chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 48-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 5 September 2008, 3 October 2008 and 9 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (20 mcg/mL, left deltoid). On 9 January 2009, the subject experienced drug dose administration interval too short. On 20 February 2009, 42 days after vaccination with the third dose of ENGERIX B, the subject experienced decreased therapeutic response. On 20 February 2009, hepatitis B surface antibody was low at 2.2. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778216A, A0778217A, A0778218A and A0778220A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Statement: ENGERIX vaccine lot numbers AHBVB703AA, AHBVB584AA AND AHBVB670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.
Problems with the plastic / Looks like the liquid was coming from the vial / It is "like it wasn't sealed; Half of the liquid or more sprayed down on patient´s arm during the injection; Sprayed down on patient´s arm during the injection; Inadvertent exposure to vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 7J2CA, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine 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 details were provided as follows: The reporter stated that the Fluarix vaccine had problems with the plastic and half of the liquid or more was sprayed down on the patient´s arm during the injection, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter stated that, it looks like the liquid was coming from the vial itself and the injection typically did not come off. The certified technician who prepared/administered the dose stated she was experienced with giving flu shots. The reporter stated that there was leak between the syringe barrel body and plunger stopper. The syringe was pre-assembled with needle maximum of 5 minutes prior to administration and used 25-gauge 1-inch size gauge needle. There was no blister or carton damaged.  The reporter did not believe so that there were any liquid traces observed on the plunger stopper rings. The luer lok not damaged. The needle which was used was in the sharps container. There was no any damage or breakage on the syringe barrel. The reporter consented to follow up by email.
Had a genital herpes outbreak that started next day. I've only had one previously about 10 years ago.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 at 14:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes 10 years ago. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a genital herpes outbreak that started next day on 19Apr2021. The patient only had one previously about 10 years ago. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had a genital herpes outbreak that started next day was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Blood pressure was 208; Light-headed; Extremely Sleepy; Lymph nodes was swollen for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was 208), DIZZINESS (Light-headed), HYPERSOMNIA (Extremely Sleepy) and LYMPHADENOPATHY (Lymph nodes was swollen for 30 minutes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo. Concomitant products included CLONIDINE for Blood pressure management, NAPROXEN SODIUM (ALEVE) and LOSARTAN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure was 208), DIZZINESS (Light-headed), HYPERSOMNIA (Extremely Sleepy) and LYMPHADENOPATHY (Lymph nodes was swollen for 30 minutes). At the time of the report, HYPERTENSION (Blood pressure was 208), DIZZINESS (Light-headed), HYPERSOMNIA (Extremely Sleepy) and LYMPHADENOPATHY (Lymph nodes was swollen for 30 minutes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 208 (High) 208.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took clonidine for blood pressure on way home and was extremely sleepy. She took losartan and felt sleepy, last night she called pharmacist and was told to take my losartan for the second time. Her niece was a nurse and checked blood pressure where it was dropping. On 05-Feb-2021, doctor said to take blood pressure medication. On 04-Feb-2021, the patient felt her lymph nodes was swollen for 30 minutes and clonidine has something to do with it, since that was taken 30 minutes after the vaccine and that makes her drowsy. She never experienced that feeling that way with that kind of sleepiness.
Both times I received the injection about  48 hours later I had a headache all over my head and nausea.  Today I was so nauseous that I vomited about 4 times.   I also noticed strangely that my birthmark on my leg which is normally a light pink had turned a very dark purple.
In the employees words "I got the flu shot and my left upper arm is swollen and red".
after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19; after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for three patients. This is the third of three reports.   The mother reported that the patient (her second child) of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19 on an unspecified date. The patient was administered monoclonal infusion as treatment. The mother asked if the patient can still get the second dose of the COVID-19 vaccine as scheduled. The outcome of the events was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130061 same reporter/ vaccine, different patient, similar event;US-PFIZER INC-2021133627 same reporter/ vaccine, different patient, similar event
Information has been received from a physician concerning a 17 year old female with no known allergies who on 06-AUG-2007 was vaccinated with a 0.5 mL first dose of varicella virus vaccine live (Oka/Merck) (Lot#658024/0833U). There was no concomitant medication. On 06-AUG-2007 or 07-AUG-2007 the patient developed a headache, chest discomfort and abdominal pain. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient was recovering. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Second dose early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose early) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: TCR Follow up received on 23 AUG 2021 contains Non significant information(reporter's contact number and Fax number)
Red bump/rash at  injection set. Red, itchy rash on neck and shoulders.
weakness started at 9:00-9:30 pm, she said she started having trouble standing up to go to the bathroom. ?hit me like a ton of bricks?. she was able to get back in bed and sleep but she called me at midnight saying she was stuck half on and half off the bed. she was having difficulty sitting up, had tried to get up and got stuck diagonally half on and half off of her bed. her heart rate was 110, but she said that?s not unusual for her. she was sweaty, possibly had a fever, and said she had thrown up. she was having trouble holding her bladder, which she said she usually is able to make it to the bathroom but couldn?t last night. this morning she tried to get up and her feet couldn?t support her and she went down to her knees and got stuck until we got help to get het back up. this morning she is still nauseous, weak, and has a bad headache
migraine headache started at 2am after recieving vaccine, headache has persisted on an intermitent basis for 3 weeks since, experienced face numbness and an episode of syncope lasting 15 minutes with "light headedness" in the shower on 12/29/21
LYMPHADENOPATHY Narrative: Patient sought medical care twice for armpit swelling and then pain in arm
Information has been received from a medical resident concerning a 68 year old female patient with osteoarthritis, hyperthyroidism, hyperlipidaemia, rhinitis allergic and migraines and a history of statin induced increase in liver function tests, hysterectomy and lumpectomy three time on the right breast who in September 2009, was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included aspirin, SYNTHROID, simavastatin, multi-vitamins (unspecified), "vel patch" and "micaluer". The medical resident reported that about seven or ten days ago, on approximately 11-JUL-2010, the patient had developed shingles. The patient had a red rash on the back midway down and extending under the right breast. No lab testes were performed. The patient sought medical attention by an office visit. At the time of the report, the patient was recovering. Additional information has been requested.
Onset of clinical symptoms of infantile spasms 12/18/11 diagnosed 1/07/2012 on TOPAMAX & ACTH injections now.
Next day felt fatigued, weak, no energy, drainey, tired. Lasted for 24 hrs.
pt recv vax 13JUN95 & 14JUN95 pt exp redness @ inj site & one-half egg sized swelling w/a large raised spot @ inj site; lasted for 7 days;
administered flublok qiv to a patient under the age of 18 with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 years old female patient to who was administered influenza quadrivalent recombinant vaccine [Flublok QIV] to a patient under the age of 18 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2022, the patient received 0.5ml dose of suspect influenza quadrivalent recombinant vaccine (lot number and expiry date not reported) via unknown route in the arm nos for Immunization to a patient under the age of 18 with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  Action taken : not applicable.  Outcome : Unknown.   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 Directive 2001/83/EC 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.
At  1020 am on 4/22/2021, I begin to feel chills generalized aching all over my body. Very  very, weak and could not stand up. had to lie down,  developed a runny( mucus) nose, the left arm from the shot became so painful and I developed a nodule under my armpit  that was very painful. The weakness  left me with loss of appetite and stomach pain.  The chills was so severe that I had to wrap up in two blankets. Took a Tylenol 500mg got some relief  within two hrs. however   the chills  and pain under the arm pit lasted until 10pm that night  at interval. Took another Tylenol and got better relief,. The  nodule is less visible at present but painful on  04/24/21 11:50 am.  The other symptoms has subsided.
patient was administered a dose of improperly stored VARIVAX on 07/09/2019; No adverse effects were reported; 4th dose of VARIVAX; administered a booster dose of VARIVAX (3rd dose); First dose of VARIVAX administered on 14-JUN-2008 and 2nd dose on 30-JUN-2008; Was administered a dose of VARIVAX on 06/14/2008, which was too early to the patient; This spontaneous report was received from a physician referring to a 11 month old patient of an unknown gender. Information regarding the patient's medical history, concurrent conditions and drug reactions/allergies was not reported.  On 14-JUN-2008, the patient was administered, too early, a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis.  On 30-JUN-2008, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis and there was not enough time between the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) and this dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (captured on #1907USA007163). Additionally, on this same date, the patient also received a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (discrepant information as it was reported as "counted as the first dose of varicella virus vaccine live (oka/merck) (VARIVAX)").  Then, on 23-JUN-2011, a booster dose (third dose) of varicella virus vaccine live (oka/merck) (VARIVAX) was administered.  On 09-JUL-2019, the patient was vaccinated with a fourth dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot No. R022116 (verified to be a valid lot number), expiration date reported and established as 02-AUG-2020, which was reconstituted with a properly stored sterile diluent.  Varicella virus vaccine live (oka/merck) (VARIVAX) was improperly stored at a temperature, total time in range, between 6°F to 14°F (7.9°F), during a time frame of 15 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.; Sender's Comments:  US-009507513-1907USA007163:
A little bit of sore arm, On October 13 my lungs started filling up with liquid and could not breathe. I went to ER, and I was admitted to the hospital.
Information has been received from a 28 year old white female nurse midwife with no allergies or medical conditions who on 02/20/98 was vaccinated with a second dose of varicella virus vaccine live. The pt was vaccinated with a first dose of varicella vaccine live on 12/11/97. Concomitant therapy included ethinyl estradiol (+) etonogrestrel for birth control. There was no illness at the time of vaccination.  The reporter indicated that a recent varicella titer did not sow seroconversion and was negative. The pt did not seek medical attention and no treatment was required. A product quality complaint was not involved. Additional information was received from the nurse midwife which indicated that on 09/25/03 a varicella zoster virus antibody immunoglobulin G was negative. The reporter was revaccinated. No further information is expected.
5/4/21- vaccinated with second Moderna 5/5/21- Patient reported fatigue and lethargy, slept a lot, "felt like someone punched me in the nose" 5/6/21- Patient reported fatigue and lethargy had subsided, but facial swelling had begun in nose and around eyes, patient reported he was able to complete shopping trip this day and other ADL's. 5/7/21- Patient awoke early in the AM with cold chills and overall not feeling well, had temp of 101, and increased facial swelling patient stated he was unable to wear eyeglasses due to swelling of nose. Patient contact PCP who referred them to the ER where he was diagnosed with cellulitis given antibiotics, steroids, and decongestant. Patient was informed by ER to follow up with PCP and return to ER if swelling progresses or does not subside by 5/9/21. Patient reports airway patent throughout  time post vaccination
abrupt onset dysarthria, left facial droop and left hemiparesis on 03/10/2020 (2 days after vaccine admin) concerning for ischemic stroke.  Found to have right ICA and M1 occlusions on imaging suggestive of large vessel occlusion as etiology of stroke.
Patient felt headache and then light headed approximately 10 minutes after vaccination. Cool chills all over body followed. Patient was provided with snack and drink (rice krispy treat and water). Patient was transferred to stretcher, where they reported improvement. Patient symptoms resolved and left approximately 30 minutes later.
Brief episode of lightheadedness, less than 10 seconds, brief tingling in left arm . Treatment included vitals and observation, resolution of symptoms and discharged home.
mom stats gave APAP following vax & the rest of day; pt ran temp 102-103 on Sundya following vax on Friday had nausea, vomiting & diarrhea; seen by MD;
Sore arm at vaccination site. Fever at 101. Persisted from onset through 24 hours. Has not resolved. Tylenol.
lowgrade fevers/he had fever; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low-grade fevers/he had fever. It was reported as consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and wanted to know if he can take Montelukast. He said that after receiving the 1st dose of the vaccine, he had fever, felt unsettled, and thought his lungs were inflamed so he took Montelukast. He said he only took it one time and wants to know if this has affected the vaccine. Consumer also mentioned that he had COVID-19 in July last year, and prior to that he has already been taking Montelukast to treat his allergies. He also said that this medication helped with his pneumonia. Consumer also mentioned that he was allergic to NSAIDs. Consumer also mentioned that he and his wife received the 1st dose of the vaccine at the same time and experienced low-grade fevers ranging from 99.7 to 99.8. He said his fever ranged from a low temperature of 96.2, and the highest it reached was 99.8. He said the fever comes and goes for a week now. He also said he had headache and felt unwell. Consumer also mentioned he and his wife took Tylenol to treat the symptoms and it seemed to have helped. Consumer said he was taking allergy shots and wants to know if it would be okay to take the shots before or after receiving his 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine. He said he was scheduled for the 2nd dose on 24Mar. The patient underwent lab tests and procedures which included pyrexia: 99.7 to 99.8 on his wife received the 1st dose of the vaccine at the same time and experienced low-grade fevers ranging from 99.7 to 99.8. Therapeutic measures were taken as a result of low-grade fevers/he had fever (pyrexia) with Tylenol. No product quality complaint was reported. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.