chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt dizzy starting 10 minutes after shot, 30 minutes after shot felt disoriented, 45 minutes after the shot had some numbess/tingling in my left arm that lasted 10 seconds, an hour after the shot my vision started to go blurry, i had zig zag black and white lines from the central part of my vision down, it did not move when i moved my eyes around,  present when I closed my eyes almost like when you have your picture taken and the flash is still visible in your vision, unable to focus my eyes, had a wave like distortion, it moved upwards in my visual field slowly, lasted until 6:30pm, I called pharmacy who said they had never had this reaction, if it got worse go to ER, then called my primary care dr who also had no explanation and said if it didn't go away to come see him in the morning, Never experienced this before, no headache with vision disturbance. Had episode of diarrhea at 6:45pm. Still feeling somewhat disoriented.
Patient reported severe pain in arm where injection was given, pain reported to be in shoulder/upper arm.
Patient received COVID-19 vaccination at pharmacy on 5/1/21. At the time of vaccination (11:24am), patient was feeling fine and reported no previous medical history of vaccination reactions, allergies to medications, foods, or vaccinations. After 4 minutes had passed, the patient was talking to his wife during his 15 minutes of observation when his eyes rolled behind his head and he became unconscious. Pharmacist rushed to patient?s aid. Pharmacist noticed his skin color was pale and she checked his pulse. The pulse was very weak and his O2 saturation was at 85. Pharmacist tried to wake him by asking his name and touching his shoulder. His wife was doing the same and patient remained unconscious.  Pharmacist had another  employee in the room call 911 while she administered 0.3 mg Epi Pen in left thigh. Patient finally came to and pharmacist lowered patient to the floor so that he was positioned lying down with his knees up. Heart rate was at 45, O2 saturation at 87, BP 128/90. Patient was able to state his name and know where he was but very weak. EMS arrived and checked vitals and blood sugar. EMS encouraged patient to go to hospital for further evaluation; however, patient refused to go to hospital and was educated to go to ER if symptoms returned. Patient was taken home by wife. A follow up call was made to patient at 3pm and wife stated patient was doing alright at home but very weak.
Essentially I experienced flu-like symptoms the next day after I took my first vaccine dose. My first symptom was my throbbing headache that lasted longer as well. My other symptoms were high fever, fatigue, chills, sweating, and sudden rapid heartbeat, a little chest pain in my left part of the chest, and muscle and body aches, and a little difficulty breathing. My fever also lasted for a couple of days and symptoms subsided at the end of the second day after the vaccination day. I would please, please like to know if it's safe for me to take the second dose? I know I would be able to handle the side effects but expected to encounter them on the second dose and not the first dose, so please let me know as my second dose date will be this  Wednesday on the 21st of April.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 7th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced fever (serious criteria other: as per reporter) and appetite lost (serious criteria other: as per reporter). The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever and appetite lost were recovered/resolved. It was unknown if the reporter considered the fever and appetite lost to be related to SHINGRIX. Additional details were reported as follows: The patient experienced loss of appetite. The patient required TYLENOL and Ibuprofen as an intervention for the symptoms and recovered a few days later. This case was one of the 3 cases reported by the same reporter.
Client received Tdap vaccine IM in left deltoid on 3/20 the following day she noticed her arm shoulder was swollen and warm - this persisted for several days. She sought medical advise on 3/24. No treatment needed. Has resolved.
dramatic hair growth; 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 male 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: HAIR GROWTH ABNORMAL (non-serious), outcome "unknown", described as "dramatic hair growth".   Additional information: Patient understand that renewed hair growth for men is a potential side effect of the Covid-19 vaccine. Patient response has been dramatic hair growth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I gave Flublock vaccine approved for 18 years old and up to a 16 year old .
Rash on neck, head, arms, and slightly on legs - began approx. 2 hours after vaccine was administered. No treatment given.
On evening following injection, pt reported injection site pain / tingling, light-headed chills, fever.  Symptoms resolved approx. 36 hrs Covid-19 test negative. No other medical attention
3 1/2 x 2cm red area, warm to touch; low grade fever, small lump at injection site; Right thigh
content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint were 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: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was one of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.  This was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR154684:Same reporter US-GSK-US2022AMR154683:Same reporter US-GSK-US2022AMR154685:Same reporter
Patient states she had soreness at site of injection and along entire upper right arm for 2 weeks post injection.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 09-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L038669 with expired date 11-AUG-2017, dose and route were unknown). No concomitant medication was reported. The reporter stated that the vaccine was stored in 34 degrees Fahrenheit for 48 hours and there was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Got struck twice with the needle during vaccination; Arm hurts bad/ her left arm hurt; It did not hurt this bad with the two primary doses/her left arm hurt was reported as worsened; Headache; Two pin pricks; Booster; 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 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 17:00 (Lot number: 33030BD) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), administration date: 2021, for COVID-19 Immunization, reaction(s): "It did not hurt this bad with the two primary doses"; Bnt162b2 (2nd Dose), administration date: 2021, for COVID-19 Immunization, reaction(s): "It did not hurt this bad with the two primary doses". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "Booster"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 07Dec2021 17:00, outcome "unknown", described as "Got struck twice with the needle during vaccination"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Arm hurts bad/ her left arm hurt"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "It did not hurt this bad with the two primary doses/her left arm hurt was reported as worsened"; HEADACHE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 07Dec2021, outcome "unknown", described as "Two pin pricks". Therapeutic measures were taken as a result of pain in extremity, pain, headache, pain.  Additional information: Patient received the booster dose of the Pfizer BioNTech Covid-19 vaccine and got struck twice with the needle during vaccination. Patient would like to know if this was okay and if she should receive another shot. Patient stated her arm hurts bad, it did not hurt this bad with the two primary doses of the Covid-19 vaccine. Patient stated when she got home she looked under the band-aid and she could see two pin pricks just above one another. Patient stated she got struck with the needle twice and it happened so fast. Stated that she had lasting effects from being stuck with the need twice of her left arm hurting. Stated that her left arm started hurting on 07Dec2021 at 5pm when she had the shot. Stated that Ibuprofen does not help. Stated that she took one dose but is going to take another dose in 6 hours. Ibuprofen strength: 200 mg.  No follow-up attempts are possible. No further information is expected.
Chills, malaise, pain in arm, stiff neck and welts/rash on injection arm.
2/1/98 to ER w/mild cough, rhinorrhea x 5d, low grade fever x2-3d;returned w/T104.6 & maculopapular rash 10-15 lesions over chest, thighs, back, arms, wrist/hand;adm to hosp to r/o sepsis;refused to walk,leg & hip pain;Dx viral synd
On 4/7/15 patient received upper LA Tdap and lower LA MCV4. After +/- 2 hours noted swelling of arm, pain increase over 2 days, today mild decrease. 12 x 8 cm. No signs of infection.
immune mediated thrombocytopenia, anemia, pulmonary embolism, pulmonary infiltrates. treated with IVIG x 2 days and prednisone 120 mg daily. started on heparin drip.
8/24/21 at around 2am pain on leg upper leg. Tight woke me up from sleep. Like a ball.  During day numbness tingling, sharp needle stabbing pain all from feet to upper legs. Feet burning pain numbness, swelling. Legs went numb all over while walking. 8/27/2021 urgent care to give it time.   9/22/2921 given meloxicam for pain.  Second vaccine9/28/2021 nausea still same is also.  Could only eat a little then felt nauseous.  12/7/2021 platelet level very low 22. Still same issue now on prednisone 60MG two weeks later 40MG. Prilosec 20MG
States developed "chicken pox" type rash on 12/26/08. C/O achiness, fever, headache.
Severe soreness on the arm (right) could not eat 2 days; could not eat 2 days; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Severe soreness on the arm (right) could not eat 2 days), FEEDING DISORDER (could not eat 2 days) and PYREXIA (fever) in a 91-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023, the patient experienced PAIN IN EXTREMITY (Severe soreness on the arm (right) could not eat 2 days), FEEDING DISORDER (could not eat 2 days) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Severe soreness on the arm (right) could not eat 2 days) and PYREXIA (fever) was resolving and FEEDING DISORDER (could not eat 2 days) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.
Red, very swelled upper arm surrounding injection site, with pain radiating in back. Area very warm.
P/receiving a dose of Td, pt exp tenderness & swelling @ the inject site; p/2 wks, a large knot that is red & hot to the touch, still remains;
Employee reports stomach pains and diarrhea since am (1/8/2021). On sight Provider ordered COVID PCR and employee sent home to rest and keep hydrated.
Rapid covid-19 self test, date: 03Jul2022, result : positive; Rapid covid-19 self test, date: 03Jul2022, result : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 08:05 as dose 1, single (Lot number: ER2613) intramuscular, in left arm, on 06Apr2021 at 09:25 as dose 2, single (Lot number: EW0151) intramuscular, in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cho (cholesterol)" (ongoing); "Are you allergic to any medications, food or other products: Bee Stings" (unspecified if ongoing); "Are you allergic to any medications, food or other products: Oysters" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM oral taken for blood cholesterol increased, start date: 12Apr2021 (ongoing); BENADRYL taken for dermatitis contact, start date: 21Apr2023, stop date: 01May2023; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Oxycodone, reaction(s): "Are you allergic to any medications, food or other products: Oxycodone"; Doxycycline, reaction(s): "Are you allergic to any medications, food or other products: Doxycycline". None prior vaccinations within 4 weeks. No history of reactions to Covid vaccines. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "recovered" and all described as "Rapid covid-19 self test, date: 03Jul2022, result : positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 137/89; Body mass index: (unspecified date) 28.95; Body temperature: (unspecified date) 97.9 Fahrenheit; Heart rate: (unspecified date) 74; Oxygen saturation: (unspecified date) 98 %; Pulmonary function test: (unspecified date) 16; SARS-CoV-2 test: (01Jul2022) Negative, notes: Comments: Tested due to cough and cold symptoms (slight fever 100 degree F); (03Jul2022) Positive, notes: Comments: Hives developed fever increases to 103 degree F; (14Jul2022) Negative, notes: cold symptoms resolved and temperature returned to normal, no longer had any symptoms; (04May2023) Negative, notes: Comments: Tested when hives began to develop post 2nd Bivalent booster; (04May2023) Negative, notes: Comments: Tested when hives began to develop post 2nd Bivalent booster; (05May2023) Negative, notes: Comments: Tested when hives and welts continued to develop; (05May2023) Negative, notes: Comments: Tested when hives and welts continued to develop.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182799 Same patient/Vaccine, different event, different vaccine dose;
Moderna booster dose to a patient under the age of 18 years old; Moderna booster dose to a patient under the age of 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose to a patient under the age of 18 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna booster dose to a patient under the age of 18 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (dose-1) and Pfizer vaccine (dose-2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 27-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose to a patient under the age of 18 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna booster dose to a patient under the age of 18 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose to a patient under the age of 18 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna booster dose to a patient under the age of 18 years old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported. No adverse events have been reported to the HCP.
Patient recieved her first Moderna booster at vaccination site. When she parked her car in observation area, she started noticing blurry vision and experienced dizziness. Vital signs by paramedics were as follows at 4:25 pm: blood pressure 158/99, heart rate 84, SPO2 100%, respirations 20. Skin color at first looked pale. Patient did not report any numbness and tingling, chest pain, shortness of breath or tightness. Patient was A&O x4, sitting in drivers seat of car with her children in car as well. Vital signs at 4:32 pm were: blood pressure 163/92, heart rate 73, SPO2 100%, respirations 18. Patient did not report any history or issues with first two primary shots. No history of hypertension, or relevant past medic past medical history. She started to report her symptoms were getting better. Vital signs at 4:34 pm were: blood pressure 145/101, heart rate 69, SPO2 100%, respiratons 18. Color returning to patients face. She was assisted by paramedics to back of her car and her daughter parked car for Safety Officer to observe longer. Patient then reported these feelings of numbess and tingling when she was on her period (which she had just started that day) along with migraine symptoms. Safety Officer observed patient for another 10 minutes with a decrease in symptoms. She was advised to go to emergency room if she experienced any shortness of breath, chest pain, disorientation, difficulty walking or breathing. Patient's daughter said they lived 10 minutes away and she would rest for the rest of the afternoon.  On 12/22/2021, patient reported she experienced dizziness and headache until 12/20/2021 but that her blood pressure was stable at systolic 120's. She was able to return to work shortly after and is having no side effects now.
Her right arm was very swollen from elbow to shoulder, hot to touch, red, itching and painful when touched.
Information has been received from a licensed practical nurse concerning a 2 year old male who on 22-DEC-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658086/0761U) instead of Varivax (Oka/Merck). The nurse stated this was an administration error; there was no product confusion. Subsequently the patient experienced no problems. The reporter felt that child having received Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) with no problems reported was not related to therapy with Zostavax (Oka/Merck). There was no product quality complaint. Additional information has been requested.
"KNOT, BIG AS AN ORANGE, HOT" RIGHT UPPER POSTERIOR ARM. PER MOTHER
severe weakness from both thighs to both lower legs, heaviness to both eyes , generalized weakness of body , most  affected is lower extremities.
This report describes the occurrence of elevated liver enzymes in a 36-year-old male who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received by the pt and has not been verified by a physician or heath care professional. The pt's medical history, concurrent medical conditions and concurrent medications were not specified. The pt had no adverse events after previous vaccinations. In May 2001, the pt received his 2nd injection of hepatitis B vaccine recombinant (Engerix-B). During that same month, the pt developed elevated liver enzymes and a rash. Prior to vaccination, the pt's liver tests showed levels of 27 whereas, after vaccination, the levels were at 48, 43, and 49. The rash developed on the pt's wrists, arms, hands and upper torso. The pt took cetirizine hydrochloride (Zyrtec) to treat the rash. The rash had resolved by 11/18/2002. The liver enzyme elevation persisted at the time of this report.
Patient received the vaccine at 1:00pm and right after the shot she started to feel weak. When we asked if she needed anything she stated she couldn't stand up or move her muscles. The ambulance was called and they arrived within 10 mins. She was brought to the ER and told that her blood pressure was low. She was treated with fluids and rest. I followed up with the patient this morning at 10am she stated she was feeling better.
He mentioned heart palpitations and back pain on 6/29/2021. Upon follow up on  6/30/2021, he mentioned both had subsided.