovered/not resolved. It was unknown if the reporter considered the abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain to be related to BOOSTRIX. Additional information provided: Husband reporting wife received a tetanus vaccine and started experiencing unusual symptoms about 4 days later. The issues seem to be getting worse. She went to ER last night, but was not hospitalized. She was told she was having a potential allergic reaction, and given a dose of BENADRYL and ADVAIR. Husband does not know if issues are related to vaccine, but he says they are wondering if it may have set off her Factor 5 issues or her Graves Disease. Wife received tetanus shot because she cut herself with a hunting knife. She is scheduled to see a specialist on Monday 10-Aug-2015.
pt recv vax 6APR99 & went into ER 9APR99 was dx w/pneumonia;pt hosp until 17APR99;MD swears shot did not give pt pneumonia;pt exp no sx until 9APR99;
Patient received PNEUMOVAX & FLUVIRIN in same arm, arm is sore, swollen, red, hard to move, & warm to the touch.
Dizziness about 10 minutes after injection, lasted off and on about 4 hours. Throat tightness about 30 minutes after injection, lasted about 20 seconds
patient was given Moderna vaccine at 5:15 pm, 2 min after Moderna was administered patient had c/o nausea/vomiting, shortness of breath/difficulty breathing, throat irritation and scratchiness.  Patient was given Epinephrine 0.3 mg IM into L thigh at 5:17 pm, vitals were taken, patient was tachycardic, tachypneic, and had elevated blood pressure, 911 was called at 5:18 pm. Patient was then taken to ED by ambulance.
Erupted with rash am of 12/23/10 - worsening over 24hrs to cover entire body. Fever with max 101. Treated with TYLENOL, Ibuprofen, and BENADRYL.
No additional AE reported; administered a dose of VARIVAX intramuscularly; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 22-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (anatomical site of vaccination was not reported; lot number W003820 has been verified to be valid, expiration date reported and established as 02-FEB-2024) administered intramuscularly for prophylaxis (incorrect route of product administration).   No additional adverse event reported (no adverse event).
Tingling tongue; Tongue swelling; This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue) and SWOLLEN TONGUE (Tongue swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling tongue) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue swelling) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA ORAL (Tingling tongue) and SWOLLEN TONGUE (Tongue swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment provided was Benadryl 50mg.  This case concerns a 57-year-old female with a serious unexpected event of paraesthesia oral and swollen tongue. Event onset about 20 minutes after first dose mRNA-1273. Treated with Benadryl. Events resolving. Based on 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.   Reporter did not allow further contact; Sender's Comments: This case concerns a 57-year-old female with a serious unexpected event of paraesthesia oral and swollen tongue. Event onset about 20 minutes after first dose mRNA-1273. Treated with Benadryl. Events resolving. Based on 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 treated for Covid in nursing home with azithromycin and "an inhaler" and had worsening symptoms and was brought to the ED.  Patient was admitted to the hospital for Covid, UTI, and dehydration and treated with remdesivir.
Localized allergic reaction. Flu shot given 9/27/18 Rt thigh. Patient developed swelling 9/29/18 with erythema skin reported by mother. Seen 10/1/18 swelling site of shot, no erythema, no tenderness. Swelling and itching. Oral steroid given. F/U 10/4/18. Pt was started on prednisone/and BENADRYL. F/U in 2 days. 10/4/18 child doing well per mother. She cannot come for appt. Pt has previous H/O allergic rash to metals. Pt has previously received flu shot without any problem.
I had no prior symptoms other than some mild itching around injection sight. However, a week after, I began to have intestinal pain that felt exactly like diverticulitis. No medication given for symptoms however, symptoms lasted a few days however went away. I have not experienced that pain since then.
received the vaccine as an inpatient in our hospital on 5/21/21.  Patient went into cardiac arrest on 5/22/21 at approximately 9:00am
Myalgia, NauseaVomiting, pain on injection site, limited mobility on left arm due to injection Narrative:
Soreness of arm reported by child, nurse noted slight redness and some swelling on 7/16 when preparing to give allergy shot.
Patient with headache, muscle aches, nausea.  then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.
Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion; Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     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 POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna Covid-19 Vaccine (Monovalent) was administered post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
patient received an expired dose of bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comments: The health care professional reported that a patient received an expired dose of Bexsero. The reporter did not consent to follow up. Additional Supportive Information: The patient received Bexsero beyond the expiration date, which led to expired vaccine used.
Hives & swelling at arm at 5 days after vaccination. F/U 1/26 - still present, resolve with BENADRYL - recur later. F/U 1/31 - no hives since x 4d.
Pt experienced a varicella like rash starting 24 hours before visit to MD. Rash on trunk, legs and arms. MD dx early onset varicella on 3/15/00. Treated with Benadryl and Zovirax. Follow up states: The vaccine lot # was not on record when sent to us. We did not administer the vaccine. Pt's are no longer with the practice.
I developed a headache within an hour of the shot. The following morning I developed a very swollen lymph node under my right arm pit. This has since migrated down my rib cage. I also experienced nausea, dizziness, headache, and muscle aches the following two days. Those have since subsided. The swollen lymph node under my arm is still with me today.
L arm swelling at site of Td.  Induration and tender erythema, 7x12 cm, chills, c/w cellulitis.
Paraphrase from provider discharge to swing bed note: 83 y/o female brought to ED for fall and left shoulder pain. Baseline dementia, poor historian, early onset Parkinson's Disease. Fully vaccinated for COVID-19, showing no obvious symptoms of COVID. Cough, no dyspnea per review of systems. Problem list includes: Anterior shoulder dislocation, reduction. COVID-19. Essential Hypertension, Acute confusion, baseline dementia, urine + for nitrite and bacteria, started on macrobid. Depression.   Unable to enter required fields for Q.#21, Hospitalization. Currently Hospitalized
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot # L016427, expiration date: 13-APR-2017, route and dose were not reported). Concomitant drug was not reported. The vaccines were at 29 F for 648 minutes and 55 F for 360 minutes because of data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
break through shingle lesion Lt temple area with pain, swelling extending to Lt eyelid and neck area
Large (3-4 in) rash on left arm.  Small rash 1 day after vaccine, disappeared after 2-3 days, reappeared approximately 1 week after vaccine
The vaccine was diluted with 0.8ml  NS instead of the correct 1.8 ml NS. Phone call to patient within 24 hours after vaccine to inform of the error;  arm was sore with movement, not swollen or warm to the touch, denied redness at site.   Denied fever chills or malaise at 24 hours.    Phone call to Pfizer, spoke with the call center concerning this incident, there were trials  with  a higher dose that did not cause harm to the patient.  Pt reassured with this information
NOV98 fatigue, hand soreness, stiffness, weakness, malaise, dec back pain;MAR99 sx decreasing-still residual problem w/hands, soreness/weakness;
Myalgia, Arthralgia, Fever, skin sensitivity, back pain, flu like symptoms Narrative:
31DEC90 mom noticed urticarial rash w/redness & swelling to knees which spread to arms & trunk. Given Benadryl 1 tsp q 4-6 hrs.
A couple of weeks after getting my second COVID vaccine dose, I became unable to eat meats. Meats began tasting like chemicals and like rotten meat, and they smell that way too. Meat and some other foods, that I was previously able to consume, now make me vomit.  This is the only thing I can link to this issue due to it not being that way before I received the COVID shot.
Pt found by mom not breathing, blue, stiff & shaking dx w/febrile seizure & bronchitis; had 2 seizures; t101-103; hospitalized x 3 days; rx meds;
A soft mass under left armpit approximately 5 inches in diameter; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 17:00 (Lot number: FL3197) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LYRICA; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ALLEGRA; ADDERALL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot number: EP6955 Anatomical location: Arm Left Vaccine Administration Time: 09:15), administration date: 27Feb2021, when the patient was 53 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLELot number: EP6955 Anatomical location: Arm Left Vaccine Administration Time: 09:15), administration date: 17Apr2021, when the patient was 53 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "dose number=3"; AXILLARY MASS (non-serious) with onset 18Dec2021 09:00, outcome "not recovered", described as "A soft mass under left armpit approximately 5 inches in diameter". Therapeutic measures were not taken as a result of axillary mass.  Additional information: Soft mass was noticed on morning of December 18th (approximately 38 hours after injection). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up attempts are completed. No further information is expected.
I received my second Pfizer shot on 4/6/2021. My period began on 4/13/2021 and it was my first cycle since getting either vaccine dose. I typically do not have mensural cramps during my cycle but I had cramping that was so painful on the night of April 13th I could not sleep. It was excruciating pain. I had to medicate with motrin in order to get a few hours of sleep that night.
fine red rash, itching on trunk & arms;lungs clear: no resp difficulty, afeb;DPH given;
presented to ED for triage with "flu-like symptoms 7/9/21, was tested for COVID.  Returned on 7/12, admitted, with increased weakness.
Severe acute hypoxemic respiratory failure. Multifactorial from severe acute lung injury and severe ACR (temporally related to third COVID vaccine received on 8/17/21) as well as bilaterally pulmonary embolism. Intubated 9/4/21.  Tracheostomy 9/14/21.  Infectious studies negative to date. COVID Ab negative on 9/9/21.
Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2; This is a literature report.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2".; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between Immune thrombocytopenia and suspect product BNT162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200986371 Same Article/drug/event; Different patient.;