chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 2 months old patient (gender not reported) who received an expired 0.5 ml first dose (frequency: once) of vaccine PENTACEL (lot C3552AA and expiry date 18-Dec-2018) via unknown route in the right thigh on 19-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation and Rhoda pack. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient had any adverse event. 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 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. List of documents held by sender: none.
Given Benadryl 25 mg PO pre-vaccination per provider. Patient had hives, swelling and tightness in throat approximately 25 min after dose. Given Benadryl 25mg PO after dose. First vaccine: had hives/rash down arms/back 15 minutes after receiving vaccine. Stable, though continued to have "scratchy throat", released from vaccination site.
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot # 647661/0055R). Subsequently, the patient developed an injection site hematoma. The patient was treated with an unspecified antibiotic. The patient recovered from the injection site hematoma. The injection site hematoma was considered to be an other important medical event. Additional information has been requested.
vaccine 4/29/21, developed chest pain 5/3/21, cardiac MRI consistent with myopericarditis, peak 5th generation troponin T 1360
about a month p/vax weak, had numbness & tingling feeling in legs-pain in back & knees sick feeling all over
Swollen muscle, warm to touch, tenderness, hard area (2") at injection site, slight erythema. Using ice packs and seems to be resolving.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, from 22-DEC-2016 to 21-APR-2017, the patients were vaccinated with improperly stored ROTATEQ, by oral route, lot number M034799, expiration date 01-FEB-2018, (dose, dose number and frequency were not reported), for prophylaxis. The ROTATEQ experienced a temperature excursion from 47 Fahrenheit Degrees to 77 Fahrenheit Degrees during a time frame of 10 minutes. The ROTATEQ did not experienced any previous excursion. The digital data logger was involved. Additional information has been requested.
Fatigue; Dizziness; Headache; Female patient was vaccinated during pregnancy; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number: EP6955) via an unspecified route of administration as a single dose on 16Mar2021 at 15:15 (at the age of 36-years-old) in the right arm for COVID-19 immunisation. Her last menstrual period was on 24Jul2020 with gestational age of 33 weeks. Her expected delivery date was 01Jun2021. Medical history of the patient was not reported. It was reported that she had no allergies to medications, food, or other products. Concomitant medications included prenatal vitamin (MANUFACTURER UNKNOWN), fluoxetine (PROZAC) and magnesium (MANUFACTURER UNKNOWN); all used for an unspecified indication (all received within 2 weeks of vaccination). Vaccines taken within 4 weeks included TDAP vaccine (MANUFACTURER UNKNOWN) on the left arm and RHOGAM vaccine (MANUFACTURER UNKNOWN) on right hip; both on 05Mar2021 for immunization. The patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 17Mar2021 at 12:00, the patient experienced dizziness, fatigue and headache. No therapeutic measures were taken to treat the events. At the time of the report, the outcomes of the reported events dizziness, fatigue and headache were recovering. The outcome of the event vaccine exposure during pregnancy was unknown.
Excessive pain resulted from Booster shot.  Left upper thigh, radiating to left buttocks and left leg.  Pain lasted approximately 5 days and made mobility very difficult.
Information has been received from a medical assistant concerning a 77 year old female who on 03-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number, route and site not reported).  On approximately 07-FEB-2009, "over the weekend" the patient developed rash.  The patient was scheduled this week to see the physician.  Additional information has been requested.
Very Extreme headache for about 18 hours starting  at 11:30 PM 4/1/21, the same day as recieving the vaccine. Chills, fever, fatigue, and joint soreness all accompanied the severe headache as well.
While vaccinating the patient, the needle popped off the syringe after injection the solution in the arm. Fluid sprayed on the vaccinator's gloved hand and the patient's arm. Unknown amount of vaccine was administered. Spoke to Dr. who gave verbal order for an immediate additional vaccination due to the patient being immunocompromised and needing maximum protection from the vaccine. Patient verbalized understanding and consented to vaccination. Patient handled second vaccination without adverse events.
Employee became lightheaded and felt 'hot.' Indicated he had some vision changes but those dissipated shortly after occurrence. Was instructed to call his PCP to discuss options for possible treatment. Employee went back to work after a few minutes and hydration, and indicated he felt much better.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided. On 13-DEC-2018, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot # R025296, expiration date 08-JUN-2020; strength, dose, frequency, route were not reported) for prophylaxis. The reporter reported that shipment of PNEUMOVAX 23 was received on 13-DEC-2018 instead of 12-DEC-2018 and was stored in the refrigerator (manufacturing product shipping issue). It was not viable because it was received too late (product storage error). The vaccines were exposed to temperature excursion of 44 Fahrenheit for 1 hour. The data logger was involved. There was no previous temperature excursion. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was unknown. No adverse effected reported.
Information has been received from a registered nurse concerning a 49 year old female with penicillin allergy, sulfa allergy, ciprofloxacin hydrochloride (Cipro) allergy, erythromycin (E-Mycin) allergy and hypothyroidism who on 15-MAR-2007 was vaccinated with Gardasil, IM. Concomitant therapy included Levaothyroxine Na (SYNTHROID), vitamin B (unspecified) and valacyclovir HC1 (VALTREX). On 15-MAR-2007, after receiving the first dose of Gardasil, the patient became drowsy and had trouble taking a deep breath. The patient was not in distress. No treatment was provided. The patient called the physician back on 16-MAR-2007 and reported she was still having trouble taking a deep breath. Additional information has been requested.
Approximately 2 PM, 5-5-10, pt was being bottle fed by his nanny.  Both his hands started shaking & this persisted 4-5 minutes.  Went to sleep after this.  At 4:25 PM, 5-5-10, mother called to report that pt's face was swollen.  Cheeks and one ear bright red.  Sent to ER. This is in follow-up to report(s) previously submitted on 05/06/2010: provided Mfr/imm. proj. reort no.
I got the shot on 3/22 and on 3/25 I was hospitalized for a flare-up of ITP with a platelet count of 14.  Got 2 units each of dexamethazone, IVIG, and platelets.  Released on 3/27 with a count of 161.  Readmitted 4/5 with a count of 11.  One round of platelets, count fell to 8 in 24 hours.  Then I got 1 round of IVIG, count raised to 10 in 24 hours, which was this morning.  Advised not to get 2nd shot.
Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 29Apr2021 as dose 2, single (Lot number: EW0170) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Facility type vaccine: Other. If other vaccine in four weeks: No. Concomitant medication(s) included in two weeks: ATORVASTATIN; PROGESTERONE; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Covid test result=Positive". If covid prior vaccination: No. If covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab. Covid test name post vaccination=Unknown. Covid test date: 28Dec2021. Covid test result: Positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2021) Positive.  No follow-up attempts are possible. No further information is expected.
Red spot at injection site appeared. Bump with hot to touch and soreness at the red area. Soreness of arm went away after a couple days prior to red spot appearing and soreness to touch. Ongoing no treatment given. I will wait and see how long it lasts, it?s been about 1 day.
Patient called about 24 hours after vaccine administration stating that she had a rash that did not itch. Patient was instructed to take BENADRYL and call MD ASAP.
I developed a bumpy itchy skin rash at the injection site 1 week after my vaccine. The bumps are itchy and are only at the injection site (upper left arm)
Initial unsolicited report received from a healthcare professional on 11-Aug-2016. This case involves an 11 years old female patient who was vaccinated with first dose of MENACTRA (batch number: U5186AA, expiry date: 14 March 2017; route of administration was not reported) in the right deltoid and dose of BOOSTRIX (batch number, expiration date, route and site of administration was not reported) on 03-Aug-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies included latex, asthma and skin sensitivity. Concomitant medication was reported as none. 09-Aug-2016, 6 days following the vaccination, in evening, the patient developed hives across her upper back tops of arms and neck. On 10-Aug-2016, it was hot and red. Laboratory data was reported as none. Corrective treatment was not reported. On 10-Aug-2016, patient was recovered red and hot hives. Outcome of hives across her upper back tops of arms and neck was reported as unknown. List of documents held by sender: none.
Felt bad after shot, went to GP as participant had trouble standing.  Heart rate was low, Participant counted BPM in the 40?s.  GP Referred to a Cardiologist in April.  Cardiologist put on heart monitor.  Cardiologist consulted test results from participant physical that was just prior to getting vaccine.  Cardiologist stated that things could not change that quickly.  Heart rate is still low, cardiologist is puzzled.  In July participant began to feel better.
11/26/2022 Late in the night patient felt unwell.  11/27 Woke up feeling unwell.  Developed a cough.  Tested with an At Home COVID-19 test, negative.  11/28 Fever peaking at 99 and tested with an At Home COVID-19 test, positive.  Televisit with doctor.  Doctor Prescribed Paxlovid.  11/29 Developed a sore throat for that day.  A little diarrhea.  No appetite for the week.  Cough continued and briefly lost sense of smell and taste.  Experienced throat and upper chest congestion for about a week.   Back to normal mostly by 12/7.
This spontaneous report was received from a licensed practical nurse referring to a 4 month old patient (gender unknown). The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 21-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date:16-NOV-2016, orally; (volume/dose reported as 2) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376:US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1612USA006673: US-009507513-1612USA006676: US-009507513-1610USA003097.
Headache 5 days later; Full ear, ear pain; Rumbling in ear; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, bartonella, babesiosis, allergies to sulfa, fluroquinolones and cephalosporin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 11Mar2021 the patient experienced headache 5 days later, full ear, ear pain, rumbling in ear. The events resulted in doctor or other health care professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache 5 days later, full ear, ear pain, rumbling in ear  was not recovered 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.
This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. This healthcare professional reported similar events for 3 female patients. This is the third of the three reports. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, at a single dose, for immunization. The patient's medical history and concomitant medications were not reported. The patient complained of significant reactions in the area of the vaccine described as large, pink, hard, wheal like lesions that lasted about 10 days on an unspecified date. The patient did not complain about the pain or itching in the area; it was more about the size of the rash. Outcome of the events was recovered on an unspecified date. Sender's Comments: Linked Report(s): US-PFIZER INC-2017340746 same reporter/drug/event, different patient; US-PFIZER INC-2017340629 same reporter/drug/event, different patient.
pt recv vax & devel hives;c/o itchy throat constantly clearing throat;P80, R20, eyes puffy & turning red;
injection site pain; injection site swelling; injections site discomfort; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 89-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site pain, injection site swelling and injection site discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site discomfort to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her influenza vaccine in September of 2018. The patient reported that after receiving the influenza vaccine, she experienced pain, swelling and discomfort at the injection site. The symptoms began the following day after the vaccination and lasted a couple of days and then resolved. The reporter consented to follow up.
Raised red rash the size of a silver dollar at the site of the injection. The rash feels hard underneath the skin.
Information has been received from a health professional concerning a 55 year old female who on 14-SEP-2006 was vaccinated with a dose of Varivax. On 25-NOV-2006, the patient was admitted to the hospital for bilateral pleural effusion and pericardial effusion. She needed bilateral chest tube insertion and a pericardial window. She was discharged on 05-DEC-2006. She was readmitted on 15-DEC-2006 with pleural effusion and was discharged on 23-Dec-2006. The reporter noted that the patient was vaccinated at another facility and did not have the lot number. The reporter also mentioned that the patient's physician felt that there were no other reasons for the patient's experiences other than the vaccination. Bilateral pleural effusion and pericardial effusion were considered to be immediately life threatening and other important medical events by the reporter. Additional information has been requested.
In Thailand the patient received three doses of the vaccine with the name Speeda, and will receive the fourth dose with Rabavert; RabAvert vaccine had to be given early; Case reference number US-BN-2022-001383, is a spontaneous case report initially received on 24-Jun-2022 from a nurse (reference number: USBAV22-0410) and concerns a female patient of unknown age. . The patient's medical history and concomitant medication details were not provided.  On an unspecified dates, the patient received the first three doses of co-suspect Speeda vaccine (Rabies vaccine inact (vero)) for post-exposure rabies immunisation due to a bite (unspecified) in Thailand, at an unknown dose, route or site of administration.  On an unspecified date, the patient was vaccinated with RabAvert ((Inactivated, Strain Flury LEP); batch number unknown) as a fourth dose for post-exposure rabies immunization due to a bite, at an unknown dose, route or anatomical location of administration (explicitly coded as 'Interchange of vaccine products'). It was stated that the RabAvert vaccine had to be given early (explicitly coded as 'inappropriate schedule of vaccine administered').  It was not reported whether the patient experience any adverse reaction after vaccination.  Additional information received on 27-Jun-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with RabAvert as a fourth dose for post-exposure rabies immunization due to a bite, after the patient received the first three doses of co-suspect Speeda vaccine, which is considered as interchange of vaccine products. It was stated that the RabAvert vaccine had to be given earlier, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. Interchange of vaccine products and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Interchange of vaccine products and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with RabAvert as a fourth dose for post-exposure rabies immunization due to a bite, after the patient received the first three doses of co-suspect Speeda vaccine, which is considered as interchange of vaccine products. It was stated that the RabAvert vaccine had to be given earlier, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. Interchange of vaccine products and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Interchange of vaccine products and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Headache starting 2pm Generalized achiness 8:20 pm and increasing in intensity through evening, night and continuing next day Fever and chills, shivering starting 11pm Weakness and deep bone pain through night into next day Fever subsided about 9:30am 1/13/21 Headache persists , weakness and joint aches  Treated with Tylenol I had at home and muscle relaxers with no relief until 1-13-21
Client reported at a follow-up appointment (11/10/11) that she had "tight chest" with mild difficulty breathing (on 11/3/11) the following day after receiving vaccines had mild "puffy eyes". These occurred after client left clinic - difficulty breathing that evening and angioedema the next AM. No other complaints per client. No physical complaints other than a "sore arm" upon administration 11/3/11. Recovered at home completely.
Got it yesterday at noon, totally fine until 10pm.  Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache.  Was on couch and walked upstairs.  By the time I got there, I was nearly vomiting and on the verge of losing consciousness.  I laid down on the cold tiles and tried to stay conscious. I couldn't even talk.  Saliva was pouring out of my mouth uncontrollably.  After awhile it let up enough to scoot into the bedroom and climb into bed.  Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears.  Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am.  Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears.  This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back.  Later today had episode of sharp chest pains front to back that resolved after about five minutes.  Treatment has been rest today.
pt recvd vax 31MAY95 & 1JUN parent phoned MD office to report that pt had a fever of 105 R;also had swelling & redness @ site;DPH & APAP prescribed;parent was instructed to contact MD again if fever did not subside
Two hours after receiving the TRUMENBA vaccine, patient complained of body aches, sore throat, headache, and fever. Came to primary care physician's office the next morning for an evaluation. Had a fever of 101.1 at that time along with stiffness and pain in the right arm. 1.5 cm x 1.5 cm redness on r. arm, 1 x 1 cm also on arm.