chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Younger than indicated age received Kinrix; Kinrix given to patient instead of Pediarix.; Pediarix 1st and 2nd, Kinrix 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (On unknown date patient received 1st dose of Pediarix) and Pediarix (On unknown date patient received 2nd dose of Pediarix).   On 13th October 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 13th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered 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: 15-JUL-2022 Reporter's Comments: The reporter was a pharmacist. The reporter stated that, the patient received Kinirix who was younger than the indicated age. The patient received Kinrix for third dose of DTaP. The patient was done with two doses of Pediarix. The reporter did the consent o follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinrix as a third dose in DTap and IPV series which was Pediarix should be the third dose which led to Inappropriate schedule of vaccine administered, and Wrong vaccine administered.
A week after my 2nd dose, I had itching and a rash under my arms. The rash was under my right arm. Two times since I had the shots. I have stabbing pains in my left eye. It was Shingles in my Left eye. I went to an eye doctor and he didn't see anything. I took the FamVir and it went away.
pt recvd vax; immediate itching sensation; swelling in the arm w/ redness; swelling & redness did not subside until approx 1 wk; felt achy immediately & ran low grade t which subsided after 2 days;
had a lot of swelling; have pain in her right leg, from the knee all the way to her ankle area (front and back sides); couldn't walk on her right leg; pain in the knee in her vein; pain in the knee in her vein; swelling in leg; hot in leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration, administered in Left Deltoid on 14Apr2021 (age at the time of vaccination 73-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced have pain in her right leg, from the knee all the way to her ankle area (front and back sides). On 24Apr2021 patient had a lot of swelling. On unspecific date in Apr2021 the patient reported couldn't walk on her right leg, pain in the knee in her vein, swelling in leg, and hot in leg. Patient states she is going to HCP on 07May2021. States whether she can take the second short of vaccine. Patient was asking whether she have to consult doctor. Therapeutic measures were taken as a result of have pain in her right leg, from the knee all the way to her ankle area (front and back sides), and had a lot of swelling includes topical gel and CBD OIL. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Had an ablation done in Jan 2020, did not have a menstrual period until a few days after taking my second shot.  I also still have a sore right arm, it is also weak and does not have full range if motion. I had no issues with the first shot in my left arm. It was only after the second shot that was in my right arm.
Redness, burning, and pain at injection site. TYLENOL 500mg was given (pt cannot take MOTRIN). Told by PCP soreness will last for awhile but will be ok.
REDNESS AT INJECTION SITE; ARM PAIN; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced redness at injection site and arm pain for more than 7 days.
pain, redness, swelling at injection site after shot administered on 6/23/20, seen in ER on 6/27/20, instructed to apply cold compresses, take Tylenol or Motrin, rx medrol dos pak. See PCP if worsens.
Patient arrived to clinic to receive her second dose of Moderna. When Vaccinator was asking her initial questions prior to receiving dose, patient disclosed that after her first dose she had tingling on her lips and received IM Benadryl. Discussed with patient her reactions and verified that she wanted second dose since symptoms were more side effects than an adverse reaction. Patient received her second dose of Moderna at 1430. Within 5 minutes after receiving dose, she complained of lips tingling. 1508 190/98, 84, 97% RA. No swelling of throat or difficulty breathing. 1515 191/101, 85, 94%. Complains of lips tingling more and going onto tongue. Discussed with patient the need to give Epinepherine. Patient requests IM Benadryl since she had it last time. 1517 184/101, 83. 1519 50 mg IM Benadryl given in Left Deltoid. 911 called. 1522 203/103, 97, 96%. Patient states tingling improving. 1525 184/104, 81, 95%. Denies headache, N/V. Tingling improving moved toward front of tongue. 1527 EMT arrived. 200/99. Pt educated on risk of high blood pressure and stroke. Pt refuses to be transferred by ambulance to Emergency Department. 1531 191/107, 77, 95%. 1536 183/90, 67, 97%. Patient resting comfortably on stretcher. 1548 173/90, 66, 96%. Pt requesting to go home. 1554 183/98 65 99%. Pt denies tingling. Pt declined further medical treatment. Reviewed signs and symptoms of when to call 911 or go to Emergency Dept. Patient and husband discharged home. Ambulated without difficulty.
Patient was seated in front of the pharmacy following the shot and fainted. This was 5 minutes after the shot.
I slept with Hugh fevers throughout the night. I woke up multiple times because my skin was just so hot it was uncomfortable to sleep. I also am experiencing pounding headaches ranging from a solid 3-5. My whole entire body feels sore, especially my left arm. I took a Tylenol  this morning and am waiting to see if the symptoms go away.
approx 15 to 20 hrs p/vax pt devel light-headedness, tingling behind neck, & fatigue; exam neg;
36 hours following injection, all of my autoimmune issues flared. My lips became swollen and were oozing pus, my eczema flared and kept me up through the night with itching, I developed a rash under my left armpit, and I also developed a yeast infection which I do not believe was a coincidence.
Extremely elevated blood sugar. This is common with type 1 diabetes when I have a viral infection, but I was not prepared for it with the vaccine. I have increased my insulin by 60% and it is still high. All type 1 diabetics should be warned of this. Thankfully I am able to manage elevated blood sugars well but not all diabetics are. They should be prepared to take ?sick day? measures with their insulin rates.
pt recv vax & devel localized tenderness @ inj site & dec ROM lasting more than 1-1/2months;this case was reported by MD;
Persistent right arm sore; This is a spontaneous report from a contactable physician, the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the right arm on 30Dec2020 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Feb2021 as a single dose for COVID-19 immunisation. Medical history included gastritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously took gadolinium (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 30Dec2020, the patient had a persistent right arm sore after the first dose and the second dose. It was three and half months after the first shot and two and half months after the second shot, and the patient still had a sore in the right arm right. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of event persistent right arm sore was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient first complained of nausea about 5 minutes after receiving the vaccine. A technician took the patient outside to get some fresh air.  Patient was brought back inside to sit by the doorway to continue getting fresh air and was given a cold bottle of water, while another group was being briefed for their shots.  Patient was reexamined and had blood shot eyes and smalls hives on the back of her neck.  After seeing the hives, an ambulance was called and the patient was taken to a more private room to lay down and receive a dose of Epinephrine at 08:37 AM.  EMS arrived with an ambulance within 5 min of the Epinephrine being given.
pt recv vax JUN96 & devel a local rash @ the inj site;SEP96 pt devel sl blistered lesions that became dry & crusted;pt MD thought pt had devel herpes;tx w/med;
two doses had been given / 7Jun2018 / and 16Sep2020 /dose was given on 23Jun2021; two doses had been given / 7Jun2018 / and 16Sep2020; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9NH54, expiry date 14th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th June 2018).   On 23rd June 2021, the patient received the 3rd dose of Shingrix. On 16th September 2020, the patient received the 2nd dose of Shingrix. On 16th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were provided as follows: The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix , which led to extra dose administered. The reporter reviewed patient's vaccine history and noticed that two doses were already given.  The reporter consented to follow up.
pt recvd vax; sx started next am; awoke w/ fever, chills,malaise, body aches; fell asleep; "slept for 3 days"; arm was hot, achy, "full of melts";
extreme fatigue, rash on forearms and torso.  Fluctuating low/hi temperature 97 - 99 deg F. 5 weeks after, 6/13/20 recurring symptoms of extreme fatigue, rash on forearms. Lack of energy, clamminess. low energy.  sleeping all the time.
General weak feeling; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (General weak feeling) and CHILLS (Chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced ASTHENIA (General weak feeling) and CHILLS (Chills). At the time of the report, ASTHENIA (General weak feeling) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
I haven't had a cold in years, but one month after receiving my second Covid vaccine I came down with a severe chest cold; Much chest congestion that lasted over a week; Runny nose; Sore throat; Cough; A slight fever and chills; A slight fever and chills; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 18Mar2021 at 14:30 (at age of 68 years old, Lot Number: ER2613) as a single dose for covid-19 immunization. Medical history included Diabetes. No known allergies. The patient not diagnosed with COVID-19 prior to vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included empagliflozin (JARDIANCE); Propranolol; Metformin; Glipizide, etc. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 25Feb2021 at 02:30 PM (at age of 68 years old, Lot Number: EN6202) as a single dose for covid-19 immunization. The patient was haven't had a cold in years, but one month after receiving second Covid vaccine he came down with a severe chest cold. He had a runny nose, sore throat, cough and much chest congestion that lasted over a week. A month later he got it again, only this time he also experienced a slight fever and chills. The patient took a Covid test both times and they came back negative. No one else in he's household had been sick and now concerned that he may be experiencing side effects from the Covid Vaccine. The events occurred on 20Apr2021. The patient received treatment included over the counter cold medication. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 22Apr2021 and on 30May2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
No additional adverse events reported.; patient received one dose of HPV vaccine at the age of 18 and did not receive any additional doses or follow-up appropriately until today; This spontaneous report as received from a pharmacist refers to a 24-year-old patient, gender unknown. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  In 2015, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), unidentified Merck hpv vaccine administered (name and lot number not provided) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The pharmacist was unable to be confirmed which valent the patient received.  It was reported that the patient did not receive any additional doses or follow-up appropriately until today, on 15-SEP-2021. The patient was vaccinated with a dose  of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) prefilled syringe, lot #: S028738, expiration date: 03-APR-2022 for prophylaxis (dose, and  route of administration, were not reported) (inappropriate schedule of product administration). No further information provided. No additional adverse events reported. No product quality complaints. 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: S028738; expirationdate: 03-APR-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
Had hives or blister like areas around mouth and inside of mouth. These lasted a couple of days.
4 days post injection, pt complained of severe pain in rt deltoid. Increasing pain to rt shoulder,neck,& flank on 2/5/00. Pt went to ER on 2/6/00. Persistant acute pain in rt deltoid w/ swelling. Orthopedist dxed as axillary neuropraxia.
Swollen, red rash at site of injection. Severe pain at site of injection, radiating up the left arm and to neck. Also pain at side of body. Slight fever rash & pain lasted for one week.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (lot # M029601, expiry date 10-DEC-2017, dose, strength, vaccination site, route unspecified) for prophylaxis. The vaccines were exposed to a temperature of 11 Fahrenheit (F) for 24 hours. Stability questions were asked about M-M-R II during the call, however no doses of improperly stored MMRII doses were administered to patients. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Lot number # M029601 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. 30-NOV-2016 a call was placed to the Medical Assistant in order to obtain additional information. The call went to voice mail. A message was left.  All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Product lot # details and narrative were updated. Sender's Comments: US-009507513-1610USA005924: MERCK 1610USA007027: Mfr number.
This spontaneous report was received from a registered nurse concerning multiple patients of unknown age and gender. It was reported that on unknown dates, multiple unspecified patients may have been administered with an improperly stored RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). RECOMBIVAX HB was exposed to 30 degrees Fahrenheit for 11.5 hours which was not supported. The nurse was unsure if this improperly stored vaccine was administered. No concomitant therapy was reported. This is one of the two reports from the same source. Additional information has been requested.
Arm became red warm to touch and lump appeared continued to get worse over next few days MD seen on 10/4/2013 prescribed antibiotic and said he thinks something was in the vaccine vial.
his thighs are getting tossed to the right; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: unknown), via an unspecified route of administration at the right deltoid on 22Dec2020 18:40 at 0.3 mL, single for covid-19 immunization. Medical history included mini strokes and master strokes, connective tissue disorder from 2018 (diagnosed 2 years ago), seizure and brain issues.  The patient experienced "his thighs are getting tossed to the right" on 24Dec2020 05:00. The morning of 24Dec2020, patient woke up and he felt like everything was getting switched to the right on his thighs. Below his calf and his torso are fine. He feels fine though, it was just his hips and thighs. His sister reminded him that this is how he felt when he had mini strokes and master strokes in the past. She reminded him that his left leg would go to the right. He was not falling or anything though. He feels fine, it just has that feeling. He would like to know if he should be seen for this. He was just asking because his sister is freaking out and asked if he should be seen. Patient takes epilepsy medication, blood thinners and thyroid medication. He will receive 2nd dose on 08Jan2020. Outcome of the event was not recovered.
patient has a history of feeling nauseous after immunizations.  This was the first time that she had lost consciousness after a immunization.  After she gained consciousness she was sweating but okay and left after the paramedics checked her vitals.
No additional adverse effect reported; on 2/14/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions and allergies was not provided.  On 14-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error); (therapy type: Digital Data Logger), lot number 1660112 and expiration date 18-OCT-2020 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at a temperature of 2 degree Celsius (1.28 Celsius) for a timeframe of 2 hours and 30 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.  No adverse events were reported.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA (Lot# J28923, Exp date 30Jun2016), intramuscular in the left arm, on 28Dec2015 at 11:00 am, at 0.5 ml single. Relevant medical history was not reported. Concomitant medication included second dose of Flu vaccine (Lot# U5321AB), intramuscular in left arm, at 0.5 ml, on 28Dec2015. Previously the patient received first dose of influenza vaccine. On 28Dec2015, the patient experienced very pale, fainted approximately 10 minutes post vaccination, cognitively out of it, impairment. Also she developed numbness and arm was sore on an unspecified date. The patient underwent lab tests and procedures on 28Dec2015 which included: blood pressure measurement: was ok. The outcome of the events was unknown. The reporter considered that the events were related to TRUMENBA. Follow-up (29Jan2016): New information received from a contactable other health professional on behalf of the nurse includes: vaccination details, concomitant details, past vaccine history, causality assessment. Follow-up attempts completed. No further information expected.
Headache, itchiness, rash on back. Received Benadryl 25 mg PO.
This spontaneous report as received from a physician refers to 2 patients of unknown age. Physician reported that two employees at his office inadvertently received the dialysis dose of RECOMBIVAX HB (route, dose and indication not reported) twice on unspecified dates. No adverse effects were reported. Additional information is not expected.