chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grey dots on legs; Vaccine administered at inappropriate site; This case was reported by a pharmacist and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number BD27G, expiry date unknown) for prophylaxis and pneumococcal vaccine (Prevenar) for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, the patient started Prevenar at an unknown dose and frequency. On 10th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171028   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots on skin after receiving Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: For tolerance to the 2nd dose refer case US2022AMR171028. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter
platelet count dropped down to 126 within a couple of weeks; Pain in left leg; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:15 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included overweight, seasonal allergies and temple headaches. Concomitant medication included ongoing hydrochlorothiazide taken for blood pressure high. The patient previously received first dose of  BNT162B2 on 12Mar2021 at 3:00 pm (Lot Number: EN6208), at the age of 54-years-old, in her left arm, for COVID-19 immunization. Temple headaches started before the first dose. Did have a temple headache before, but they seemed worse after first vaccine. The patient experienced sore arm on 18Apr2021 and pain in left leg on 19Apr2021. The patient got the second COVID vaccine on 18Apr2021 (Sunday), a couple of days ago. She noticed that her left leg is sort of painful. She had soreness in her arm Sunday and yesterday, but it's better now. Her questions were about the pain in her left leg. She was wondering if this is part of the muscle ache problem or is it probably something different? was there a way to know the difference on if this is from the vaccine or something else. Yesterday morning, her leg felt fine. In the afternoon it started to feel a little achy. It wasn't anything bad. She took Tylenol which seemed to work. Her leg really bothered her this morning since she woke up this way. She got the first COVID vaccine on 12Mar2021, and on the 17Mar2021, she went to get her blood work done. Her platelet count was down to 148. It is supposed to be 150. Her doctor told her to hold off on the second until they rechecked her platelets. She went and got blood work done again and they dropped down to 126 within a couple of weeks. The events didn't result emergency room or physician office visit. The patient underwent lab tests and procedures which included platelet count 148 on 17Mar2021 and platelet count: 126 on an unknown date. Treatment of the event pain in left leg included Tylenol. The outcome of the event sore arm was recovering. The outcome of the event pain in left leg was not recovered. The outcome of the other event was unknown.  No follow-up attempts are needed. No further information is expected.
Tired/ sore arm around 8pm. Fever started around 10pm and went up 1 degree in an hours time until 4am reaching 102.4. Most concerning was a resting heart-rate of 120bpm just sitting doing nothing. Heart-rate would fluctuate as if it skipped a beat and become racing/rapid with little to no movement.
Body aches, severe headache and fever. Fever broke at 8a 3/31/2021.
Patient looked like she had a slight seizure for about a minute at about 10:30 am. EMT called 10:31am and arrived at 10:39am. Patient was alert and refused transport.
redness; warmth; Soreness at the injection; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received Shingrix. On 30th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 1st November 2020, the patient experienced erythema and feeling of warmth. On an unknown date, the outcome of the injection site pain, erythema and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix in the left arm at a pharmacy and went into the reporter's office on the day of reporting for medical treatment.  The soreness at the injection presented on the same day after the administration.  Two days later, redness and warmth presented distal of the injection site. The reporter did not consent to follow up.
Constant "tingling" from below elbow down to thumb and hand.  I have not reported this to my doctor.  Planning to "wait and see" if it clears soon.
I experienced COVID-19 in February 18 2023.   I had some headaches, sinus, coughing, sick feeling of body aches, sneezing, chills, felt hot and cold at times. I called my doctor office to employee services, showed results of my home COVID test which was positive. My symptoms got worse with time, had difficult to sleep and had that sick feeling for awhile. My doctor prescribed Paxlovid and I took it for the entire time it was prescribed. I can say I am recovering but I still have some loss of voice, from the sinus drainage. I also had some adnominal pain about one month ago which was due to my irritable bowel syndrome and having lot of diarrhea. My stomach is better and taking Omeprazole.
Administered Novartis H1N1 (4 yrs and older) vaccine 0.25mL IM left deltoid. Should have given Sanofi Pasteur H1N1 (6 mo and older) 0.25mL IM. No signs or symptoms of distress noted.
p/vax pt felt a little dizzy & in the afternoon notice lt upper arm deltoid very itchy, red, swollen & small vesicle @ site;
Urticaria rash with slight itching, involving face and body. Started about 24 hours after the administration. Atarax was used for relief.
This is a spontaneous report from a contactable other-HCP (registered medical assistant) calling for the doctor. A 17-year-old Caucasian female patient received the 1st dose of TRUMENBA, ( lot # TS2805 or T52805, it looks S to the reporter at the moment, as reported, Expiry Date Aug2019) intramuscular at 0.5 mg, single on 25Sep2018 for immunisation. The patient medical history and concomitant medications were none. The patient experienced a rash around the site and on the face starting underneath the eyes and then on top of eye lids on 26Sep2018. She took BENADRYL on 27Sep2018 for it. The outcome of the events was not recovered. Lab work were none. Causality was reported as related.
7/21/05 I was informed today that lot # for ActHib shot given 6/16/05 did not match ActHIB; matched TriHibit instead. In case that was inadvertently given, gave ActHib today to make up for possible invalid dose 6/16/05. Parents deny any adverse reaction from 6/16/05 vaccines.
This spontaneous report as received on 12-JUL-2017 from a pharmacist (Pharm D) refers to a female patient of unknown age. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The pharmacist (Pharm D) reported that the first dose of VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) was administered to the female patient on an unspecified date "two years ago"  for prophylaxis. No symptoms reported. The pharmacist (Pharm D) was reporting on 12-JUL-2017 that an adult female patient was at the pharmacy right now (on 12-JUL-2017) to receive a second dose of VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) which will be late. The indication for the vaccine is prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT)(Lot number and expiration date were not reported).     The outcome of the adverse experience of inappropriate schedule of drug administration was reported as unknown. The pharmacist was busy at the time of this report and could not answer further questions. No further information was reported. Additional information has been requested.
odd smell to it/Felt the sensation as if someone sprayed something up her nose, like a foul smell up her nose; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot Number: EN5318, Expiration Date: 31May2021), via an unspecified route of administration, in left arm at the dose of 30mcg/0.3mL on 29Jan2021 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive concomitant medications. The patient previously took second shingles shot (two weeks and 7 hours prior to COVID-19 vaccine). The patient did not underwent lab investigations. Caller said she had gotten the first dose of BNT162B2 vaccine on 29Jan2021, which was on a Friday. She had no symptoms at all from it. The following Thursday on 04Feb2021 she was in her kitchen and went to get something on the fridge, and she felt the sensation as if someone sprayed something up her nose, like a foul smell up her nose/ an odd smell to it. It lasted 30 seconds or something. It was quick and not debilitating. It was a very unusual sensation. She wanted to see if anything like this has been reported? Some people are sensitive to smells, but she was not sensitive to smells. She does not tend to notice odor or smells. She was not sure if it was connected to the vaccine, but if it was not she does not know what it would be connected to. Her cousin was a nurse and she told her to search it. She did find it in the internet it was not connected with the vaccine, but connected with people who have had COVID. She had never done research on this before. Caller clarifies that she has not had COVID before. She was tested and did it that way. She has been tested for COVID and antibodies. She has not tested positive for either. She also has no symptoms or anything of COVID. She has never tested positive. The day she got the shot on 29Jan2021, two weeks and 7 hours prior to that, she had gotten her second shingles shot. She had asked 3 different pharmacists about this, and they had all said to wait 2 weeks to get the COVID vaccine after any other vaccinations. The event was assessed as non-serious by the reporter. Outcome of the event was recovered on 04Feb2021.
started with runny nose, then cough then high fever. The doctor's office noted on 1/21 URI symptoms then on 1/23 we brought my son in for wheezing which he then was prescribed medication for bronchitis.  My son's over health would get worse with each vaccine as well as his development slowed down after this vaccine and the MMR stopped his development all together.
This spontaneous report as received from a nurse refers to a 70 years old female patient with no drug reactions/allergies. On 23-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number J004056 is an invalid not number for PNEUMOVAX23, Exp date 22-JUL-2014), (dose not reported), intramuscular on the left deltoid in the physician's office. Other suspect therapies was ZOSTAVAX, (lot#, dose, route and anatomical location not reported) received in patient's local unspecified pharmacy at the same day. Concomitant medications included unspecified cholesterol medication and unspecified high blood pressure medication. The reporter stated that patient was seen in the physician's office on 25-OCT-2013, with redness, swelling, tenderness and warmth that initially started at injection site but had now spread all the way down the left arm past the elbow. The patient received an injection of DEPO-MEDROL and a prescription of KEFLEX as treatment for the symptoms of the PNEUMOVAX23 injection site reaction. The outcome of the events was reported as not recovered. Additional information has been requested.
Feeling dizzy and anxious. Pt was trendelenburg, supine, then sitting. Feeling better, given goldfish crackers, and water. Back to normal.  1533: HR 86, Resp 18, BP 96/64, O2 sats 99%. 1548: HR 87, Resp 18, BP 105/73, O2 sats 100%. D/C'd to home with mother @ 1550.
States she got the shot on the 17th and it didn't bother her at the time but by 11pm the next night it started hurting and when she woke up the next morning she felt like her R shoulder was dislocated she couldn't lift it or move it much.  She stated the pain got worse, no redness that she could tell or swelling that she could see.  She was icing it and taking warm showers and letting the water run on it, she was taking Alieve for the pain but nothing was really helping it. She finally went to the doctors on 10/31/2019 and it was swollen and still painful.  She was prescribed a steroid dose pack to take.  She states  the pain is a little less the past 2 nights she has been able to sleep.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 01-Oct-2018, the patient received a first dose 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261LA, expiry date 30-Jun-2019 via intramuscular route in the right deltoid. On 05-Oct-2018 he also received a second dose 0.5ml of the same vaccine lot UJ035AA, 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to extra dose administered. It was reported that 5 yr old patient was inadvertently given 2 doses of FLUZONE QUAD. Nurse reported patients dad brought patient in on 01-Oct-2018 and received the flu vaccine. Then patients aunt brought patient in on 05-Oct-2018 and did not know patient already received the flu vaccine and it was administered a second time. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a 70 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and Magnetic resonance imaging brain (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Chills; headache; very achy; Fatigue; This is a spontaneous report received from a contactable consumer (Patient herself). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on 04Mar2021 13:00 as unknown, single dose for COVID-19 immunization. Medical history included Restless leg syndrome, COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Since the vaccination, the patient was not received any treatment and patient had not been tested for COVID-19 as well. Concomitant medication included calcium, colecalciferol (D3), magnesium, macrogol 3350 (MIRALAX) and Multi vitamin. On 05Mar2021 12:00 the patient stated that she experienced some of the same symptoms as when she had the virus in August, Chills, headache, very achy and fatigue. The patient did not receive any treatment for events. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
APPROX ONE HOUR AFTER INJECTION LEFT SIDED HEADACHE.  24 HOURS AFTER INJECTION HEADACHE, NAUSEA, CHILLS, SWEATS, AND 101.0F FEVER.  LASTED 36 HOURS.NO SORE THROAT, COUGH, RUNNY NOSE, OR JOINT PAIN.  LOCALIZED INJECTION SITE ERYTHEMA, DISCOMFORT, & WARMTH.  ERYTHEMA FROM ELBOW TO DELTOID AREA OF LEFT ARM.  NO LESIONS.
Within two hours of booster, had tenderness and swelling from armpit to neck, especially around collarbone. Painful lump at collarbone. Overnight had fever symptoms (chills, etc) that extended through the next day. Fatigue /ache
No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 19-MAR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(rha) lot # R004441, expiration date 12-AUG-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) for 2 hours and 7 minutes. There was previous temperature from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012684: US-009507513-1905USA009915: US-009507513-1905USA012683:
Patient complained of chest feeling heavy and throat feeling swollen a few minutes after administration of vaccine. We therefore called 911 for an ambulance, and monitored patient to watch for signs of difficulty breathing. After paramedics arrived, they took her away on stretcher to ambulance to administer Benadryl. Patient later informed us that when she was in the ambulance, her entire body became numb.
Vaccine had expired on 09/30/2022, vaccine was given to child today, no adverse events experienced by child
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The reporter indicated that she was not sure whether the patient received FLUMIST IV or not. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 30-Jan-2012: the reporter stated that the patient did not experience any late occurring adverse events.
After Shingrix vaccine on 9/20/21 site began swelling and itching and turning red 9/21. Continued to worsen and she went to urgent care 9/24 where diagnosed with cellulitis.  redness too deltoid area to below elbow.  treated with Keflex 500mg 4 x daily.  followed up with Dr. 10/8 and still a few spots and small amount of redness.  PCP unsure cellulitis vs normal strong Shingrix reaction.
Information has been received from a physician concerning a 11 year old white male who on 29-APRI-1998 was vaccinated in the left arm with a dose of Varivax. On 19-NOV-2006, the patient broke out with chickenpox. There was no illness at the time of vaccination. Subsequently, the patient recovered from chickenpox. It was also reported in the patient's record of immunizations that he received the following vaccinations: a first, second, and third dose of hepatitis B virus vaccine (manufacturer unknown) on 11-OCT-1995, 07-NOV-1995, and 17-JUL-1996;l a first, second, third and fourth dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis vaccine (unspecified) (+) tetanus toxoid on 08-DEC-1995, 09-FEB-1996, 26-APR-1996, and 10-JAN-1997; a first, second, and third dose of IPOL on 08-DEC-1995, 09-FEB-1996, and 26-APR-1996; and a first dose of MMR on 10-JAN-1997. Additional information is not expected.