Sex: U
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: photophobia; This is a literature-spontaneous report. The reporter reported the same event for 2 patients, this is second of 2 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced photophobia (medically significant). Outcome of the event unknown.   Photophobia Up to 31Mar2021, Agency, the WHO database of individual case safety reports (ICSRs), contained 1,247 unique cases, from 34 countries reporting the term photophobia following vaccination against COVID-19 with the mRNA-based Pfizer/BioNTech and Moderna vaccines, and the adenovirus vector vaccines from AstraZeneca and Johnson&Johnson portionate reporting for the Agency preferred term photophobia was observed with a calculated expected number of reports of 319 compared to the observed number of 1,247 reports (resulting in an information component of 1.9). The expected value is based on the total number of reports fonthe coViD-19 vaccines and the proportion of all son photophobia in Agency, as Information on the vaccine do was In 551 cases the reaction was reported to have occurred after the first dose and in 60 cases after the second. Information on the time-to-onset (TTO) was available in 806 cases with a median of 0 days (ranging from 0 to 118 days). TTO was observed be slightly shorter after the first dose (median = 0 days, ranging from 0 to 33 days) compared to the second dose (median = 1 day, ranging from 0 to 29 days). When divided by platform, information on TTO was available in 227 cases for the vector vaccines (225 cases reporting photophobia after the first dose, and two cases reporting its onset after the second dose), and in 75 cases for the mRNA-based vaccines (43 cases reporting the onset after 32 after the second). Median TTO was observed to be zero days (range 0-19 days) after the first dose and one and a half days (range 0-3 days) after the second dose for the vector-based vaccines, compared to a median TTO of one day (range 0-33 days) after the first dose as well as one day (range 0-29 days) after the second dose for the mRNA-based vaccines. first dose and constituted a mere 140% and in 2% the gender was not reported. When comparing patients' characteristics of these reports to all 394,350 reports including the COVID-19 vaccines as suspected in Agency some substantial differences can be observed in 75% of all COVID-19 vaccine reports the affected patients are female, 23% are male, and for 2.2% patients' sex is unspecified. Patients' age was reported in 1,175 cases, resulting in a median age of 41 years (ranging from 16 to 90 years). This is in line with patients' age when looking at all reports for COVID-19 vaccines in Agency. Forty percent of the patients are observed in the age group between 18 and 44 years, followed by 45 to 64 year old patients (37%). A high proportion of reports was classified as serious (n=689; 55%).   Photophobia with migraine headaches Up to 31Mar2021, Agency contained 6,939 ICSRs reporting migraine and related terms (Agency high level term "Migraine headaches") in combination with the active ingredient "COVID-19 vaccine". One hundred and fifty-three of those that included photophobia as co-reported term. Affected patients were mainly female (n-143; 93%) and the median age was 38 years (range 18 to 80 years). Ninety-four of the 153 reports (61%) were classified as serious indicating "Other medically important condition" (n=78), "Disabling/incapacitating" (n-25), and "Caused/prolonged hospitalization" (n=6) as seriousness criterial Thirty-three of these patients suffered from underlying migraines. Several patients suffering from chronic migraines stated that the reported episode was more intense than usual or that they had not suffered from migraine attacks for long periods before receiving the vaccine. In several cases the migraine headaches were so intense that they woke the patients up in the middle of the night. In most cases the headaches resolved with pharmacotherapy. Photophobia with meningitis Up to 31Mar2021, Agency contained 24 ICSRs reporting meningitis following COVID-19 vaccination, two of those cases additionally included the preferred term photophobia (one duplicate report was excluded). The affected patients were females aged 42 and 52 years old. The suspected vaccines were the AstraZeneca's and Pfizer- BioNTech's, respectively. One patient had suffered from two episodes of viral meningitis in the past. In the second, a reactive meningitis secondary to the COVID-19 vaccine was diagnosed. In both cases the outcome of the event was reported as unknown or not resolved at the time of reporting. Photophobia with optic neuritis Up to 31Mar2021, Agency included 38 ICSRs of optic neuritis following the vaccination with the COVID-19 vaccines, two of which additionally reported patients suffering photophobia after receiving the Pfizer BionTech vaccine. Both affected patients were female and 41 and 54 years old. The TTO of symptoms related to the optic neuritis was 12 hours and two days, respectively. Outcome was reported as "not recovered at the time of reporting in both cases, Photophobia with ocular inflammations Up to 31Mar2021, Agency included 308 cases of inflammatory conditions of the eye, such as conjunctivitis (n=212), uveitis (n=42), episcleritis (n=20), iridocyclitis (n=20), keratitis (n=12), and iritis (n=9), following immunization with the COVID-19 vaccines. Of these, 13 co reported photophobia (conjunctivitis (n=4), uveitis (n=3), iridocyclitis (n=3), keratitis (n=2), iritis (n=1), and episcleritis (n=1)). Affected patients were predominantly female (12; 92%) with a median age of 51 years (range 30 to 74 years). Half of the reports (n=7) were classified as serious. In most reports the Pfizer-BioNTech vaccine was suspect (n=9; 69%), in three reports (23%) AstraZeneca's and in one (7.7%) Moderna's. In the two cases reporting keratitis, the patients had suffered from previous episodes. One of these reported a reactivation of herpetic keratitis that resolved after increasing the daily dose of acyclovir. In another case an episode of anterior uveitis was reported. The patient was reported to have suffered from previous episodes related to immune stress. The last of these episodes was reported to have occurred two years prior. Additionally, the patient was reported to have experienced a cutaneous herpes simplex outbreak following the vaccination One of the three patients with photophobia and acute anterior uveitis, was suspected to have had a stroke prior to the diagnosis. Literature and Labelling Photophobia is not labelled as an adverse drug reaction in the Summaries of Product Characteristics (SmPCs) of the four COVID-19 vaccines included in the assessed case series, nor are the listed potential causes, apart from the typical post-vaccination symptoms in the non-serious photophobia reports. COVID-19 Infection with the novel coronavirus SARS-COV-2 itself is known to present with ocular symptoms such as conjuctivitis. Results from a cross-sectional study conducted in withheld showed that the most commonly occurring ocular symptom associated with COVID-19 was photophobia. Also, in a clustering study conducted, 9% of included COVID-19 patients presented with photophobia. The authors discussed encephalitis and aseptic meningitis, as well as adverse drug reactions, as possible reasons   Possible underlying causes None of the above listed potential causes for photophobia are listed in the included COVID-19 vaccines' SmPCs. No reports of migraine headaches, meningitis, optic neuritis or ocular inflammations following COVID-19 vaccination are published in the available scientific literature. However, ocular inflammations, such as conjunctivitis have been reported to occur as a symptom in COVID-19 patients.  There is no product complaint associated with this case.  No follow-up attempts are possible. No further information is expected.