chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a dose of Adacel in the left deltoid, dose that was administered was expired with no reported adverse event; Initial information was received on 12-Jan-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 11 years old male patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in the left deltoid, dose that was administered was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI).  On 12-Jan-2023, the patient received Total 0.5 ml once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA, route, strength, formulation: Unknown) in the left deltoid for Immunization (Immunisation) that was administered was expired on 18-Nov-2022 with no reported adverse event (expired product administered) (Unknown latency)  It was reported that " Today about 20 minutes ago a patient received a dose of Adacel in the left deltoid. The dose that was administered was expired on 18-Nov-2022. Treatment The caller stated they would plan to call the patient back as soon as possible to repeat the dose."   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event received a dose of adacel in the left deltoid, dose that was administered was expired with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Two days after the administration, the patient started to feel headaches that lasted all the way through January 3, 2021.
Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: pt had syncope event. pt did not pass out, but almost did. blood pressure was taken and bp was low. heart rate 84. pt recovered within 5 minutes and drank gatorade
body hurt so bad; head to toe rash that is red blotches, it does not itch or burn; felt like she had COVID all over again; symptoms put her in bed; throwing up; developed diarrhea; body aches; severe headache that felt almost like a migraine; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt like she had covid all over again, symptoms put her in bed, body hurt so bad, throwing up, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine.  The patient's medical history was not provided. Concomitant medications reported were Cecalafram, Eliquis, Hydroxychloroquine, prednisone, flimorsimite, omethrazal, pramitexole, metoparal, rovestatin, womens daily vitamin, C,B,D vitamins for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) felt like she had covid all over again, symptoms put her in bed. On an unknown date, the patient experienced the event(s) body hurt so bad, throwing up, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine.  Treatment details included liquid tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Feb 2021 the outcome of event(s), symptoms put her in bed, throwing up was resolved. The outcome of event(s), felt like she had covid all over again, body hurt so bad, head to toe rash that is red blotches, it does not itch or burn, developed diarrhea, body aches, severe headache that felt almost like a migraine was unknown.
Developed shingles two days after booster. This is the third time I've developed shingles since I started the COVID-19 vaccinations; two of the three times were within a few days of an injection. Generally speaking, I have a significant inflammatory response to the vaccine: joint pain and swelling that last several days. I have assumed this is because I have EDS. I often get joint swelling when I'm ill.
turned pale approximately 5 minutes after vaccines were administered and fell from the chair,slumped on the ground.per MD was a vasovagal response
Approximately 10 min after receiving a Moderna vaccination, patient experienced syncope and passed out for a few seconds. When he regained consciousness he said he felt lightheaded, sweaty, and arms felt tingly. Asked patient how his breathing was, he said it was fine. We gave him a bottle of water, which he drank. Started feeling better. He remained sitting on floor. Blood pressure 10 minutes after syncope: 96/60. Patient said he remembers passing out in the 4th grade after receiving a vaccination. He said his blood pressure always runs low. We had him remain sitting for another 15 minutes. He said he felt much better, so we had him stand up and sit in a chair. No dizziness. We offered to call his family but patient did not feel it was necessary.  One hour after receiving vaccination patient said he felt perfectly fine and left pharmacy.
feels pretty sick; Nauseous; going to the bathroom a lot; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received BNT162b2, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history included tooth extraction and bone graft, and was not feeling real well after that. The patient's concomitant medications were not reported. Patient received COVID vaccine on 28Dec2020. Patient stated she feels pretty sick since getting the COVID-19 Vaccine, saying she is mainly nauseous and going to the bathroom a lot; all from 30Dec2020. The patient said she went to the dentist, and got an antibiotic. She was prescribed Amoxicillin 500mg, three times a day, by her dentist. She said she took her first dose of Amoxicillin 500mg this morning (31Dec2020). She said after she took the first Amoxicillin 500mg dose, she thought she better check to see if it is OK to take an antibiotic after receiving the COVID-19 Vaccine. She did not necessarily think the nausea and going to the bathroom a lot had to do with receiving the COVID-19 Vaccine. She wanted to know if she takes an antibiotic after receiving the COVID-19 Vaccine, will the antibiotic cause a problem with the COVID-19 Vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product events most likely due to patient underlying contributory factors
This new born was given a Hep B vaccine on 11/30/00, and a duplicate dose on 12/01/00. No adverse symptoms.
pt recv vax & devel an inj site rxn characterized by swelling, redness & warmth;tx w/symptomatically & recovered;
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 31-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVIs 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 48 hours, at a lowest temperature recorded of 34 degrees F (1.11111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Erythema and warmth just distal to site of injection, c/w cellulitis.
Swelling in the left Armpit; Very Very Sore Left Armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in the left Armpit) and PAIN IN EXTREMITY (Very Very Sore Left Armpit) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced SWELLING (Swelling in the left Armpit) and PAIN IN EXTREMITY (Very Very Sore Left Armpit). At the time of the report, SWELLING (Swelling in the left Armpit) and PAIN IN EXTREMITY (Very Very Sore Left Armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was included. No treatment medication was included.   This case was linked to MOD-2021-050013 .
Muscle strain of neck. Gradual onset to disabling pain in neck. Seeking treatment and physical therapy
Pt stated 3 hours after shot felt dizzy, nauseous, had H/A, tested blood sugar & was almost 400 which is never that high, took double dose of Glipizide 10 mg & B/S remained high throughout day close to 200) & again at 24 hours later.
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided
Six hours after injection developed hives all over body. Face became swollen, was itchy. Pt was seen in urgent care, was given a steroid injection and prescriptions for prednisone and Atarax.
patient felt light headed and a person standing by notified pharmacy. I, staff RPh, assessed patient quickly and helped her to a supine position on the floor with legs elevated. Patient fainted as she was being helped to the floor. Patient's eyes was dilated, we called 911 and I grabbed the BP unit and checked pulse. Pt regained consciousness after about 7 to 8 seconds. Pt was able to identify herself and answer all questions. We grabbed an orange juice for the patient as she had not had anything to eat and had just worked out. Pt's BP was 108/90 and remained around that range for about 5 or so readings. PT drank and was encouraged to lie in supine position with legs elevated for 15 more minutes even though she stated she thought she was fine. Pt waited until 12:55pm and also stated she had fainted with a past blood draw. Pt appeared fine by 12:55pm, bp still around 100/80, pupils is back to normal. 911 was cancelled per patients request shortly after regaining consciousness.
Day after DTaP  vaccines given patient presented to clinic with a cellulitis medial to the injection site
woke up to arm serve itch and a red patch broke out  dr said appers to be hives reaction
Injection Site pain about one day, A little bit of tiredness about a day. Headache after 12 hours and lost about  4 hours. Chills after 12 hours and lost for 2 hours. Starting have fever after 9 hours and getting  fever around 99.7 F after 16 hours. Getting better after one day.
Patient stated they developed a fever 4 days after the vaccine . Fever went up to 100.3 degrees Fahrenheit and then went away. However, patient also developed a rash the spread on their arm and also on their backside as well. The rash is not painful and patient stated it was only itchy around the waist. Patient did not report and swelling of face/lips/tongue or difficulty breathing.
Information has been received from a registered nurse referring to 20 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (dose and route not reported, lot # L023385 with expiration date 25-JUN-2017 and therapy type rHA). No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
This case is linked with case 2012-10121 adverse event developed following the administration of FLUZONE HD (Lot number not provided) case reported by same reporter. Initial report received from a consumer who is also the patient daughter on 12 October 2012. An elderly male patient, whose exact age was not reported and medical history and concomitant medications were unknown, received a dose of FLUZONE HD (lot number, route and site of vaccination was unknown) on an unspecified date. On an unspecified date, the patient developed unspecified adverse event with "FLUZONE for over 65". Corrective medication was not reported and laboratory investigation was unknown. The patient's outcome was unknown.
I received the Moderna booster vaccine, and 10 days after I noticed itching a hives on my body. After the hives got very bad and spread all over my body, I made an allergist appointment. I also was experiencing swelling in my hands She said I am the 5th person to come in around 2 weeks after the Moderna booster with the same symptoms. She told me to take Xyzal every night and it helped only a tiny bit. Since it did not go away, I went to the ER and they gave me prednisone to take for about 3 days. Although it slowed it down, the hives were still there. It is almost a month later and I am having the exact same symptoms. After going to the dermatologist, I was told to do a specific routine for 2 weeks and if it is not better to go get an allergy test.  I have been on Xyzal, Allegra, Zyrtec, and steroid cream for about 5 days now and there is no change.  *I did not change anything in my routine- therefore I do not think it is an allergy issue.
VACCINE GIVEN 10 DAYS  (10/14/22) AFTER USE BY DATE (10/4/22)
Patient states their arm was swollen and had rash around the injection site. Patient also state their arm was painful and symptom lasted for 3 days.
5.5 x 5.5 cm erythema on upper (Lt) shoulder. 3 x 3 erythema just anterior to 1st area. Mildly TTP.
This spontaneous report as received from a female nurse at her mid 50's who concerned herself. The nurse reported that after she reconstituted and administered the 0.65 ml dose of ZOSTAVAX (lot # unknow, exp: September 2013), subcutaneously to a patient, she noticed "discomfort" in her eyes. The nurse described AE as "discomfort underneath her eyes and they felt swollen and very puffy" and the event would cause her to rub her eyes continuously and experienced the discomfort for the rest of the day. The nurse stated she was wearing gloves and she would not develop any adverse reaction upon reconstitution of the vaccine. The nurse told that she did not have this problem when she administered other vaccines (products unspecified) so she was making the correlation to the ZOSTAVAX being the cause. After checking with the PQC department, no PQC involved because the nurse at no point did any of the ZOSTAVAX vaccine content actually touch her. The outcome of the event was reported as recovered/resolved. Additional information has been requested.
Patient Started getting very thirsty 4 months after the shot.  He went into the hospital after it persisted for a few weeks of not being able to quench his thirst.  Blood glucose level was over 700.  He was diagnosed with Type 1 diabetes.  Will need to take insulin now to regulate his blood sugar.
This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # J011332, expire date 13-SEP-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
feeling sick; nausea; soreness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nausea) and MYALGIA (soreness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 025A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (feeling sick), NAUSEA (nausea) and MYALGIA (soreness). At the time of the report, MALAISE (feeling sick), NAUSEA (nausea) and MYALGIA (soreness) outcome was unknown.            Treatment medication include Pepcid  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011245.
Breathing Issues, shortness of breath, fatigue, that has gotten progressively worse. I was an active and healthy person and have been unable to do normal activity and exercise since receiving my second vaccine.
Kinrix given to 8 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number SKBG9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 18-Jan-2023 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Stronger pain of headache/Had few pangs of headaches which wasn't long term; Hay fever; Sneezing and blowing; Forehead swelled up/Had to go to Emergency Care because my forehead swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number; NDC number: Unknown, Expiration date: Unknown), via an unspecified route on 19May2021 as a single dose for covid-19 immunization. Medical history included problems with preservatives and histamine. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) as a single dose for covid-19 immunization and had a couple days of fatigue. On an unknown date after second dose, patient experienced swelling and had a few pangs of headaches which wasn't long term. She mentioned that 10 days later she ate a chocolate chip cookie and she had to go to Emergency Care because as her forehead swelled up and more headache was from the cookie she ate and more stronger pain of headache. She had a forehead swell up from a Wendy's chocolate chip cookie she ate. There was bleached flour in the cookie. She didn't look up ingredients of the cookie. She did not think about it and she ate it. She had hay fever (the night before), she was sneezing and blowing then her forehead swelled up. She had problems with preservatives and histamine. There was bleached flour in the cookie. She did not look up ingredients of the cookie. The doctor prescribed prednisone for 3 to 5 days for a couple times a day. The swelling went down after 1 prednisone. She had a headache last night but not today. She only going to take 1 pill. She was not going to take any more. She wanted to know if it effects the efficacy of the vaccine if she took 120 mg prednisone, 10 days after the second vaccine. She mentioned that she goes to exercise class and those who has the vaccine, they dont wear the mask and she doesnt feel its safe. She enquired about the duration of protection after the second dose and discussed the response of those who are immunocompromised and those receiving immunosuppressant therapy and asked if older people have a diminished response. There was no PQC (Product quality complaint) present. The clinical outcome of the headache was recovered on an unspecified date in 2021, and outcome of other event was unknown.  Information about batch/lot number is requested.
Client stated she had a slight fever on 6/18/2021, a day after receiving the rabies vaccine. Client stated she had a blister on her hand on Saturday 6/19/21. Then swelling occurred in fingers bilaterally and progressed to her palms. Client complaint on itching and pain at the sites of the swelling. Client stated today she now having swelling in her feet. Client denied any other symptoms. Client stated she did very well with the first rabies vaccine. She stated that the Tetanus injection site was redden and swollen.
syncope; POTS; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2012 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), syncope and dizziness. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.