chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cardiac pacemaker insertion; Slurred speech; Low blood pressure; Methicillin-resistant Staphylococcus aureus infection; COVID-19; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from a company (manufacturer control number: 21K-163-4154049-00).   A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization; upadacitinib (RINVOQ), oral from an unspecified date (Lot Number: 1150513), at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on Jan2021, cardiac pacemaker insertion (medically significant) on an unspecified date, slurred speech on an unspecified date, low blood pressure on an unspecified date, methicillin-resistant staphylococcus aureus infection on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: low on an unspecified date, COVID 19: covid 19 on Jan2021. The patient went to hospital for low blood pressure and slurring words. She had Covid 19 in Jan2021. She had methicillin resistant staphylococcus aureus infection. She had a pacemaker put in. The adverse event information provided by patient was related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer BioNTech. The action taken in response to the events for upadacitinib was unknown. The outcome of the events was unknown.  Causality for BNT162B2: The reporter's causality for the events Cardiac pacemaker insertion, Low blood pressure, COVID-19, Methicillin-resistant Staphylococcus aureus infection, Slurred speech was possible.  Causality for RINVOQ (upadacitinib): The reporter's causality for the events of put pacemaker in, low blood pressure, covid 19, methicillin resistant staphylococcus aureus infection and slurred words was not provided.  Conpany's opinion is that there is no reasonable possibility that the events of put pacemaker in and covid 19 are related to rinvoq (upadacitinib). Company's opinion is that the events of low blood pressure, methicillin resistant staphylococcus aureus infection and slurred words are not assessable.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The events of COVID-19, Cardiac pacemaker insertion, Dysarthria, Hypotension and Staphylococcal infection are related to the suspect product BNT162B2 based on plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020) for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms were unknown. The reporter considered the injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The patient was also a nurse. The patient received SHINGRIX on right arm and experienced a number of reactions such as; redness, heat, and the color orange knot the size of an orange at the injection site. The patient also experienced flu-like symptoms such as nausea, chills, and fever. It started at 3 AM and lasted for 24 hours. The healthcare professional (HCP) was not aware if there was a doctor visit.
Areas of erythema (R) 4x3 cm. (+) tenderness, (L) 6x2 cm (=) tenderness. 4x with KEFLEX 500mg TID x 5 day and Ibuprofen 600 mg every 6 hours.
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves elderly patient (age not reported) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot UI933AB, expiry date: 18-Mar-2019) via intramuscular route in the left deltoid on an unknown date. The patient's medical history and concomitant medications were not reported. It was a case of syringe issue since 0.5 ml dose was running down the patient's arm that could have leaked from the needle hub or there could have been a crack in the syringe. It was unknown if any adverse event occurred following the vaccination. Documents held by sender: none.
Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). In May 2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast), 0.5 mL, IM, and developed nausea. The patient sought medical attention at the office. At time of reporting, the patient had not recovered. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received KINRIX. On 25th September 2014, the patient received the 1st dose of KINRIX. On 25th September 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional details: No other AE's voiced other than the administration.
Delayed rash/swelling at injection site. Reaction began 9 days after vaccine. Pain, redness, numbness, itching, muscle weakness, pain in neck (also left side), fatigue. The rash/swelling is about 4x4 inches
Information has been received from a physician refers to an 18 year old patient (gender unknown). Information about medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 injection (dose, strength, route, lot# and expiration date unknown) for prophylaxis. On an unknown date in March 2018, the patient was vaccinated with the third dose of GARDASIL 9 injection (dose, strength, route, lot# and expiration date unknown) for prophylaxis. On 22-AUG-2018, the patient was vaccinated with the fourth dose of GARDASIL 9 (indication prophylaxis; dose, strength, route, lot# and expiration date unknown). No adverse effects reported.
Strong sharp pains in her heart; Took one shot already and it was about 6 weeks ago and has not got the second one; This is a spontaneous report received from a non-contactable consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated she was calling about the COVID 19 vaccine. Caller stated she took one shot already and it was about 6 weeks ago and had not got the second one. Caller stated the reason she did not take the second one was because she was afraid since after the first one she experienced strong sharp pains in her heart and was still in the process of checking this out before she got the second vaccine. Caller stated what she wanted to know was if she can get the second vaccine more than 6 weeks apart. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pulmonary embolism; This is a spontaneous report from a non-contactable pharmacist. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0177; Expiration date was not reported) on 15May2021 (13:45) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 17May2021, the patient had pulmonary embolism. The event had resulted into an emergency room/department or urgent care. The patient had received enoxaparin (LOVENOX) as treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan, chest CT/MRI and coagulation panel, counteractive treatment measures and concomitant medications including any history of use of oral contraceptives. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Case number PHHY2011US66794 is an initial spontaneous report received from a health care professional (nurse) on 21 Jul 2011 with a follow-up received from a nurse on 01 Aug 2011. This report refers to an 18 year old male patient. He was vaccinated with MENVEO (batch number: X10029) subcutaneously on 05 Jul 2011. But, he received only the Men A lyophilized powder component which was reconstituted with sterile water for diluent (instead of Men CYW-135 liquid conjugate). No adverse reaction was reported following this drug administration error. Follow-up received from a nurse on 01 Aug 2011: Updated information about patient's demographics, batch number and route of administration of MENVEO.
experienced a breakthrough COVID infection; experienced a breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 11 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced a breakthrough COVID infection".  Clinical course includes that, Verbatim and Event Description: During an interview with a consumer, he stated that his daughter was fully vaccinated (received both doses), with the Pfizer COVID-19 vaccine, but still experienced a breakthrough COVID infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient walked out of vaccination room to sit and wait for 15 minutes. He fainted while sitting and fell to the floor. Patient came to and was dazed at first. Talked to him for a few minutes and he stated he had a fear of needles/shots. Had patient wait another 15 minutes to make sure he was ok to leave. EMS was called but patient declined treatment. Event occurred minutes after the vaccine was given.
Woke up with a pounding headache. I was seeing flashes and halos in vision. I could not focus my eyes. I was very dizzy and nauseous, my stomach was very upset and I kept going to the bathroom. My heart rate was elevated as well as my blood pressure.
No adverse effect; administered improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S002736 with expiration date on 28-JAN-2021 (the exact dose and route of administration were not reported) for prophylaxis.  The suspect vaccine underwent a temperature excursion of 6 to 14 (7.7) degrees Fahrenheit for 305 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. The sterile diluent used to reconstitute the vaccines was stored properly.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011314:
muscle soreness; tiredness; chills; flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 22Jan2021 as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced muscle soreness, tiredness, chills and flu-like symptoms. The patient was calling to ask how long she can expect her side effects to last. She states she started experiencing symptoms which include muscle soreness that was worse at night, tiredness, chills, and flu-like symptoms. She states her MD was not concerned and told her that it was her immune system working after receiving the vaccine. Outcome of the events were unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Swollen, red left upper arm with fluid palpable in bursa. Diagnosed as cellulitis.  Chills and sweats.
Hospitalized for COVID pneumonia - respiratory failure on bipap- treated with dexamethasone for 10 days, remdesivir for 4 days.
Patient given 2nd booster in error.  Should have not received this due to age being under current authorization.   Pt contacted by telephone and advised of the event.  She denied any ill effects.
This spontaneous report as received from a doctor of pharmacy refers to a 65 years old female patient with penicillin allergy, getting migraines after tetracycline, with shingles about 3 years ago and still experiencing residual postherpetic neuralgia. The patient was vaccinated with lot # (671775/0466AE, exp. 28-FEB-2013), 0.65 ml ZOSTAVAX, SC, left arm on 29-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 31-JUL-2012, the patient developed pain at the SI (sacroiliac) joint. No treatment was provided. The outcome of pain at the sacroiliac joint was reported as not recovered. The patient sought medical attention by calling pharmacy. The relatedness for pain at the sacroiliac joint is unknown for ZOSTAVAX. Additional information is not expected.
On day 2 left arm very sore and area around injection site became red and swollen. Day 4 no soreness at site and redness / swelling  had abated. Night of day 6  soreness, swelling  and redness at injection site returned. and is hot to touch and this continues on Sunday January  10th  ( day  9).  Red area is 2 in by 2 in in size.
4x4.75 inch area of erythema left deltoid area (DTaP).
Vaccinated with Smallpox vaccine (Lot#40200770 and Diluent Lot # 802236A) on 03/11/2003 @ Health Department on left upper arm. Take check varied on 3/18/2003 as major by R.N. Started with C/o shortness of breath while performing routine gardening activites on 3/38-29-2003. Within the next 2-3 days developed stiffness and swelling in all joints both of upper and lower extremities. Impaired mobility and dexterity of both hands. Incapacitating for normal work activities in practice for Monday 3/31/03, 04/01 and 04/02/2003. After information regarding cardiac recommendation, seen by M.D. and EKG, CBC, and CPK obtained. All testing reported as normal. Resumed office duties on 04/03/03 with residual stiffness of joints.  Denies chest pain or other cardiac symptoms.
10/28/09-vomiting in evening. OK next day. 10/30/09-fever 103 degrees in evening-OK next day.
dont have menstruation/It should be but its late since 8 day; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION DELAYED (dont have menstruation/It should be but its late since 8 day) 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 29-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (dont have menstruation/It should be but its late since 8 day). At the time of the report, MENSTRUATION DELAYED (dont have menstruation/It should be but its late since 8 day) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0171) at the age of 33 years as dose 2, single and intramuscular, administered in arm left, administration date 21Apr2021 15:30 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. The following information was reported: COVID-19 (medically significant) with onset 27Dec2021 02:30, outcome "recovering", VACCINATION FAILURE (medically significant) with onset 27Dec2021 02:30, outcome "unknown" and all described as "Tested positive for Covid-19". The event "tested positive for covid-19" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318; Expiration date was not reported) on 28Jan2021 (16:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on the left arm on 08Jan2021 (when the patient was 25 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021, the patient had nausea and vomiting. The patient did not receive any treatment for the reported events. The outcome of the events, nausea and vomiting, was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not tested positive post-vaccination.
Extremely swollen parotid glands, fever, headache, malaise, loss of appetite.
This spontaneous report was received from a healthcare worker refers to a 13 months old patient of unknown gender. On 02-DEC-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Influenza vaccine Quadrivalent (unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's daughter. The age at the vaccination was not reported. The reporter stated that the people were getting flu like symptoms from the flu shot all at the same time, after they got their shots. Sometimes these symptoms were much worse. The reporter's father (patient) got sick with flu like symptoms. The reporter stated that that Flu shots were not properly tested and well known not to be effective and these flu like symptoms were contagious. This case is 1 of the 3 linked cases reported by the same reporter.
Headache, Fever, Sore are, stiff neck, body aches Narrative:  Other Relevant History:
Initial misuse report received from a healthcare professional on 14 January 2014. An 11-month-old patient had received a 0.5 ml dose of FLUZONE on an unspecified date. It ws reported that FLUZONE 0.5 ml was administered to an 11 month old who should have received 0.25 ml. No adverse event was reported. List of documents held by sender: none.