chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; rash; skin irritation; redness; This is a spontaneous report from a contactable consumer (patient).   A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6203), via intramuscular route, administered in left arm on 26Feb2021 10:00 (at the age of 25-years-old) as dose 1, single for covid-19 immunization.  The patient medical history was not reported.     There were no concomitant medications.  The patient previously took amoxicillin and experienced allergy. About 48 hours after getting the vaccine patient had a reaction. He had skin irritation. It was not at the injection site, but mostly in the back of his neck and on his chest and back area. He had redness and hives. He went to see the dermatologist regarding this reaction. The events were treated with Benadryl one at night. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected
Chest pain Shortness of breath  Elevated heart rate Elevated Blood pressure Elevated Troponin Elevated D-Dimer
Guillain-Barre; sometimes I feel a shooting or sharp pain in the muscle; tingling in my leg (right); progressed to pain in leg muscle/ then pain in back and arms too; then pain in back and arms too; headache; nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included muscle pain in legs and anxiety. The patient's concomitant medications were not reported. Caller received 1st dose on Monday, approximately 11 am.  Caller says, "later in the day" experienced a headache. On Tuesday caller woke up (approx. 4 am) with "tingling in my leg (right)", "progressed to pain in leg muscle. "then pain in back and arms too" on 26Jan2021. Caller says that "taking Advil helps a little". "sometimes I feel a shooting or sharp pain in the muscle (usually in arms)". Today, caller experience, " a little jab in the arm muscles". Caller says she was worried she was "getting Guillain-Barre". Caller mentions that she has experienced muscle pain in legs in the past. Caller states, "I was never diagnosed with Fibromyalgia". Caller says she does have history of anxiety. Caller says, "sometimes I feel a little spacey, but I feel like that before, that's nothing new". Caller also says, "I think I might have had nausea the first day (after vaccine)." The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
fever (up to 101.5); extreme fatigue; sore arm; tightness/pressure in chest; lack of energy or will to do anything
Skin rash, numbness and tingling in arm and hand, swollen painful lymph nodes in armpit
Symptoms of Bells Palsy. Facial paralysis on the left side of my face. Cannot smile on the side and some slight drooping. Mild pain behind my ear and a headache only in the left temple area. Odd mouth sensations as well.
received a small cut due to finger flange breaking during administration; received a small cut due to finger flange breaking during administration; received a small cut due to finger flange breaking during administration; This spontaneous report was received from a nurse, concerning a female employee of unknown age. Information regarding the employee's pertinent medical history, concomitant medications and previous drug reactions or allergies was unknown by the reporter.  On 13-MAY-2021, the employee while administering hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number T025370, which was verified to be a valid lot number, expiration date reported as 05-DEC-2022 and upon internal validation established as 01-DEC-2022) (dose, frequency, route of administration, vaccination scheme and anatomical location were not reported), as vaccination to a patient, received a small cut due to the finger flange breaking during administration (injury associated with device, accidental exposure to product and occupational exposure to product). It was unknown by the reporter if the employee received a treatment for the event. Furthermore, the nurse stated the cut was small and the employee was fully recovered.  Causality assessment was not provided by the reporter.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2105USA003646:
(L) arm with pain, itching, red demarcated area that grew larger every day for 3 day. Heat & hardness to area.
This spontaneous report was received from a registered nurse and refers to a 14 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 113 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 22-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient experienced difficulty breathing through the nose and odd sensation on upper palette of the mouth. Patient was given water and two 25mg tablets of Benadryl. Patient felt anxious and nauseated which lead to one instance vomiting. Patient felt significantly better after 10 minutes and requested to go home. Patient was informed to speak to her physician about the event and was advised that a second dose may not be beneficial due to potential for allergy.
At least 5 inch reddened area where shot was given, also swelled & warm to touch: Face flushed, low grade temp 100.5, headache, fatigue, sweating
This spontaneous report was received from a pharmacist via company representative refers to a 2 patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and route of administration not provided). No concomitant therapy was reported. On an unknown date, the patient experienced shingles, one year after receiving ZOSTAVAX. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Patient was given his 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose.
Daily headaches- July 03. Changes in short term memory/ cognitive functioning- Aug 03. Fatigue Oct 03. Altered sensation in both feet and ankles- late Oct 03. Hematochezia- Jun 04. Anthrax #2 left- 7 July 2003-Symptoms: Local: Does not recall specific local reaction. Systemic: Joint pain in elbows and wrists continued from vaccine #2. Pain resolved after approximately 2-3 weeks. Pain did not limit duties. See above discussion in HPI for details of other symptoms following anthrax vaccine #3. 24-year-old F who was in her usual state of good health until she began having headaches in June 2003. No history of headaches prior to June 2003, except for occasional headaches associated with colds and sinus congestion. Initially, headaches were intermittent, 2-3 times a week. After her 3rd anthrax vaccine in July, headaches became daily, and by August 2003, were near constant. Current headache pain described as constant, bi-frontal pressure with more severe sharp, shoting pains 1-3 times a day. Intense episodes with onset and resolution within a perior of 5-15 minutes. Level of pain intensity of constant, bi-frontal pain rated as level 2-3 on pain scale of 0-10, and pain intensity of sharp shooting pains usually rated as level 7-8, but has been as high as a level 10. Unable to associate headaches with menstrual cycle, environmental changes, including changes in pressure during flying, stress, or foods. Bright sunlight after leaving poorly lit building aggravates headaches and somewhat triggers sharp, shooting pains. No problems with balance, visual changes, speech or swallowing difficulties, sinus congestion or drainage. Denies history of head trauma. No family history of headaches. Sough evaluation of headaches in August 2003. Initial evaluation and treatment by primary care provider. Referred for civilian Neurologist in October 2003. Referred to military Neurologist in December 2003. Treatments tried include: NSAIDs (no relief), allergy medications (Claritin and Sudafed, Flonase- not effective) and antibiotics (no relief), relaxation- no releif, Imitrex- minimal relief, Relpax- (no relief), Amerge- (no relief),  Maxa;t 10 mg, Axert 12.4 mg and Frova 2.5 mg (no improvement), Lexapro 10 mg (stopped secondary to nausea), Zoloft 25 mg (discontinued secondary to sedation and no improvement of headache), Prednisone taper (decreased intensity of pain while taking, but headaches returned within 2 weeks of last dose), Neurontoin (currently taking with dose adjustment on March 2004.) Evaluation is ongoing through Clinic, with civilian Neurology follow-up in April.
patient was given an extra varicella vaccine. The Proquad vial was laced in the MMR box by mistake. Parent and provider were both contacted along with Health Dept.
So basically I believe I have Bell's palsy  .  After about an hour after receiving the vaccine I noticed I was having a weird taste in my mouth. Sort of a metallic taste. As the weekend went on it seemed to get worse. Then Monday morning I noticed when brushing my teeth that I wasn?t able to  gurgle my mouth wash. And saw that my mouth and eye seemed to be drooping slightly. Now Thursday the 21st and it seems to be effecting my speech to were I now have a lisp. Can definitely see it when I?m speaking to someone. Which people have commented on.  Not sure what can be done . But at this point I?m hoping it doesn?t get worse. Thanks
pt recvd vax; devel severe rash; fever of 105; swelling in joints; approx 10 days after vax, pt started running fever; next day devel rash; initially dx as having rxn to ceclor; lasted approx 10-15 days;
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Pt. seen in office 01-26-17 for 5yr WCE, rec'd routine vaccinations. Developed S/S and seen again 01/27/17 for erythema, pruritus to (Lt) arm. Afebrile. Area=12 x 18 cm with (+) warmth. No rash. TX=Ibuprofen every 6 hours; BENADRYL PRN; ice packs.
Pain in legs and knee - dopler studies to check for DVT - neg - knee pain requires brace - joint pain continues - 1230 to dr's with elevated BP 159/91 -BP elevated for 2 weeks. Put on LISINOPRIL 5 mg for elevated BP on 12/30/09. Never had high BP before this.
I always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 0.3 ml single (Lot number: EN5318, Expiration Date: 31May2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: amoxicillin due to history of a hip replacement. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I always get a sore arm where I get the shot".  Additional information: She states she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. She mentioned, at the time, "I always get a sore arm where I get the shot.
Moderna booster. Problems with right arm, knot in arm since 2nd shot @ injection site.
Patient given excessive dosage of Pfizer vaccine. Dose given without saline dilutant To date we do not know if patient experienced any adverse effects from dose given
Evening following vaccine injection, developed large reddened, sore, hot to touch area on arm, no fever. Gradually resolving. Related to Pneumonia site.
Sharp pain in the shoulder/When he raises the arm, the shoulder hurts a lot; Sharp pain in the arm; A 51-year-old patient received Fluad Quadrivalent; This spontaneous case was received on 06-Oct-2020 from a pharmacist via agency (reference number SEQW20-02977) and concerned a 51-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On 22-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis (explicitly coded as 'Inappropriate age at vaccine administration'). The batch number reported was 279813, expiry date was 30-Jun-2021.    On the same day, after receiving Fluad Quadrivalent, the patient experienced sharp pain in the arm and sharp pain in the shoulder. When the patient raised the arm, the shoulder hurt a lot. The patient took ibuprofen and ice as a treatment.  At the time of initial reporting on 06-Oct-2020, the patient had not recovered from the events 'shoulder pain' and pain in arm'. As reported, the patient was not improving.   The reporter did not provide a causality assessment.  The reporter assessed these events as non-serious.  Company comment: Musculoskeletal pain and pain in extremity were associated with the use of the suspect product - Fluad Quadrivalent. The event occurred on the same day making chronology suggestive. The patient's medical history and concomitant medications were not reported. Causality is assessed as possibly related due to suggestive chronology and lack of another confounding factor. Information regarding anatomical location of administration is needed. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: Musculoskeletal pain and pain in extremity were associated with the use of the suspect product - Fluad Quadrivalent. The event occurred on the same day making chronology suggestive. The patient's medical history and concomitant medications were not reported. Causality is assessed as possibly related due to suggestive chronology and lack of another confounding factor. Information regarding anatomical location of administration is needed. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Received Boostrix instead of Flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 14-NOV-2022 Reporters comment: The medical assistant reported that a colleague received a dose of Boostrix instead of an unnamed flu vaccine, and wished to know how to proceed, initials, and gender were given for the patient, but specific age was withheld.  The vaccine administration facility was the same as primary reporter The reporter consent to follow-up. Additional Supportive information:The patient received Boostrix instead of an unnamed flu vaccine, which led to wrong vaccine administered. This case has been linked to the cases US2022168196 and US2022168201 reported by the same reporter.; Sender's Comments:  US-GSK-US2022168201:Same reporter US-GSK-US2022168196:Same reporter
patient was exposed to someone with COVID on 7/16/2021, she has been asymptomatic, tested positive on 7/19/2021
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema, local swelling and skin warm. On an unknown date, the outcome of the localized erythema, local swelling and skin warm were recovered/resolved.  It was unknown if the reporter considered the localized erythema, local swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in late May or early June. After receiving SHINGRIX, the patient experienced some redness and swelling and also it was hot, a couple of inches below the injection site. This occurred not right at the injection site. It took a while for the events to go away. It took more than 3 days for the events to go away. The patient did not give consent to follow-up. Events considered without marking them at the injection site since the patient emphasized that it was not right at the injection site. The patient declined providing her information. She also ended the conversation so unable to clarify further information.
This is a 4 year old female who came to our clinic for vaccine injection. Pt was to receive DTaP, however medical assistant gave Tdap. They contacted the Deputy Medical Director. Pt should continue regular vaccine schedule and still receive the 5th dose of Dtap and Tdap at age 11-12. Supervisor reviewed the 5 patient's right for med administration.
Rapid heart rate, elevated blood pressure, tingling in the hands and feet, dizziness and feeling like I was going to pass out, and difficulty breathing. Occurred approximately 4-5 days after 1st and 2nd doses of the vaccine and lasted for 1 full day. It has occurred intermittently over the last 1 year in episodes lasting  from a few minutes to hours. I also now randomly experience joint pain, muscle fatigue, general fatigue, anxiety, abdominal bloating & heartburn, and feeling disoriented in regards to speech, vision, and thinking.
Left arm swelled to a baseball size knot that was red, hot and itchy. Went to ER.  Diagnosed as cellulitis and received antibiotics.
At time of shot, blood glucose level was at 160. I drank a 20oz soda which was 60 grams of sugar and carbs. To cover the soda I took 3 units of insulin instead of the full 6 units I would normally take. At this time which was 12:45PM I did not have any active insulin in my system. At 2:45PM I had 2 slices of bread with peanut butter and no insulin. At 3:15PM I felt light headed and dizzy so I checked my blood glucose levels and it was 46. I ate an entire bowl of cereal and drank 2 tbsp of maple syrup. After the hypoglycemia incident, I tested my blood sugar at 3:30 and it was 94.
The Patient got the Janssen shot and Passed out several minuets later. After coming to He was provided a bottle of water. He drank the water and said that he mainly just felt really hot. We asked that he stay in the store an additional 30 minuets, his mother was with him and kept a constant eye on him with the pharmacist checking in in 5 minuet increments. Patient was feeling better and left, at the end of the additional 30 minuet waiting period.
She noticed on her chest and all around her neck is broken out in rash; she has welts on chest; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 11:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient noticed on her chest and all around her neck was broken out in rash and she had weltes on chest on 22Jan2021. Should she go to the emergency room? The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient presented with SOB, weakness, fatigue, and cough requiring supplemental oxygen. Tested positive for COVID on 8/21.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). Other suspect therapies included on 10-MAR-2014, MMR II and VARIVAX (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
This spontaneous report as received from a health care worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB. On an unknown date the patient experienced flu-like symptoms, pain, swelling and injection site redness. The outcome of swelling, injection site redness, pain and flu-like symptoms was unknown. Additional information is not expected.