chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracranial pressure with vision loss requiring VP shunt placement; This is a spontaneous report from a contactable nurse (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Jan2021 at 12:00 (Lot Number: EK9231)(at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, all from an unknown date and unknown if ongoing. Known allergies: KEFLEX, LEVAQUIN, Penicillin. Concomitant medication included levothyroxine; lisinopril; trazodone and HCTZ, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 04Jan2021 at 15:00 (Lot Number: EL0140) (at the age of 40-year-old) as single dose for COVID-19 immunisation. On 26Jan2021 at 14:00, the patient experienced increased intracranial pressure with vision loss requiring VP shunt placement. The events required emergency room visit and physician office visit.  The patient was hospitalized due to the events for 2 days.  The patient underwent lab tests and procedures which included intracranial pressure (CSF pressure): increased on 26Jan2021, SARS-COV-2 test (Nasal Swab): negative on an unspecified date.  Therapeutic measures were taken as a result of the events and included 3 lumbar punctures and surgery for VP shunt. The patient outcome of the events was recovering.; Sender's Comments: The 41-year-old patient had medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, and was on multiple concomitant medications.  Intracranial pressure increased and blindness were most likely due to concurrent disease, and unlikely related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become 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.
Approximately 2 minutes after administration, the patient fainted in our store twice, but immediately recovered consciousness both times. His parents were with him.  We offered paramedics but they refused.  We gave him water and let him sit for 15 minutes.  Afterward, the patient felt better and they left our store.
I was very weak and I nervous like shaking and very sleepy it just lasted about 1 day. When I woke up this morning I was feeling okay.
Hypoxic at home, diagnosed with COVID 3 days PTA. Fully vaccinated. O2, lovenox, singulair, zinc, steroids. Weaned to RA and discharged home.
pt had swelling, redness & warmth to touch of lt deltoid region area about the size of hands, according to pt;
Redness diffuse, itching diffuse, throat, neck swelling, dizziness, hypotension, nausea.
This is s Adacel T-dap vaccine:  She got her vaccine at the clinic, she was fine initially.  Two days after she had a swollen, sore arm at the deltoid at the site of injection with some warmth.  No erythema, no purulence from the injection site.  It seemed to improve after a week.  Then it became again sore, swollen and it's been 3 weeks and she is still dealing with this.  Her PCP told her to take ibuprofen with Tylenol alternating and warm compresses, conservative approach and to notify if it got worse.  She spoke with her PCP a week ago and was reassuring and she called again today stating she still has the problem.    Last week she said it was sore, her PCP offered her an anti-inflammatory.   She then called today and said she noticed it was more sore with lifting weights, and was informed to stop lifting weights until symptoms improved that she may  have a microtear.
Pt states pain at injection site and radiating up her neck x 5 days, muscles spasms, numbness, fever, dizzy, nausea. Refused referral to urgent care and primary care provider.
I had just taken a Tylenol to prevent any temp, muscle aches or chills. I felt like I was going to faint and before I could sit down, I fainted hitting the zygomatic arch of my face. Later that day I went to the hospital for CT scan to insure I had not broken anything. I was diagnosed with a medial blowout fracture of the right eye. Also followed up three days later at another health facility to insure there was no damage to the eye itself.
pt recvd vax & devel a localized react @ inject site; ER physician dx cellulitis;
Right arm pneumonia shot. Smarted upon injection Pain and numbness grew intolerance within hours, E.R. doc. prescribed PERCOCET for pain. That was almost 4 weeks ago!
Information has been received from a physician concerning a teen age female who on 13-MAR-2008 was IM vaccinated with GARDASIL (dose # unknown, Lot number unspecified). On 13-MAR-2008 the patient fainted just after the vaccine was given. The patient sought unspecified medical treatment while still in the office. No other symptoms were noted. The patient fully recovered. Additional information has been requested.
Always nauseated for 24 hours; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media on 17-Nov-2020.  This case involved a patient of an unknown age and gender who was always nauseated for 24 hours (Nausea), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient was always nauseated for 24 hours (Nausea).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Rash beginning at injection site. Upon examination on 04/07/2014: rash is noted that is diffuse in location; the color is mainly red; it is best characterized as lacy or reticular and raised, rough. Site of her MMR is especially concerning because it is still warm, with induration, and tender to touch despite the fact that it has been nearly 2 weeks since pt had the vaccination administered.
Client reported feeling faint and nauseated. Cold compress applied and ammonia salts. Vitals stable B/P92/60; HR 56; RR 20; alert and oriented times 4.  Home with parent
patients received the wrong dose/double dosage of fluzone qiv with no reported adverse event; Initial information received on 27-Oct-2023 (with live follow up processed together CSD: 27-OCT-2023) regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender 51 patients who received the wrong dose/double dosage of influenza quadrival A-B multidose vaccine preserved [Fluzone QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2023, the patients received a standard dose of suspect influenza quadrival A-B multidose vaccine preserved Suspension for injection at a dose of 1 mL (lot U80968A, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization.  In OCT-2023 the patients received the wrong dose/double dosage of influenza quadrival A-B multidose vaccine preserved with no reported adverse event (incorrect dose administered) (latency- same day).  Reportedly, She reports that they have been administering 1 mL of FLUZONE QIV , not 0.5 mL of FLUZONE QIV. Office manager mentioned that the vaccination happened from 06Oct2023 to 25Oct2023. No further patient and event information was provided during the call.  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.
Rash that was like hives; Itching; Rash on neck, chest and back; Muscle aches/ muscle soreness; Woke up in sweats; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-03632) on 01-Oct-2019, concerning a 46-year-old, female patient.   The patient's relevant medical history included seizures and migraine headaches. The patient's concomitant medications included seizure medication.  On 29-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right upper arm, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, a short while after vaccination, the patient experienced muscle aches.  On an unspecified date, the patient woke up in sweats.  On 30-Sep-2019, the patient experienced itching, rash on neck, chest and back.  On 01-Oct-2019, the patient stated that she continued to have muscle soreness, itching and rash that was like hives and became crusty.   The outcome for the events of muscle aches/ muscle soreness', itching', rash that was like hives' and rash on neck, chest and back' was not recovered, at the time of initial reporting.  The outcome for the event of night sweats' was not reported, at the time of initial reporting.  The reporter assessed the case as non serious but did not provide causality assessment to Afluria.; Sender's Comments: A 46-year-old female patient has experienced night sweats, myalgia, urticaria, pruritus and rash associated with Afluria Quadrivalent. Chronology seems plausible. The patient concomitant medications - seizure medications may have contributed in developing this events. Considering chronology, causality is assessed as possible for all events.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received BEXSERO (batch number 165801, expiry date 30th October 2018) for prophylaxis. On 14th June 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 14th June 2018, less than a day after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of BEXSERO about a month ago in the left arm and experienced local arm pain. This case has been linked with case US2018129638 (for 2nd dose), reported by the same reporter for the same patient.
felt a little bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    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 FEELING ABNORMAL (felt a little bad). At the time of the report, FEELING ABNORMAL (felt a little bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received through a pregnancy registry from a physician and from a 36 year old female patient with a concurrent condition of low blood pressure, an allergy to "talabet" and a medical history of 2 pregnancies with no birth defects, still births or miscarriages who on 08-DEC-2003 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX "2 days before conception". There was no concomitant medication. No adverse symptoms were noted. Diagnostic laboratory tests performed on 19-MAR-2004 were: ultrasound: "normal fetal anatomy: anatomic survey"; amniocentesis: "46 xx; normal female karotype" and "MSAPP" was "WNL". The LMP was 14-Nov-2003. The EDD was 24-AUG-2004. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up information was received from a physician who reported that the pt had no infections, illnesses or complications during her pregnancy, and no complications during her labor/delivery. It was also noted that the mother did not have any local reaction, varicella or herpes zoster symptoms post vaccination. It was noted the pt did not have concurrent medical conditions. Other medications used during pregnancy included nitrofurantoin 500 mg twice per day, started on 15-MAR-2004 for seven days to treat a urinary tract infection, bismuth subgallate (+) praxomine hydrochloride occasional, prn and ferrous sulfate started on 07-JUL-2004. On 26-AUG-2004 38 5/7 weeks from LMP the mother delivered an 8 pond 8.6 ounce normal live born female infant. It was noted that the infant had no congenital anomalies or other complications or abnormalities. The reporter did mention that the infant experienced an adverse event (no further details provided).
my daughter, 30 year old, on disability with POTS, MCAS, EDS, dysautonomia, received the JJ COVID vaccine at 1:30 PM on 4/9/2021.. She started vomiting 20 minutes after the vaccine was administered and the pharmacist said it was because she was anxious and has not eaten much. We went home, she was very tired and slept most of the afternoon. At 6 PM she started vomiting again. It continued till 10:30 PM when she could not drink anything. We went to the hospital where she exhibited what looked like a seizure in the waiting room and was admitted to the hospital for observation. Discharged 4/10/2021 evening. 4/11/2021 exhibited restless leg syndrome, could not sit, lay down, whole body aches. 4/12/2021 extremely sore arm, could not move it without pain. Area of injection looks read but not hot and no swelling.
having muscle cramping; This case was reported by a consumer via (Shingrix Chatbot) interactive digital media and described the occurrence of muscle cramp in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle cramp. On an unknown date, the outcome of the muscle cramp was unknown.   It was unknown if the reporter considered the muscle cramp to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient had been having muscle cramping since vaccination. The patient was asked if was this something to worry about.
About 30 mins after injection felt brain fog and had a hard time finding words/ like we were having to concentrate more than usual to do routine stuff; About 30 minutes after injection felt brain fog and had a hard time finding words. Another nurse that got vaccinated at the same time felt the same way. It's like we were having to concentrate more t; About 30 mins after injection felt brain fog and had a hard time finding words/ like we were having to concentrate more than usual to do routine stuff; This is a spontaneous report from a contactable consumer.  This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A patient of unspecified age and gender started to receive (PFIZER-BIONTECH COVID-19 VACCINE, Lot number Ej1685), intramuscularly, as first single dose on 20Dec2020 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.   On 20Dec2020, about 30 minutes after injection felt brain fog and had a hard time finding words. Another nurse that got vaccinated at the same time felt the same way. It's like we were having to concentrate more than usual to do routine stuff. Outcome of the events about 30 mins after injection felt brain fog and had a hard time finding words/ like we were having to concentrate more than usual to do routine stuff was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020503261 same drug, same event and different patient
Information has been received from a physician concerning four female patients who were vaccinated with doses of GARDASIL. Subsequently the patients experienced postural hypotension. Unspecified medical attention was sought. At the time of this report, the outcomes were unknown. Follow up information was received from a physician concerning a female patient. The physician stated that after further discussions, it was decided that there was no relation to these events and the GARDASIL vaccination. The physician was confident that the patient was fine. This is one of several cases from the same source. No further information is available.
Began with itching on both temples then developed 3-4 wheals to temples and one to upper lip.  No tongue or throat irritation or swelling.  No injection site itching or erythema. Symptoms began resolving after approx one hour without treatment.
This literature marketed report as received from a public article, refers to a 75 year old male patient. The patient initially developed radiographic evidence of a mediastinal mass at the age of 65 years. Further evaluation and biopsy revealed the presence of a thymoma. Three years after the resection of the thymoma, the patient developed recurrent thrush, esophageal candidiasis, and onychomycosis. The patient was hospitalized for pneumonia 4 times per year before treatment. At the age of 73 years, with no prior history of muscle disease, he developed proximal muscle weakness that involved, most prominently, the muscles of his neck and shoulders. Elevated muscle enzyme levels (creatine phosphokinase, aldolase, and serum glutamic oxaloacetic transaminase) suggested a myopathy. A left deltoid muscle biopsy specimen revealed inflammatory myopathy without inclusive bodies. Degeneration and regeneration of muscle fibers were noted accompanied by focal perimysial and endomysia lymphatic infiltrates. Electromyographic analysis suggested myopathic changes. Laboratory evaluation performed at 75 years of age revealed a low total absolute CD3+ cell count of 570 cells/mm3, an absolute CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+ CD8+ cell count of 141 cells/mm3. The response to mitogen and antigen stimulation was markedly diminished (phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311 cpm; concanavalin A: 20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm. Absolute CD19+ cells counts were low at 30 cells/mm3. Serum IgG levels were low at a level of 535 mg/dL. He received the PNEUMOVAX 23 (for antigen stimulation), and both the prevaccine and 30-day postvaccine titers were absent. He was treated with intravenous immunoglobulin, 1 g/kg every 4 weeks, and oral fluconazole every other day. These therapeutic options stabilized his condition for several years. He eventually died of respiratory failure during a pneumonia infection. The association of thymoma with autoimmune and paraneoplastic disorders is well documented. Polymyositis is found in approximately 5% of thymoma cases; however, polymyositis has never been previously documented in a patient with confirmed GS. This case represents the first association of Good Syndrome (GS) (with thymoma and immunodeficiency) and polymyositis. Clarification was received stating that the indication should be changed to "prophylaxis" since the patient was hospitalized 4 times for pneumonia and the event of absent titers should be captured as it synonymously conveys vaccine failure even though not reported. Additional information has been requested.
This initial spontaneous case, was received from pharmacist on 06-Oct-2017, concerning a 61-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 01044621A, expiry date: 30-Jun-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine, which had floating particulate matter in the vial after refrigeration (explicitly coded as poor-quality vaccine administered). It was reported that, the product had very fine white particles, which looked foggy and did not suspended in the solution (explicitly coded as particle present in liquid product). The patient did not experience any adverse event after the vaccination. The reporter stated that, product was always stored in the refrigerator within the recommended storage conditions. As per the PTC (product technical complaint) (PTC reference number: PR436457) investigation performed, it was concluded that, the particulate matter in the returned complaint sample was confirmed to be consistent with the appearance of Influenza Virus Vaccine; it contained protein typical to that of influenza virus with no atypical structures. As there was no safety issue associated with the batch (01044621A), the final severity for the PTC was re-assessed as low. Retention sample description testing was also performed and confirmed the AFLURIA vials were satisfactory. Manufacturing and Filling investigations were not able to determine a causal link to the reported particulate matter observed by the consumer. This investigation confirmed all manufacturing processes were performed as per registered procedures and test requirements. The Quality attribute review had demonstrated that, the filled lot and associated Bulk and Monovalent Pooled Harvest lots were within statistically derived process control limits and specification. Trending of the PTC event was performed and determined that, the complaint report was not part of an emerging trend for the lot or complaint type. A Safety Assessment completed by the clinical safety physician determined no safety issue has been identified for lot 01044621A. This complaint was not considered indicative of a quality issue for the batch and lot 01044621A was considered suitable for continued use in the market. The reporter assessed the events as non-serious. Non-significant follow-up received on 14-Nov-2017: Updated PTC Reference Number: PR436457. The narrative was amended accordingly. Follow up received on 06-Dec-2017: The PTC investigations results were updated. The narrative was amended accordingly.
Temperature of 104 16 hours after injection. Laying around; decreased PO intake. Fever lasted two days. No fever 3 and 4 days after but fever 104 on the 5th day. Brought to Pediatrician on 5th day. Dx'ed with OM.